Welcome New Members

• BOME Pharma LLC
• FloatR Inc.
• Neumentum, Inc.
• Princeton Creative
• Vignetic Inc.

Learn more at www.BioNJ.org/Membership.

How the Secrecy of Middlemen Inflates Drug Prices

Most Americans believe drugs cost too much and big pharma is to blame. That powerful political sentiment undergirds Medicare’s new authority to negotiate prices directly with manufacturers. The negotiations may result in lower revenues for pharma but will also imperil future drug development. There is a better solution: Force transparency into the drug supply chain, unleashing market forces on middlemen whose hidden deals generate excessive profits. They contribute nothing to the development of new medicines yet soak billions of dollars from taxpayers, employers and patients.  

New Poll Shows Strong Bipartisan Support for PBM Reform

Big health insurance companies and their pharmacy benefit managers (PBMs) game the health care system at patients’ expense. They place barriers between patients and medicines, ultimately driving up patient costs while insurers and PBMs line their own pockets. New Morning Consult/PhRMA polling finds strong bipartisan support for holding middlemen accountable. Voters want to see policy solutions that lower their costs by reforming the PBM system and holding middlemen accountable.

R&D Leaders to Biden Administration: Your Policies are Undermining the Cancer Moonshot

America’s biopharmaceutical companies share President Biden’s commitment to eradicating cancer. With more than 1,300 medicines in the research pipeline, the science has never been more promising. But as industry research and development leaders warn in a new letter to the Biden Administration, the Cancer Moonshot might have to call off its mission before it can get off the ground. That’s because the administration is pursuing several misguided policies that impede the innovation needed to develop the next generation of treatments and cures. 

BioNJ CEO Assesses the State of NJ’s Life Sciences Industry

For nearly 30 years, BioNJ has served as the life sciences trade association in the Garden State – representing some 400 research-based life sciences organizations across the health care ecosystem from early stage start-ups to the largest biopharmaceutical companies. Debbie Hart, the organization’s president and CEO, recently reflected on developments in the industry over the past 12 months. “It has been a busy year and I think a very successful year,” she told NJBIZ.

Governor Murphy Visits Hsinchu Biomedical Science Park for MOU Signing Between BioNJ and Taiwan BIO

New Jersey Governor Phil Murphy visited Hsinchu Biomedical Science Park in Taiwan during the Choose New Jersey Governor-led economic mission to East Asia where he celebrated the signing of a Memorandum of Understanding (MOU) between life sciences trade associations BioNJ and Taiwan BIO. “Many companies throughout Taiwan and the U.S. and certainly in New Jersey have engaged in long and well-established strategic partnerships,” said Debbie Hart, President & CEO of BioNJ. “Alliances, such as the one between BioNJ and Taiwan BIO, are important in fostering new business opportunities and research collaborations. We look forward to bringing our members together to support the life sciences industry as a whole ― ultimately bringing new medical innovation to patients around the world.”

PTC Therapeutics Announces Evrysdi® Royalty Agreement With Royalty Pharma for Up To $1.5 Billion

South Plainfield-based BioNJ Member PTC Therapeutics announced an agreement with Royalty Pharma plc. to monetize up to $1.5 billion of the Evrysdi royalty stream. Under the agreement, Royalty Pharma acquires additional royalties on Evrysdi for $1.0 billion upfront. The agreement includes options for PTC to sell up to all of its retained royalties on Evrysdi for up to $500 million or for Royalty Pharma to acquire half of such retained royalties for up to $250 million at a later date. PTC maintains all economics associated with up to $250 million in remaining commercial sales milestones associated with Evrysdi global net sales. This agreement builds on the previous strategic partnership established with Royalty Pharma in 2020. 

Novartis Pluvicto® Shows Clinically Meaningful and Highly Statistically Significant rPFS Benefit in Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer in the Pre-Taxane Setting

East Hanover-based BioNJ Member Novartis presented data from the Phase III PSMAfore trial. Data presented showed that Pluvicto® (lutetium Lu 177 vipivotide tetraxetan) met its primary endpoint with a clinically meaningful and statistically significant benefit in radiographic progression-free survival (rPFS) in patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) after treatment with androgen receptor pathway inhibitor (ARPI) therapy, compared to a change in ARPI. The trial met its primary endpoint of rPFS with a 59% reduction in the risk of radiographic disease progression in patients with Pluvicto versus a change of ARPI. 

Y-mAbs Therapeutics Announces U.S. FDA Clearance of Investigational New Drug Application for CD38-SADA

BioNJ Member Y-mAbs Therapeutics, Inc. with a site in Nutley, announced that the U.S. Food and Drug Administration has cleared the company’s Investigational New Drug (“IND”) application for CD38-SADA, the company’s second program within its Self-Assembly DisAssembly Pre-targeted Radioimmunotherapy (“SADA Y-PRIT”) Theranostic Platform. The Phase 1 trial is a first-in-human, dose-escalation, open-label, single-arm, multi-center trial (Study 1201) investigating the safety and tolerability of the CD38-SADA: 177Lu-DOTA Drug Complex in patients with Relapsed or Refractory non-Hodgkin Lymphoma. This trial will have two parts: Part A, CD38-SADA dose escalation with fixed 177Lu-DOTA payload doses to explore optimal CD38-SADA protein dose and interval between the SADA protein administration and the payload; and Part B, 177Lu-DOTA therapeutic dose escalation with the CD38-SADA dose determined in Part A. Patients will receive up to three cycles of therapy. 

BioAegis Therapeutics Awarded $20 Million BARDA DRIVe Contract to Advance Gelsolin, an Immune Regulator, as a Treatment for Patients With Acute Respiratory Distress Syndrome (ARDS)

New Brunswick-based BioNJ Member BioAegis Therapeutics announced a second partnership with the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services. This partnership comes with the award of a $20 million contract from BARDA’s Division of Research, Innovation and Ventures (DRIVe), to advance gelsolin, a master regulator of the innate immune system, for the treatment of Acute Respiratory Distress Syndrome (ARDS). This significant injection of funding accelerates BioAegis’ ARDS program and the execution of its strategy to transform the treatment of inflammatory diseases.

TIVDAK® (tisotumab vedotin-tftv) Significantly Prolonged Overall Survival in Patients With Recurrent or Metastatic Cervical Cancer Compared With Chemotherapy in Global Phase 3 innovaTV 301 Trial

Princeton-based BioNJ Member Genmab A/S and Seagen Inc. announced additional results from the Phase 3 innovaTV 301 randomized global trial, which showed treatment with TIVDAK demonstrated a statistically significant and clinically meaningful 30 percent reduction in the risk of death in recurrent or metastatic cervical cancer patients with disease progression on or after front-line therapy, compared with chemotherapy (HR: 0.70, 95 percent CI: 0.54-0.89, p=0.0038i). Topline results from innovaTV 301 were disclosed earlier this year following a pre-specified interim analysis conducted through an independent data monitoring committee. The safety profile of TIVDAK in innovaTV 301 was consistent with its known safety profile as presented in the U.S. prescribing information, and no new safety signals were observed.  

Dupixent® (dupilumab) Phase 3 Results Show Sustained Efficacy for Up to One Year in Children 1 to 11 Years of Age With Eosinophilic Esophagitis (EoE)

Bridgewater-based BioNJ Member Sanofi announced positive results from a Phase 3 trial demonstrated the efficacy and safety profile of Dupixent® (dupilumab) for up to one year (52 weeks) in children aged 1 to 11 years with eosinophilic esophagitis (EoE) was consistent. These results represent the first analysis of longer-term data in this age group and will be featured in the American College of Gastroenterology Scientific Meeting. The data to be presented at ACG feature results from children enrolled in the extended active treatment period (Part B) of a Phase 3 trial, following 16 weeks of Dupixent treatment or placebo in Part A of the trial. All children in Part B were treated with higher or lower dose Dupixent for an additional 36 weeks, providing up to 52 weeks of data.

U.S. FDA Approves Pfizer’s VELSIPITY™ for Adults With Moderately to Severely Active Ulcerative Colitis (UC)

BioNJ Member Pfizer, with a site in Peapack, announced that the U.S. Food and Drug Administration (FDA) has approved VELSIPITY™ (etrasimod), an oral, once-daily, selective sphingosine-1-phosphate (S1P) receptor modulator for adults with moderately to severely active ulcerative colitis (UC). The approved recommended dose for VELSIPITY is 2 mg. UC is a chronic and often debilitating condition¹ that affects an estimated 1.25 million people in the United States. Symptoms of UC can include chronic diarrhea with blood and mucus, abdominal pain, and urgency. However, its impact can span beyond the physical to other aspects of life due to the chronic and unpredictable nature of symptoms.

FDA Approves PENBRAYA™, the First and Only Vaccine for the Prevention of the Five Most Common Serogroups Causing Meningococcal Disease in Adolescents

BioNJ Member Pfizer, with a site in Peapack, announced that the U.S. Food and Drug Administration (FDA) has approved PENBRAYA™ (meningococcal groups A, B, C, W and Y vaccine), the first and only pentavalent vaccine that provides coverage against the most common serogroups causing meningococcal disease in adolescents and young adults 10 through 25 years of age. PENBRAYA combines the components from two meningococcal vaccines, Trumenba® (meningococcal group B vaccine) and Nimenrix® (meningococcal groups A, C, W-135, and Y conjugate vaccine) to help protect against the five most common meningococcal serogroups that cause the majority of invasive meningococcal disease (IMD) globally.

BRUKINSA® Receives Positive Recommendation from NICE in U.K. for Adult Patients With Chronic Lymphocytic Leukemia

BioNJ Member BeiGene, with a site in Hopewell, announced the National Institute for Health and Care Excellence (NICE) of the United Kingdom (U.K.) has issued a final draft guidance (FDG) recommending BRUKINSA® (zanubrutinib) for the treatment of eligible adult patients with untreated chronic lymphocytic leukemia (CLL) if there is a 17p deletion or TP53 mutation (high risk) or untreated CLL without a 17p deletion or TP53 mutation, and fludarabine-cyclophosphamide-rituximab (FCR) or bendamustine plus rituximab (BR) is unsuitable and relapsed or refractory CLL. “We are delighted that NICE has recognized the clinical and economic benefit of BRUKINSA for patients with CLL,” said Dr. Robert Mulrooney, General Manager, U.K. & Ireland at BeiGene. 

BeiGene Receives Positive CHMP Opinion for BRUKINSA® (zanubrutinib) in Relapsed or Refractory Follicular Lymphoma

BioNJ Member BeiGene, with a site in Hopewell, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending approval of BRUKINSA® (zanubrutinib), a Bruton’s tyrosine kinase inhibitor (BTKi), in combination with obinutuzumab for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior lines of systemic therapy. “Today’s positive CHMP opinion is a testament to our continued commitment to bringing innovative medicines to patients and demonstrates the value of BRUKINSA, which – if approved in FL – will become the BTK inhibitor with the broadest label in the EU,” said Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene.

BeiGene Announces the Phase 3 RATIONALE 315 Trial Met Primary Endpoints of Major Pathological Response Rate and Event-Free Survival for Tislelizumab Plus Chemotherapy in Patients With Resectable Non-Small Cell Lung Cancer (NSCLC)

BioNJ Member BeiGene, with a site in Hopewell, announced that the Phase 3 RATIONALE 315 study met its dual primary endpoints of major pathological response (MPR) by Blinded Independent Pathology Review (BIPR) and event-free survival (EFS) by Blinded Independent Central Review (BICR), demonstrating statistically significant and clinically meaningful improvements in patients with resectable Stage II or IIIA NSCLC treated with tislelizumab in combination with chemotherapy before surgery and as a single agent after surgery versus neoadjuvant chemotherapy plus placebo followed by placebo after surgery. The tislelizumab plus chemotherapy regimen also showed a statistically significant improvement in pathological complete response (pCR), the key secondary endpoint, after neoadjuvant therapy versus chemotherapy. 

BeiGene Announces Late-Breaking Data at ESMO Showing Tislelizumab plus Chemotherapy Significantly Improved Overall Survival at Final Analysis in First-Line Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

BioNJ Member BeiGene, with a site in Hopewell, announced results from the final analysis of the Phase 3 RATIONALE 305 trial showing tislelizumab plus chemotherapy significantly improved overall survival (OS) in the intent-to-treat (ITT) population as a first-line treatment for patients with advanced gastric or gastroesophageal junction adenocarcinoma (GC/GEJC). No new safety signals were identified. In the final analysis of 997 intent-to-treat patients from the Phase 3 RATIONALE 305 trial, tislelizumab plus chemotherapy (oxaliplatin 130 mg/m2 IV Q3W (day 1) and oral capecitabine 1000 mg/m2 twice daily (days 1-14) Q3W (XELOX), or cisplatin 80 mg/m² IV Q3W (day 1) and 5-fluorouracil 800 mg/m2/day IV (days 1-5) Q3W (FP)) showed a median OS of 15.0 months compared with an OS of 12.9 months for chemotherapy alone (HR: 0.80 [95% CI: 0.70, 0.92]; P = 0.0011) in first line advanced GC/GEJC.

Teva Phase IV UNITE Study Shows AJOVY® (fremanezumab) Reduced Migraine Attacks and Depression Symptoms in Migraine Sufferers With Major Depressive Disorder

Parsippany-based BioNJ Member Teva Pharmaceutical announced that data from the UNITE study show that AJOVY® (fremanezumab) reduced migraine attacks and depression symptoms in migraine patients with major depressive disorder. AJOVY® is currently approved for the preventive treatment of migraine in adults. Depression is one of the most prevalent psychiatric co-morbidities in migraine and patients with comorbid depression experience an increased risk of migraine ‘chronification’. This is characterized by an increase in the number of headache days, a greater degree of headache disability, decreased quality of life and a poorer response to migraine treatments. UNITE is a double-blind, randomised, placebo-controlled, Phase 4 study sponsored by Teva investigating the efficacy, safety and impact of fremanezumab on patients with migraine and major depressive disorder.

Gilead Sciences Announces New Clinical Trial in Europe to Assess Lenacapavir for HIV Prevention as Part of Landmark Purpose Program

BioNJ Member Gilead Sciences, with a site in Morris Plains, announced PURPOSE 5, the first Phase 2 clinical trial to evaluate an investigational long-acting HIV prevention option in Europe. The study will assess the persistence — defined as consistent and continuous use — of lenacapavir compared with emtricitabine/tenofovir disoproxil fumarate (F/TDF) in people who may benefit from pre-exposure prophylaxis (PrEP) and who are not currently taking PrEP. The study has an intentional focus on recruiting participants from groups across France and the United Kingdom that are disproportionally affected by HIV and often underrepresented in clinical trials. Lenacapavir is a first-in-class HIV capsid inhibitor that can be administered as a twice-yearly subcutaneous injection. It is currently approved, in combination with other antiretrovirals, for HIV treatment in persons with multidrug-resistant HIV-1 infection.

Real-World Evidence Reinforces Biktarvy® as a Long-Term Treatment Option With a High Barrier to Resistance for People With HIV and a Range of Comorbidities

BioNJ Member Gilead Sciences, with a site in Morris Plains, announced new long-term real-world data from the BICSTaR study highlighting the safety and efficacy profile of Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) as a treatment regimen for a broad range of people with HIV, including those with a prior treatment history or comorbidities. New real-world data from the ongoing, multinational, observational, real-world BICSTaR study were collected from individuals with HIV who were enrolled in Canada, France and Germany. Overall, Biktarvy was found to be highly effective for trial participants after three years of follow-up, with 97% (58/60) of treatment-naïve and 97% (356/367) of treatment-experienced participants virologically suppressed (HIV-1 RNA <50 copies/mL; missing=excluded analysis). Additionally, there were no reports of treatment-emergent resistance.

Gilead and Assembly Biosciences Establish Partnership to Develop Next-Generation Therapeutics for Serious Viral Diseases

BioNJ Member Gilead Sciences, with a site in Morris Plains, and Assembly Biosciences, Inc. announced that the companies have entered into a 12-year partnership to advance the research and development of novel antiviral therapies, with an initial focus in Assembly Bio’s established areas of herpesviruses, hepatitis B virus (HBV) and hepatitis D virus (HDV). Assembly Bio’s current portfolio of small molecule antiviral therapeutics includes both clinical and preclinical programs, including next-generation core inhibitor ABI-4334 for the treatment of HBV, long-acting helicase-primase inhibitor ABI-5366 for herpes simplex virus (HSV), an orally bioavailable HDV entry inhibitor ABI-6250, and a pan-herpes polymerase inhibitor program.

New Data Presented at EACS 2023 Further Demonstrate Strong Clinical Profile of Twice-Yearly Sunlenca® for Adults With Multi-Drug Resistant HIV

BioNJ Member Gilead Sciences, with a site in Morris Plains, presented new data supporting Sunlenca® (lenacapavir) as an important treatment option for adults with multi-drug resistant (MDR) HIV who have extensive treatment history. These findings highlight the significance of lenacapavir, the first long-acting injectable HIV treatment medication administered twice-yearly, as a person-centric therapy option and its potential to help transform the future of coordinated HIV clinical care. The latest results include two-year data from the Phase 2/3 CAPELLA trial, which demonstrate that resistance to Sunlenca occurred in a minority of participants and only among those with inadequate adherence to their optimized background regimen (OBR) or without fully active antiretrovirals as part of their OBR. 

AbbVie Announces Upadacitinib (RINVOQ®) Met the Primary Endpoint in Phase 2 Clinical Trial of Vitiligo as Program Advances to Phase 3

BioNJ Member AbbVie, with a site in Madison, announced that its Phase 2b study evaluating upadacitinib (RINVOQ®) in adults with non-segmental vitiligo (NSV) met the primary endpoint of percent change from baseline in the Facial Vitiligo Area Scoring Index (F-VASI) at week 24 with the 11 mg and 22 mg doses versus placebo. The percent reduction from baseline in F-VASI at week 52 was numerically greater than results at week 24 for all upadacitinib doses. No new safety signals were identified beyond the known safety profile for upadacitinib. Based on these data, AbbVie is advancing its clinical program of upadacitinib in vitiligo to Phase 3.

Novo Nordisk to Buy Hypertension Drug for $1.3B

Plainsboro-based BioNJ Member Novo Nordisk announced it has agreed to acquire a hypertension medication from KBP Biosciences PTE Ltd. for up to $1.3 billion. Novo Nordisk said ocedurenone is intended for uncontrolled hypertension with potential treatments of cardiovascular and kidney disease. “Hypertension is a leading risk factor for cardiovascular events, heart failure, chronic kidney disease and premature death,” Martin Holst Lange, Executive Vice President, and Head of Development at Novo Nordisk, said. “With its expected benefit-risk profile, ocedurenone has best-in-class potential in treating uncontrolled hypertension and could help address a major unmet medical need in people living with cardiovascular disease and chronic kidney disease.” 

FDA Approves Lilly's Omvoh™ (mirikizumab-mrkz), A First-in-Class Treatment for Adults With Moderately to Severely Active Ulcerative Colitis

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced that the U.S. Food and Drug Administration (FDA) has approved Omvoh™ (mirikizumab-mrkz) infusion (300 mg/15 mL)/injection (100 mg/mL), the first and only interleukin-23p19 (IL-23p19) antagonist for the treatment of moderately to severely active ulcerative colitis (UC) in adults. Marking a significant milestone, Omvoh is the only UC treatment that selectively targets the p19 subunit of IL-23, which plays a role in inflammation related to UC. The approval was based on results from the LUCENT program, which included two randomized, double-blind, placebo-controlled Phase 3 clinical trials consisting of one 12-week induction study (UC-1) and one 40-week maintenance study (UC-2) for 52 weeks of continuous treatment.

Lilly's Tirzepatide Shows Additional 21.1% Weight Loss after 12 weeks of Intensive Lifestyle Intervention, for a Total Mean Weight Loss of 26.6% from Study Entry Over 84 weeks

Detailed results from BioNJ Member Eli Lilly and Company, with a site in Branchburg, 

Phase 3 SURMOUNT-3 clinical trial evaluating tirzepatide in adults with obesity or overweight with weight-related comorbidities, excluding type 2 diabetes, were published in Nature Medicine. Tirzepatide met both co-primary endpoints for the efficacy estimandi and treatment-regimenii estimand, demonstrating superiority to placebo during the 72-week double-blind treatment period. "In this study, people who added tirzepatide to diet and exercise saw greater, longer-lasting weight reduction than those taking placebo," said Jeff Emmick, MD, Ph.D., Senior Vice President, Product development, Lilly. "While intensive lifestyle intervention is an important part of obesity management, these results underscore the difficulty some people face maintaining weight loss with diet and exercise alone."

Nearly 80% of Patients With Moderate-to-Severe Atopic Dermatitis Maintained Clear or Almost Clear Skin With Lilly's Lebrikizumab Monthly Maintenance Dosing at Two Years

Patients with moderate-to-severe atopic dermatitis who continued treatment with investigational lebrikizumab for up to two years experienced sustained skin clearance, itch relief and reduced disease severity with monthly maintenance dosing as demonstrated in the ADjoin long-term extension study from BioNJ Member Eli Lilly and Company, with a site in Branchburg. Lebrikizumab is an interleukin-13 (IL-13) inhibitor that specifically blocks IL-13 signaling. The cytokine IL-13 is key in atopic dermatitis, driving the type-2 inflammatory loop in the skin, leading to skin barrier dysfunction, itch, skin thickening and infection. ADjoin is the two-year extension of the lebrikizumab monotherapy trials ADvocate 1 and ADvocate 2 and ADhere, the combination trial with topical corticosteroids. 

Lilly's Retevmo® (selpercatinib) Phase 3 Results in RET Fusion-Positive Non-Small Cell Lung Cancer and RET-Mutant Medullary Thyroid Cancer Both Published in The New England Journal of Medicine and Presented in a Presidential Symposium at ESMO Congress 2023

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced results from both the LIBRETTO-431 Phase 3 study, which evaluated Retevmo® (selpercatinib) versus platinum-based chemotherapy — with or without pembrolizumab — as an initial treatment for patients with advanced or metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC), and the LIBRETTO-531 Phase 3 study, which evaluated Retevmo versus multikinase inhibitors (MKIs) in patients with advanced or metastatic RET-mutant medullary thyroid cancer (MTC). In both clinical studies, results were based on pre-specified interim efficacy analyses conducted by independent data monitoring committees (IDMC). Results from the LIBRETTO-431 and LIBRETTO-531 Phase 3 trials were published in the New England Journal of Medicine.

Landmark 5-Year monarchE Outcome Data Demonstrate Verzenio® (abemaciclib)'s Long-Term Impact on Cancer Recurrence in High-Risk Early Breast Cancer

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced five-year outcomes from a pre-planned analysis of the Phase 3 monarchE study evaluating two years of adjuvant Verzenio® (abemaciclib) in combination with endocrine therapy (ET) compared with ET alone in patients with HR+, HER2-, node-positive early breast cancer (EBC) at a high risk of recurrence. The data include results from a pre-specified analysis reflecting a median follow-up of 4.5 years. All patients have completed the Verzenio treatment course, with more than 80% of patients having been followed for at least two years after completion. In the intent-to-treat (ITT) population, the risk of developing invasive disease was reduced by 32% (HR=0.680, 95% CI: 0.599, 0.772; nominal p<0.001). 

U.S. Food and Drug Administration Approves Opdivo® (nivolumab) as Adjuvant Treatment for Eligible Patients With Completely Resected Stage IIB or Stage IIC Melanoma

Princeton-based BioNJ Member Bristol Myers Squibb announced that Opdivo®(nivolumab) was approved by the U.S. Food and Drug Administration (FDA) for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected stage IIB or IIC melanoma, expanding upon the existing adjuvant indication for Opdivo and further reinforcing the company’s legacy of providing treatment options for melanoma patients. The approval is based on the Phase 3 CheckMate -76K trial, which compared Opdivo (n=526) to placebo (n=264). In the trial, Opdivo reduced the risk of recurrence, new primary melanoma, or death in patients with completely resected stage IIB or IIC melanoma by 58% compared to placebo (Hazard Ratio [HR] 0.42; 95% Confidence Interval [CI]: 0.30-0.59; P<0.0001). 

Phase 3 CheckMate -67T Trial of Subcutaneous Nivolumab (nivolumab and hyaluronidase) Meets Co-Primary Endpoints in Advanced or Metastatic Clear Cell Renal Cell Carcinoma

Princeton-based BioNJ Member Bristol Myers Squibb announced that the Phase 3 CheckMate -67T noninferiority trial evaluating the subcutaneous formulation of Opdivo (nivolumab) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20) (herein referred to as “subcutaneous nivolumab”) compared to intravenous (IV) Opdivo in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received prior systemic therapy met its co-primary pharmacokinetics endpoints and key secondary endpoint. Subcutaneous nivolumab demonstrated noninferiority of Cavgd28 (time averaged Opdivo serum concentration over 28 days) and Cminss (trough serum concentration at steady state) compared to IV Opdivo, the study’s co-primary endpoints. Additionally, subcutaneous nivolumab showed a noninferior objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) vs. IV Opdivo, a key secondary endpoint. 

Perioperative Regimen of Neoadjuvant Opdivo (nivolumab) and Chemotherapy Followed by Adjuvant Opdivo Shows Significant Improvement in Event-Free Survival for Patients With Resectable Non-Small Cell Lung Cancer in Phase 3 CheckMate -77T Trial

Princeton-based BioNJ Member Bristol Myers Squibb announced the first disclosure of data from the Phase 3 CheckMate -77T trial evaluating the perioperative regimen of neoadjuvant Opdivo (nivolumab) with chemotherapy followed by surgery and adjuvant Opdivo in patients with resectable stage IIA to IIIB non-small cell lung cancer (NSCLC). In the study, the perioperative regimen showed a statistically significant and clinically meaningful improvement in the primary efficacy endpoint of event-free survival (EFS) as assessed by Blinded Independent Central Review (BICR) compared to neoadjuvant chemotherapy and placebo followed by surgery and adjuvant placebo.With a median follow-up of 25.4 months, in patients treated with neoadjuvant Opdivo and chemotherapy followed by surgery and adjuvant Opdivo, the risk of disease recurrence, progression or death was reduced by 42% (EFS Hazard Ratio [HR] 0.58; 97.36% Confidence Interval [CI]: 0.42 to 0.81; p=0.00025). 

Neoadjuvant Opdivo (nivolumab) with Chemotherapy Provides Benefits for Patients With Resectable Non-Small Cell Lung Cancer Across PD-L1 Expression Levels With Three-Year Follow Up in CheckMate -816 Trial

Princeton-based BioNJ Member Bristol Myers Squibb announced three-year follow-up results from exploratory analyses of the Phase 3 CheckMate -816 trial, demonstrating sustained event-free survival (EFS) and promising overall survival (OS) trends with three cycles of Opdivo (nivolumab) in combination with platinum-based chemotherapy for the neoadjuvant treatment of patients with resectable non-small cell lung cancer (NSCLC), regardless of PD-L1 expression levels. Neoadjuvant Opdivo with chemotherapy also showed improvements in pathologic complete response (pCR) and major pathologic response (MPR) over chemotherapy alone in PD-L1 ≥1% and <1% patient populations. The safety profile of the Opdivo-based regimen was consistent across all PD-L1 subgroups. 

The Robert A. Winn Diversity in Clinical Trials Award Announces Third Group of Physicians in Program to Increase Diversity in Clinical Trials

Princeton-based BioNJ Member Bristol Myers Squibb together with Virginia Commonwealth University (VCU), the American Association for Cancer Research (AACR), BioNJ Member Gilead Sciences, Inc. and BioNJ Member Amgen announced that an additional 65 physicians have been selected to receive the Robert A. Winn Diversity in Clinical Trials Career Development Award (Winn CDA). The broader Robert A. Winn Diversity in Clinical Trials Award Program (Winn Award Program) aims to train, develop and mentor more than 308 clinical trialists and 308 medical students by 2027 who are diverse or who have a demonstrated commitment to clinical trial diversity. The third cohort of physicians joins the 114 early stage investigator physicians who have so far been trained in the Winn CDA, one of four awards offered by the Robert A. Winn Diversity in Clinical Trials Award Program.

Bristol Myers Squibb Announces U.S. FDA Breakthrough Therapy Designation for Investigational LPA1 Antagonist for Progressive Pulmonary Fibrosis

Princeton-based BioNJ Member Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for BMS-986278, a potential first-in-class, oral, lysophosphatidic acid receptor 1 (LPA1) antagonist, for the treatment of progressive pulmonary fibrosis (PPF), a devastating, life-threatening illness. Currently, there is only one therapy approved for the treatment of PPF. The Breakthrough Therapy Designation is based on results from the global, randomized Phase 2 study that assessed the safety and efficacy of BMS-986278 treatment versus placebo in people living with idiopathic pulmonary fibrosis (IPF) and PPF. Stable background use of antifibrotics in the IPF cohort and/or select immunosuppressives in the PPF cohort were allowed. 

TREMFYA® (guselkumab) Maintains Key Efficacy Endpoints Through Three Years for Adults With Moderately to Severely Active Crohn's Disease in a Phase 2 Study

Raritan-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced new data from the long-term extension (LTE) of the GALAXI Phase 2 study demonstrating the durable clinical and endoscopic efficacy of TREMFYA® (guselkumab), a selective IL-23 p19 inhibitor, in patients with moderate-to-severe Crohn’s disease (CD), now through a total of three years. Rates of clinical remission and endoscopic response were maintained through three years. The safety profile of TREMFYA was consistent with that of its currently approved indications. Both TREMFYA treatment arms demonstrated similar benefits in this study. The study was not designed to evaluate efficacy differences between individual TREMFYA doses or TREMFYA versus STELARA.

Landmark Phase 3 MARIPOSA Study Shows RYBREVANT® (amivantamab-vmjw) Plus Lazertinib Resulted in 30 Percent Reduction in Risk of Disease Progression or Death Compared to Osimertinib in Patients With EGFR-Mutated Non-Small Cell Lung Cancer

Raritan-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced results from the Phase 3 MARIPOSA study showing RYBREVANT® (amivantamab-vmjw) in combination with lazertinib compared to osimertinib resulted in a 30 percent reduction in the risk of disease progression or death (Hazard Ratio [HR]=0.70; 95 percent Confidence Interval [CI], 0.58–0.85; p value P<0.001) in the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with either epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution Results also showed a favorable trend in overall survival (OS) for RYBREVANT® and lazertinib in these patients compared to osimertinib (HR=0.80; 95 percent CI, 0.61–1.05; P=0.11) at a first interim analysis. 

Phase 3 MARIPOSA-2 Study Shows RYBREVANT® (amivantamab-vmjw) Plus Chemotherapy Given With or Without Lazertinib Reduced Risk of Disease Progression or Death by 56 and 52 Percent Respectively in Patients With EGFR-Mutated Non-Small Cell Lung Cancer who Progressed on or after Osimertinib

Raritan-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced results from the Phase 3 MARIPOSA-2 study showing the regimen of RYBREVANT® (amivantamab-vmjw) given with or without lazertinib and combined with chemotherapy reduced the risk of disease progression or death by 56 and 52 percent respectively (Hazard Ratio [HR]=0.44; 95 percent Confidence Interval [CI], 0.35–0.56; p value P<0.001 and HR=0.48; 95 percent CI, 0.36–0.64; P<0.001) compared to chemotherapy alone in patients with locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution, after disease progression on or after osimertinib. Results also showed that the two RYBREVANT® regimens significantly improved objective response rate (ORR), intracranial progression-free survival (PFS), and duration of response (DOR) compared to chemotherapy alone in these patients. 

First Results With Erdafitinib-Releasing Intravesical Delivery System (TAR-210) Show Early Evidence of Positive Clinical Activity in Patients With Non-Muscle-Invasive Bladder Cancer With Select Fibroblast Growth Factor Receptor Alterations

Raritan-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced the first results from an open-label, multicenter Phase 1 study evaluating the safety and efficacy of TAR-210, an intravesical delivery system designed to provide sustained, local release of erdafitinib into the bladder in patients with non-muscle-invasive bladder cancer (NMIBC) with select fibroblast growth factor receptor (FGFR) alterations. Results featured data from Cohort 1 [(C1); patients with recurrent, Bacillus Calmette-Guérin (BCG)-unresponsive high-risk (HR) NMIBC (high-grade Ta/T1; papillary only) who refused or were ineligible for radical cystectomy] and Cohort 3 [(C3); patients with intermediate-risk (IR) NMIBC (Ta/T1) low-grade papillary disease] left in situ as tumor marker lesions.

TAR-200 Intravesical Delivery System Results Show 77 Percent Complete Response Rate in Patients With Bacillus-Calmette-Guérin Unresponsive, High-Risk Non-Muscle-Invasive Bladder Cancer

Raritan-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced that data from the Phase 2b SunRISe-1 study evaluating the efficacy and safety of TAR-200 monotherapy in patients with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC), who are ineligible for, or decline, radical cystectomy, showed that 77 percent of patients (23 out of 30 [95 percent Confidence Interval (CI), 58-90]) achieved a complete response (CR). TAR-200 is an investigational intravesical drug delivery system designed to provide sustained local release of gemcitabine into the bladder. Results presented today included an evaluation of 54 patients (median age of 71; range 40-85; 33 percent with concurrent papillary disease) who received TAR-200 monotherapy. 

New Phase 3 TREMFYA® (guselkumab) Results in Ulcerative Colitis Show a 77 Percent Overall Clinical Response Rate and Early Symptom Improvement

Raritan-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced new data from the QUASAR Phase 3 Induction Study demonstrating the efficacy and safety profile of TREMFYA® (guselkumab), a selective IL-23 p19 inhibitor, in patients with moderately to severely active ulcerative colitis (UC) through 24 weeks. High rates of clinical response were observed at Weeks 12 or 24, with no new safety signals observed compared to the safety profile of TREMFYA in its approved indications. Symptomatic response and improvements in patient-reported outcomes of rectal bleeding and absolute stool number were observed as early as one week after a single intravenous (IV) induction dose, with symptomatic response evident in more than two-thirds of patients at Week 12.

Merck’s KEYTRUDA® (pembrolizumab) Plus Concurrent Chemoradiotherapy Significantly Improved Progression-Free Survival (PFS) Versus Concurrent Chemoradiotherapy Alone in Newly Diagnosed, High-Risk Locally Advanced Cervical Cancer

Rahway-based BioNJ Member Merck & Co. announced results from the pivotal Phase 3 KEYNOTE-A18 trial, also known as ENGOT-cx11/GOG-3047, investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with external beam radiotherapy (EBRT) plus concurrent chemotherapy, followed by brachytherapy (also known as concurrent chemoradiotherapy) for newly diagnosed patients with high-risk locally advanced cervical cancer (stage 1B2-2B with lymph node-positive disease, and stage 3-4A with and without lymph node-positive disease). Results from the trial showed that KEYTRUDA in combination with concurrent chemoradiotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to concurrent chemoradiotherapy alone for these patients. 

FDA Approves KEYTRUDA® (pembrolizumab) for Treatment of Patients With Resectable (T≥4 cm or N+) NSCLC in Combination With Chemotherapy as Neoadjuvant Treatment, Then Continued as a Single Agent as Adjuvant Treatment After Surgery

Rahway-based BioNJ Member Merck & Co. announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, for the treatment of patients with resectable (tumors ≥4 centimeters [cm] or node positive) non-small cell lung cancer (NSCLC) in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. With this approval, KEYTRUDA has six indications in NSCLC, across both metastatic and earlier stages of NSCLC. The approval was based on data from the Phase 3 KEYNOTE-671 trial evaluating KEYTRUDA in combination with chemotherapy as neoadjuvant treatment followed by surgery and continued adjuvant treatment with KEYTRUDA as a single agent, for patients with resectable stage II, IIIA or IIIB (N2) NSCLC per the American Joint Committee on Cancer eighth edition (AJCC 8th edition).

Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) Plus Chemotherapy as First-Line Treatment for HER2-Negative Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Expressing PD-L1 (CPS ≥1)

Rahway-based BioNJ Member Merck & Co. announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma in adults whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1). “This positive CHMP opinion builds on our efforts to treat advanced gastric and gastroesophageal junction cancer in Europe, including in patients with HER2-negative disease, which accounts for the vast majority of gastric cancer cases,” said Dr. Marjorie Green, Senior Vice President and Head of Late-Stage Oncology, Global Clinical Development, Merck Research Laboratories. 

European Commission Approves KEYTRUDA® (pembrolizumab) as Adjuvant Treatment for Adults With Non-Small Cell Lung Cancer at High Risk of Recurrence Following Complete Resection and Platinum-Based Chemotherapy

Rahway-based BioNJ Member Merck & Co. announced that the European Commission (EC) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as a monotherapy for the adjuvant treatment of adults with non-small cell lung cancer (NSCLC) who are at high risk of recurrence following complete resection and platinum-based chemotherapy. “In the unfortunate scenario that non-small cell lung cancer recurs after surgery, most patients have to face limited palliative treatment strategies, underscoring the need to improve treatment outcomes for earlier stages of NSCLC,” said Dr. Solange Peters, Chair of the Medical Oncology and Thoracic Malignancies Department, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland. “This approval of KEYTRUDA marks the first immunotherapy option approved in the EU for patients with non-small cell lung cancer who are at high risk of disease recurrence following surgery and chemotherapy, regardless of PD-L1 expression.”

Merck Receives Positive EU CHMP Opinion for PREVYMIS® for Prevention of CMV Disease in High-Risk Adult Kidney Transplant Recipients and Extended 200-Day Dosing in Adult HSCT Recipients at Risk for Late CMV Infection and Disease

Rahway-based BioNJ Member Merck & Co. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of PREVYMIS® (letermovir) for prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (Donor CMV-seropositive/Recipient CMV-seronegative [D+/R-]). The CHMP has also recommended the approval for extending dosing for PREVYMIS from 100 days to 200 days following transplant in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT) who are at risk for late CMV infection and disease. The CHMP’s recommendations will now be reviewed by the European Commission for marketing authorization in the European Union (EU) and a final decision is expected this year.

KEYTRUDA® (pembrolizumab) Plus Chemotherapy Before Surgery and Continued as Single Agent After Surgery Reduced Risk of Death by 28% Versus Pre-Operative Chemotherapy in Resectable Stage II, IIIA or IIIB Non-Small Cell Lung Cancer (NSCLC)

Rahway-based BioNJ Member Merck & Co. announced results from the Phase 3 KEYNOTE-671 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, as a perioperative treatment regimen, which includes treatment before surgery (neoadjuvant) and after surgery (adjuvant), for patients with resectable stage II, IIIA or IIIB non-small cell lung cancer (NSCLC). At the trial’s prespecified second interim analysis with a median follow-up of 36.6 months (range, 18.8 to 62.0), neoadjuvant KEYTRUDA plus chemotherapy followed by KEYTRUDA as a single agent after surgical resection significantly improved overall survival (OS), reducing the risk of death by 28% (HR=0.72 [95% CI, 0.56-0.93]; one-sided p=0.00517) in patients with resectable stage II, IIIA or IIIB NSCLC versus neoadjuvant placebo plus chemotherapy followed by adjuvant placebo, regardless of PD-L1 expression. 

KEYTRUDA® (pembrolizumab) Plus Trastuzumab and Chemotherapy Significantly Improved Progression-Free Survival (PFS) Versus Trastuzumab and Chemotherapy in First-Line HER2-Positive Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

Rahway-based BioNJ Member Merck & Co. announced results from the Phase 3 KEYNOTE-811 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with human epidermal growth factor receptor 2 (HER2)-positive locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. These data are being discussed with regulatory authorities worldwide. After a median follow-up of 28.4 months, the KEYTRUDA regimen demonstrated a statistically significant improvement in progression-free survival (PFS) in the intention-to-treat (ITT) advanced HER2-positive study population, reducing the risk of disease progression or death by 28% (HR=0.72 [95% CI, 0.60-0.87]; p=0.0002) compared to trastuzumab and chemotherapy alone.

KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) Reduced Risk of Death by More Than Half Versus Chemotherapy in Patients With Previously Untreated Locally Advanced or Metastatic Urothelial Cancer

Rahway-based BioNJ Member Merck & Co. announced results from the Phase 3 KEYNOTE-A39 trial (also known as EV-302), which was conducted in collaboration with Seagen and Astellas, evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, plus Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate, compared to chemotherapy (gemcitabine plus cisplatin or carboplatin) in patients with previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC). “These results, showing a 53% reduction in the risk of death for the combination compared to chemotherapy, are striking and may open a new chapter for the treatment of these patients diagnosed with advanced urothelial carcinoma, who face an urgent need for new therapies,” said Dr. Thomas Powles, KEYNOTE-A39 primary investigator, Professor of Genitourinary Oncology and Director, Barts Cancer Center.

Merck’s WELIREG® (belzutifan) Significantly Improved Progression-Free Survival and Objective Response Rates Versus Everolimus in Certain Previously Treated Patients With Advanced Renal Cell Carcinoma (RCC)

Rahway-based BioNJ Member Merck & Co. announced results from the Phase 3 LITESPARK-005 trial investigating WELIREG, Merck’s first-in-class, oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult patients with advanced renal cell carcinoma (RCC) that progressed following PD-1/L1 and vascular endothelial growth factor receptor (VEGFR) targeted therapies. In the study, WELIREG demonstrated a statistically significant improvement in one of the trial’s dual primary endpoints of progression-free survival (PFS) and in a key secondary endpoint of objective response rate (ORR) compared to everolimus. At the first pre-specified interim analysis (IA1) at a median follow-up of 18.4 months (range, 9.4-31.7), WELIREG significantly reduced the risk of disease progression or death by 25% (HR=0.75 [95% CI, 0.63-0.90]; p<0.001) versus everolimus in these patients. 

Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy Showed Statistically Significant Improvement in Pathological Complete Response (pCR) Rate as Neoadjuvant Therapy Versus Chemotherapy in High-Risk, Early Stage ER+/HER2- Breast Cancer

Rahway-based BioNJ Member Merck & Co. announced the first presentation of results from the neoadjuvant part of the Phase 3 KEYNOTE-756 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy as neoadjuvant treatment, followed by KEYTRUDA plus endocrine therapy as adjuvant treatment, for patients with high-risk, early stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer. KEYTRUDA plus chemotherapy before surgery met one of its dual primary endpoints of pathological complete response (pCR), demonstrating a statistically significant improvement in pCR rate compared to placebo plus chemotherapy. The pCR rate increased from 15.6% in patients treated with neoadjuvant chemotherapy alone (n=100/643) to 24.3% in patients treated with neoadjuvant KEYTRUDA plus chemotherapy (n=154/635), an estimated increase of 8.5 percentage points (p=0.00005).

GSK Receives Positive CHMP Opinion Recommending Approval of Jemperli (dostarlimab) plus Chemotherapy as a New Frontline Treatment for dMMR/MSI-H Primary Advanced or Recurrent Endometrial Cancer

Warren-based BioNJ Member GSK announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of Jemperli (dostarlimab) in combination with carboplatin-paclitaxel (chemotherapy), for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer and who are candidates for systemic therapy. The CHMP opinion is one of the final steps prior to a marketing authorization decision by the European Commission. GSK’s application for the authorization of dostarlimab is based on interim analysis results from Part 1 of the RUBY/ENGOT-EN6/GOG3031/NSGO Phase III trial. 

GSK Highlights New Data in Non-Small Cell Lung Cancer and Endometrial Cancer at the European Society for Medical Oncology (ESMO) Congress 2023, Reinforcing Potential of Jemperli (dostarlimab) as a Backbone Immuno-Oncology Therapy

Warren-based BioNJ Member GSK presented data at the ESMO Congress 2023 focusing on Jemperli (dostarlimab) and Zejula (niraparib) that further demonstrate advancements in immuno-oncology and gynaecologic cancers and improving patient outcomes. GSK will share updates from the PERLA trial evaluating dostarlimab plus chemotherapy versus pembrolizumab plus chemotherapy in the first-line treatment of metastatic non-squamous NSCLC. Expanding upon the primary data presented at the ESMO Immuno-Oncology Congress 2022, late-breaking results at ESMO 2023 (LBA64) will highlight a positive numerical trend in OS outcomes, favouring dostarlimab plus chemotherapy vs. pembrolizumab plus chemotherapy. The PERLA phase II trial is a randomised, double-blind trial of 243 patients and is the largest global head-to-head trial of programmed death receptor-1 (PD-1) inhibitors in this patient population.

GSK Enters Exclusive License Agreement With Hansoh for HS-20089

Warren-based BioNJ Member GSK and Hansoh Pharma announced that they have entered into an exclusive license agreement for HS-20089, a B7-H4 targeted antibody-drug conjugate (ADC) currently in phase I (NCT05263479) clinical trials in China. Under the agreement, GSK will obtain exclusive worldwide rights (excluding China’s mainland, Hong Kong, Macau and Taiwan) to progress development and commercialization of HS-20089. Hesham Abdullah, SVP, Global Head Oncology, R&D, GSK, said, “Given early clinical data, we believe that HS-20089 has best-in-class potential in ovarian and endometrial cancer with opportunities in other solid tumors. This agreement is in line with our approach to advancing novel treatment options for patients with gynecologic cancers.”

New Data for Arexvy, GSK’s RSV Vaccine, Show Potential to Help Protect Adults Aged 50 to 59 at Increased Risk for RSV Disease

Warrren-based BioNJ Member GSK plc announced positive preliminary results from its Phase III trial [NCT05590403] evaluating the immune response and safety of Arexvy (respiratory syncytial virus vaccine, adjuvanted) in adults aged 50 to 59, including those at increased risk of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) due to certain underlying medical conditions. This vaccine is currently approved in the US for active immunisation for the prevention of RSV-LRTD in adults 60 years of age and older. It is also approved in Europe, Japan and several other countries. The vaccine elicited an immune response in adults aged 50 to 59 at increased risk for RSV disease due to select underlying medical conditions that was non-inferior to that observed in adults aged 60 and above, meeting the trial’s primary co-endpoint.

ENHERTU® Demonstrated Clinically Meaningful Survival Across Multiple HER2 Expressing Advanced Solid Tumors in DESTINYPanTumor02 Phase 2 Trial

Daiichi Sankyo, with at site in Basking Ridge, announced positive results from the ongoing DESTINYPanTumor02 phase 2 trial showed that ENHERTU® (trastuzumab deruxtecan) continued to demonstrate clinically meaningful and durable responses, leading to a clinically meaningful survival benefit in previously treated patients across multiple HER2 expressing advanced solid tumors. These results, which include the first progression-free survival (PFS) and overall survival (OS) findings reported from the trial, were published in the Journal of Clinical Oncology. ENHERTU is a specifically engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca. 

ENHERTU® Approved in the EU as the First HER2 Directed Therapy for Patients With HER2 Mutant Advanced Non-Small Cell Lung Cancer

Daiichi Sankyo, with at site in Basking Ridge, announced ENHERTU® (trastuzumab deruxtecan) has been approved in the European Union (EU) as a monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumors have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy. The approval by the European Commission (EC) follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) and is based on results from the DESTINY-Lung02 Phase 2 trial. In DESTINY-Lung02, ENHERTU (5.4 mg/kg) demonstrated a confirmed objective response rate (ORR) of 49.0% (95% confidence interval [CI]: 39.0-59.1) in patients with previously treated advanced or metastatic HER2 mutant NSCLC as assessed by blinded independent central review (BICR).

Raludotatug Deruxtecan Continues to Demonstrate Promising Clinical Activity in Patients With Advanced Ovarian Cancer in Early Trial

Daiichi Sankyo, with at site in Basking Ridge, announced updated results from a subgroup analysis of a first-in-human Phase 1 trial showed that raludotatug deruxtecan (R-DXd) continues to demonstrate promising clinical activity in patients with heavily pretreated platinum-resistant advanced ovarian cancer. Raludotatug deruxtecan is a specifically engineered potential first-in-class CDH6 directed DXd antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo and BioNJ Member Merck & Co. Approximately 70% to 80% of patients diagnosed with ovarian cancer will have a recurrence of disease following standard treatment with platinum-based chemotherapy regimens. An estimated 65% to 85% of patients with ovarian cancer have expression of CDH6, which is associated with poor prognosis.

Datopotamab Deruxtecan Improved Progression-Free Survival Versus Chemotherapy in Patients With Previously Treated Non-Small Cell Lung Cancer in TROPION-Lung01 Phase 3 Trial

Daiichi Sankyo, with at site in Basking Ridge, announced positive results from the pivotal TROPION-Lung01 Phase 3 trial showed that datopotamab deruxtecan (Dato-DXd) demonstrated a statistically significant improvement for the primary endpoint of progression-free survival (PFS) compared to docetaxel, the current standard of care, in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) treated with at least one prior line of therapy. Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo and AstraZeneca.  Datopotamab deruxtecan reduced the risk of disease progression or death by 25% compared to docetaxel (hazard ratio [HR]=0.75; 95% confidence interval [CI]: 0.62-0.91; p=0.004) as assessed by blinded independent central review (BICR).

Datopotamab Deruxtecan Plus Durvalumab Demonstrated Robust and Durable Tumor Responses in First-Line Treatment of Patients With Metastatic Triple Negative Breast Cancer in BEGONIA Phase 1b/2 Trial

Daiichi Sankyo, with at site in Basking Ridge, announced updated results from the BEGONIA Phase 1b/2 trial for the cohort of patients treated with datopotamab deruxtecan (Dato-DXd) plus durvalumab (Arm 7) showed that the combination demonstrated durable tumor responses and no new safety signals in patients with previously untreated advanced or metastatic triple negative breast cancer (TNBC) with six months additional follow-up from the previous data cut-off. Approximately 300,000 people worldwide are diagnosed annually with TNBC, the most aggressive breast cancer subtype. Less than half of patients with metastatic TNBC respond to current first-line treatment options which can include chemotherapy alone or in combination with an immunotherapy.

iQure Pharma Secures $1.2M Funding from Ventura BioMed and OKG Capital

Princeton-based iQure Pharma Inc., a biotech company focused on the development of new therapeutics for neurodegenerative diseases, recently said it raised $1.2 million in funding to progress with IND-enabling pivotal tox studies for its lead asset, iQ-007, a novel therapeutic candidate to treat epilepsy and other neurodegenerative conditions. The funding round was led by Munich-based life science fund Ventura BioMed Investors and anchor early stage medtech investor OKG Capital. Both investors see this round as a first step toward further funding to complete preclinical development and start Phase 1 trials. “Addressing neurodegeneration and preventing seizures in an effective and safe manner is a critical medical and social need,” Pawel Zolnierczyk, iQure CEO, said.

Citius Pharma Sets Sights on $675M Merger Deal

Cranford-based Citius Pharmaceuticals Inc. and TenX Keane Acquisition announced they entered into a definitive agreement to merge TenX and Citius Pharma’s wholly owned oncology subsidiary. If approved, the newly combined public company will be called Citius Oncology Inc. Under the terms, Citius Pharma would receive 67.5 million shares in Citius Oncology at $10 per share and retain majority ownership of approximately 90%. Citius Oncology would focus on developing and commercializing novel targeted oncology therapies. Currently, Citius is seeking U.S. Food and Drug Administration approval of LYMPHIR for the treatment of persistent or recurrent cutaneous T-cell lymphoma, a rare form of non-Hodgkin lymphoma. 

New Jersey CSIT Info Session on SBIR/STTR Direct Financial Assistance Program - YouTube

Did you miss the webinar? Watch the archived version!

Rutgers, CMIC to Create Center for Advanced Pharmaceutical Manufacturing — Bring Additional Jobs to N.J.

CMIC USA, a subsidiary of Japan’s top contract development and manufacturing organization, and Rutgers announced a partnership to establish a Center of Excellence in Advanced Pharmaceutical Manufacturing at CMIC’s 224,000-square-foot facility in New Jersey. The move will help CMIC double its manpower in New Jersey. Gov. Phil Murphy, who announced the agreement during the 2023 New Jersey East Asian Economic Mission, said he couldn’t be more excited. “This is a big deal for us,” he said. “CMIC’s presence in New Jersey was already a big deal. But this collaboration with Rutgers will take your presence, and I believe Rutgers’ presence, to a different level.

Hiroshima University Partners With NJ Institutions on Cancer Research

Rutgers University, RWJBarnabas Health and Hiroshima University have signed a letter of intent (LOI) creating a joint effort to advance cancer research and education between New Jersey and Japan. A memorandum of understanding (MOU) between Rutgers University and Hiroshima University was signed during the Choose New Jersey governor-led economic mission to East Asia. “With today’s ceremony, we will establish a new, cross-continental partnership — one that will enable our top minds in New Jersey to engage and exchange ideas with researchers here in Hiroshima,” said Governor Murphy. “In the years to come, I am confident that this partnership will lead to important breakthroughs, especially when it comes to caring for cancer patients in New Jersey, Japan and around the world.”

2 for 1: Rutgers, NJIT Both to Become Research Partners With Taipei Tech

In a sign of commitment to STEM education as well as a commitment to working together, Rutgers University and the New Jersey Institute of Technology announced the creation of new academic partnerships with National Taipei University of Technology, one of the top research universities in Taiwan. Chancellor Francine Conway said, “Rutgers-New Brunswick is the nation’s No. 15 top public university and a home to interdisciplinary research — where the life sciences, engineering and other fields come together to solve problems and discover new knowledge. “We are proud to partner with National Taipei University of Technology and look forward to jointly discovering new innovations and elevating the academic and career paths of our students.”

Institute for Life Science Entrepreneurship Announces Winners of the $50,000 Translational Research Competition

The Institute for Life Science Entrepreneurship (ILSE) at Kean University awarded prizes totaling $50,000 to three research groups investigating new approaches to breast milk preservation, inhibiting Salmonella carriage in poultry and treatments for immune deficiencies. Ten finalists vied for the top prizes in ILSE’s inaugural Translational Research Competition. The winners will receive a cash award and a customized package of services and support to move their technologies through the development process. “The ILSE research team and our professional service firms will be working with the winners to develop robust plans to advance these technologies further,” said Keith Bostian, Ph.D., ILSE CEO and Associate Provost for Science and Technology at Kean University.

Kean University Partners With EY to Build Vitality Index

Kean University has become the first higher education institution in the nation to team up with EY, the global professional services firm, to build a Vitality Index; a tool for bolstering physical, mental, social and financial health among members of the campus community. “Kean University has always valued the well-being of its students, faculty and staff, but this new initiative allows us to take that commitment to the next level,” said Kean President Lamont O. Repollet, Ed.D. “By creating and using our Vitality Index, Kean University leaders are able to use data to take the pulse of Kean community members and work to close any gaps in well-being.”

NJII and Cooper University Health Care Introduce Health Hackathon

New Jersey Innovation Institute (NJII), a New Jersey Institute of Technology subsidiary, announced it is partnering with Cooper University Health Care to sponsor the first New Jersey Social Determinants of Health Hackathon in 2023. The collaboration aims to explore ways to leverage health information technology to better engage at-risk populations and improve access and health outcomes at both the local and state level. This event brings together stakeholders from across New Jersey to look at ways in which health IT and new technologies can improve the lives of underserved communities.

Liberty Science Center, EY Partner on Proactive Health Care Initiative

Liberty Science Center (LSC) and Ernst & Young LLP (EY US) announced a new and expansive collaboration this week to transform health care in the United States. As part of that partnership, EY US will assume the role of lead orchestrator of a unique interdisciplinary Healthcare Innovation Engine at SciTech Scity, the 30-acre “Science City of Tomorrow” innovation campus being developed by LSC adjacent to its main facility in Jersey City. SciTech Scity aims to galvanize world-changing, scientific research, developing breakthrough technologies and catalyzing businesses that use science and technology to address humanity’s greatest challenges. The first $450 million phase of the project is scheduled to open in 2025 and 2026.

Innovations in Breast Cancer Care

Although the incidence of breast cancer hasn’t necessarily declined, patients at New Jersey hospitals and cancer centers are living longer – and enjoying a better quality of life – thanks to ongoing advancements in everything from genetic testing to targeted therapies for specific gene mutations. These innovations have allowed physicians to better customize treatment to each individual patient so that a breast cancer diagnosis no longer automatically requires chemotherapy, radiation or surgery. “Over the past decade or two, we’ve moved away from a one-size-fits-all approach of treating every breast cancer patient with chemotherapy,” explains Dr. Serena Wong, breast oncologist at the Memorial Sloan Kettering Cancer Center in Middletown. “Instead, we’re trying to personalize our approach by pinpointing a particular mutation that’s driving each individual patient’s cancer, and then providing a therapy that targets that specific driver.”

9 From NJ Named to Newsweek’s Inaugural Best-In-State Hospitals List

For the first time, Newsweek has released a list of America’s Best-In-State Hospitals, and nine health care facilities in New Jersey made the cut. According to Newsweek Global Editor in Chief Nancy Cooper, the complete list recognizes 600 leading hospitals across the U.S. Along with research and consumer data firm Statista, the ranking identifies the top hospitals at the state level. New Jersey hospitals to make the list include (in order of ranking) Morristown Medical Center, Hackensack University Medical Center, Overlook Medical Center, Englewood Hospital and Medical Center, Robert Wood Johnson University Hospital, Cooper University Hospital, Valley Hospital, Chilton Medical Center and Saint Peter’s University Hospital.

Y-mAbs Names Michael Rossi as President and Chief Executive Officer and Director

BioNJ Member Y-mAbs Therapeutics, Inc., with a site in Nutley, announced that its Board of Directors has appointed Michael Rossi as President and Chief Executive Officer and a member of the Board of Directors with an expected start date of November 6, 2023. Mr. Rossi brings more than 30 years of experience in the radiopharmaceutical industry, including building out and leading the U.S. Business for Advanced Accellerators Applications, a Novartis company, led the growth of Jubilant Radiopharm into a vertically integrated radiopharmaceutical leader, and spent after over a decade at GE Healthcare and, more recently, served as President, Medical Group at Mirion Technologies, Inc. 

BD Names SVP Greg Rodetis as Head of Investor Relations

BD, formally known as Becton, Dickinson and Co., announced Greg Rodetis, currently BD Senior Vice President and Treasurer, will also add Head of Investor Relations to his responsibilities. In this expanded role, Mr. Rodetis will continue as company treasurer and also lead all aspects of communicating progress of the Franklin Lakes-based company’s strategy to investors and the financial community, including the company’s initiatives that drive shareholder value. Mr. Rodetis will continue to report to Chris DelOrefice, Executive Vice President, and Chief Financial Officer for BD. “Greg’s deep knowledge of BD, coupled with his expertise of the capital markets and existing relationships with the investment banking community, make him well-positioned to lead our investor relations function,” Mr. DelOrefice said.

The TiE Women Global Pitch Competition

Hosted by TiE-NJ

November 2023

Calling all women entrepreneurs! Apply now for TIE Women Global Pitch Competition 2023.

The TiE Women Global Pitch Competition is a prestigious event that provides a platform for women entrepreneurs to pitch their innovative ideas and gain recognition and support. This is a great opportunity for women entrepreneurs in New Jersey to gain visibility and access to a Global network, in addition to mentorship and support from the local chapter. More about TiE Women here: www.tiewomen.org

NJADDC Oncology Symposium

Hosted by New Jersey Academic Drug Discovery Consortium

November 16, 2023

The 2023 NJADDC symposium will bring academic, industry, and hospital system partners together for an engaging networking opportunity with the goal of developing regional partnerships, enhancing NJ as a collaborative nexus, and showcasing oncology research from across the state. This year's event will be hosted at Princeton University's Frick Chemistry Laboratory.