A Positive from Pandemic: Increased Interest in Studying Infectious Diseases

There aren’t a lot of doctors like David Perlin, the highly accomplished and globally recognized biomedical researcher who runs the Center for Discovery and Innovation for Hackensack Meridian Health as its chief scientific officer. But it’s not just his world-class smarts that sets Perlin apart — it’s his willingness to devote himself to the important (but far from glamorous) work of developing molecular insights and technologies to detect, combat and prevent deadly infections. That may be changing. The work of Perlin and other infectious disease specialists during the pandemic not only drew appreciation from others — it has spurred a new generation of scientific researchers to consider the field.

The Powerful Private Organization Putting a Price on Life – Again and Again

Every year on Groundhog Day, those of us who grew up in snowy states will wait to see whether Punxsutawney Phil will spot his shadow. But for millions of families living with Alzheimer’s disease, this Groundhog Day may feel more like the time loop trap from the 1993 Bill Murray movie. That's because this year, an influential non-governmental organization – which markets itself as the arbiter of which medical treatments are worth insurance coverage – has made February 2nd the final day for patients to voice their opinions on the value of a new Alzheimer's drug. 

Survey Shows Strong Bipartisan Support for Investing in Research

Americans weigh in before the President’s State of the Union address: “important for the U.S. to be a global leader in science and technology.” According to data released from a January 2023 survey commissioned by Research!America, Americans across the political spectrum agree R&D investment drives job creation, innovation and global leadership. There is strong, bipartisan support for federal investment in our nation’s science and technology enterprise. Some takeaways: 1) 91% of Americans agree it is important for the U.S. to be a global leader in science and technology. 2) More than 3 in 4 Americans say R&D investment is creating employment opportunities for people in this country. 3) 63% of Americans are willing to pay $1 dollar more per week in taxes in support of medical and health research.

BioNJ Celebrates 30 Years at Anniversary Dinner

“As always, tonight is dedicated to you, New Jersey’s remarkable life sciences ecosystem making the dreams of patients around the world come true,” BioNJ President and CEO Debbie Hart told a packed room gathered at the East Brunswick Hilton for the organization’s 30th anniversary of the Annual Dinner Meeting & Innovation Celebration. “In 2022, nearly 50% of new FDA [U.S. Food and Drug Administration] approvals came from companies with a footprint in New Jersey, officially continuing our legacy as the ‘Medicine Chest of the World.’” The annual event celebrates the State’s life sciences industry and honors medical innovation. Hart said the program is dedicated to patients, innovators, advocates, policymakers and service providers who are working together to bring new therapies and cures to those around the world in need.

BioNJ Elects Board Chair, Officers and Trustees

BioNJ, New Jersey's life sciences trade association, announced the election of its 2023 Officers and Board Members. The election preceded BioNJ's 30th Annual Dinner Meeting and Innovation Celebration on February 2 at the Hilton East Brunswick where hundreds of life sciences leaders turned out to celebrate the industry and its accomplishments over dinner, networking and awards presentations. Newly elected Officers include Chair Amadou Diarra, Ph.D., Senior Vice President, Global Policy, Advocacy & Government Affairs, Bristol Myers Squibb; Vice Chair Emer Leahy, Ph.D., MBA, President & CEO, PsychoGenics; Treasurer Jayne C. Gershkowitz, Chief Patient Advocate, Amicus Therapeutics; and Secretary Christopher Mortko, Ph.D., MBA, Vice President & Head, HQ Research and Evaluation, Merck Business Development & Licensing.

BioNJ Celebrates Garden State’s Life Science Industry

Last night, BioNJ hosted its 30th Annual Dinner Meeting and Innovation Celebration at the Hilton East Brunswick. The event brought together industry leaders across the life sciences ecosystem and honored the medical innovation emanating from New Jersey. “The Garden State remains a leading innovation powerhouse, with nearly 50% of all new FDA approvals in 2022 coming from companies with a footprint in New Jersey,” said BioNJ President and CEO Debbie Hart. The evening featured several honoree traditions, including recognizing the 19 companies that received FDA approvals last year; presenting the Dr. Sol J. Barer Award for Vision, Innovation and Leadership to Dr. David Perlin, Chief Scientific Officer and Executive Vice President of the Hackensack Meridian Center for Discovery for Innovation (CDI); and awarding the Heart of BioNJ Award to Maria Kefalas, founder of The Calliope Joy Foundation.

Hackensack Meridian’s David Perlin Receives BioNJ Award

David Perlin, Ph.D., Chief sScientific Officer and Executive Vice President of the Hackensack Meridian Center for Discovery and Innovation (CDI) has been honored with BioNJ’s 2023 Dr. Sol J. Barer Award for Vision, Innovation and Leadership. Dr. Perlin has served as the founding chief scientific officer of the CDI since its inception in 2019 to address unmet medical needs in infectious diseases, cancers, behavioral health, autoimmune, and neurocognitive disorders, as well as other acute and chronic health problems. “Dr. Perlin is an exceptional leader whose expertise and dedication elevates and advances our health network mission to transform health care and serve as a leader of positive change,” said Robert C. Garrett, FACHE, CEO of Hackensack Meridian Health.

HELIX in New Brunswick Becomes First Project Approved Under the Aspire Tax Credit Program

The New Jersey Economic Development Authority Board approved the first award under the Aspire program to support the development of the New Jersey Health + Life Sciences Exchange (HELIX) in downtown New Brunswick. The HELIX will bring together New Jersey’s public, private and academic sectors to create a world-class hub of innovation and a strong base of support and talent pipeline for innovative companies. “Today’s announcement is incredibly important,” said BioNJ President and CEO Debbie Hart. “The HELIX will be a game-changer for New Jersey – bringing together public and private sectors, along with academia and investors, allowing for ‘new businesses to be born’ and ‘new jobs to be created.’ This is a significant milestone for New Jersey’s innovation ecosystem.”

U.S. FDA Approves Trodelvy® in Pre-treated HR+/HER2- Metastatic Breast Cancer

BioNJ Member Gilead Sciences, Inc., with a site in Morris Plains, announced the U.S. Food and Drug Administration (FDA) has approved Trodelvy® (sacituzumab govitecan-hziy) for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. The approval is based on statistically significant and clinically meaningful progression-free survival and overall survival data from the Phase 3 TROPiCS-02 study. Trodelvy is now also recommended as a Category 1, preferred treatment for metastatic HR+/HER2- breast cancer by the National Comprehensive Cancer Network® (NCCN®) as defined in the Clinical Practice Guidelines in Oncology (NCCN Guidelines®). 

Y-mAbs and the European Medicines Agency Reach Agreement on the Pediatric Investigation Plan for Naxitamab

BioNJ Member Y-mAbs Therapeutics, Inc., with a site in Nutley, announced that the European Medicines Agency (“EMA”) has agreed to the company’s proposed Pediatric Investigation Plan (“PIP”) for naxitamab. The decision follows a positive opinion from EMA’s Pediatric Committee (“PDCO”). Naxitamab is being developed by Y-mAbs for the treatment of patients with relapsed/refractory high-risk neuroblastoma, which is the indication targeted by the PIP, as well as osteosarcoma. A PIP outlines a pharmaceutical company’s strategy for investigation of the new medicinal product in the pediatric population and is a required submission as part of the regulatory process for the registration of new medicines in Europe. An approved PIP is a prerequisite for filing a Marketing Authorization Application (“MAA”) for any new medicinal product in Europe.

PTC Therapeutics Receives 2023 EURORDIS Black Pearl Company Award for Innovation

South Plainfield-based BioNJ Member PTC Therapeutics announced that the company has been named the winner of 2023 EURORDIS Black Pearl Company Award for Innovation. The Black Pearl Awards recognize and celebrate companies who have undertaken ground-breaking activities to advance rare disease research and medicine development. "We are honored to accept this award and deeply appreciate the recognition of PTC's commitment to providing access to best-in-class treatments for people living with rare diseases with little to no treatment options," said Stuart W. Peltz, Ph.D., Chief Executive Officer, PTC Therapeutics. "This award is especially meaningful as we proudly celebrate our 25-year history of serving the rare disease community."

Spesolimab Meets Primary and Key Secondary Endpoint for Prevention of Generalized Pustular Psoriasis Flares

BioNJ Member Boehringer Ingelheim, with a site in North Brunswick, announced that EFFISAYIL™ 2 met its primary and key secondary endpoint, demonstrating that spesolimab, an anti-interleukin-36 receptor antibody, can prevent flares in adolescents and adults with generalized pustular psoriasis (GPP) up to 48 weeks. Safety data were in line with previously conducted clinical trials with spesolimab. “Painful GPP flares can occur suddenly, escalate quickly, and may require urgent hospital care leaving people anxious and uncertain about what the future might hold,” said Carinne Brouillon, Member of the Board of Managing Directors, responsible for Human Pharma, Boehringer Ingelheim. “The EFFISAYIL™ 2 results reinforce the potential of spesolimab to prevent GPP flares, giving patients the power to plan their lives, regardless of their disease.” 

Agile Therapeutics Provides Clinical Update on Twirla and Status of Pipeline Evaluation

Princeton-based BioNJ Member Agile Therapeutics, Inc. provided an update on the Twirla® post marketing studies and status of its ongoing evaluation of the company’s pipeline. As part of Twirla’s approval, the United States Food and Drug Administration (FDA) required the company to conduct a long-term prospective, multi-center clinical post-marketing requirement study (PMR) comparing the risks of venous thromboembolism (VTE) and arterial thromboembolism (ATE) in new users of Twirla to new users of combined hormonal contraceptives (CHCs) and Ortho Evra generic patches. In January 2023, the FDA agreed with the company’s proposal to address this PMR using electronic health records (EHR) and insurance claims from a large database from multiple healthcare systems. The FDA also agreed to extend the study timelines. 

Hillstream BioPharma Signs an Exclusive Option Agreement to Advance Next-Generation Anti-MUC1-C Agents for Drug Resistant Cancers

Bridgewater-based BioNJ Member Hillstream BioPharma, Inc. announced signing an exclusive option agreement with Dana-Farber Cancer Institute to license technology targeting the MUC1-C oncoprotein. The MUC1 gene was identified by Dr. Donald Kufe, Distinguished Physician and Researcher at Dana-Farber and based on its overexpression in human cancers. Dr. Kufe’s long-standing work has supported the premise that prolonged activation of MUC1-C in settings of chronic inflammation promotes cancer. “We look forward to this unique opportunity to work with Dr. Kufe and Dana-Farber,” said Randy Milby, CEO of Hillstream. “This agreement allows Hillstream to leverage our Quatramer platform to advance anti-MUC1-C agents targeting CSCs for the treatment of highly aggressive tumors, which represents a major unmet need for patients.” 

First Wave BioPharma Announces Initiation of Phase 2 Trial Investigating Enhanced Adrulipase Formulation in Exocrine Pancreatic Insufficiency in Patients With Cystic Fibrosis

BioNJ Member First Wave BioPharma, Inc., with a site in Roseland, announced that the company will initiate its planned Phase 2 clinical trial of an enhanced enteric microgranule delivery formulation for adrulipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF). The U.S. Food and Drug Administration (FDA) has reviewed the Investigational New Drug (IND) amendment and after requesting and receiving a modified protocol, has not provided any further comments in the 60-day period of review. The Phase 2 multi-center study is designed to investigate the safety, tolerability and efficacy of an enteric microgranule delivery formulation for adrulipase in a titrated dose-escalation study involving an estimated twelve (12) patients. 

First Wave BioPharma Announces First Patient Screened for Phase 2 SPAN Adrulipase Trial in Cystic Fibrosis

BioNJ Member First Wave BioPharma, Inc., with a site in Roseland, announced that the first patient was screened for the Phase 2 SPAN clinical trial investigating an enhanced enteric microgranule delivery formulation of adrulipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF). Patient dosing is expected to commence by mid-February with topline results from the study to be available by mid-2023. The Phase 2 multi-center clinical trial is designed to investigate the safety, tolerability and efficacy of an enteric microgranule delivery formulation for adrulipase in a titrated dose-escalation study involving an estimated twelve (12) patients. The primary efficacy endpoint is the coefficient of fat absorption (CFA), with secondary endpoints of stool weight, signs and symptoms of malabsorption and coefficient of nitrogen absorption (CNA). 

Dupixent® (dupilumab) Approved by European Commission as the First and Only Targeted Medicine Indicated for Eosinophilic Esophagitis

Bridgewater-based BioNJ Member Sanofi announced that The European Commission (EC) has expanded the marketing authorization for Dupixent® (dupilumab) in the European Union (EU) to treat eosinophilic esophagitis (EoE) in adults and adolescents 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy. EoE is a chronic, progressive inflammatory disease that damages the esophagus and prevents it from working properly. With this approval, Dupixent is the first and only targeted medicine specifically indicated to treat EoE in Europe and the U.S.

Dupixent® (dupilumab) Recommended for Expanded EU Approval by the CHMP to Treat Children as Young as Six Months Old With Severe Atopic Dermatitis

Bridgewater-based BioNJ Member Sanofi announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Dupixent® (dupilumab), recommending expanded approval in the European Union (EU) to treat severe atopic dermatitis in children 6 months to 5 years old who are candidates for systemic therapy. The European Commission is expected to announce a final decision on the Dupixent application in the coming months. In June 2022, Dupixent was approved by the U.S. Food and Drug Administration for children in this age group. The positive CHMP opinion is supported by data from a Phase 3 trial in children 6 months to 5 years of age recently published in The Lancet, which met all primary and secondary endpoints. 

NEJM Publishes Once-Weekly Efanesoctocog Alfa Phase 3 Data Demonstrating its Potential to Transform the Treatment Landscape for People With Hemophilia A

Bridgewater-based BioNJ Member Sanofi announced that pivotal study data published in The New England Journal of Medicine (NEJM) continues to highlight the efficacy, safety and pharmacokinetic profile of efanesoctocog alfa, an investigational treatment for hemophilia A. These data demonstrate that efanesoctocog alfa delivered normal to near-normal factor activity levels (>40%) for the majority of the week with once-weekly dosing. Efanesoctocog alfa is currently under priority review by the United States Food and Drug Administration (FDA) and the target action date for the decision is February 28, 2023. The data from the pivotal XTEND-1 Phase 3 study published in NEJM show that efanesoctocog alfa met primary and key secondary endpoints, demonstrating clinically meaningful prevention of bleeds and superior bleed protection compared to prior factor VIII prophylaxis based on an intra-patient comparison. 

Jesduvroq (daprodustat) Approved by U.S. FDA for Anaemia of Chronic Kidney Disease in Adults on Dialysis

Warren-based BioNJ Member GSK announced that the US Food and Drug Administration (FDA) has approved Jesduvroq (daprodustat), an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the once-a-day treatment of anaemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least four months. Jesduvroq is the first innovative medicine for anaemia treatment in over 30 years and the only HIF-PHI approved in the US, providing a new oral, convenient option for patients in the US with anaemia of CKD on dialysis. The FDA approval is based on results from the ASCEND-D trial, assessing the efficacy and safety of Jesduvroq for the treatment of anaemia of CKD in patients on dialysis. 

Benlysta Granted Orphan Drug Designation by U.S. FDA for the Potential Treatment of Systemic Sclerosis

Warren-based BioNJ Member GSK announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Benlysta (belimumab), a B-cell inhibiting monoclonal antibody, for the potential treatment of systemic sclerosis. GSK plans to initiate a Phase II/III trial of belimumab for systemic sclerosis associated interstitial lung disease (SSc-ILD) in the first half of 2023. Systemic sclerosis (SSc) is a rare autoimmune disease that causes atypical growth of connective tissues and can affect the musculoskeletal system, heart, lungs, kidneys, skin and other organs. Interstitial lung disease (ILD) is the leading cause of death in SSc, affecting as many as half of people living with the disease. The U.S. FDA’s ODD is a special status granted to support the development and evaluation of potential new medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S.

U.S. FDA Approves Jaypirca™ (pirtobrutinib), the First and Only Non-Covalent (Reversible) BTK Inhibitor, for Adult Patients With Relapsed or Refractory Mantle Cell Lymphoma After at Least Two Lines of Systemic Therapy, Including a BTK Inhibitor

Loxo@Lilly, the oncology unit of BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced that the U.S. Food and Drug Administration (FDA) approved Jaypirca™ (pirtobrutinib, 100 mg & 50 mg tablets) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor. Jaypirca was approved under the FDA's Accelerated Approval pathway based on response rate from the open-label, single-arm, international, Phase 1/2 study, called the BRUIN trial.¹ Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Jaypirca, a highly selective kinase inhibitor, utilizes a novel binding mechanism and is the first and only FDA approved non-covalent (reversible) BTK inhibitor. 

Patients With Hidradenitis Suppurativa Experienced Sustained Efficacy and Symptom Improvement at One Year When Treated With Novartis Cosentyx®

East Hanover-based BioNJ Member Novartis announced that The Lancet has published long-term data from the pivotal SUNSHINE and SUNRISE trials evaluating Cosentyx® (secukinumab) in moderate-to-severe hidradenitis suppurativa (HS). In two of the largest Phase III trials conducted in HS, Cosentyx treatment response rates continued to improve beyond the primary endpoint analysis at Week 16 to more than 55% of patients achieving a HS Clinical Response (HiSCR) measure at Week 52. Overall, at Week 52, more than 60% of patients were free of flares. Additionally, more than 50% experienced a meaningful reduction in pain, which has been identified by patients as the most burdensome symptom of HS. 

Sandoz Biologics License Application for Proposed Biosimilar Denosumab Accepted by US FDA

Princeton-based BioNJ Member Sandoz, a Novartis division, announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for proposed biosimilar denosumab. The application includes all indications covered by the reference medicines Prolia® (denosumab) and Xgeva® (denosumab) for treating a variety of conditions, including osteoporosis in postmenopausal women and in men at increased risk of fractures, treatment-induced bone loss, prevention of skeletal related complications in cancer that has spread to the bone, giant cell tumor of the bone, and treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. “In addition to being an important medicine for cancer of the bone, denosumab is critical in the treatment of osteoporosis and potential prevention of osteoporosis-related fractures that so many women over 50 are at risk of,” said Keren Haruvi, President, Sandoz Inc. & Head of North America.

Sandoz Receives Positive CHMP Opinion for Citrate-Free High Concentration Formulation of Adalimumab Biosimilar

Princeton-based BioNJ Member Sandoz, a Novartis division, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), has adopted a positive opinion for marketing authorization for a citrate-free high concentration formulation (HCF) of its biosimilar Hyrimoz® (adalimumab). The authorization includes all indications covered by the reference medicine*: rheumatoid arthritis, Crohn's disease, ulcerative colitis, plaque psoriasis and uveitis.¹ Upon approval, the adalimumab citrate-free HCF (100 mg/mL) formulation will offer reduced injection volume and potentially decrease the number of injections required for patients who need 80 mg/mL dosing. The HCF formulation will have the same auto-injector as currently offered, aiming for an enhanced yet familiar patient experience.

Janssen Announces Unblinding of Phase 3 CARTITUDE-4 Study of CARVYKTI® (cilta-cel) as Primary Endpoint Met in Treatment of Patients With Relapsed and Refractory Multiple Myeloma

Raritan-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced that the Phase 3 CARTITUDE-4 study evaluating CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) versus pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd) for the treatment of patients with relapsed and lenalidomide-refractory multiple myeloma met its primary endpoint of significant improvement in progression-free survival (PFS) at the first pre-specified interim analysis. As a result of meeting the primary endpoint, the Independent Data Monitoring Committee recommended the unblinding of the study. Results from the CARTITUDE-4 study will be presented at an upcoming scientific congress and shared with health authorities in planned submission applications.

Bristol Myers Squibb Receives Positive CHMP Opinion for Reblozyl® (luspatercept) for Adult Patients With Anemia-Associated, Non-Transfusion-Dependent (NTD) Beta Thalassemia

Princeton-based BioNJ Member Bristol Myers Squibb announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended approval of Reblozyl® (luspatercept) as a treatment for adult patients with anemia associated with non transfusion-dependent (NTD) beta thalassemia. The recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for use in the European Union (EU). Upon approval, this would represent the third authorized indication for Reblozyl in the EU. Reblozyl is an erythroid maturation agent approved in the EU, the United States, China and Canada to address anemia-associated, transfusion-dependent beta thalassemia and transfusion-dependent lower-risk myelodysplastic syndromes, representing an important class of therapy for eligible patients.

Bristol Myers Squibb Announces Positive CHMP Opinion for Once-Daily Sotyktu (deucravacitinib) as a Treatment for Adults With Moderate-to-Severe Plaque Psoriasis

Princeton-based BioNJ Member Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the approval of Sotyktu (deucravacitinib) for the treatment of adults with moderate-to-severe plaque psoriasis. Sotyktu, an oral medication taken once-daily,is a first-in-class, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy. The CHMP recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union (EU). The CHMP adopted this positive opinion based on results from the pivotal Phase 3 POETYK PSO-1 and POETYK PSO-2 trials, which evaluated once-daily Sotyktuin patients with moderate-to-severe plaque psoriasis versus placebo and twice-daily Otezla® (apremilast), as well as an additional two years of data from the POETYK PSO long-term extension trial. 

Bristol Myers Squibb Announces TRANSCEND CLL 004 Trial of Breyanzi® (lisocabtagene maraleucel) Met Primary Endpoint of Complete Response Rate in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

Princeton-based BioNJ Member Bristol Myers Squibb announced topline results from TRANSCEND CLL 004, a Phase 1/2, open-label, single-arm, multicenter study evaluating Breyanzi (lisocabtagene maraleucel) in adults with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Results from TRANSCEND CLL 004 showed the study met the primary endpoint of complete response rate compared to historical controlin the prespecified subset of patients with R/R CLL that was refractory to a BTK inhibitor and pretreated with a BCL-2 inhibitor. Anne Kerber, Senior Vice President, Head of Cell Therapy Development, Bristol Myers Squibb, said, “In a population that has limited options, the TRANSCEND CLL 004 study represents the first multicenter trial evaluating a CAR T cell therapy in heavily pre-treated patients with relapsed or refractory CLL or SLL, with results showing the potential of Breyanzi as a personalized one-time treatment approach for patients with this difficult-to-treat disease.” 

Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy Met Primary Endpoint of Progression-Free Survival (PFS) as First-Line Therapy for Advanced or Recurrent Endometrial Carcinoma

Kenilworth-based BioNJ Member Merck & Co. announced that the Phase 3 NRG-GY018 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with standard of care chemotherapy (carboplatin and paclitaxel) met its primary endpoint of progression-free survival (PFS) for the treatment of patients with stage III-IV or recurrent endometrial carcinoma regardless of mismatch repair status. At a pre-specified interim analysis review conducted by an independent Data Monitoring Committee, KEYTRUDA in combination with chemotherapy then continued as single agent every six weeks for up to 14 cycles demonstrated a statistically significant and clinically meaningful improvement in PFS compared with chemotherapy alone in these patients whose endometrial carcinoma was either mismatch repair proficient (pMMR) or mismatch repair deficient (dMMR). 

FDA Approves KEYTRUDA® (pembrolizumab) as Adjuvant Treatment Following Surgical Resection and Platinum-Based Chemotherapy for Patients With Stage IB (T2a ≥4 Centimeters), II, or IIIA Non-Small Cell Lung Cancer (NSCLC)

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, as a single agent, for adjuvant treatment following surgical resection and platinum-based chemotherapy for adult patients with stage IB (T2a ≥4 centimeters [cm]), II, or IIIA non-small cell lung cancer (NSCLC). 

“Six years ago, KEYTRUDA was the first anti-PD-1 therapy approved for the first-line treatment of metastatic non-small cell lung cancer and has changed the way metastatic disease is treated. Today’s approval marks the fifth indication for KEYTRUDA in non-small cell lung cancer and the first indication for KEYTRUDA in patients with resected stage IB (T2a ≥4 cm), II, or IIIA disease following adjuvant chemotherapy,” said Dr. Gregory Lubiniecki, Vice President, Oncology Global Clinical Development, Merck Research Laboratories. 

Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy Significantly Improved Overall Survival Versus Chemotherapy in First-Line Advanced or Unresectable Biliary Tract Cancer in KEYNOTE-966 Trial

Kenilworth-based BioNJ Member Merck & Co. announced positive results from the Phase 3 KEYNOTE-966 trial. In the final analysis of this trial, KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with standard of care chemotherapy (gemcitabine and cisplatin) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) versus chemotherapy alone for the first-line treatment of patients with advanced or unresectable biliary tract cancer (BTC). The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies. Merck has an extensive clinical development program evaluating KEYTRUDA in gastrointestinal cancers and is continuing to study KEYTRUDA for multiple uses in gastric, hepatobiliary, esophageal, pancreatic and colorectal cancers.

10 NJ Companies Make Bloomberg’s 2023 Gender-Equality Index (updated)

Ten corporations headquartered in New Jersey were named to the 2023 Bloomberg Gender-Equality Index (GEI). The GEI – which tracks the performance of public companies committed to transparency in gender-data reporting – measures gender equality across five pillars: female leadership and talent pipeline, equal pay and gender pay parity, inclusive culture, anti-sexual harassment policies and pro-women brand. BioNJ Members on the list include Merck & Co., Novartis and Organon & Co. 

Lecanemab Receives Priority Review Status in Japan

Nutley-based Eisai Co., Ltd. and BioNJ Member Biogen Inc. announced that an application for manufacturing and marketing approval for lecanemab (generic name, U.S. brand name: LEQEMBI™), an anti-amyloid-β (Aβ) protofibril* antibody, in Japan has been designated for Priority Review by the Japanese Ministry of Health, Labour and Welfare (MHLW). Priority Review in Japan is granted to new medicines recognized as having high medical utility for serious diseases, and once designated for Priority Review, the target total review period is shortened. In Japan, Eisai submitted the manufacturing and marketing approval for lecanemab to the Pharmaceuticals and Medical Devices Agency (PMDA) on January 16, 2023. This application is based on the results of the Phase III Clarity AD study and the Phase IIb clinical study (Study 201), which demonstrated that lecanemab treatment showed a reduction of clinical decline in early AD.

TROPION-Lung07 Phase 3 Trial Initiated to Evaluate Datopotamab Deruxtecan in Combination With Pembrolizumab in Patients With Previously Untreated Metastatic Non-Small Cell Lung Cancer

Basking Ridge-based Daiichi Sankyo announced that the first patient has been dosed in the global, randomized TROPION-Lung07 Phase 3 trial evaluating datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab with or without platinum chemotherapy, in patients with previously untreated advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with PD-L1 expression less than 50% (TPS<50%) and without actionable genomic alterations. Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN). Among patients with NSCLC, nearly half are diagnosed at an advanced stage and generally have a poor prognosis. While first-line treatment with pembrolizumab or other checkpoint inhibitors, with or without chemotherapy, has improved outcomes in patients with NSCLC without actionable genomic alterations, disease progression still occurs in the majority of patients. 

ENHERTU ® Approved in the EU as the First HER2 Directed Therapy for Patients With HER2 Low Metastatic Breast Cancer

Basking Ridge-based Daiichi Sankyo and AstraZeneca’s ENHERTU® (trastuzumab deruxtecan) has been approved in the European Union (EU) as monotherapy indicated for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy. ENHERTU is a specifically engineered HER2 directed antibody drug conjugate (ADC) jointly developed and commercialized by Daiichi Sankyo and AstraZeneca. The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use and is based on results from the DESTINY-Breast04 Phase 3 trial.

Amarin Announces VAZKEPA® (Icosapent Ethyl) Approved by Medsafe in New Zealand

Bridgewater-based Amarin Corporation announced that Medsafe in New Zealand has granted approval to VAZKEPA (icosapent ethyl) to reduce the risk of cardiovascular (CV) events in adult statin-treated patients with high CV risk with elevated triglycerides. “The regulatory approval of VAZKEPA in New Zealand adds to the ongoing progress by Amarin to bring an important treatment to patients to help address their residual cardiovascular disease risk,” said Steven Ketchum, EVP & President, Research & Development, Amarin. “We are proud of this important step in our effort to extend the reach and access to this important product to patients around the world who may benefit from the treatment and reduce their risk of a cardiovascular event.”

New Study Publication Reinforces the Clinical Benefits of Blue Light Cystoscopy in the ASC Setting; Supports Ongoing Initiatives to Further Improve Reimbursement

Photocure ASA, The Bladder Cancer Company, with a site in Princeton, announced the publication of the study 'Clinical and Economic Impact of Blue Light Cystoscopy in the Management of NMIBC at U.S. Ambulatory Surgical Centers: What is the Site-of-Service Disparity?' in Urologic Oncology. The research objective was to quantify the clinical and economic impact of the incorporation of BLC in the management of NMIBC in ambulatory surgical centers (ASCs) considering 2022 Center for Medicare Services (CMS) patient-physician coverage and reimbursement. The authors conclude that due to the modeled results, "the Medicare program will incur increased costs. The current discrepancy in reimbursement disincentivizing community-based ASCs from adopting BLC, resulting in suboptimal patient care while increasing downstream treatment costs to Medicare, necessitated when missed disease progresses to higher stage/grade disease. The findings have important clinical implications for the optimal management of NMIBC and should inform healthcare policies that promote cost-effectiveness and enhanced patient outcomes."

Idorsia Submits European Marketing Authorisation Application for Aprocitentan for the Treatment of Patients With Resistant Hypertension

Idorsia Ltd, with a site in Cherry Hill, announced that it has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for aprocitentan, Idorsia’s investigational, novel dual endothelin receptor antagonist, for the treatment of patients with resistant hypertension. Idorsia is developing aprocitentan together with BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson. Janssen Biotech has sole commercialization rights worldwide. The MAA includes data from a comprehensive clinical and non-clinical development program. In the Phase 3 registration study, PRECISION, aprocitentan showed statistically significant and clinically meaningful reduction in blood pressure (BP) which was maintained for up to 48 weeks when added to combination background antihypertensive therapy in patients with resistant hypertension. In PRECISION, aprocitentan was generally well tolerated with no major safety concerns. 

Pharmaceutical Company Expands Footprint in Hillsborough

A pharmaceutical tenant is widening its presence in Somerset County to occupy a total 4,218 square feet at the Hillsborough Business Center. Larken Associates announced the 1,500-square-foot lease expansion for NanoTech Pharma Inc. The pre-clinical stage specialty drug delivery company works on the nanomedicine development of biological and small molecules that deploy its proprietary drug delivery platforms of liposome, nanocrystal, albumin-bound nanoparticle and microsphere. Its pipeline includes innovative and patented nanomedicine for oncology, serious infections and cardiovascular disease, among others. Rob Marek, Executive Vice President of Raider Realty, the in-house brokerage division of Larken Associates, said, “It’s been impressive to witness Nanotech Pharma Inc.’s growth and we’re thrilled to provide the space needed to meet their growing needs.”

Evotec SE: Laetitia Rouxel to Succeed Enno Spillner as Chief Financial Officer

Princeton-based BioNJ Member Evotec SE announced that the company's Supervisory Board has appointed Laetitia Rouxel as new Chief Financial Officer and member of the Management Board. Ms. Rouxel has more than 25 years of finance experience in various sectors. After graduating from the French Business school "ISG", she started her career with finance and commercial roles in the pharma industry at Pfizer and J&J. After working for the French multinational food-products corporation Danone, where she covered various leading finance positions in multiple regions for R&D, Medical and Baby Nutrition based in France and in the Netherlands, she then joined the beauty company Coty in Switzerland in 2018, where she became divisional CFO, before being nominated Global CFO of Wavin, a solutions leader for the building and infrastructure industry.

Daiichi Sankyo Announces New President & COO

Basking Ridge-based Daiichi Sankyo announced the appointment of a new President & Chief Operating Officer (COO) effective as of April 1, 2023. The current Chief Financial Officer (CFO) Hiroyuki Okuzawa will be promoted to the post of president and COO. Sunao Manabe, current president and CEO, will become chairman and CEO. With the aim of enhancing management structure to further strengthen execution in order to successfully achieve the 5YBP and realize the 2030 vision, “Innovative Global Healthcare Company Contributing to the Sustainable Development of Society,” a new Representative Director, President & COO, was appointed at the Board of Directors meeting based on the recommendation of the Nomination Committee. Mr. Okuzawa joined Sankyo in April 1986. In 2017, he was appointed as the Vice President, Business Planning Dept. Later 2018, he started serving as the Corporate Officer, President.

Rutgers, NJASCU Partner to Support NJ Innovation Ecosystem

Rutgers’ Office for Research Innovation Ventures announced that it will participate in a technology transfer partnership with the New Jersey Association of State Colleges and Universities. Rutgers said the move is part of an effort to expand and enhance the State’s research and innovation ecosystem, and to help advance these schools’ entrepreneurial efforts. As part of the agreement, Innovation Ventures, which is responsible for all Rutgers’ technology commercialization and transfer, will provide information and guidance to eight New Jersey state colleges and universities: Kean University, Montclair State University, New Jersey City University, Ramapo College, Stockton University, The College of New Jersey, Thomas Edison State University and William Paterson University. Rutgers said it will help guide these schools on processes related to intellectual property, such as patenting, licensing and overall commercialization, in hopes of helping the institutions transform their innovations into products, services and partnerships.

Rutgers to Open Alzheimer’s Research, Treatment Center

With the support of a $5 million gift from an alumnus, Rutgers Biomedical and Health Sciences announced it will open the Herbert and Jacqueline Krieger Klein Alzheimer’s and Dementia Clinical Research and Treatment Center this fall. Based at the Rutgers Brain Health Institute, the center will offer research from the institute, Rutgers Robert Wood Johnson Medical School, Rutgers New Jersey Medical School and the Rutgers Institute for Health, Health Care Policy and Aging Research. The announcement said the center will also facilitate clinical research about Alzheimer’s that could lead to new treatments. Michal Beeri was appointed Director of the new center. Ms. Beeri will join Rutgers from the Mount Sinai School of Medicine, where she is a professor in the psychiatry department. 

BioCentriq Releases Results of Study Designed to Test Transfection of T-cells Using Kytopen’s Flowfect® Technology

BioCentriq,Inc., located in Newark, announced that they’ve completed a study designed to test transfection of T-cells with GFP mRNA for evaluation of cell viability, transfection efficiency, and post transfection growth using Kytopen’s Flowfect® technology. During the study, which was conducted at BioCentriq by their process development team, cells were transfected with mRNA encoding for GFP, which was analyzed using flow cytometry as a measure of transfection efficiency. Transfection is an invaluable tool used in cell engineering applications to study and modify gene expression by introducing mRNA or DNA into a recipient cell. Traditional transfection methods, such as static electroporation, typically result in adverse effects to cell viability, delivery efficiency and subsequent cell growth. 

Rowan Student Named N.J.’s Top Student Entrepreneur by Global Student Entrepreneur Awards

New Jersey has been known for innovation and ideas. It therefore comes as no surprise that two Garden State students have placed first and second at the local level of the Global Student Entrepreneur Awards. Six finalist student entrepreneurs competed for the chance to win $7,500, as well as business mentoring and other resources from New Jersey Chapter of Entrepreneurs’ Organization members. This year’s winner is Harrison Nastasi, founder of Bobica Bars. The Rowan University freshman created the world’s first superfood-glazed granola bars to provide a healthy grab-and-go snack that is high in nutritional benefits while being gluten free, dairy free and vegan. The runner-up was Sanya Majmudar, a New Jersey Institute of Technology sophomore who founded Medical Wonders, a non-profit dedicated to educating and advising health care students around the globe about medical procedures, careers, discoveries and devices. 

College rankings: Princeton, NJIT in Top 100 of List Based on Return on Investment

If you are one of those people rubbing your dimes together in an effort to put someone through school, you might be interested in a ranking that aims to rate colleges on the return on investment of your tuition. Degree Choices, which describes itself as “a team of education researchers working together to provide valuable financial advice and guide prospective students to find schools and careers that best suit their needs,” released its rankings this month. Officials from Degree Choices said they had two parameters: how educational costs measure up to the additional earnings a student can expect to make because of their degree, and how this earning potential compares to that student’s peers. After evaluating more than 2,200 four-year colleges and universities, nine schools from New Jersey were ranked.

Drew University Names Next President

Drew University’s board of trustees and presidential search committee announced Hilary Link will serve as the institution’s 15th President. Ms. Link succeeds President Thomas Schwarz, who will step down in June after a three-year commitment. She takes the helm July 1. Ms. Link most recently served as President of Allegheny College in Meadville, Pa., from 2019 to September 2022. Prior to that role, she was Dean of Temple University Rome and Vice Provost at Barnard College of Columbia University. She began her career in higher education as Director of scholar programs at New York University. We are delighted to have attracted a candidate who has spent decades in leadership roles at prominent institutions of higher education with such outstanding pedigrees and reputations,” Fredrick Fuest, chair of the search committee and vice chair of the board of trustees, said in a statement. 

TiE New Jersey Gala

February 25, 2023

Annual Gala & Awards Night at The Mansion at Natirar

400 Natirar Drive, Peapack-Gladstone, NJ 07977

NORD New Jersey Rare Action Network Rare Disease Day

February 28, 2023

One of the greatest challenges individuals living with a rare disease, their families, and patient advocates have is finding and accessing information and resources to help them advocate for themselves and their loved ones, as well as to raise awareness of issues facing others in the community. To help alleviate these daily burdens and ensure individuals and advocates can navigate local and state-based resources, NORD New Jersey Rare Action Network will be hosting a State Resource Fair for the rare disease community to coincide with Rare Disease Day. There is no cost to participants to attend this event.

IP & Licensing Basics: A One Day Review

March 20, 2023

Whether you are an entrepreneur in the making, a principal investigator or student at any level who wants a better grasp of the basics, or an aspiring technology transfer professional, this course will give you the tools you need to understand and participate effectively in the process of protecting IP and facilitating its commercialization. Delivered over one day, this course consists of 4 modules: IP Basics; IP Commercialization Basics; Licensing Fees & Royalty Rates and Managing Risk.

ON Helix

July 6, 2023

This one-day conference will address key bio innovation trends, from developments in life sciences and technology research to their translation into new diagnostics, prevention tools or treatments. Delegates and Supporters will connect with the One Nucleus network to explore New Horizons for Bio Innovation. BioNJ Members enjoy a 10% discount. Contact RBromberg@BioNJ.org for the discount code.