Welcome to the latest edition of the BioLines Weekender...

COVID-19 has exposed just how vulnerable so many communities are in the face of disease and just how critical access to necessary treatment is to protecting and maintaining patient health. The pandemic has also exposed how deep health inequities continue to leave many underserved communities behind. Unfortunately, lawmakers are increasingly looking to the Institute for Clinical and Economic Review (ICER) and drug value assessment frameworks for how to accurately price new and innovative medical treatments -- many of which are being developed by life sciences companies that call New Jersey home. ICER uses the "Quality Adjusted Life Years" (QALY) methodology to determine the value of new drugs and then issues reports on these therapies when they come to the market. The value of a drug - as ICER sees it - can be determined by an equation that uses an arbitrary evaluation of one year of "perfect health" to determine this value.

A legal analysis of the QALY methodology found that it may actually violate the Americans with Disabilities Act (ADA), outlining how using the equation could reduce treatment access for people living with a disability. A similar analysis found that the QALY could deny access to treatments for senior populations. In a recent op-ed published in the Star-Ledger, BioNJ President and CEO Debbie Hart discusses the negative impact of QALY methodology in providing health equity for communities of color, seniors and patients with a rare disease. Click here for the full op-ed. 

Meanwhile, last week H.R. 3 was reintroduced in Congress. Unfortunately, this legislation will have a detrimental impact on innovation, reduce access to ground-breaking medicines and result in significant economic disruption to New Jersey's biopharmaceutical sector. Patients deserve legislation that encourages cures for diseases such as cancer and Alzheimer's, not drastic polices that would keep innovative therapies from the Patients who need them most. At a time when the biopharmaceutical industry continues to develop Vaccines and treatments to fight COVID-19, we urge New Jersey's U.S. Senators and Congressional delegation to oppose H.R.3 and instead support bipartisan solutions that will encourage future innovation and lower Patient out-of-pocket costs. 

Visit www.BioNJ.org/Protect-Medical-Innovation and join us in our efforts to protect medical innovation and ensure that patients have the medicines they need when they need them...Because Patients Can't Wait®. 

Because Patients Can't Wait®,
The BioNJ Team
BioNJ Calendar

BioNJ Finance Briefing: SEC Rule Changes, American Rescue Plan & New Jersey Economic Recovery Act
May 5, 2021
BioNJ BioPartnering Virtual Conference With J.P. Morgan and Johnson & Johnson Innovation
May 18-19, 2021
BioNJ Virtual Clinical Development Briefing
May 27, 2021
Value of Medical Innovation

Researchers at the National Pharmaceutical Council (NPC) and Discern Health published an article in the Journal of Clinical Pathways that offers recommendations to the Biden administration to make cancer care more patient-centered. The researchers suggest that the key to elevating patient voices is using the right tools when developing a value-based payment (VBP) model: patient-reported measures (PRMs), tools that capture patients' voices related to their care experiences and outcomes and patient-reported performance measures (PR-PMs), tools that translate PRM responses into metrics to compare health care performance and track changes over time.

Commercial health insurers are starting to admit what the biopharmaceutical research industry has been warning for some time: copay accumulator adjustment programs hurt patient outcomes and shift costs onto patients at the pharmacy counter. Those are some of the key findings from two new surveys that help demonstrate why these programs don't serve the best interests of patients. In a survey from MME, about 60% of insurers strongly agree that accumulator adjustment programs can shift costs to patients. And over half of insurers believe these programs can deter patients from taking their medicines as prescribed by their doctors.

BioNJ in the News
BioNJ Op-ed as published April 20, 2021 in the Star-Ledger

COVID-19 has exposed just how vulnerable so many communities are in the face of disease and just how critical access to necessary treatment is to protecting and maintaining patient health. The pandemic has also exposed how deep health inequities continue to leave many underserved communities behind. President Biden and lawmakers in New Jersey and states across the country have rightly made commitments to bridge these systemic disparities in our healthcare system and to improve treatment access and affordability. Unfortunately, lawmakers are increasingly looking to the Institute for Clinical and Economic Review (ICER) and drug value assessment frameworks for how to accurately price new and innovative medical treatments -- many of which are being developed by life sciences companies that call New Jersey home.

Pride of New Jersey

Live, play, work -- and help the State build an innovative economy that can compete on a global scale? That's the goal of The Cove JC. Upon completion, the mixed-use campus will encompass more than 13 acres, comprising 1.4 million square feet of lab/tech office space and 1.6 million square feet of residences, with ample room for parking. The Cove JC is being billed as a global hub for life sciences, tech and medicine offering an unrivalled ecosystem for discovery that will become the premier flagship destination for academic and commercial life sciences, tech and medical entities in New Jersey and the greater New York City area.

NJ Company News

Ramsey-based BioNJ Member ADMA Biologics, Inc. announced that the U.S. Food and Drug Administration has granted approval for the company's expanded manufacturing process, enabling fractionation and purification of a 4,400-liter plasma pool for the manufacture of Intravenous Immune Globulin. The 4,400-liter IVIG plasma pool scale for BIVIGAM® will allow ADMA to expand its manufacturing plant's total processing capacity from 400,000 liters to an anticipated peak throughput of up to 600,000 liters. ADMA now has FDA approval to produce BIVIGAM® at an expanded capacity with the same high quality as the previous manufacturing scale, while using the same equipment, release testing assays, disposables and labor force.

Princeton-based BioNJ Member Enalare Therapeutics Inc. announced that it has received an initial contract from the Biomedical Advanced Research and Development Authority, part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, to support development of the company's lead product ENA-001. The funding will be used to advance development of an intramuscular formulation for ENA-001, a New Chemical Entity with a novel mechanism of action and potential broad applications as an agnostic respiratory stimulant.

Plainsboro Township-based BioNJ Member Novo Nordisk announced the decision to enter Phase 3a development in obesity with oral semaglutide 50 mg. The decision follows the completion of the STEP phase 3a clinical programme with once-weekly subcutaneous (sc) semaglutide 2.4 mg. Novo Nordisk intends to initiate a pivotal phase 3a programme with approximately 1,000 people with obesity or overweight with comorbidities. The global 68-week trial is planned for initiation in the second half of 2021 and will investigate the efficacy and safety of oral semaglutide compared to placebo.

Princeton-based BioNJ Member Advaxis announced that the company has received the second milestone payment related to its licensing agreement for ADXS31-164, also known as ADXS-HER2, to OS Therapies for evaluation in the treatment of osteosarcoma in humans. Under the terms of the license agreement, OS Therapies, in collaboration with the Children's Oncology Group (COG), is responsible for the conduct and funding of a clinical study evaluating ADXS-HER2 in recurrent, completely resected osteosarcoma. OS Therapies recently completed a financing, triggering the second milestone payment.

Princeton-based BioNJ Member Soligenix, Inc. announced that Ellen Kim, M.D., Medical Director, Dermatology Clinic, Perelman Center for Advanced Medicine, Professor of Dermatology at the Hospital of the University of Pennsylvania, and the Lead Principal Investigator for the Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study, delivered a presentation at the American Academy of Dermatology Association Virtual Meeting. The presentation, which was designated "Top 12 Late-Breaking Research," expanded on data related to the efficacy and safety of HyBryte™ (SGX301) in the treatment of cutaneous T-cell lymphoma (CTCL).

Princeton-based BioNJ Member Soligenix, Inc. announced that its Senior Vice President and Chief Scientific Officer, Oreola Donini, Ph.D., delivered a presentation demonstrating the potency of the CiVax™ (COVID-19 vaccine) development program in mice and non-human primates (NHPs), at the Annual Conference on Vaccinology Research (ACVR). Utilizing its heat-stabilization technology, in conjunction with a novel, clinically-tested, adjuvant (CoVaccine HT™), Soligenix and its collaborators at the University of Hawaiʽi at Mānoa are developing a heat-stable subunit vaccine, targeted to enable ambient shipping and storage.
Bridgewater-based BioNJ Member Eli Lilly and Company Taltz® demonstrated greater success in key measured treatment outcomes compared to other biologics in adults with moderate to severe plaque psoriasis. In the first one-year network meta-analysis based on area under the curve, Taltz showed numerically greater cumulative benefits on completely clear skin over one year compared to seven other biologics, as measured by Psoriasis Area Severity Index 100. In three real-world analyses of U.S. claims data ranging from one to three years, patients treated with Taltz stayed on treatment longer, were more adherent to the prescription and had more days on monotherapy compared to the other biologics studied.

Bridgewater-based BioNJ Member Eli Lilly and Company announced results from a second Phase 3 trial evaluating the efficacy and safety of once-daily baricitinib 2-mg and 4-mg in adults with severe alopecia areata. The data are consistent with findings from the first Phase 3 clinical trial, BRAVE-AA2, top-lined earlier this year. In both investigational trials, a statistically significant proportion of patients treated with baricitinib achieved the primary endpoint of hair regrowth across the two dosing regimens at Week 36 compared to patients treated with placebo.

BioNJ Member Pfizer Inc., with offices in Peapack, and BioNTech SE announced they will supply an additional 100 million doses of COMIRNATY®, the companies' COVID-19 vaccine, to the 27 European Union (EU) member states in 2021. This announcement is a result of the European Commission's (EC) decision to exercise its option to purchase an additional 100 million doses under its expanded Advanced Purchase Agreement. This brings the total number of doses to be delivered to the EU to 600 million.

BioNJ Member Pfizer Inc., with offices in Peapack, announced that it has acquired Amplyx Pharmaceuticals, Inc. Amplyx's lead compound, Fosmanogepix, is a novel investigational asset under development for the treatment of invasive fungal infections. More than 1.5 million cases of invasive fungal infections occur worldwide each year, with mortality rates as high as 30-80% across infection types. Fosmanogepix is currently in Phase 2 clinical trials evaluating the safety and efficacy of both intravenous (IV) and oral formulations for the treatment of patients with life-threatening invasive fungal infections caused by molds, yeasts and rare molds (e.g., Aspergillus spp, Candida spp including Candida auris, Fusarium spp. and Scedosporium spp).

Bridgewater-based BioNJ Member Sanofi has entered into an agreement with Moderna, under which Sanofi will help manufacture Moderna´s COVID-19 vaccine, supporting the COVID-19 pandemic and vaccine supply needs. Sanofi will leverage its established infrastructure and manufacturing expertise at its site in Ridgefield, NJ, to perform fill and finish of up to 200 million doses of Moderna's COVID-19 vaccine. This marks Sanofi's third commitment to provide manufacturing support. Earlier this year, Sanofi announced the company will provide support to BioNTech for 125 million doses for the European Union.

Bridgewater-based BioNJ Member Sanofi announced the European Commission (EC) has approved Sarclisa® in combination with carfilzomib and dexamethasone for the treatment of adult patients with relapsed multiple myeloma who have received at least one prior therapy. This marks the second EC approval of Sarclisa in combination with a standard of care regimen in less than 12 months. "This new therapeutic regimen has the potential to become a standard of care for patients with relapsed multiple myeloma, who now have another treatment option earlier in the progression of their disease," said Philippe Moreau, M.D., Department of Hematology, University Hospital of Nantes, France.

Bridgewater-based BioNJ Member Sanofi announced new analyses from Dupixent® (dupilumab) trials evaluated infection incidence reduction and reinforced the need for no laboratory monitoring in patients six years and older with moderate-to-severe atopic dermatitis. Additional analyses evaluated response rates across a broad population, and the impact of Dupixent on disease extent and severity, quality of life (QoL) and itch.

Bridgewater-based BioNJ Member Sanofi announced positive topline results from the Phase 3 MELODY trial showed nirsevimab reduced lower respiratory tract infections requiring medical attention (inpatient or outpatient) due to respiratory syncytial virus in healthy preterm and term infants. RSV is the most common cause of LRTI and the leading cause of hospitalizations in all infants. Nirsevimab reached its primary endpoint, achieving a statistically significant absolute reduction of LRTI caused by RSV in healthy preterm and term infants compared to placebo through a typical RSV season.

Berkeley Heights-based BioNJ Member Amgen announced that the U.S. Food and Drug Administration granted Breakthrough Therapy Designation for investigational bemarituzumab as first-line treatment for patients with fibroblast growth factor receptor 2b (FGFR2b) overexpressing and human epidermal growth factor receptor 2 (HER2)-negative metastatic and locally advanced gastric and gastroesophageal adenocarcinoma in combination with modified FOLFOX6 (fluoropyrimidine, leucovorin, and oxaliplatin), based on an FDA-approved companion diagnostic assay showing at least 10% of tumor cells overexpressing FGFR2b.

Berkeley Heights-based BioNJ Member Amgen announced Otezla® (apremilast) improved measures of disease severity in adults with mild-to-moderate plaque psoriasis regardless of their Body Surface Area affected by the disease, according to findings from the placebo-controlled, Phase 3 ADVANCE trial. In ADVANCE, oral Otezla 30 mg twice daily achieved a statistically significant improvement of the primary endpoint of static Physician's Global Assessment (sPGA) response at week 16 compared to placebo (21.6% vs. 4.1%, p<0.0001). These clinical improvements were maintained through week 32.

Princeton-based BioNJ Member Evotec announced that the company has invested into OxVax, a new immuno-oncology company based on research from Oxford University, which enables the development of the next generation of cancer vaccines with the potential to overcome the limitations of the current approaches. OxVax is developing an innovative cancer vaccine platform based on a unique and proprietary population of dendritic cells capable of inducing a potent anti-tumour immune response.
Princeton-based BioNJ Member Evotec announced that Princeton-based BioNJ Member Bristol Myers Squibb has decided to exercise their option to extend its partnership with Evotec in the field of targeted protein degradation. Evotec and Bristol Myers initiated this strategic drug discovery and development partnership in 2018 with the goal to identify first-in-class drug candidates initially focusing on solid tumours. The partnership leverages Evotec's proprietary PanOmics platform, which combines enhanced throughput proteomics, high throughput transcriptomics and cell imaging with the integrated data analysis platform PanHunter.

Princeton-based BioNJ Member Bristol Myers Squibb announced that Opdivo (nivolumab) (injection for intravenous use), in combination with fluoropyrimidine- and platinum-containing chemotherapy, was approved by the U.S. Food and Drug Administration for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma, regardless of PD-L1 expression status. The approval is based on the Phase 3 CheckMate -649 trial evaluating Opdivo in combination with mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin), compared to chemotherapy (mFOLFOX6 or CapeOX) alone.

Princeton-based BioNJ Member Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adults with unresectable malignant pleural mesothelioma (MPM). The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP recommendation. The positive CHMP opinion is based on results from CheckMate -743, the first and only positive Phase 3 immunotherapy trial in first-line MPM.

Princeton-based BioNJ Member Bristol Myers Squibb announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Onureg® (azacitidine tablets; CC-486) as a maintenance therapy in adult patients with acute myeloid leukemia (AML) who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, hematopoietic stem cell transplantation (HSCT).

Princeton-based BioNJ Member Bristol Myers Squibb announced positive results from two pivotal Phase 3 trials evaluating deucravacitinib, an oral, selective tyrosine kinase 2 (TYK2) inhibitor, for the treatment of patients with moderate to severe plaque psoriasis. The POETYK PSO-1 and POETYK PSO-2 trials, which evaluated deucravacitinib 6 mg once daily, met both co-primary endpoints versus placebo, with significantly more patients achieving Psoriasis Area and Severity Index (PASI) 75 response and a static Physician's Global Assessment score of clear or almost clear (sPGA 0/1) after 16 weeks of treatment with deucravacitinib. Deucravacitinib was well tolerated with a low rate of discontinuation due to adverse events (AEs).

Warren-based BioNJ Member GlaxoSmithKline announced the European Commission has granted conditional marketing authorisation for JEMPERLI (dostarlimab), a programmed death receptor-1 (PD-1)-blocking antibody, for use in women with mismatch repair-deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer who have progressed on or following prior treatment with a platinum containing regimen. The approval makes dostarlimab the first anti-PD-1 therapy available for endometrial cancer in Europe.

Warren-based BioNJ Member GlaxoSmithKline announced that the U.S. Food and Drug Administration (FDA) has approved JEMPERLI (dostarlimab-gxly), a programmed death receptor-1 (PD-1) blocking antibody, based on the company's Biologics License Application. JEMPERLI is indicated for the treatment of adult patients with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that have progressed on or following prior treatment with a platinum-containing regimen. This indication is approved under accelerated approval based on tumor response rate and durability of response.

East Hanover-based BioNJ Member Novartis announced new post hoc data from the Phase III ASCLEPIOS trials showing Kesimpta® (ofatumumab) reduced the risk of disability progression independent of relapse activity (PIRA) at three and six months vs teriflunomide in a subgroup of newly diagnosed, treatment-naïve patients with relapsing forms of multiple sclerosis (RMS). These data further support Kesimpta as a first-choice treatment option for adults with RMS.

East Hanover-based BioNJ Member Novartis announced plans to initiate SMART, a Phase 3b clinical study to evaluate the safety and efficacy of Zolgensma® (onasemnogene abeparvovec) in young children with spinal muscular atrophy (SMA) weighing ≥ 8.5 kg and ≤ 21 kg, following a one-time, intravenous (IV) infusion. The new clinical data will supplement emerging real-world evidence and use of this innovative therapy in the European Union and Canada, where regulatory approval includes dosing guidance for babies and young children up to 21 kg.

New Brunswick-based BioNJ Member Johnson & Johnson made the Top 100 of Forbes' list of America's Best Employers for Diversity in 2021. Johnson & Johnson came in at No. 44. Forbes ranked 500 companies for the fourth annual version of the list. The final list ranks the 500 employers that not only received the most recommendations, but also boast the most diverse boards and executive ranks, as well as the most proactive diversity and inclusion initiatives. A number of companies on the list have a strong presence in New Jersey.

Raritan-based BioNJ Member BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced new Phase 3 data which showed TREMFYA® (guselkumab) sustained durable, complete skin clearance rates in a majority of adults with moderate to severe plaque psoriasis (PsO) through five years (252 weeks), and improved disease activity and axial symptoms in adults with active psoriatic arthritis (PsA) through one year (52 weeks). TREMFYA is the first and only selective interleukin (IL)-23 inhibitor therapy approved in the U.S. to treat both adults with moderate to severe plaque PsO who are candidates for systemic therapy or phototherapy and adults with active PsA.

Morris Plains-based BioNJ Member Gilead Sciences, Inc. announced that in response to the rapid increase in COVID-19 cases in India, the company is providing its voluntary licensing partners with technical assistance, support for the addition of new local manufacturing facilities and the donation of active pharmaceutical ingredient (API) to rapidly scale up production of remdesivir. Remdesivir is approved in India for restricted emergency use for the treatment of suspected or laboratory confirmed COVID-19 in adults and children hospitalized with severe disease. In addition to providing support to its licensees to expand their local manufacturing capacity.

Kenilworth-based BioNJ Member Merck & Co. announced that the company has entered into non-exclusive voluntary licensing agreements for molnupiravir with five established Indian generics manufacturers. Molnupiravir is an investigational oral antiviral agent currently being studied in a Phase 3 trial for the treatment of non-hospitalized patients with confirmed COVID-19. Merck is developing molnupiravir in collaboration with Ridgeback Biotherapeutics. Merck has entered into these agreements to accelerate availability of molnupiravir in India and in other low- and middle-income countries (LMICs) following approvals or emergency authorization by local regulatory agencies.

Woodcliff Lake-based Eisai Co., Ltd. and MSD K.K., a subsidiary of BioNJ Member Merck & Co., announced an application submission in Japan for the additional indication of Eisai's in-house discovered and developed multiple receptor tyrosine kinase inhibitor, LENVIMA® (generic name: lenvatinib mesylate), in combination with Merck's  KEYTRUDA® (generic name: pembrolizumab) as a treatment for patients with advanced uterine body cancer. This application is based on the results of the pivotal Phase 3 Study 309/KEYNOTE-775 for the treatment of patients with advanced endometrial carcinoma (advanced uterine body cancer in Japan), following at least one prior platinum-based regimen.

Woodcliff Lake-based Eisai Co., Ltd. and BioNJ-Member Biogen Inc. announced the publication of an article, "A Randomized, Double-Blind Phase 2b Proof of Concept Clinical Trial in Early Alzheimer's Disease with Lecanemab, an Anti-Aβ Protofibril Antibody", in Alzheimer's Research and Therapy. The manuscript describes results from Study 201, a Phase 2b proof-of-concept clinical trial that explored the impact of treatment with lecanemab (BAN2401) on reducing brain amyloid beta (Aβ) and clinical decline. The manuscript concluded that the pre-specified analysis showed consistent reduction of clinical decline across several clinical and biomarker endpoints at the highest doses, which the Phase 3 clinical trial Clarity AD aims to confirm.

Mendham-based Antios Therapeutics, Inc. announced that it has dosed the first patients in its Sustained Anti-Viral Efficacy (SAVE) clinical trial, a Phase 2a study of ATI-2173, an Active Site Polymerase Inhibitor Nucleotide (ASPIN) in clinical development as a backbone of a potentially curative regimen for chronic HBV. The double-blind randomized controlled trial plans to enroll 30 patients and will assess the safety and efficacy of 25mg and 50mg doses of ATI-2173 in combination with tenofovir (TDF) compared with TDF plus ATI-placebo (control) in chronic HBV-infected subjects.

New Providence-based ADC Therapeutics SA announced that the U.S. Food and Drug Administration (FDA) has approved ZYNLONTA™ (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low grade lymphoma and high-grade B-cell lymphoma.1 ZYNLONTA, a CD19-targeted antibody drug conjugate (ADC), has been granted accelerated approval by the FDA based on overall response rate.

Monmouth Junction-based Tris Pharma, Inc. announced that it has acquired Park Therapeutics, a company developing a unique, first-in-class, investigational NCE for the treatment of pain which is Phase III-ready. Studies have demonstrated the potential for the NCE to provide strong efficacy in nociceptive and neuropathic pain, while maintaining a highly differentiated safety profile results from its unique, first-in-class dual mechanism of action as a highly potent agonist of the nociceptin/orphanin FQ (NOP), DOP and MOP receptors and partial agonist of KOP receptors.

Florham Park-based Shionogi & Co., Ltd. announced that Shionogi has concluded a research collaboration agreement with InveniAI® LLC regarding AI-powered multi-target drug discovery in area of psycho-neurological system using AlphaMeld®. AlphaMeld® is a machine learning algorithm built on datasets accumulated over more than a decade that not only selects target molecules related to specified diseases, but also visualizes factors associated with that disease. It is an AI drug discovery platform that enables the identification of multiple targets related to a specific disease and the mechanisms for treating those diseases.

Florham Park-based Shionogi & Co., Ltd. announced that Shionogi filed application for marketing approval of Th2 chemokine TARC kit "HISCL® TARC reagent", which is being marketed as anin vitro diagnostics, for the purpose of assisting in predicting exacerbation in novel coronavirus (SARS-CoV-2)-positive patients. This test kit is available as an aid in assessing the severity of atopic dermatitis. It is possible to easily measure TARC, which is a type of chemokine (strain name: CCL17) that increases as the symptomatic worsening of atopic dermatitis.

Ridgefield Park-based BeiGene announced positive results from a planned interim analysis of the Phase 3 ALPINE trial comparing BRUKINSA® (zanubrutinib) against ibrutinib in adults with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). BRUKINSA met the primary endpoint of the trial, demonstrating non-inferiority in objective response rate (ORR) by both investigator and independent review committee (IRC) assessments (p < 0.0001).

Basking Ridge-based Daiichi Sankyo Company announced that it has entered into an exclusive licensing agreement with Esperion Therapeutics, Inc. to market bempedoic acid, their proprietary oral oncedaily drug for the treatment of hypercholesterolemia, in South Korea, Brazil, Taiwan, Hong Kong, Macao, Thailand, Vietnam, Myanmar and Cambodia. Under the Agreement, Daiichi Sankyo will be responsible for the commercialization of bempedoic acid and the bempedoic acid/ezetimibe combination, while Esperion will be responsible for their manufacture.



People in the News

ROI-NJ announces its first-ever Influencers Technology List. We're overwhelmed with the quality of honorees on the list -- and humbled to know that there are many others out there deserving of the recognition. We're confident this list will only grow each year. Congratulations to these BioNJ Members for making the list:
Top 10:
Joel Bloom, New Jersey Institute of Technology; Nariman Farvadin, Stevens Institute of Technology and Kathleen Coviello, New Jersey Economic Development Authority

Founders: 
Andras Forgacs, Modern Meadows

Investors: 
Jim Gunton and Steve Socolof, Tech Council Ventures and Lyneir Richardson, Rutgers Business School

Thought Leaders: 
Ruha Benjamin, Princeton University; Judith Sheft, New Jersey Commission on Science, Innovation and Technology and David Sorin, McCarter & English  

Academics:
David Bader, New Jersey Institute of Technology; Jason Corso, Stevens Institute of Artificial Intelligence; Andrea Goldsmith and Rod Priestley, Princeton University; Pavita Howe, Rutgers University and Simon Nynens, New Jersey Innovation Institute

Iselin-based BioNJ Member Helsinn announced the appointment of Dr. Mary Lynne Hedley as a new member of its Board of Directors..Dr. Hedley is an immunologist and cancer cell biologist, with a vast level of experience within the pharmaceutical industry, specifically within the field of oncology. Most recently, Dr Hedley was Director, President and Chief Operating Officer at TESARO, a biotechnology company she co-founded in 2010, focused on the development and global commercialization of oncology therapeutics. During her time at TESARO the team built up a pipeline of early and late stage drug candidates including the commercial product niraparib, a PARP inhibitor that changed the treatment paradigm for women diagnosed with ovarian cancer.

Mendham-based Antios Therapeutics, Inc. announced the appointments of two experienced drug development executives, Katie Laessig, M.D., as Senior Vice President, Global Regulatory Affairs, and Karen Fusaro as Senior Vice President, Clinical Operations. These appointments add significant depth to the company's drug development team, which is focused on the clinical development of ATI-2173, an Active Site Polymerase Inhibitor Nucleotide (ASPIN), for the treatment of patients with chronic hepatitis B virus (HBV) infection. Both will report to Douglas Mayers, M.D., Chief Medical Officer of Antios.

Ewing-based Antares Pharma, Inc. announced the appointment of Peter Richardson, MRCP, as Executive Vice President, Research and Development and Chief Medical Officer. In this role, Dr. Richardson will oversee the Company's proprietary research and development programs, including ideation, formulation, clinical operations, pharmacovigilance and medical affairs. Dr. Richardson has over 25 years of research and development experience in the pharmaceutical and medical device industry. He has created centers of excellence that have enabled and supported product development pipelines encompassing small molecules, biologics, novel formulations, combination products and medical devices.

Franklin Lakes-based BD (Becton, Dickinson and Company), announced the appointment of Elizabeth McCombs as executive vice president and Chief Technology Officer, succeeding succeeding John DeFord. Ms. McCombs will be responsible for continuing to drive the company's category innovation strategy and leading all research and development (R&D) activities, including executing the current innovation pipeline and developing the future product portfolio. Ms. McCombs, who brings more than 20 years of extensive experience in advanced medical device innovation to her new role, joined BD in 2019 as the senior vice president of R&D for the BD Medical Segment.

Academia/Healthcare/institutions

Five universities in New Jersey were among 209 honored by the Princeton Review on its Best Value Colleges list. Drew University, New Jersey Institute of Technology, Princeton University, Stevens Institute of Technology and The College of New Jersey were among the schools honored. The schools were listed alphabetically; there was no numerical ranking.
Princeton Review listed the following for its methodology: "Our Best Value Colleges list is based on a combination of institutional and student survey data, including academic rigor, affordability and career outcomes for graduates, among others."

Prrinceton University will undergo one of the most extensive building programs in its history over the next decade -- adding some 3 million square feet in new construction to house more students, expand research facilities, and replace aging buildings and infrastructure.
The plans include new residential colleges to permit the University to increase its undergraduate student body by 10 percent; new facilities to support teaching and research in engineering and environmental studies; additional graduate student housing; added parking; and expanded athletic facilities, including a 2,100-seat soccer stadium and a racquet center with fitness space.

Princeton University will be able to greatly enhance numerous opportunity initiatives it is using to enable more students to find a pathway to success to, through and beyond the school, thanks to a generous donation from alumna Emma Bloomberg. Thanks to the gift from Bloomberg and Bloomberg Philanthropies, the university will establish the Emma Bloomberg Center for Access and Opportunity at Princeton. Princeton officials said the center will unite and strengthen the university's access and opportunity initiatives for first-generation and lower-income applicants, while creating a model and providing resources for bolstering similar efforts at universities across the country.

Federally funded research at Princeton University can be directly traced to two start-up companies that have contributed $6.3 million to the national gross domestic product and spurred creation of 62 jobs in research and operations, according to a recent report. The report, issued by the nonprofit research-advocacy organization the Science Coalition, details the economic benefits stemming from federal investment in fundamental research at its more than 50 member universities, including Princeton. Statewide, spinouts from the New Jersey-based universities featured in the report (including Princeton) generated $12.8 million in tax revenue for New Jersey, $46 million in tax revenue for the United States and $208 million in GDP from 2015 to 2019.

Eileen White of Rutgers University and Peter Constantin of Princeton University were among 120 new members elected to the National Academy of Sciences. The honor is given in recognition of distinguished and continuing achievements in original research. Thirty international members also were elected. Dr. White, the associate director at the Rutgers Cancer Institute of New Jersey, was one of 59 women to be so honored -- the most elected in a single year. Those elected bring the total number of active members to 2,461 and the total number of international members to 511.

The proposal calls for a type of breathalyzer that collects the particles of breath into an electronic biosensor, and then quickly produces a result "in minutes and without the need for an uncomfortable swab test." Edward DeMauro, the project's lead researcher, said the aim is to have a turnaround in no more than 10 minutes. "In addition to helping diagnose COVID-19, the goal of the project is to create a platform that can be expanded into a future, easy-to-use, non-invasive rapid breathalyzer to diagnose respiratory diseases, including possible future pandemics," said Dr. DeMauro, an assistant professor at Rutgers' Department of Mechanical and Aerospace Engineering.

The New Jersey State Cancer Registry, under the direction of the State Department of Health in partnership with Rutgers Cancer Institute of New Jersey, has been awarded a seven-year, $9,085,109 contract (75N91021D00009) from the National Cancer Institute (NCI) to support core infrastructure and research activities as part of the Surveillance, Epidemiology, and End Results (SEER) Program. The SEER Program is considered to be the most authoritative source of information on cancer incidence and survival in the United States. The NJSCR is one of only 18 population-based CORE registries in the country that are part of the SEER Program and is one of only three awarded SEER CORE infrastructure contracts during this highly competitive round of funding from the NCI.

T-cell acute lymphoblastic leukemia (T-ALL) is an aggressive type of leukemia in which too many T-cell lymphoblasts, or immature white blood cells, are found in the bone marrow and blood. Researchers from Rutgers Cancer Institute of New Jersey, the State's only National Cancer Institute-designated Comprehensive Cancer Center, recently discovered that a mitochondrial uncoupling drug is toxic against leukemic cells, revealing a potential therapeutic strategy against T-ALL. Daniel Herranz, PharmD, Ph.D., resident researcher at Rutgers Cancer Institute and assistant professor of pharmacology at Rutgers Robert Wood Johnson Medical School, is senior author of the work.

Rutgers Cancer Institute of New Jersey Associate Chief of Urology and Urologic Oncology and Director of the Kidney Cancer Program Eric A. Singer, M.D., MA, MS, FACS, has been named a Fellow of the American Society of Clinical Oncology. Dr. Singer, an expert in the management of kidney cancer, has been a member of ASCO since 2003 and has served on the ethics committee, clinical practice guidelines committee, annual meeting education committee, and twice as a guideline chair. Singer works closely with his medical oncology and radiation oncology colleagues to offer patients an individualized and comprehensive cancer treatment plan that minimizes side effects and maximizes quality-of-life.

Rutgers University President Jonathan Holloway announced that Antonio D. Tillis will assume the post of chancellor of Rutgers University-Camden. Mr. Tillis will lead Rutgers University-Camden, the southernmost campus of Rutgers, The State University of New Jersey, with more than 7,200 undergraduate and graduate students enrolled in 39 undergraduate and 29 graduate programs. Mr. Tillis recently served as interim president of the University of Houston-Downtown, a comprehensive urban institution offering more than 50 degree-granting programs and serving more than 15,000 students.

Morristown Medical Center and Hackensack University Medical Center were among 200 hospitals on the World's Best Hospitals rankings by Newsweek. Both hospitals were ranked in the 101-200 category. Five New Jersey medical centers made the list of the top hospitals in the U.S.: Morristown, Hackensack, Valley Hospital (Ridgewood), Overlook Medical Center (Summit) and Newark Beth Israel Medical Center.

BioNJ Member Services Provider Directory

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 [email protected], or 609-890-3185. Find providers in these categories:

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