Welcome to the latest edition of the BioLines Weekender...
 
We hope to see you next week at BioNJ's Virtual BioPartnering Conference, developed and presented in concert with J.P. Morgan and Johnson & Johnson Innovation. Taking place May 18 and 19, BioNJ's BioPartnering Conference is a unique opportunity to connect with life sciences executives, investors, institutional collaborators and business development professionals; schedule 1:1 meetings with potential partners; present and watch Company and Start-up Pitch Presentations; hear from industry experts; discuss business and research opportunities with world-renowned institutions and network directly with other conference attendees. Click here for a list of topics and speakers. 
 
Meanwhile, from the Biden Administration announcing support for WTO TRIPS Waiver to subcommittees holding drug pricing hearing, there is a lot happening on the policy front. Please see this week's Public Policy Update here for more information.

In additional policy news, a recent analysis by Vital Transformation regarding NIH Grants show (what we already knew) that our world-leading U.S. biopharmaceutical research and development system is nearly entirely reliant on private investment for research, manufacturing and commercialization. However, sadly, this system, which is literally saving the world from the pandemic, is imperiled by pricing proposals, such as H.R. 3 which will reduce innovation and Patient access. BioNJ continues to urge our New Jersey congressional delegation to seek commonsense alternatives to H.R. 3. Click here for the full report. 

To join BioNJ in our efforts to ensure future medical innovation as well as Patient access to the medicines they need when they need them, please email our Team at BioNJ@BioNJ.org.  

Because Patients Can't Wait®,
The BioNJ Team

BioNJ Calendar

BioNJ BioPartnering Virtual Conference With J.P. Morgan and Johnson & Johnson Innovation
May 18-19, 2021
BioNJ Virtual Clinical Development Briefing
May 27, 2021
HR Briefing: Vaccines and the Workplace 
June 2, 2021
AI in Drug Discovery
June 8, 2021

Click here to read this article featured in The Star-Ledger.

NJ Company News

Jersey City-based BioNJ Member Apprentice.io is staying in Jersey City, signing a long-term lease for a new headquarters in the city, according to real estate firm Cushman & Wakefield. The intelligent life science manufacturing technology company signed a 10-year agreement for 32,000 square feet at 101 Hudson St., where it will occupy the 38th floor of the tower. "We ... are thrilled to move our rapidly growing team into Apprentice's new home in Jersey City," co-founder and CEO Angelo Stracquantanio said in a prepared statement. "We truly believe in the potential of Jersey City and know it's a great base to both serve our customers, the leading life science companies, and bring together our diverse team of local and remote employees.




Edison-based BioNJ Member Hepion Pharmaceuticals, Inc. announced that it has completed recruitment for its Phase 2a 'AMBITION' clinical trial, with all NASH patients in the 225 mg CRV431 dosing cohort now enrolled. "Over the past few months, the COVID-19 pandemic, compounded by the inclement weather experienced at some of our clinical trial sites in Texas, which resulted in power outages, presented difficulties in the recruitment of subjects for the second and final dosing cohort for our Phase 2a NASH trial," said Dr. Robert Foster, Hepion's CEO.

Cranbury-based BioNJ Member
Amicus Therapeutics announced the completion of a successful Type B Pre-Biologics License Application (BLA) meeting with the U.S. Food and Drug Administration (FDA) for AT-GAA (cipaglucosidase alfa co-administered with miglustat), its investigational two-component therapy for the treatment of Pompe disease. Based on this formal pre-BLA meeting and the final written communication received from the FDA, Amicus intends to complete the rolling BLA submission for cipaglucosidase alfa and submit a New Drug Application for miglustat. 

Bridgewater-based BioNJ Member Insmed Incorporated announced the closing of the previously announced registered underwritten public offering (the "Equity Offering") of 11,500,000 shares of its common stock (the "Shares"), including 1,500,000 Shares issued pursuant to the exercise in full of the underwriters' option to purchase additional Shares, at a price to the public of $25.00 per share before deducting underwriting discounts and commissions, and the previously announced registered underwritten public offering (the "Notes Offering") of $575 million aggregate principal amount of its 0.75% convertible senior notes due 2028 (the "Notes"), including $75 million aggregate principal amount of Notes purchased pursuant to the exercise in full of the underwriters' option to purchase additional Notes, solely to cover over-allotments. 

Florham Park-based BioNJ Member Celularity Inc. will form a multi-year strategic partnership to leverage the unique combined strengths of Palantir's Foundry platform with Celularity's deep dataset to accelerate and advance cellular therapies. Celularity will use Palantir Foundry, a platform that leverages artificial intelligence (AI) and allows for the integration of siloed data sources into a common operating picture, leading to better data-driven decision making. Celularity will employ Palantir's Foundry platform to secure deeper insights into data obtained from Celularity's discovery and process development as well as manufacturing and biorepository operations.
Princeton-based BioNJ Member Agile Therapeutics, Inc. announced that a post hoc analysis of the Phase 3 SECURE Trial evaluating the safety and efficacy of Twirla® (levonorgestrel and ethinyl estradiol) transdermal system in women with BMI < 25 kg/m2 and women with BMI 25-30 kg/m2 was presented at the American College of Obstetricians and Gynecologists Annual Clinical and Scientific Meeting. "The results of this post hoc analysis help to inform providers counseling women that fall within BMI 25-30 kg/m2 who may be considering a non-oral, noninvasive contraception option," said Anita Nelson, M.D., Lead Author and Primary Investigator in the SECURE study."

BioNJ Member Pfizer Inc.,with offices in Peapack, and BioNTech SE announced that the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for their COVID-19 vaccine to include individuals 12 to 15 years of age. This is the first COVID-19 vaccine authorized in the U.S. for use in this age group. The FDA based its decision on data from a pivotal Phase 3 clinical trial, which enrolled 2,260 participants aged 12 to 15 years. Topline results from this trial, announced on March 31, 2021, showed a vaccine efficacy of 100% in participants with or without prior SARS-CoV-2 infection and robust antibody responses. In the trial, the vaccine was also generally well tolerated. 

BioNJ Member Pfizer Inc.,with offices in Peapack, and BioNTech SE announced the initiation of a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for approval of their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. Data to support the BLA will be submitted by the companies to the FDA on a rolling basis over the coming weeks, with a request for Priority Review. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA will be set once the BLA is complete and formally accepted for review by the agency. The Pfizer-BioNTech COVID-19 Vaccine is currently available in the U.S. under an Emergency Use Authorization (EUA) granted by the FDA .

Bridgewater Township-based BioNJ Member Sanofi has entered into a three-year research collaboration with Stanford University School of Medicine. Together, the two organizations and their scientists will work to advance the understanding of immunology and inflammation through open scientific exchange. Additionally, Sanofi will provide funding and scientific inputs into projects of mutual interest, crossing multiple therapeutic areas including autoimmune diseases and inflammatory conditions. Sanofi and Stanford Medicine will create a Joint Steering Committee to fund up to three programs a year. 

Bridgewater Township-based BioNJ Member Sanofi and Basking Ridge-based Regeneron Pharmaceuticals, Inc. announced positive results from the Phase 3 trial investigating the PD-1 inhibitor Libtayo® (cemiplimab) in patients with recurrent or metastatic cervical cancer who had previously progressed on chemotherapy. "In this Phase 3 trial, Libtayo demonstrated a significant improvement in overall survival in women with advanced cervical cancer after progression on chemotherapy, reducing the risk of death by 31% compared to chemotherapy in the overall population," said Krishnansu S. Tewari, M.D., Professor and Director of the Division of Gynecologic Oncology at the University of California, Irvine and a trial investigator. 

Warren-based BioNJ Member GlaxoSmithKline plc announced the European Commission has approved the expanded use of intravenous and subcutaneous BENLYSTA (belimumab) in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis (LN) in Europe, in addition to systemic lupus erythematosus (SLE). The EU marketing authorisation follows the recent approval for the similar expanded LN indication in the U.S. The marketing authorisation application was based on data from the BLISS-LN (Efficacy and Safety of Belimumab in Adult Patients with Active Lupus Nephritis) study, which showed that, over two years, belimumab added to standard therapy increased renal response rates and helped to prevent worsening of kidney disease in patients with active lupus nephritis compared to standard therapy alone.

Warren-based BioNJ Member GlaxoSmithKline plc and Vir Biotechnology, Inc. announced that the European Medicines Agency (EMA) has started a rolling review of data on sotrovimab (previously VIR-7831), an investigational dual-action SARS-CoV-2 monoclonal antibody, for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with coronavirus disease 2019 (COVID-19) who do not require oxygen supplementation and who are at risk of progressing to severe COVID-19. The EMA will evaluate all data on sotrovimab, including evidence from clinical trials, as they become available.

Berkeley Heights-based BioNJ Member Amgen announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for Otezla® (apremilast) for the treatment of adults with mild-to-moderate plaque psoriasis who are candidates for phototherapy or systemic therapy. "Otezla has been prescribed to hundreds of thousands of patients with moderate-to-severe plaque psoriasis. Based on the positive Phase 3 ADVANCE data, we believe it could play an important role in addressing the unmet need for adults affected by mild-to-moderate plaque psoriasis who have had challenges managing their disease with existing topical therapies alone," said  David M. Reese, M.D., Executive Vice President, Research and Development at Amgen.

Berkeley Heights-based BioNJ Member Amgen announced its partner AstraZeneca submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for tezepelumab, a potential first-in-class medicine in severe asthma. The submission is supported by positive clinical trial results from the PATHFINDER clinical program including the pivotal NAVIGATOR Phase 3 trial, which demonstrated a statistically significant and clinically meaningful reduction in the annualized asthma exacerbation rate (AAER) in patients with severe, uncontrolled asthma compared to placebo. Tezepelumab is the only biologic to consistently and significantly reduce AAER in a broad population of severe asthma patients irrespective of the baseline eosinophil counts across Phase 2 and Phase 3 clinical trials.

Bridgewater-based BioNJ Member Eli Lilly and Company announces new initiatives to help COVID-19 patients in India as part of its commitment to bring the full force of its scientific and medical expertise to attack the coronavirus pandemic around the world. Lilly is offering donations of baricitinib to the Indian government through Direct Relief while simultaneously working with local Indian pharmaceutical companies to execute royalty-free voluntary licensing agreements to accelerate the manufacturing and distribution of the medicine in India during the pandemic. An initial donation of 400,000 baricitinib tablets is being made immediately available to the Indian government for eligible hospitalized COVID-19 patients in India and Lilly will work urgently to increase the quantity of donated product multifold over the coming weeks.

Bridgewater-based BioNJ Member Eli Lilly and Company signed strategic international agreements with four companies - DexCom, Inc., Glooko Inc., myDiabby Healthcare and Roche - to advance connected solutions and streamline care for people living with diabetes in markets outside of the United States. These companies offer unique diabetes management platforms that will be compatible with Lilly's Tempo Pen™ (approved in several global markets) and Tempo Smart Button™ (currently in late-stage development) to support people with diabetes and healthcare professionals.

Bridgewater-based BioNJ Member Eli Lilly and Company is donating COVID-19 therapies to Direct Relief, enabling the humanitarian organization to provide COVID-19 therapies at no cost to low- and lower-middle-income countries most heavily impacted by the pandemic. This donation furthers both Lilly and Direct Relief's charitable goal of providing access to COVID-19 treatments to patients in need by providing these medicines free of charge to low- and lower-middle-income countries. Lilly will donate both baricitinib (4 mg tablet) as well as bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together - providing options to treat COVID-19 patients at different stages of the disease.

Bridgewater-based BioNJ Member Eli Lilly and Company and MiNA Therapeutics Limited announced a global research collaboration to develop novel drug candidates using MiNA's proprietary small activating RNA (saRNA) technology platform. Under the terms of the agreement, MiNA will utilize its saRNA platform to research up to five targets selected by Lilly that aim to address diseases across Lilly's key therapeutic focus areas. Lilly will be responsible for preclinical and clinical development of candidates and will retain exclusive commercialization rights for any products resulting from the collaboration. MiNA will receive a $25 million upfront payment and is eligible to receive potential development and commercialization milestones up to a total of $245 million per target, as well as tiered royalties from the low-single to low-double digits on product sales resulting from the collaboration.

NJ TRANSIT has kicked off a new public-private partnership to help New Jersey residents get vaccinated, by offering complimentary rides to and from vaccination sites.  The "VAXRIDE" program is funded through the generosity of sponsors led by East Hanover-based BioNJ Member Novartis and provides for approximately eleven thousand NJ residents to receive up to two free round trips to get vaccinated. Global healthcare company Novartis is the program's lead sponsor with a commitment of $120,000 for the initiative. NJ-based Catalent, a global provider of drug delivery technologies and manufacturing solutions, is donating $12,000 to help launch the VAXRIDE program. 

Princeton-based BioNJ Member Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) for the adjuvant treatment of patients with surgically resected, high-risk muscle-invasive urothelial carcinoma, based on results from the CheckMate -274 trial. The FDA granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of September 3, 2021. The filing was based on results from the pivotal CheckMate -274 trial, the first positive Phase 3 trial of an immunotherapy in this setting. In the trial, Opdivo demonstrated a statistically significant and clinically meaningful increase in disease-free survival (DFS) vs. placebo, regardless of patients' PD-L1 expression levels. 

Princeton-based BioNJ Member Evotec SE announced that the company, together with Princeton-based BioNJ Member Bristol-Myers Squibb Company, has launched beLAB1407, a new $ 20 m academic BRIDGE to identify and advance novel and breakthrough drug discovery opportunities across therapeutic areas from the UK's top-tier academic institutions. Through a unique combination of Evotec's drug discovery and development platforms and early stage therapeutic concepts from the Universities of Birmingham, Edinburgh, Nottingham, and Dundee, beLAB1407 offers a unique route to the advancement of first-in-class therapeutics and the creation of spin-out companies.

North Brunswick-based BioNJ Member Ascendia Pharmaceuticals, Inc. ("Ascendia") is a specialty contract development and manufacturing organization (CDMO) dedicated to developing and manufacturing enhanced formulations for pre-clinical, clinical stage drug candidates, and marketed drug products. The investment was made by Signet Healthcare Partners ("Signet"), a New York-based growth equity firm specializing in healthcare investments. The proceeds will be used to fund Ascendia's facility expansion to support the growing demand in the sector.

Basking Ridge-based BioNJ Member Caladrius Biosciences, Inc. announced that it has received $1.4 million in non-dilutive funding as an approved participant of the Technology Business Tax Certificate Transfer Program sponsored by the New Jersey Economic Development Authority (NJEDA). The Program enables qualifying New Jersey-based biotechnology or technology companies to sell a percentage of their New Jersey net operating losses and research and development tax credits to unrelated qualifying corporations. "This additional capital combined with the $90 million we have raised in the public markets since the beginning of 2021 will, among other things, continue to support the advancement and expansion of our CD34+ cell therapy pipeline," said David J. Mazzo, Ph.D., President and Chief Executive Officer of Caladrius.

Kenilworth-based BioNJ Member Merck & Co. announced positive results from the pivotal neoadjuvant/adjuvant Phase 3 KEYNOTE-522 trial investigating KEYTRUDA, Merck's anti-PD-1 therapy, in combination with chemotherapy as pre-operative (neoadjuvant) treatment and then continuing as a single agent (adjuvant) treatment after surgery. KEYNOTE-522 met its dual primary endpoint of event-free survival (EFS) for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC). Based on an interim analysis conducted by the independent Data Monitoring Committee (DMC), neoadjuvant KEYTRUDA plus chemotherapy followed by adjuvant KEYTRUDA as monotherapy showed a statistically significant and clinically meaningful improvement in EFS compared with neoadjuvant chemotherapy alone.







Basking Ridge-based Daiichi Sankyo Company and AstraZeneca's datopotamab deruxtecan (Dato-DXd), a TROP2 directed DXd antibody drug conjugate (ADC), showed preliminary response and disease control in patients with metastatic triple negative breast cancer (TNBC) with disease progression following standard treatment. The preliminary objective response rate (ORR), assessed by blinded independent central review, was 43% in 21 evaluable patients treated with datopotamab deruxtecan [6 mg/kg (n=19) or 8 mg/kg (n=2)]. Five confirmed complete or partial responses (CR/PRs) were seen, with four additional CR/PRs awaiting confirmation at the time of data cut-off of January 8, 2021.

Woodcliff Lake-based Eagle Pharmaceuticals, Inc. announced that TREAKISYM RI (50ml) liquid formulation has been filed with the Pharmaceuticals and Medical Devices Agency ("PMDA") in Japan. The application is based on the results of clinical studies investigating the safety and pharmacokinetics of TREAKISYMRTD administered by 10-minute intravenous infusion. "We are pleased that the RI application has been submitted ahead of schedule, which will enable patients and providers alike to reap the benefits of this formulation. We believe we can get close to peak income of $20-$25 million as early as next year from the RTD and RI products," stated Scott Tarriff, Chief Executive Officer.

Woodcliff Lake-based Eagle Pharmaceuticals, Inc. announced that TREAKISYM ready-to-dilute ("RTD") (bendamustine hydrochloride 120 mg/m2) liquid formulation has been approved for a new indication in combination with rituximab ("BR therapy") as treatment for relapsed or refractory diffuse large B-cell lymphoma ("r/r DLBCL") by the Pharmaceuticals and Medical Devices Agency ("PMDA") in Japan. In September 2017, Eagle licensed to SymBio intellectual property necessary to develop, market and sell RTD and RI formulations of bendamustine under the trade name TREAKISYM in Japan utilizing Eagle's proprietary technology.

Ridgefield Park-based BeiGene, Ltd. announced that its PARP inhibitor pamiparib has received conditional approval from the China National Medical Products Administration (NMPA) for the treatment of patients with germline BRCA (gBRCA) mutation-associated recurrent advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more lines of chemotherapy. The new drug application was previously granted priority review by the Center for Drug Evaluation (CDE) in July 2020. BeiGene is preparing to launch pamiparib this month.

Jersey City-based Heron Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved ZYNRELEF (bupivacaine and meloxicam) extended-release solution for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty. ZYNRELEF, the first and only extended-release dual-acting local anesthetic (DALA), delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of the nonsteroidal anti-inflammatory drug (NSAID) meloxicam. The synergy between bupivacaine and meloxicam in ZYNRELEF has resulted in patients experiencing significantly less pain, including severe pain, and significantly more patients requiring no opioids (opioid-free) after surgery as compared to bupivacaine solution, the current standard-of-care. 

Bedminster-based Tessa Therapeutics Ltd. announced enrollment of 12 patient Pilot cohort of its Phase 2 trial (NCT04268706) in relapsed / refractory Classical Hodgkin Lymphoma (R/R cHL). The next step in the two-part study is enrollment of the 82 patient Pivotal cohort to assess the safety and antitumor efficacy of Tessa's autologous CD30 CAR-T in R/R cHL, which is planned to commence in 2H 2021. CD30 is a well validated lymphoma target with homogeneous expression in 98% of classical Hodgkin Lymphoma (cHL) and a significant proportion of subsets of non-Hodgkin Lymphomas. Tessa's technology modifies the patient's T-cells by introducing a CD30 directed Chimeric Antigen Receptor, or CAR, to target and kill cHL.

Florham Park-based Phathom Pharmaceuticals, Inc. announced that in PHALCON-HP, its pivotal Phase 3 clinical trial for the eradication of H. pylori infection, both vonoprazan-based regimens successfully met their primary endpoints and met all secondary endpoints. The trial studied vonoprazan in combination with amoxicillin and clarithromycin ("vonoprazan triple therapy") and vonoprazan in combination with amoxicillin ("vonoprazan dual therapy") compared to lansoprazole in combination with amoxicillin and clarithromycin ("lansoprazole triple therapy"). PHALCON-HP is the largest Phase 3 registration trial ever conducted in H. pylori infection, randomizing 992 patients with confirmed H. pylori infection.

Summit-based Seqirus presented new Phase 3 clinical data demonstrating that the company's cell-based quadrivalent seasonal influenza vaccine (QIVc) was as safe and immunogenic as a standard quadrivalent seasonal influenza vaccine (QIV) in children six months through <4 years of age during the U.S. 2019/20 influenza season. This Phase 3 clinical study was designed to support an application currently under review with the U.S. Food and Drug Administration (FDA) for an expanded age indication for people six months of age and above for QIVc, marketed as FLUCELVAX® QUADRIVALENT in the U.S.

Bedminster-based Mallinckrodt plc announced data from its Phase 4, multi-center, open-label study to assess the efficacy and safety of Acthar® Gel (repository corticotropin injection) in adult patients with treatment-resistant, severe non-infectious keratitis, a disease which involves painful inflammation of the cornea. Acthar Gel is approved by the U.S. Food and Drug Administration (FDA) for the treatment of severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation.

Monmouth Junction-based Notitia Biotechnologies Company announced that its COVID-19 Phase 2 study (COVGUT20) for NBT-NM108 has been given support by the Food and Drug Administration (FDA) to expand its study population to all symptomatic COVID-19 patients. "Previously, our trial focused on COVID-19 patients with type 2 diabetes and prediabetes. Now with this timely expansion to our study population, we can help more people and test NBT-NM108's efficacy not just for diabetic patients, but for anyone with COVID-19 symptoms," said Jeffrey Zhao, Co-founder and CEO at Notitia. NBT-NM108 was created by Rutgers University professor Dr. Liping Zhao and was given the Investigational New Drug status by the FDA as a potential treatment for early stage COVID-19.

Metuchen-based Tevogen Bio announced that its investigational COVID-19 therapy, TVGN-489, demonstrated strong antiviral activity against SARS-CoV-2 in the preclinical study. TVGN-489 is a highly enriched product of cytotoxic T cells (CTLs) trained to recognize peptides encoded by SARS-CoV-2 and eliminate viral infected cells. Tevogen's proprietary technology resulted in at least a 600-fold expansion and enrichment of the COVID-19 reactive cells found in the blood of individuals who had recovered from a COVID-19 infection without any evidence that these cells were demonstrating phenotypic or functional evidence of exhaustion. 

Florham Park-based Hutchison China MediTech Limited has initiated a registration-intent Phase II clinical trial of HMPL-689, its highly selective and potent PI3Kδ inhibitor, in China in patients with relapsed or refractory follicular lymphoma ("FL") and marginal zone lymphoma ("MZL"), two subtypes non-Hodgkin's lymphoma ("NHL"). The first patient was dosed April 29, 2021. The clinical trial is a multi-center, single-arm, open-label clinical study to evaluate the efficacy and safety of HMPL-689 once a day oral monotherapy in approximately 100 patients with relapsed/refractory FL and approximately 80 patients with relapsed/refractory MZL.

Morristown-based Melinta Therapeutics and Hikma Pharmaceuticals PLC announced they have entered into an exclusive licensing agreement for Vabomere® (meropenem and vaborbactam) and Orbactiv® (oritavancin), two novel anti-infective injectable products, for the Middle East and North Africa (MENA) region. Under the terms of the agreement, Hikma is responsible for the registration and commercialization of these two products across its 18 MENA markets. This extends Hikma's existing partnership with Melinta for their intravenous and oral formulations of Baxdela® (delafloxacin), a novel antibiotic product. 

The Franklin Lakes-based business, also known as Becton, Dickinson & Co., said the new company -- yet to be named -- would create long-term value for shareholders and optimize its product portfolio to better meet customer and patient needs. "The decision to spin off our Diabetes Care business is part of our active portfolio management and consistent with our BD 2025 strategy to 'Grow, Simplify and Empower,'" Chairman, CEO and President Tom Polen said in a prepared statement. "The spinoff will allow BD to strengthen its growth profile, enables a greater investment focus on our other core businesses and high-growth opportunities, and makes a greater impact for our customers and patients."

Boonton-based Enteris BioPharma, Inc. announced the expansion of its Boonton, NJ manufacturing facility and the launch of its CDMO business segment, providing custom solutions for the formulation, development and manufacturing of solid oral doses for difficult to formulate BCS III and IV compounds, including peptides and highly potent compounds. Enteris now provides bench to market services, including the development, manufacture, testing and release of Phase 1 to Phase 3 clinical trial supplies, and commercial production. The expanded 32,000-square-foot facility includes 6,000 square feet of cleanroom space with approximately 2,500 square feet dedicated to the containment and processing of high potency API (HPAPI).  

North Brunswick-based NJ Biopharmaceuticals LLC is moving its headquarters from North Brunswick to Princeton. NJ Bio said that it is moving to a 35,000-square-foot laboratory space at 350 Carter Road, a former Bristol-Myers Squibb site, by July 1 -- and has plans to expand further at the location. "Our expansion to this advanced facility demonstrates the rapid growth of NJ Bio in just over two years," CEO and President Nareshkumar Jain said in a prepared statement. "This new location, well-equipped with the latest instruments and staffed by exceptional scientists, will ensure that NJ Bio continues to remain an outstanding partner to our clients, delivering high value and results for their most challenging research and development needs."

Princeton-based WCG announced it has acquired another Princeton company, a life sciences consulting firm. The deal for the Avoca Group will expand WCG's portfolio of solutions for reducing time and expenses of clinical trials, including fortifying its benchmarking and analytics and more. "The Avoca Group brings exceptionally strong leadership to WCG and the respect and engagement of top-tier biopharmaceutical companies, (contract research organizations) and clinical research sites in their work of establishing clinical trial best practices. The combination of the Avoca Group and WCG will provide the energy needed to drive quality management transformation throughout the industry," said Chairman and CEO Donald A. Deieso.

Acasti Pharma Inc. announced it has entered into a definitive agreement to acquire East Brunswick-based Grace Therapeutics, Inc., a privately held emerging biopharmaceutical company focused on developing innovative drug delivery technologies for the treatment of rare and orphan diseases. Subject to the completion of the Proposed Transaction, Acasti will acquire Grace's pipeline of drug candidates addressing critical unmet medical needs with the potential to deliver significant value to patients and providers. It is anticipated that the cash at closing of about $64 million will be principally used to pursue the clinical development of the first two assets through Phase 3, and further advance earlier pipeline assets into the clinic.



People in the News

Jersey City-based BioNJ Member SCYNEXIS, Inc. announced the appointment of Christine Coyne as Chief Commercial Officer. Ms. Coyne will play a significant role in the anticipated U.S. launch and commercialization of Brexafemme, the expected trade name for ibrexafungerp, an oral antifungal product candidate for the treatment of vulvovaginal candidiasis (VVC), also known as vaginal yeast infection. The New Drug Application (NDA) for Brexafemme is under review by the U.S. Food and Drug Administration (FDA). Ms. Coyne joins SCYNEXIS with 30 years of experience in launch and commercialization of products across multiple therapeutic areas. Most recently, Ms. Coyne served as Senior Vice President, Commercial at Paratek Pharmaceuticals, where she was instrumental in launching the company's first product and adjusting tactics to ensure success, even during external challenges such as the COVID-19 pandemic. 

Cranbury-based BioNJ Member Amicus Therapeutics announced the appointment of Sébastien Martel as Senior Vice President of Strategy and Business Development. Mr. Martel will lead the Company's corporate strategy and business and corporate development endeavors. He will be a member of the Amicus senior leadership team. Mr. Martel brings 25 years of diversified pharmaceutical and biotechnology expertise to Amicus, with extensive experience in rare disease, most recently as Senior Vice President, Global Head of Rare Diseases at Sanofi. Mr. Martel has played a key role in managing the launch and growth of several products across therapeutic areas and has had significant involvement in strategic merger and acquisition transactions and business development deals.

Florham Park-based Shionogi Inc. announced the expanded leadership roles of Executive Vice President Nathan McCutcheon and Senior Vice President Gianine Esposito. Mr. McCutcheon has been appointed to the newly created position of Chief Operating Officer. In his new role, Mr. McCutcheon will be responsible for achieving the company's annual financial targets and leading all commercial operations, distribution and business development activities. Ms. Esposito, senior vice president, human resources, will join the Shionogi Inc. Executive Committee. In her current role, she is responsible for all aspects of human resources, corporate development and communications.

Woodcliff Lake-based Eagle Pharmaceuticals, Inc. announced the appointment of Luciana ("Lu") Borio, M.D., to its Board of Directors. Dr. Borio brings more than a dozen years of high-level experience advancing major regulatory and policy initiatives on behalf of the U.S. government, notably in her roles at the U.S. Food and Drug Administration. Dr. Borio has served as Senior Vice President of In-Q-Tel, an independent strategic investment firm that supports the mission of the United States national security community, since 2019, and served as a member of President Biden's Transition COVID-19 Advisory Board from November 2020 to January 2021. Previously, Dr. Borio was Director, Medical and Biodefense Preparedness Policy, for the White House National Security Council from 2017 to 2019.

Parsippany-based Zoetis Inc. announced leadership changes that will accelerate its long-term growth strategy in key markets and add new talent to its executive team. Glenn David, Executive Vice President and Chief Financial Officer for Zoetis, has been named Executive Vice President and Group President, overseeing International Operations and other business units. In addition, the company announced Wetteny Joseph will join Zoetis as Executive Vice President and Chief Financial Officer, reporting to CEO Kristin Peck, and assume responsibility for the oversight of the company's financial management, planning and business development group.


Institution and Education News

In an effort to close the gap when it comes to women, minorities and other populations in the fields of science, technology, engineering and mathematics (STEM), a bill by Assembly Democrats Mila Jasey and Daniel Benson to require the creation of a program that would assist universities in recruiting and retaining individuals from these underrepresented groups was signed into law. The law (formerly bill A-1070) requires the Secretary of Higher Education to establish a program with the purpose of developing guidance and strategies for identifying cultural and institutional barriers that prevent underrepresented students from entering or remaining in STEM fields. The program will also provide these students with institutional support to help them reach their academic goals.

Gov. Phil Murphy has long talked about creating an innovative economy in New Jersey. It appears there are a number of high schools ready to help in that goal. High Technology High School in Freehold was named the top STEM high school in the country, according to the 2021 rankings from U.S. News and World Report. Four other New Jersey schools were ranked in the Top 50 nationally -- including a second in the Top 10 -- and 11 schools made the Top 100 overall. Congratulations to the top ranked N.J. schools: High Technology High School; Middlesex County Academy for Science, Mathematics and Engineering Technologies; Bergen County Academies; West Windsor-Plainsboro North; West Windsor-Plainsboro South; County Magnet High School (Scotch Plains); Westfield; Montgomery; Ridge" Academy for Allied Health Sciences (Scotch Plains) and Summit.

Princeton-based Princeton University is the home of a new branch of the Ludwig Institute for Cancer Research, an international community of distinguished scientists dedicated to preventing and controlling cancer. The Ludwig Princeton Branch will focus on cancer metabolism and its promise for new and better ways to prevent and treat cancer, addressing questions like: Since tumors feast on glucose, should cancer patients eat more sugary treats or fewer? When advanced cancer patients see their bodies wasting away, should they fight back with carb loading or steak? How does cancer hijack a patient's metabolism to grow and metastasize?

New Brunswick-based Rutgers has been selected as a clinical trial site for the global



New Brunswick-based Rutgers has received $1 million from the New Jersey Office of the Secretary of Higher Education to establish a policy lab that will analyze solutions to critical issues facing the Garden State. The State Policy Lab, housed in Rutgers' Edward J. Bloustein School of Planning and Public Policy and managed in conjunction with the Rutgers-Newark School of Public Affairs and Administration, will include expertise from a network of scholars, community members and external policy experts. "Rutgers-New Brunswick and its Bloustein School have always focused on serving the people of New Jersey," said Rutgers-New Brunswick Chancellor Christopher J. Molloy. "We are proud to collaborate with the state on this partnership, which provides another important venue by which our world-class research will help enhance the quality of life in the Garden State."

New Brunswick-based The New Jersey State Cancer Registry (NJSCR), under the direction of the State Department of Health in partnership with Rutgers Cancer Institute of New Jersey, has been awarded a seven-year, $9,085,109 contract (75N91021D00009) from the National Cancer Institute (NCI) to support core infrastructure and research activities as part of the Surveillance, Epidemiology, and End Results (SEER) Program. The SEER Program is considered to be the most authoritative source of information on cancer incidence and survival in the United States.  The NJSCR is one of only 18 population-based CORE registries in the country that are part of the SEER Program and is one of only three awarded SEER CORE infrastructure contracts during this highly competitive round of funding from the NCI. 

Funding

The New Jersey Economic Development Authority (NJEDA) is currently accepting applications for its 2021 Net Operating Loss (NOL) Program, which was recently expanded as part of the New Jersey Economic Recovery Act of 2020. The NOL Program enables early stage technology and life sciences companies in the Garden State to sell their New Jersey net operating losses and unused research and development (R&D) tax credits to unrelated profitable corporations for cash. The NJEDA is accepting applications online through June 30, 2021 at http://www.njeda.com/nol.

Gov. Phil Murphy announced an additional $235 million in funding for small business relief and $40 million in funding for an excluded residents fund to assist individuals negatively impacted by the COVID-19 pandemic. The new small business funding, proposed by the Governor's Office and agreed upon by legislative leadership, will fulfill existing Phase IV small business grant requests made to the New Jersey Economic Development Authority (EDA), while the new direct cash assistance program will help New Jerseyans in need who have been excluded from previous rounds of COVID-19 relief.

Thought Leadership from BioNJ Members
Article by RSM US

As COVID-19 moves from a pandemic crisis to an endemic fact of life, governments, economies and communities have to define what the new normal is going to look like. Communities will need to make affirmative decisions as to how the world and their specific social, political and economic ecosystems will function post-pandemic. For life sciences companies, that will involve consideration of new technologies, business models and consumer preferences.

Events
May 22, 2021

The 2021 SAPA Scientific Symposium is one of the SAPA flagship annual events attracting prominent biotech executives, academic and industry scientists, entrepreneurs and investors, as well as professionals from different healthcare fields locally and internationally. The theme of this year's symposium is "Science Today, Life-Saving Medicines Tomorrow". The symposium will focus on the current trends of biomedical innovation and breakthroughs in the following areas: COVID-19 Vaccine and Therapies, New Frontier in Clinical Development and New Technologies in Drug Discovery. This year we have invited world-renowned scientists, entrepreneurs, as well as senior executives of leading pharmaceutical companies to share their perspectives. 

The New Jersey Commission on Science, Innovation and Technology (CSIT) announced that it will host webinars in May and June for emerging innovation-focused companies in the Garden State that are interested learning how the federal Small Business Innovation Research (SBIR) and the Small Business Technology Transfer Program (STTR) can help fuel their growth. Representatives from the National Science Foundation and the United States Department of Defense will speak on May 26 and June 9 respectively to give an overview of their agencies' SBIR/STTR programs. During these two-hour webinars, attendees will learn the benefits of engaging with these federal programs and get tips and advice for successfully applying for support.
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.

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:

Please contact BioNJ at BioNJ@BioNJ.org 
or call 609-890-3185 with any questions.