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April 28, 2023

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

Last week, BioNJ released a new whitepaper, entitled Health Equity in Clinical Trials MBA Business Case Competition: Identifying Innovative Approaches to Strengthening Diversity Within Clinical Trials.” The paper provides an overview of BioNJ’s Inaugural Health Equity in Clinical Trials MBA Business Plan Case Competition and features highlights from all the submitted business plans, summaries of proposals that received top awards, and learnings from the inaugural competition.

The competition, which took place on December 3, 2022, at Rutgers Business School, was designed to promote the next generation of diverse clinical trial innovators and identify innovative approaches and successful models that can be used nationally to strengthen diversity in clinical trials and expand health equity. Awards to the top three teams were based on written proposals and in-person pitches evaluated by a panel of expert judges. Case prizes totaled $20,500. A digital resume book documents the breadth of academic and professional diversity within and across the competing teams. Click here for a copy of the whitepaper.

In addition to the release of the paper, the three winning teams – 1) Johns Hopkins University, 2) Rutgers University and 3) a combined team of Baylor College of Medicine, Northwestern University & Rice University – presented their business plans to potential partners, collaborators and investors at BioNJ's BioPartnering Conference which took place on April 18 at The Palace at Somerset Park.

One of BioNJ’s signature events, the BioPartnering Conference brought together nearly 600 life sciences executives, investors, academic collaborators and business development professionals for networking, 1-1 partnering, company and start-up pitch presentations, exhibits and plenary sessions. Click here for our photo gallery.

Visit to learn more about BioNJ's Health Equity in Clinical Trials Initiative and to peruse BioNJ's upcoming calendar of events.

Because Patients Can't Wait®,

Debbie Hart

President and CEO


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Upcoming BioNJ Events


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June 13, 2023

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September 13, 2023

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October 6, 2023

Putting Patients First:

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Recent Stories in the News


ICYMI: PhRMA President and CEO Stephen J. Ubl Discusses Patient Affordability

PhRMA president and CEO Stephen J. Ubl spoke recently on “Pathways to Patient Affordability.” He spotlighted patients’ affordability challenges, the unintended consequences we’re already seeing from the government price setting provisions in the Inflation Reduction Act (IRA) and how policymakers can address harmful pharmacy benefit manager (PBM) practices.

AHIP’s Latest Misinformation Campaign & What It’s Trying to Hide

If we needed any more proof that the health insurance and pharmacy benefit manager (PBM) industries are one and the same, look no further than a new ad campaign by America’s Health Insurance Plans (AHIP). With PBMs facing increasing scrutiny on Capitol Hill, AHIP is hitting the airwaves to deflect any responsibility for the high cost of medicine many people face. Insurance companies use PBMs to determine what patients pay at the pharmacy and what medicines are covered. They claim that all they do is negotiate savings for patients, but if that were true, then why are they facing lawsuits, investigations and regulation by state attorneys general, state legislatures, the Federal Trade Commission and United States Congress for their role in rising health care costs?

PBMs are Modern-Day Drug Price Gangsters and Must be Held Accountable

In March, Ohio Attorney General Dave Yost filed a groundbreaking lawsuit challenging the coercive tactics of the shadowy, modern-day health care mafia known as pharmacy benefit managers (PBMs). You may not have heard of PBMs before, but they play a critical role in controlling which medications your insurer covers. While that may sound like a relatively minor job, PBMs have become the gatekeepers of the prescription drug industry, exploiting their monopoly power to jack up prices, limit access to affordable medicines, and line their pockets with billions of dollars in profit. Using behind-the-scenes negotiations and secret deals, this cartel has enriched themselves by extorting patients, pharmacies, and health care providers across the country. The lawsuit targets Express Scripts and Prime Therapeutics — two of the largest PBMs in the U.S. Together, they control a mysterious and secretive company in Switzerland called Ascent, which Yost alleges is merely a front for a price-fixing conspiracy that would make even the Genovese crime family proud.

BioNJ in the News


BioNJ BioPartnering Conference Returns In-Person and Bigger Than Ever

Featured in NJBIZ

“Today is about growing the ecosystem and partnering to bolster medical innovation,” President and CEO Debbie Hart told a packed room at The Palace at Somerset Park during BioNJ’s 13th Annual BioPartnering Conference, which was back in person for the first time in three years. The annual event, co-sponsored by J.P. Morgan, Johnson & Johnson and Morgan Lewis, brings together life sciences executives, investors, academic collaborators and business development professionals for networking, one-on-one partnering, startup pitches, exhibits and plenary sessions. Samuele Butera, President, U.S. Pulmonary Hypertension and Retina at Janssen Pharmaceutical, opened with "Every major breakthrough happens because of many, many people. It’s the innovators in the room. It’s the funders in the room. It’s the capital. It’s the ecosystem that we all represent here that makes innovation possible and makes us a crucial part in saving lives.”

Biotech Success Means Partnerships

Featured in New Jersey Business Magazine

More than 575 people attended BioNJ’s 13th Annual BioPartnering Conference, where some 70 companies from across the US made pitch presentations to investors on their respective innovations. If there was a common theme surrounding the event, which was held at The Palace in Somerset, it was that innovative success happens because of collaborations. Steven Cohen, Partner and Chair, Emerging Business and Technology Practice, at the law firm of Morgan Lewis, added that among the top three traits of a biotech industry leader is the ability to collaborate: “No one can develop a drug on their own. It takes biology, chemistry, legal, regulatory and financial acumen,” he said. Biotech industry collaboration is also necessary when it comes to workforce development, as discussed in the panel presentation titled, “Building a Workforce for Biopharma Manufacturing.”

NJ Company News


U.S. Food and Drug Administration Accepts for Priority Review Taiho Oncology’s Supplemental New Drug Application for the Use of Trifluridine/Tipiracil (LONSURF®) in Combination With Bevacizumab for Refractory Metastatic Colorectal Cancer

Princeton-based BioNJ Member Taiho Oncology, Inc. and Taiho Pharmaceutical Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental new drug application (sNDA) for trifluridine/tipiracil (LONSURF®) as monotherapy or in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. A Priority Review designation by the FDA reduces the review period of the sNDA by four months. In this case, the FDA provided an anticipated Prescription Drug User Fee Act (PDUFA) action date of August 13, 2023.

Boehringer Ingelheim Reaches More Patients Than Ever in 2022 as Innovative Medicines Drive Growth

BioNJ Member Boehringer Ingelheim, with a site in North Brunswick, reported a strong performance in 2022, a year in which 30 million patients benefited from its innovative medicines, while deepening investments in the search for new treatments. Research & development investments reached 5 billion EUR, or 21 percent of net sales. Net sales rose by a currency-adjusted 10.5 percent to 24.1 billion EUR. Development of the pipeline progressed very well in 2022. Boehringer Ingelheim received one Breakthrough Designation, three Fast Track Designations, and two Orphan Drug Designations from the FDA. In the next seven years the company expects about 20 regulatory approvals in human pharma. Throughout the current year, Boehringer Ingelheim expects to present additional data from its pipeline.

BioAegis Therapeutics Announces Two Studies Exploring the Role of ‘Inflammation Regulator’ Gelsolin in Type 2 Diabetes

New Brunswick-based BioNJ Member BioAegis Therapeutics, Inc. announced the publication of two new research studies exploring gelsolin’s role in type 2 diabetes, an inflammation-related metabolic disease. The research study, Blood-Borne Microparticles Are an Inflammatory Stimulus in Type 2 Diabetes Mellitus, was led by Dr. Stephen R. Thom at the University of Maryland School of Medicine and supported by grants from the National Institute of Health and the US Office of Naval Research. It explored the role of microparticles (MPs) which drive inflammation in individuals with diabetes. A second study, Plasma Gelsolin Levels Are Associated With Diabetes, Sex, Race and Poverty in the Journal of Translational Medicine, was supported by the Intramural Research Program of the National Institute on Aging, National Institutes of Health, to understand gelsolin in a racially diverse population with and without Type 2 diabetes. 

Y-mAbs Announces First Patient Dosed in Phase 1 Clinical Trial of GD2-SADA

BioNJ Member Y-mAbs Therapeutics, Inc., with a site in Nutley, announced that the first patient has been dosed with both the protein dose and the 177Lu-DOTA imaging dose in its Phase 1 clinical trial, evaluating the Company’s pre-targeted radioimmunotherapy Self-Assembly and Disassembly-Bispecific (“SADA”) technology platform for the treatment of certain GD2-positive solid tumors, including small cell lung cancer, sarcoma and malignant melanoma. The two-step approach separating the administration of SADA protein (“pre-targeting”) from the administration of radioactive ligand is believed to differentiate SADA constructs from most other radioimmunotherapy approaches. The Phase 1 dose-escalation, single-arm, open-label, non-randomized, multicenter trial (NCT05130255) targets malignant melanoma, sarcoma and small cell lung cancer. 

FDA Grants Accelerated Approval for QALSODY™ (tofersen) for SOD1-ALS, a Major Scientific Advancement as the First Treatment to Target a Genetic Cause of ALS

BioNJ Member Biogen Inc. announced that the U.S. Food and Drug Administration (FDA) has approved QALSODY™ (tofersen) 100 mg/15mL injection for the treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene. This indication is approved under accelerated approval based on reduction in plasma neurofilament light chain (NfL) observed in patients treated with QALSODY. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).1 The ongoing Phase 3 ATLAS study of tofersen in people with presymptomatic SOD1-ALS will serve as the confirmatory trial. Neurofilaments are proteins that are released from neurons when they are damaged, making them a marker of neurodegeneration. QALSODY is the first approved treatment to target a genetic cause of ALS.

Soligenix Submits Type A Meeting Request to U.S. FDA to Review Proposed Study Design for a Second Phase 3 Study Evaluating HyBryte™ in the Treatment of Cutaneous T-Cell Lymphoma

Princeton-based BioNJ Member Soligenix announced that the company has submitted a Type A Meeting Request to the United States (U.S.) Food and Drug Administration (FDA) to initiate formal discussions regarding the design of a second, Phase 3 pivotal study evaluating HyBryte™ (hypericin sodium) in the treatment of early stage cutaneous T-cell lymphoma (CTCL), a rare cancer, where it has successfully demonstrated statistically significant results in the first Phase 3 clinical trial. The Type A Meeting is the highest priority classification of meeting the FDA grants and is expected to occur approximately 30 days from the FDA's receipt of the meeting request.

First Wave Biopharma Exceeds 50% Enrollment Target for Phase 2 Span Adrulipase Clinical Trial in Cystic Fibrosis

BioNJ Member First Wave BioPharma, Inc., with an office in Roseland, announced that it has now surpassed the 50% enrollment target in its ongoing 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). 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). Topline results from the study are anticipated by mid-2023.

Genmab and argenx Enter Partnership to Advance Antibody Therapies in Immunology and Oncology

Plainsboro-based BioNJ Member Genmab and argenx announced that they have entered into a collaboration agreement to jointly discover, develop, and commercialize novel therapeutic antibodies with applications in immunology, as well as in oncology therapeutic areas. The multiyear collaboration will leverage the antibody engineering expertise and knowledge of disease biology of both companies to accelerate the identification and development of novel antibody therapeutic candidates with a goal to address unmet patient needs in immunology and cancer. “Genmab is entering the therapeutic area of immunology and inflammation as a steppingstone to achieving its vision that by 2030, our knock-your-socks-off “KYSO” antibody medicines will be transforming the lives of people with cancer and other serious diseases,” said Jan van de Winkel, Ph.D., Chief Executive Officer, Genmab. 

AbbVie Announces Late-Breaking Results from Phase 3 Trial Evaluating Atogepant (QULIPTA®) for the Preventive Treatment of Episodic Migraine Among Patients With Prior Treatment Failure at the 2023 AAN Annual Meeting

BioNJ Member AbbVie, with a site in Madison, announced positive data from its Phase 3 ELEVATE study, evaluating atogepant for the preventive treatment of episodic migraine in people who had previously failed two to four classes of oral preventive medications. The results of the study demonstrated adult patients in the atogepant 60 mg once daily (QD) arm experienced a decrease of 4.20 days in their mean monthly migraine days (MMDs) across the 12-week treatment period, which was statistically significantly greater than the 1.85-day reduction observed in the placebo arm (p<0.0001). The ELEVATE study met all primary and secondary endpoints and demonstrated a statistically significant reduction in MMDs for those with episodic migraine taking atogepant 60 mg QD compared to placebo. 

U.S. FDA Approves QULIPTA® (atogepant) for Adults With Chronic Migraine

BioNJ Member AbbVie, with a site in Madison, announced that the U.S. Food and Drug Administration (FDA) has approved expanding the indication of QULIPTA® (atogepant) for the preventive treatment of migraine in adults. The approval makes QULIPTA the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist approved to prevent episodic and chronic migraine. People living with chronic migraine experience headaches for 15 or more days per month, with at least eight of those days associated with migraine. "This approval makes AbbVie the only company with three treatments across the spectrum of migraine, including QULIPTA as a preventive treatment for both episodic and chronic migraine; BOTOX® (onabotulinumtoxinA), our foundational, first FDA-approved preventive treatment for chronic migraine; and UBRELVY® (ubrogepant), an acute treatment for migraine attacks." said Roopal Thakkar, Senior Vice President, Chief Medical Officer, AbbVie.

AbbVie Announces European Commission Approval of RINVOQ® (upadacitinib) for the Treatment of Moderately to Severely Active Crohn's Disease

BioNJ Member AbbVie, with a site in Madison, announced the European Commission (EC) approved RINVOQ® (upadacitinib, 45 mg [induction dose] and 15 mg and 30 mg [maintenance doses]) as the first oral Janus Kinase (JAK) inhibitor for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent. The EC approval is supported by data from two induction studies, U-EXCEED and U-EXCEL, and the U-ENDURE maintenance study. Statistical significance was achieved for the co-primary endpoints and key secondary endpoints with RINVOQ 45 mg in the induction studies and RINVOQ 15 mg and 30 mg in the maintenance study compared to placebo. 

Pre-Clinical Data of Palatin's Melanocortin Agonist Demonstrating Therapeutic Effects in Diabetic Retinopathy and Uveitis Published in the International Journal of Molecular Sciences

Cranbury-based BioNJ Member Palatin Technologies, Inc. announced The International Journal of Molecular Sciences published a manuscript, "Stimulating the Melanocortin System in Uveitis and Diabetes Preserves the Structure and Anti-Inflammatory Activity of the Retina" by Tat Fong Ng and Andrew W. Taylor from Department of Ophthalmology, Boston University Chobanian and Avedisian School of Medicine, in Boston, Massachusetts. The manuscript summarizes data demonstrating the effects of PL8331 in two mouse models of retinal disease, experimental autoimmune uveoretinitis (EAU) and diabetic retinopathy (DR). Palatin and the National Institute of Health (NIH) and the Massachusetts Lions Eye Research Foundation provided funding for the study.

BeiGene and SpringWorks Present Clinical Data on Lifirafenib, in Combination With Mirdametinib, in Patients with Advanced or Refractory Solid Tumors With MAPK Pathway Aberrations at the American Association for Cancer Research Annual Meeting 2023

BioNJ Member BeiGene, Ltd., with a site in Hopewell, and SpringWorks Therapeutics, Inc. announced that they will present updated clinical data from the Phase 1b trial of BeiGene’s RAF dimer inhibitor, lifirafenib, in combination with SpringWorks’ MEK inhibitor, mirdametinib, in patients with advanced or refractory solid tumors with RAS mutations, RAF mutations and other MAPK pathway aberrations. “The lifirafenib plus mirdametinib combination represents a novel targeted approach to treat solid tumors driven by RAS/RAF mutations, and other MAPK pathway aberrations. The early clinical data reported here demonstrate the potential of this vertical combination strategy in addressing the substantial unmet medical need represented by patients with tumors driven by these genetic alterations.” said Lusong Luo, Ph.D. Senior Vice President, External Innovation at BeiGene.  

MapKure, BeiGene and SpringWorks Present Clinical Data on BGB-3245, a Selective Next-Generation B-RAF Inhibitor, in Adult Patients With Advanced or Refractory Solid Tumors at the American Association for Cancer Research Annual Meeting 2023

BioNJ Member BeiGene, Ltd., with a site in Hopewell, MapKure, LLC, and SpringWorks Therapeutics, Inc. announced that they will present updated clinical data from the Phase 1a/1b study of BGB-3245, an investigational, selective RAF dimer inhibitor, in adult patients with advanced or refractory solid tumors harboring MAPK pathway aberrations. “The promising data we are sharing at AACR demonstrate the value of our next-generation RAF dimer inhibitor, BGB-3245, as a monotherapy in patients with MAPK pathway-altered cancers, especially its potential to address key primary and resistance gene alterations that are currently unaddressed by approved therapies,” said Lusong Luo, Ph.D., Acting CEO of MapKure and Senior Vice President, External Innovation at BeiGene.  

BeiGene Announces Positive Phase 3 Tislelizumab Trial in Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

BioNJ Member BeiGene, with a site in Hopewell, announced the global RATIONALE 305 trial demonstrating superior overall survival (OS) compared with chemotherapy in patients with advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, regardless of PD-L1 status. No new safety signals were identified for tislelizumab. BeiGene previously announced superior OS for the combination compared with chemotherapy in the PD-L1 high group at a planned interim analysis and the trial continued according to pre-specified statistical hierarchy testing. At the final analysis, tislelizumab, in combination with chemotherapy, demonstrated superior OS compared with chemotherapy in the intent-to-treat (ITT) population. Tislelizumab is currently under review by the U.S. Food and Drug Administration and the European Medicines Agency (EMA) for advanced or metastatic esophageal squamous cell carcinoma after prior chemotherapy. 

Veklury® (Remdesivir) Efficacy and Safety Profile Further Demonstrated in Vulnerable Patient Populations

BioNJ Member Gilead Sciences, Inc., with a site in Morris Plains, announced positive results from several COVID-19 clinical and real-world evidence studies. A Phase 3 clinical study demonstrated that Veklury® (remdesivir) was generally well tolerated in people with moderate to severe renal impairment. Additional data includes a retrospective real-world study which demonstrated that Veklury treatment is associated with a lower risk of death from COVID-19 for people living with cancer. A separate real-world analysis demonstrated that use of Veklury is also associated with reduced hospital readmission risk in immunocompromised patients hospitalized with COVID-19. Results from a Phase 1 study evaluating the safety, tolerability, and pharmacokinetics (PK) of obeldesivir, previously known as GS-5245, a novel investigational oral compound being developed by Gilead for the treatment of SARS-CoV-2 infection, showed obeldesivir reaches expected therapeutic plasma concentrations for the treatment of COVID-19.

Regulatory Applications Accepted Across Three Regions Globally for Abecma for Earlier Use in Adults With Triple-Class Exposed Relapsed and/or Refractory Multiple Myeloma

Princeton-based BioNJ Member Bristol Myers Squibb and 2seventy bio, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the companies’ supplemental Biologics License Application (sBLA) for Abecma (idecabtagene vicleucel) with the KarMMa-3 study that investigated the treatment of adult patients with relapsed and refractory multiple myeloma who have received an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. The European Medicines Agency (EMA) has also validated Bristol Myers Squibb’s Type II variation application for Abecma based on the KarMMa-3 study. Validation of the application confirms the submission is complete and begins the procedure and scientific assessment. In addition, Japan's Ministry of Health, Labour and Welfare has accepted Bristol Myers Squibb’s supplemental New Drug Application (sNDA) for Abecma based on the KarMMa-3 study.

Bristol Myers Squibb Submits Application for Abecma®, a CAR T Cell Therapy, for Patients With Relapsed or Refractory Multiple Myeloma Who Have Received at Least Two Prior Therapies

Princeton-based BioNJ Member Bristol Myers Squibb announced that the company has submitted the supplemental New Drug Application for the manufacturing and marketing approval of an additional indication for Abecma® (idecabtagene vicleucel), a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, for patients with relapsed or refractory multiple myeloma (RR/MM) who have received at least two prior regimens, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody. The application is based on the interim analysis from KarMMa-3 (BB2121-MM-003), a global Phase 3 study that evaluated the efficacy and safety of Abecma® in subjects with relapsed or refractory multiple myeloma who had received two to four prior regimens, including an immunomodulatory agent, a proteasome inhibitor and daratumumab.

Novo Nordisk and Aspect Biosystems Enter Partnership to Develop Bioprinted Tissue Therapeutics for Diabetes and Obesity

Plainsboro-based BioNJ Member Novo Nordisk and Aspect Biosystems announced a collaboration, development and license agreement to develop bioprinted tissue therapeutics designed to replace, repair or supplement biological functions inside the body with the aim of delivering a new class of truly disease-modifying treatments for diabetes and obesity. The collaboration will leverage Aspect’s proprietary bioprinting technology and Novo Nordisk’s expertise and technology in stem cell differentiation and cell therapy development and manufacturing. Under the terms of the agreement, Novo Nordisk will receive an exclusive, worldwide license to use Aspect’s bioprinting technology to develop up to four products for the treatment of diabetes and/or obesity. Aspect will receive initial payments of 75 million dollars, including an upfront payment, research funding and an investment in the form of a convertible note. 

Novartis Presents New Five-Year Data on Disability Outcomes and Safety of Kesimpta® (ofatumumab) in People Living With Relapsing Multiple Sclerosis

East Hanover-based BioNJ Member Novartis announced new long-term data from the ALITHIOS open-label extension study showing that up to five years, patients treated earlier and continuously with Kesimpta® (ofatumumab) had fewer disability worsening events and low brain volume change versus those who started on teriflunomide and were later switched to Kesimpta. A separate analysis showed that treatment with Kesimpta for up to five years was well-tolerated, with no new or increased safety risks identified. In people with RMS who continued in the ALITHIOS study for up to five years, earlier treatment with Kesimpta was associated with fewer confirmed disability worsening (CDW) events, including progression independent of relapse activity and relapse associated worsening, versus those who switched later from teriflunomide. 

GSK Reaches Agreement to Acquire Late-Stage Biopharmaceutical Company BELLUS Health

Warren-based BioNJ Member GSK and BELLUS Health Inc. announced that they have entered into an agreement under which GSK will acquire BELLUS, a late-stage biopharmaceutical company working to better the lives of patients suffering from refractory chronic cough (RCC) for US$14.75 per share of common stock in cash representing an approximate total equity value of US$2.0 billion (£1.6 billion). The acquisition provides GSK access to camlipixant, a potential best-in-class and highly selective P2X3 antagonist currently in phase III development for the first-line treatment of adult patients with RCC. It is estimated that 28 million patients suffer from chronic cough, with 10 million patients globally and 6 million in the United States (US) and European Union (EU) suffering from RCC for over a year. 

FDA Accepts Application for Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy as First-Line Treatment for Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Rahway-based BioNJ Member Merck & Co. announced the U.S. Food and Drug Administration (FDA) has accepted for review a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. The sBLA is based on data from the KEYNOTE-859 trial, in which KEYTRUDA plus chemotherapy demonstrated a statistically significant improvement in overall survival (OS) versus chemotherapy alone, regardless of PD-L1 expression, in patients who were human epidermal growth factor receptor 2 (HER2) negative. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of December 16, 2023. 

Merck and Moderna Announce mRNA-4157 (V940), an Investigational Individualized Neoantigen Therapy, in Combination With KEYTRUDA® (pembrolizumab), Demonstrated Superior Recurrence-Free Survival in Patients With High-Risk Stage III/IV Melanoma Following Complete Resection Versus KEYTRUDA

Rahway-based BioNJ Member Merck & Co. and Moderna, Inc. announced the first presentation of detailed results from the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial evaluating mRNA-4157 (V940), an investigational individualized neoantigen therapy (INT), in combination with KEYTRUDA, Merck’s anti-PD-1 therapy, in patients with resected high-risk melanoma (stage III/IV). In the overall intention-to-treat population, adjuvant treatment with mRNA-4157 (V940) in combination with KEYTRUDA demonstrated a statistically significant and clinically meaningful improvement in recurrence-free survival (RFS) and reduced the risk of recurrence or death by 44% (HR=0.56 [95% CI, 0.309-1.017]; one-sided p value=0.0266) compared with KEYTRUDA alone. Based on data from KEYNOTE-942/mRNA-4157-P201, the U.S. Food and Drug Administration and European Medicines Agency granted Breakthrough Therapy Designation and the PRIME scheme, respectively, for mRNA-4157 (V940) in combination with KEYTRUDA for the adjuvant treatment of patients with high-risk melanoma following complete resection. 

Merck to Acquire Prometheus Biosciences for $10.8B

In a move that will enable Rahway-based BioNJ Member Merck & Co. to increase its efforts in autoimmune diseases, the company announced that it will spend $10.8 billion to acquire Prometheus Biosciences, a leader with a promising experimental treatment for ulcerative colitis and Crohn’s disease. Merck will pay $200 per share for Prometheus — an incredible 75% premium to its $114 closing price. The transaction, subject to numerous approvals, is expected to close in the third quarter. Merck Chair and CEO Robert Davis said the company is worth the price. “At Merck, we are committed to delivering on our purpose to save and improve lives and continue to identify and secure opportunities where compelling science and value creation align,” he said.

Lilly's Tirzepatide Achieved Up to 15.7% Weight Loss in Adults With Obesity or Overweight and Type 2 Diabetes in SURMOUNT-2

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced that tirzepatide (10 mg and 15 mg) achieved superior weight loss compared to placebo at 72 weeks of treatment in results from SURMOUNT-2. The study met both co-primary objectives and all key secondary objectives for tirzepatide compared to placebo for both estimandsi. Those taking tirzepatide lost up to 15.7% (34.4 lb. or 15.6 kg) of body weight for the efficacy estimand. SURMOUNT-2 is the second global phase 3 clinical trial that evaluated the efficacy and safety of tirzepatide for chronic weight management. The trial evaluated 938 adult participants with obesity or overweight and type 2 diabetes.

HuidaGene Receives Orphan Drug Designation for Gene Therapy of Blindness

Clinton-based HuidaGene Therapeutics announced that the US. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) for HG004, HuidaGene's lead gene replacement therapy for the treatment of inherited retinal disease caused by RPE65 mutations. Patients who are suffering from RPE65 mutation-associated inherited retinal diseases (IRDs), a group of rare blinding conditions caused by biallelic RPE65 mutations, affect the retina and pass on to children. "We are pleased to have received this significant regulatory feedback from the US FDA. Receiving ODD is an important milestone as we are advancing our HG004 gene replacement therapy program to clinical trial designed to provide safe, durable, and high-quality treatment to children and adults suffering from RPE65 mutation-associated inherited retinal diseases," said Xuan Yao, PhD, Co-Founder and Chief Executive Officer of HuidaGene.

Huidagene Announces IND Approval of the First China Multi-Regional, Multi-National Master Protocol of HG004 by NMPA

Clinton-based HuidaGene Therapeutics announced that the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) has approved its investigational new drug (IND) application for the planned multi-regional, multi-national clinical trial of HG004 for the treatment of patients suffering from RPE65-associated inherited retinal dystrophies, a group of genetic diseases caused by the mutations in RPE65 gene affecting the retina and passed on to the children. Previously, the company announced HG004 has granted orphan drug designation in March 2023 and its multi-national IND has also been cleared in Jan-2023 by the US FDA.

Quizartinib NDA Review for Patients With Newly Diagnosed FLT3- ITD Positive AML Extended by FDA

Basking Ridge-based Daiichi Sankyo announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) of quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as continuation monotherapy following consolidation, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive. The FDA has extended the Prescription Drug User Fee Act (PDUFA) action date by three months to July 24, 2023, to allow additional time to review requested updates to the proposed Risk Evaluation and Mitigation Strategies (REMS) included in this application. No additional efficacy or safety data has been requested.

Pyramid Biosciences Expands Oncology Pipeline With In-Licensing of GQ1010, a Potential Best-in-class TROP2 Targeted Antibody Drug Conjugate (ADC), from GeneQuantum Healthcare

Bridgewater-based Pyramid Biosciences, Inc. announced that it has entered into an exclusive license agreement with GeneQuantum Healthcare (Suzhou) Co. Ltd. to develop and commercialize GQ1010, a potential best-in-class antibody drug conjugate (ADC) targeting TROP2, worldwide except for Greater China (mainland China, Hong Kong, Macau and Taiwan). GQ1010 has shown a highly differentiated preclinical profile and is anticipated to enter a first-in-human trial within the next 12 months. "By leveraging the unique features of the GeneQuantum bioconjugation platform and Pyramid's deep expertise in oncology drug development, this partnership significantly expands our growing oncology portfolio. This highly differentiated program has the potential to address substantial limitations of current ADCs and unmet needs for patients with TROP2-expressing tumors, a clinically validated target in oncology," said Brian Lestini, M.D., Ph.D., Chief Executive Officer of Pyramid Biosciences.

Quest Diagnostics to Acquire Haystack Oncology for $300M

Secaucus-based Quest Diagnostics said it plans to acquire Haystack Oncology for $300 million in cash at closing, net of cash acquired, and up to an additional $150 million on achieving future performance milestones. Haystack Oncology is an early-stage oncology company based in Baltimore that has established a liquid biopsy technology that helps identify cancer recurrence after surgery and treatment. Founded in 2021, Haystack Oncology developed a circulating tumor DNA minimal residual disease technology, based on 20 years of research and development by world-renowned luminaries from Johns Hopkins University. Together, Quest and Haystack hope to improve patient outcomes by enabling early, accurate detection of minimal residual disease.

ESG Best Practices

BeiGene Announces Goals Focused on Sustainable Growth and Workforce Diversity in New ESG Report

BioNJ Member BeiGene announced several new Environmental, Social and Governance (ESG) goals, including targets related to carbon emissions and workforce diversity. These goals are outlined in the company’s newly released “Change Is the Cure: 2022 Environmental, Social and Governance Report.” The report highlights BeiGene’s ESG strategy, the progress the company has made against past goals and how it intends to achieve its bold new targets. This report comes at a time of tremendous growth for BeiGene, which received U.S. approval for BRUKINSA in chronic lymphocytic leukemia (CLL) in January.



Your STEM Journey Starts Here!

The Governor’s STEM Scholars introduces high school and college students to all New Jersey has to offer in research, development, and innovation. Through conferences, field trips, and research projects, our Scholars gain a 360° look at the state’s STEM opportunities for college and career. Applications are open through Friday, June 9, 2023 for New Jersey high school and college students with a passion for STEM. Learn if you are eligible for the Governor’s STEM Scholar on our website. 

Princeton Review Names 5 NJ Schools as ‘Best Value Colleges’

The Princeton Review included five New Jersey higher education institutions on its annual list of Best Value Colleges based on an analysis of more than 40 data points that cover academics, affordability and career outcomes for graduates. The New Jersey schools on nationwide list of Best Value Colleges for 2023 include, in alphabetical order, The College of New Jersey in Ewing; Drew University in Madison; New Jersey Institute of Technology (NJIT) in Newark; Princeton University in Princeton; and Stevens Institute of Technology in Hoboken. In the other specialized ranking lists, Princeton University and Stevens Insitute of Technology are among the top 20 private schools for career placement. NJIT was among the top 20 public colleges for career placement. Princeton University was also among the top 20 private schools for financial aid and the top 20 best value private schools for students without a demonstrated financial need.

HMH Teams Up With Tech Startup to Find Cancer Tumors Earlier With AI

Hackensack Meridian Health is partnering with, a healthcare technology start-up that builds artificial intelligence (AI) applications, to detect bladder tumors difficult to see with the naked eye, even for specialists. The partnership between New Jersey’ largest health network and the tech start-up aims to develop an AI based product/solution utilizing the potential of endoscopic images of the bladder to detect early stage carcinoma in situ (CIS). The investment and collaboration are being spearheaded by the health network’s Office of Innovation and Commercialization and the Bear’s Den Innovation Program within the Hackensack Meridian Health Research Institute (HMHRI). “Hackensack Meridian Health is deeply committed to supporting research and innovation that will help us deliver tomorrow’s cures today,” said Robert C. Garrett, CEO of Hackensack Meridian Health. “We will continue to explore possible advances in AI that can save lives and change lives.’’

How HMH Was Part of Highly Promising Potential Breakthrough in Melanoma Research

Leaders at the John Theurer Cancer Center in Hackensack were thrilled when results of a new clinical study presented at the American Association of Cancer Research Meeting showed promise in the fight against melanoma, the most serious type of skin cancer. The AACR researched showed that an investigational messenger RNA vaccine, used in combination with an FDA-approved immunotherapy for certain cancers, dramatically reduced the possibility of melanoma from recurring or causing death by 44%, compared with use of the immunotherapy alone. Dr. Andrew Pecora, a skin cancer specialist at the John Theurer Cancer Center at Hackensack University Medical Center who served as a co-investigator of Phase 2 of the study, said the breakthrough is validation of immunotherapy treatments.

Rutgers Launches Pediatric Lyme Disease Vaccine Study

The Pediatric Clinical Research Center at Rutgers Robert Wood Johnson Medical School recently said it is participating in the effort to determine the efficacy of what could be the first vaccine to prevent Lyme disease in children ages 5 to 17. Rutgers, one of approximately 50 research sites nationwide and the only clinical trial site in New Jersey, was selected as a clinical trial site for the national research study by Pfizer Inc. and French vaccine maker Valneva SE to evaluate the safety and efficacy of a vaccine for the prevention of Lyme disease in children over the age of 5. The university is enrolling 50 to 100 children ages 5 to 17 who have not been diagnosed with Lyme disease in the past three months for the two-year study, which will include 3,000 children.

Bayer Collaborating With NJIT & Stevens to Cultivate Data Science Talent

The Consumer Health North America division of Bayer announced a new strategic collaboration with two New Jersey polytechnic universities – New Jersey Institute of Technology (NJIT) and Stevens Institute of Technology (Stevens) – to create learning opportunities for students in the field of data science as a way to educate, engage and inspire the next generation of data science talent in the State. “Data is core to informing how we market our products to our consumers and evolve with their changing needs – from developing the right messaging to price-point to launch timing. As we continue our digital transformation at Bayer, we expect to engage data science talent to build solutions that leverage our unique data assets. Both NJIT and Stevens generate excellent talent that is critical to our future success in this space,” said Manik Gupta, Chief Analytics and Insights Officer, Bayer Consumer Health North America.


Gennao Bio Appoints New CEO

Pennington-based BioNJ Member Gennao Bio announced the appointment of Christopher Duke, MBA, M.P.H., as Chief Executive Officer. Mr. Duke succeeds Executive Chairman and founding Chief Executive Officer, Stephen Squinto, M.D., who will transition to a scientific advisor. Mr. Duke brings more than 25 years of global research and development, operational and commercial experience at several leading rare disease and immuno-oncology companies. He has served as Gennao’s interim Chief Executive Officer since 2022 and previously held the role of Chief Operating Officer, where he established and led key corporate functions, including business development, program management, manufacturing, legal, business operations, human resources and information technology.

Legend Biotech Appoints Former Eli Lilly Oncology Expert as Chief Medical Officer

Somerset-based BioNJ Member Legend Biotech Corp. appointed Dr. Mythili Koneru as Chief Medical Officer. In this role, Dr. Koneru will be responsible for overseeing the company’s clinical development and medical affairs programs. Dr. Koneru joins Legend Biotech from Marker Therapeutics, where she served as Chief Medical Officer, leading the development of the company’s cell therapies and peptide vaccines in its immuno-oncology portfolio. Prior to her time at Marker Therapeutics, Dr. Koneru served as Associate Vice President of Immuno-oncology at Eli Lilly and Co., where she focused on the clinical development of immuno-oncology assets in the company’s early phase oncology portfolio. Prior to Eli Lilly, Dr. Koneru was an oncology fellow at Memorial Sloan-Kettering Cancer Center, where she developed adoptive T-cell therapies in both leukemia and solid tumor malignancies in early phase clinical trials.

Elisabeth Moreno to Join Sanofi's Diversity, Equity and Inclusion Board

Bridgewater-based BioNJ Member Sanofi announced the appointment of Elisabeth Moreno, former French Minister for Gender Equality, Diversity and Equal opportunities, to its Diversity, Equity, and Inclusion (DE&I) Board for the next three years. Elisabeth Moreno brings a strong corporate experience, as she worked in various industries and fast paced international environments, such as France Télécom (now Orange), Dell and Lenovo. One of her latest positions was Lead for the African continent organization at Hewlett Packard. In 2020, she was appointed by the President of the French Republic, Emmanuel Macron, as Minister for Gender Equality, Diversity and Equal opportunities in the French government, where she successfully introduced a bill intended to protect victims of domestic violence and another one to promote women economic emancipation and a law to protect victims of conversion therapies.

Regeneron Announces Retirement of Board Chair, Dr. P. Roy Vagelos, Accomplished Physician-Businessman and Industry Luminary

BioNJ Member Regeneron Pharmaceuticals, Inc., with a site in Basking Ridge, announced that P. Roy Vagelos, M.D., will retire from his role as Chair of the company’s Board of Directors and will not stand for reelection at the company’s 2023 Annual Meeting of Shareholders. Dr. Vagelos has served as Chair since January 1995 and will complete his current term through the conclusion of the Annual Meeting on June 9, 2023. Effective upon the conclusion of that meeting, the Board plans to appoint Leonard S. Schleifer, M.D., Ph.D., and George D. Yancopoulos, M.D., Ph.D., as Co-Chairs of the Board, in addition to their roles as President and Chief Executive Officer and President and Chief Scientific Officer, respectively.

Amarin Names Aaron Berg Interim President & Chief Executive Officer and Adds Oliver O’Connor to Company’s Board of Directors

Bridgewater-based Amarin Corporation announced that the Company’s Board of Directors has appointed Aaron Berg, currently Amarin’s Executive Vice President and President of the U.S. Business, as Interim President and Chief Executive Officer (CEO). In addition, the board has appointed Oliver O’Connor as a new independent Director of the company. Both appointments are effective immediately. “As the board works quickly to identify a permanent CEO, we are excited to have Aaron step up to lead Amarin at this important time,” said Odysseas Kostas, M.D., and Chairman of the Board. “Aaron brings immense experience in the cardiovascular space and a strong commitment to Amarin and the value of VASCEPA® for patients worldwide.”

HuidaGene Appoints New Members to the Scientific Advisory Board

Clinton-based HuidaGene Therapeutics announced the selection of Drs. Haiyan Jiang and Alvin Luk as the new members of the Scientific Advisory Board (SAB). The SAB, which includes internationally renowned experts in gene and cell therapies, from discovery to translational research, and clinical development across different therapeutic areas, will provide strategic guidance for the global development of HuidaGene's expansive pipeline products. "To meaningfully alter the course of genetic diseases, we must advance better-validated therapeutic candidates," said Dr. Haiyan Jiang. "My longstanding interest and commitment in gene and cell therapies have led me to HuidaGene's technology platforms that offer a potential cure to diseases with high unmet medical needs, and I am eager to work with the HuidaGene team to move their pipeline forward." 

BrainStorm Cell Therapeutics Strengthens Leadership Team With Appointment of Kirk Taylor, M.D., as Executive Vice President and Chief Medical Officer

BrainStorm Cell Therapeutics Inc., with a site in Hackensack, announced the appointment of Kirk Taylor, M.D., as Executive Vice President and Chief Medical Officer, effective May 1, 2023. Dr. Taylor will serve on BrainStorm's executive leadership team reporting to Stacy Lindborg, Ph.D., co-CEO of BrainStorm. Dr. Taylor will lead the global medical affairs function and launch activities, including product launches, post-approval commercialization efforts and deepening relationships with the medical community. He will also support clinical development and overall corporate strategy, including advancement of the Company's long-term business model. "Kirk's appointment is the first important step in strengthening a targeted, capability build to expand our medical, regulatory and advocacy teams in preparation for anticipated growth," said Chaim Lebovits, President, and CEO of BrainStorm.

Industry Events


FDA Centers of Excellence Initiative

Hosted by Rutgers University

May 16, 2023

Rutgers University is leading a major initiative to be designated as a National Centers of Excellence in Advanced and Continuous Manufacturing. These centers will be selected and robustly funded by the FDA to support the adoption of advanced and continuous methodologies in the pharmaceutical space. Rutgers and its partners have organized six events across the country to present the initiative and to gather stakeholders’ input. Industry’s opinion is essential, so join Rutgers’ event on May 16. Learn more and register:

Navigating the Funding Landscape: Insights for Early Stage Biotechs

Hosted by LES USA & Canada

May 18, 2023

Join us for an engaging and timely event on May 18 at the Basking Ridge Country Club. Discover what it takes for early stage biotechs to secure funding in today's challenging market conditions. This event will shed light on the unique challenges and opportunities facing the industry through in-depth case studies, insightful discussions, and a comprehensive analysis of current funding trends. Don't miss out on this invaluable opportunity to gain a competitive edge in the world of pharma deals. Register now and be a part of the conversation!

Stand Up for Science at BIO 2023 Hosted by BIO International Convention

June 5-8, 2023

Stand up for innovation. Stand up for truth. And stand up for science. It’s time to inspire, honor and recognize the true value of the breakthrough work biotech performs for society. Today. And every day. Well into the future. Join the global power players in the biotech and pharma industry at the world's most influential biotech meeting! Sign up for updates to receive everything you need to know about the BIO International Convention.

ON Helix Hosted by One Nucleus

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 for the discount code.

Winds of Change: Dealmaking Trends in the Evolving Innovation Economy

Hosted by LES USA & Canada

October 15-18, 2023

Under the theme of Winds of Change: Dealmaking Trends in the Evolving Innovation Economy, our dynamic international IP community will meet in Chicago for two action-packed days of education, outstanding programming, and networking, with global deal making opportunities. The month of May will be here before we know it! Register before May 1, 2023 and save.

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