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

Earlier this week we released the agenda and speaker roster for our Inaugural Diversity, Equity & Inclusion...Because It Matters Conference, taking place virtually on March 24 and 25, 2021. 

"As a global industry that strives to improve global health and address its many disparities, we believe it is our moral imperative to lead by example and make a positive impact on our communities," said Will Lewis, Chair of the BioNJ Board and Chair and CEO of Insmed. "BioNJ's vision is to have diversity, equity and inclusion immersed not only in health care but in all aspects of our lives. Through this Conference, we hope to inspire the community by sharing case studies, vignettes, workshops and tools to effect change in the critical domains of culture, self, talent and business."
 
"Through the leadership of an impassioned volunteer Committee," added President and CEO of BioNJ, Debbie Hart, "we have assembled an impressive roster of thought leaders, including Valerie Irick Rainford, Chief Executive Officer, Elloree Talent Strategies; Glenn Singleton, President and Founder of Pacific Educational Group and his award-winning protocol for effectively engaging, sustaining and deepening interracial dialogue, Courageous Conversations™; Professor Jerry Kang, Distinguished Professor of Law and Former Founding Vice Chancellor for Equity, Diversity and Inclusion at UCLA, known for his work and talks on implicit bias; Patricia Mae Doykos, Ph.D., Lead, Health Equity Initiative and Director of the BMS Foundation; Michele Meyer-Shipp, Chief People & Culture Officer for Major League Baseball as well as New Jersey Attorney General Gurbir S. Grewal."

Click here for the full speaker roster and click here for the two-day agenda. 

The Mission of the Conference is to "Engage, Empower and Inspire All to Enable and Impact Diversity, Equity and Inclusion". Please register today and join the community on March 24 and 25 for this crucial conversation where we'll explore solutions, best practices and new ideas for addressing this very real problem.

Because Patients Can't Wait®,
The BioNJ Team

BioNJ Calendar

BioNJ's Diversity, Equity and Inclusion Conference...Because It Matters
March 24-25, 2021
BioNJ BioPartnering Virtual Conference With J.P. Morgan and Johnson & Johnson Innovation
May 18-19, 2021
BioNJ Membership Webinar: Learn About the Benefits of Membership
Save the Date!
April 15, 2021!
Putting Patients First: The Value of Medical Innovation


Click Here for BioNJ's Digital Advocacy Toolkit on Protecting Medical Innovation in New Jersey.

NJ Pride

New Brunswick-based BioNJ Member Johnson & Johnson announced that the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) has recommended the first single-shot COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, for individuals 18 years of age and older under the Emergency Use Authorization (EUA) issued by the U.S. Food and Drug Administration (FDA). Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson, said "This recommendation follows the FDA's decision to grant an Emergency Use Authorization for our single-shot vaccine, which has the potential to play a pivotal role in helping to end the COVID-19 pandemic."

BioNJ in the News

Bridgewater-based BioNJ Member Insmed had a big year in 2020. As CEO Will Lewis boasted, the biopharmaceutical developer evolved from a single-product company to one with three promising programs -- and it accomplished that feat during a deadly global pandemic that caused widespread business disruptions. As if to top off the year of gains, Mr. Lewis was installed recently as the Chair of BioNJ, the trade association for the life sciences industry in New Jersey. For the latest edition of NJBIZ Conversations, Editor Jeff Kanige spoke with Mr. Lewis about Insmed's products -- which target rare and serious diseases, including COVID-19, his outlook for the next several months and the role BioNJ and its members can and should play in the State's health care industry. 

Last year's version of this list was published just a few weeks before the COVID-19 pandemic swept through the State and the country. Reading through the 2020 list today is like opening a time capsule. The decision to rank the Governor as number one again was easy. The question of who should occupy the rest of the top ten was also relatively simple. Health care always plays a prominent role in the business of the State and that role was even more critical over the past 12 months. 

In addition to BioNJ's President and CEO, Debbie Hart, congratulations to these BioNJ Members for making this prosperous list:
Dr. Joel Bloom, New Jersey Institute of Technology; Tom Bracken, New Jersey State Chamber of Commerce; Dale Florio, Princeton Public Affairs Group; Kenneth Frazier, Merck & Co.; Dr. Robert Garrett, Hackensack Meridian Health; Alex Gorsky, Johnson & Johnson; Dr. Jonathan Holloway, Rutgers, The State University of New Jersey; Thomas Kendris, Novartis; Jose Lozano, Choose New Jersey; George Norcross, Conner Strong Buckelew; Christopher Porrino, Lowenstein Sandler; Michele Siekerka, NJBIA; Dr. Brian Strom, Rutgers, The State University of New Jersey; Tim Sullivan, NJEDA and Michael Tardugno, Celsion, Corp.

This year's ROI Influencers: Power List rankings include the 30 most influential people in the State, as well as lists of the most influential people in 14 individual sectors or categories. Congratulations to BioNJ President and CEO, Debbie Hart, for making ROI Influencers: Power List 2021, as well as these BioNJ Members: 
 
Guillermo Artiles, McCarter & English; Carl Bagell, Friedman LLP; Dr. Joel Bloom, New Jersey Institute of Technology; Joe Boccassini, McCarter & English; Linda Bowden, PNC Bank; Matthew Boxer, Lowenstein Sandler; Tom Bracken, New Jersey Chamber of Commerce; Dr. Andrew Brooks, Rutgers, The State University of New Jersey; Chrissy Buteas, NJBIA; Dr. Nancy Cantor, Rutgers, The State University of New Jersey; Tai Cooper, NJEDA; Kathleen Coviello, NJEDA; Enrico Della Corna, PNC Bank; Michael Egenton, New Jersey State Chamber of Commerce; Chris Eisgruber, Princeton University; Kenny Esser, Hackensack Meridian Health; Dr. Nariman Farvardin, Stevens Institute of Technology; Dale Florio, Princeton Public Affairs; Dr. Kate Foster, The College of New Jersey; Ken Frazier, Merck & Co.; Dr. Bob Garrett, Hackensack Meridian Health; Alex Gorsky, Johnson & Johnson; Jim Gunton, Tech Council Ventures; Bill Hagaman, Withum; Dr. Jonathan Holloway, Rutgers, The State University of New Jersey; Dr. Ali Houshmand, Rowan University; Scott Kobler, McCarter & English; Dr. Patrick Leahy, Monmouth University; Jose Lozano, Choose New Jersey; George Norcross, Conner Strong & Buckelew; Simon Nynens, New Jersey Innovation Institute; Dr. Joseph Nyre, Seton Hall University; Brendan O'Grady, TEVA Pharmaceuticals; Bill Palatucci, McCarter & English; Bill Pascrell III, Princeton Public Affairs; Chris Porrino, Lowenstein Sandler; Steven Schinella, CohnReznick; Judith Sheft, New Jersey Commission of Science, Innovation and Technology; Michele Siekerka, NJBIA; Steve Socolof, Tech Council Ventures; David Sorin, McCarter & English; Tim Sullivan, NJEDA; Diane Wasser, EisnerAmper and Gary Wingens, Lowenstein Sandler.

NJ Company News

South Plainfield-based BioNJ Member PTC Therapeutics, Inc. announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Evrysdi™ (risdiplam) for the treatment of 5q spinal muscular atrophy (SMA) in patients 2 months and older, with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 with one to four SMN2 copies. The CHMP review was completed under the accelerated assessment pathway, which is offered to medicines deemed to be of major interest for public health and therapeutic innovation.

South Plainfield-based BioNJ Member PTC Therapeutics, Inc. announced the publication of results from the dose finding Part 1 of the pivotal FIREFISH study evaluating Evrysdi™ (risdiplam) in infants with symptomatic type 1 spinal muscular atrophy (SMA) in The New England Journal of Medicine. The Part 1 data showed that patients treated with Evrysdi at 12 months demonstrated significant improvement in survival and developmental milestones, including the ability to survive without permanent ventilation, and the ability to sit without support for at least five seconds. Data from the study also demonstrated increased levels of survival motor neuron (SMN) protein, which is critical for maintaining nerve and muscle function.

Jersey City-based BioNJ Member SCYNEXIS, Inc. announced positive results from the third interim efficacy analysis of the ongoing open-label Phase 3 FURI study and the first interim analysis of the ongoing open-label Phase 3 CARES study. The global, open-label Phase 3 FURI study is designed to evaluate oral ibrexafungerp as a salvage treatment for patients with a variety of difficult-to-treat mucocutaneous and invasive fungal infections that are refractory to, intolerant of current standards of care, or require a non-azole oral step-down therapy for the treatment of azole-resistant species.

Jersey City-based BioNJ Member SCYNEXIS, Inc. announced it has partnered with Amplity Health in connection with the anticipated U.S. launch of Brexafemme (ibrexafungerp). Amplity, a leading global contract commercialization organization, specializes in designing, implementing, and managing customer facing and inside sales, service, medical and clinical teams. Brexafemme is the expected trade name for ibrexafungerp, an oral antifungal product candidate for the treatment of vulvovaginal candidiasis (VVC), also known as vaginal yeast infection. 
Bridgewater-based BioNJ Member Hillstream BioPharma, Inc. announced that two abstracts highlighting the progress of HSB-1216 will be presented as an e-poster at the 2021 American Association for Cancer Research Virtual Annual Meeting. "We are actively evaluating the potential utility of HSB-1216 in several solid tumor types," stated Randy Milby, President and CEO of Hillstream BioPharma. "Independent emerging research confirms our own studies regarding the novel mechanism of HSB-1216, and we are pleased to share our latest updates at this year's AACR meeting, as we focus on progressing this compound to the clinic as soon as possible."
Princeton-based BioNJ Member Soligenix, Inc. announced publication of pre-clinical immunogenicity studies for CiVax™ (heat stable COVID-19 vaccine program) demonstrating rapid-onset, broad-spectrum, neutralizing antibody and cell-mediated immunity is confirmed using full-length Spike protein antigens. The article titled, "Recombinant protein subunit SARS-CoV-2 vaccines formulated with CoVaccine HT adjuvant induce broad, Th1 biased, humoral and cellular immune responses in mice," has been posted as an accelerated preprint on bioRxiv.
Pennington-based BioNJ Member OncoSec Medical Incorporated announced the publication of research demonstrating the ability of its lead candidate TAVO™ (tavokinogene telseplasmid), a DNA-based interleukin-12 (IL-12), to activate tumor antigen specific antitumor immunity in patients with triple negative breast cancer (TNBC) in the peer-reviewed medical journal Clinical Cancer Research. The manuscript by Melinda L. Telli, M.D. et al. is titled, "Intratumoral plasmid IL-12 expands CD8+ T cells and induces a CXCR3 gene signature in triple-negative breast tumors that sensitizes patients to anti-PD-1 therapy," and is available online.

Bedminster-based BioNJ Member Kyowa Kirin Co., Ltd. announces that the Phase 2 study of investigational agent KHK4083 in patients with atopic dermatitis has met the primary endpoint. KHK4083 is a potential first-in-class, anti-OX40 fully human monoclonal antibody for the treatment of autoimmune diseases, including atopic dermatitis. KHK4083 was first discovered by Kyowa Kirin, and is produced with the company's patented POTELLIGENT® defucosylation technology to enhance its antibody dependent cellular cytotoxicity (ADCC) activity.

Bedminster-based BioNJ Member Kyowa Kirin Co., Ltd. and Harvard University announce that they have entered into a strategic research alliance. The 5-year alliance, established by Harvard's Office of Technology Development (OTD), aims to fuel scientific collaboration among academic and industry researchers to accelerate discovery and early stage innovation in translational biomedical science. By creating opportunities for formal scientific collaboration, the alliance will leverage industry insight and drug development expertise to advance biomedical innovations developed in Harvard labs toward the clinical development of important new therapies.
Princeton-based BioNJ Member Otsuka Pharmaceutical Development & Commercialization, Inc. and Click Therapeutics, Inc. announce the initiation of the Mirai study, a landmark fully remote clinical trial to investigate the effectiveness of digital therapeutics in reducing depressive symptoms in adults diagnosed with major depressive disorder (MDD) who are on antidepressant monotherapy. The pivotal, randomized, controlled trial will enroll up to 540 patients nationwide. Trial participation will be 10 weeks and efficacy will be evaluated as a change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. 
Ramsey-based BioNJ Member ADMA Biologics, Inc. announced that its plasma collection center received approval from the Korean Ministry of Food and Drug Safety (MFDS) for the sale of source plasma into South Korea. In conjunction with the South Korean approval, ADMA additionally announced the Kennesaw plasma collection center received FDA approval to implement a Hepatitis B immunization program, enabling ADMA to collect source plasma from donors immunized with an FDA-licensed Hepatitis B vaccine.

Berkeley Heights-based BioNJ Member Amgen announced that data from a multicenter, randomized Phase 3 study evaluating the efficacy, safety and tolerability of BLINCYTO® (blinatumomab) compared with consolidation chemotherapy before allogeneic hematopoietic stem cell transplantation (alloHSCT) in pediatric patients with high-risk first-relapse B-cell precursor acute lymphoblastic leukemia (B-ALL) were published in The Journal of the American Medical Association. BLINCYTO demonstrated significantly prolonged event-free survival (events were defined by relapse, death, second malignancy or failure to achieve complete remission) compared with chemotherapy.

Berkeley Heights-based BioNJ Member Amgen and AstraZeneca announced positive full results from the pivotal NAVIGATOR Phase 3 trial, which showed the potential of tezepelumab to be a first-in-class medicine in severe asthma. When added to standard of care (SoC), tezepelumab demonstrated a statistically significant and clinically meaningful reduction in the annualized asthma exacerbation rate (AAER) in patients with severe, uncontrolled asthma, compared to placebo. NAVIGATOR is a pivotal Phase 3 trial that will form the basis of regulatory filing.

Berkeley Heights-based BioNJ Member AbbVie announced that upadacitinib (45 mg, once daily) met the primary endpoint of clinical remission (per Adapted Mayo Score) and all ranked secondary endpoints in the Phase 3 induction study, U-ACCOMPLISH. In the study, 33 percent of patients receiving upadacitinib achieved clinical remission (per Adapted Mayo Score) at week 8 compared to 4 percent of patients receiving placebo (p<0.001). U-ACCOMPLISH is the second of two Phase 3 induction studies to evaluate the safety and efficacy of upadacitinib in adults with moderate to severe ulcerative colitis.

Madison-based BioNJ Member Allergan, an AbbVie company, announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration for investigational AGN-190584 (pilocarpine 1.25%) ophthalmic solution for the treatment of presbyopia. The FDA is expected to act on the NDA by the end of 2021. Approximately 128 million adults in the U.S. experience presbyopia, a common and progressive eye condition that reduces the eye's ability to focus on near objects and usually impacts people after age 40. 

Bridgewater-based BioNJ Member Loxo Oncology at Lilly, a research and development group of Eli Lilly and Company, announced that The Lancet has published data from the pirtobrutinib (previously referred to as LOXO-305) global Phase 1/2 BRUIN clinical trial in relapsed or refractory chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), and other non-Hodgkin's lymphomas. Pirtobrutinib is an investigational, highly selective, non-covalent Bruton's tyrosine kinase (BTK) inhibitor.

Tirzepatide led to superior A1C and body weight reductions from baseline across all three doses compared to injectable semaglutide 1 mg in adults with type 2 diabetes in Bridgewater-based BioNJ Member Eli Lilly and Company's 40-week SURPASS-2 clinical trial. In topline results from the largest SURPASS trial to date, using the efficacy estimandi, the highest dose of tirzepatide (15 mg) reduced A1C by 2.46 percent and body weight by 12.4 kg (27.3 lb., 13.1 percent). The lowest dose of tirzepatide (5 mg) reduced A1C by 2.09 percent and body weight by 7.8 kg (17.2 lb., 8.5 percent) compared to semaglutide at 1.86 percent and 6.2 kg (13.7 lb., 6.7 percent).

Bridgewater-based BioNJ Member Eli Lilly and Company and Welldoc, Inc. announced a collaboration and licensing agreement to integrate Welldoc's software into Lilly's connected insulin solutions, currently in development. Under the terms of the agreement, Lilly and Welldoc will collaborate to create a new version of the BlueStar® insulin management solution that integrates insulin dosing data for several Lilly insulins. Lilly will commercialize the pen platform, which will include the new app and Lilly's connected insulin pen solutions.

Bridgewater-based BioNJ Member Eli Lilly and Company announced the U.S. government has agreed to purchase a minimum of 100,000 doses of bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together. Bamlanivimab and etesevimab together recently received emergency use authorization for the treatment of recently diagnosed, mild to moderate COVID-19 in patients who are at high risk of progressing to severe COVID-19 and/or hospitalization. Additionally, the NIH recently updated the COVID-19 Treatment Guidelines to recommend the use of bamlanivimab plus etesevimab for the treatment of outpatients with mild to moderate COVID-19 who are at high risk of clinical progression.

Bridgewater-based BioNJ Member Eli Lilly and Company announced top-line results from BRAVE-AA2, a Phase 3 study evaluating the efficacy and safety of once-daily baricitinib 2-mg and 4-mg in adults with severe alopecia areata (AA). Both doses of baricitinib met the primary efficacy endpoint at Week 36, demonstrating a statistically significant improvement in scalp hair regrowth compared to those randomized to placebo. AA is an autoimmune disease that causes patchy hair loss on the scalp, face and sometimes on other areas of the body that can progress. 
BioNJ Member Pfizer, with offices in Peapack, announced the U.S. Food and Drug Administration (FDA) approved Pfizer Inc.'s supplemental New Drug Application (sNDA) for LORBRENA® (lorlatinib), expanding the indication to include first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). LORBRENA is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test. The FDA action also converts the 2018 accelerated approval to full approval. The application was approved under the FDA's Real-Time Oncology Review (RTOR) pilot program.
BioNJ Member Pfizer, with offices in Peapack, announced that the U.S. Food and Drug Administration (FDA) accepted for Priority Review the company's Biologics License Application (BLA) for TicoVac™, its tick-borne encephalitis (TBE) vaccine for active immunization to prevent TBE in individuals 1 year of age and older. If approved, TicoVac would be the first vaccine in the U.S. to help protect adults and children who are visiting or living in TBE endemic areas. In line with Priority Review designation, the FDA will target an action within six months of the application submission date, with the anticipated Prescription Drug User Fee Act (PDUFA) action date expected for August 2021.
BioNJ Member Pfizer, with offices in Peapack, and BioNTech SE announced they have begun an evaluation of the safety and immunogenicity of a third dose of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) to understand the effect of a booster on immunity against COVID-19 caused by the circulating and potential newly emerging SARS-CoV-2 variants. The study will draw upon participants from the Phase 1 study in the United States who will be offered the opportunity to receive a 30 µg booster of the current vaccine 6 to 12 months after receiving their initial two-dose regimen. 
BioNJ Member Pfizer, with offices in Peapack, announced that the European Medicines Agency (EMA) accepted for review the Marketing Authorization Application (MAA) for its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate, as submitted for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults ages 18 years and older. With the MAA acceptance, the formal review process by the EMA's Committee for Medicinal Products for Human Use (CHMP) begins.
BioNJ Member Pfizer, with offices in Peapack, announced that the European Medicines Agency (EMA) has validated for review the Marketing Authorization Application (MAA) for somatrogon, a long-acting recombinant human growth hormone that is intended to be administered once-weekly for the treatment of pediatric patients with growth hormone deficiency (GHD). Pfizer expects a decision from the European Commission in 2022. The submission is supported by the results of a global, Phase 3 trial evaluating the safety and efficacy of somatrogon administered once-weekly to pediatric patients with GHD.

East Hanover-based BioNJ Member Novartis announced that it has signed an initial agreement to manufacture the mRNA and bulk drug product for the COVID-19 vaccine candidate CVnCoV from CureVac to aid in the fight against the COVID-19 pandemic. Preparations for the start of production, technology transfer and test runs are already underway. Following final agreement, Novartis plans to start production in the second quarter of 2021. First deliveries of the bulk drug product to CureVac are expected in the summer 2021.

East Hanover-based BioNJ Member Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted the final opinion for a type II label variation for Cosentyx® (secukinumab) to include data for axial manifestations of psoriatic arthritis (PsA), from the first-of-its-kind MAXIMISE trial. Cosentyx is the only fully human interleukin (IL)-17A inhibitor to demonstrate efficacy and safety in a dedicated Phase IIIb study of axial manifestations in PsA. It is the first biologic with proven efficacy in all six key manifestations of PsA including peripheral disease, enthesitis, dactylitis, skin psoriasis and nail psoriasis.

East Hanover-based BioNJ Member Novartis announced that it has closed the in-licensing of tislelizumab from BeiGene, Ltd. in North America, Europe and Japan. Tislelizumab is a uniquely designed anti-PD-1 antibody, specifically engineered to minimize binding to FcyR on macrophages, that is approved in China for certain patients with non-small cell lung cancer, classical Hodgkin's lymphoma and metastatic urothelial carcinoma. Novartis has identified multiple opportunities to combine tislelizumab with other therapies in the Novartis portfolio and pipeline. Tislelizumab is currently being studied in non-small cell lung cancer, gastric cancer, hepatocellular carcinoma and nasopharyngeal carcinoma, with broad potential in several other solid tumors.

Kenilworth-based BioNJ Member Merck & Co. announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company's New Drug Application (NDA) for gefapixant, an investigational, orally administered, selective P2X3 receptor antagonist, for the treatment of refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults. This application for gefapixant will be discussed at an upcoming advisory committee meeting. No date has been set yet. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action date, of Dec. 21, 2021.

Kenilworth-based BioNJ Member Merck & Co. and Pandion Therapeutics, Inc. announced that the companies have entered into a definitive agreement, under which Merck, through a subsidiary, will acquire Pandion, a clinical-stage biotechnology company developing novel therapeutics designed to address the unmet needs of patients living with autoimmune diseases, for $60 per share in cash. This represents an approximate total equity value of $1.85 billion.

Kenilworth-based BioNJ Member Merck & Co. announced it has entered into multiple agreements to support efforts to expand manufacturing capacity and supply of SARS-CoV-2/COVID-19 medicines and vaccines. The Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), will provide Merck with funding of up to $268.8 million to adapt and make available a number of existing manufacturing facilities for the production of SARS-CoV-2/COVID-19 vaccines and medicines. Merck has also entered into agreements with BioNJ Member Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to support the manufacturing and supply of Johnson & Johnson's SARS-CoV-2/COVID-19 vaccine. 

New Brunswick-based BioNJ Member Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in individuals 18 years of age and older. This decision was based on the totality of scientific evidence, including data from the Phase 3 ENSEMBLE study that demonstrated the vaccine was 85 percent effective in preventing severe disease across all regions studied, and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination.

Bridgewater-based BioNJ Member Sanofi has entered into an agreement with BioNJ Member Janssen Pharmaceutical NV and Janssen Pharmaceuticals, Inc., two of the Janssen Pharmaceutical Companies of Johnson & Johnson, under which Sanofi will support manufacturing of Janssen´s COVID-19 vaccine in order to address the COVID-19 pandemic and supply needs. Sanofi will provide Johnson & Johnson access to the established infrastructure and expertise of its vaccine manufacturing plant in Marcy l'Etoile, France, to formulate and fill vials of Janssen's COVID-19 vaccine candidate in 2021, at a rate of approximately 12 million doses per month. 

Bridgewater-based BioNJ Member Sanofi announced the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) as an add-on treatment for children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. Dupixent is currently approved as an add-on treatment for patients with uncontrolled moderate-to-severe asthma aged 12 and older with elevated eosinophils or oral corticosteroid dependent asthma. The target action date for the FDA decision is October 21, 2021 and the EU regulatory submission for children aged 6 to 11 years with asthma is planned for Q1 2021.

Bridgewater-based BioNJ Member Sanofi announced the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for a second indication for Sarclisa® (isatuximab), in combination with carfilzomib and dexamethasone (Kd), for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy. Sarclisa is currently approved for use in the European Union (EU) in combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed and refractory MM who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy. 

Bridgewater-based BioNJ Member Sanofi and GSK announced the initiation of a new Phase 2 study with 720 volunteers aged 18 and over to select the most appropriate antigen dosage for Phase 3 evaluation of their adjuvanted recombinant protein COVID-19 vaccine candidate. In parallel to the new Phase 2 study and recognizing the global emergence of new SARS-CoV-2 variants and their potential impact on vaccine efficacy, Sanofi has commenced development work against new variants, which will be used to inform next stages of the Sanofi/GSK development program.

Warren-based BioNJ Member GlaxoSmithKline plc and Vir Biotechnology, Inc. announced they have signed a binding agreement to expand their existing collaboration to include the research and development of new therapies for influenza and other respiratory viruses. The expanded collaboration, which builds on the agreement signed in 2020 to research and develop therapies for coronaviruses, provides GSK exclusive rights to collaborate with Vir on the development of potential best-in-class monoclonal antibodies (mAbs) for the prevention or treatment of influenza. 

Warren-based BioNJ Member GlaxoSmithKline plc announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending dostarlimab, an anti-programmed death-1 (PD-1) monoclonal antibody, for use as monotherapy in women with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer who have progressed on or following prior treatment with a platinum containing regimen. The CHMP opinion is one of the final steps in the marketing authorisation procedure prior to approval by the European Commission.
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 Cabometyx® (cabozantinib) for the first-line treatment of adults with advanced renal cell carcinoma (RCC). The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP recommendation.
Princeton-based BioNJ Member Bristol Myers Squibb announced it has donated a total of $11 million to 56 non-profit organizations focused on advancing health equity in the United States. These organizations will deliver programs to improve access to high-quality care as well as increase disease awareness and education in racially and ethnically diverse and medically underserved communities, and to improve diversity in clinical research. The donations, awarded in response to a special request for proposals, leverage $11 million of the $150 million pledged by the company in August 2020 to advance diversity, inclusion and health equity.
Princeton-based BioNJ Member Bristol Myers Squibb and the American Music Therapy Association, a premier organization aimed at progressing the therapeutic use of music in rehabilitation, special education and community settings, announce their partnership with award-winning actor, singer and songwriter Ben Platt ("The Politician," "Dear Evan Hansen") and his sister-in-law Courtney Platt, a dancer, choreographer and actor ("So You Think You Can Dance," "Glee," "VH1's Hit the Floor," "The Simpsons") who lives with relapsing multiple sclerosis (RMS), to launch MS in Harmony. MS in Harmony is the first and only digital offering of its kind and guides people living with multiple sclerosis on how they may achieve mind-body harmony through music therapy.

Morris Plains-based BioNJ Member Gilead Sciences, Inc. announced the completion of the previously announced transaction to acquire MYR GmbH for up to approximately €1.45 billion in aggregate cash consideration. The acquisition provides Gilead with Hepcludex® (bulevirtide), which was conditionally approved by the European Medicines Agency for the treatment of chronic hepatitis delta virus (HDV) in adults with compensated liver disease in July 2020. "Hepcludex is an important new addition to the Gilead portfolio. With this first-in-class therapy for HDV, the most severe form of viral hepatitis, we have the opportunity to address an area of high unmet medical need," said Daniel O'Day, Chairman and CEO, Gilead Sciences.

The 147,000-square-foot building in Florham Park that serves as BioNJ Member Celularity Inc.'s corporate headquarters and manufacturing facility has been sold for $46.6 million. The 147,215-square-foot property at 170 Park Ave. had been vacant until a recent transformation into the life sciences facility that is now 100% leased to Celularity. "The seller, Celularity and the entire design/construction team in partnership truly created one of the most advanced life sciences facilities in the country," Jeffrey Dunne, a Vice Chairman with CBRE.

Sparta-based PLx Pharma Inc. announced that the U.S. Food and Drug Administration approved supplemental new drug applications ("sNDAs") for its lead products, VAZALORE™ 325 mg and VAZALORE™ 81 mg (referred to together as "VAZALORE"), the first ever novel, liquid-filled aspirin capsule. "The approval of the VAZALORE sNDAs marks a significant milestone that brings us closer to providing an innovative aspirin to millions of patients who need reliable and predictable antiplatelet therapy," stated  Natasha Giordano, President and Chief Executive Officer of PLx.
Princeton-based Oblato, Inc. announces that the FDA granted Fast Track Designation of OKN-007, the proprietary drug for Diffuse Intrinsic Pontine Glioma (DIPG). The FDA Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. DIPG is a rare pediatric brainstem cancer with limited treatment options. After a DIPG diagnosis, ninety percent of the patients die within 24 months, and the overall 5-year survival is less than one percent.
In addition to the Fast Track Designation, Oblato has already received Rare Pediatric Disease designation for DIPG.

Cliffside Park-based Palisades Therapeutics (PT) announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application's plan to proceed in proposed trials for its lead small molecule, PT150, in the treatment of patients diagnosed with COVID-19 in a Phase II/III outpatient clinical trial setting. PT150 is in development for the treatment and prevention of respiratory viral infections, including SARS-CoV-2 Infection (COVID-19). The study is a randomized, double-blind, placebo-controlled Phase II/III study to assess the efficacy and safety of PT150 in adult COVID-19 outpatients is being conducted in collaboration with a study team from the Veterans Administration (VA).

Basking Ridge-based Regeneron Pharmaceuticals, Inc. announced detailed results from a Phase 2 proof-of-concept trial evaluating the investigational antibody cocktail REGN1908-1909 in cat-allergic patients with mild asthma. The trial met the primary endpoint of preventing early asthma reactions (EAR, defined as a ≥20% decline in forced expiratory volume over one second [FEV1]). The trial also met key secondary endpoints, including improved lung function and an increased amount of cat allergen that patients could tolerate following a single dose of treatment, from as early as the first assessment conducted at week 1. 

Ridgefield Park-based BeiGene, Ltd. announced that BRUKINSA® (zanubrutinib) has been approved by Health Canada for the treatment of adult patients with Waldenström's macroglobulinemia (WM). "BRUKINSA is a highly selective BTK inhibitor designed to provide deep and durable response for patients with hematologic malignancies while reducing the frequency of certain side effects. With today's approval, we are looking forward to bringing this potentially best-in-class BTK inhibitor to Canadians affected by WM," said  Josh Neiman, Chief Commercial Officer for North America and Europe at BeiGene. 

Monmouth Junction-based Tris Pharma, Inc. and Athena Bioscience LLC announced that they have entered into an agreement by which Athena received exclusive rights to commercialize a long-acting antihypertensive product developed using  Tris' proprietary technology. The licensed product upon launch, will be the only once-daily formulation containing an established Active Pharmaceutical Ingredient (API), which physicians can optionally prescribe alone or concomitantly with other antihypertensive agents to pursue desired outcomes.

Basking Ridge-based Daiichi Sankyo Company, Limited announced that they have entered a strategic research collaboration to study valemetostat (DS-3201), Daiichi Sankyo's potential first-in-class EZH1/2 dual inhibitor, in B-cell malignancies starting with a Phase 2 study in patients with five subtypes of relapsed/refractory B-cell lymphoma. The collaboration brings together Daiichi Sankyo's innovative science and the multidisciplinary expertise of the Lymphoma Study Association (LYSA), the Lymphoma Academic Research Organization (LYSARC) and the CALYM research consortium to conduct clinical and translational research that will build upon the ongoing Phase 1 study of valemetostat in patients with relapsed/refractory non-Hodgkin lymphoma.

Red Bank-based Provention Bio, Inc. announced that extended follow-up data from the pivotal "At-Risk" TN-10 Study were published in Science Translational Medicine. Results show that a single 14-day infusion course of teplizumab (PRV-031) delayed the onset of clinical disease and insulin dependence in at-risk type 1 diabetes (T1D) patients by approximately three years (median of 32.5 months), adding one year to previously reported results. The TN-10 Study was conducted through the Type 1 Diabetes TrialNet, an international research collaboration aimed at discovering ways to delay or prevent type 1 diabetes.

Bedminster-based Mallinckrodt plc announced publication of results from its pivotal Phase 3 CONFIRM study to assess the efficacy and safety of its investigational agent terlipressin in adults with hepatorenal syndrome type 1 (HRS-1). HRS-1 is an acute and life-threatening syndrome involving acute kidney failure in patients with cirrhosis, and has a median survival time of approximately two weeks and greater than 80 percent mortality within three months if left untreated. As previously announced, the Phase 3 CONFIRM study met its primary endpoint of Verified HRS Reversal, which is defined as renal function improvement, avoidance of dialysis and short-term survival. 

People in the News

Basking Ridge-based Daiichi Sankyo Company, Limited announced Ken Takeshita, M.D. will be named the new Global Head of Research & Development as of April 1, 2021. On that date, Dr. Junichi Koga will retire from the position, after a successful and industrious career, including more than 12 years at Daiichi Sankyo. Dr. Takeshita joins Daiichi Sankyo from Kite Pharma, a Gilead Company, where he was Senior Vice President and Global Head of Development since 2019, and interim Head of Research. Dr. Takeshita is a highly experienced physician with deep experience in oncology and rare diseases. 

Infinity BiologiX, a leading next-generation central laboratory providing sample collection and processing, storage, analytical services, and scientific and technical support, announced the latest addition to its executive team, naming Amit Bhalla as vice president and chief financial officer. In this role, Dr. Bhalla will be tasked with leading IBX's financial functions as the company enters its next phase of growth following its August spinoff from Rutgers University. He joins IBX at a time of rapid progress. Earlier this year, IBX received FDA emergency use authorization for its innovative COVID-19 saliva test, which was the first test to utilize saliva as the primary biomaterial for SARS-CoV-2.

Institution and Education News

The 3D structures of more than 1,000 SARS-CoV-2 coronavirus proteins are freely available from the RCSB Protein Data Bank headquartered at Rutgers University-New Brunswick. The data bank reached the milestone with 1,018 proteins. The first SARS-CoV-2 structure, a high-resolution crystal structure of the coronavirus main protease (PDB 6lu7), was released early in the pandemic on Feb. 5, 2020. Rapid public release of SARS-CoV-2 structure data has greatly increased our understanding of COVID-19. Open access to Protein Data Bank structures has facilitated design of effective vaccines against SARS-CoV-2.

Twenty-one scientists from 14 universities and life science companies have formed the Consortium of Scientists for Pandemic Preparedness (CSPP) to combat current challenges in the COVID19 pandemic and create therapeutic, diagnostic and vaccine products to help protect against future outbreaks. CSPP comprises physical and social scientists who will work together to accelerate the development of impactful therapies and medical technologies. The scientists come from Kean University, Institute for Life Science Entrepreneurship, Hackensack Meridian Health, Rutgers University, Princeton University, Harvard University, Massachusetts Institute of Technology, University of Memphis, The Ohio State University, Certara, as well as independent drug developers.

Gov. Phil Murphy and New Jersey Secretary of Higher Education Dr. Brian Bridges outlined two new initiatives for the State's colleges and universities that have been facing challenges during the ongoing COVID-19 pandemic. The first is the Opportunity Meets Innovation Challenge, a competitive grant program open to all institutions of higher education that receive state funding. The program will provide awards totaling $28.5 million, ranging from $500,000 to $1.5 million, to spur the implementation of plans in key areas that impact degree completion. The second initiative is the Hunger Free Campus Grant program, which will provide $1 million toward eliminating hunger and food insecurity on college campuses.

Funding News

The New Jersey Commission on Science, Innovation and Technology (CSIT) announced that it will begin accepting applications next month for a competitive matching grant that will provide $225,000 to a New Jersey technical assistance provider vying for participation in the Federal and State Technology (FAST) Partnership Program. CSIT plans to award the grant to one organization seeking to execute state/regional programs that bolster the number of proposals submitted to the federal Small Business Innovation Research (SBIR) and Small Business Technology Transfer Program (STTR) Support programs. The application for the grant opens March 22 and will be available at http://www.njeda.com/csit.  

The New Jersey Commission on Science, Innovation and Technology (CSIT) announced that it has awarded a total of $450,000 to 16 early stage companies through the State's Small Business Innovation Research (SBIR) and Small Business Technology Transfer Program (STTR) Direct Financial Assistance Program. Each of the awardees is currently engaged in the federal SBIR and/or STTR programs. The awards will enhance the State's innovation economy by strengthening the competitiveness of Garden State businesses participating in the federal programs. To date, CSIT has awarded a total of $825,000 to 29 New Jersey companies during the program's two funding rounds.

Special Programs from Our Partners for BioNJ Members
March 10, 2021

While many founders focus on valuation and vesting, other terms such as control provisions and anti-dilution rights can often have a greater impact on whether you and your start-up are successful or fail. This workshop will focus on what you, as a first-time founder, need to know before negotiating the terms of your Series Seed or Series A funding. Join start-up attorney Jason Meyer and venture investor Tom Meyer for a robust discussion of what these important terms mean, and how to maximize your negotiating leverage as founders.
March 15-17, 2021

Take advantage of this unique opportunity for professionals to make connections, start collaborations and forge partnerships in North America's life sciences and health technology hub. The agenda co-created by the organizing committee is aimed at entrepreneurs, scientists, researchers, students, investors and life sciences and health technology professionals in Canada and abroad. 
March 15, 2021

A panel of biotech leaders, scientists, entrepreneurs and policymakers will discuss how recent biopharma breakthroughs usher in opportunities for New York city to reinvent itself and identify those activities and resources which help promote new life sciences companies to be formed.
March 16-18, 2021

Join over 150 leading VCs, Corp VCs, Angel Investors and over 100 Top Innovators at #VSVC Venture Summit Virtual Connect West. Dedicated Life sciences / Health care Track, One-on-One (zoom) investor meetings, two days of content, including timely panel discussions, workshops and an inspiring keynotes. Contact RBromberg@BioNJ.org for 20% discount code for BioNJ Members.
March 18, 2021

Princeton Innovation Center BioLabs is pleased to bring to the Central New Jersey community, and others, the opportunity to learn about different accelerators for early stage start-ups in all industries. MassChallenge is the the global network for innovators. They support entrepreneurs and their start-ups through early stages of building a business. At this event, founders will learn what's in store for the 2021 program and what it takes to apply. Click here for more information and registration.



BioNJ Member Services Provider Directory

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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The NJBAC is a state agency offering free and confidential assistance to help your business grow. As a "one-stop shop," NJBAC can help businesses of all sizes and types manage the state's regulatory processes, boost exports, gain access to financial resources where applicable and tackle other obstacles along the way. You can download the NJBAC guide by clicking here or contact their business advocates at 1-800 JERSEY 7.

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