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September 24, 2021

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


BioNJ recently released the speaker roster for our Ninth Annual C-Suite Summit, entitled "Transitional to the 'Next Normal': Biopharma's Role in Addressing the COVID-19 Crisis and What's Next," taking place virtually Friday, October 15, 2021, from 8:30 a.m.-2:15 p.m. After closely monitoring updates from the Centers for Disease Control and Prevention and State and local health agencies, as well as speaking with leading epidemiologists, BioNJ has decided to present this year's full-day C-Suite Summit virtually, instead of its originally planned in-person format.

 

Realizing the desire for many of our Members to have the opportunity to network live in a safe environment, BioNJ is excited to kick off the Summit with an in-person Networking Reception the evening before, Thursday, October 14, from 4:00 p.m.-6:00 p.m. at the Basking Ridge Country Club. Following safety guidelines -- including requiring C-Suite Summit registration, on-site proof of vaccination and masks -- attendees will enjoy networking, cocktails, a staff-served buffet dinner and first-hand views of the beautifully manicured fairways of the Club's golf course and 260 private acres.

 

Join us for the October 15 Summit as we hear valuable insights from FDA, Ferring, Genmab, Incedo, Intrepid Alliance, Janssen, Merck, Organon, Otsuka, Pfizer, Sanofi, Deloitte, DLA Piper, EY, McKinsey, Morgan Lewis, RSM, Thermo Fisher and ZS Associates! Click here for the full agenda.


Meanwhile, we hope to see you next Wednesday, September 29, for BioNJ's Virtual Manufacturing Briefing, entitled "Pandemic-Induced Innovation and Adaption," featuring thought leaders from BMS, Catalent, Moderna, Pfizer, PTC Therapeutics, Tevogen, Thermo Fisher, BioCentriq, CBRE Life Sciences, CDN Advising, EY-Parthenon, McKinsey and Pall! Click here for the agenda. Thank you.


Because Patients Can' Wait®,

The BioNJ Team

WELCOME

NEW MEMBERS!


Learn more at

www.BioNJ.org/Membership

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Hikal Ltd.

Modal Technology Corp.

Neurofibromatosis, Inc.

Silence Therapeutics

WhizAI

Upcoming BioNJ Virtual Events

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Manufacturing Briefing: Pandemic-Induced Innovation & Adaptation

Register Today!

September 29, 2021

Virtual C-Suite Summit: Transitioning to the "Next Norm" With an In-Person Reception on October 14!

Register Today!

October 15, 2021

IT/Cyber Security Briefing

Mark Your Calendar!

November 17, 2021

Membership Webinar

Mark Your Calendar!

November 18, 2021

Inspiring Women in STEM Conference 

Mark Your Calendar!

December 3, 2021

Patient Advocacy Summit

Mark Your Calendar!

December 9, 2021

Putting Patients First:

The Value of Medical Innovation

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Five Reasons Tying VA Prices to Medicare Part D Misses the Mark

Some members of Congress are considering a government “negotiation” plan that would tie medicine prices in Medicare to those in the U.S. Department of Veterans Affairs (VA). This misguided approach is just the latest in a series of government price-setting proposals that threaten patients’ access to medicines and future innovation. Here are five reasons why the VA is a wrong model for Medicare: 1) Unlike Medicare Part D, the VA uses a one-size-fits-all system that restricts access to medicines. 2) The majority of VA beneficiaries rely on other sources to help supplement their drug coverage, including Medicare Part D. 3) The VA relies on quality-adjusted life year (QALY)-based assessments to set prices for medicines. 4) Imposing the VA system on Medicare is wildly unpopular with seniors. 5) Comparisons between Medicare Part D and the VA fail to acknowledge inherent structural distinctions between the two programs.  

NORD Statement on Proposed Changes to the Orphan Drug Tax Credit

The National Organization for Rare Disorders (NORD) issued a statement in response to upcoming congressional consideration of the Build Back Better Act in the House Committee on Ways and Means. Section 138141 of the Build Back Better Act would dramatically curtail the Orphan Drug Tax Credit for qualified clinical testing expenses by removing this critical incentive for all but the first approved orphan use of a new drug. Over 90% of rare diseases lack an FDA-approved treatment indicated for the specific rare disease. Each time a new orphan use of a drug is added to the label of a drug, more rare disease patients receive assurance that the drug is safe and effective for them.

NJ Company News

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Soligenix to Advance Synthetic Hypericin Development in Psoriasis

Princeton-based BioNJ Member Soligenix, Inc. announced that following the validation of synthetic hypericin's biologic activity in the positive pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study in cutaneous T-cell lymphoma (CTCL), as well as positive proof-of-concept (PoC) demonstrated in a small Phase 1/2 pilot study in mild-to-moderate psoriasis patients, the company will be expanding this novel therapy under the research name SGX302 into psoriasis, a large and underserved market with a significant unmet medical need. Visible light-activated synthetic hypericin is a novel, first-in-class, photodynamic therapy (PDT) that is expected to avoid much of the long-term risks associated with other PDT treatments. Synthetic hypericin is a potent photosensitizer that is topically applied to skin lesions and taken up by cutaneous T-cells.

STRIDE Data Show Translarna™ Delays Loss of Ambulation by More Than Five Years in Boys with Nonsense Mutation Duchenne Muscular Dystrophy

South Plainfield-based BioNJ Member PTC Therapeutics recently presented real-world results from the STRIDE patient registry demonstrating that treatment with Translarna™ (ataluren) delays loss of ambulation by more than five years in boys with nonsense mutation Duchenne muscular dystrophy (nmDMD) compared to standard of care (SoC) alone. Pulmonary function decline was also delayed by 1.8 years in those treated with Translarna and SoC. A time-to-event analysis of five years of registry datashows that boys treated with Translarna plus SoC had a median age of loss of ambulation of 17.9 years old compared with 12.5 years old for those on SoC alone. At 12 years old, 80% of boys receiving Translarna plus SoC are still walking, compared to 52% of the boys receiving SoC alone.

SCYNEXIS Announces Hansoh Pharma’s Application to National Medical Products Administration (NMPA) in China for Phase 3 Trial of Ibrexafungerp for Treatment of Vulvovaginal Candidiasis (VVC)

Jersey City-based BioNJ Member SCYNEXIS announced that Hansoh Pharmaceutical Group Company Limited has filed an investigational new drug (IND) application with the National Medical Products Administration (NMPA) of the People’s Republic of China for a Phase 3 study evaluating the efficacy and safety of ibrexafungerp for the treatment of vulvovaginal candidiasis (VVC), also known as vaginal yeast infection. Ibrexafungerp, the first and only new class of antifungal drug approved by the U.S. Food and Drug Administration (FDA) in more than 20 years, received U.S. regulatory authorization in June.

Legend Biotech Begins Phase 1 Clinical Trial in the US to Evaluate Investigational Anti-CD4 CAR-T Therapy for Relapsed or Refractory T-Cell Lymphoma

Somerset-based BioNJ Member Legend Biotech has announced the start of a Phase 1 clinical trial in the United States for LB1901, an investigational autologous CD4-targeted chimeric antigen receptor T-cell (CAR- T) therapy for the treatment of adults with relapsed or refractory peripheral T-cell lymphoma (PTCL) or cutaneous T-cell lymphoma (CTCL). LB1901 targets CD4, a surface membrane glycoprotein uniformly expressed in most TCL subtypes. The trial follows the U.S. Food and Drug Administration (FDA) clearance of the Investigational New Drug (IND) application submitted by Legend Biotech.

Celldex Announces Initiation of CDX-0159 Subcutaneous Formulation Study

Hampton-based BioNJ Member Celldex announced that the first cohort has been dosed in the Phase 1 study of the subcutaneous formulation of CDX-0159 in healthy volunteers. CDX-0159 is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity. The company intends to utilize the subcutaneous formulation of CDX-0159 in its Phase 2 program in chronic urticarias, planned for initiation in the first half of 2022. Celldex is currently studying an intravenous formulation of CDX-0159 in Phase 1 studies in chronic spontaneous and chronic inducible urticarias and will initiate a third intravenous study in prurigo nodularis later this year.

Otsuka America Wins ACE Award for Gender Diversity, Leadership Opportunities

Princeton-based BioNJ Member Otsuka America Pharmaceuticals has been selected as an ACE Awards winner by the Healthcare Businesswomen’s Association. HBA’s Advancement Commitment Engagement Awards recognize companies that are committed to ensuring that gender diversity and leadership opportunities for women are part of their organizational DNA. “Gender equality in health care is not a women’s issue, it’s a business imperative,” HBA CEO Susan O’Connor said. “A Catalyst study showed that more women in management positions led to 35% more return on equity than firms that lack gender diversity.” BioNJ Member Merck & Co. is also being recognized for its Women’s Network initiative. 

Genmab and Seagen Announce FDA Accelerated Approval for TIVDAK™ (tisotumab vedotin-tftv) in Previously Treated Recurrent or Metastatic Cervical Cancer

Princeton-based BioNJ Member Genmab and Seagen announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to TIVDAKTM (tisotumab vedotin-tftv), the first and only approved antibody-drug conjugate (ADC) for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. TIVDAK is approved under the FDA’s Accelerated Approval Program based on tumor response and the durability of the response. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

Genmab and Seagen Present Interim Results from the innovaTV 205 Study for Tisotumab Vedotin Combination Therapy Treatment of Recurrent or Metastatic Cervical Cancer at ESMO Virtual Congress 2021

Princeton-based BioNJ Member Genmab and Seagen presented interim data from two cohorts of the Phase 1b/2 innovaTV 205 multi-cohort, open-label trial of tisotumab vedotin in recurrent or metastatic cervical cancer. Initial results from these two dose expansion cohorts of the study showed encouraging and durable anti-tumor activity with tisotumab vedotin in combination with carboplatin (Cohort D) as first-line therapy for patients with advanced cervical cancer who had not received prior systemic therapy, with a 55% objective response rate (ORR) and with tisotumab vedotin in combination with pembrolizumab (Cohort F) for patients with advanced cervical cancer who experienced disease progression after 1-2 lines of prior systemic therapy, with a 38% ORR. 

Catalent to Manufacture Gastric-Acid Drug Once FDA Approves It

Florham Park-based BioNJ Member Phathom Pharmaceuticals has signed a commercial supply agreement with Catalent, a drug delivery company based in Somerset. Catalent will manufacture and package Phathom’s lead compound, vonoprazan, if the drug receives approval from the U.S. Food and Drug Administration. “This agreement is the start of long-term partnership between Catalent and Phathom, and we are pleased to be able to be part of a program that aligns with our ‘patient first’ philosophy, as this drug offers a true innovation for patients,” said Dr. Aris Gennadios, President of softgel and oral technologies at Catalent. Phathom develops and commercializes novel treatments for gastrointestinal diseases, and vonoprazan is a new class of medicines that block acid secretion in the stomach.

Phathom Pharmaceuticals Secures $200 Million Term Loan Facility from Hercules Capital

Florham Park-based BioNJ Member Phathom Pharmaceuticals reported it has obtained a $200 million term loan facility from Hercules Capital, Inc. This additional capital further strengthens Phathom’s balance sheet in advance of anticipated key catalysts, including data from the pivotal PHALCON-EE Phase 3 trial of vonoprazan for the treatment of erosive esophagitis in October 2021, data from the Phase 2 trial of vonoprazan for the treatment of non-erosive reflux disease in the first quarter of 2022, and FDA approval and commercial launch of vonoprazan-based regimens for the treatment of H. pylori in the second half of 2022. This non-dilutive financing extends Phathom’s projected cash runway to mid-2023 based on the company’s current operating plans.

Lilly to Supply 388,000 Doses of Etesevimab to U.S. Government for Treatment of COVID-19

Bridgewater-based BioNJ Member Eli Lilly Company announced an additional purchase by the U.S. government for its neutralizing antibody therapies authorized for emergency use as a treatment for COVID-19. As part of the agreement, Lilly will supply 388,000 doses of etesevimab to complement doses of bamlanivimab previously purchased by the U.S. government, with approximately 200,000 doses expected to ship Q3 2021 and the remaining to be shipped in Q4. This transaction is expected to generate approximately $330 million in revenue in the second half of 2021.

Lilly Announces Procurement Agreement With European Commission to Supply Bamlanivimab and Etesevimab Together for the Treatment of Confirmed COVID-19

Bridgewater-based BioNJ Member Eli Lilly Company announced a Joint Procurement Agreement with the European Commission (EC) to supply up to 220,000 doses of bamlanivimab and etesevimab for the treatment of confirmed COVID-19 in patients aged 12 years and older who do not require supplemental oxygen for COVID-19 and who are at increased risk of progressing to severe COVID-19. This agreement helps to provide access to treatments by enabling participating countries in the European Union (EU) and European Economic Area (EEA) to purchase the products directly from Lilly, following national approval for emergency use, or marketing authorization at the EU level.

Emergency Use Authorization for Lilly's Bamlanivimab and Etesevimab Administered Together Expanded to Include Post-Exposure Prophylaxis For COVID-19

The U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for bamlanivimab 700 mg and etesevimab 1400 mg administered together to include post-exposure prophylaxis (PEP) in certain individuals for the prevention of SARS-CoV-2 infection, Bridgewater-based BioNJ Member Eli Lilly Company announced. The neutralizing antibodies can now be used together to treat high-risk individuals 12 years of age and older who have not been fully vaccinated against COVID-19 or are not expected to mount an adequate immune response to complete vaccination and have been exposed to someone infected with SARS-CoV-2 or who are at high risk of exposure in an institutional setting, including a nursing home or prison. This authorization follows the national reopening of distribution earlier this month.

Lilly Announces the Early Tender Results of Its Pending Cash Tender Offer for Up to $1.5 Billion Combined Aggregate Principal Amount of Its Outstanding Debt Securities and Removal of the Note Caps for Its 3.950% Notes due 2049 and Its 4.150% Notes due 2059

Bridgewater-based BioNJ Member Eli Lilly Company announced the early tender results of its previously announced cash tender offer for specified series of its outstanding debt securities. Lilly also announced that it has removed the previously announced note caps setting forth the maximum principal amounts of its 4.150% Notes due 2059 and its 3.950% Notes due 2049 that Lilly will accept for purchase pursuant to the tender offer. Except as described in this press release, all other terms of the tender offer as described in the Offer to Purchase, dated September 7, 2021 (the "Offer to Purchase"), and the related Letter of Transmittal remain unchanged.

Johnson & Johnson Announces Real-World Evidence and Phase 3 Data Confirming Strong and Long-Lasting Protection of Single-Shot COVID-19 Vaccine in the U.S.

New Brunswick-based BioNJ Member Johnson & Johnson announced new data reinforcing the strong and long-lasting protection of its COVID-19 vaccine. New data also showed that protection against COVID-19 increases when a booster shot of the Johnson & Johnson vaccine is administered. The safety profile of the vaccine remained consistent and was generally well-tolerated when administered as a booster. “Our single-shot vaccine generates strong immune responses and long-lasting immune memory. And, when a booster of the Johnson & Johnson COVID-19 vaccine is given, the strength of protection against COVID-19 further increases,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson.

Johnson & Johnson Ebola Vaccine Regimen Demonstrated Robust and Durable Immune Response in Adults and Children in Data Published in The Lancet Infectious Diseases

Data from two papers published in The Lancet Infectious Diseases demonstrated that New Brunswick-based BioNJ Member Johnson & Johnson's Ebola vaccine regimen, Zabdeno® (Ad26.ZEBOV) and Mvabea® (MVA-BN-Filo), generated robust humoral (antibody) immune responses in adults and children (ages 1-17) with the immune responses persisting in adults for at least two years. The data also showed that booster vaccination with Ad26.ZEBOV, administered to adults two years after the initial vaccination, induced a strong anamnestic (immune) response within seven days.

Janssen Presents Results from Phase 1b/2 NORSE Study in Patients With Metastatic or Locally Advanced Urothelial Carcinoma Treated With BALVERSA®(erdafitinib) in Combination with Cetrelimab, a PD-1 Inhibitor

Raritan-based BioNJ Member Janssen Pharmaceutical Companies of Johnson & Johnson announced results from the Phase 1b/2 NORSE (NCT03473743) study evaluating BALVERSA® (erdafitinib) in combination with cetrelimab, an anti-programmed cell death protein 1 (PD-1) monoclonal antibody, compared to BALVERSA® monotherapy in patients with locally advanced or metastatic urothelial carcinoma (mUC) with fibroblast growth factor receptor (FGFR)3 or FGFR2 genetic alterations who are ineligible for cisplatin, a current standard of care treatment for mUC. Preliminary findings suggest robust clinical activity and depth of response in patients treated with BALVERSA® in combination with cetrelimab. The overall safety of treatment with BALVERSA® in combination with cetrelimab was generally consistent with BALVERSA® monotherapy and aligned with the known safety profile of approved anti–PD-1 therapies.

ERLEADA® (apalutamide) Oral Presentations Demonstrate Importance of Prostate Specific Antigen (PSA) as Key Efficacy Indicator and Show Strong Patient Adherence Rates

Raritan-based BioNJ Member Janssen Pharmaceutical Companies of Johnson & Johnson announced new data demonstrating robust prostate-specific antigen (PSA) response and strong adherence rates in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) treated with ERLEADA® (apalutamide) in the real-world clinical setting. The strong PSA response was also seen in a separate post-hoc analysis that showed a correlation between rapid and deep PSA response and prolonged survival in both metastatic castration-sensitive prostate cancer (mCSPC) and nmCRPC. The post-hoc analysis also supports the use of PSA as a predictive biomarker in the treatment of patients with advanced prostate cancer.

RYBREVANT® (amivantamab-vmjw) Provides Higher Activity and Longer Duration of Response When Used in Combination With Lazertinib in Patients With Advanced EGFR-Mutant Non-Small Cell Lung Cancer Who Have Failed Osimertinib

Raritan-based BioNJ Member Janssen Pharmaceutical Companies of Johnson & Johnson announced a new analysis from the CHRYSALIS (NCT02609776) study evaluating RYBREVANT® (amivantamab-vmjw) monotherapy and a combination regimen with lazertinib in advanced non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutations who progressed after osimertinib. The analysis showed higher activity and longer duration of response (DOR) in patients treated with the combination therapy, demonstrating the potential benefit of targeting the extracellular (outer) and catalytic (internal) domains of EGFR, even in patients with documented resistance to third-generation EGFR tyrosine kinase inhibitors (TKIs).

New Data on RYBREVANT® (amivantamab-vmjw) in Combination With Lazertinib Show Early Activity in Patients With Non-Small Cell Lung Cancer Whose Disease Has Progressed After Both Osimertinib and Platinum-Based Chemotherapy

Raritan-based BioNJ Member Janssen Pharmaceutical Companies of Johnson & Johnson announced preliminary results from the Phase 1b CHRYSALIS-2 (NCT04077463) study evaluating RYBREVANT® (amivantamab-vmjw) in combination with lazertinib in the treatment of patients with non-small cell lung cancer (NSCLC) characterized by epidermal growth factor receptor (EGFR) exon 19 deletion or L858R mutations whose disease had progressed after treatment with osimertinib and platinum chemotherapy. While previously reported results have demonstrated durable responses with RYBREVANT® in combination with lazertinib in chemotherapy-naïve patients previously treated with osimertinib, these new data suggest that intervening chemotherapy does not impact activity with the combination..

Pfizer and Biontech Announce Positive Topline Results from Pivotal Trial of Covid-19 Vaccine in Children 5 To 11 Years

BioNJ Member Pfizer, with offices in Peapack, and BioNTech SE announced results from a Phase 2/3 trial showing a favorable safety profile and robust neutralizing antibody responses in children 5 to 11 years of age using a two-dose regimen of 10 µg administered 21 days apart, a smaller dose than the 30 µg dose used for people 12 and older. The antibody responses in the participants given 10 µg doses were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age immunized with 30 µg doses. The 10 µg dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to 11 years of age. These are the first results from a pivotal trial of a COVID-19 vaccine in this age group.

Pfizer and BioNTech Receive First U.S. FDA Emergency Use Authorization of a COVID-19 Vaccine Booster


BioNJ Member Pfizer, with offices in Peapack, announced that the U.S. Food and Drug Administration (FDA) has authorized for emergency use a booster dose of the Pfizer-BioNTech COVID-19 Vaccine for individuals 65 years of age and older, individuals 18 through 64 years of age at high risk of severe COVID-19, and individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19. The booster dose is to be administered at least six months after completion of the primary series, and is the same formulation and dosage strength as the doses in the primary series. 

Pfizer’s and Astellas’ Xtandi® (Enzalutamide) Reduced Risk of Death By 34% in Men With Metastatic Hormone-Sensitive Prostate Cancer in Phase 3 Arches Study

BioNJ Member Pfizer, with offices in Peapack, and Astellas Pharma announced that XTANDI® (enzalutamide) improved overall survival (OS) in the ARCHES study in men with metastatic hormone-sensitive prostate cancer (mHSPC, also known as metastatic castration-sensitive prostate cancer). The Phase 3, randomized, double-blind, placebo-controlled trial compared XTANDI plus androgen deprivation therapy (ADT) versus placebo plus ADT in men with mHSPC and OS was a key secondary endpoint. In the study, XTANDI plus ADT reduced the risk of death by 34% (n=1,150; hazard ratio [HR]=0.66; [95% confidence interval [CI]: 0.53-0.81]; p<0.0001) compared to placebo plus ADT. 

Opdivo (nivolumab) Plus Yervoy (ipilimumab) Demonstrates Durable Overall Survival at Three Years Compared to Chemotherapy in First-Line Unresectable Malignant Pleural Mesothelioma in Phase 3 CheckMate -743 Trial

Princeton-based BioNJ Member Bristol Myers Squibb announced three-year data from the CheckMate -743 trial that demonstrated a durable survival benefit with first-line treatment with Opdivo (nivolumab) plus Yervoy (ipilimumab) compared to platinum-based standard-of-care chemotherapy in patients with unresectable malignant pleural mesothelioma (MPM), regardless of histology. The safety profile for Opdivo plus Yervoy remained consistent with previously reported data in first-line MPM, with no new safety signals identified.

According to New Multinational Survey, Health Care Providers Believe Immunotherapy Has Potential to Positively Impact Earlier-Stage Cancer Treatment Landscape Across Tumor Types

Princeton-based BioNJ Member Bristol Myers Squibb announced results of a new multinational survey of health care providers revealed that the majority of participants expect immunotherapy to have a positive impact on the treatment landscape for patients with earlier-stage cancers in the adjuvant (after surgery), neo-adjuvant (before surgery) and peri-operative (both before and after surgery) settings, if approved by regulatory bodies. The survey, commissioned by BMS, included over 250 oncologists, surgeons and specialists in the U.S., Japan, Germany, Italy and France who currently treat patients with stage I-III disease across eight different types of cancer. While health care providers surveyed are more satisfied with current treatments in cancers where earlier options are well established, they do not always use treatment before or after surgery, and the vast majority of respondents express enthusiasm for the potential of immunotherapy in earlier-stage cancers.

Five-Year Data from CheckMate -214 Show Opdivo (nivolumab) Plus Yervoy (ipilimumab) Demonstrates Longest Median Overall Survival Currently Reported in Phase 3 Trial of Patients With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

Princeton-based BioNJ Member Bristol Myers Squibb announced that Opdivo (nivolumab) plus Yervoy (ipilimumab) continued to demonstrate durable, long-term survival in the Phase 3 CheckMate -214 trial, with a five-year survival rate of 48% in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC). After a median follow-up of 67.7 months, Opdivo plus Yervoy maintained superior overall survival (OS) and response benefits versus sunitinib in both patients with intermediate- and poor-risk prognostic factors, the primary endpoint population, and across all randomized patients.

Bristol Myers Squibb Receives Positive CHMP Opinion for Opdivo (nivolumab) + Chemotherapy for Patients With HER2-Negative Advanced or Metastatic Gastric, Gastroesophageal Junction or Esophageal Adenocarcinoma Whose Tumors Express PD-L1 with CPS ≥ 5

Princeton-based BioNJ Member Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab) in combination with fluoropyrimidine and platinum-containing chemotherapy for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma whose tumors express PD-L1 with a combined positive score (CPS) ≥ 5.The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP recommendation.

U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Application for LAG-3-Blocking Antibody Relatlimab and Nivolumab Fixed-Dose Combination as Treatment for Patients With Unresectable or Metastatic Melanoma

Princeton-based BioNJ Member Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for the LAG-3-blocking antibody relatlimab and nivolumab fixed-dose combination, administered as a single infusion, for the treatment of adult and pediatric patients (12 years and older and weighing at least 40 kg) with unresectable or metastatic melanoma. The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 19, 2022. The BLA submission was based on the efficacy and safety results of the Phase 2/3 RELATIVITY-047 trial, which demonstrated a statistically significant and clinically meaningful progression-free survival benefit of a combination therapy over standard of care anti-PD-1 monotherapy in metastatic melanoma.

Novartis Announces First FDA Filing Acceptance for Anti-PD-1 Antibody Tislelizumab for People With Esophageal Cancer

East Hanover-based BioNJ Member Novartis announced that the US Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) for anti-PD-1 immune checkpoint inhibitor tislelizumab for the treatment of unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) in people who had received prior systemic therapy. Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody being developed both as a monotherapy and in combination with other therapies.

Novartis Reports Positive Health-Related Quality of Life Data For 177Lu-PSMA-617 Radioligand Therapy in Patients With Advanced Prostate Cancer At ESMO 2021

East Hanover-based BioNJ Member Novartis announced positive health-related quality of life (HRQoL) data from its Phase III VISION study evaluating 177Lu-PSMA-617, an investigational targeted radioligand therapy, plus standard of care for metastatic castration-resistant prostate cancer (mCRPC) versus standard of care alone. Many patients with mCRPC live with reduced physical functioning as well as significant pain. This data from a quality-of-life assessment of the VISION trial, referred to as HRQoL, showed delayed worsening of these difficult to bear symptoms in the 177Lu -PSMA-617 plus standard of care arm compared to standard of care alone arm. No new or unexpected safety concerns, including changes in creatinine clearance, were noted.

Novartis Announces Findings from a Real-World Study of Alpelisib Demonstrating Clinical Benefit in People With PIK3CA-Related Overgrowth Spectrum (PROS)

East Hanover-based BioNJ Member Novartis announced important findings from a real-world study evaluating the safety and efficacy of alpelisib for people living with PIK3CA-Related Overgrowth Spectrum (PROS) who received treatment daily for at least 24 weeks. Results from EPIK-P1 showed alpelisib effectively reduced volume of clinically significant PROS-related lesions and improved signs and symptoms in pediatric and adult patients. In EPIK-P1, alpelisib reduced target lesion volume and improved PROS-related symptoms and manifestations.

Novartis Presents New Kisqali® Data Showing Longest Median Overall Survival Ever Reported in HR+/HER2- Advanced Breast Cancer

East Hanover-based BioNJ Member Novartis announced results of the final overall survival (OS) analysis of the Phase III MONALEESA-2 study, which evaluated Kisqali® (ribociclib) in combination with letrozole compared to placebo plus letrozole in postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer with no prior systemic treatment for advanced disease. Kisqali in combination with letrozole met its key secondary endpoint of OS, demonstrating a statistically significant and clinically meaningful improvement in survival (median 63.9 vs. 51.4 months; HR=0.76; 95% CI: 0.63-0.93; p=0.004).

Novartis Announces Collaboration on HARMONIA, A Phase III, Head-To-Head Trial Evaluating Kisqali® Vs. Ibrance® in Patients With HR+/HER2- Advanced Breast Cancer

East Hanover-based BioNJ Member Novartis announced a collaboration with SOLTI Innovative Cancer Research (SOLTI) on HARMONIA, an international, randomized, Phase III, multicenter, open-label study of Kisqali® (ribociclib) versus Ibrance® (palbociclib), both in combination with endocrine therapy, in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer with a HER2-enriched (HER2E) intrinsic subtype. HARMONIA is the first prospective Phase III trial to enroll patients selected by RNA-based molecular subtyping of their tumors and the first to directly compare two CDK4/6 inhibitors in patients with HR+/HER2- advanced breast cancer.

Novartis Acquires Arctos Medical, Expanding Optogenetics Portfolio to Bring Gene Therapies to Patients With Severe Vision Loss

East Hanover-based BioNJ Member Novartis announced that it has acquired Arctos Medical, adding a pre-clinical optogenetics-based AAV gene therapy program and Arctos’ proprietary technology to its ophthalmology portfolio. The acquisition underscores the Novartis commitment to finding treatments for patients with vision loss and the potential of optogenetics as the basis of successful therapeutics. Arctos developed its technology as a potential method for treating inherited retinal dystrophies (IRDs) and other diseases that involve photoreceptor loss, such as age-related macular degeneration (AMD). Existing gene therapy treatments aim to correct a specific gene, so only a small subset of patients can benefit.

Sanofi Completes Acquisition of Translate Bio, Accelerating the Application of mRNA in New Vaccines and Therapeutics

Bridgewater-based BioNJ Member Sanofi announced the completion of its acquisition of Translate Bio, further accelerating the company’s efforts to develop transformative vaccines and therapies using mRNA technology. The acquisition adds a critical pillar to the company’s mRNA Center of Excellence which aims to unlock the potential of next-generation mRNA vaccines and other strategic areas such as immunology, oncology and rare diseases.

ESMO Late-Breaking Data Show Libtayo® (Cemiplimab) and Chemotherapy First-Line Treatment Combination Significantly Improved Overall Survival in Patients With Advanced NSCLC

Positive Phase 3 results for Bridgewater-based BioNJ Member Sanofi and Basking Ridge-based Regeneron Pharmaceuticals, Inc.’s Libtayo® (cemiplimab) combination treatment was presented during a late-breaking session at the European Society for Medical Oncology Virtual Congress 2021. The trial, which met its primary overall survival (OS) endpoint and all key secondary endpoints, assessed the investigational use of PD-1 inhibitor Libtayo in combination with a physician’s choice of platinum-doublet chemotherapy (Libtayo combination) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) irrespective of histology and across all PD-L1 expression levels, compared to chemotherapy alone. These results were also achieved in a patient population with varied baseline characteristics and will form the basis of regulatory submissions, including in the U.S. and European Union (EU).

GSK Receives CHMP Positive Opinions Recommending Approval of Nucala (Mepolizumab) in Three Additional Eosinophil-Driven Diseases

Warren-based BioNJ Member GlaxoSmithKline announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued positive opinions recommending Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), for use in three eosinophil-driven diseases; hypereosinophilic syndrome (HES), eosinophilic granulomatosis with polyangiitis (EGPA) and chronic rhinosinusitis with nasal polyps (CRSwNP). The CHMP opinion is one of the final steps in the marketing authorisation procedure prior to approval decision by the European Commission.

Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) in Combination With Chemotherapy for Certain Patients With Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer Whose Tumors Express PD-L1 (CPS ≥10)

Kenilworth-based BioNJ Member Merck & Co. announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy for the treatment of locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) in adults whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10) and who have not received prior chemotherapy for metastatic disease. The positive opinion is based on progression-free survival (PFS) and overall survival (OS) results from the Phase 3 KEYNOTE-355 trial, which showed that treatment with KEYTRUDA in combination with chemotherapy (nab-paclitaxel, paclitaxel or gemcitabine/carboplatin), as compared to chemotherapy alone, significantly improved PFS and OS in these patients.

Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy Reduced Risk of Death by 27% Versus Chemotherapy as First-Line Treatment for Patients With Metastatic Triple-Negative Breast Cancer Whose Tumors Expressed PD-L1 (CPS ≥10)

Kenilworth-based BioNJ Member Merck & Co. announced the final overall survival (OS) results from the pivotal Phase 3 KEYNOTE-355 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy (paclitaxel, nab-paclitaxel or gemcitabine/carboplatin) for the first-line treatment of patients with metastatic triple-negative breast cancer (mTNBC). KEYTRUDA is the first anti-PD-1 therapy in combination with chemotherapy to demonstrate a statistically significant and clinically meaningful improvement in OS for these patients. In this study, KEYTRUDA plus chemotherapy reduced the risk of death by 27% (HR=0.73 [95% CI, 0.55-0.95]; p=0.0093) in patients with mTNBC whose tumors expressed PD-L1 (Combined Positive Score [CPS] ≥10), as compared to chemotherapy alone.

Merck’s KEYTRUDA® (pembrolizumab) Demonstrated Superior Recurrence-Free Survival (RFS) in Patients With Resected High-Risk Stage II Melanoma Compared to Placebo in the Adjuvant Setting

Kenilworth-based BioNJ Member Merck & Co. announced the first results from the Phase 3 KEYNOTE-716 trial, in which adjuvant treatment with KEYTRUDA, Merck’s anti-PD-1 therapy, showed a statistically significant and clinically meaningful improvement in recurrence-free survival (RFS), the trial’s primary endpoint, compared to placebo in patients with resected high-risk stage II melanoma; KEYTRUDA is the first anti-PD-1 therapy to demonstrate this. At the first interim analysis, KEYTRUDA reduced the risk of disease recurrence or death by 35% (HR=0.65 [95% CI, 0.46–0.92]; p=0.00658) compared to placebo. 

Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy With or Without Bevacizumab Reduced Risk of Death by One-Third Versus Chemotherapy With or Without Bevacizumab as First-Line Treatment for Persistent, Recurrent or Metastatic Cervical Cancer

Kenilworth-based BioNJ Member Merck & Co announced the presentation of the full results from the pivotal Phase 3 KEYNOTE-826 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy with or without bevacizumab for the first-line treatment of persistent, recurrent or metastatic cervical cancer. This is the first combination regimen with an anti-PD-1/PD-L1 therapy to improve overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) compared to chemotherapy with or without bevacizumab as a first-line treatment of persistent, recurrent or metastatic cervical cancer.

AbbVie Submits Regulatory Applications to FDA and EMA for Upadacitinib (RINVOQ®) for the Treatment of Adults With Moderately to Severely Active Ulcerative Colitis

Madison-based BioNJ Member AbbVie announced that it has submitted applications seeking approval for upadacitinib (15 mg and 30 mg (maintenance dose) and 45 mg (induction dose)) for the treatment of adults with moderately to severely active ulcerative colitis to the U.S. Food and Drug Administration (FDA), and to the European Medicines Agency (EMA) for the treatment of adults with moderately to severely active ulcerative colitis, who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent. The applications are supported by data from two Phase 3 induction studies and one maintenance study.

AbbVie and REGENXBIO Announce Eye Care Collaboration

Madison-based BioNJ Member AbbVie and Rockville-based REGENXBIO announced a partnership to develop and commercialize RGX-314, a potential one-time gene therapy for the treatment of wet age-related macular degeneration (wet AMD), diabetic retinopathy (DR) and other chronic retinal diseases. RGX-314 is currently being evaluated in patients with wet AMD in a pivotal trial utilizing subretinal delivery, and in patients with wet AMD and DR in two separate Phase II clinical trials utilizing in-office suprachoroidal delivery. Under the collaboration, REGENXBIO will be responsible for completion of the ongoing trials of RGX-314. AbbVie and REGENXBIO will collaborate and share costs on additional trials of RGX-314, including the planned second pivotal trial evaluating subretinal delivery for the treatment of wet AMD and future trials. AbbVie will lead the clinical development and commercialization of RGX-314 globally.

AbbVie Submits Regulatory Application to FDA for Risankizumab-rzaa (SKYRIZI®) for the Treatment of Patients 16 Years and Older With Moderate to Severe Crohn's Disease

Madison-based BioNJ Member AbbVie announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking approval for risankizumab-rzaa (600 mg intravenous (IV) induction and 360 mg subcutaneous (SC) maintenance therapy), an interleukin-23 (IL-23) inhibitor, for the treatment of patients 16 years and older with moderate to severe Crohn's disease. The submission is supported by safety and efficacy data from three Phase 3 studies – ADVANCE, MOTIVATE and FORTIFY. In the analysis plans for the U.S. submission of the ADVANCE and MOTIVATE induction studies, a significantly greater proportion of patients with Crohn's disease treated with either dose of risankizumab-rzaa IV induction therapy (600 mg or 1200 mg) met the co-primary endpoints of clinical remission and endoscopic response at week 12 compared to placebo.

LUMAKRAS™ (Sotorasib) Combined With Vectibix® (Panitumumab) Showed Encouraging Efficacy And Safety In Patients With KRAS G12C-Mutated Colorectal Cancer

Berkeley Heights-based BioNJ Member Amgen announced the first combination study results from the Phase 1b/2 CodeBreaK 101 study, the most comprehensive global clinical development program in patients with KRAS G12C-mutated advanced colorectal cancer (CRC). These new data show that combining LUMAKRAS™ (sotorasib) with Vectibix® (panitumumab), Amgen's monoclonal antibody epidermal growth factor receptor (EGFR) inhibitor, demonstrated encouraging efficacy and safety. Overall, the objective response rate (ORR) was 27% (confirmed and unconfirmed) among 26 patients in the efficacy analysis set (which included 5 patients who had progressed with prior sotorasib monotherapy). The disease control rate (DCR) was 81%. ORR and DCR were secondary endpoints. 

Boehringer Ingelheim Enters Clinical Collaboration With Amgen to Study BI 1701963, a SOS1::pan-KRAS Inhibitor, in Combination With LUMAKRAS™ (sotorasib), a KRASG12C Inhibitor

North Brunswick-based Boehringer Ingelheim announced a clinical Phase I collaboration with BioNJ Member Amgen to evaluate the combination of BI 1701963, the first and most advanced SOS1::pan-KRAS inhibitor exhibiting activity against a broad spectrum of KRAS alleles, and LUMAKRAS™ (sotorasib), the first U.S. Food and Drug Administration (FDA) approved KRASG12C inhibitor for adult patients with locally advanced or metastatic non-small cell lung cancer. The trial will investigate potential synergistic effects of this combination, possibly improving therapeutic outcomes beyond those of KRASG12C inhibitor therapy alone, specifically for people living with lung and colorectal cancers. 

Boehringer Ingelheim Receives Positive Opinion for the Combined Use of Ingelvac Circoflex® and Ingelvac PRRSFLEX EU® in the EU

North Brunswick-based Boehringer Ingelheim announces positive opinion for the combined use of Ingelvac CircoFLEX® and Ingelvac PRRSFLEX EU®, received in the European Union. The combined administration of both vaccines represents innovation in pig health management. From now on, two of the most prominent and costly diseases, Porcine Circovirus Disease (PCVD) and Porcine Reproductive and Respiratory Syndrome (PRRS), can be prevented with a single injection. In modern pig production most pigs receive vaccines to protect against these two diseases.

BeiGene Announces U.S. FDA Acceptance of Biologics License Application for Tislelizumab in Esophageal Squamous Cell Carcinoma

Ridgefield Park-based BeiGene announced that the U.S. Food and Drug Administration (FDA) accepted for review a Biologics License Application (BLA) for its anti-PD-1 antibody tislelizumab as a treatment for patients with unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic therapy. The Prescription Drug User Fee Act (PDUFA) target action date is July 12, 2022. The BLA submission is based on results from RATIONALE 302, a randomized, open-label, multicenter global Phase 3 trial (NCT03430843) designed to evaluate the efficacy and safety of tislelizumab when compared to investigator’s choice chemotherapy as a second-line treatment for patients with advanced or metastatic ESCC.

U.S. FDA Grants BRUKINSA® (Zanubrutinib) Accelerated Approval in Relapsed or Refractory Marginal Zone Lymphoma

Ridgefield Park-based BeiGene announced that BRUKINSA® (zanubrutinib) has received accelerated approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory (R/R) marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen. This accelerated approval is based on overall response rate (ORR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The FDA approval of BRUKINSA is based on efficacy results from two single-arm clinical trials, with ORR as assessed by independent review committee (IRC) per 2014 Lugano Classification as the primary endpoint.

BeiGene Receives Positive CHMP Opinion for BRUKINSA® (Zanubrutinib) for the Treatment of Adults With Waldenström’s Macroglobulinemia

Ridgefield Park-based BeiGene announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending approval of BRUKINSA (zanubrutinib) for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy or first-line treatment for patients unsuitable for chemo-immunotherapy. The positive CHMP opinion is based on results from the randomized, Phase 3 ASPEN clinical trial, evaluating BRUKINSA compared to ibrutinib in patients with relapsed or refractory (R/R) or treatment-naïve (TN) WM who are unsuitable for chemo-immunotherapy. 

AbbVie, Eisai, and EA Pharma Launch “Humira® Support Tool Ordering Service for Patients” -- an Initiative to Improve Patients’ Adherence to Humira® Therapy

Woodcliff Lake-based Eisai, Madison-based BioNJ Member AbbVie and Titusville-based EA Pharma announced that the companies launched “Humira® Support Tool Ordering Service for Patients” an initiative intended to improve patients’ adherence to Humira® therapy. “Humira Support Tool Ordering Service for Patients” is a free-of-charge service that assists patients on Humira therapy by directly delivering support tools to their home or other requested location. Patients can use this service by applying on the website or using a designated form to request support tools such as containers for disposal of used syringes, bags for disposal of used pens, disease-specific health management notebooks and disease-specific medication guides for patients. 

DESTINY-Gastric06 Phase 2 Trial of ENHERTU® Initiated in China in Patients With HER2 Positive Advanced Gastric Cancer

Basking Ridge-based Daiichi-Sankyo announced that the first patient was dosed in DESTINY- Gastric06, a Phase 2 trial in China evaluating the safety and efficacy of ENHERTU® (trastuzumab deruxtecan) in patients with HER2 positive locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma previously treated with at least two prior regimens including a fluoropyrimidine and a platinum agent. Approximately half of all worldwide cases of gastric cancer occur in China, with about 80% of patients presenting with advanced disease at the time of diagnosis. 

DS-7300 Data at ESMO Shows Promising Early Clinical Activity in Patients With Advanced Solid Cancers

New first-in-human data from DS-7300, a B7-H3 directed DXd antibody drug conjugate (ADC) being developed in strategic collaboration between Basking Ridge-based Daiichi Sankyo and Sarah Cannon Research Institute showed promising early clinical activity in patients with several types of advanced solid tumors. B7-H3 is frequently overexpressed in a wide range of cancers including lung, prostate, breast, head and neck squamous cell carcinoma, and esophageal squamous cell carcinoma, and its overexpression is associated with poor prognosis. No B7-H3 directed therapies are currently approved for treatment of any cancer.

ENHERTU® Demonstrated Robust and Durable Tumor Response of 54.9% in Patients With HER2 Mutant Metastatic Non-Small Cell Lung Cancer

Detailed primary results from the positive pivotal DESTINY-Lung01 Phase 2 trial of ENHERTU® (trastuzumab deruxtecan), Basking Ridge-based Daiichi Sankyo and AstraZeneca HER2 directed antibody drug conjugate (ADC), showed a robust and durable tumor response in previously treated patients with HER2 mutant unresectable and/or metastatic non-squamous non-small cell lung cancer (NSCLC). Results that were published in The New England Journal of Medicine confirm ENHERTU as the first HER2 directed therapy to show a strong tumor response in this patient population.

ENHERTU® Reduced the Risk of Disease Progression or Death by 72% Versus Trastuzumab Emtansine (T-DM1) in Patients With HER2 Positive Metastatic Breast Cancer

Detailed positive results from the head- to-head DESTINY-Breast03 Phase 3 trial showed that ENHERTU® (trastuzumab deruxtecan), Basking Ridge-based Daiichi Sankyo and AstraZeneca HER2 directed antibody drug conjugate (ADC), demonstrated superior progression-free survival (PFS) versus trastuzumab emtansine (T- DM1), a HER2 directed ADC currently approved to treat patients with HER2 positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane. At a pre-specified interim analysis of DESTINY-Breast03, ENHERTU demonstrated a 72% reduction in the risk of disease progression or death compared to T-DM1 (hazard ratio [HR] = 0.28; 95% CI: 0.22-0.37; p=7.8x10-22).

Datopotamab Deruxtecan Shows Encouraging Tumor Response in Patients With Advanced Non-Small Cell Lung Cancer with Actionable Genomic Alterations

New data for datopotamab deruxtecan (Dato-DXd), a TROP2 directed DXd antibody drug conjugate (ADC) being developed by Basking Ridge-based Daiichi Sankyo Company and AstraZeneca, show an encouraging tumor response rate in patients with advanced non-small cell lung cancer (NSCLC) with actionable genomic alterations. Lung cancer is the second most common cancer and the leading cause of cancer-related mortality worldwide, with 80 to 85% classified as NSCLC. A confirmed objective response rate (ORR) of 35% was observed in 34 evaluable patients with NSCLC with actionable genomic alterations treated with datopotamab deruxtecan as assessed by blinded independent central review.

Regeneron Announces New U.S. Government Agreement to Purchase Additional Doses of Regen-Cov™ (Casirivimab and Imdevimab) Antibody Cocktail

Basking Ridge-based Regeneron Pharmaceuticals announced that the U.S. Department of Health and Human Services (HHS) and the Department of Defense (DOD) will purchase 1.4 million additional doses of REGEN-COV (casirivimab and imdevimab). The government will continue to provide REGEN-COV at no cost to patients. "More than a year and a half into this pandemic, too many people are still being hospitalized and dying due to COVID-19," said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. "While vaccination remains the first line of defense to decrease the burden of COVID-19, REGEN-COV is a key tool that reduces the risk of hospitalization or death by 70% in high-risk individuals when given early in the course of the infection."

Esmo Late-Breaking Data Show Libtayo® (Cemiplimab) and Chemotherapy First-Line Treatment Combination Significantly Improved Overall Survival in Patients With Advanced NSCLC

Basking Ridge-based Regeneron Pharmaceuticals announced positive Phase 3 results for a Libtayo® (cemiplimab) combination treatment. The trial, which met its primary overall survival (OS) endpoint and all key secondary endpoints, assessed the investigational use of PD-1 inhibitor Libtayo in combination with a physician's choice of platinum-doublet chemotherapy (Libtayo combination) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) irrespective of histology and across all PD-L1 expression levels, compared to chemotherapy alone. These results were also achieved in a patient population with varied baseline characteristics and will form the basis of regulatory submissions, including in the U.S. and European Union (EU).

Aerie Pharmaceuticals Announces Novel Dry Eye Product Candidate AR-15512 (TRPM8 Agonist) Ophthalmic Solution Achieved Statistical Significance Over Multiple Symptoms and Signs in Successful Phase 2b Clinical Study for the Treatment of Dry Eye Disease

Bedminster-based Aerie Pharmaceuticals reported positive topline results of its Phase 2b clinical study, named COMET-1, for AR-15512 (TRPM8 Agonist) (“AR-15512”) ophthalmic solution for the treatment of patients with dry eye disease. The randomized, double-masked, vehicle-controlled Phase 2b clinical study was conducted at 15 sites throughout the United States and evaluated the efficacy and safety of AR-15512 in patients with dry eye disease. A total of 369 patients were randomized across three arms, AR-15512 (0.0014%), AR-15512 (0.003%) or AR-15512 vehicle, in each case dosed twice daily over 84 days. Patients were evaluated at Days 1, 14, 28 and 84.

Zelis to Acquire Healthcare Transparency Leader Sapphire Digital

Bedminster-based Zelis announced it entered into a definitive agreement to acquire Sapphire Digital, the health care industry’s leading platform for provider selection, patient access, price transparency and digital consumer navigation. More than 100 million people rely on Sapphire to help them price, select and access care with confidence. As part of the transaction, the Sapphire leadership team will join Zelis to help lead the combined company’s health care consumer solutions business. Sapphire Digital provides a comprehensive, integrated healthcare consumer shopping and navigation platform, including provider search, quality ratings and reviews, appointment scheduling, pricing data and cost calculators and other tools to find the lowest cost and highest quality care available.

HUREL Products and Services Are Now Part of Visikol

BICO has acquired the assets and operations of HUREL Corp. The acquired assets and operations of HUREL will be integrated into Hampton-based Visikol, a subsidiary in BICO. The addition of the HUREL liver co-culture models provides the market’s most comprehensive liver in vitro model and assay offerings to meet the diverse requirements of its customers. BICO has acquired assets and operations of HUREL for a purchase price of approximately USD 2.5 million. Visikol as a company recognizes that customers always need tailor made solutions for in vitro models, and that every in vitro assay is a balance between cost, throughput and in vivo relevancy depending on a customer’s needs and their stage in the drug discovery process.

Infinity BiologiX Acquires Roylance Pharma

Piscataway-based IBX has acquired UK-based biospecimen storage specialists Roylance Pharma. We are excited to welcome the Roylance Pharma team into the IBX family. Combining our two great organizations serves to strengthen the support we provide our clients whilst accelerating our already impressive growth on an international scale,” said Robin Grimwood, Infinity BiologiX CEO. “The team and capabilities within Roylance Pharma perfectly complement those within IBX. Establishing a solid biobanking and bioprocessing hub in the UK servicing Europe, reinforces not only the IBX strategy and mission but also our proposition to clients and commitment to providing world leading biomaterial services,” said Grimwood. 

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BioNJ's Emerging Company in the Spotlight sponsored by JFK Communications.

Click here to read.

BioNJ is pleased to shine the spotlight on one of our Innovation Members featuring their progress and work on behalf of Patients and their impact on the New Jersey life sciences ecosystem.

People in the News

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Celularity Appoints Andrew L. Pecora, M.D., FACP, CPE, as President


Florham Park-based BioNJ Member Celularity Inc. announced the appointment of Andrew L. Pecora, M.D., FACP, CPE, as President. Reporting to Robert J. Hariri, M.D., Ph.D., Chairperson and Chief Executive Officer, Dr. Pecora will provide senior leadership to advance Celularity’s clinical pipeline toward U.S. Food and Drug Administration (FDA) approval, including responsibility for preclinical and clinical development and regulatory affairs. Dr. Pecora is an award-winning clinician, scientist, and healthcare executive and innovator, with a track record of success leading biotechnology companies to pioneer novel cellular medicines. He is among the world’s foremost experts in blood and bone marrow stem cell transplantation, drug development, and the advancement of novel cell therapies. 

Rafael Holdings Appoints Patrick Fabbio as Chief Financial Officer

Newark-based Rafael Holdings, Inc., a pharmaceutical holding company focused on developing novel cancer metabolism therapeutics through its Barer Institute and investment in Rafael Pharmaceuticals, Inc., announced the appointment of Patrick Fabbio as Chief Financial Officer. Mr. Fabbio has more than 25 years of financial, operational and transactional leadership experience in both publicly traded and privately held life science and pharmaceutical companies. Prior to joining Rafael Holdings, he was Chief Financial Officer of WindMIL Therapeutics Inc.

Aerie Pharmaceuticals Announces Appointment of Carolyn McAuliffe, Senior Director, Communications

Bedminster-based Aerie Pharmaceuticals announced the appointment of Carolyn McAuliffe, Senior Director, Communications, reporting to Tad Heitmann, Aerie’s Vice President of Marketing. Ms. McAuliffe will be responsible for the development and execution of Aerie’s marketing and medical communications activities. She most recently held a related position at Masimo Corporation.

Funding

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Governor Murphy, NJEDA Announce Participation in Four Coalitions Applying to the U.S. EDA Build Back Better Regional Challenge

Governor Phil Murphy and the New Jersey Economic Development Authority (NJEDA) announced the NJEDA’s participation in four regional coalitions preparing applications for the U.S. Economic Development Authority (U.S. EDA) Build Back Better Regional Challenge (BBBRC). The Challenge is a federal grant program to help communities adopt and implement transformational, industry-based economic development strategies that strengthen economic diversity and resiliency in the wake of the COVID-19 pandemic. The four coalitions that NJEDA has joined focus on regional industry clusters that are part of Governor Murphy’s Stronger and Fairer Economic Plan, including biomanufacturing, clean energy, aviation and smart ports. BioNJ is proud to be a participant in the Biomanufacturing coalition that is working on this important grant proposal.

Governor Murphy Announces Agreement to Establish U.S. Headquarters in Newark for the Hax Start-up Development Program Focused on Industrial Tech and Decarbonization

Governor Phil Murphy announced that the New Jersey Economic Development Authority (NJEDA) and Princeton-based venture capital firm SOSV intend to form a new entity (HAX LLC) to bring SOSV’s acclaimed HAX hard tech start-up development program to Newark. SOSV will also establish the U.S. headquarters of the HAX program at the Newark site. HAX provides complete support for emerging companies, including a $250,000 initial investment in each participating company, 180 days of hands-on collaboration, and a global founder community for early stage founders building hard tech start-ups. The Murphy Administration has worked tirelessly to establish an emerging innovation economy, attracting key investments and bringing new jobs to New Jersey.

Academia/Institutions/Incubators

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Institute for Life Science Entrepreneurship at Kean University Receives Federal Prize to Support Inclusive Entrepreneurship

The Institute for Life Science Entrepreneurship (ILSE) at Kean University has received a U.S. Small Business Administration award to spur investment in underrepresented communities within the innovation economy and encourage diversity and inclusion in entrepreneurship. ILSE, a life science technology accelerator based at Kean University in Union, New Jersey, received one of 84 prizes nationwide in the 2021 Growth Accelerator Fund Competition. Each prize is $50,000. “Equity and opportunity for all are core principles at Kean University, so this award for ILSE is very gratifying,” said Kean President Lamont O. Repollet, Ed.D. “We will continue to work with ILSE and throughout the University to make the STEM fields more inclusive and give our diverse students and graduates the chance to bring their unique approaches and ideas to the marketplace.”

How the Pandemic Has Changed Clinical Trials

Rutgers pioneers a virtual approach to clinical trials, revolutionizing how studies are performed and increasing participant access, leading to stronger scientific results and accelerated treatment. Rutgers has pioneered a decentralized approach to clinical trials that is allowing researchers to accelerate the pace of finding cures, recruit lower-income and underrepresented populations that were previously unable to engage in clinical trials and broaden the studies’ geographic coverage, allowing for more diverse participants and, ultimately, better scientific outcomes.

15 NJ Colleges, Universities Make Forbes’ Best List

The 2021 Forbes America’s Top Colleges list recognizes 15 New Jersey public and private higher education institutions – including Princeton University, which was ranked No. 3 in the nation. New Jersey had eight public higher education institutions and seven private universities included on the list. Forbes compiled its 2021 list using a new methodology that counts low-income student outcomes and adds a giant federal database of information on student debt and salaries after graduation. The other New Jersey colleges and universities on Forbes’ best list include: Stevens Institute of Technology, The College of New Jersey, New Jersey Institute of Technology, Rutgers University, Seton Hall University, Ramapo College of New Jersey, Montclair State University, Drew University, Rowan University, Fairleigh Dickinson University, Monmouth University, Stockton University, Peter’s University and New Jersey City State University. 

Princeton is No. 1 in U.S. News Rankings for 11th Consecutive Year

Princeton University was ranked as the top school in the country for the 11th consecutive year by U.S. News & World Report, which released is 2021 rankings Monday morning. New Jersey placed two other universities in the Top 100: Rutgers University-New Brunswick tied with four others at No. 63; Stevens Institute of Technology tied with nine others at No. 83. New Jersey Institute of Technology finished just outside the Top 100, as it tied with 13 others at No. 103.

NJIT Climbs the Rankings of U.S. News & World Report, A Top 50 Public University

New Jersey Institute of Technology has risen 15 spots in the 2022 edition of the U.S. News & World Report’s Best National University Rankings. NJIT is ranked 103 out of nearly 400 schools on this list. NJIT also is ranked among the Top 50 Public Universities, coming in at No. 46. NJIT’s peer reputation score also increased over last year’s, marking the second consecutive year of gains on this metric. This is the third time in four years the perception of NJIT has improved among its peers. NJIT has made the biggest gain in reputation score among New Jersey schools during the last four years and is tied for second nationally in reputational improvement during that period. 

Rowan University Opens New School of Nursing & Health Professions

Rowan University’s board of trustees has approved the creation of a new School of Nursing & Health Professions, a move that’s expected to expand programs and opportunities for students. Dr. Peter Rattigan, a professor of health and exercise science, will serve as the school’s founding dean. The School of Nursing & Health Professions is expected to increase the visibility of its nursing programs, lead to joint allied health professions offerings, provide oversight for internships and clinical affiliations, foster relationships with other colleges and the medical schools and offer diverse educational pathways for students interested in nursing and health professions careers.

Coriell Institute for Medical Research, Van Andel Institute Awarded Estimated $12.4 Million SPORE Grant from National Cancer Institute

The Coriell Institute for Medical Research and Van Andel Institute have been awarded a prestigious Specialized Programs of Research Excellence (or SPORE) grant from the National Cancer Institute. The five-year grant valued at an estimated $12.4 million will support nearly 20 scientists as they work to improve epigenetic therapies for cancer. The project is co-led by Coriell’s President and CEO Jean-Pierre Issa, M.D., Van Andel Institute’s Chief Scientific Officer Peter A. Jones, Ph.D., DSc (hon), and Johns Hopkins University and VAI’s Stephen Baylin, M.D. This prestigious grant is the first of its kind at both Coriell and VAI, establishing them as premier institutions for cancer research. The award currently is the only SPORE grant awarded to an organization in New Jersey.

Hackensack Meridian School of Medicine Dean Bonita Stanton Honored With National Medical Fellowships’ Legacy Award

Bonita Stanton, M.D., the Founding Dean of the Hackensack Meridian School of Medicine, will receive the National Medical Fellowships’ Legacy Award. Dr. Stanton is being honored for helping to create “a school that recognizes inequity in health outcomes and that is demonstrating to students that healthcare disparities are born of structural and systemic racism.” NMF holds the Champions of Health Awards to “honor those individuals who have made a lasting impact on healthcare and diversity in healthcare as well as outstanding corporate leaders whose role and influence drives positive change in the business community and the communities they serve.”

AtlantiCare Celebrates Next Milestone in Construction of $38M Medical Arts Pavilion

The AtlantiCare community ceremoniously marked the completion of the steel structure for the health care system’s new Medical Arts Pavilion. The $38.3 million, three-story, 69,700-square-foot facility is located on the very same block where the health care system established its roots as Atlantic City Hospital in 1898. More than a ceremonial “beam placement,” the event celebrated AtlantiCare’s history of serving, and being an integral member of, the community for 123 years, while reinforcing its commitment to providing the vision, leadership and innovation that set the standard for health care excellence.

Inspira Health Appoints Julie H. Ellis, MBA, SHRM-SCP, as Vice President of Human Resources

Inspira Health announced the appointment of Julie H. Ellis, MBA, SHRM-SCP, to Vice President of Human Resources. Aligned with Inspira’s new strategic plan, Ms. Ellis has been chosen to further elevate the organization and quality of care through employee recruitment and retention efforts, as well as notable partnerships with the business community and other stakeholders. Ms. Ellis has more than 20 years of experience in human resources within the health care industry, most recently serving as Assistant Vice President of Human Resources for Kennedy Health System, now part of Thomas Jefferson University. 

Bayer Fund Donates $3.5M Across State to STEM, Food Insecurity Programs

Bayer Fund, the philanthropic arm of life sciences company Bayer, awarded $3.5 million in grants to 175 charities and nonprofit organizations throughout the United States — including $525,200 to eight organizations in New Jersey. As part of Bayer’s broader vision, Health for All, Hunger for None, each grant provided by Bayer Fund will go toward a program that will help tackle some of the biggest challenges faced in the country — combating malnutrition and food insecurity, support services for patients and families managing cardiovascular disease and cancer and enhancing STEM education in school systems. Students 2 Science in East Hanover received a STEM initiative grant for $125,000.

Events

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The Cove JC Launch Event

September 28, 2021, Liberty House

You’re invited for a day of discussion and exploration at the beautiful Liberty House, directly in front of The Cove JC site. Life sciences leaders in private industry, educational institutions, government agencies, and medical/scientific/community organizations will discuss working together to catalyze community building and economic development. We'll also explore how health care and cultural resources can encourage economic growth. Join us as we redefine the innovation district for the 21st century. BioNJ’s President and CEO, Debbie Hart, is part of the program! 


Thought Leadership from BioNJ Members

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Leadership Development & Virtual Delivery: Using Technology to Unlock Highly Engaging Socially Distanced Events

In these uncertain times, employees look to their companies for reassurance and stability, and organizations are now compelled to be agile and creative in engaging a remote workforce. Digital has become the “new normal” approach to investing in your team’s professional development. In this whitepaper by BioNJ Member A.J. O’Connor, you’ll learn how to pivot from an in-person learning and development engagement to a digital format.

BioNJ Member Services Provider Directory

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BioNJ recognizes the vital role that our Service Provider Members play in the growth of New Jersey's robust life sciences ecosystem. For this reason, we are delighted to remind our community about BioNJ's Member Service Provider Directory, a categorical listing of BioNJ Members by service sector. By working with fellow BioNJ Member organizations, you are not only supporting our community, but benefiting from a wide variety of high quality organizations. To learn how you can become a Member and be featured on this resource tool, please contact Kim Minton at KMinton@BioNJ.org, or 609-890-3185. Find providers in these categories:




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Please contact BioNJ with any questions.

BioNJ@BioNJ.org  | 609-890-3185 | www.BioNJ.org

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