Welcome to the latest edition of the BioLines Weekender...
Thank you to everyone who joined us last week for BioNJ's 11th Annual BioPartnering Conference. Presented in concert with J.P. Morgan and Johnson & Johnson Innovation on May 18 and 19, the Conference brought together life sciences professionals from 9 countries and 20 states as well as the District of Columbia and featured nearly 70 company and pitch presentations, hundreds of 1:1 partnering meetings and plenary sessions led by industry leaders and world-renowned research institutions from the region.
This year's Company and Pitch Presentation Award Honorees in six categories are:
Diagnostics & Enabling Technologies: Elizabeth Holmberg, Chief Financial Officer,
Third Pole Therapeutics; Devices: Joe Muldoon, CEO, Fast BioMedical; Oncology Therapeutics: Michael
Ferraresso, Chief Commercial Officer, AVEO Oncology; Pitch Presentations: Alexander Ploss, Ph.D., President, Acurasset Therapeutics; Therapeutics & Enabling Technologies: Ira Spector, Ph.D., MBA CEO, SFA Therapeutics, Inc. and Therapeutics: Susanne Wilke, Ph.D., MBA, President & CEO, Cognoptix.
Meanwhile, things on the policy front have been heating up. In particular, a May 14 hearing featured a discussion of A-2418, legislation to create a Prescription Drug Affordability Board in New Jersey. A-2418 would give an independent Prescription Drug Affordability Board the authority to set drug price controls without taking Patient preferences into account. The Board could even look to the Institute for Clinic and Economic Review (ICER) to make drug price and access decisions.
BioNJ Board Chair and Insmed Chair and CEO Will Lewis testified before the Committee on the dangers of price controls to both continued investment in new treatments and cures as well as Patient access to those cures. The COVID-19 pandemic has taught us just how critical innovation can be in protecting our health. It has also shown us how inequitable parts of our health care system are. At a time of great awakening, A-2418 would be a step in the wrong direction to improve equity and Patient health.
BioNJ opposes this legislation, and we look forward to working with the New Jersey Legislature to support drug pricing solutions that both lower Patient costs and protect New Jersey's innovation economy. Please join us in our opposition of A-2418 and instead support policies and solutions that ensure access to care while controlling health care costs in a way that promotes innovation in New Jersey and beyond. Contact [email protected] to learn more.
Because Patients Can't Wait®,
The BioNJ Team
P.S. Join BioNJ's new Inspiring Women in STEM LinkedIn Group designed to bring together the life sciences community to share anecdotes, tools and resources to support women involved in all aspects of science, technology, engineering and math. It's the perfect place to find mentors and connect with other industry professionals! Click here to join.
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HR Briefing: Vaccines and the Workplace
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June 2, 2021
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AI in Drug Discovery
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June 8, 2021
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Entrepreneurs, start-ups and well-known stalwarts in the life sciences sector from 9 countries and 20 states as well as the District of Columbia met last week with investors, academic collaborators, and business development professionals at BioNJ's 11th annual BioPartnering Conference. Speakers discussed the impact the COVID-19 pandemic has had on the industry from a business investment standpoint as well as from a technology and healthcare delivery standpoint.
Tom Cavanaugh, President, immunology, Janssen Biotech, said there were "eye opening levels of collaborations" going on amongst scientists, companies (many of whom are competitors) and between the private sector and the federal government. He said that 40% of drug therapies for COVID-19 were being developed by teams of companies. This is higher than the 21% of collaborations for H1N1 virus therapies, 11% for Zika, and 9% for Ebola.
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Princeton-based BioNJ Member Soligenix, Inc. announced that the Japan Patent Office has allowed the patent application titled "Systems and Methods for Producing Synthetic Hypericin". The allowed claims are directed to unique, proprietary methods to produce a novel, highly purified form of synthetic hypericin, and are similar to those previously allowed in the United States (U.S.). Synthetic hypericin is the active pharmaceutical ingredient in HyBryte™ (SGX301), the company's photodynamic therapy, for which positive primary endpoint results in a pivotal Phase 3 study for the treatment of cutaneous T-cell lymphoma (CTCL) were recently announced. This new patent is the first allowed in Japan covering the proprietary methods developed by the company and further expands the comprehensive HyBryte™ patent estate.
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South Plainfield-based BioNJ Member PTC Therapeutics, Inc. announced that both the United States Food and Drug Administration (FDA) and European Commission (EC) have granted Orphan Drug Designation (ODD) for PTC923 for the treatment of patients with hyperphenylalaninemia. Phenylketonuria (PKU) accounts for 98% of all hyperphenylalaninemia cases and is a metabolic condition that can lead to cognitive disabilities and seizures. PTC923 is an oral formulation of synthetic sepiapterin, a precursor to intracellular tetrahydrobiopterin, which is a critical enzymatic cofactor involved in the metabolism and synthesis of numerous metabolic products.
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Parsippany-based BioNJ Member Ferring Pharmaceuticals and Rebiotix, a Ferring Company, announced the first presentation of interim data from a Phase 3 open-label study showing strong trends in efficacy and safety for investigational microbiota-based live biotherapeutic RBX2660 in reducing recurrent Clostridioides difficile (C. difficile) infection over six months, consistent with previous findings in the comprehensive RBX2660 clinical development program. The study also enrolled patients diagnosed with co-morbid conditions such as inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS). The patients enrolled closely reflect the recurrent C. difficile infection patients who healthcare providers treat every day.
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Princeton-based BioNJ Member Advaxis, Inc. announced updated data from the company's ongoing Phase 1/2 study evaluating ADXS-503 in combination with KEYTRUDA®. ADXS-503 is the first drug construct from the ADXS-HOT off-the-shelf, cancer-type specific, immunotherapy program which leverages Advaxis' proprietary Lm technology platform to target hotspot mutations that commonly occur in specific cancer types as well as other proprietary, tumor-associated antigens.
Ken Berlin, Chief Executive Officer of Advaxis, said, "The clinical activity observed to date in this challenging patient population, combined with a favorable safety profile, suggest that ADXS-503 may be an important new off-the-shelf immunotherapy treatment option."
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Bridgewater-based BioNJ Member Nevakar Inc. announces the establishment of Vyluma Inc., a newly formed company with a focus on the development and commercialization of therapies to treat ophthalmic diseases. At inception Vyluma will operate as a wholly owned subsidiary of Nevakar Inc. Vyluma will focus on first-in-class and best-in-class ophthalmic pharmaceutical therapies, with an emphasis on refractive errors. Currently, there are no pharmaceutical treatment options approved for refractive errors such as childhood myopia, presbyopia, night vision disturbance, and hyperopia. NVK002 is Vyluma's lead product candidate in late Phase III clinical development with readouts anticipated in the fourth quarter of 2022.
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Bridgewater-based BioNJ Member Nevakar Inc. announces the establishment of Nevakar Injectables Inc., a newly formed company with an established portfolio of products focused on critical patient care, acute pain management, long acting injectables and hospital infections. At inception Nevakar Injectables will operate as a wholly owned subsidiary of Nevakar Inc. Nevakar Injectables launches with 13 active programs, three of which have been filed with FDA under the 505(b)(2) regulatory pathway. The company's first NDA was approved by the FDA in October 2020. Five of Nevakar Injectables' critical care products were out-licensed to Endo Pharmaceuticals for commercialization in the U.S. and Canada.
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Kenilworth-based BioNJ Member Merck & Co. announced V114, the company's investigational 15-valent pneumococcal conjugate vaccine, met its primary immunogenicity and safety endpoints in two trials of the V114 Phase 3 pediatric clinical program. These data support the potential use of V114 in healthy infants who may have previously started a pneumococcal vaccination series with the currently available 13-valent pneumococcal conjugate vaccine (PCV13) (PNEU-DIRECTION), and in a catch-up setting for healthy children who were either pneumococcal vaccine-naïve or who previously received a full or partial regimen with lower valency pediatric pneumococcal conjugate vaccines (PCV) (PNEU-PLAN).
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Kenilworth-based BioNJ Member Merck announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of KEYTRUDA, Merck's anti-PD-1 therapy, in combination with platinum- and fluoropyrimidine-based chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus or human epidermal growth factor receptor 2 (HER2)-negative gastroesophageal junction (GEJ) adenocarcinoma in adults whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10). The CHMP's recommendation will now be reviewed by the European Commission for marketing authorization in the European Union, and a final decision is expected in the second quarter of 2021.
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BioNJ Member Pfizer Inc., with offices in Peapack, and BioNTech SE announced a new agreement with the European Commission (EC) to supply 900 million doses of COMIRNATY®, the companies' COVID-19 vaccine, to the European Union (EU), with an option for the EC to request up to an additional 900 million doses. This new agreement is in addition to the 600 million doses that have already been committed to the EU. As part of the agreement, the EC also has an option to increase the number of doses delivered by up to an additional 900 million, bringing the total number of potential doses delivered to the EC, inclusive of all agreements, to up to 2.4 billion. All doses for the EC are planned to be manufactured in the European Union.
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BioNJ Member Pfizer Inc., with offices in Peapack, announced that the first enrolled subjects have received their immunizations as part of a new study in adults ages 65 or older exploring the coadministration of the company's 20-valent pneumococcal conjugate vaccine (20vPnC) candidate following a booster dose of the Pfizer-BioNTech COVID-19 Vaccine, currently authorized by the Food and Drug Administration (FDA) under an Emergency Use Authorization (EUA). The primary objective in the trial is to describe safety when both vaccines are co-administered, with follow up six months after vaccination. Secondary objectives are to describe immune responses produced by each of the vaccines.
The trial will include 600 adults who will be recruited from the pivotal Phase 3 Pfizer-BioNTech COVID-19 Vaccine trial and will have received their second dose of the vaccine at least six months prior to entering the coadministration study.
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Late-breaking data analyses presented by Madison-based BioNJ Member AbbVie showed significantly greater proportions of patients with moderately to severely active Crohn's disease treated with both doses of investigational risankizumab (600 mg or 1200 mg) met the co-primary endpoints of clinical remission and endoscopic response at week 12 compared to placebo (p<0.001 for each) in two Phase 3 induction studies. This is the first presentation of data from these two studies, ADVANCE and MOTIVATE, following the announcement of top-line data earlier this year. The ADVANCE study included patients with past intolerance or inadequate response to conventional therapy (non-bio-IR) and/or biologic therapy (bio-IR).
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Madison-based BioNJ Member AbbVie announced The Lancet published primary analysis results from the pivotal global Phase 3 clinical trials -- Measure Up 1, Measure Up 2 and AD Up -- evaluating RINVOQ ® (upadacitinib) in adults and adolescents with moderate to severe atopic dermatitis who were candidates for systemic treatment. The publication of Measure Up 1 and Measure Up 2 shares efficacy and safety results of patients treated with upadacitinib (15 mg or 30 mg, once daily) monotherapy versus placebo for 16 weeks. The publication of AD Up shares efficacy and safety results of patients treated with either dose of upadacitinib with topical corticosteroids (TCS) versus placebo with TCS for 16 weeks. Across all three studies, RINVOQ met all primary and secondary endpoints.
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Madison-based BioNJ Member AbbVie announced that the European Commission (EC) has approved VENCLYXTO® (venetoclax) in combination with a hypomethylating agent, azacitidine or decitabine, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. The approval is valid in all 27 member states of the EU, as well as Iceland, Liechtenstein, and Norway.
"VENCLYXTO has proven incremental overall survival in treating newly diagnosed AML in patients who are ineligible for intensive chemotherapy when treated with VENCLYXTO plus azacitidine compared to those treated with azacitidine alone," said Mohamed Zaki, M.D., Ph.D., Vice President and Head, Global Oncology Development, AbbVie.
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Bridgewater-based BioNJ Member Sanofi released detailed results from a Phase 3 trial showed Dupixent® (dupilumab) significantly reduced severe asthma attacks, and within two weeks rapidly improved lung function in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma, with evidence of type 2 inflammation. Dupixent also significantly improved overall asthma symptom control and reduced an airway biomarker of type 2 inflammation that plays a major role in asthma, called fractional exhaled nitric oxide (FeNO). The Phase 3, randomized, double-blind, placebo-controlled VOYAGE trial evaluated the efficacy and safety of Dupixent (100 mg or 200 mg every two weeks, based on weight) combined with standard-of-care asthma therapy in 408 children with uncontrolled moderate-to-severe asthma.
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Bridgewater-based BioNJ Member Sanofi presented Phase 1 data from the AMEERA-1 study evaluating amcenestrant, an investigational oral selective estrogen receptor degrader (SERD). In a pooled analysis, amcenestrant in combination with palbociclib showed encouraging antitumor activity in postmenopausal women with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC). In this preliminary analysis from the open-label AMEERA-1 study, amcenestrant was evaluated in dose escalation cohorts (Part C) at 200mg (n=9) and 400mg (n=6) daily and in a dose expansion cohort (Part D; n=30) at 200mg daily, all in combination with a standard dose of palbociclib.
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The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions for Bridgewater-based BioNJ Member Sanofi and Regeneron's PD-1 inhibitor Libtayo® (cemiplimab) as monotherapy in two advanced cancers. The CHMP recommended the approval of Libtayo for the first-line treatment of adults with non-small cell lung cancer (NSCLC) expressing PD-L1 in ≥50% of tumor cells with no EGFR, ALK or ROS1 aberrations. Patients must have metastatic disease or locally advanced disease that is not a candidate for definitive chemoradiation. Libtayo was also recommended for approval in adults with locally advanced or metastatic basal cell carcinoma (BCC) who have progressed on or are intolerant to a hedgehog pathway inhibitor (HHI).
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BioNJ Members Bridgewater-based Sanofi and Warren-based GSK adjuvanted recombinant COVID-19 vaccine candidate achieved strong rates of neutralizing antibody responses, in line with those measured in people who have recovered from COVID-19, in all adult age groups in a Phase 2 study with 722 volunteers. A global pivotal Phase 3 study is expected to start in the coming weeks. The Phase 2 interim results showed 95% to 100% seroconversion following a second injection in all age groups (18 to 95 years old) and across all doses, with acceptable tolerability and with no safety concerns. Overall, the vaccine candidate elicited strong neutralizing antibody levels that were comparable to those generated by natural infection, with higher levels observed in younger adults (18 to 59 years old).
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BioNJ Members Bridgewater-based Sanofi and Warren-based GSK started enrollment in their Phase 3 clinical study to assess the safety, efficacy and immunogenicity of their adjuvanted recombinant-protein COVID-19 vaccine candidate. The global randomized, double-blind, placebo-controlled Phase 3 study will include more than 35,000 volunteers aged 18 and older from several countries, including sites in the US, Asia, Africa and Latin America. The primary endpoint of the study is the prevention of symptomatic COVID-19 in SARS-CoV-2 naïve adults, with secondary endpoints being the prevention of severe COVID-19 disease and prevention of asymptomatic infection. In a two-stage approach, the study will initially investigate the efficacy of a vaccine formulation targeting the original D.614 virus (Wuhan), while a second stage will evaluate a second formulation targeting the B.1.351 (South African) variant.
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Warren-based BioNJ Member GlaxoSmithKline and Medicago are pleased to report positive interim Phase 2 clinical trial safety and immunogenicity data for Medicago's plant-derived COVID-19 vaccine candidate, which has been tested in combination with GSK's pandemic adjuvant. These results are part of the ongoing Phase 2/3 study and reiterate the promising profile observed during Phase 1 testing. Immunogenicity, as measured by the neutralising antibody titer, was high: about 10 times higher than those in a panel of sera from patients recovering from COVID-19. No related severe adverse events were reported and reactogenicity was generally mild to moderate and short in duration.
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Warren-based BioNJ Member GlaxoSmithKline and Vir Biotechnology, Inc. announced that the European Medicines Agency's (EMA) Committee for Human Medicinal Products (CHMP) has issued a positive scientific opinion following the referral of sotrovimab to the CHMP under Article 5(3) of Regulation 726/2004. The opinion relates to the use of sotrovimab for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with COVID-19 who do not require oxygen supplementation and who are at risk of progressing to severe COVID-19. The CHMP opinion under Article 5(3) can now be considered by the national authorities in EU member states when taking evidence-based decisions on the early use of the medicine prior to marketing authorisation.
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East Hanover-based BioNJ Member Novartis announced that it has delivered one billion courses of antimalarial treatment since 1999. More than 90% of this artemisinin-based combination therapy (ACT) was supplied without profit to malaria-endemic countries around the globe. ACTs are the standard of care for the treatment of P. falciparum malaria, the most deadly form of the disease, responsible for over 99% of cases in Africa and half of cases in Asia. Since the turn of the century, ACTs have transformed malaria treatment and contributed to the dramatic reduction in malaria deaths. Working with Chinese partners, Novartis launched the first fixed-dose ACT (artemether-lumefantrine) in 1999.
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A radiologic and therapy company has expanded its footprint in Millburn, buying a 5,000-square-foot flex space. A dvanced Accelerator Applications, a BioNJ Member Novartis company, purchased 45 E. Willow St., which is adjacent to its U.S. headquarters at 57 E. Willow St. West Orange-based Sheldon Gross' Barbara Gross and Bob Nathin brokered the transaction. "We originally worked with AAA several years ago, in its acquisition of 57 E. Willow, which the company completely overhauled," Gross said in a prepared statement. "More recently, the company needed to expand, but 45 E. Willow wasn't on the market. We approached the owners and negotiated terms favorable to both parties. This, in turn, made it possible for AAA to keep its headquarters employees together at one location.
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East Hanover-based BioNJ Member Novartis and Molecular Partners announced the start of the clinical trial EMPATHY, a Phase 2 and 3 study, to explore the use of its novel DARPin® therapeutic candidate ensovibep (MP0420) for the treatment of COVID-19. Novartis will conduct the clinical trial program for ensovibep, with Molecular Partners as sponsor of the studies. In March 2021, Molecular Partners reported positive initial Phase 1 results in healthy volunteers. The EMPATHY clinical trial program is investigating the safety and efficacy of ensovibep in patients with COVID-19, who are in the early stages of infection, to prevent worsening symptoms and hospitalization.
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East Hanover-based BioNJ Member Sandoz, a Novartis division, announced plans to further strengthen its European antibiotics manufacturing network by further expanding production capabilities in Kundl, Austria and in Palafolls, Spain. By modernizing and simplifying its manufacturing setup, Sandoz will improve its ability to consistently deliver high-quality medicines to patients, while remaining cost-competitive on the global market.
In line with plans announced with the Austrian government, Sandoz confirms that in a first step it will proceed to invest more than €100 million to introduce new manufacturing technology for the production of oral amoxicillin, an active pharmaceutical ingredient (API) for its leading penicillin product.
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Princeton-based BioNJ Member Bristol Myers Squibb announced additional data from multiple studies evaluating Zeposia (ozanimod) in ulcerative colitis (UC). These data deepen the understanding of Zeposia and reinforce Bristol Myers Squibb's commitment to understanding and addressing unmet needs in gastroenterology. "Together, these new data presented at Digestive Disease Week highlight the potential of Zeposia to address the need for additional safe and effective oral treatment options for adults with moderately to severely active ulcerative colitis," said Mary Beth Harler, M.D., Head of Immunology and Fibrosis Development, Bristol Myers Squibb.
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Princeton-based BioNJ Member Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approval of Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal cancer (mCRC) after prior fluoropyrimidine-based combination chemotherapy. The opinion was based on data from the Phase 2 CheckMate -142 trial. The European Commission (EC), which is authorized to approve medicines for the European Union (EU), will now review the CHMP recommendation.
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Princeton-based BioNJ Member Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has approved Opdivo ® (nivolumab, injection for intravenous use) for the adjuvant treatment of completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT). The approval is based on results from the Phase 3 CheckMate -577 trial that evaluated Opdivo (n=532) compared to placebo (n=262) in esophageal or GEJ cancer patients with residual pathologic disease following neoadjuvant CRT and complete resection.
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Princeton-based BioNJ Member Bristol Myers Squibb announced that Opdivo (nivolumab) plus Yervoy (ipilimumab) with two cycles of chemotherapy showed a durable survival benefit compared to four cycles of chemotherapy alone after two years of follow-up in previously untreated patients with advanced non-small cell lung cancer (NSCLC). In the Phase 3 CheckMate -9LA trial, 38% of patients who received Opdivo plus Yervoy with two cycles of chemotherapy were alive at two years, compared to 26% of those who received chemotherapy alone. With additional follow-up, median overall survival (OS), the trial's primary endpoint, was 15.8 months with the dual immunotherapy combination vs. 11.0 months with chemotherapy alone (Hazard Ratio [HR] 0.72; 95% Confidence Interval [CI]: 0.61 to 0.86).
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Princeton-based BioNJ Member Bristol Myers Squibb announced that Part 1 of the Phase 3 CheckMate -227 trial continues to demonstrate the long-term survival benefits of first-line treatment with Opdivo (nivolumab)plus Yervoy (ipilimumab) compared to chemotherapy in patients with advanced non-small cell lung cancer (NSCLC), regardless of PD-L1 expression level or histology, with a minimum follow-up of over four years (49.4 months). In the primary population of patients with PD-L1 expression ≥1%, the four-year survival rate for Opdivo plus Yervoy was 29%, compared to 18% for chemotherapy (Hazard Ratio [HR] 0.76; 95% Confidence Interval [CI]: 0.65 to 0.90). In an exploratory analysis of patients with PD-L1 expression <1%, more than twice as many patients treatedwith Opdivo plus Yervoy were alive at four years compared to chemotherapy (24% vs. 10%, respectively; HR 0.64; 95% CI: 0.51 to 0.81).
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Princeton-based BioNJ Member Bristol Myers Squibb and bluebird bio, Inc. announced new data and analyses from the pivotal KarMMa study evaluating Abecma (idecabtagene vicleucel), a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell therapy. These data include updated results and analysis of characteristics of treatment-associated neurotoxicity from the KarMMa study of Abecma in triple-class exposed relapsed or refractory multiple myeloma. In the pivotal KarMMa study, 128 patients with relapsed or refractory multiple myeloma who had received at least three prior treatment regimens including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody were treated with Abecma at the target dose levels of 150 x 106 to 450 x 106 CAR-positive T cells.
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Somerset-based BioNJ Member Legend Biotech Corporation announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) submitted by BioNJ Member Janssen Biotech, Inc. for ciltacabtagene autoleucel (cilta-cel), an investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy. The Prescription Drug User Fee Act (PDUFA) target action date has been set for November 29, 2021. Cilta-cel previously received Breakthrough Therapy Designation in December 2019, which is intended to expedite the development and review time for a potential new medicine.
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Raritan-based BioNJ Member Janssen Pharmaceutical Companies of Johnson & Johnson announced updated data from the Phase 1 CHRYSALIS study showing treatment with amivantamab in combination with lazertinib led to a median duration of response (DOR) of 9.6 months in chemotherapy-naïve patients with non-small cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) exon 19 deletion or L858R mutations whose disease had progressed after treatment with osimertinib. These data also provide new insights on the importance of biomarkers to identify a subgroup of patients more likely to respond to amivantamab and lazertinib.
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Raritan-based BioNJ Member Janssen Pharmaceutical Companies of Johnson & Johnson announced new data from the fixed-duration cohort of the investigational Phase 2 CAPTIVATE study, showing that 95 percent of patients treated with combined IMBRUVICA® plus venetoclax were alive and progression-free at two years. Deep remissions were seen across all subgroups, including patients with high-risk chronic lymphocytic leukemia (CLL). In addition, long-term data from the RESONATE-2 (PCYC-1115/1116) study will be presented, providing the longest follow-up Phase 3 data for any BTK inhibitor to date. These data reinforce the long-term survival benefits and well-established safety profile of single-agent IMBRUVICA® for patients with CLL.
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Raritan-based BioNJ Member Janssen Pharmaceutical Companies of Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) has granted the accelerated approval of RYBREVANTTM (amivantamab-vmjw) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. RYBREVANTTM is the first fully-human, bispecific antibody approved for the treatment of patients with NSCLC that targets EGFR exon 20 insertion mutations, which are the third most prevalent activating EGFR mutation.
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Raritan-based BioNJ Member Janssen, the Pharmaceutical Companies of Johnson & Johnson announced that the European Commission (EC) has approved PONVORY (ponesimod) for the treatment of adult patients with relapsing multiple sclerosis (RMS) with active disease defined by clinical or imaging features. "Relapsing multiple sclerosis is an unpredictable and complex disease that can present very differently from individual to individual, placing a heavy burden on the patient and their loved ones," said Professor Gavin Giovannoni, MBBCh, Ph.D., FCP (Neurol., SA), FRCP, FRCPath, Professor of Neurology at Queen Mary University of London. "I welcome the European Commission's approval of ponesimod as an additional treatment option for those living with relapsing multiple sclerosis."
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Raritan-based BioNJ Member Janssen Pharmaceutical Companies of Johnson & Johnson announced longer follow-up results from the Phase 1 MajesTEC-1 study, the first-in-human dose-escalation study of teclistamab, an off-the-shelf T-cell redirecting bispecific antibody, in the treatment of patients with relapsed or refractory multiple myeloma (NCT03145181). With a median follow-up of more than six months, an overall response rate (ORR) of 65 percent was observed at the recommended subcutaneous (SC) Phase 2 dose (RP2D) in a cohort of heavily pretreated patients (n=40) who had received a median of five prior lines of therapy
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Raritan-based BioNJ Member Janssen Pharmaceutical Companies of Johnson & Johnson announced follow-up data from the MonumenTAL-1 Phase 1 first-in-human dose-escalation study of the investigational product talquetamab, the only off-the-shelf T-cell redirecting bispecific antibody in clinical development to target both GPRC5D, a novel multiple myeloma target and CD3 on T-cells (NCT03399799). With a median follow-up of more than six months, updated results in 30 patients with relapsed or refractory multiple myeloma treated with talquetamab by subcutaneous (SC) administration at the recommended Phase 2 dose (RP2D) showed an overall response rate (ORR) of 70 percent, with 60 percent of patients achieving a very good partial response (VGPR) or better among those who had received a median of six prior lines of therapy.
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Raritan-based BioNJ Member Janssen Pharmaceutical Companies of Johnson & Johnson announced patient-reported outcomes (PRO) data from the pre-specified final analysis of the Phase 3 TITAN study in patients with metastatic castration-sensitive prostate cancer (mCSPC). The TITAN study previously demonstrated statistically significant improvement in overall survival (OS) after a median follow-up of 44 months in patients receiving ERLEADA® plus androgen deprivation therapy (ADT). The new PRO data showed that the addition of ERLEADA® to ADT maintained patients' health-related quality of life (HRQoL) and did not worsen side effect burden, consistent with ADT alone.
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Raritan-based BioNJ Member Janssen Pharmaceutical Companies of Johnson & Johnson announced updated results from the Phase 3 ANDROMEDA study, which evaluated DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for the treatment of patients with newly diagnosed light chain (AL) amyloidosis, a rare blood cell disorder associated with the deterioration of vital organs, most notably the heart, kidneys and liver. Longer-term results from a median follow-up of 20. 3 months showed rates of hematologic complete response (hemCR) remained significantly higher in patients treated with DARZALEX FASPRO® in combination with bortezomib (VELCADE®), cyclophosphamide and dexamethasone (D-VCd) compared to VCd alone (Abstract #8003).
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Princeton-based BioNJ Member Genmab A/S announced that the U.S. Food and Drug Administration (U.S. FDA) has approved Janssen's RYBREVANT™ (amivantamab-vmjw), a fully human bispecific antibody, for the treatment of adult patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. Genmab entered into a collaboration with Janssen to create and develop bispecific antibodies using Genmab's DuoBody technology platform. This is the first regulatory approval for a product that was created using Genmab's proprietary DuoBody® technology platform.
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Princeton-based BioNJ Member Genmab A/S announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion and recommended granting marketing authorization for the daratumumab subcutaneous (SC) formulation (daratumumab and hyaluronidase-fihj), known as DARZALEX® SC in the European Union, in combination with bortezomib, cyclophosphamide and dexamethasone (VCd) for the treatment of adult patients with newly diagnosed systemic light-chain (AL) amyloidosis. The CHMP also issued a positive opinion recommending DARZALEX SC in combination with pomalidomide and dexamethasone (Pd) for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor (PI) and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a PI and have demonstrated disease progression on or after the last therapy.
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Tirzepatide led to superior A1C and body weight reductions from baseline across all three doses in adults with type 2 diabetes who have increased cardiovascular (CV) risk compared to titrated insulin glargine in topline results from Bridgewater-based BioNJ Member Eli Lilly and Company's SURPASS-4 clinical trial. For the efficacy estimandi, the highest dose of tirzepatide led to an A1C reduction of 2.58 percent and reduced body weight by 11.7 kg (25.8 lb., 13.0 percent) compared to results for those treated with insulin glargine (A1C reduction of 1.44 percent and weight gain of 1.9 kg [4.2 lb., 2.2 percent]) at 52 weeks.
The overall safety profile of tirzepatide was consistent with the glucagon-like peptide-1 (GLP-1) receptor agonist class in this patient population.
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In a pre-specified analysis of the Phase 2 SERENITY study, Bridgewater-based BioNJ Member Eli Lilly and Company's mirikizumab improved fatigue in patients with moderately to severely active Crohn's disease (CD) at 12 weeks, as measured by the mean change in FACIT-Fatigue scores compared to placebo, with improvements that were sustained up to one year. Mirikizumab is being studied for UC and CD, two forms of inflammatory bowel disease that can cause serious and debilitating symptoms, and disruptions in daily life. In SERENITY, patients treated with mirikizumab saw improvements in fatigue during the induction period of 12 weeks, as measured by the mean change in FACIT-Fatigue scores from baseline compared to placebo (mirikizumab 200 mg: 10.81±1.73, p<0.001; 600 mg: 9.09±1.72, p=0.004; 1000 mg 9.62±1.22, p<0.001; placebo: 2.90±1.21).
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Visikol the health care imaging technology company founded in 2016 and based in Hampton, has been acquired by CELLINK Group in a deal worth $7.5 million. According to the terms of the deal, CELLINK -- a bioconvergence company based in Sweden -- will acquire all outstanding shares in Visikol for a purchase price of $7.5 million on a cash- and debt-free basis. Visikol, founded by entrepreneurs out of Rutgers University, focuses on accelerating the discovery and development of therapeutics by providing pharmaceutical and biotech companies with best-in-class 3D cell culture, 3D tissue imaging, multiplex imaging and digital pathology services.
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Woodcliff Lake-based Eisai Co., Ltd. announced that it has launched the anticancer agent "Remitoro® for Intravenous Drip Infusion 300μg" (Denileukin Diftitox (Genetical Recombination)) with the indications of relapsed or refractory Peripheral T-cell Lymphoma (PTCL) and relapsed or refractory Cutaneous T-cell Lymphoma (CTCL), in Japan. Eisai obtained the manufacturing and marketing approval of Remitoro. Remitoro was included to Japan's National Health Insurance Drug Price List. The agent is a fusion protein consisting of interleukin-2 (IL-2) and partial sequence of diphtheria toxin, and specifically binds to the IL-2 receptor on the surface of tumoral lymphocytes.
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Ridgefield Park-based BeiGene, Ltd. announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental new drug application (sNDA) for BRUKINSA® (zanubrutinib) for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy and granted priority review. The Prescription Drug User Fee Act (PDUFA) target action date is September 19, 2021. Clinical data in the sNDA submission include results from the single-arm, open-label, multicenter, Phase 2 MAGNOLIA trial (NCT03846427) in patients with relapsed or refractory (R/R) MZL with supportive data from a global Phase 1/2 trial (NCT02343120) in patients with B-cell malignancies.
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Ridgefield Park-based BeiGene, Ltd. announced that the Phase 3 RATIONALE 309 trial of its anti-PD-1 antibody tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as a first-line treatment for patients with recurrent or metastatic nasopharyngeal cancer (NPC) met its primary endpoint of progression-free survival (PFS) at the interim analysis, as recommended by an independent data monitoring committee. In the trial results, tislelizumab in combination with chemotherapy demonstrated a statistically significant improvement in PFS in the intention-to-treat (ITT) population when compared to chemotherapy alone, as assessed by an independent review committee (IRC).
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Edison-based Eight Biopharmaceuticals Inc. and Institut Bergonié announce the treatment of the first patient in their collaboration to study BDB001. Institut Bergonié is the sponsor of the AGADIR Phase II protocol, "Atezolizumab combined with BDB001 and Immunogenic Radiotherapy in patients with advanced solid tumors" (NCT03915678), which will enroll patients with difficult-to-treat solid tumors across 10 clinical centers in France. The study is funded in a public-private partnership by a grant from the French National Cancer Institute (Institut National du Cancer, INCa) and the Fondation ARC (La Fondation ARC pour la recherche sur le cancer) (INCa-ARC_13579) and performed in collaboration with Roche, who will supply atezolizumab.
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Florham Park-based PDS Biotechnology Corporation announced the receipt of $4.5 million from the net sale of tax benefits to an unrelated, profitable New Jersey corporation pursuant to the company's participation in the New Jersey Technology Business Tax Certificate Transfer Net Operating Loss (NOL) program for State Fiscal Year 2020. "We are pleased to receive an allocation from the New Jersey NOL program," said Frank Bedu-Addo, CEO of PDS Biotech. "The funding will be beneficial to us as we continue to efficiently utilize our resources to advance our immuno-oncology pipeline through development."
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Basking Ridge-based Timber Pharmaceuticals, Inc. announced that it is completing patient enrollment in the Phase 2b CONTROL study evaluating TMB-001, a topical pharmaceutical composition of isotretinoin, in patients with moderate to severe subtypes of congenital ichthyosis (CI) on May 31, 2021 in order to move forward with Phase 3 trial planning. "Based on the positive safety and efficacy data from our unblinded Phase 2a program and feedback from investigators in our Phase 2b CONTROL study on the results achieved in many of the 35 enrolled subjects, we feel we are in a strong position to end enrollment early (trial originally planned for 45 subjects) so that we can prepare for our pivotal Phase 3 study, starting by requesting end of Phase 2 meetings with the U.S. Food and Drug Administration (FDA) and global health authorities in the near future," said
Alan Mendelsohn, M.D., Chief Medical Officer of Timber.
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 | People in the News |  |
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The manufacturing sector played a huge role in helping New Jersey survive during the COVID-19 pandemic. It just didn't get a lot of recognition. That stops today. Instead of naming individuals, we are using our first-ever ROI Influencers: Manufacturing list to honor 65 companies that stepped up in the fight against the pandemic. From creating test kits and vaccines ... to providing the products and services that helped so many essential operations and pieces of equipment to keep the economy going ... to pivoting their production lines to created badly-needed pieces of personal protective equipment, New Jersey manufacturers were at their best in our toughest times. Congratulation to BioNJ Members Alex Gorsky, Johnson & Johnson; Ken Frazer, Merck & Co. and Paul Hudson, Sanofi, for making the list.
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Pennington-based BioNJ Member OncoSec Medical Incorporated announced the appointment of Robert M. Schinagl, Ph.D., as Vice President of Program and Alliance Management. "We are thrilled to welcome Dr. Schinagl to OncoSec's management team as the company continues to make progress in the development of our lead product candidate, TAVO™," said Daniel J. O'Connor, President and CEO of OncoSec. "As we actively seek opportunities through strategic partnerships and uphold our mission to bring transformative solutions to patients in need, we believe Dr. Schinagl's significant leadership expertise in project and alliance management will help drive OncoSec in the direction of joining forces and leveraging a fully-integrated immuno-oncology platform."
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Florham Park-based BioNJ Member Celularity Inc. announced the appointment of Bradley Glover, Ph.D., a global business and technical operations executive with more than 20 years of experience in the pharmaceutical industry, as Executive Vice President and Chief Technology Officer. At Celularity, Dr. Glover will be responsible for leading all aspects of Celularity's technical operations, including process development, quality, manufacturing, supply chain, IT, facilities and engineering, and strategy and business operations for commercial products and clinical pipeline programs. Dr. Glover joins Celularity from Kite Pharma, where he has held several executive roles in Corporate Development and Technical Operations.
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Princeton-based BioNJ Member Bristol Myers Squibb announced that its Board of Directors has elected Manuel Hidalgo Medina, M.D., Ph.D., to the Board. Dr. Hidalgo will serve as a member of the Science & Technology Committee of the Board of Directors. "We are delighted to welcome Manny to our Board of Directors," said Giovanni Caforio, M.D., Board Chair and Chief Executive Officer, Bristol Myers Squibb. "As an internationally-renowned physician, scientist and academic, Dr. Medina's deep expertise in oncology and track record in leading research will help us deliver on our mission of developing new, transformational medicines that benefit patients with serious diseases, further progress our pipeline and advance our long-term strategy."
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Florham Park-based PDS Biotechnology Corporation announced the appointment of Dr. Olivera Finn and Dr. Mark Frohlich to its Scientific Advisory Board. Dr. Olivera Finn is a Distinguished Professor of Immunology at the University of Pittsburgh, School of Medicine. Dr. Finn brings over three decades of expertise in translational research in immunology and oncology, including the discovery of the first tumor-associated protein (antigen) recognized by T-cells, called MUC-1. Dr. Mark Frohlich is a renowned medical oncologist and biopharma executive who brings over 20 years of experience in developing immunotherapies for cancer.
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Cranbury-based Experic, has named a new Chairman and CEO. D avid Wood brings more than 30 years of experience with life sciences companies to the new role. He succeeds Jeffrey McMullen, one of the company founders, who served on an interim basis since early 2019. "I am excited to work with the talented Experic team, and impressed with their dedication to serving clients," Wood said in a prepared statement. "Combined with a great facility and capabilities, Experic is an organization that brings expertise and value to its pharmaceutical clients as they race to address the challenges of product development and commercialization."
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| Institution and Education News |  |
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Stepping into the role of Princeton's Dean for Research in 2013, Pablo Debenedetti knew he wanted to grow the University's capacity to explore new frontiers of knowledge as well as its ability to impact technological progress and societal well-being. In the highly competitive world of grant funding, monetary support for exploratory research is scarce. Debenedetti envisioned a fund that would identify and promote investigations in the sciences and humanities while fostering the sort of collaborations that spark new directions when people come together across disciplinary lines. To spur this exploratory research and collaboration, Debenedetti, with support from then-provost University President Christopher L. Eisgruber, initiated a new University funding program: the Dean for Research Innovation Funds.
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Liberty Science Center has selected Alpine Residential to create Scholars Village at SciTech Scity. Scholars Village is anticipated to consist of two state-of-the-art, sustainable 200,000-square-feet, 200-unit market-rate apartment buildings, as well as ground floor retail space and parking, for entrepreneurs, teachers, students, families, and individuals who want to be part of a community that is harnessing the power of science to create a better world. SciTech Scity is the Center's planned 30-acre "City of Tomorrow" that will launch and grow dozens of world-changing science and technology companies and reimagine public school science education.
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New Jersey Institute of Technology and Ørsted have signed a memorandum of understanding for a 10-year, $1.5 million partnership that will create new scholarship and career development opportunities in the field of offshore wind for NJIT's engineering and computer science undergraduate students. The agreement addresses science, technology, engineering and math education gaps for underrepresented students in Newark, as it will expand a range of STEM outreach events, initiatives and college-prep programming for local elementary, middle school and high school students at NJIT, offered through the university's Center for Pre-College Programs and the NJIT-Newark Math and Science Initiative.
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| Funding |  |
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Trenton-based BioNJ Member the New Jersey Economic Development Authority (NJEDA) announced that it is accepting public feedback on the proposed rules for the expanded Angel Investor Tax Credit Program. Members of the public can read the draft rules and provide written feedback at www.njeda.com/program-specific-feedback. The Angel Investor Tax Credit Program was expanded under the New Jersey Economic Recovery Act of 2020 (ERA). The rule proposal aligns with changes made to the program pursuant to P.L. 2019 c. 145 and implements changes in the ERA. This includes: an increase to the amount of tax credits available each year, an increase in the amount of tax credits available per qualified investment, the availability of bonus credits for qualified investments in targeted locations or in certified minority or women-owned businesses, and the ability for investors to receive a tax credit for investments made in qualified venture funds.
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Applications are now open for the Emerge program, a new jobs-based tax credit program created under the New Jersey Economic Recovery Act (ERA) of 2020 and administered by the New Jersey Economic Development Authority (NJEDA). The Emerge program will drive economic development in New Jersey by making tax credits available to projects that invest private capital into the state and create good-paying jobs, with a focus on the State's priority sectors. The Emerge program application, as well as complete rules, eligibility requirements, award sizes, and other information, are available at https://www.njeda.com/emerge.
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| Events |  |
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Friday, June 11, 2021
Join BioCentriq for a panel discussion with leaders from higher education and industry to listen and learn about how these two groups can unite to identify and operationalize innovations that create industry advancements. The esteemed panel will review how collaborative efforts have driven recent innovation in life sciences that are both cost effective and timely. This is a live session with opportunity for questions and answers at the end.
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Featuring BioNJ President and CEO, Debbie Hart
June 15-17, 2021
The Jersey City Summit by Roundtable & Advisory is a foundational series of leadership gatherings to help accelerate and build awareness and momentum for city and regional leading projects, programs and initiatives. Cross-sector leaders convening to discuss the areas driving municipal innovation -- economic, real estate, community & cultural development. Principals sharing best practices, recent successes and inspiring new collaborations, new innovations and a platform for leading edge idea exchange.
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June 21-22, 2021
The National Academies of Sciences, Engineering, and Medicine will host a dynamic virtual workshop to explore the current structural barriers driving the underrepresentation of women entrepreneurs across science, technology, engineering and medical industries and strategies to overcome these barriers. The focus of the workshop will not be on "fixing the women", but rather, on fixing the structural inequities contributing to the underrepresentation of women in entrepreneurship. The two-day workshop will bring together experts and leaders to identify promising practices for advancing aspiring and current women entrepreneurs and provide insights on how stakeholders in the innovation ecosystem can address various structural barriers facing women entrepreneurs from diverse backgrounds.
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The disruptions and opportunities created by a new generation of digital healthcare innovations will lead to winners and losers, and a changed landscape for patients, practitioners and others throughout the healthcare ecosystem. While COVID-19 has accelerated this digital transformation, the pace of change will continue well into the future.
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| 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 [email protected], or 609-890-3185. Find providers in these categories:
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