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October 21, 2022

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

Committed to the vision of Health Equity for All, BioNJ has launched a Health Equity in Clinical Trials Initiativewith the intention to define concrete issues that can be remedied with impact, identify long-term interventions, support companies to improve equity and access in their clinical trials strategies, benchmark best practices and shape policy.


An important workstream of the Health Equity in Clinical Trials Initiative is an MBA Business Plan Case Competition. The goal of the Health Equity in Clinical Trials MBA Business Plan Case Competition is to promote the next generation of diverse clinical trial innovators and identify revolutionizing business models. Participating teams – each representing 4-5 diverse, cross-disciplinary students from MBA and other allied graduate programs – will contribute innovative, out of the box ideas to improve health equity and transform clinical trials as they compete for more than $20,000 in prize money.


In addition to the Business Case Competition, key deliverables include:

  • New Jersey BaselineBioNJ will partner with a variety of organizations with expertise in clinical trials recruitment to develop as clear a picture as possible of the current state of demographic representation in clinical trials throughout New Jersey and identify strategies to achieve more equitable access and participation.

  • Collecting & Connecting the DotsBioNJ will create a publicly accessible virtual health equity portal featuring the work of innovator companies to increase information flow and collaboration between and amongst companies. There is currently no unified platform through which companies can share strategies and publicize their initiatives.


To learn how you and your organization can get involved and become a supporter of BioNJ's Health Equity in Clinical Trials Initiative, email For more information on the program, visit you. 

Because Patients Can't Wait®,

The BioNJ Team

Upcoming BioNJ Events


BioNJ's IT/Cybersecurity Breakfast Briefing

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October 27, 2022

BioNJ's Member Café

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November 9, 2022

BioNJ's Inspiring Women in STEM Conference

Save the Date!

December 2, 2022

BioNJ's Patient Advocacy Summit

Attendance is exclusive to Patient Advocacy Groups and R&D company Patient advocacy and government affairs professionals.

Register Today!

December 13, 2022

Putting Patients First:

The Value of Medical Innovation


PODCAST: The Surprising Role of Patient Advocates in Drug Development

Patient Advocates do more than raise money—they are active participants in the drug development process. While the ALS Ice Bucket Challenge garnered global attention, lesser-known patient advocates also flex their expertise to drive new treatments and cures. In this podcast, two moms talk about their work as partners in research and development, helping bring treatments for two rare diseases to the market.

BIO Encourages Administration to "Bring Transparency to the Broken Rebate System"

After the White House announced plans to sign an Executive Order directing the Department of Health and Human Services (HHS) to explore additional actions to lower prescription drug costs, Nick Shipley, Chief Advocacy Officer at the Biotechnology Innovation Organization (BIO), made the following remarks: "The Administration cannot truly address Medicare patients’ out-of-pocket cost concerns unless HHS reforms the shadow rebate market in which PBMs operate. These middlemen have distorted the marketplace as they have consolidated in recent years -- and PBMs have continued to leverage their size and market influence to ensure they can rake in enormous profits at the expense of vulnerable patients and their checkbooks.

AMA Examines PBM Market Competition and Integration With Insurers

A new analysis (PDF) by the American Medical Association (AMA) finds a widespread lack of competition in local markets across the United States where prescription drug middlemen known as pharmacy benefit managers (PBMs) provide services to commercial health insurers. The AMA analysis is the first to shed light on variations in market shares and competition among PBMs at the state and metropolitan levels. Based on 2020 data for individuals with a commercial drug benefit tied to a medical benefit and the PBMs used by insurers, the AMA’s competition analysis presents national and local market insight on five different PBM services performed for insurers: rebate negotiation, retail network management, claim adjudication, formulary management and benefit design.

Many Seniors Are Paying More for Part D Medicines Than Their Insurer

For seniors who rely on Medicare Part D, the out-of-pocket costs for medicines can sometimes be a barrier. Insurers and pharmacy benefit managers (PBMs) continue to shift more and more costs to patients. And a new analysis from the Medicare Payment Advisory Commission (MedPAC) shows why this is a problem that must be addressed. MedPAC’s analysis shows that rebates and other payments from manufacturers and pharmacies lowered Part D spending by 33% in 2020. And while insurers and PBMs who sponsor Part D plans are saving money, Part D beneficiaries are paying more. That’s because seniors’ cost sharing isn’t based on the discounted net price Part D plans pay. 

NJ Company News


Insmed Announces Strategic Financings Totaling $775 Million

Bridgewater-based BioNJ Member Insmed Incorporated announced three strategic financings resulting in aggregate gross proceeds of $775 million. Proceeds from the transactions will strengthen Insmed's financial position, which will place the company in a position to deliver clinical data from each of its four pillars. "Insmed is at a pivotal moment in its history, as we prepare to serve significantly more patients with serious and rare diseases. We believe these financings provide the company with ample resources to advance our four pillars through key clinical trials and prepare for the potential commercial availability of ARIKAYCE for frontline NTM lung disease and brensocatib for bronchiectasis," commented Will Lewis, Chair and CEO of Insmed. "We appreciate the extensive due diligence completed by the investors involved and share their enthusiasm for the Insmed pipeline and our vision for the future."

SCYNEXIS Provides Corporate, Commercial and R&D Strategy Updates to Expand Market Potential for Its First-in-Class Antifungal

Jersey-City-based BioNJ Member SCYNEXIS, Inc. announced a new corporate strategic direction expected to provide higher long-term return by refocusing its resources on the clinical development of ibrexafungerp for severe, hospital-based indications with both the oral and liposomal intravenous (IV) formulations, as multiple ongoing Phase 3 studies are progressing for a potential first approval in hospital indications in 2024 and a Phase 2 study of the IV formulation is planned for 2023. SCYNEXIS intends to out-license BREXAFEMME® (ibrexafungerp tablets) for vulvovaginal candidiasis (VVC) and is actively pursuing a U.S. commercialization partner that can build on the positive sales momentum to date and maximize its commercial value for the treatment of VVC and for the anticipated indication of prevention of recurrent vulvovaginal candidiasis (RVVC) pending approval on November 30.

Evotec Launches PanOmics Data Analysis Platform PanHunter at Bio-IT World

Princeton-based BioNJ Member Evotec announced the launch of the first commercial version of its PanOmics data analysis platform PanHunter at Bio-IT World. PanHunter is Evotec’s PanOmics data access and analytics platform and was developed and used successfully internally and in industry-shaping drug discovery partnerships over many years. Evotec now makes PanHunter available to collaborators and partners as a software-as-a-service product. PanHunter originates from Evotec’s commitment towards patient-centric, PanOmics-driven drug discovery. The amount of available PanOmics data is growing at exponential rates in the public domain and in the pharmaceutical industry. More PanOmics data has been generated in the last two years than in all previous years combined. These PanOmics data hold an overwhelming amount of information about the condition of the respective patients, the molecular biological context, and causes of diseases. 

BeiGene Announces Positive Topline Results from Final Progression-Free Survival Analysis of BRUKINSA® (zanubrutinib) Compared to IMBRUVICA® (ibrutinib) in Phase 3 Chronic Lymphocytic Leukemia (CLL) Trial

BioNJ Member BeiGene, with a site under development in Hopewell, announced that BRUKINSA® (zanubrutinib) achieved superior Progression-Free Survival (PFS) versus IMBRUVICA® (ibrutinib) in a final analysis of the Phase 3 ALPINE trial, as assessed by an independent review committee (IRC) and investigator. BRUKINSA was generally well tolerated; safety findings at the final PFS analysis were consistent with prior reports. “This positive result adds to the growing body of evidence underpinning our belief in the potential for BRUKINSA to provide new hope for CLL patients facing this intractable disease. With this final PFS analysis, BRUKINSA has achieved superior progression free survival, as well as superiority in overall response rate versus ibrutinib,” said Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene.  

BeiGene Receives Positive CHMP Opinion for BRUKINSA® (zanubrutinib) for the Treatment of Adults With CLL

BioNJ Member BeiGene, with a site under development in Hopewell, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of BRUKINSA® (zanubrutinib) for the treatment of adult patients with chronic lymphocytic leukemia (CLL). The CHMP recommendation is based on two global head-to-head Phase 3 clinical trials in which BRUKINSA demonstrated superior efficacy: ALPINE (NCT03734016) comparing BRUKINSA to ibrutinib in patients with R/R CLL and SEQUOIA (NCT03336333) comparing BRUKINSA to BR in patients with TN CLL. These two studies enrolled patients from a total of 17 countries, including the United States, China, Australia, New Zealand and multiple countries in Europe. 

Advaxis and Ayala Pharmaceuticals Enter into Merger Agreement

Monmouth Junction-based BioNJ Member Advaxis, Inc. and Ayala Pharmaceuticals, Inc. announced that they have entered into a definitive merger agreement. The merger would result in a combined company that will focus predominantly on the development and commercialization of Ayala’s lead program AL102 for the treatment of desmoid tumors and Advaxis’s candidate ADXS-504 in development for prostate cancer. Kenneth A. Berlin, President and CEO of Advaxis, said, “Advaxis took a thorough approach in our quest to find the right partner with the right products. This merger is expected to enhance Advaxis’s portfolio of clinical assets, with Ayala’s proprietary gamma secretase inhibitors that are being developed as targeted therapies for rare and aggressive tumors. 

Bristol Myers Squibb Presents Data from CheckMate -76K Showing Opdivo (nivolumab) Reduced the Risk of Recurrence or Death by 58% Versus Placebo in Patients With Completely Resected Stage IIB or IIC Melanoma

Princeton-based BioNJ Member Bristol Myers Squibb ( announced results from the Phase 3 CheckMate -76K trial, in which Opdivo (nivolumab) as an adjuvant therapy demonstrated a statistically significant and clinically meaningful benefit in recurrence-free survival (RFS) versus placebo in patients with completely resected stage IIB or IIC melanoma. At a pre-specified interim analysis, the trial met its primary endpoint of recurrence-free survival (RFS); Opdivo reduced the risk of recurrence or death by 58% versus placebo (hazard ratio [HR] 0.42; 95% CI 0.30-0.59; p < 0.0001). Twelve-month RFS rates for Opdivo were 89% (95% CI: 86-92) versus 79% (95% CI: 74-84) for placebo. The RFS benefit was observed across predefined subgroups in the trial, including T category and disease stage. 

Teva Announces Largest-Ever Trial to Collect Information from Patients and Physicians About TD, its Impact and Progression Over Time, and Evaluate Treatment-Related Outcomes

Parsippany-based BioNJ Member Teva Pharmaceuticals announced the initiation of a 3-year longitudinal registry and study to assess the impact of tardive dyskinesia (TD) and real-world treatment patterns and outcomes. The Phase 4, multicenter, prospective, observational two-part study is the largest-ever study of its kind for TD and will collect information from both patients and physicians on TD. The study will evaluate how the condition progresses over time and impacts a person’s quality of life, as well as outcomes related to treatment with AUSTEDO (deutetrabenazine) tablets. “TD is a chronic, highly debilitating condition that affects one in four people who take certain mental health treatments, yet the long-term impact, burden and treatment patterns in everyday clinical practice are not well understood,” said Richard Jackson, M.D., Assistant Clinical Adjunct Professor, Psychiatry, University of Michigan School of Medicine, and the study’s lead investigator.  

U.S. FDA Accepts for Priority Review the Supplemental Biologics License Application for Gilead’s Trodelvy® for Pre-Treated HR+/HER2- Metastatic Breast Cancer

BioNJ Member Gilead Sciences, Inc., with a site in Morris Plains, announced the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for Trodelvy® (sacituzumab govitecan-hziy) for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. The FDA grants priority review for therapies that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. 

Gilead and MacroGenics Announce Oncology Collaboration to Develop Bispecific Antibodies

BioNJ Member Gilead Sciences, Inc., with a site in Morris Plains, and MacroGenics announced an exclusive option and collaboration agreement to develop MGD024, an investigational, bispecific antibody that binds CD123 and CD3 using MacroGenics’ DART® platform, and two additional bispecific research programs. The collaboration agreement grants Gilead the option to license MGD024, a potential treatment for certain blood cancers, including acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). A leader in the bispecific antibody space, MacroGenics has extensive experience applying its proprietary DART platform to develop novel therapeutics. MGD024 is a next-generation, bispecific that incorporates a CD3 component that is designed to minimize cytokine-release syndrome (CRS), a potentially life-threatening toxicity, while increasing the magnitude of antitumor activity with a longer half-life to permit intermittent dosing. 

AbbVie Acquires DJS Antibodies, Further Strengthening Immunology Pipeline

BioNJ Member AbbVie, with a site in Madison, announced the acquisition of DJS Antibodies Ltd ("DJS"), a privately-held UK-based biotechnology company dedicated to discovering and developing antibody medicines that target difficult-to-drug disease-causing proteins, such as G protein-coupled receptors (GPCRs). DJS's lead program is DJS-002, a potential first-in-class lysophosphatidic acid (LPA) receptor 1 (LPAR1) antagonist antibody currently in investigational preclinical studies for the treatment of Idiopathic Pulmonary Fibrosis (IPF) and other fibrotic diseases. IPF is an aggressive, high mortality disease caused by fibrotic scarring in the lungs and remains an area of high unmet medical need. DJS's proprietary HEPTAD platform is a novel approach to antibody discovery with specific capabilities targeting transmembrane protein targets. A key benefit of this acquisition is for AbbVie, through DJS, to access the HEPTAD platform as a complement to its current robust capabilities in biotherapeutics research.

Sampled Expands SMART Labs Laboratory and Biorepository in Piscataway into 140,000 sq. ft. Facility

BioNJ Member Sampled announced the expansion of its Sampled SMART Labs facility into a state-of-the-art, 140,000-square-foot laboratory and biorepository in Piscataway. Construction is expected to be completed by early 2023. The multimillion-dollar investment will increase the firm formerly known as Infinity BiologiX & Roylance Pharma’s worldwide biorepository capabilities and enable it to store, manage, analyze, research and transport up to 20 million biosamples. The expansion will also expand Sampled’s laboratory capabilities, enabling clients to conduct research or launch new health products faster and easier. The new facility is expected to house over 800 freezers and 230 liquid nitrogen tanks with a secure, access-controlled environment, wireless monitoring and full generator and liquid nitrogen backup.

Dupixent® (dupilumab) Late-Breaking Phase 3 Data Presented at UEG Week 2022 Showed Significant Histological Remission of Eosinophilic Esophagitis (EoE) in Children 1 to 11 Years Old

Bridgewater-based BioNJ Member Sanofi announced late-breaking positive results from a Phase 3 trial evaluating the investigational use of Dupixent® (dupilumab) in children aged 1 to 11 years with active eosinophilic esophagitis (EoE). The data will be submitted to regulatory authorities around the world, starting with the U.S. Food and Drug Administration (FDA) in 2023. In May 2022, Dupixent 300 mg weekly was approved by the FDA to treat EoE in people aged 12 years and older, weighing at least 40 kg. Dupixent led to significant improvements in the primary efficacy measure for higher (n=37) and lower (n=31) dose groups at 16 weeks in the randomized, placebo-controlled Phase 3 trial.

Novartis Receives Positive CHMP Opinion for Pluvicto® for Patients With Progressive, PSMA-Positive Metastatic Castration-Resistant Prostate Cancer

East Hanover-based BioNJ Member Novartis announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion and recommended granting a marketing authorization for Pluvicto® (INN: lutetium (177Lu) vipivotide tetraxetan) (formerly referred to as 177Lu-PSMA-617), a radioligand therapy, in combination with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition, for the treatment of adult patients with progressive prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with AR pathway inhibition and taxane based chemotherapy. The positive CHMP opinion is based on data from the Phase III VISION study, in which Pluvicto® plus best standard of care (BSoC) demonstrated significantly improved overall survival in PSMA-positive mCRPC patients previously treated with AR pathway inhibition and taxane-based chemotherapy compared to BSoC alone. 

Lilly to Acquire Akouos to Discover and Develop Treatments for Hearing Loss

BioNJ Member Eli Lilly and Company, with a site in Branchburg, and Akouos, Inc. announced a definitive agreement for Lilly to acquire Akouos, a precision genetic medicine company that is developing a portfolio of first-in-class adeno-associated viral gene therapies for the treatment of inner ear conditions, including sensorineural hearing loss. Akouos has integrated expertise across otology, inner ear drug delivery and gene therapy with the goal of addressing the needs of people living with disabling hearing loss worldwide. Akouos's lead product candidate, AK-OTOF, is a gene therapy for the treatment of hearing loss due to mutations in the otoferlin gene (OTOF). Additional pipeline programs span across multiple inner ear conditions, and include AK-CLRN1 for Usher Type 3A, an autosomal recessive disorder characterized by progressive loss of both hearing and vision; GJB2 (which encodes connexin 26) for a common form of monogenic deafness and hearing loss; and AK-antiVEGF for the treatment of vestibular schwannoma.

Merck Recognized on Fortune’s 2022 Change the World List for Expanding Access to HPV Vaccines

Kenilworth-based BioNJ Member Merck & Co. announced they have been named to Fortune’s 2022 Change the World list. The annual list recognizes companies that have had a positive social impact through activities that are part of their core business strategy. Merck was selected for its work expanding global access to the company’s human papillomavirus (HPV) vaccines. This recognition marks the third time in five years that Merck has been included on Fortune’s Change the World list. Fortune selects companies for this honor based on a set of criteria including the measurable social impact of their work to meet unmet social needs, the links between this work and successful business results, the degree of innovation demonstrated and integration of their socially beneficial work into their larger corporate identity. 

Merck Announces Positive Top-line Results from Pivotal Phase 3 STELLAR Trial Evaluating Sotatercept for the Treatment of Adults With Pulmonary Arterial Hypertension (PAH)

Kenilworth-based BioNJ Member Merck & Co. announced positive top-line results from the pivotal Phase 3 STELLAR trial evaluating the safety and efficacy of sotatercept, an investigational activin receptor type IIA-Fc (ActRIIA-Fc) fusion protein being evaluated as an add-on to stable background therapy for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1). “In the Phase 3 STELLAR study, sotatercept added to currently approved background therapy showed a profound effect on the primary efficacy outcome measure of improvement from baseline to 24 weeks in six-minute walk distance. The results from the secondary efficacy outcomes, including a favorable benefit seen in patients’ time to a clinical-worsening event, are especially noteworthy,” said Dr. Dean Y. Li, President, Merck Research Laboratories. 

Merck and Moderna Announce Exercise of Option by Merck for Joint Development and Commercialization of Investigational Personalized Cancer Vaccine

Kenilworth-based BioNJ Member Merck & Co. and Moderna, Inc. announced that Merck has exercised its option to jointly develop and commercialize personalized cancer vaccine (PCV) mRNA-4157/V940 pursuant to the terms of its existing Collaboration and License Agreement. mRNA-4157/V940 is currently being evaluated in combination with KEYTRUDA, Merck’s anti-PD-1 therapy, as adjuvant treatment for patients with high-risk melanoma in a Phase 2 clinical trial being conducted by Moderna. “This long-term collaboration combining Merck’s expertise in immuno-oncology with Moderna’s pioneering mRNA technology has yielded a novel tailored vaccine approach,” said Dr. Eliav Barr, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, Merck Research Laboratories. 

Merck and the Bill & Melinda Gates Medical Research Institute Announce Licensing Agreement for Novel Tuberculosis Antibiotic Candidates

Kenilworth-based BioNJ Member Merck & Co. and the Bill & Melinda Gates Medical Research Institute announced a licensing agreement for two preclinical antibacterial candidates for evaluation as potential components of combination regimens for the treatment of tuberculosis (TB). These candidates were discovered by Merck scientists as part of the TB Drug Accelerator (TBDA). The TBDA is a collaboration established amongst biopharmaceutical companies, research organizations and universities to accelerate the discovery and development of novel therapeutic candidates against TB. The initiative was established with support and leadership from the Bill & Melinda Gates Foundation. Tuberculosis is a major global cause of illness, disability, and is one of the leading causes of death from an infectious disease worldwide, responsible for an estimated 1.5 million deaths per year.

Pfizer and BioNTech Announce Positive Early Data from Clinical Trial of Omicron BA.4/BA.5-Adapted Bivalent Booster in Individuals 18 Years and Older

BioNJ Member Pfizer, with a site in Peapack, and BioNTech announced early data from a Phase 2/3 clinical trial evaluating the safety, tolerability, and immunogenicity of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine (Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)). A 30-µg booster dose of the Omicron BA.4/BA.5-adapted bivalent vaccine demonstrated a substantial increase in the Omicron BA.4/BA.5 neutralizing antibody response above pre-booster levels based on sera taken 7 days after administration, with similar responses seen across individuals aged 18 to 55 years of age and those older than 55 years of age (40 participants in each age group). 

Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster in Children 5 Through 11 Years of Age

BioNJ Member Pfizer, with a site in Peapack, and BioNTech announced that the U.S. Food and Drug Administration granted Emergency Use Authorization for a 10-µg booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children 5 through 11 years of age. Pending recommendation from the Centers for Disease Control and Prevention, 10-µg doses will be shipped immediately. “As families across the country take part in fall festivities and plan for the upcoming holiday season, we aim to provide school-aged children with additional protection against the Omicron BA.4/BA.5 subvariants, which continue to account for more than 80% of cases in the U.S.,” said Albert Bourla, Chairman and CEO, Pfizer. “Anticipating this need, we manufactured millions of booster doses, which will be made available, pending CDC recommendation, to help families stay up to date with COVID-19 vaccinations.”

U.S. FDA Approves BOOSTRIX for Immunization During Pregnancy for the Prevention of Whooping Cough in Newborn Infants

Warren-based BioNJ Member GSK announced that the U.S. Food and Drug Administration has approved BOOSTRIX (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed; Tdap) for immunization during the third trimester of pregnancy to help prevent pertussis (whooping cough) in infants younger than two months of age. BOOSTRIX is currently approved in over 80 countries worldwide, including the U.S., most European Union countries, Canada, Australia and New Zealand for immunization against tetanus, diphtheria and pertussis. Since 2010, the Centers for Disease Control and Prevention has reported 15,000 to 48,000 pertussis cases among people of all ages in the United States each year. Infants are at high risk of complications from whooping cough because their immune systems are still developing. 

GSK Announces Positive Headline Results from PERLA, the Phase II Trial of Jemperli (dostarlimab) Plus Chemotherapy in Patients With Metastatic Non-Squamous Non-Small Cell Lung Cancer

Warren-based BioNJ Member GSK announced positive headline results of the PERLA Phase II trial, which met its primary endpoint of objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) criteria as determined by blinded independent central review. The trial evaluated dostarlimab in combination with chemotherapy versus pembrolizumab in combination with chemotherapy in first-line patients with metastatic non-squamous non-small cell lung cancer (NSCLC). The PERLA Phase II trial is a randomized, 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 population. The trial was not designed to demonstrate superiority. The safety and tolerability profile of dostarlimab in the PERLA Phase II trial was consistent with previous clinical trials of similar regimens. 

GSK’s Older Adult Respiratory Syncytial Virus (RSV) Vaccine Candidate Shows 94.1% Reduction in Severe RSV Disease and Overall Vaccine Efficacy of 82.6% in Pivotal Trial

Warren-based BioNJ Member GSK announced positive pivotal Phase III trial results for its respiratory syncytial virus (RSV) vaccine candidate for adults aged 60 years and above to be presented at IDWeek 2022. The vaccine candidate was highly efficacious, demonstrating overall vaccine efficacy of 82.6% (96.95% CI, 57.9–94.1, 7 of 12,466 vs. 40 of 12,494) against RSV lower respiratory tract disease (RSV-LRTD), meeting the trial’s primary endpoint. Consistent high vaccine efficacy was also observed across a range of pre-specified secondary endpoints, highlighting the impact the vaccine candidate could have on the populations most at risk of the severe outcomes of RSV. Efficacy against severe RSV-LRTD, defined as LRTD with at least two lower respiratory signs or assessed as severe by the investigator and confirmed by the external adjudication committee, was 94.1% (95% CI, 62.4–99.9, 1 of 12,466 vs. 17 of 12,494). 

U.S. FDA Approves Menveo in a New Single-Vial Presentation to Help Prevent Disease Caused by Meningococcal Bacteria Serogroups A, C, Y, and W

Warren-based BioNJ Member GSK announced that the U.S. Food and Drug Administration (FDA) has approved a new presentation of Menveo [Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diptheria CRM197 Conjugate Vaccine] for individuals aged 10 to 55 years to help prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W. The Menveo one-vial presentation now comes in a ready to use single vial giving healthcare providers a more convenient option. The Menveo one-vial presentation will initially be available to US federal customers, with broader availability anticipated in mid-2023. Roger Connor, President, Vaccines and Global Health, GSK, said “Outbreaks of this dangerous disease continue to occur, impacting families, health systems and society. This FDA approval of Menveo one-vial presentation offers greater convenience to healthcare providers to help prevent this disease in at-risk populations in the United States.”

GSK Announces Expanded Collaboration With Tempus in Precision Medicine to Accelerate R&D

Warren-based BioNJ Member GSK and Tempus have entered into a three-year collaboration agreement that provides GSK with access to Tempus’ AI-enabled platform, including its library of de-identified patient data. Through its leading Artificial Intelligence and Machine Learning (AI/ML) capability, GSK will work together with Tempus to improve clinical trial design, speed up enrollment and identify drug targets. This will contribute to GSK’s R&D success rate and provide patients with more personalized treatment faster. The new collaboration builds from the existing relationship between the companies that began in 2020 on clinical trial enrollment of patients with certain types of cancer. It will now expand GSK’s access to de-identified patient data bringing greater scale and detail. 

Results of Novel Clinical Study of Guselkumab and Golimumab Combination Therapy Show Adults With Moderately to Severely Active Ulcerative Colitis Maintained Higher Rates of Clinical, Histologic and Endoscopic Remission at Week 38

Titusville-based BioNJ Member, the Janssen Pharmaceutical Companies of Johnson & Johnson, announced data from an ongoing analysis of a Phase 2a clinical trial showing adults with moderately to severely active ulcerative colitis (UC) who received 12 weeks of combination induction therapy with guselkumab and golimumab, followed by a transition to guselkumab alone for maintenance, achieved a clinical remission rate (based on the modified Mayo score [mMayo]) at week 38 of 47.9 percent, a higher rate than induction and maintenance treatment with either guselkumab alone (31.0 percent) or golimumab alone (20.8 percent). Patients had comparable rates of adverse events (AEs) across the treatment groups. Guselkumab alone, or the combination of guselkumab and golimumab are under clinical investigation and not approved for the treatment of adults with UC in the U.S.

STELARA® (ustekinumab) Demonstrated Sustained Symptomatic and Corticosteroid-Free Remission Through Four Years in Adults With Moderately to Severely Active Ulcerative Colitis

Titusville-based BioNJ Member, the Janssen Pharmaceutical Companies of Johnson & Johnson, announced final data from the long-term extension (LTE) of the Phase 3 UNIFI study demonstrating efficacy and safety of STELARA® (ustekinumab) through four years of treatment in adult patients with moderately to severely active ulcerative colitis (UC). “The final LTE results of the UNIFI study demonstrated that STELARA can be an effective long-term treatment option for patients living with moderately to severely active ulcerative colitis, including in patients who are biologic-naive,” said UNIFI presenting study author Waqqas Afif, M.D., Associate Professor, Department of Medicine, Division of Experimental Medicine and Division of Gastroenterology at McGill University Health Centre in Montreal, Canada. 

Eagle Pharmaceuticals Announces Submission of Investigational New Drug Application to U.S. Food and Drug Administration for CAL02, a Novel First-in-Class Broad-Spectrum Anti-Virulence Agent for the Treatment of Severe Community-Acquired Bacterial Pneumonia

Woodcliff Lake-based Eagle Pharmaceuticals, Inc. announced that it has submitted an investigational new drug application to the U.S. Food and Drug Administration for CAL02, a novel first-in-class broad-spectrum anti-virulence agent for the treatment of severe community-acquired bacterial pneumonia. The IND filing includes a protocol for an adequately powered global Phase 2 study to evaluate the efficacy and safety of CAL02 when added to standard of care therapy in patients with SCABP. The design, entry criteria, and endpoints for the proposed Phase 2 study have been discussed with the FDA in a pre-IND meeting held on September 19, 2022. The Phase 2 study plans to enroll approximately 276 patients with SCABP at 120 sites worldwide. 

EYLEA® (aflibercept) Injection sBLA for Treatment of Retinopathy of Prematurity (ROP) Accepted for FDA Priority Review

Regeneron Pharmaceuticals, Inc., with a site in Basking Ridge, announced the U.S. Food and Drug Administration has accepted for Priority Review the supplemental Biologics License Application for EYLEA® (aflibercept) Injection to treat Retinopathy of Prematurity (ROP) in preterm infants. The target action date for the FDA decision is February 11, 2023. ROP is a leading cause of childhood blindness worldwide. Each year in the U.S., between 1,100 to 1,500 infants develop disease severe enough to require medical treatment. The rare eye disease often impacts infants who are born before 31 weeks of pregnancy have been completed or who weigh less than 1,500 grams (3.3 lbs) pounds at birth. 

Libtayo® (cemiplimab) Receives Positive CHMP Opinion Recommending Approval to Treat Advanced Cervical Cancer

Regeneron Pharmaceuticals, Inc., with a site in Basking Ridge, announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Libtayo® (cemiplimab) as a monotherapy for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy. The European Commission is expected to make a final decision on the application in the coming months. Libtayo is currently approved in the European Union and other countries for the treatment of certain patients with advanced basal cell carcinoma (BCC), advanced cutaneous squamous cell carcinoma (CSCC) and advanced non-small cell lung cancer (NSCLC).

CSL Announces Positive Preclinical Data for Self-Amplifying Messenger RNA (sa-mRNA) Influenza Vaccine Candidates

CSL, with a site in Summit, announced results from the preclinical studies of the company’s self-amplifying messenger RNA (sa-mRNA) influenza vaccine candidates, the next generation of mRNA vaccines. The data, published in Molecular Therapy – Methods and Clinical Development, indicate that the sa-mRNA influenza vaccine candidates produced a potent, cross-reactive immune response against pandemic and seasonal influenza strains, A(H5N1) and A(H1N1). “These preclinical data show the potential of sa-mRNA technology to provide protection against pandemic and seasonal influenza in one vaccine dose,” said Ethan Settembre, Ph.D., Vice President, Research, CSL R&D Seqirus Vaccines Innovation Unit and study author. “As we look toward initiating our Phase 1 clinical trials in the near future, these data are an encouraging testament to the value of pursuing innovative vaccine technology platforms, like sa-mRNA.”

CSL Seqirus Announces U.S. Government Award to Manufacture and Clinically Assess Influenza A(H5N8) Pre-Pandemic Vaccine

CSL Seqirus, with a site in Summit, announced that the Biomedical Advanced Research and Development Authority, part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, selected CSL Seqirus to deliver an H5N8 A/Astrakhan virus vaccine candidate for assessment in a Phase 2 clinical study that is anticipated to begin in Q2 2023. Over the past year, outbreaks of highly pathogenic avian influenza (HPAI) A(H5) viruses among wild and farmed birds, as well as commercial poultry, have been reported in the U.S.1 and other parts of North America, as well as across Africa, Asia and Europe.2 BARDA has requested the manufacture and clinical assessment of the H5N8 vaccine candidate to support its pandemic preparedness program.

Shionogi Presents Real-World Evidence Showing Strong Efficacy with Fetroja® (cefiderocol) Against Treatment Resistant Bacterial Infections at IDWeek 2022

Florham Park-based Shionogi Inc. announced that new Fetroja® (cefiderocol) data will be presented at IDWeek 2022, including new real-world evidence demonstrating Fetroja’s strong efficacy against some of the most difficult-to-treat Gram-negative bacterial infections.

New data from PROVE (Retrospective Cefiderocol Chart Review) demonstrated that Fetroja achieved clinical cure in 63% (48/76) of patients with Acinetobacter baumannii infections and 63% (76/120) of patients with Pseudomonas aeruginosa infections. PROVE is an ongoing international retrospective study assessing real-world outcomes and safety of Fetroja in hospitalized patients with Gram-negative bacterial infections. Of the Acinetobacter baumannii infections, 96% were resistant to carbapenems (a last-line antibiotic), and 97% of the Pseudomonas aeruginosa infections were carbapenem-resistant. Safety and tolerability data were generally consistent with the safety profile of Fetroja in clinical studies. 

BD’s New Onclarity HPV Test Greatly Improves Standard of Care for Women

Each year in the U.S., about 14,000 new cases of cervical cancer are diagnosed, according to figures from the Centers for Disease Control and Prevention. That’s why when, in 2020, the Franklin Lakes-based firm BD, also known as Becton, Dickinson and Co., received approval for a pre-market supplement from the U.S. Food and Drug Administration for an expanded version of its BD Onclarity HPV Assay, knew it would be a game-changer. Molly Broache, Associate Director with BD said, “We are not trying to find cervical cancer with an HPV test or a pap, we are trying to find precancer, because, when you find precancer, it is relatively easy to treat, and you will never get to the point of having cancer.”  

People in the News


Agile Therapeutics Announces Reorganization of Leadership Team

Princeton-based BioNJ Member Agile Therapeutics, Inc. announced that it has reorganized and streamlined its executive leadership team to align with its business plan to promote Twirla® (levonorgestrel and ethinyl estradiol) transdermal system growth. As part of the changes, the company announced the appointment of Amy Welsh to Chief Commercial Officer and Geoffrey P. Gilmore to the newly created role of Chief Administrative Officer. The company’s executive leadership team will also include Robert G. Conway, Chief Corporate Planning and Supply Chain Officer, who will be responsible for the manufacturing and supply chain functions as well as corporate planning, and Paul Korner, M.D., M.B.A, Chief Medical Officer, who will be responsible for the medical and research functions and will be part of the business development team.



Researchers Find Tumor Microbiome Interactions May Identify New Approaches for Pancreatic Cancer Treatment

Investigators from Rutgers Cancer Institute of New Jersey, together with RWJBarnabas Health, examined the microbiome of pancreatic tumors and identified particular microorganisms at single cell resolution that are associated with inflammation and with poor survival. According to the researchers, these microorganisms may be new targets for earlier diagnosis or treatment of pancreatic cancer, which is the fourth leading cause of cancer death for both men and women in the United States. The study findings suggested that the immune responses were mostly responding to the microbes in the tumor and not to the cancer cells. “Our observations provide a new view about why pancreatic cancers are so difficult to treat,” notes Dr. Blaser, who is also a research member at Rutgers Cancer Institute and professor of epidemiology and biostatistics at Rutgers School of Public Health. “But better understanding these interactions may identify new approaches for therapies.”

R&D Council of NJ to Honor Innovators at Annual Edison Patent Awards

The Research & Development Council of New Jersey (R&D Council) announced the honorees and winners of the 2022 Edison Patent Awards, the State’s highest recognition for inventors and innovators. The R&D Council will honor Princeton Chemist and Nobel Prize Winner David W.C. MacMillan, Ph.D. with its highest honor: the Science and Technology Medal; New Jersey Health Commissioner Judith M. Persichilli will receive the Chairman’s Award; New Jersey Senate Majority Leader Teresa Ruiz will be honored with the Educator of the Year Award. 2022 Edison Patent Award winners include BASF, Celularity, Inc., Colgate-Palmolive, Ethicon, Inc. – a Johnson & Johnson Company, Kulite Semiconductor Products, Inc., Merck, New Jersey Institute of Technology, Princeton Plasma Physics Laboratory, Rowan University, Rutgers, The State University of New Jersey, Siemens Healthineers, Siemens Technology, and Stryker. 

Funding/Economic Development

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NJEDA Approves 24 Early Stage Companies to Receive Approximately $75 Million Through the 2022 Net Operating Loss Program

Twenty-four technology and biotechnology companies that are in the building and investing stages of their business have been approved to participate in the state’s Technology Business Tax Certificate Transfer Program, more commonly known as the Net Operating Loss (NOL) Program, the New Jersey Economic Development Authority (NJEDA) announced today. Combined, these companies were approved to receive a total of approximately $75 million through the program to fund working capital or research and development (R&D), the maximum amount available through the program. Now in its 23rd year, the NOL Program enables participants to sell their New Jersey net operating losses and unused R&D tax credits to unrelated profitable corporations for cash.

Governor Murphy Announces Creation of Grant Program to Support Growth of New Jersey's Manufacturers

Governor Phil Murphy announced the creation of a pilot program that will provide New Jersey manufacturers grants for the purchase of equipment they need to improve their operations. The New Jersey Manufacturing Voucher Program (MVP) will be developed and administered by the New Jersey Economic Development Authority (NJEDA) and funded with $20 million from the FY2023 budget. The program will focus on New Jersey manufacturers within targeted industries that will purchase equipment to integrate advanced or innovative technologies, processes, and materials to improve the manufacturing of their products. The MVP will offer grants valued at 30 to 50 percent of the cost of eligible equipment, including installation, up to a maximum award amount of $250,000.



The Center for Advanced Human Brain Imaging Research

November 2, 2022

We extend a warm invitation to attend the Center for Advanced Human Brain Imaging Research (CAHBIR) Fall Open House. CAHBIR provides state-of-the-art neuroimaging resources for both academic and industry research in central New Jersey. Come visit our new facility and meet our team of dedicated neuroimaging research specialists. RSVP is appreciated, but not required. If you are interested in the possibility of performing studies at CAHBIR but cannot attend the open house, please feel free to email the Center’s Director, Dr. David Zald.

Genesis 2022

December 7, 2022

The annual Genesis conference has been a pillar of the life science sector for over two decades. Bringing together key opinion leaders, investors and innovators from across the sector to share insight, debate key trends and generate deals. Under a headline theme of “Maximizing Returns from Life Science Innovation”, we expect 2022 to be no different! 

Princeton Chemical & Biological Engineering Graduate Student Symposium Networking Fair

December 9, 2022

The annual Graduate Student Symposium (GSS) is a day-long event organized by the graduate students in the Department of Chemical and Biological Engineering at Princeton University. GSS showcases current graduate student research in the department, ranging from mathematical modeling and simulations to materials science, bioengineering and beyond. At GSS 2022, upper level graduate students in their fourth year and above will be giving oral presentations, and third year students will be presenting posters. If you have questions about GSS 2022, please feel free to reach out to Drew Carson at

Biotech Showcase: The Investor Conference for Innovators

January 9-11, 2023

The Biotech Showcase, now in its 15th year, will be delivered in-person with a virtual component and this year's event provides valuable opportunities to engage with key players from the life science ecosystem. You will discover groundbreaking therapies in innovative biotech presentations - delivered during Biotech Showcase, have access to partneringONE starting 6 weeks prior to the conference and 3 months after the conference and submission of up to 150 meeting requests per company. BioNJ members will receive a $200 discount off their registration fees. Contact for the discount code. 

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