House Passes Bill to Help Biotech Start-ups Build Capital

Innovative biotech firms stand to gain from legislation that would help start-ups gain access to capital they need and spend more of that capital on research. The Expanding Access to Capital Act (H.R. 2799), sponsored by House Financial Services Committee Chairman Patrick McHenry (R-NC), was passed by the House on March 8. The bill incorporates previous legislative proposals as well as some last-minute amendments that facilitate investment in new ideas. As one of the most research-intensive industries in the world, biotech has a lot to gain from the bill. H.R. 2799 would reduce various regulatory burdens for small, emerging companies. As one example, the bill would allow a company to forgo securities registration when its security offering over 12 months totals $250,000 or less.

March-in Rights Under the Bayh-Dole Act & NIH Contributions to Pharmaceutical Patents

New research released by Vital Transformation (VT) finds the pharmaceutical industry is the

dominant source of innovation for funding new FDA approved medicines. By studying a cohort of 361 new FDA approved medicines and patents protecting the assets between 2011-2020, VT

found that 92% of the medicines they researched were directly discovered by industry, and have

no government interest statement (GIS), federally funded co-development, or federal partnership program associated with any patents core to the development of the medicine. 

Felician University, NJDOL Partner to Provide Job Opportunities for Veterans

Felician University announced that it partnered with the New Jersey Department of Labor & Workforce Development for the Life Sciences and Health Care Veterans Job Fair. This free event is designed to provide opportunities for veterans transitioning to civilian life, veterans with existing civilian work experience, members of the National Guard and Reserve Forces as well as military spouses and other members of military families. The job fair will bring together leading employers in the life sciences and health care sectors, eager to connect with skilled and dedicated veterans seeking career opportunities. Attendees will have the chance to explore a wide range of positions for companies such as Johnson & Johnson, Quest Diagnostics, Bergen New Bridge Medical Center, Hackensack Meridian Health, BioNJ, Weiss-Aug Group Surgical Products, N.J. Veterans Memorial Home Paramus, New Jersey State Police and many more.

ADMA Biologics Announces FDA Approvals of Extended Room Temperature Storage Conditions for ASCENIV™ & BIVIGAM®

Ramsey-based BioNJ Member ADMA Biologics, Inc. announced the United States Food and Drug Administration’s (“FDA”) approval for its supplemental Biologics License Applications (BLAs) for both ASCENIV and BIVIGAM to extend the approved 4-week room temperature (25°C) storage conditions during the first 24 months of shelf life, to allow for a 4-week room temperature storage at any time during the entire 36-month approved shelf life. The room temperature approval applies to all existing ASCENIV and BIVIGAM lots currently in the commercial supply chain as well as to future production of ASCENIV and BIVIGAM.“With the FDA-approved extension of room temperature storage conditions, the company expects to reach more customers who were previously inaccessible due to limited refrigeration space and cold chain capacity constraints,” said Adam Grossman, President and Chief Executive Officer of ADMA. 

BeiGene Announces FDA Accelerated Approval of BRUKINSA for the Treatment of Relapsed or Refractory Follicular Lymphoma

Hopewell-based BioNJ Member BeiGene announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to BRUKINSA® (zanubrutinib) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL), in combination with the anti-CD20 monoclonal antibody obinutuzumab, after two or more lines of systemic therapy. The indication is approved under accelerated approval based on response rate and durability of response, marking BRUKINSA’s fifth indication in B-cell malignancies in the U.S. “This accelerated approval of BRUKINSA represents an important advancement, offering the first and only BTK inhibitor treatment for follicular lymphoma patients in the U.S. who have either not responded to initial therapies or have experienced relapse,” said Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene.

New Phase 2b Results for Amlitelimab Support Potential for Best-in-Class Maintenance of Response in Atopic Dermatitis

Bridgewater-based BioNJ Member Sanofi announced positive results from Part 2 of the investigational amlitelimab Phase 2b study STREAM-AD showing sustained improvement of signs and symptoms for 28 weeks in adults with moderate to severe AD who previously responded to amlitelimab and continued treatment. High responder rates were also observed in participants who were taken off amlitelimab. The safety profile was consistent with Part 1 of the study with amlitelimab being well-tolerated and no new safety concerns identified. These results support the quarterly (every 12-week) dosing of amlitelimab 250 mg with 500 mg loading dose (LD) now being investigated in a larger Phase 3 clinical program (OCEANA).

New Post Hoc Analysis of in Tandem3 Study Demonstrates Improvements in Glycemic Control With Sotagliflozin Treatment in Patients With Type 1 Diabetes and Chronic Kidney Disease

BioNJ Member Lexicon Pharmaceuticals, Inc., with a site in Bridgewater, announced that a post hoc analysis of clinical data from its inTandem3 Phase 3 trial demonstrated that treatment with sotagliflozin resulted in improved glycemic control in patients with type 1 diabetes and chronic kidney disease (CKD). In this important patient population, treatment with sotagliflozin successfully lowered A1C, body weight and systolic blood pressure with safety similar to the total study cohort. Using data from the 24-week, multinational, placebo-controlled trial, the effects of sotagliflozin 400 mg daily added to insulin therapy on A1C, body weight, systolic blood pressure, eGFR, total insulin dose, adjudicated severe hypoglycemia and DKA were evaluated in a subgroup of patients (228 [16.3%] of 1402]) with type 1 diabetes and CKD (eGFR <60 mL/min/1.73 m2 and/or UACR ≥30 mg/g). 

PRALUENT® (ALIROCUMAB) Injection Receives FDA Approval to Treat Children With Genetic Form of High Cholesterol

BioNJ Member Regeneron Pharmaceuticals, Inc., with a site in Basking Ridge, announced the U.S. Food & Drug Administration (FDA) has extended the approval of Praluent® (alirocumab) as an adjunct to diet and other low-density lipoprotein cholesterol (LDL-C) lowering therapies to include pediatric patients aged 8 and older with heterozygous familial hypercholesterolemia (HeFH). “Many children with heterozygous familial hypercholesterolemia (HeFH) are able to substantially improve their LDL-C (bad cholesterol) with currently available therapies. But for those children whose LDL-C remains dangerously high, this approval is an important milestone as it gives these children and their families an additional option to help reduce and manage their LDL-C levels much earlier in their lives,” said Mary P. McGowan, M.D., Chief Medical Officer of the Family Heart Foundation.

Soligenix Announces Recent Accomplishments

Princeton-based BioNJ Member Soligenix, Inc. announced its recent accomplishments and financial results for the year ended December 31, 2023. "Our primary focus in 2024 continues to be advancing our multiple clinical programs in our rare disease pipeline," said Christopher J. Schaber, Ph.D., President and CEO of Soligenix. "Our collaborative discussions continue with the FDA regarding the design of a second, confirmatory Phase 3 pivotal study evaluating HyBryte™ (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL), where we successfully demonstrated statistically significant results in the first Phase 3 clinical trial. We also continue to engage in discussions with the European Medicines Agency to explore potential marketing approval and partnership in Europe. Recently, we shared successful preliminary top-line results of our ongoing Phase 2a clinical trial of SGX302 (synthetic hypericin) for the treatment of mild-to-moderate psoriasis. Following the clearance of the Investigational New Drug (IND) application for a Phase 2a clinical trial with SGX945 (dusquetide) in Behçet's Disease and the recent receipt of "Fast Track" designation from the FDA."

Gilead and Merus Announce Collaboration to Discover Novel Antibody-Based Trispecific T-Cell Engagers

BioNJ Member Gilead Sciences, with a site in Morris Plains and Merus N.V., announced a research collaboration, option and license agreement to discover novel dual tumor-associated antigens (TAA) targeting trispecific antibodies. Gilead and Merus agreed to collaborate on the use of Merus’ proprietary Triclonics® platform along with Gilead’s oncology expertise to research and develop multiple, separate preclinical research programs. Merus is a clinical-stage oncology company developing innovative, full-length, multispecific antibodies (Biclonics® and Triclonics®), referred to together as Multiclonics®, that are generated by a proprietary common light chain technology. The Triclonics® or trispecific platform provides the unique opportunity to design antibodies capable of simultaneously binding to three targets at once.

Biktarvy® Demonstrates High Rates of Viral Suppression in People With HIV and Comorbidities

BioNJ Member Gilead Sciences, with a site in Morris Plains, announced new data from three studies evaluating the efficacy and safety profile of Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) for a broad range of people with HIV, including those with HIV/hepatitis B (HBV) coinfection and HIV/tuberculosis (TB) coinfection. “People with HIV and comorbid conditions or pre-existing treatment resistance can often face complex and evolving treatment needs. These studies were conducted to help bridge the unmet HIV treatment gap and better understand the potential of Biktarvy in a broad range of people and communities affected by HIV and their diverse health needs," said Jared Baeten, M.D., Ph.D., Vice President, HIV Clinical Development, Gilead Sciences. 

Gilead and Merck Announce Phase 2 Data Showing an Investigational Oral Once-Weekly Combination Regimen of Islatravir and Lenacapavir Maintained Viral Suppression at Week 24

BioNJ Member Gilead Sciences, with a site in Morris Plains, and Rahway-based BioNJ Member Merck & Co. announced results from the Phase 2 clinical study evaluating the investigational combination of islatravir, an investigational nucleoside reverse transcriptase translocation inhibitor, and lenacapavir, a first-in-class capsid inhibitor. At 24 weeks, the novel investigational combination maintained a high rate (94.2%) of viral suppression (HIV-1 RNA <50 copies/mL), which is a secondary endpoint of the study. Results of the primary endpoint (HIV-1 RNA ≥50 copies/mL (c/mL) showed that one participant (1.9%) treated with islatravir and lenacapavir had a viral load of >50 copies/mL at Week 24; the participant later suppressed on islatravir and lenacapavir at Week 30.

Merck Completes Acquisition of Harpoon Therapeutics, Inc.

Rahway-based BioNJ Member Merck & Co. announced the completion of the acquisition of Harpoon Therapeutics, Inc. Harpoon is now a wholly-owned subsidiary of Merck, and Harpoon’s common stock will no longer be publicly traded or listed on the Nasdaq Stock Market. “We continue to augment and diversify our oncology pipeline with innovative approaches to help people with cancer worldwide,” said Dr. Dean Y. Li, President, Merck Research Laboratories. “We are pleased to welcome our Harpoon colleagues to Merck and look forward to working together to advance a novel portfolio of T-cell engagers, including MK-6070.” Harpoon’s lead candidate, MK-6070 (formerly known as HPN328), is a T-cell engager targeting delta-like ligand 3 (DLL3), an inhibitory canonical Notch ligand that is expressed at high levels in small cell lung cancer (SCLC) and neuroendocrine tumors. 

Merck’s KEYTRUDA® (pembrolizumab) Plus Chemoradiotherapy (CRT) Significantly Improved Overall Survival (OS) Versus CRT Alone in Patients With Newly Diagnosed High-Risk Locally Advanced Cervical Cancer

Rahway-based BioNJ Member Merck & Co. announced  that the Phase 3 KEYNOTE-A18 trial, also known as ENGOT-cx11/GOG-3047, investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemoradiotherapy (CRT) met its primary endpoint of overall survival (OS) for the treatment of newly diagnosed patients with high-risk locally advanced cervical cancer. At a pre-specified interim analysis conducted by an independent Data Monitoring Committee, KEYTRUDA in combination with concurrent CRT showed a statistically significant and clinically meaningful improvement in OS versus concurrent CRT alone. The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies; no new safety signals were identified. Results will be presented at an upcoming medical meeting and shared with regulatory authorities worldwide.

Merck Announces Plans to Conduct Clinical Trials of a Novel Investigational Multi-Valent Human Papillomavirus (HPV) Vaccine and Single-Dose Regimen for GARDASIL^®9

Rahway-based BioNJ Member Merck & Co. announced plans to initiate clinical development of a new investigational multi-valent HPV vaccine designed to provide broader protection against multiple HPV types. Separately, the company also plans to conduct clinical trials in both females and males to evaluate the efficacy and safety of a single-dose regimen of GARDASIL®9 (Human Papillomavirus 9-valent, recombinant), compared to the approved three-dose regimen. “Evidence continues to emerge showing the importance of GARDASIL and GARDASIL 9 to public health,” said Dr. Eliav Barr, Senior Vice President, Head of Global Clinical Development and Chief Medical Officer, Merck Research Laboratories. “These significant investments build upon our leadership and importantly provide the opportunity to further impact the global burden of certain HPV-related cancers and disease.”

Sandoz Receives FDA Approval for First and Only Denosumab Biosimilars

Princeton-based BioNJ Member Sandoz announced that the U.S. Food and Drug Administration (FDA) approved Wyost® (denosumab-bbdz) and Jubbonti® (denosumab-bbdz), the first and only FDA-approved denosumab biosimilars, to treat all indications of the reference medicines. Keren Haruvi, President Sandoz North America, said "Sandoz has achieved the first FDA approval for biosimilars to denosumab, a medicine that can address primary and secondary bone loss, such as osteoporosis, as well as cancer-related skeletal events, which are disease states that can profoundly reduce quality of life for patients. I am proud that Sandoz continues to pioneer access to these life-changing medicines for the patients who need them most."

Sandoz Acquires CIMERLI® Business from Coherus, Further Building Biosimilar and Ophthalmology Leadership in U.S. Market

Princeton-based BioNJ Member Sandoz announced it has completed the acquisition of the U.S. biosimilar CIMERLI®* (ranibizumab-eqrn) from Coherus BioSciences, Inc., ahead of anticipated timelines. The acquisition builds on the leading Sandoz ophthalmic platform in the US and lays an even stronger foundation for future product launches. Keren Haruvi, President Sandoz North America said: “Today we further expand the Sandoz biosimilar portfolio, while advancing our mission in the U.S. of pioneering patient access to more affordable and much-needed medicines. With the addition of CIMERLI® to our existing ophthalmology franchise, we can now offer even more treatment options for U.S. patients with vision impairment and loss.”

Bristol Myers Squibb Announces New Data from the Long-Term DAYBREAK Study Reinforcing Efficacy and Safety of Zeposia (ozanimod) in Patients With Relapsing Forms of Multiple Sclerosis

Princeton-based BioNJ Member Bristol Myers Squibb announced new results from the Phase 3 DAYBREAK open-label extension trial, demonstrating the long-term efficacy and safety profile of Zeposia (ozanimod) in patients with relapsing forms of multiple sclerosis (MS). In the DAYBREAK long-term extension study, treatment with Zeposia demonstrated a low annualized relapse rate of 0.098. Three- and six-month confirmed disability progression was absent in 82.8% and 84.8% of participants in the trial respectively. At Month 60, the adjusted mean number of new/enlarging T2 lesions per scan (range: 0.79–0.93) and the adjusted mean number of gadolinium-enhancing lesions (0.06–0.08) were similar across patient cohorts.

U.S. Food and Drug Administration Approves Opdivo ® (nivolumab), in Combination With Cisplatin and Gemcitabine, for First-Line Treatment of Adult Patients With Unresectable or Metastatic Urothelial Carcinoma

Princeton-based BioNJ Member Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) approved Opdivo® (nivolumab), in combination with cisplatin and gemcitabine, for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), the most common type of bladder cancer. This approval is based on results from the Phase 3 CheckMate –901 trial which evaluated Opdivo in combination with cisplatin and gemcitabine followed by Opdivo monotherapy (n=304), compared to cisplatin-gemcitabine alone (n=304), for patients with previously untreated, unresectable or metastatic UC. The primary efficacy endpoints were overall survival (OS) and progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR).

European Commission Approves Pfizer’s PREVENAR 20® to Help Protect Infants and Children Against Pneumococcal Disease

BioNJ Member Pfizer, with a site in Peapack, announced that the European Commission (EC) has granted marketing authorization for the company’s 20-valent pneumococcal conjugate vaccine, marketed in the European Union under the brand name PREVENAR 20®, for active immunization for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to less than 18 years of age. The authorization follows the recent positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP). The authorization is valid in all 27 EU member states plus Iceland, Lichtenstein and Norway. It also follows the approval of PREVNAR 20 for infants and children by the U.S. Food and Drug Administration (FDA) in April 2023, and approvals in several other countries including Canada, Australia and Brazil.

Pfizer Announces Positive Top-Line Data for Full Season Two Efficacy of ABRYSVO® for RSV in Older Adults

BioNJ Member Pfizer, with a site in Peapack, announced top-line ABRYSVO® vaccine efficacy and safety data for respiratory syncytial virus (RSV) in adults 60 years of age and older following a second season in the Northern and Southern Hemispheres from the ongoing pivotal Phase 3 clinical trial RENOIR (RSV vaccine Efficacy study iNOlder adults Immunized against RSV disease). Vaccine efficacy against RSV-associated lower respiratory tract disease (LRTD), defined by three or more symptoms, after disease surveillance in season two was 77.8% (95.0% CI: 51.4, 91.1); vaccine efficacy following season one was 88.9% (95.0% CI: 53.6%, 98.7%), which demonstrates durable efficacy after two seasons.

Pfizer Announces Positive Overall Survival in Phase 3 Trial of ADCETRIS® Regimen in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)

BioNJ Member Pfizer, with a site in Peapack, announced that a Phase 3 study of the antibody-drug conjugate ADCETRIS® (brentuximab vedotin) in combination with lenalidomide and rituximab for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) showed a statistically significant and clinically meaningful improvement in overall survival (OS) compared to lenalidomide and rituximab plus placebo. Positive outcomes were also observed in key secondary endpoints, including progression free survival (PFS) and overall response rate (ORR). The safety and tolerability of ADCETRIS in the ECHELON-3 trial were consistent with what has been previously presented for patients with relapsed/refractory DLBCL treated with ADCETRIS in clinical trials. 

EmphyCorp Rx Nasal Spray Expanded Phase III Clinical Trial for Long COVID is Added to the N115 Drug Pipeline

Flemington-based BioNJ Member EmphyCorp Inc. specializes in Rx Non-Steroidal Nasal and Oral Spray Technology for the treatment of Interstitial Lung Disease (orphan drug designation), Core Respiratory Diseases, Allergic Rhinitis, Long COVID, Flu, and COVID-19. The Patented N115 Technology Platform has demonstrated efficacy, with no known side effects, in 23 human clinical studies for all lung and sinus diseases tested including COPD, Interstitial Lung Disease (Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis, Cystic Fibrosis), Long COVID, Allergic Rhinitis, Chronic Rhinitis and Sinusitis. The Drug Pipeline also includes treatments for Pulmonary Hypertension. EmphyCorp/Cellular Sciences has added an Expanded Phase III Clinical Trial for our Rx Nonsteroidal Nasal Spray with no known side effects for Long COVID to the Rx N115 Nasal and Oral Spray Drug Pipeline. 

RYBREVANT® (amivantamab-vmjw) in Combination With Chemotherapy Is the First FDA Approved Therapy for First-line Treatment of Patients With Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations

Raritan-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced that following a priority review, the U.S. Food and Drug Administration (FDA) has approved RYBREVANT® (amivantamab-vmjw) in combination with chemotherapy (carboplatin-pemetrexed) for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by an FDA-approved test. This FDA action converts the May 2021 accelerated approval of RYBREVANT® to a full approval based on the confirmatory Phase 3 PAPILLON study. Worldwide, lung cancer is one of the most common cancers, with NSCLC making up 80 to 85 percent of all lung cancer cases. Alterations in EGFR are the most common actionable driver mutations in NSCLC.

Johnson & Johnson Completes Acquisition of Ambrx

New Brunswick-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced that it has successfully completed the acquisition of Ambrx Biopharma, Inc., a clinical-stage biopharmaceutical company with a proprietary synthetic biology technology platform to design and develop next-generation antibody drug conjugates (ADCs), in an all-cash merger transaction for a total equity value of approximately $2.0 billion, or $1.9 billion net of estimated cash acquired, as announced on January 8, 2024. The acquisition presents a distinct opportunity for Johnson & Johnson to design, develop and commercialize targeted oncology therapeutics. Ambrx’s proprietary ADC technology incorporates the advantages of highly specific targeting monoclonal antibodies securely linked to a potent chemotherapeutic payload to achieve targeted and efficient elimination of cancer cells without the prevalent side effects typically associated with chemotherapy.

Johnson & Johnson Submits Supplemental Biologics License Application to U.S. FDA Seeking Approval of TREMFYA®(guselkumab) for the Treatment of Adults With Moderately to Severely Active Ulcerative Colitis

New Brunswick-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of TREMFYA® (guselkumab) for treatment of adults with moderately to severely active ulcerative colitis (UC). The submission is based on results from the Phase 3 QUASAR program evaluating the efficacy and safety of TREMFYA® in the treatment of individuals living with moderately to severely active UC who had an inadequate response or intolerance to conventional therapy, prior biologics and/or JAK inhibitors. The data show statistically significant and clinically meaningful improvements in symptoms, patient reported outcomes such as fatigue and measures of disease activity including high bar endpoints such as endoscopic and histologic remission.

New Data Shows JNJ-2113, the First and Only Investigational Targeted Oral Peptide, Maintained Skin Clearance in Moderate-to-Severe Plaque Psoriasis Through One Year

New Brunswick-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced the first data from FRONTIER 2, the long-term extension of the Phase 2b FRONTIER 1 clinical trial evaluating JNJ-2113, the first and only investigational targeted oral peptide designed to block the IL-23 receptor (Abstract #S026). IL-23 plays a critical role in pathogenic T-cell activation in moderate-to-severe plaque psoriasis (PsO) and underpins the inflammatory response in PsO and other dermatological, rheumatological and gastroenterological IL-23-mediated diseases. “Data from the FRONTIER 2 study showed that the skin clearance as seen by PASI 75 and higher-bar PASI 90 and 100 responses at 16 weeks was maintained at 52 weeks with no new safety signals across all JNJ-2113 treatment groups,” said Laura Ferris, M.D., Ph.D., Professor of Dermatology, University of Pittsburgh. 

Insmed Enlists Actress Seymour to Tackle ‘Unseenism’ in Health Care

Bridgewater-based BioNJ Member Insmed Inc. is teaming up with award-winning actress Jane Seymour for a campaign to raise awareness of gender and age biases in health care. The partnership seeks to empower patients who feel overlooked, unheard or ignored by encouraging them to speak up. Known as “unseenism,” the social phenomenon is especially prevalent for those with chronic conditions, according to Insmed. Leading up to the initiative’s launch, Insmed conducted a nationwide survey of 2,000 participants. The effort sought to discover how the feeling can shape health decisions of people aged 40 and up. Insmed Executive Director of Patient Advocacy & Professional Society Engagement Alana Clemens-Saliba pointed to the survey’s findings. She said they highlight “the urgent need to bridge communication gaps and amplify health education initiatives for patients who feel unseen.”

GSK Announces Positive Results From DREAMM-8 Phase III Trial for Blenrep Versus Standard of Care Combination in Relapsed/Refractory Multiple Myeloma

Warren-based BioNJ Member GSK announced positive headline results from an interim analysis of the DREAMM-8 phase III head-to-head trial evaluating Blenrep (belantamab mafodotin), in combination with pomalidomide plus dexamethasone (PomDex), versus a standard of care, bortezomib plus PomDex, as a second line and later treatment for relapsed or refractory multiple myeloma. The trial met its primary endpoint of progression-free survival (PFS) at a pre-specified interim analysis and was unblinded early based on the recommendation by an Independent Data Monitoring Committee (IDMC). The belantamab mafodotin combination significantly extended the time to disease progression or death versus the standard of care combination. A positive overall survival (OS) trend favouring the Blenrep combination was also observed at the time of this analysis. The trial continues to follow up for OS. 

More than Two-Thirds of People With Atopic Dermatitis and Skin of Color Experienced Skin Improvement in a First-of-its-Kind Lebrikizumab Study

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced results from a first-of-its-kind study of lebrikizumab specifically designed for people with skin of color and moderate-to-severe atopic dermatitis, commonly called eczema. In this study, treatment with lebrikizumab, an investigational medicine, showed improvement in skin clearance and itch relief. The lebrikizumab efficacy results from this trial are consistent with data in other Phase 3 studies, which further reinforces lebrikizumab's potential to be a first-line biologic treatment following topical prescription therapies for people across a range of skin tones with moderate-to-severe atopic dermatitis. The initial 16-week data from this study evaluated 50 patients with moderate-to-severe atopic dermatitis and darker skin tones as measured by the Fitzpatrick scale, including people who self-identify as Black or African American (80%), Asian (14%), American Indian or Alaska Native (6%). 

Wegovy® Approved in the US for Cardiovascular Risk Reduction in People With Overweight or Obesity and Established Cardiovascular Disease

Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for Wegovy® based on a supplemental New Drug Application (sNDA) for the indication of reducing risks of major adverse cardiovascular events (MACE) including cardiovascular death, non-fatal heart attack (myocardial infarction) or non-fatal stroke in adults with either overweight or obesity and established cardiovascular disease (CVD). The approval is based on the SELECT cardiovascular outcomes trial, which demonstrated that Wegovy® statistically significantly reduced the risk of MACE by 20% compared to placebo when added to standard of care. The exact mechanism of cardiovascular risk reduction has not been established.

Taiho Pharma Enters Exclusive License Agreement With Haihe Biopharma for Gumarontinib (SCC244), an Agent for Non-Small Cell Lung Cancer

Princeton-based BioNJ Member Taiho Pharmaceutical Co., and Haihe Biopharma Co., Ltd. announced that two companies have entered into an exclusive license agreement regarding the development, manufacturing and commercialization of gumarontinib (development code: SCC244), agent for non-small cell lung cancer, which application for marketing authorization has been submitted and is currently being reviewed in Japan by Haihe Biopharma K. K., fully owned affiliate of Haihe. Under the license agreement, Taiho will obtain exclusive rights in Japan, Asia (excluding China) and Oceania to develop, manufacture and commercialize, gumarontinib, Haihe will receive an upfront payment, development and sales milestones, and royalty based on sales revenue from Taiho.

Boehringer Ingelheim and Sosei Heptares Join Forces to Develop First-in-Class Treatments Targeting all Symptoms of Schizophrenia

BioNJ Member Boehringer Ingelheim, with a site in North Brunswick, and Sosei Group Corporation announced they have entered a global collaboration and exclusive option-to-license agreement. At the center is a joint mission to develop and commercialize Sosei Heptares’ portfolio of first-in-class GPR52 agonists, a novel G protein-coupled receptor (GPCR) target, with the intent to improve patient outcomes by simultaneously addressing positive, negative, and cognitive symptoms of schizophrenia. The impact of these symptoms on people’s ability to cope with normal day-to-day life is significant and the related burden on carers and society at large is substantial, especially since the age of onset of the disease is typically in the 20’s. While ‘positive’ symptoms can be stabilized with antipsychotics, some of which can have side effects, there are currently no approved medicines for ‘negative’ or cognitive symptoms. 

Novartis Buys IFM Subsidiary for $90M+; Set to Develop STING Antagonist Program That Targets Immune System

East Hanover-based BioNJ Member Novartis announced it is purchasing IFM Due, a subsidiary company of IFM Therapeutics in a deal that includes $90 million in upfront payments and could be worth up to $835 million if milestones are met. The move comes after Novartis funded research with a focus on developing small molecules that inhibit the cGAS-STING pathway at the subsidiary in 2019. Under the terms of an option exercise Novartis laid out at the time, IFM received $90 million in upfront payment and will be eligible for up to $745 million in milestone payments, adding up to $835 million in total consideration. The acquisition provides Novartis with full rights to IFM Due’s portfolio of STING antagonists, which have the potential to treat an array of serious inflammation-driven diseases characterized by excessive interferon and other pro-inflammatory cytokine signaling.

Vaxine Nominated to the Vaccine Industry Excellence - ViE Awards in the Categories of Best New COVID Vaccine and Best Therapeutic Vaccine

BioNJ Member Vaxine has made it as finalist to the ViE Awards in the categories of Best New COVID Vaccine Award and Best Therapeutic Vaccine Award. Showcasing excellence in the global vaccine industry, the 17th Annual ViE Awards 2024 celebrate the industry’s most outstanding achievements. The Best New COVID Vaccine award nomination for Vaxine recognizes its Covax-19 COVID19 vaccine distributed under the brand name SpikoGen, a recombinant protein-based vaccine developed in-house. The nomination for Best Therapeutic Vaccine award highlights Vaxine’s development of RadVAX, a novel simplified cancer vaccine approach whereby antigens are extracted from tumor samples using a proprietary extraction and process and then formulated with Advax adjuvant. 

Mallinckrodt Announces U.S. FDA Approval of Supplemental New Drug Application for Acthar® Gel (repository corticotropin injection) Single-Dose Pre-filled SelfJect™ Injector

Mallinckrodt plc, with a site in Bedminster, announced that the U.S. Food and Drug Administration (FDA) has approved Mallinckrodt's supplemental New Drug Application (sNDA) for the Acthar® Gel (repository corticotropin injection) Single-Dose Pre-filled SelfJect™ Injector, a new delivery device for Acthar Gel for appropriate patients with a range of chronic and acute inflammatory and autoimmune conditions. SelfJect is intended to provide the appropriate subcutaneous dose of Acthar Gel, as prescribed by a healthcare professional, and is designed to help give patients control of their administration. Acthar Gel is a naturally sourced complex mixture of adrenocorticotropic hormone analogs and other pituitary peptides. Acthar Gel is approved by the U.S. FDA for the treatment of several autoimmune disorders and medical conditions known to cause inflammation. 

Pacira Biosciences Announces PCRX-201 Granted Regenerative Medicine Advance Therapy (RMAT) Designation for the Treatment of Osteoarthritis of the Knee

Parsippany-based Pacira BioSciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to PCRX-201 (enekinragene inzadenovec), the company’s novel, intra-articular helper-dependent adenovirus (HDAd) gene therapy product candidate that codes for interleukin-1 receptor antagonist (IL-1Ra), for the treatment of osteoarthritis of the knee. The company’s RMAT application was supported by the preliminary safety and efficacy findings from a Phase 1 open-label, proof-of-concept, single ascending dose trial that enrolled 72 patients in two three-dose cohorts: a co-administered intra-articular steroid cohort and a cohort that did not receive a steroid. PCRX-201 was well tolerated, with efficacy observed through at least 52 weeks at all doses and cohorts.

Two Datopotamab Deruxtecan Applications Validated in the EU for Patients With Advanced Nonsquamous Non-Small Cell Lung Cancer or HR Positive, HER2 Negative Breast Cancer

The European Medicines Agency (EMA) has validated two marketing authorization applications (MAAs) for Basking Ridge-based Daiichi Sankyo and AstraZeneca’s datopotamab deruxtecan (Dato-DXd) in two types of cancer. One MAA is for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who require systemic therapy following prior treatment. The other MAA is for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have progressed on and are not suitable for endocrine therapy and received at least one additional systemic therapy. Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo and AstraZeneca.

Shionogi Announces Xocova® (Ensitrelvir Fumaric Acid) Obtained Standard Approval in Japan for the Treatment of SARS-CoV-2 Infection

Shionogi & Co., Ltd., with a site in Florham Park, announced that it has obtained standard approval from the Ministry of Health, Labour and Welfare (MHLW) for Xocova® (Generic name: ensitrelvir fumaric acid), a novel anti-SARS-CoV-2 drug for the indication of SARS-CoV-2 infection in Japan. Shionogi obtained emergency regulatory approval for Xocova® in November 2022 and submitted an application for standard approval in May 2023. Xocova® is the first COVID-19 treatment antiviral to receive standard approval in Japan.The standard approval of Xocova® is based on positive results from the Phase 3 portion of Phase 2/3 study (SCORPIO-SR) conducted in Japan, South Korea and Vietnam. The study was conducted in a predominantly vaccinated population, regardless of risk factors for severe disease.

Calliditas Announces an Additional Seven Year Orphan Drug Exclusivity Period for TARPEYO®

Calliditas Therapeutics AB, with a site in Hoboken, announced that the FDA has granted an orphan drug exclusivity period of seven years for TARPEYO®, expiring in December 2030 based on when the company obtained full approval with a new indication for this drug product. Following full approval in December 2023, TARPEYO® (budesonide) is indicated “to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression”. The exclusivity period reflects the new indication covering all adult patients with primary IgAN at risk of disease progression based on a confirmed reduction of kidney loss reflecting a clinical benefit on kidney function for adult patients with primary IgAN.

Agile Therapeutics Completes Pay-Off Of Debt And Remains Focused On Business Plan Execution

Princeton-based Agile Therapeutics, Inc. announced that it has paid-off the remainder of its debt facility with Perceptive Advisors. This significant milestone completes the repayment schedule contemplated by the Loan Agreement between the company and Perceptive, which originated in 2020 and ended as of March 11, 2024. The Company remains focused on growing Twirla® and advancing the company’s business plan. “Eliminating the entirety of our debt with Perceptive is a pivotal moment for us, signaling our readiness to embrace new opportunities while continuing to execute our business plan and grow Twirla,” said Agile Chief Executive Officer and Chairperson Al Altomari. “We believe this step will provide us with more flexibility on our balance sheet as we move forward.”

Rutgers Cancer Institute of New Jersey and RWJBarnabas Health Retains its Position as New Jersey's Only National Cancer Institute-Designated Comprehensive Cancer Center

Rutgers Cancer Institute of New Jersey, together with RWJBarnabas Health, the State's leading cancer center and only Comprehensive Cancer Center as recognized by the National Cancer Institute (NCI), has scored in the "exceptional" range and was redesignated by the National Cancer Institute, placing it among the top cancer centers reviewed in 2023. The prestigious designation from the NCI, held by only 56 such centers across the nation, is granted competitively to institutions characterized by the highest level of scientific excellence in cancer research and the ability to translate research discoveries into novel treatments. In its comprehensive review of Rutgers Cancer Institute programs, the NCI recognized the Institute's innovative, paradigm changing research, the impact on the relevant needs of the New Jersey population, notable community outreach, education and engagement efforts and strong integration with its research consortium partner Princeton University. 

Rowan Aims to Have 38,500 Students by 2033

"Essentially doubling your economic impact in the region in five years — to nearly $3 billion — is terrific," said Rowan University President Ali Houshmand. But, it’s only a start. Mr. Houshmand said he intends for the school to dramatically increase its enrollment (to 38,500) by 2033, dramatically increase its capital expansion ($1.5 billion in new projects in the next decade) and dramatically increase its economic impact (to $4.4 billion) in the process. Mr. Houshmand said the power of public-private partnerships that he has leveraged so well in his nearly dozen years as the president will enable Rowan to grow in a way that will benefit the community and its residents without costing them.

Hackensack Meridian Neuroscience Institute Leading Way in Comprehensive Multiple Sclerosis Research

Treatment options for progressive types of multiple sclerosis have expanded significantly, and experts are looking at several promising experimental therapies, including neurologist-researchers at the Hackensack Meridian Neuroscience Institute at Hackensack University Medical Center’s Comprehensive Care Center for Multiple Sclerosis and Related Diseases, where two clinical trials are now being offered to patients who are living with multiple sclerosis. During MS Awareness Month this March, numerous clinical trials are ongoing at the Hackensack Meridian Neuroscience Institute.

Hackensack Meridian Health Awarded Nearly $1M in Grants by New Jersey Health Foundation

Hackensack Meridian Health said it was recently awarded 22 grants totaling nearly $915,202 from Princeton-based New Jersey Health Foundation for important research and community health projects. The grants support work across the state’s largest and most comprehensive health network, spanning not only the Hackensack Meridian Health Research Institute and clinical and basic research, but also the Hackensack Meridian School of Medicine and a multitude of sites across the Garden State. Among the areas supported by the grants: cancer, infectious disease, community health, education, diabetes and rheumatology, among other topics.

Christopher & Dana Reeve Foundation Announces $3.1M in Spinal Cord Injury Research Grants

The Christopher & Dana Reeve Foundation announced three new spinal cord injury research grants totaling $3.1 million. The grants support clinical trials and research tools aimed at accelerating the therapeutic development of SCI treatments. The Short Hills-based nonprofit organization is dedicated to curing spinal cord injury by funding innovative research and improving the quality of life for individuals and families impacted by paralysis. Two grants have been awarded to NeuroRestore, a research, innovation and treatment center that develops and applies bioengineering strategies involving neurosurgical interventions to restore neurological functions. Paramus-based BioNJ Member PsychoGenics, a central nervous system-focused contract research organization that designs and executes preclinical drug discovery and early development programs, received the third grant.

Celebrating 7 Years of STEM Excellence With NJ STEM Month 2024!

New Jersey STEM Pathways Network (NJSPN) kicked off NJ STEM Month at the BioNJ Member Princeton Innovation Center BioLabs. For the seventh year in a row, March is recognized as NJ STEM Month as designated by gubernatorial proclamation. NJ STEM Month is a celebration co-hosted by the NJSPN and its parent organization, the Research & Development Council of New Jersey (R&D Council of NJ). The month highlights the Garden State’s tremendous impact in science, technology, engineering, math (STEM) and innovation. The goal of NJ STEM Month 2024 is to impact 40,000 learners. The kickoff event drew 80 STEM leaders from diverse organizations across the state to the Princeton Innovation Center BioLabs. 

Y-mAbs Appoints Oncology Executive Mary Tagliaferri, M.D. to its Board of Directors

BioNJ Member Y-mAbs Therapeutics, Inc., with a site in Nutley, announced the appointment of Mary Tagliaferri, M.D. to the company’s Board of Directors. Dr. Tagliaferri brings nearly 30 years of biopharmaceutical industry experience and oncology therapeutic development expertise to the Y-mAbs Board of Directors. “We are thrilled to welcome Mary to our Board of Directors during such an exciting time for Y-mAbs,” said Michael Rossi, President and Chief Executive Officer. “Her extensive industry leadership experience and expertise in developing cancer therapies will be invaluable as we continue to advance our novel Self-Assembly DisAssembly Pretargeted Radioimmunotherapy (“SADA PRIT”) technology platform and our lead clinical programs.” “Y-mAbs’ highly differentiated SADA PRIT technology platform is exciting,” said Dr. Tagliaferri.”

Hepion Pharmaceuticals Strengthens Board of Directors With Appointment of Michael Purcell

Edison-based BioNJ Member Hepion Pharmaceuticals, Inc. announced the appointment of Michael Purcell to the company’s Board of Directors. Mr. Purcell has more than 37 years of professional experience with Deloitte & Touche LLP, serving as a consultant from 2015 to 2017 and an Audit Partner from 1979 until 2015. Mr. Purcell also currently serves as a financial advisor to several emerging growth companies. Mr. Purcell is a certified public accountant and has provided assurance and advisory services to public and private enterprise clients of all sizes over the course of his career. Mr. Purcell previously served as a member of the Board of Tabula Rasa HealthCare, Inc. from 2018 and Chair from 2022 until its acquisition by Nautic Partners in 2023.

Mallinckrodt Announces Appointment of Paul O'Neill as Executive Vice President, Quality and Operations, Specialty Brands

Mallinckrodt plc, with a site in Bedminster, announced that Paul O'Neill has been appointed Executive Vice President, Quality and Operations, Specialty Brands. Mr. O'Neill previously served as the company's Senior Vice President, Quality and Operations, Specialty Brands. He will continue to be responsible for leading Quality and Operations for Mallinckrodt's Specialty Brands business, overseeing internal and external manufacturing, supply chain distribution, device engineering, quality, technical services and product support. In addition, Mr. O'Neill will join the company's Executive Committee. Since joining Mallinckrodt, Mr. O'Neill has led several key initiatives in Mallinckrodt's Specialty Brands business. He has more than 25 years of experience in manufacturing operations, plant start-ups, technology transfer and supply chain management and has held numerous leadership positions at biopharmaceutical companies, including Merck, Pfizer and Wyeth. 

Bayer's Expert Mondays 2024

Select Mondays in March – December 2024

Calling pre-seed and seed innovators and entrepreneurs in Oncology, Cell & Gene Therapy, Cardiovascular, Immunology, Radiology and Digital Health! Do you have disruptive science but struggle to bring it to life in the entrepreneurial world? Bayer's passion is to enable and support standout healthcare innovation! Take your innovation to new heights and join Bayer´s Expert Mondays 2024, a series of knowledge exchange sessions to supercharge your start-up’s growth. 

Navigating the New Era of Bayh-Dole March-In Rights Practical Application Strategies and Insights

March 19 – Ballard Spahr

Attend this comprehensive webinar to explore the latest developments surrounding March-In Rights under the Bayh-Dole Act. This two-part series will offer a deep dive into the regulatory landscape and its direct implications for various sectors, especially life sciences and education. Don't miss this opportunity to gain invaluable insights and strategic perspectives that can shape your organization's approach in navigating these evolving regulatory waters. During these sessions, we will dissect the recent news from Capitol Hill and delve into the potential upcoming policy changes, including comments received and the uncertainty surrounding final implementations.

Annual Healthcare Symposium

April 18 – Rutgers Business School

The Inflation Reduction Act (IRA) of 2022 brought a tremendous change in the Medicare Part D Prescription Drug benefit operation and coverage. Academia and the industry has been analyzing the impact of the IRA on biopharma R&D, access to drugs by the elderly population in the USA, drugs approvals and employment. This will have a spillover effect on the prescription drugs in the private market. The symposium will bring together industry experts, academia and patients advocacy groups to discuss in front of our students, and faculty, and give them an opportunity to interact with the experts in the form of Q&A session. The symposium is open to all students, faculty and industry executives. It is a free event.

Panel Discussion: Tricks of the Trade — Partnering With Pharma Companies

April 30 – Princeton Innovation Center BioLabs

Panelists with expertise in pharma, biotech, diagnostics, venture and technical and laboratory services, will offer large and small company perspectives on working with value-added partners as well as buy-side and sell-side partnering approaches and business models. This is a great opportunity to interact with experts who have hands-on experience putting together collaborations and creating agreements to advance products and technologies, and secure capital. This program is cosponsored by Princeton Innovation Center BioLabs, the NJEDA’s New Jersey Bioscience Center, and BioNJ.