Patients Empowered With New “Clinical Trials: The Power of Participation” Website

The Biotechnology Innovation Organization (BIO) announced the launch of Clinical Trials: The Power of Participation (CTPoP), a website that addresses how clinical trials work, how to enroll in a clinical trial and what to expect as a clinical trial participant with sound, science-based information. “Knowledge is power and our goal for the new website is to serve as a resource for patients and their families to learn about clinical trials with information that’s scientifically sound and easily understood,” said BIO’s President and CEO, Dr. Michelle McMurry-Heath. “Having more diverse groups in trials helps address systemic health disparities, ensuring that people are not left out of potentially lifesaving opportunities, and leading to a better understanding of how therapies and/or vaccines will work in more populations.”

Cyclacel Announces Dosing of First Patient in Phase 1/2 Study of Oral Fadraciclib in Patients With Leukemias or Myelodysplastic Syndromes

Berkeley Heights-based BioNJ Member Cyclacel Pharmaceuticals announced dosing of the first patient in the Company’s multi-cohort Phase 1/2 study of oral fadraciclib in patients with leukemias or myelodysplastic syndromes (MDS). “We are proud to have achieved this second key clinical milestone and corporate objective following the start of the oral fadraciclib Phase 1/2 solid tumor and lymphoma study last quarter,” said Spiro Rombotis, Cyclacel’s President and CEO. “After opening these two streamlined, registration-directed Phase 1/2 studies with fadraciclib as planned, we will next evaluate the clinical potential of oral CYC140, our PLK1 inhibitor, first in solid tumors and lymphomas and then in leukemias. We look forward to providing periodic updates on our clinical progress and data from these open-label studies when available.” 

Soligenix Announces Publication Demonstrating Enduring Protection of its Thermostable RiVax® Vaccine

Princeton-based BioNJ Member Soligenix announced the publication of pre-clinical immunogenicity studies for RiVax® (heat stable ricin toxin vaccine) demonstrating enduring protection for at least 12 months post-vaccination. The article titled "Durable Immunity to Ricin Toxin Elicited by a Thermostable, Lyophilized Subunit Vaccine" has been accepted for publication in the journal mSphere. The article results from collaborative work with the Wadsworth Center of the New York State Department of Health. Coupled with previous demonstration of efficacy in mice and non-human primates (NHPs) as well as long-term thermostability (at least 1 year at 40°C or 104°F), these results reinforce the practicality of stockpiling and potentially utilizing the RiVax® vaccine in warfighters and civilian first responders without the complexities that arise for vaccines that require stringent cold chain handling. This same thermostabilization approach is also being advanced in the development of Soligenix's CiVax™ vaccine for COVID-19. 

Soligenix Granted Pediatric Investigational Plan Waiver for HyBryte™ in CTCL in the United Kingdom

Princeton-based BioNJ Member Soligenix announced that it has been granted a Pediatric Investigation Plan (PIP) product-specific waiver from the Medicines and Healthcare products Regulatory Agency (MHRA) for HyBryte™ (SGX301 or synthetic hypericin), which has successfully concluded a Phase 3 pivotal clinical study for the treatment of early stage cutaneous T-cell lymphoma (CTCL). The waiver was provided for all subsets of the pediatric population from birth to less than 18 years of age on the grounds that clinical studies in this rare population are not feasible. Earlier this year the European Medicines Agency (EMA) also granted a waiver to the Pediatric Investigational Plan requirements for the European Union (EU). With the withdrawal of the United Kingdom (UK) from the EU effective January 1, 2021, the MHRA became the UK's standalone medicines and medical devices regulator. "This achievement is an important regulatory milestone as we move forward with marketing applications worldwide," stated Christopher J. Schaber, Ph.D., President and CEO of Soligenix. 

Soligenix Announces Recent Accomplishments and Second Quarter 2021 Financial Results

Princeton-based BioNJ Member Soligenix announced its recent accomplishments and financial results for the quarter ended June 30, 2021. Christopher J. Schaber, Ph.D., President and Chief Executive Officer of Soligenix stated, "2021 remains a crucial year for Soligenix. Under our Specialized BioTherapeutics business segment, our HyBryte™ (SGX301) positive pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study in cutaneous T-cell lymphoma (CTCL) was recently selected for presentation at the United States Cutaneous Lymphoma Consortium (USCLC) Annual Meeting. Additionally, HyBryte™ received a Pediatric Investigation Plan (PIP) waiver from the European Medicines Agency (EMA), which is a key component of the regulatory process for marketing authorization in Europe. We continue to move our pipeline forward with multiple data readouts expected this year under our Public Health Solutions business segment. This data is critical in our efforts to advance our therapeutic and vaccine candidates such as CiVax™, our heat stable COVID-19 vaccine." 

Vyant Bio Reports Third Quarter 2021 Results and Provides Strategic Business Updates

Cherry Hill-based BioNJ Member Vyant Bio is rapidly identifying small and large molecule therapeutics to treat central nervous system (CNS) and oncology-related diseases. With leading-edge capabilities in data science, biological and chemical sciences, engineering, and regulatory affairs, Vyant Bio capitalizes on in silico, human cell-derived in vitro disease models, and in vivo discovery technologies to identify novel biological targets and valuable therapeutics for patients. “We are pleased with the progress our R&D team is making to further our CNS rare disease and oncology related HER2+ drug discovery programs,” stated Jay Roberts, CEO of Vyant Bio. The timing of Dr. Robert Fremeau’s arrival as our Chief Scientific Officer coincides well with our acceleration to later-stage drug discovery. Dr. Fremeau’s extensive experience with scientific research and drug discovery will be invaluable to us as we complete feasibility programs with leading biopharma companies and develop our preclinical and translational strategy for driving a portfolio of therapeutic candidates from early discovery to human proof-of-concept”.

Celldex Presents Positive Preclinical Data from PD-1/ILT4 Bispecific Antibody Program CDX-585 at SITC 2021

Hampton-based BioNJ Member Celldex Therapeutics announced positive preclinical data from CDX-585, the company’s bispecific antibody with dual targeting of ILT4 and PD-1 checkpoint pathways, developed from its bispecific antibody platform. These data were presented in a poster session as part of the Society for Immunotherapy of Cancer’s 36th Annual Meeting (SITC 2021). The data show CDX-585 effectively combines the blockade of ILT4 and PD-1 into one molecule, with favorable biophysical and functional characteristics, supporting the initiation of development activities including manufacturing and IND-enabling studies. CDX-585 is the first compound from Celldex’s research and collaboration agreement with Biosion, Inc. and combines Celldex’s ILT4 mAb with Biosion’s PD-1 mAb. In the preclinical data presented at SITC, the simultaneous inhibition of ILT4 and PD-1 checkpoints with CDX-585 led to myeloid and T cell activation which may potentially demonstrate clinical utility, particularly in the T cell checkpoint inhibitor refractory setting.

Organon to Acquire Finland Pharma Company With Novel Treatment for Endometriosis in its Pipeline

Jersey-City Based BioNJ Member Organon will acquire Finland-based Forendo Pharma. The transaction includes a $75 million upfront payment, assumption of approximately $9 million of Forendo debt, payments upon the achievement of certain development and regulatory milestones of up to $270 million and commercial milestone payments of up to $600 million, which together could amount to total consideration of $954 million. The deal is expected to close in December 2021. Forendo is pioneering the science of intracrinology, addressing disease through a novel, tissue-specific approach. Its lead clinical compound is an investigational, potentially first-in-class oral 17β-hydroxysteroid dehydrogenase type 1, or HSD17B1, inhibitor in early clinical development for endometriosis, being evaluated for its potential effect on endometriotic lesions. Endometriosis is a common and chronic condition that affects up to 1 in 10 women of reproductive age, causes abdominal pain and is associated with infertility.

Celsion Provides Update on its Application to Sell $1.5 Million of New Jersey Net Operating Losses

Lawrenceville-based BioNJ Member Celsion Corporation announced it was notified by the New Jersey Economic Development Authority (NJEDA) that the company’s application to sell $1.5 million of its unused New Jersey net operating losses (NOLs) for the tax year 2020 under the Technology Business Tax Certificate Transfer (NOL) program has been approved by the NJEDA’s Board of Directors. The company anticipates it will be able to transfer this credit to a qualified company and receive approximately $1.4 million of net cash proceeds. “With this non-dilutive funding, we are positioned to continue to advance our DNA vaccine initiative. Additionally, we expect these funds to cover full patient enrollment and primary efficacy read-out of the Phase II OVATION 2 Study for GEN-1, depending upon the extent to which Progression Free Survival (PFS) is achieved,” said Michael H. Tardugno, Celsion’s Chairman, President and CEO.

Safety and Tolerability of New Liposomal IV Formulation Confirmed to Reach Target Exposure in Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study

Jersey City-based BioNJ Member SCYNEXIS announced the successful completion of a Phase 1 clinical study to evaluate the safety, tolerability and pharmacokinetics of a liposomal intravenous (IV) formulation of ibrexafungerp in healthy subjects. “The data from this study support the safety of the liposomal IV formulation of ibrexafungerp, allowing us to progress its development,” said David Angulo, M.D., Chief Medical Officer, SCYNEXIS. “Having the flexibility to easily switch between IV and oral formulations, when needed, will enable physicians to maximize the potential benefits from this innovative antifungal in a broad range of clinical settings often involved in the management of invasive fungal diseases, including intensive care units, hospital wards and outpatient services.” The randomized double-blind, placebo-controlled trial, designed as a single ascending dose (SAD) and multiple ascending dose (MAD) study, was conducted in 64 healthy volunteers with treatment durations of up to seven days. 

Rafael Pharmaceuticals Announces First Patient Enrolled in APOLLO 613 Phase 1/2 Clinical Trial of CPI-613® (Devimistat) in Patients With Relapsed Clear Cell Sarcoma

Cranbury-based BioNJ Member Rafael Pharmaceuticals announced that the first patient has been enrolled in the APOLLO 613 Phase 1/2 clinical trial of CPI-613® (devimistat) in combination with hydroxychloroquine in patients with clear cell sarcoma at City of Hope in Duarte, California. Two additional sites have also been opened for enrollment in the trial at Cleveland Clinic Children’s and University of Michigan’s Rogel Cancer Center. “With the aggressive nature of clear cell sarcoma, finding a treatment for this rare cancer is a priority of ours,” said Sanjeev Luther, President and CEO of Rafael Pharmaceuticals. “Enrolling a patient so soon after we opened the trial demonstrates the dire need for a treatment and the hope that devimistat brings to the rare cancer community. We opened two additional sites in order to increase access to the trial for patients in need.” 

xFOREST Therapeutics, Axcelead DDP and Kyowa Kirin Initiated a Collaboration in RNA Structures Targeted Drug Discovering

Princeton-based BioNJ Member Kyowa Kirin, xFOREST Therapeutics, and Axcelead DDP announce that the three companies have entered into a joint research agreement to discover multiple drugs that target RNA structures. Axcelead DDP and Kyowa Kirin originally started collaboration on the development of innovative small-molecule drugs based on a novel drug discovery technology platform in October 2020. Under the terms of the agreement among three companies announced here, xFOREST participates in the research being conducted by Axcelead DDP and Kyowa Kirin on the drug discovery targeting RNA structures. xFOREST will provide its proprietary FOREST technologies, a suite of large-scale parallel analysis platforms, to promote systematic small-molecule drug discovery research targeting RNA structures. Kyowa Kirin has exclusive rights to develop and commercialize RNA-targeted small-molecules discovered from the collaboration. 

Sanofi Completes Acquisition of Kadmon

Bridgewater-based BioNJ Member Sanofi announced the completion of its acquisition of Kadmon Holdings, Inc. The acquisition further strengthens growth and expansion for the General Medicines portfolio. Sanofi completed its acquisition of Kadmon through the merger of a wholly owned subsidiary of Sanofi with and into Kadmon, pursuant to Section 251 of the General Corporation Law of the State of Delaware, with Kadmon continuing as the surviving corporation and becoming an indirect, wholly owned subsidiary of Sanofi. Kadmon common stock has ceased to be traded on the NASDAQ Global Select Stock Market and will be subsequently deregistered. Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. 

Sanofi Invests $180 Million Equity in Owkin’s Artificial Intelligence and Federated Learning to Advance Oncology Pipeline

Bridgewater-based BioNJ Member Sanofi announced an equity investment of $180 million and a new strategic collaboration with Owkin comprised of discovery and development programmes in four exclusive types of cancer, with a total payment of $90 million for three years plus additional research milestone-based payments. Owkin, an artificial intelligence (AI) and precision medicine company, builds best-in-class predictive biomedical AI models and robust data sets. With the ambition to optimize clinical trial design and detect predictive biomarkers for diseases and treatment outcomes, this collaboration will support Sanofi’s growing oncology portfolio in core areas such as lung cancer, breast cancer and multiple myeloma. To accelerate medical research with AI in a privacy-preserving way, Owkin has assembled a global research network powered by federated learning, which allows data scientists to securely connect to decentralized, multi-party data sets and train AI models without having to pool data.

Antios Therapeutics Announces Agreement With IRBM, INGM and OSR to Acquire Fourth-Generation HBV Capsid Assembly Modulators (CAMs)

Mendham-based BioNJ Member Antios Therapeutics announced they entered into an agreement for Antios to purchase the IP rights to a novel series of fourth-generation capsid assembly modulators (CAMs) being developed for the treatment of HBV. The CAMs were originated and developed at IRBM in conjunction with Promidis/CNCCS (a subsidiary of IRBM), Istituto Nazionale Genetica Molecolare (INGM) and San Raffaele Hospital (OSR). These CAMs enable the selection of a new pipeline candidate, which will be the second molecule in Antios' HBV portfolio. The total potential value of the deal to the Italian sellers/parties is up to $50 million, in addition to royalties. Derived from a novel chemical scaffold, the CAMs have shown a strong in vitro and in vivo activity in a transgenic mouse model of HBV infection. Early in vivo data point to a differentiated mechanism of action which prevents accumulation of empty capsids, unlike most CAMs, and potentially provides for a more targeted, productive clearance by the immune system. 

Novo Nordisk to Acquire Dicerna Pharmaceuticals Including the RNAi Research Technology Platform

Plainsboro-based BioNJ Member Novo Nordisk announced that it has entered into a definitive agreement to acquire Dicerna Pharmaceuticals (Dicerna). The acquisition of Dicerna’s ribonucleic acid interference (RNAi) platform is a strategic addition to Novo Nordisk’s existing research technology platforms and supports the strategy of using a broad range of technology platforms applicable across all Novo Nordisk’s therapeutic focus areas. Dicerna is a publicly held company focusing on RNAi-based therapeutics. Using its proprietary GalXC™ and GalXC-Plus™ RNAi technologies, Dicerna develops RNAi-based therapies to selectively silence genes that cause or contribute to disease. Dicerna’s RNAi technology platform enables access to intracellular disease targets across hepatic and extrahepatic cell and tissue types.

Johnson & Johnson Enters Agreement With COVAX to Provide its Single-Shot COVID-19 Vaccine

New Brunswick-based BioNJ Member Johnson & Johnson has agreed with the U.S. Government and Gavi, the Vaccine Alliance, to offer its single-shot COVID-19 vaccine through the World Health Organization-backed COVAX Humanitarian Buffer that is focusing on providing shots to around 167 million displaced people around the world. The first deliveries to the COVAX Humanitarian Buffer are anticipated to begin in the coming days. “We believe our single-shot COVID-19 vaccine has a critical role to play in conflict zones and other humanitarian settings that can’t be reached by government vaccination campaigns, and we are proud to be part of this effort to protect the world’s most vulnerable people,” said Dr. Paul Stoffels, Vice Chairman of the Executive Committee and Chief Scientific Officer.  

Johnson & Johnson Announces Plans to Accelerate Innovation, Serve Patients and Consumers, and Unlock Value Through Intent to Separate Consumer Health Business

New Brunswick-based BioNJ Member Johnson & Johnson announced its intent to separate the company’s Consumer Health business, creating a new publicly traded company. The planned separation would create two global leaders that are better positioned to deliver improved health outcomes for patients and consumers through innovation, pursue more targeted business strategies and accelerate growth. Following the planned separation, the new Johnson & Johnson would remain the world’s largest and most diverse healthcare company and continue its commitment to lead in global healthcare R&D and innovation, with a portfolio that blends its strong Pharmaceutical and Medical Device capabilities focused on advancing the standard of care through innovation and technology. 

Late-Breaking Phase 2 Data for Investigational Oral Factor XIa Inhibitor Milvexian Suggest Favorable Antithrombotic Profile Across a Wide Range of Doses

Princeton-based BioNJ Member Bristol Myers Squibb in collaboration with BioNJ Member Janssen Pharmaceuticals of Johnson and Johnson announced results from the Phase 2 AXIOMATIC-TKR study, which showed investigational oral milvexian reduced the risk of postoperative venous thromboembolism (VTE) in a dose dependent manner without increasing the risk of bleeding compared with enoxaparin in patients undergoing total knee replacement (TKR) surgery. The trial met both of its pre-specified proof-of-principle requirements: the dose response for efficacy with twice-daily milvexian was significant (p<0.001), and the 12% rate of VTE with combined twice-daily doses of milvexian was significantly lower (p<0.0001) than the prespecified benchmark rate of 30%.

Neoadjuvant Opdivo (nivolumab) Plus Chemotherapy Significantly Improves Event-Free Survival in Patients With Resectable Non-Small Cell Lung Cancer in Phase 3 CheckMate -816 Trial

Princeton-based BioNJ Member Bristol Myers Squibb announced the Phase 3 CheckMate -816 trial met the primary endpoint of improved event-free survival (EFS) in patients with resectable stage IB to IIIA non-small cell lung cancer (NSCLC). In a prespecified interim analysis, Opdivo (nivolumab) plus chemotherapy showed a statistically significant and clinically meaningful improvement in EFS compared to chemotherapy alone when given before surgery. This combination previously showed a significant improvement of pathologic complete response (pCR), the trial’s other primary endpoint. The safety profile of Opdivo plus chemotherapy was consistent with previously reported studies in NSCLC. “The positive event-free survival data seen with neoadjuvant nivolumab plus chemotherapy is groundbreaking and can have important implications for how we treat resectable non-small cell lung cancer,” said Nicolas Girard, M.D., Ph.D., Professor of Respiratory Medicine at Paris Saclay University and Head of the Thorax Institute Curie Montsouris.

Bristol Myers Squibb Launches Could It Be HCM? Campaign to Increase Awareness of Hypertrophic Cardiomyopathy (HCM), the Most Common Inherited Heart Disease

Princeton-based BioNJ Member Bristol Myers Squibb announced the launch of Could It Be HCM?, an education campaign to help raise awareness of hypertrophic cardiomyopathy (HCM). Could It Be HCM? encourages those experiencing possible signs and symptoms of HCM to talk to their doctor about what they’re feeling and ask if they should see a cardiologist. The reported prevalence of HCM ranges from 1 in 200 to 1 in 500 people in the general population. However, only about 100,000 people in the U.S. have been diagnosed with HCM, suggesting that approximately 85 percent may remain undiagnosed. HCM is also the most common inherited heart condition and can be passed down within families. HCM can be a challenge for healthcare providers to diagnose because it can be asymptomatic and its symptoms, which can include shortness of breath, unexplained tiredness, chest pain, rapid heartbeat and fainting, among others, can be similar to those of other conditions, such as anxiety, asthma, heart failure, coronary heart disease and atrial fibrillation (irregular heartbeat). 

Novartis Iptacopan Meets Primary Endpoints in Phase II Study in Rare Kidney Disease C3 Glomerulopathy (C3G)

East Hanover-based BioNJ Member Novartis announced that a Phase II study of investigational iptacopan (LNP023) – a first-in-class, oral, selective factor B inhibitor – in patients with C3 glomerulopathy (C3G) met primary endpoints in both patient cohorts. In the final analysis from the open-label, two-cohort Phase II study (NCT03832114), patients were treated with 200mg of iptacopan twice daily for 12 weeks, in addition to background therapy. Patients in cohort A (16 with C3G, but who have not had a kidney transplant [native C3G]) showed a significant 45% reduction in proteinuria (protein in urine) compared to baseline, as measured by 24-hour urinary protein to creatine ratio (UPCR 24h; P=0.0003). Patients in cohort B (7 whose C3G had returned following a kidney transplant) showed significantly reduced C3 protein deposits compared to baseline, as measured by C3 deposit score (based on immunofluorescence microscopy) from kidney biopsy. 

Leqvio® (inclisiran) Reduced LDL-C in People Who are Overweight or Obese

East Hanover-based BioNJ Member Novartis announced results from a pooled post-hoc analysis of Phase III ORION-9, -10 and -11 trials, exploring the impact of body mass index (BMI) levels on the efficacy and safety of twice-yearly Leqvio® (inclisiran). At month 17, Leqvio was well-tolerated and provided effective and sustained reduction of approximately 50%, difference from placebo, in low-density lipoprotein cholesterol (LDL-C) when used in addition to other lipid-lowering therapies across all BMI types. Regardless of BMI, Leqvio showed effective and sustained lipid lowering compared to placebo across a range of atherogenic lipids demonstrating that its pharmacology does not appear to be impacted by excessive body weight. In addition to lowering LDL-C levels by approximately 50%, reductions were also seen across triglycerides (~10%), total cholesterol (~33%), non-HDL-C (~45%) and ApolipoproteinB (~40%). 

Novartis Announces New Publication in Cephalalgia of Data Showcasing Superior Tolerability and Efficacy of Aimovig® (Erenumab) Compared With Topiramate in Migraine Prevention

East Hanover-based BioNJ Member Novartis announced that data from HER-MES has been published in Cephalalgia. This is the first and only randomized, double blind, double-dummy, active-controlled, parallel-group Phase IV study of Aimovig (erenumab) against topiramate, an anticonvulsant, in patients with episodic and chronic migraine. Results showed that Aimovig had a superior tolerability profile compared with topiramate, with a significantly lower treatment discontinuation rate due to adverse events (10.6% with Aimovig® vs 38.9% with topimarate). Aimovig also demonstrated superior efficacy against topiramate, with patients having a significantly higher probability of achieving a clinically meaningful improvement in migraine frequency when they were randomized to Aimovig compared to topiramate (55.4% vs 31.2%). The positive outcomes in the Aimovig group translated into a major improvement in quality of life and in functional impairment for the patients. 

Novartis Presents Positive Phase III Results for Cosentyx® in Children With Active Enthesitis-Related Arthritis (ERA) and Juvenile Psoriatic Arthritis (Jpsa) at ACR 2021

East Hanover-based BioNJ Member Novartis new analyses from the two-year positive Phase III JUNIPERA study, which demonstrated the treatment response of Cosentyx® (secukinumab) in children and adolescents with enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) – two categories of juvenile idiopathic arthritis (JIA). The safety profile was consistent with that of Cosentyx in adults with plaque psoriasis, psoriatic arthritis, non-radiographic axial spondyloarthritis and ankylosing spondylitis. Two-year results from JUNIPERA demonstrated that patients treated with Cosentyx had a significantly longer time to flare, showing a 72% reduction in the risk of flare (P<.001) versus placebo, in children and adolescents ages two to 17 years old with active ERA (n=52; mean age: 13.7) and active JPsA (n=34; mean age: 12.2). 

Merck and Ridgeback Announce Japanese Government to Purchase 1.6 Million Courses of Molnupiravir, an Investigational Oral COVID-19 Antiviral Medicine, Upon Authorization or Approval

Kenilworth-based BioNJ Member Merck & Co. and Ridgeback Therapeutics announced that the Japanese government will purchase, upon authorization or approval, approximately 1.6 million courses of molnupiravir (MK-4482, EIDD-2801), an investigational oral antiviral medicine. Merck is developing molnupiravir in collaboration with Ridgeback Biotherapeutics. Merck’s applications for the potential authorized use of molnupiravir are under review by Japan’s Pharmaceuticals and Medical Devices Agency, the U.S. Food and Drug Administration, and the European Medicines Agency. Molnupiravir is authorized in the United Kingdom for the treatment of mild-to-moderate COVID-19 in adults with a positive SARS-CoV-2 diagnostic test and who have at least one risk factor for developing severe illness. Under the agreement, if molnupiravir receives authorization or approval by Japan’s Pharmaceuticals and Medical Devices Agency, Merck will supply approximately 1.6 million courses of molnupiravir to the Japanese government for approximately $1.2 billion including applicable taxes. 

Merck Gets U.K. Authorization for World’s 1st Oral COVID-19 Treatment Pill

Kenilworth-based BioNJ Member Merck & Co. received approval from regulators in Britain for its experimental drug molnupiravir, marking the first authorization from a public health body for an oral antiviral treatment for COVID-19 in adults. “The first global authorization of molnupiravir is a major achievement in Merck’s singular legacy of bringing forward breakthrough medicines and vaccines to address the world’s greatest health challenges,” said Robert Davis, CEO and President, Merck. “In pursuit of Merck’s unwavering mission to save and improve lives, we will continue to move with both rigor and urgency to bring molnupiravir to patients around the world as quickly as possible.” Merck said the trademark for molnupiravir in other countries has not been approved. Merck announced its application with the U.S. Food and Drug Administration for Emergency Use Authorization of molnupiravir is under review, and recently announced the European Medicines Agency has initiated a rolling review of the company’s Marketing Authorization Application.

Merck Announces Initiation of Phase 3 Study Evaluating VERQUVO® (vericiguat) in Patients with Chronic Heart Failure and Reduced Ejection Fraction Who Have Not Had a Recent Worsening Heart Failure Event

Kenilworth-based BioNJ Member Merck & Co. announced the initiation of VICTOR (VerICiguaT in adults with ChrOnic heart failure and Reduced ejection fraction), a pivotal Phase 3 randomized, placebo-controlled cardiovascular clinical trial of VERQUVO® (vericiguat) in patients with chronic heart failure and reduced ejection fraction of 40% or less who have not had a recent worsening heart failure event. Recruitment for the VICTOR trial has begun. The study is slated to enroll approximately 6,000 adults with chronic heart failure and reduced ejection fraction who have not been hospitalized for heart failure for 6 months or received outpatient IV diuretic use within 3 months prior to randomization. The primary efficacy endpoint is the time to first event of cardiovascular death or hospitalization for heart failure. 

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) as Adjuvant Therapy for Certain Patients With Renal Cell Carcinoma (RCC) Following Surgery

Kenilworth-based BioNJ Member Merck & Co. announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. The approval is based on data from the pivotal Phase 3 KEYNOTE-564 trial, in which KEYTRUDA demonstrated a statistically significant improvement in disease-free survival (DFS), reducing the risk of disease recurrence or death by 32% (HR=0.68 [95% CI, 0.53-0.87]; p=0.0010) compared to placebo. Median DFS has not been reached for either group.

OLUMIANT® Long-Term Safety Profile Established Up to 9.3 Years in Integrated Analysis of More Than 3,700 Patients With Rheumatoid Arthritis

OLUMIANT® (baricitinib) maintained a consistent safety profile in a long-term, integrated safety analysis of patients with rheumatoid arthritis (RA) who received OLUMIANT for 14,744 patient years of exposure, in line with previously published findings. Bridgewater-based BioNJ Member Eli Lilly and Company will present these results, along with real-world safety results from 3,445 patients with RA in Japan, at ACR Convergence 2021, the American College of Rheumatology's virtual annual meeting taking place November 3-9, 2021. Detailed and additional results from the long-term, integrated safety study for OLUMIANT were recently published in the Annals of the Rheumatic Diseases. A pooled analysis across nine randomized studies and one long-term extension study evaluated the safety of OLUMIANT 4-mg and OLUMIANT 2-mg over time in 3,770 patients with RA, who were exposed to treatment for a total of 14,744 patient years of exposure. 

U.S. FDA Accepts Supplemental New Drug Application and Grants Priority Review for Jardiance® for Adults With Heart Failure Independent of Left Ventricular Ejection Fraction

The U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for Jardiance® (empagliflozin) 10 mg, which is being investigated as a potential new treatment to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure independent of left ventricular ejection fraction (LVEF), North Brunswick-based BioNJ Member Boehringer Ingelheim and Bridgewater-based BioNJ Member Eli Lilly and Company announced. "If approved, Jardiance would be the first and only therapy clinically proven to significantly improve outcomes in a heart failure population that included a majority of people with preserved ejection fraction," said Mohamed Eid, M.D., M.P.H., M.H.A., Vice President, Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc. 

Empagliflozin Shows Consistent Cardio-Renal Benefits in Adults With Heart Failure With Left Ventricular Ejection Fraction Over 40 Percent Regardless of Chronic Kidney Disease Status

North Brunswick-based BioNJ Member Boehringer Ingelheim and BioNJ Member Eli Lilly and Company announced Empagliflozin reduced the risk for the composite primary endpoint of cardiovascular death or hospitalization for heart failure and slowed kidney function decline in adults with heart failure with left ventricular ejection fraction (LVEF) over 40 percent regardless of chronic kidney disease status at baseline, according to findings from a new prespecified sub-analysis of the EMPEROR-Preserved® Phase III trial. In EMPEROR-Preserved®, two thirds of enrolled adults had heart failure with preserved ejection fraction (HFpEF; LVEF of at least 50 percent) and one third had mildly reduced LVEF (greater than 40 percent but less than 50 percent). Nearly half of adults with heart failure also have chronic kidney disease. Together, these conditions are associated with high mortality rates and risk for hospital admission. More than 60 million people worldwide have heart failure, and approximately half of them have HFpEF.

Emgality® Versus Nurtec® ODT Head-to-Head Migraine Preventive Treatment Study Now Enrolling Patients

North Brunswick-based BioNJ Member Boehringer Ingelheim and announced that enrollment is now open for the CHALLENGE-MIG clinical trial, the first and only head-to-head trial comparing two anti-calcitonin gene-related peptide (CGRP) medicines for the preventive treatment of episodic migraine in adults. The study is evaluating once-monthly Emgality® (galcanezumab-gnlm) injection compared to Nurtec® ODT (rimegepant), a tablet patients take every other day, on patient-centric measures, including reductions in monthly migraine headache days and quality of life improvement. While Nurtec ODT and Emgality are both medications that target CGRP, because Emgality is a monoclonal antibody (mAb) that binds to CGRP (a protein found in the brain thought to play a key role in migraine), it works differently than gepants like Nurtec ODT, that bind to and block the CGRP receptor.

GSK Announces Positive Phase III Efficacy and Safety Data for Daprodustat in Patients With Anaemia Due to Chronic Kidney Disease

Warren-based BioNJ Member GlaxoSmithKline announced positive results from the Phase III ASCEND (Anaemia Studies in Chronic Kidney Disease: Erythropoiesis via a novel prolyl hydroxylase inhibitor Daprodustat) program for daprodustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), during a presentation at the American Society of Nephrology’s Kidney Week 2021. The positive primary efficacy and safety results confirm the potential for daprodustat to be a new oral treatment for patients with anaemia due to chronic kidney disease (CKD) in both non-dialysis and dialysis settings. Daprodustat was developed based upon the unique Nobel Prize-winning science that demonstrated how cells sense and adapt to oxygen availability. The ASCEND program is comprised of five Phase III studies assessing the efficacy and safety of daprodustat for the treatment of anaemia due to CKD across the CKD disease course. 

Primary Endpoint Met in COMET-TAIL Phase III Trial Evaluating Intramuscular Administration of Sotrovimab for Early Treatment of COVID-19

Warren-based BioNJ Member GlaxoSmithKline and Vir Biotechnology announced headline data from the randomised, multi-centre, open-label COMET-TAIL Phase III trial, which achieved its primary endpoint, demonstrating intramuscular (IM) administration of sotrovimab was non-inferior to intravenous (IV) administration for the early treatment of mild-to-moderate COVID-19 in high-risk, non-hospitalised adults and adolescents (12 years of age and older). The COMET-TAIL Phase III trial was designed to evaluate the efficacy, safety, and tolerability of sotrovimab delivered via IM administration compared to IV administration in high-risk patients up to seven days after symptom onset. In the IM administration (500mg) arm of the trial, there was a 2.7% rate of progression to hospitalisation for more than 24 hours or death through Day 29 of the trial, compared to 1.3% in the IV administration arm (also 500mg). 

Pfizer and Biohaven Enter Strategic Collaboration for the Commercialization of Rimegepant Outside the United States

BioNJ Member Pfizer, with offices in Peapack, and Biohaven Pharmaceutical Holding Company announced a strategic commercialization arrangement for rimegepant in markets outside of the United States upon approval. Rimegepant is commercialized as Nurtec® ODT in the U.S. and is indicated for the acute treatment of migraine attacks with or without aura and the preventive treatment of episodic migraine in adults. An application for the approval of rimegepant is currently under review by the European Medicines Agency and several additional regulatory authorities outside of the U.S. Under the terms of the arrangement, Biohaven would remain primarily responsible for further clinical development of rimegepant and the parties will cooperate in regulatory activities to secure approval for the product. Biohaven will continue to solely commercialize Nurtec ODT in the U.S and Pfizer would commercialize rimegepant, upon approval, in all regions outside the U.S. 

Zipline, Pfizer and Biontech Collaboration Paves the Way for Automated, On-Demand Delivery of First mRNA COVID-19 Vaccines in Ghana

BioNJ Member Pfizer, with offices in Peapack, Zipline and BioNTech SE announced that Zipline has successfully completed the first long-range drone delivery of both authorized mRNA COVID-19 vaccines requiring ultra-cold-chain in Ghana. The collaboration of the companies, which worked together earlier this year to develop and test an end-to-end vaccine delivery solution, will allow for the distribution of approximately 50,000 doses of the Pfizer-BioNTech COVID-19 Vaccine in Ghana, pioneering a new model for vaccine distribution. In addition to financial support for the pilot program, Pfizer and BioNTech provided technical assistance and know-how specific to the management and storage of the Pfizer-BioNTech COVID-19 Vaccine at -90°C to -60°C. This partnership has paved the way for drone deliveries of all mRNA vaccines. The companies share a goal to help ensure the safe and equitable distribution of COVID-19 vaccines. 

Pfizer Seeks Emergency Use Authorization for Novel COVID-19 Oral Antiviral Candidate

BioNJ Member Pfizer, with offices in Peapack, announced it is seeking Emergency Use Authorization (EUA) of its investigational oral antiviral candidate, PAXLOVID™ (PF-07321332; ritonavir), for the treatment of mild to moderate COVID-19 in patients at increased risk of hospitalizations or death. This submission to the U.S. Food and Drug Administration (FDA) includes clinical data from the Phase 2/3 EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) interim analysis. Rolling submission of non-clinical data for PAXLOVID was initiated with the U.S. FDA in October 2021. If authorized or approved, PAXLOVID would be the first oral antiviral of its kind, a 3CL protease inhibitor specifically designed to combat SARS-CoV-2 that could be prescribed as an at-home treatment to high-risk patients at the first sign of infection, potentially helping patients avoid severe illness which can lead to hospitalization and death. 

Pfizer and the Medicines Patent Pool (MPP) Sign Licensing Agreement for COVID-19 Oral Antiviral Treatment Candidate to Expand Access in Low- and Middle-Income Countries

BioNJ Member Pfizer, with offices in Peapack, and the Medicines Patent Pool announced the signing of a voluntary license agreement for Pfizer’s COVID-19 oral antiviral treatment candidate PF-07321332, which is administered in combination with low dose ritonavir (PF-07321332; ritonavir). The agreement will enable MPP to facilitate additional production and distribution of the investigational antiviral, pending regulatory authorization or approval, by granting sub-licenses to qualified generic medicine manufacturers, with the goal of facilitating greater access to the global population. Under the terms of the head license agreement between Pfizer and MPP, qualified generic medicine manufacturers worldwide that are granted sub-licenses will be able to supply PF-07321332 in combination with ritonavir to 95 countries, covering up to approximately 53% of the world’s population. This includes all low- and lower-middle-income countries and some upper-middle-income countries in Sub-Saharan Africa as well as countries that have transitioned from lower-middle to upper-middle-income status in the past five years. 

Pfizer to Provide U.S. Government With 10 Million Treatment Courses of Investigational Oral Antiviral Candidate to Help Combat COVID-19

BioNJ Member Pfizer, with offices in Peapack, announced an agreement with the U.S. government to supply 10 million treatment courses of its investigational COVID-19 oral antiviral candidate, PAXLOVID™ (PF-07321332; ritonavir), subject to regulatory authorization from the U.S. Food and Drug Administration (FDA). If approved or authorized, PAXLOVID, which originated in Pfizer’s laboratories, would be the first oral antiviral of its kind, a 3CL protease inhibitor specifically designed to combat SARS-CoV-2. Pfizer is seeking Emergency Use Authorization (EUA) of PAXLOVID with the U.S. FDA; rolling submissions have also commenced in several countries, and the company will continue working to submit applications to regulatory agencies around the world. Under the terms of the agreement, the U.S. government will acquire 10 million treatment courses to be delivered by Pfizer beginning later this year and concluding in 2022.

Pfizer’s XELJANZ® (Tofacitinib) Receives Marketing Authorization in the European Union for the Treatment of Active Ankylosing Spondylitis

BioNJ Member Pfizer, with offices in Peapack, announced that the European Commission has approved XELJANZ® (tofacitinib) 5 mg twice daily for the treatment of adults with active ankylosing spondylitis (AS) who have responded inadequately to conventional therapy. XELJANZ is the first and only oral Janus kinase (JAK) inhibitor approved for five indications in the European Union (EU), including in adults with moderate to severe active rheumatoid arthritis (RA), adults with active psoriatic arthritis (PsA), adults with moderately to severely active ulcerative colitis (UC), and patients 2 years of age or older with active polyarticular juvenile idiopathic arthritis (pcJIA) and juvenile psoriatic arthritis (PsA). The approval of XELJANZ for AS is based on data from a Phase 3, multicenter, randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of tofacitinib 5 mg twice daily versus placebo in 269 adult patients living with active AS.

AbbVie Presents New Efficacy Data on Upadacitinib (RINVOQ®) in People With Active Psoriatic Arthritis and Axial Involvement at ACR Convergence 2021

Madison-based BioNJ Member AbbVie announced results from new post-hoc analyses from the Phase 3 SELECT-PsA 1 and SELECT-PsA 2 trials assessing the efficacy of upadacitinib (RINVOQ®) on axial symptoms in adult patients with active psoriatic arthritis (PsA) and axial involvement. The analysis showed that patients with active PsA demonstrated numerically greater clinical responses related to their axial involvement with upadacitinib (15 mg, once daily) compared to placebo at week 24 across both studies and consistently numerically higher responses compared to HUMIRA® (adalimumab) at week 24 in SELECT-PsA 1. Axial involvement was defined by investigator assessment and patient-reported-outcome-based criteria (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥4 and BASDAI Question 2 ≥4 at baseline). 

AbbVie to Present New Long-term Analysis Evaluating the Sustainability of Response to RINVOQ® (Upadacitinib) Among Patients With Rheumatoid Arthritis

Madison-based BioNJ Member AbbVie announced new results from a post-hoc analysis of the Phase 3 SELECT-BEYOND clinical trial evaluating RINVOQ® (upadacitinib; 15 mg, once daily) in patients with moderate to severe rheumatoid arthritis (RA) on stable background of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) with prior inadequate response or intolerance to at least one biologic DMARD. Results showed that 34% of patients receiving RINVOQ and background csDMARDs achieved Clinical Disease Activity Index (CDAI) remission (CDAI ≤2.8) at first occurrence of response before week 60, while 79% achieved CDAI low disease activity (LDA) (CDAI ≤10). Maintenance of response, defined as not losing response at two consecutive study visits, was seen for CDAI remission and CDAI LDA in 39% and 61% of patients, respectively, at 60 weeks. 

AbbVie, University of Chicago Extend Research Collaboration to Support Preclinical Oncology Research Through 2025

Madison-based BioNJ Member AbbVie and the University of Chicago have extended their collaboration agreement through 2025 to support preclinical oncology research. To date, the collaboration has led to novel insights related to biomarkers and therapeutic applications for existing AbbVie programs. This has included the development of novel drug delivery approaches to enhance anti-tumor immune response and incorporating unique 3D screening methodologies for selecting novel therapeutic molecules. "Our oncology collaboration with the University of Chicago enables us to combine our expertise in understanding the underlying biology in key areas of interest, such as immuno-oncology, oncogenic pathways, and biomarkers of drug sensitivity or disease," said Steve Davidsen, Vice President, Oncology Discovery Research at AbbVie. Under the agreement, the organizations will continue working together to advance research in several areas, focusing on oncology, and AbbVie gains an option for an exclusive license to certain University of Chicago discoveries made as part of the collaboration.

AbbVie Expands Immunology Portfolio in the European Union with the European Commission Approval of SKYRIZI® (risankizumab) for the Treatment of Adults with Active Psoriatic Arthritis

Madison-based BioNJ Member AbbVie announced that the European Commission (EC) has approved SKYRIZI® (risankizumab, 150 mg, subcutaneous injection at week 0, week 4 and every 12 weeks thereafter) alone or in combination with methotrexate (MTX), for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Marking the second indication for SKYRIZI, the Marketing Authorization will be valid in all member states of the European Union, as well as Iceland, Liechtenstein, Norway and Northern Ireland. SKYRIZI received EC approval based on data from two Phase 3 clinical studies, KEEPsAKE-1 and KEEPsAKE-2. In these studies, SKYRIZI met the primary endpoint of ACR20 response at week 24 versus placebo, and ranked secondary endpoints including, but not limited to, improvements in several clinical manifestations of psoriatic arthritis such as physical function (as measured by the Health Assessment Questionnaire Disability Index [HAQ-DI]) and minimal disease activity (MDA) at week 24.

Everest Medicines and Gilead Sciences Jointly Announce Phase 2b Study of Sacituzumab Govitecan Conducted in China of Patients With Metastatic Triple-Negative Breast Cancer Meets Primary Overall Response Rate Endpoint

Morris Plains-based BioNJ Member Gilead Sciences reported that the Everest Medicines (HKEX 1952.HK) sponsored Phase 2b EVER-132-001 study of sacituzumab govitecan (marketed as Trodelvy® in the United States) met its primary endpoint of overall response rate (ORR) in metastatic triple-negative breast cancer. EVER-132-001 is a single-arm, multi-center Phase 2b registrational study evaluating sacituzumab govitecan in 80 patients enrolled in China for the treatment of adults with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one for metastatic disease. The results demonstrated an ORR of 38.8% (CI: 95%) as evaluated by an Independent Review Committee. The safety profile of sacituzumab govitecan was similar to that reported in prior studies, and no new safety signals were identified. 

LUMYKRAS® (sotorasib) Receives Positive Opinion from EMA CHMP for Patients With KRAS G12C-Mutated Advanced Non-Small Cell Lung Cancer

Berkeley Heights-based BioNJ Member Amgen announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending conditional marketing authorization of LUMYKRAS® (sotorasib), known as LUMAKRAS® in the U.S., for the treatment of adults with advanced non-small-cell lung cancer (NSCLC) with KRAS G12C mutation and who have progressed after at least one prior line of systemic therapy. If the European Commission follows the recommendation for approval, LUMYKRAS will be the first targeted therapy available in the European Union (EU) for the KRAS G12C mutation, one of the most prevalent biomarkers in NSCLC. The CHMP based its positive opinion on results from the Phase 2 CodeBreaK 100 clinical trial, the largest trial conducted to date exclusively for patients with the KRAS G12C mutation. 

The European Commission Grants Marketing Authorization for VUMERITY® (diroximel fumarate) as Oral Treatment for Relapsing-Remitting Multiple Sclerosis

BioNJ Member Biogen, with offices in Princeton, announced that the European Commission (EC) has granted marketing authorization for VUMERITY® (diroximel fumarate) to treat adults with relapsing-remitting multiple sclerosis (MS). VUMERITY is a next-generation fumarate that offers the convenience of an oral medication with the established efficacy and well-characterized safety of TECFIDERA® (dimethyl fumarate). Globally, an estimated 2.8 million people live with MS, with more than 1 million people in Europe living with the disease. The EC’s approval of VUMERITY is based on data from pharmacokinetic bridging studies comparing VUMERITY and TECFIDERA to establish bioequivalent exposure of monomethyl fumarate, the active metabolite, and relied in part on the well-established long-term efficacy and safety profile of TECFIDERA. The approval was also based on findings from EVOLVE-MS-2, a large, randomized, double-blind, five-week, multi-center Phase 3 study to evaluate the gastrointestinal (GI) tolerability of VUMERITY compared to TECFIDERA in patients with relapsing-remitting MS. 

New Phase 3 Data Show Positive Correlation Between ADUHELM™ Treatment Effect on Biomarkers and Reduction in Clinical Decline in Alzheimer’s Disease

Woodcliff Lake-based Eisai Co. and BioNJ Member Biogen Inc. announced that data from approximately 7,000 plasma samples from more than 1,800 patients in the ADUHELM™ (aducanumab-avwa) Phase 3 clinical trials showed a statistically significant correlation between plasma p-tau reduction and less cognitive and functional decline in Alzheimer’s disease. Reductions in plasma p-tau181 were also correlated with a lowering of amyloid beta plaque. The pre-specified analysis of plasma samples was conducted by an independent lab, drawing from the two pivotal ADUHELM Phase 3 EMERGE and ENGAGE trials. The analysis highlighted that ADUHELM significantly reduced tau pathology, a defining feature of Alzheimer’s disease, as measured by plasma p-tau181, when compared to placebo. The effect was greater with higher doses and longer duration of ADUHELM treatment.

Eisai Presents New Analysis of Lecanemab Clinical Efficacy Results from Phase 2b Study at Clinical Trials on Alzheimer’s Disease (CTAD) Conference

Woodcliff Lake-based Eisai Co. and BioNJ Member Biogen Inc. announced results of sensitivity analyses evaluating the consistency of lecanemab efficacy results across multiple statistical models in patients with Mild Cognitive Impairment (MCI) due to Alzheimer’s disease (AD) and mild AD (collectively known as early AD). In September 2021, Eisai initiated a rolling submission of a Biologics License Application (BLA) for lecanemab, an investigational anti-amyloid beta protofibril antibody, for the treatment of early AD, to the U.S. Food and Drug Administration (FDA) under the accelerated approval pathway. Study 201, a multicenter, double-blind, placebo-controlled, Phase 2b trial conducted in 856 patients with early AD, evaluated key efficacy assessments, including clinical change on the Alzheimer’s Disease Composite Score (ADCOMS) at the primary endpoint of 12 months and at select key secondary endpoints, Clinical Dementia Rating-Sum-of-Boxes (CDR-SB) and Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14) at 18 months. 

Introduction of First-of-a-Kind Plasma-Based Biomarker Screening to Facilitate Identification of Subjects for Phase 3 Ahead 3-45 Trial Presented at Clinical Trials on Alzheimer’s Disease (CTAD) Conference

Woodcliff Lake-based Eisai Co. and BioNJ Member Biogen Inc. announced a presentation about exploring the use of plasma-based biomarkers in the Phase 3 AHEAD 3-45 study of lecanemab (BAN2401), an investigational anti-amyloid beta (Aβ) protofibril antibody. AHEAD 3-45 is the first preclinical Alzheimer’s disease (AD) trial to use these biomarkers to detect AD pathology and potentially accelerate the screening process. The AHEAD 3-45 clinical study will evaluate the efficacy of treatment with lecanemab in participants with preclinical AD and elevated amyloid and in participants with early preclinical AD and intermediate amyloid. In September 2021, Eisai initiated a rolling submission of a Biologics License Application (BLA) for lecanemab for the treatment of early AD, to the U.S. Food and Drug Administration (FDA) under the accelerated approval pathway.

Dian-Tu Selects Lecanemab as Background Anti-Amyloid Therapy in Clinical Trial Evaluating Investigational Therapy Targeting Tau for Dominantly Inherited Alzheimer's Disease

Woodcliff Lake-based Eisai Co. announced that the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, has an agreement with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to amend the clinical study (Tau NexGen) design to include a background anti-amyloid agent. The Tau NexGen clinical study was originally designed to focus on therapies that target tau. With increasing evidence from clinical studies showing that targeting amyloid can reduce biomarkers of Alzheimer’s disease (AD), the Tau NexGen clinical trial leaders selected Eisai’s investigational anti-amyloid beta (Aβ) protofibril antibody lecanemab as the background anti-amyloid agent. The purpose of the Tau NexGen study is to assess the safety, tolerability, biomarker and cognitive efficacy of investigational therapies in people who have an Alzheimer’s disease-causing gene mutation.  

BeiGene and NewBridge Pharmaceuticals Announce Approval in Saudi Arabia of BRUKINSA® (Zanubrutinib) for the Treatment of Patients With Relapsed or Refractory Mantle Cell Lymphoma

Ridgefield Park-based BeiGene and New Bridge Pharmaceuticals announced that BRUKINSA® (zanubrutinib) has received approval from the Saudi Food and Drug Authority (SFDA) for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. BeiGene and New Bridge Pharmaceuticals are working together to bring BRUKINSA to health care providers and people living with MCL in Saudi Arabia and other MENA markets following regulatory approvals. “Non-Hodgkin’s lymphoma is a leading cause of cancer incidence and mortality in Saudi Arabia, representing a significantly unmet need for those living with diseases, such as MCL. BRUKINSA is a next-generation BTK inhibitor designed to improve tolerability issues often associated with the class and has demonstrated efficacy in clinical trials for patients with relapsed or refractory MCL,” said Dr. Ahmad Absi, Hematology Section Head at the National Guard Health Affairs in Jeddah, Kingdom of Saudi Arabia. 

New Phase 3 Analyses Show That a Single Dose of Regen-Cov® (Casirivimab and Imdevimab) Provides Long-Term Protection Against COVID-19

Basking Ridge-based Regeneron Pharmaceuticals announced additional positive results from a Phase 3 trial jointly run with the National Institute of Allergy and Infectious Diseases, which assessed use of a single dose of investigational REGEN-COV® (1,200 mg administered via 4 subcutaneous injections) to prevent COVID-19 in uninfected individuals. The new analyses show REGEN-COV reduced the risk of contracting COVID-19 (i.e., laboratory-confirmed symptomatic SARS-CoV-2 infections) by 81.6% during the pre-specified follow-up period (months 2-8), maintaining the 81.4% risk reduction during the first month after administration, which was previously reported in The New England Journal of Medicine. "These results demonstrate that REGEN-COV has the potential to provide long-lasting immunity from SARS-CoV-2 infection, a result particularly important to those who do not respond to COVID-19 vaccines including people who are immunocompromised," said Myron S. Cohen, M.D., who leads the monoclonal antibody efforts for the NIH-sponsored COVID Prevention Network.

Regeneron Antibody Cocktail Approved by European Commission to Treat and Prevent COVID-19

Basking Ridge-based Regeneron Pharmaceuticals announced that the European Commission (EC) has approved the casirivimab and imdevimab antibody cocktail, known as REGEN-COV® in the U.S. and Ronapreve™ in the European Union (EU) and other countries. The EC granted marketing authorization for the antibody cocktail for people aged 12 years and older for the treatment of non-hospitalized patients (outpatients) with confirmed COVID-19 who do not require oxygen supplementation and who are at increased risk of progressing to severe COVID-19, and to prevent COVID-19. "With today's approval, we hope countries in the European Union will accelerate their adoption of this formidable tool to reduce the burden of COVID-19. For non-hospitalized infected individuals, our antibody cocktail was shown to reduce the risk of hospitalization or death by 70%; and in the prevention setting it reduced the risk of symptomatic infections by 82%," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron.

New Analysis to be Presented at the American Heart Association Scientific Sessions 2021 Evaluating Cardiovascular Benefits Across Baseline Kidney Function

Basking Ridge-based Lexicon Pharmaceuticals announced that a new analysis of sotagliflozin results from the SOLOIST and SCORED Phase 3 outcomes studies will be presented at the virtual American Heart Association Scientific Sessions 2021. The presentation is entitled, “Cardiovascular Benefits of Sodium Glucose Cotransporter-1/2 Inhibition with Sotagliflozin Across Baseline Kidney Function.” SOLOIST was a multi-center, randomized, double-blinded, placebo-controlled Phase 3 study evaluating the cardiovascular efficacy of sotagliflozin versus placebo when added to standard of care in 1,222 patients with type 2 diabetes who had recently been hospitalized for worsening heart failure. The primary endpoint was the total number of events comprised of deaths from cardiovascular causes, hospitalizations for heart failure and urgent visits for heart failure in patients treated with sotagliflozin compared with placebo.

BD Launches FDA-Approved, Highly Automated Cervical Cancer Screening System

Cervical cancer is most commonly caused by human papillomavirus, or HPV, a sexually transmitted disease that affects the uterus. Each year, over 13,000 individuals are diagnosed with cervical cancer in U.S. But, an influx of screening and awareness on the importance of vaccination has lowered these numbers. Franklin Lakes-based BD, or Becton, Dickinson and Co., is taking that screening one step further by recently launching a fully automated, high-throughput diagnostic system to screen for cervical cancer. The BD COR PX/GX System won approval from the U.S. Food and Drug Administration in late August, clearing the way for it to be used in the U.S. The system has been available in Europe since 2019, and is ready for use in centralized labs that can handle high-volume processing and increases in efficiency.

Bayer, Microsoft Enter Partnership to Optimize Digital Capabilities for Agribusinesses

Global enterprise corporation Bayer, which has a major presence in Whippany, announced a strategic partnership with Microsoft to build a new cloud-based set of digital tools and data science solutions for use in agriculture and similar industries. This partnership is a significant, strategic step forward in accomplishing Bayer’s ambitious target of 100% digitally enabled sales in the Crop Science division by 2030 and accelerating its ability to deliver outcomes-based, digitally enabled solutions to customers. Under the agreement, Bayer will work with Microsoft to codevelop new solutions that address critical industry scenarios such as farming operations, sustainable sourcing, manufacturing and supply chain improvement, and ESG monitoring and measurement. The companies will do this by developing the go-forward infrastructure for digital farming solutions and data science capabilities.

ADMA Biologics Senior Vice President of Plasma Services Cyndi Tolman Elected to PPTA Source Board of Directors

Ramsey-based BioNJ Member ADMA Biologics announced that Cyndi Tolman, ADMA’s Senior Vice President of Plasma Services, has been elected to serve on the PPTA Source Board of Directors for the 2022 to 2024 election term. “Mrs. Tolman’s appointment to the PPTA Source Board of Directors is a well-deserved testament to her leadership capabilities and accomplishments as a part of the rapid and successful expansion of the ADMA BioCenters collection network,” said Adam Grossman, President and CEO of ADMA. “ADMA welcomes the opportunity to have a voice on the PPTA Source Board and we are confident in Cyndi’s ability and decades-long experience, that will allow her to provide valuable input to further the industry’s mission to advocate for access of plasma-derived therapies for patients in need.” 

Citius Pharmaceuticals Expands Management Team With Appointment of Kelly Creighton, Ph.D. as Executive Vice President of Chemistry, Manufacturing and Controls

Cranford-based Citius Pharmaceuticals announced the appointment of pharmaceutical industry veteran Kelly Creighton, Ph.D. as Executive Vice President of Chemistry, Manufacturing and Controls. Mr. Creighton will be responsible for the global strategic regulatory and manufacturing development plans for Citius's five pipeline programs. "With two late Phase 3 trials nearing completion, we continue to prepare the organization for commercial success. Kelly is a seasoned pharmaceutical veteran whose accomplishments include more than 50 investigational new drug (IND) submissions and 20 approved market applications spanning multiple therapeutic areas including oncology, infectious disease and cell therapy. Kelly has been a longstanding advisor to the Citius team on all aspects of the regulatory pathway for Mino-Lok® and we anticipate a seamless transition into this newly created in-house role," stated Myron Holubiak, CEO of Citius.

Angel Medical Systems Appoints Device Expert as Chief Commercial Officer

Eatontown-based Angel Medical Systems appointed Mike Gillem as Chief Commercial Officer, responsible for the direction and management of all sales and marketing activities for the Guardian System, the company’s cardiac monitoring product. “Mike will be instrumental in our goals to accomplish key milestones in the launch of the Guardian, as well as building a sales force for the future,” said Brad Snow, CEO. “Mike’s leadership and broad experience of launching disruptive technologies will be key to establishing a strong foundation, systems and processes with a scalability that exceeds expectations.” Mr. Gillem brings more than 29 years of medical device experience in cardiology and orthopedics serving in various sales and sales leadership roles. Prior to joining AngelMed, he served as chief commercial officer for McGinley Orthopedics.

BrainStorm Cell Therapeutics Expands Leadership Team to Support Clinical Development and Medical Affairs

Hackensack-based BrainStorm Cell Therapeutics announced executive appointments as the company prepares for future growth. Sidney A. Spector, M.D., Ph.D., was named Senior Vice President Global Strategy and Medical Affairs and Kim Thacker, M.D., was named Senior Vice President, Medical Affairs and Clinical Innovation. BrainStorm also has expanded the responsibilities of Stacy Lindborg, Ph.D., Executive Vice President, appointing her to the new position of Chief Development Officer. These appointments mark an investment in accelerating BrainStorm's progress. Reporting to Ralph Kern, M.D., MHSc, President and Chief Medical Officer, Dr. Spector and Dr. Thacker will work together to create a formal global Medical Affairs function as the company prepares for anticipated growth. As Chief Development Officer, Dr. Lindborg will build a leadership team required for development and regulatory affairs to support clinical development in multiple disease areas and technologies. 

NJEDA Board Approves Rules for Aspire Development Tax Credit Program

The New Jersey Economic Development Authority Board approved rules for the Aspire Program, a place-based economic development program created under the New Jersey Economic Recovery Act of 2020 (ERA) that supports mixed use, transit-oriented development by providing tax credits to commercial and residential real estate development projects that have financing gaps. As authorized by the ERA, the Board approved rules that will be effective immediately for a short-term duration, enabling the NJEDA to move forward with instituting the program this year. Concurrently, the Board also approved publishing the rules for public comment prior to adopting longer-term rules. “The Aspire Program is a much-needed incentive that will support the construction of new housing and commercial projects throughout the state, with an emphasis on communities that have been left out of growth in the past,” said Governor Phil Murphy.

NJEDA Releases Updated Net Operating Loss (NOL) Program Rules for Public Feedback

The New Jersey Economic Development Authority (NJEDA) released for public feedback rules for the Net Operating Loss (NOL) Program as updated under the New Jersey Economic Recovery Act of 2020 (ERA) and P.L. 2021, c. 160, including new measures to support woman- and minority-owned businesses. Members of the public are encouraged to review the preliminary rules and submit written feedback through an online form available on the Economic Recovery Act website. The NOL Program enables tech and life sciences companies to sell their New Jersey net operating losses and/or research and development (R&D) tax credits for cash. Buyers can purchase tax credits at a discount and apply them to reduce taxable income. Draft NOL Program rules will be available for public comment until November 24, 2021. Members of the public can review the rules and provide comment at https://www.njeda.com/economicrecoveryact/program-specific-feedback/.

Governor Murphy Announces $400 Million in Capital Facilities Funding to Support New Jersey’s Higher Education Sector

Governor Murphy announced that the State will release a total of $400 million in capital facilities grant funding in a joint solicitation of four revolving bond programs to support the growing needs of New Jersey’s institutions of higher education and students. “We want our high-achieving young people and out-of-state students to find the right college match in New Jersey,” said Governor Murphy. “Whether it is a top-notch science lab or a state-of-the-art technology center, we need to ensure our campuses include these critical resources to compete and win these young hearts and minds to seek their educational futures here. With this investment, we are committed to meeting the infrastructure needs of our higher education institutions while creating good-paying union jobs and achieving our goals of college affordability and competitiveness.” 

Tel Aviv University to Increase Collaboration With Rutgers, Take Space at the Hub

Rutgers University and Tel Aviv University, in an effort to further the collaboration between the two schools, signed a memorandum of understanding that will establish a presence by TAU at the still-to-be-built New Jersey Innovation & Technology Hub in New Brunswick. The Hub, a 550,000-square-foot, $665 million project, will be home to a new Rutgers translational research facility and the Rutgers Robert Wood Johnson Medical School. The MOU was signed in Tel Aviv, Israel, by Rutgers President Jonathan Holloway and TAU President Ariel Porat. “I traveled to Tel Aviv to sign this memorandum of understanding in person because this is an important initiative that reflects Rutgers’ commitment to excellence and our recognition that there is no limit to the power of partnerships,” Holloway said.

Rutgers Cancer Inst. & RWJBarnabas Launch Home Infusion Program

Rutgers Cancer Institute of New Jersey and RWJBarnabas Health have partnered with Horizon Blue Cross Blue Shield of New Jersey to launch a collaborative pilot program which provides home infusion cancer treatments for eligible patients. The Horizon Home Infusion Pilot Program, which first launched in September 2020, delivers oncology care to patients in the comfort of their own home with the goal of preventing disruption of chemotherapy during the coronavirus pandemic and limiting exposure to hospital settings. The presence of COVID-19 has caused many people to fear venturing out for vital medical services like cancer treatment, resulting in an increased emphasis on telehealth and home care. Home infusion offers many potential benefits for patients, including the ability to stay in a safe and protected environment without having to travel or risk exposure to infectious disease.

NJIT Partners With the New York Red Bulls

The New York Red Bulls announced a new partnership with the New Jersey Institute of Technology (NJIT). The university will now be a Presenting Partner for Goals for Perfect Attendance Program and the After School All-Stars Mentorship Program. The goals for the Public Attendance Program is a collaborative effort between NJIT and the Red Bulls to improve attendance by establishing an incentive-based program across all district high schools in Newark, N.J. “Building a pipeline of Newark students attending college, especially a STEM school like NJIT, starts with being in the classroom," said NJIT President Joel. S. Bloom. Every other month, students will be selected to participate in a workshop hosted by the Red Bulls and NJIT, which will provide students with engaging learning opportunities. Additionally, After School All-Stars has provided mentoring that supports students in developing skills and habits needed to succeed in life, school and their future careers.

LSC High Aims to be Country’s Top STEM School

There are many STEM high schools across the State and the country that are providing cutting-edge educational opportunities to the next generation of scientists and researchers. Most have top instructors, and some have state-of-the-art lab space for students to learn. None will be able to match what will be available at the still-to-be-formally-named Liberty Science Center High School. Scheduled to open in 2024, it will be housed next to the Edgeworks incubator in SciTech Scity on the grounds of Liberty Science Center. That will make all difference, LSC CEO Paul Hoffman said. “All the students that are there will be able to do meaningful work experiences and mentorships at the companies based in Edgeworks. They will also have the resources of Liberty Science Center. That’s going to distinguish it from schools anywhere else,” added Hoffman.

Rowan and Virtua Enhance Healthcare/Academic Partnership

The boards of trustees for Rowan University and Virtua Health have approved the signing of a letter of intent to expand their organizations’ relationship, further collaborating across education, research and patient care. The new affiliation agreement will be completed in the next several months to define how the two organizations will work together to establish a sought-after program for preparing the health and wellness workforce of the future, expanding the number and diversity of health professionals educated through Rowan University and Virtua Health. According to Rowan University President Ali A. Houshmand, Ph.D., the new affiliation “will strengthen Rowan’s School of Osteopathic Medicine, its School of Nursing & Health Professions and create a new School of Translational Biomedical Engineering & Sciences, among other initiatives.” 

Velez, Diaz Named to Senior Leadership Team at Horizon BCBSNJ

Jennifer Velez and Uli Diaz were named to the senior leadership team at Horizon Blue Cross Blue Shield of New Jersey. Ms. Velez will become Senior Vice President and General Counsel, succeeding Linda Willett, who is retiring from Horizon at the end of 2021 after 12 years with the company. Mr. Diaz is being promoted to Senior Vice President of Government Affairs.“Jen has devoted much of her professional career to improving the health and quality of life of all New Jerseyans, especially for those who have struggled to overcome health disparities. Uli has given our members a strong voice at the table when decisions affecting their health care are being made in Trenton and Washington, D.C.,” said Horizon CEO Gary St. Hilaire.

Engage 2021 Conference

December 1-2, 2021 • Virtual

Organized by the Princeton University Office of Corporate Engagement and Foundation Relations for Princeton Innovation, Engage 2021 is virtual, free and open to all. We'll zero in on connections and skills to accelerate the impact of research and innovation on complex problems: Practical information and specific resources and opportunities you can use to advance your work. We'll step back and explore the big picture: How can Princeton and partners propel the development of a robust and inclusive innovation ecosystem.

BioNJ recognizes the vital role that our Service Provider Members play in the growth of New Jersey's robust life sciences ecosystem. For this reason, we are delighted to remind our community about BioNJ's Member Service Provider Directory, a categorical listing of BioNJ Members by service sector. By working with fellow BioNJ Member organizations, you are not only supporting our community, but benefiting from a wide variety of high quality organizations. To learn how you can become a Member and be featured on this resource tool, please contact Kim Minton at KMinton@BioNJ.org, or 609-890-3185. Find providers in these categories:



• Accounting Services
• Biobanking/Bioprocessing
• Clinical Research Centers
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• Contract Manufacturing / Supply Chain & Logistics Management
• Contract Research Organizations & Consulting Services
• Digital Health & Life Sciences IT/Data Science Technologies
• Financial / Investment / Funding Sources and Services
• HR / Talent Acquisition / Professional Development
• Insurance Services
• IT/Data Management and Software Platform Technologies/Cybersecurity
• Laboratory Services
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• Supplies - Laboratory / Environmental / Research Instrumentation & Other