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November 4, 2022

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


TEConomy/BIO's Report Confirms New Jersey's Continued National Industry Leadership

 

The U.S. biotech sector is a vital economic engine in all 50 states, providing 2.1 million jobs and a $2.9 trillion impact on the economy in 2021, according to a comprehensive report published by the Biotechnology Innovation Organization (BIO) and the Council of State Bioscience Associations (CSBA) in partnership with TEConomy. The report, “The U.S. Bioscience Industry: Fostering Innovation and Driving America’s Economy Forward,” details each of the biosciences subsectors including, biotechnology, pharmaceuticals, health care technology systems, agriculture and therapeutic devices at the national, state and metropolitan area levels.

 

In the report, New Jersey’s bioscience industry is cited amongst the national leaders in its size, specialized concentration of employment and diversity of strengths. The industry grew its employment base by 9 percent from 2018 through 2021, reaching nearly 105,000 direct jobs across 4,340 business establishments. New Jersey has a high degree of industry specialization with a 79 percent greater concentration of bioscience industry employment relative to the nation (location quotient is 1.79).

 

Further, the State stands out in its breadth of industry strengths with a specialized employment concentration in three of the five industry subsectors—pharmaceuticals; research, testing, and medical labs; and bioscience-related distribution—as well as a high concentration in a fourth subsector: medical devices and equipment. New Jersey is in the top tier of states in patent activity, with 7,309 patents awarded during the 2018-21 period in bioscience-related technology classes. Venture capital investments in New Jersey’s bioscience companies have increased in recent years and totaled more than $700 million in both 2020 and 2021.

 

“We couldn't be more proud of New Jersey's continued and growing national leadership in the biosciences industry and in the medical innovation it brings to Patients around the world," said BioNJ President and CEO Debbie Hart. "Because Patients Can't Wait®, we thank all of our Members and New Jersey's biosciences community for your unwavering work...making a difference for Patients everywhere." 


Click here to download the report. 


Because Patients Can't Wait®,

The BioNJ Team

Welcome New Members


 Learn more at www.BioNJ.org/Membership.

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Upcoming BioNJ Events

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BioNJ's Member Café

Register Today!

November 9, 2022

Webinar: Funding and Support for Entrepreneurial Innovation in Translational Sciences

Register Today!

November 30, 2022

BioNJ's Inspiring Women in STEM Conference

Register Today!

December 2, 2022

BioNJ's Patient Advocacy Summit

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

Register Today!

December 13, 2022

Putting Patients First:

The Value of Medical Innovation

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Identifying and Addressing Health Disparities: PhRMA's First Chart Pack on Health Equity

PhRMA is proud to announce the release of its first ever chart pack on health equity. This chart pack contains information on health equity in three sections: (1) A Snapshot of Health Disparities in America, (2) Inequities in Access to Screenings and Medicines Allow Health Disparities to Persist, and (3) PhRMA’s Commitment to Building a More Equitable Health Care System for All. Health equity means that all patients have the opportunity to reach their highest health potential – and accessing health services supports and medicines is an important part of the equation. Unfortunately, some populations face unequitable access to care due to their background, where they live, or how much money they make, among other factors. It is crucial that we make an effort to understand and discuss these inequities while working to build a more just, equitable health care system for all patients.

Hans Sauer is Sour on the WTO’s Waivers of mRNA IP

In this podcast, Duane Schulthess speaks with Hans Sauer, the Deputy General Counsel for Intellectual Property for the Biotechnology Innovation Organization (BIO) and a Professor at Georgetown Law School, about the enormous potential negative consequences of the Biden Administration allowing the WTO to waive IP rights of mRNA technology, potentially creating huge negative consequences for U.S. innovation. Hans attended the WTO meeting and is considered one of the world’s leading patent attorneys in the biopharma sector.

Innovation Brings Unwavering Patient Support in a New Era of Specialty Medicine

Developments in the specialty medication space could throw speed bumps in an already complex access journey. An incoming tide of new specialty therapies, including biosimilars, cell and gene therapies and oncology therapies, are expected to launch within the next year. In 2021, 72 novel active substances launched in the U.S. with more than half indicated for rare diseases. The drug pipeline continues to grow, with over 6,000 products in active development globally, a 68% increase over 2016. While people living with complex conditions may have more medication options, these specialty medications often come with variables such as high out-of-pocket costs and utilization management requirements. Patients’ benefit design, health system and location can prove to further complicate the journey to specialty medication access.

Navigating the Patient Experience: The Barriers and Burdens Standing Between Patients and Care

This is the third report of PhRMA’s Patient Experience Survey, a research initiative designed to explore the barriers patients face in accessing health care and prescription medicines. This installment examines how insured Americans navigate unclear and unaffordable insurance coverage, the disproportionate impact such coverage has on vulnerable communities and the patient-centered policy solutions that insured Americans desire.

BioNJ in the News

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ROI Influencers: Health Care 2022 — Debbie Hart

Battling health care inequities while addressing the social determinants of health is just one of the ways the industry’s reach goes far beyond the hospital walls. And all of this takes place while the sector works to find new cures and create better spaces to treat those afflicted. ROI's Influencers: Health Care list acknowledges a wide range of people doing all this and more. Congratulations to BioNJ President and CEO, Debbie Hart for making the list. Excerpt from ROI... "Ms. Hart, long one of the top association heads in the state, is a power player in the life sciences industry. The coming years, with all of the research headed to New Jersey, could be fruitful for the industry — which increasingly is coming under fire with regard to prescription drug prices."

NJ Company News

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Cyclacel Reports Preliminary Data from Its Phase 1/2 Clinical Trial of Oral Fadraciclib in Patients With Solid Tumors and Lymphoma at ENA 2022

Berkeley Heights-based BioNJ Member Cyclacel Pharmaceuticals, Inc. reported preliminary dose escalation data from its ongoing 065-101 Phase 1/2 clinical study of oral fadraciclib, a cyclin dependent kinase (CDK) 2/9 inhibitor, for the treatment of patients with advanced solid tumors and lymphoma. Of the 18 patients evaluable for response, two out of three T cell lymphoma patients treated achieved partial response and 11 out of 15 patients with various solid tumors achieved stable disease. No dose-limiting toxicities have been observed thus far. “We are excited by the progress of oral fadraciclib in the 065-101 study. We believe that the combination of daily dosing and dual targeting of both CDK2 and CDK9 at efficacious doses without dose limiting toxicities could potentially result in a competitive product profile for oral fadraciclib,” said Spiro Rombotis, President and CEO, Cyclacel. 

SCYNEXIS Presents Positive Interim Data of Oral Ibrexafungerp for Severe Fungal Infections from Ongoing Phase 3 FURI Study During IDWeek 2022

Jersey City-based BioNJ Member SCYNEXIS, Inc. announced the presentation of cumulative interim outcomes and all-cause mortality data in patients with refractory candidiasis treated with oral ibrexafungerp from the ongoing Phase 3 FURI study. “We are pleased to present these aggregate data from previous interim analysis showing favorable outcomes in our ongoing FURI trial, which focuses on the potential of ibrexafungerp to help patients with challenging fungal infections,” said David Angulo, M.D., Chief Medical Officer, SCYNEXIS. “These results reinforce our conviction that ibrexafungerp has the potential to benefit patients with severe fungal disease and limited treatment options, and they are supportive of our plans to pursue a salvage therapy indication for ibrexafungerp.”

Soligenix Invited to Submit BARDA Contract Proposal for Development of Thermostabilized Subunit Vaccines for Sudan Ebola and Marburg Viruses

Princeton-based BioNJ Member Soligenix announced that the company has been invited by the Biomedical Advanced Research and Development Authority (BARDA) Division of Chemical, Biological, Radiological and Nuclear (CBRN) Medical Countermeasures to submit a full contract proposal for the development of single-vial, adjuvanted, heat stable subunit vaccines to prevent filovirus infection. This submission supports a potential multi-year, multi-million-dollar contract to develop SuVax™ and MarVax™ vaccine candidates as medical countermeasures (MCM) for use in the event of a Sudan ebolavirus or Marburg marburgvirus outbreak. Soligenix was invited to submit this proposal following a review of its white paper entitled, "SuVax™: A Safe and Thermostable Single-Vial Adjuvanted Subunit Vaccine with Rapid Onset Immunity to Sudan ebolavirus", which proposed development of SuVax™ through Phase 1 clinical studies in a $25 million program of work over 5 years. 

Soligenix Announces Formation of Psoriasis Medical Advisory Board

Princeton-based BioNJ Member Soligenix announced the formation of a Medical Advisory Board (MAB) to provide medical/clinical strategic guidance to the Company as it advances the Phase 2a clinical development of SGX302 (synthetic hypericin) for the treatment of mild-to-moderate psoriasis. The company previously announced that the U.S. Food and Drug Administration (FDA) had cleared the investigational new drug (IND) application and Phase 2a clinical protocol. Comprised of dermatologic thought leaders with extensive experience in psoriasis, the MAB will play an important advisory role in the conduct of the upcoming Phase 2a clinical study, as well as in the design of subsequent clinical studies and associated regulatory interactions with health authorities.  

Matinas BioPharma Announces Positive Interim Data from the Phase 2 EnACT Trial of MAT2203 for the Treatment of Cryptococcal Meningitis, Exceeding Primary Endpoint Threshold; Patient Survival in All-Oral Cohort 4 Regimen Currently 90%

Bedminster-based BioNJ Member Matinas BioPharma announced positive interim data from Cohort 4, the fourth and final cohort of the Phase 2 EnACT trial evaluating MAT2203, an oral LNC formulation of amphotericin B, for the treatment of cryptococcal meningitis. Importantly, Cohort 4 (an all-oral treatment regimen with MAT2203) met its prespecified primary endpoint, exceeding the target rate of CSF yeast clearance threshold of >0.20 colony forming units (CFUs) per mL of cerebrospinal fluid per day. Overall survival in Cohort 4, a key secondary endpoint of the study, is 95 % at two weeks and currently 90% overall, with ongoing final follow-up through 18 weeks. Matinas plans to initiate the Phase 3 registration trial of MAT2203 as step-down therapy in cryptococcal meningitis in the first quarter of 2023.

PTC Therapeutics Announces Strategic Financing Collaboration With Blackstone With Up to $1 Billion in Funding

South Plainfield-based BioNJ Member PTC Therapeutics announced that it has entered into a strategic financing collaboration with funds managed by Blackstone to support its mission to reach a steady-state of delivering at least one therapy every 2-3 years to continue to bring transformative medicines to patients globally. As part of the collaboration, funds managed by Blackstone Life Sciences and Blackstone Credit will provide PTC with an initial $500 million commitment, including $350 million in low-cost, low-dilution capital at close. This collaboration with Blackstone capitalizes on PTC's multiple innovative therapeutic platforms and its proven track record of delivering transformative treatments to patients living with rare diseases. The customized senior secured term loan investment by Blackstone is collateralized by Translarna™, Emflaza®, Upstaza®, sepiapterin and vatiquinone.

BeiGene Expands Reach of its Innovative BTK Inhibitor With Recent Regulatory Approvals in Latin America

BioNJ Member BeiGene, with a site under development in Hopewell, announced significant progress in efforts to unlock global opportunities for BRUKINSA® (zanubrutinib) with recent regulatory approvals in six Latin American countries. “It has only been one year since the first approval for BRUKINSA in Latin America and these approvals, including the most recent in Argentina, demonstrate our drive to accomplish our mission and broaden access to innovative medicines,” said Eduardo Molinari, Senior Director of New Market Development in Latin America, BeiGene. “I look forward to collaborating with our partner, Adium, on commercialization activities to provide this important treatment option to people living with MCL, MZL, and WM in Latin America.” 

BeiGene Receives European Commission Approval for BRUKINSA® (zanubrutinib) for the Treatment of Adults with Marginal Zone Lymphoma

BioNJ Member BeiGene, with a site under development in Hopewell, announced that the European Commission (EC) has granted marketing authorization of BRUKINSA® (zanubrutinib) for the treatment of adult patients with relapsed/refractory (R/R) marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy. The approval is applicable to all 27 member states of the European Union (EU), plus Iceland and Norway. BeiGene is focused on developing innovative and affordable oncology medicines to improve treatment outcomes and access for patients worldwide. Notably, the EC granted an additional year of marketing protection because the data submitted for the therapeutic indication demonstrated a significant clinical benefit for BRUKINSA in comparison with existing therapies. 

Phathom Pharmaceuticals Completes Patient Enrollment in Phase 3 PHALCON-NERD-301 Daily Dosing Trial of Vonoprazan in Non-Erosive Gastroesophageal Reflux Disease (NERD)

Florham Park-based BioNJ Member Phathom Pharmaceuticals, Inc. announced it has completed enrollment in its PHALCON-NERD Daily Dosing Phase 3 trial of vonoprazan in non-erosive gastroesophageal reflux disease (NERD). Vonoprazan is an investigational first-in-class potassium-competitive acid blocker (PCAB) from a novel class of medicines that block acid secretion in the stomach. The Company expects to share topline data from the primary endpoint in the first quarter of 2023 and full results from the study in late 2023. If successful, Phathom believes that the trial will form the basis of a supplemental New Drug Application (sNDA) for vonoprazan as once daily therapy for the treatment of symptomatic NERD in adults in 2023.

Phathom Pharmaceuticals Presents New Data Evaluating First-in-Class Potassium-Competitive Acid Blocker (PCAB) Vonoprazan as Novel On-Demand Treatment in NERD at American College of Gastroenterology (ACG) 2022 Annual Scientific Meeting

Florham Park-based BioNJ Member Phathom Pharmaceuticals, Inc. announced that detailed results from an investigational Phase 2 study evaluating the efficacy of vonoprazan in non-erosive gastroesophageal reflux disease (NERD) and other data will be presented at the American College of Gastroenterology Annual Scientific Meeting. The double-blind, placebo-controlled PHALCON-NERD study randomized 207 patients who were eligible for on-demand (“as needed”) treatment following a 4-week daily dosing run-in period in which patients received vonoprazan 20 mg once-daily. Patients without heartburn in the last seven days of the run-in period were evenly randomized to receive 10 mg, 20 mg or 40 mg of vonoprazan or placebo for six weeks.

Phathom Pharmaceuticals Announces Placement of the Remaining $40 Million in Non-Dilutive Capital under its up to $300 Million Revenue Interest Financing Agreement

Florham Park-based BioNJ Member Phathom Pharmaceuticals, Inc. announced that up to an additional $40 million in non-dilutive capital has been secured from an additional investor under the terms of Phathom’s revenue interest financing agreement. Up to $40 million has been committed, comprised of $15 million upon FDA approval of vonoprazan for treatment of EE, and $25 million upon achievement of a sales milestone. This additional potential funding is subject to the revenue interest financing agreement with Sagard Healthcare Partners, NovaQuest Capital Management, and Hercules Capital, Inc. which provided Phathom with the option to add additional investors for up to $40 million in additional funding. This additional $40 million in potential funding increases the total financing available to Phathom under the agreement to up to $300 million.

Gilead Presents Real-World Evidence Reinforcing the Use of Biktarvy® for the Treatment of People Living With HIV With a Range of Comorbidities

BioNJ Member Gilead Sciences, Inc., with a site in Morris Plains, announced the presentation of real-world results from the BICSTaR study, highlighting Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) as a generally well tolerated and efficacious regimen regardless of prior treatment and comorbidity status in people with HIV. The latest five-year data from two Phase 3 studies (Study 1489 and Study 1490) provide evidence of the long-term safety and efficacy profile of Biktarvy in those who switch from a dolutegravir-containing regimen. New real-world data was presented from the 24-month BICSTaR follow-up analysis, evaluating the effectiveness and safety of Biktarvy in clinical practice across nine countries. The analysis included follow-up during the COVID-19 pandemic and considered age, race, sex, adherence and late diagnosis in the population group. 

U.S. Food and Drug Administration Approves Vemlidy® (tenofovir alafenamide) for Treatment of Chronic Hepatitis B Virus Infection in Pediatric Patients

BioNJ Member Gilead Sciences, Inc., with a site in Morris Plains, announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Vemlidy® (tenofovir alafenamide) 25 mg tablets as a once-daily treatment for chronic hepatitis B virus (HBV) infection in pediatric patients 12 years of age and older with compensated liver disease. Vemlidy is a novel, targeted prodrug of tenofovir that was previously approved by the FDA in 2016 as a once-daily treatment for adults with chronic HBV infection with compensated liver disease. It is recommended as a preferred or first-line treatment for adults with chronic HBV with compensated liver disease in guidelines from the American Association for the Study of Liver Diseases (AASLD) and European Association for the Study of the Liver (EASL).

RINVOQ® (Upadacitinib) Receives Its Sixth U.S. FDA Approval

BioNJ Member AbbVie, with a site in Madison, announced that the U.S. Food and Drug Administration (FDA) has approved RINVOQ® (upadacitinib 15 mg, once daily), an oral therapy, for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation who have had an inadequate response or intolerance to tumor necrosis factor (TNF) blocker therapy. This additional indication follows the FDA approval of RINVOQ in April of this year for adults with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more TNF blockers, making it the first and only JAK inhibitor that is approved for both conditions.

AbbVie Announces Submissions of Regulatory Applications for Epcoritamab (DuoBody®-CD3xCD20) for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) and Large B-Cell Lymphoma (LBCL)

BioNJ Member AbbVie, with a site in Madison, announced that the European Medicines Agency (EMA) has validated a Marketing Authorization Application (MAA) for epcoritamab (DuoBody®-CD3xCD20), an investigational subcutaneous bispecific antibody, for the treatment of adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Additionally, BioNJ Member Genmab has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for epcoritamab for the treatment of adult patients with R/R large B-cell lymphoma (LBCL) after two or more lines of systemic therapy. The regulatory submissions are supported by previously announced results from the LBCL cohort of the EPCORE™ NHL-1 open-label, multi-center Phase 2 trial evaluating the safety and preliminary efficacy of investigational epcoritamab in adult patients with relapsed, progressive, or refractory CD20+ mature B-cell non-Hodgkin's lymphoma (NHL), including DLBCL.

Evotec Enters Partnership With Hannover Medical School to Create Molecular Patient Database in Autoimmune Diseases

Princeton-based BioNJ Member Evotec announced that the company has entered a partnership with Hannover Medical School (“MHH”), one of the leading German universities, to generate a molecular patient database for Sjögren’s syndrome (“SjS”) and systemic lupus erythematosus (“SLE”). The strategic partnership between Evotec and MHH aims at achieving a better disease understanding of SjS and SLE by creating a unique longitudinal PanOmics database from the analysis of patient material. Biospecimens from several hundred SjS and SLE patients will be collected by MHH and analysed on Evotec’s PanOmics platform, which includes genomics, transcriptomics, proteomics, and metabolomics as well as single-cell sequencing technologies. Together with supplementary pseudonymised patient data, these PanOmics data will feed into Evotec’s proprietary translational molecular patient data platform E.MPD, which serves as the central data repository for molecular patient data.

Evotec, CDP Venture Capital and Angelini Ventures Launch Translational Partnership “Extend” With Leading Italian Academic Institutions

Princeton-based BioNJ Member Evotec announced the launch of “Extend”, a translational BRIDGE partnership in cooperation with CDP Venture Capital Sgr, a strategic pillar to Italy's economic growth and innovation, and Angelini Ventures, the Corporate Venture Capital arm of the multi-business industrial group Angelini Industries. Extend is a joint venture between Evotec, CDP Venture Capital and Angelini Ventures to develop translational drug discovery partnerships with highly renowned universities and research centers in Italy. Extend aims to use Evotec’s best-in-class technology platforms to accelerate the translation of academic innovation into robust and investable data points and Angelini Ventures’ network and knowledge of the life science sector to launch successful new companies. 

Hepion Pharmaceuticals Announces Publication of Food Effect Study With Rencofilstat

Edison-based BioNJ Member Hepion Pharmaceuticals, Inc. announced the peer-reviewed journal, Clinical Pharmacology in Drug Development, has published the results of a clinical trial examining the effect of food on the oral bioavailability of rencofilstat, the company’s lead drug candidate. The article reviews a Phase 1, randomized, open-label trial in healthy subjects which assessed the bioavailability of a single dose of rencofilstat in both fasted and high-fat conditions. “This study showed that taking rencofilstat with a high fat meal increases the absorption of this cyclophilin inhibitor and confirms the safety of the drug while providing the flexibility for patients to take rencofilstat with or without food,” Patrick Mayo, Ph.D., Hepion’s Senior Vice President, Clinical Pharmacology & Analytics. 

Hepion Pharmaceuticals Announces Publication of Phase 2a ‘AMBITION’ Clinical Trial Results

Edison-based BioNJ Member Hepion Pharmaceuticals, Inc. announced that the peer-reviewed journal, Hepatology Communications, has published a paper by Harrison et al. entitled, “Rencofilstat, a cyclophilin inhibitor: A Phase 2a, multicenter, single-blind, placebo-controlled study in F2/F3 NASH,” reviewing the results of Hepion’s ‘AMBITION’ clinical trial. The Phase 2a, multicenter, single-blind, placebo-controlled study randomized 49 presumed F2/F3 NASH subjects to receive either 75 mg or 225 mg of rencofilstat, or placebo, once daily for 28 days. The aim of the study was to determine safety, tolerability and pharmacokinetics, while exploring NASH efficacy biomarkers, including multi-omic and AI-POWR™ analyses. As previously reported, the AMBITION clinical trial demonstrated rencofilstat was safe and well tolerated. A majority of subjects (28/47; 59.6%) who were dosed with rencofilstat, or placebo experienced no adverse events.

Kyowa Kirin Announces NDA Submission of Tenapanor Hydrochloride (KHK7791) for Improvement of Hyperphosphatemia in Chronic Kidney Disease Patients on Dialysis in Japan

BioNJ Member Kyowa Kirin Co., with a site in Bedminster, announced the submission of a New Drug Application (NDA) for tenapanor hydrochloride (Code name: KHK7791, “tenapanor”), a small molecule compound licensed from Ardelyx, Inc. to the Japanese Ministry of Health, Labor and Welfare for improvement of hyperphosphatemia in chronic kidney disease patients on dialysis. “We are pleased that we have submitted an NDA for tenapanor for improvement of hyperphosphatemia in chronic kidney disease patients on dialysis,” said Yoshifumi Torii, Ph.D., Executive Officer, Vice President, Head of R&D Division, Kyowa Kirin. “We strongly believe that tenapanor, with its unique mechanism of action, will provide a new treatment option for the improvement of hyperphosphatemia and contribute to the benefit of patients receiving maintenance dialysis.”

Ferring Pharmaceuticals and Blackstone Life Sciences Restructure Novel Gene Therapy Collaboration

BioNJ Member Ferring Pharmaceuticals, with a site in Parsippany, and Blackstone Life Sciences announced that they have reached an agreement to restructure their 2019 collaboration in nadofaragene firadonavec, an investigational novel gene therapy in late-stage development for patients with high-grade, Bacillus Calmette-Guerin unresponsive, non-muscle invasive bladder cancer. As part of this restructuring, Ferring will now assume full and sole control of FerGene and nadofaragene firadonavec. The restructured agreement allows for a return on capital already invested by Blackstone and provides Blackstone with the option to make a passive financial investment in nadofaragene firadonavec upon achievement of a specified regulatory event in exchange for a royalty interest. 

Clinics Across Florida, New Jersey & California Advancing Mental Health in Underserved Communities – Awarded Funding from Teva Pharmaceuticals, Direct Relief and NAFC

Parsippany-based BioNJ Member Teva Pharmaceutical and the National Association of Free and Charitable Clinics (NAFC) and Direct Relief announced – as part of a two-year, $2 million commitment – the awarding of $825,000 in grant funding for 11 free and charitable clinics addressing mental health across Florida, New Jersey and California. “At Teva, we know how critical it is to enable access to medicines that help improve people’s lives and look forward to seeing how these local clinics create or expand needed programs that drive real impact for patients. “The grant awardees were selected for their innovative and practical approaches to mental health care, which include efforts to expand healthcare access for underserved and vulnerable patients experiencing mental and behavioral health issues, with a focus on depression and anxiety. 

European Commission Expands Merck’s VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) Indication to Include Infants, Children and Adolescents

Kenilworth-based BioNJ Member Merck & Co. announced that the European Commission (EC) has approved an expanded indication for VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) to include active immunization for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae (S. pneumoniae) in infants, children and adolescents from 6 weeks to less than 18 years of age. The approval facilitates availability of VAXNEUVANCE for this population in all 27 European Union (EU) Member States plus Iceland, Norway and Lichtenstein. VAXNEUVANCE is also indicated in the EU for active immunization for the prevention of invasive disease and pneumonia caused by S. pneumoniae in individuals 18 years of age and older. The use of VAXNEUVANCE in the EU should be in accordance with official recommendations. 

Merck’s PREVYMIS™ Demonstrates Efficacy in Phase 3 Study for Prevention of Cytomegalovirus Disease in Adults After Kidney Transplantation

Kenilworth-based BioNJ Member Merck & Co. announced the presentation of findings from a Phase 3 clinical trial that assessed safety and efficacy of PREVYMIS™ (letermovir) compared to valganciclovir for cytomegalovirus (CMV) prophylaxis in 601 adult kidney transplant recipients at high risk for CMV disease (D+/R-). At 52 weeks following kidney transplant, trial results met the primary endpoint demonstrating that PREVYMIS was effective and non-inferior to valganciclovir for preventing CMV disease -- 10.4% (n=30) of participants who received PREVYMIS developed CMV disease versus 11.8% (n=35) of participants on valganciclovir (stratum adjusted difference = -1.4, [95% CI, -6.5, 3.8]). In a pre-specified safety analysis, PREVYMIS-treated participants had significantly less myelotoxicity, as measured by rates of leukopenia or neutropenia, compared to valganciclovir-treated participants; 26.0% (n=76) versus 64.0% (n=190), (95% CI, -45.1, -30.3; p-value <0.0001). 

Merck and Veeva Form Long-Term Strategic Partnership

Veeva Systems announced a ten-year strategic partnership agreement with Kenilworth-based BioNJ Member Merck & Co. that builds on the existing 12-year partnership between the companies. Under the terms of the agreement, Merck will take a Veeva-first approach to new industry-specific software and data, selecting Veeva products when they are fit for purpose to maximize the value of Veeva's integrated, cloud-based platform and products. Veeva will provide Merck with a strategic pricing approach and Merck will have input into Veeva's product roadmap. The partnership helps accelerate Merck's digital strategy and makes it more efficient for Merck to evaluate, purchase, operate, and create value from Veeva products and services.

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

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

Pfizer Announces Positive Top-Line Data of Phase 3 Global Maternal Immunization Trial for its Bivalent Respiratory Syncytial Virus (RSV) Vaccine Candidate

BioNJ Member Pfizer, with a site in Peapack, announced positive top-line data from the Phase 3 clinical trial (NCT04424316) MATISSE (MATernal Immunization Study for Safety and Efficacy) investigating its bivalent RSV prefusion vaccine candidate, RSVpreF or PF-06928316, when administered to pregnant participants to help protect their infants from RSV disease after birth. The pre-planned, interim efficacy analysis conducted by an external and independent Data Monitoring Committee (DMC) met the success criterion for one of two primary endpoints. The observed efficacy for severe medically attended lower respiratory tract illness (severe MA-LRTI) was 81.8% (CI: 40.6%, 96.3%) through the first 90 days of life. Substantial efficacy of 69.4% (CI: 44.3%, 84.1%) was demonstrated for infants over the six-month follow-up period. 

Pfizer and BioNTech Announce Updated Clinical Data for Omicron BA.4/BA.5-Adapted Bivalent Booster Demonstrating Substantially Higher Immune Response in Adults Compared to the Original COVID-19 Vaccine

BioNJ Member Pfizer, with a site in Peapack, and BioNTech SE announced updated data from a Phase 2/3 clinical trial demonstrating a robust neutralizing immune response one-month after a 30-µg booster dose of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine (Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)). Immune responses against BA.4/BA.5 sublineages were substantially higher for those who received the bivalent vaccine compared to the companies’ original COVID-19 vaccine, with a similar safety and tolerability profile between both vaccines. These results reinforce the previously reported early clinical data measured 7 days after a booster dose of the bivalent vaccine, as well as the pre-clinical data, and suggest that a 30-µg booster dose of the Omicron BA.4/BA.5-adapted bivalent vaccine may induce a higher level of protection against the Omicron BA.4 and BA.5 sublineages than the original vaccine.

Pfizer’s Elranatamab Granted FDA Breakthrough Therapy Designation for Relapsed or Refractory Multiple Myeloma

BioNJ Member Pfizer, with a site in Peapack, announced its investigational cancer immunotherapy, elranatamab, received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of people with relapsed or refractory multiple myeloma (RRMM). Elranatamab is a B-cell maturation antigen (BCMA)-CD3-targeted bispecific antibody (BsAb). BsAbs are a novel form of cancer immunotherapy that bind to and engage two different targets at once. One arm binds directly to specific antigens on cancer cells and the other arm binds to T-cells, bringing both cell types together. Elranatamab is designed to bind to BCMA, which is highly expressed on the surface of multiple myeloma (MM) cells, and the CD3 receptor found on the surface of T-cells, bridging them together and activating the T-cells to kill the myeloma cells. 

New Data Presented at the American College of Gastroenterology Annual Scientific Meeting Demonstrate Continuous Zeposia (ozanimod) Treatment Prevents Disease Relapse Over One Year in 86.1% of Patients Who Respond at the End of the Induction Period

Princeton-based BioNJ Member Bristol Myers Squibb announced new post hoc analyses from the Phase 3 True North study evaluating the duration of response following continuous Zeposia (ozanimod) treatment for up to one year and following treatment interruption in patients with moderately to severely active ulcerative colitis (UC). After achieving a clinical response at the end of the induction period, 86.1% of patients who remained on Zeposia showed no disease relapse at Week 52 (Kaplan-Meier [KM] estimates of no disease relapse at Week 52: Zeposia/Zeposia, 86.1%; Zeposia/placebo, 62.6%). Additional analyses presented demonstrate no additional safety signals were observed after approximately two years of continuous Zeposia treatment. 

New Zeposia (ozanimod) Data Highlight COVID-19 Outcomes and Preservation of Long-Term Cognitive Function from Separate Analyses in Patients With Relapsing Forms of Multiple Sclerosis

Princeton-based BioNJ Member Bristol Myers Squibb announced new retrospective analyses on serologic responses and clinical outcomes with COVID-19 vaccination in participants treated with Zeposia (ozanimod) from the ongoing Phase 3 DAYBREAK open-label extension (OLE) study in relapsing multiple sclerosis (MS). More than 92% (137/148) of all study participants in these analyses mounted a serological response following vaccination. In addition, among participants with prior COVID-19 exposure, seroconversion was observed in 100% (39/39) of individuals following full COVID-19 mRNA or non-mRNA vaccination. COVID-19-related adverse events were reported in 10% (15/148) of vaccinated participants (12/148 confirmed; 3/148 suspected), all of which were nonserious. 

Bristol Myers Squibb Announces Positive Topline Results of Phase 3 COMMANDS Trial

Princeton-based BioNJ Member Bristol Myers Squibb announced the COMMANDS study, a Phase 3, open-label, randomized trial evaluating Reblozyl®(luspatercept-aamt), met its primary endpoint, demonstrating a highly statistically significant and clinically meaningful improvement in red blood cell transfusion independence (RBC-TI) with concurrent hemoglobin (Hb) increase in the first-line treatment of adult patients with very low-, low- or intermediate-risk myelodysplastic syndromes (MDS) who require RBC transfusions. This result was based on a pre-specified interim analysis conducted through an independent review committee. Safety results in the trial were consistent with the safety profile of Reblozyl previously demonstrated in the MEDALIST study (NCT02631070), and no new safety signals were reported. 

GSK’s Respiratory Syncytial Virus Older Adult Vaccine Candidate Granted Priority Review by U.S. FDA

Warren-based BioNJ Member GSK announced that the U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for its respiratory syncytial virus (RSV) older adult vaccine candidate. The U.S. FDA grants Priority Review to applications for vaccines that, if approved, would offer significant improvements in the safety or effectiveness of the treatment or prevention of serious conditions when compared to standard applications. The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is 3 May 2023. If approved, GSK’s RSV older adult vaccine candidate has the potential to be the first vaccine available to help protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection.

GSK Regulatory Submission Accepted by Japanese Regulator for Respiratory Syncytial Virus Older Adult Vaccine Candidate

Warren-based BioNJ Member GSK announced that a new drug application for its respiratory syncytial virus (RSV) older adult vaccine candidate has been accepted for review by the Japanese Ministry of Health, Labor and Welfare (MHLW). The proposed indication is for adults aged 60 years and above to prevent lower respiratory tract diseases (LRTD) caused by RSV. The filing is based on positive data from a prespecified interim analysis of the pivotal AReSVi-006 (Adult Respiratory Syncytial Virus) phase III trial which showed high overall vaccine efficacy against RSV-LRTD in adults aged 60 years and above, with a favorable safety profile. Consistent high vaccine efficacy was observed against LRTD in severe disease, adults aged 70-79 years, adults with underlying comorbidities and across RSV A and B strains.

GSK Marketing Authorization Application for Respiratory Syncytial Virus Older Adult Vaccine Candidate Accepted by European Medicines Agency Under Accelerated Assessment

Warren-based BioNJ Member GSK announced that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for its respiratory syncytial virus (RSV) older adult vaccine candidate. MAAs may be eligible for accelerated assessment if the EMA’s Committee for Medicinal Products for Human Use decides the product is of major interest for public health and therapeutic innovation. A European regulatory decision is anticipated in Q3 2023. If approved, GSK’s RSV older adult vaccine candidate has the potential to be the first vaccine available to help protect older adults from RSV lower respiratory tract disease (LRTD). This is the second major regulatory development for GSK’s RSV older adult vaccine candidate following Japanese regulatory submission acceptance. 

Novartis Investigational Oral Monotherapy Iptacopan Demonstrates Clinically Meaningful Superiority Over Anti-C5 Treatment in Phase III APPLY-PNH Study

East Hanover-based BioNJ Member Novartis announced the pivotal Phase III APPLY-PNH trial met its two primary endpoints, showing investigational oral monotherapy iptacopan was superior to anti-C5 therapies (eculizumab or ravulizumab) in adults with paroxysmal nocturnal hemoglobinuria (PNH) experiencing residual anemia despite prior treatment with anti-C5s. Detailed results will be presented at an upcoming medical meeting and included as part of global regulatory submissions in 2023. Topline results showed a statistically significant and clinically meaningful increase in the proportion of patients treated with iptacopan (200 mg twice daily) achieving hemoglobin-level increases of 2 g/dL or more from baseline without the need for blood transfusions at 24 weeks, compared to anti-C5 therapies, a primary endpoint of the study.

New TREMFYA® (guselkumab) Data Show an Overall Clinical Response Rate of Approximately 80 Percent in a Phase 2b Induction Study of Adults With Moderately to Severely Active Ulcerative Colitis

Titusville-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced new data from the Phase 2b QUASAR Induction Study 1 in adults with moderately to severely active ulcerative colitis (UC) with inadequate responses to previous treatments. The data presented at the 2022 American College of Gastroenterology (ACG) Annual Scientific Meeting show an overall clinical response rate of approximately 80 percent in patients who were randomized to TREMFYA® (guselkumab). Clinical response at weeks 12 or 24 of the study was ultimately achieved by 80.2 percent of patients who were randomized to intravenous (IV) TREMFYA 200 mg arm and by 78.5 percent of patients who were randomized to IV TREMFYA 400 mg arm. 

U.S. FDA Approves TECVAYLI™ (teclistamab-cqyv), the First Bispecific T-cell Engager Antibody for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma

Titusville-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) approved TECVAYLI™ (teclistamab-cqyv) for the treatment of adult patients with relapsed or refractory multiple myeloma, who previously received four or more prior lines of therapy, including a proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody. TECVAYLI™ is a first-in-class, bispecific T-cell engager antibody that is administered as a subcutaneous treatment.1 This off-the-shelf (or ready to use) therapy uses innovative science to activate the immune system by binding to the CD3 receptor expressed on the surface of T-cells and to the B-cell maturation antigen (BCMA) expressed on the surface of multiple myeloma cells and some healthy B-lineage cells.

Johnson & Johnson to Acquire Abiomed

New Brunswick-based BioNJ Member Johnson & Johnson and Abiomed announced that they have entered into a definitive agreement under which Johnson & Johnson will acquire through a tender offer all outstanding shares of Abiomed, for an upfront payment of $380.00 per share in cash, corresponding to an enterprise value of approximately $16.6 billion which includes cash acquired. Abiomed shareholders will also receive a non-tradeable contingent value right (CVR) entitling the holder to receive up to $35.00 per share in cash if certain commercial and clinical milestones are achieved. The transaction was unanimously approved by both companies’ boards of directors. The transaction broadens Johnson & Johnson MedTech’s (JJMT) position as a growing cardiovascular innovator, advancing the standard of care in one of healthcare’s largest unmet need disease states: heart failure and recovery.

LEO Pharma Announces European Commission Approval of Adtralza® (tralokinumab) for the Treatment of Moderate-to-Severe Atopic Dermatitis in Adolescents

LEO Pharma, with a site in Madison, announced that the European Commission (EC) has extended the marketing authorization for Adtralza® (tralokinumab) to include adolescents aged 12 to 17 with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy. The approval is based on data from the Phase 3 ECZTRA 6 trial, which evaluated the efficacy and safety of Adtralza (150 mg or 300 mg) monotherapy compared to placebo in adolescents with moderate-to-severe AD who were candidates for systemic therapy. The approved dose for adolescent patients is an initial dose of 600 mg followed by 300 mg administered every other week, which is the same dosing as for adult patients.

Regeneron Receives Six Months of U.S. Pediatric Exclusivity for EYLEA® (aflibercept) Injection

Regeneron Pharmaceuticals, Inc., with a site in Basking Ridge, announced the U.S. Food and Drug Administration (FDA) has granted pediatric exclusivity for EYLEA® (aflibercept) Injection. This grant extends the period of U.S. market exclusivity for EYLEA by an additional six months through May 17, 2024. The pediatric exclusivity determination is based on data from two Phase 3 trials – BUTTERFLEYE and FIREFLEYE – which were submitted in response to the FDA's Written Request to evaluate the use of EYLEA as a treatment for retinopathy of prematurity (ROP) in preterm infants. The two Phase 3 trials also formed the basis of a supplemental Biologics License Application for EYLEA in ROP that was recently accepted for Priority Review by the FDA. 

Inmazeb® (atoltivimab, maftivimab and odesivimab-ebgn) Wins Prestigious 2022 Prix Galien USA Best Biotechnology Product Award

Regeneron Pharmaceuticals, Inc., with a site in Basking Ridge, announced that Inmazeb® (atoltivimab, maftivimab and odesivimab-ebgn) has been recognized as the "Best Biotechnology Product" of 2022 by the Galien Foundation, which acknowledges extraordinary scientific innovations that improve the human condition. The Prix Galien USA Award was presented in a ceremony in New York City. "Our groundbreaking 'rapid response' application of our VelociSuite® technologies to address the Ebola outbreak laid the foundation for our COVID-19 efforts," said Christos Kyratsous, Ph.D., Senior Vice President, Research, at Regeneron. "By strategically pursuing a multi-antibody approach, parallel tracking certain steps and speeding hand-offs between groups, we are able to advance novel antibody treatments in a very expedited manner. Thank you for this recognition of the decades of diligent scientific research and technological investment that led to this important therapeutic discovery."

Boehringer Ingelheim Enrolls First Patient in Phase III Trial of BI 1015550 in Idiopathic Pulmonary Fibrosis

Boehringer Ingelheim, with a site in North Brunswick, announced that the first patient has enrolled in FIBRONEER™-IPF, a global Phase III trial evaluating BI 1015550, an investigational phosphodiesterase 4B (PDE4B) inhibitor, in people living with idiopathic pulmonary fibrosis (IPF). The trial is part of the FIBRONEER™ global program, which includes two Phase III studies – FIBRONEER™-IPF in patients with IPF and FIBRONEER™-ILD in people living with other progressive fibrosing interstitial lung diseases (ILDs). “New treatments for idiopathic pulmonary fibrosis and other forms of progressive fibrosing interstitial lung diseases are needed to complement existing therapies and to help potentially stop, rather than slow, disease progression,” said the coordinating investigator, Toby Maher, M.D., Ph.D., Professor of Clinical Medicine, Keck School of Medicine, USC Los Angeles. 

Bayer’s KERENDIA® (finerenone) Recommended as Part of Comprehensive Treatment Strategy for Chronic Kidney Disease Associated With Type 2 Diabetes in Newly Published Clinical Recommendations

Whippany-based Bayer announced KERENDIA® (finerenone), a first-in-class, non-steroidal mineralocorticoid receptor antagonist (ns-MRA), was recommended as part of a comprehensive treatment strategy for patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) in a newly published update to the Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease and in a consensus report jointly issued by KDIGO and the American Diabetes Association (ADA). KDIGO and the ADA in their combined statement as well as KDIGO in its new clinical guidelines recommended KERENDIA’s inclusion in the treatment plans of patients with CKD associated with T2D who have an estimated glomerular filtration rate (eGFR) of ≥25 mL/min/1.73 m2, normal serum potassium concentration and albuminuria (urine albumin-to-creatinine ratio [ACR] ≥30 mg/g) despite taking a maximum tolerated dose of a renin-angiotensin system (RAS) inhibitor.

Quizartinib Granted Priority Review in the U.S. for Patients With Newly Diagnosed FLT3-ITD Positive Acute Myeloid Leukemia

Basking Ridge-based Daiichi Sankyo announced they’ve received notification of acceptance by the U.S. Food and Drug Administration (FDA) of the New Drug Application (NDA) of quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as continuation monotherapy following consolidation, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive. The application has been granted Priority Review. The FDA grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance. 

New Analyses of Sotagliflozin from the SOLOIST-WHF and SCORED Trials in High Cardiovascular Risk Patients to be Presented at the American Heart Association Scientific Sessions 2022

Lexicon Pharmaceuticals, Inc. with a site in Basking Ridge, announced the presentation of new analyses of results from the SOLOIST-WHF and SCORED Phase 3 outcomes studies of its investigational sotagliflozin product at the American Heart Association Scientific Sessions. SCORED was a multi-center, randomized, double-blinded, placebo-controlled Phase 3 study evaluating the cardiovascular efficacy of sotagliflozin versus placebo when added to standard of care in 10,584 patients with type 2 diabetes, chronic kidney disease with eGFR of 25 to 60 ml per minute per 1.73 m2 of body-surface area and risks for cardiovascular disease. SOLOIST-WHF was a multi-center, randomized, double-blinded, placebo-controlled Phase 3 study evaluating the cardiovascular efficacy of sotagliflozin versus placebo when added to standard of care in 1,222 patients with type 2 diabetes who had recently been hospitalized for worsening heart failure. 

Doehler to Expand Flavor Business With New Customer-Facing Creation Center

North Brunswick-based Doehler said it is establishing a new customer-facing innovation and technology center that will focus on taste at the New Jersey Bioscience Center. The new dedicated flavor facility includes labs for flavor creation and analysis, application development and sensory testing, which will enable further innovation and rapid co-creation to drive continued growth with customers in North America. It will allow Doehler to leverage its vertical integration to deliver innovations that meet consumers’ needs and will be home for its team of industry experts, who have years of experience in natural flavor creation and taste modulation, together with technology and applications experts, delivering great tasting food, beverage and nutrition solutions.

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

Florham Park-based Shionogi Inc. announced that new Fetroja® (cefiderocol) data will be presented at IDWeek 2022 including new real-world evidence demonstrating Fetroja’s strong efficacy against some of the most difficult-to-treat Gram-negative bacterial infections. New data from PROVE (Retrospective Cefiderocol Chart Review) demonstrated that Fetroja achieved clinical cure in 63% (48/76) of patients with Acinetobacter baumannii infections and 63% (76/120) of patients with Pseudomonas aeruginosa infections. PROVE is an ongoing international retrospective study assessing real-world outcomes and safety of Fetroja in hospitalized patients with Gram-negative bacterial infections. Of the Acinetobacter baumannii infections, 96% were resistant to carbapenems (a last-line antibiotic), and 97% of the Pseudomonas aeruginosa infections were carbapenem-resistant.

Photocure Partner Asieris Announces 1[st] Patient Enrolled in Hexvix Phase III Trial in China

Photocure, The Bladder Cancer Company, with a site in Princeton, announced that its partner Asieris Pharmaceuticals has communicated today on the treatment of the first patient in the Hexvix® phase III bridging trial. The objective of the multicenter Phase III trial is to achieve regulatory approval of Hexvix in Mainland China for use in patients with bladder cancer, by investigating the detection rate and safety of Hexvix and blue light cystoscopy (BLC®) versus white light cystoscopy in patients with non-muscle invasive bladder cancer (NMIBC). The bridging trial is intended to confirm results from prior clinical trials in a Chinese population. The clinical trial protocol follows the protocols for registration studies in countries where Hexvix already has market authorization. This study will be led by Peking Union Medical College Hospital and the Chinese Academy of Medical Sciences.

People in the News

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Biopharma Veteran Ivor Macleod Joins SCYNEXIS as Chief Financial Officer

Jersey City-based BioNJ Member SCYNEXIS, Inc. announced that Ivor Macleod, an accomplished biopharma industry executive, has joined the company as Chief Financial Officer. Mr. Macleod joined SCYNEXIS from Athersys, Inc. where he served as Chief Financial Officer since January of 2020. Previously, he served as the Chief Financial Officer and Chief Compliance Officer of Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., Prior to joining Eisai, he served as Vice President Finance - Merck Research Labs at Merck & Co., Inc. Before joining Merck, he served from 1998 to 2012 at F. Hoffmann-La Roche, Inc., in various roles, including as North American Chief Financial Officer from 2000 to 2011 and General Manager from 2010 to 2011.

ADC Therapeutics Appoints Kristen Harrington-Smith as Chief Commercial Officer and Peter Graham as Chief Legal Officer

BioNJ Member ADC Therapeutics, with a site in New Providence, announced the appointment of Kristen Harrington-Smith as Chief Commercial Officer. The company also announced the appointment of Peter Graham as Chief Legal Officer. Both Ms. Harrington-Smith and Mr. Graham will serve on the company’s leadership team. Ms. Harrington-Smith is a seasoned leader with over 20 years of experience in the pharmaceutical industry. Most recently, she has served as Chief Commercial Officer of Immunogen where she has been responsible for building the commercial organization and preparing for the launch of its first commercial product. Mr. Graham is a senior legal executive with over 25 years of legal, compliance and executive management experience primarily in publicly traded biotechnology, pharmaceutical and medical device companies.

Robert M. Davis to Succeed Kenneth C. Frazier as Chairman of Merck

Kenilworth-based BioNJ Member Merck & Co. announced that the Merck board of directors has unanimously elected Robert M. Davis to serve as chairman of the board, effective Dec. 1, 2022. He will succeed Kenneth C. Frazier, who plans to retire on Nov. 30, 2022, after a long-tenured career at Merck that began in 1992. Frazier led the company for 10 years as president and chief executive officer, from 2011 through 2021. He has served as a Merck director since January 2011 and chairman of its board of directors since December 2011. Davis, who currently serves as president and chief executive officer, became Merck’s president in April 2021 and was named Merck’s chief executive officer and a member of its board in July 2021. 

Genomic Prediction Promotes Kelly Ketterson to Chief Executive Officer

North Brunswick-based BioNJ Member Genomic Prediction announced that Kelly Ketterson has been promoted to CEO. Ms. Ketterson has served as Genomic Prediction COO since January of this year. “Kelly’s decades of experience successfully leading at other top companies in the industry, and the enormous progress she's made here in her last ten months as COO make this promotion a natural progression" said Chief Science Officer and co-founder of Genomic Prediction, Dr. Nathan Treff. Prior to her role with Genomic Prediction, Ms. Ketterson served CooperSurgical as their Vice President, Operations, Vice President of Medical Affairs and launched the CooperSurgical U.S. Center of Excellence. 

About Robert Davis, the New Chair of Merck

Robert Davis was unanimously elected to serve as Chairman of the Board of Kenilworth-based BioNJ Member Merck & Co., effective Dec. 1. Mr. Davis, who succeeded Merck’s longtime leader, Ken Frazier, as CEO in July 2021, will now succeed Mr. Frazier as Chairman of the Board. Before becoming CEO, Mr. Davis served as Merck’s President, responsible for the company’s operating divisions — Human Health, Animal Health, Manufacturing and Merck Research Laboratories. Prior to that, he was Executive Vice President, Global Services, and the company’s Chief Financial Officer. Mr. Davis joined the company as Chief Financial Officer in 2014 with additional responsibility for real estate operations, corporate strategy and business development. 

Amarin Appoints Adam Berger and Geraldine Murphy to Board of Directors

Bridgewater-based BioNJ Member Amarin Corporation announced the appointment of Adam Berger and Geraldine Murphy as independent members of the company’s Board of Directors. The company also announced that, as part of their planned retirement, Lars Ekman, M.D., Ph.D and Patrick O’Sullivan, Directors of Amarin since 2008 and 2011, respectively, will retire from the Board, effective at the end of the year. With these changes, the Amarin Board will remain at eight directors, seven of whom are independent and five of whom have been appointed in the past year as part of the Board replenishment process which seeks to add international experience to support the company’s global expansion efforts.

Academia/Institutions/Incubators

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BioCentriq Cuts the Ribbon to Officially Open Additional GMP Manufacturing Site in South Brunswick, NJ

BioNJ Member BioCentriq, Inc. held a Ribbon Cutting Ceremony for the grand opening of its newly constructed GMP manufacturing facility at the Princeton Corporate Plaza in South Brunswick, NJ. Designed to accommodate a variety of cell and gene therapy projects, the additional clean rooms and supporting infrastructure are a strategic and much desired addition to the current pilot plant operations at the Princeton Corporate Plaza. BioCentriq is already utilizing clean rooms for clinical manufacturing at their Newark, NJ site. The new GMP facility now open in South Brunswick, NJ will provide additional capacity to support market demand.

Lilly Commits $92.5 Million to Purdue to Establish an Innovative Pharmaceutical Manufacturing Scholarship Program and to Extend Research Collaboration

Purdue University and BioNJ Member Eli Lilly and Company are establishing an innovative new pharmaceutical manufacturing scholarship program and have renewed their strategic research collaboration in a series of moves that will expand their impact in Indiana and improve lives on a global scale. Lilly has committed $92.5 million to the West Lafayette campus through these two programs. Lilly's commitment includes $42.5 million over 10 years to fund pharmaceutical manufacturing scholarships for incoming Purdue undergraduate students, offering 75-100 talented students each year full tuition with a guaranteed internship or co-op at Lilly and a promise of coordinated interaction with company leaders. 

NJIT Receives $3M Donation to Support Honors College Growth

Pioneering venture capitalist John Martinson is donating $3 million to the New Jersey Institute of Technology (NJIT) to broaden and deepen the curriculum and real-world experiences for top scholars at its Albert Dorman Honors College (ADHC) and throughout the university. The largest single gift in the 27 years of ADHC will enable the college to add two new educational tracks, triple the number of scholars in the Honors Summer Research Institute – more than double the number of scholars who study abroad – add internships and cooperative educational experiences, restructure its course offerings and create new opportunities for faculty affiliations in the college.

Governor Murphy Signs Legislation Expanding Access to STEM Education

Governor Phil Murphy signed legislation (S2563) amending the New Jersey Department of Education grant program for STEM teachers established by the Governor in 2019. Signed amid a nationwide teacher shortage, the law will incentivize public school STEM teachers to participate in the program and ensure that nonpublic school students have access to STEM education.The legislation expands the number of educators who are eligible to provide STEM instruction at nonpublic schools in addition to their public school duties. The law also broadens the hours at which public school teachers can teach at nonpublic schools, in addition to increasing teacher compensation for participating in the program.

Events

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“How to build a biotech company from academia. How is this trend reflected in NJ and how can it be accelerated”?

November 16, 2022

There are many factors that are involved in building an effective company out of an idea from academia. There needs to be an assessment of the potential for impact, a business plan needs to be created, investors need to be found, as well as other considerations. The topic for this Academy will focus on this life science start-up trend out of academia in New Jersey and discuss ways to attempt to perform this successfully and in a potentially accelerated way. Join us and offer your perspective on this issue.

Regional Biotechnology Conference Innovating Innovation: Leveraging Lessons from COVID-19

November 17, 2022

The Regional Biotechnology Conference is an annual conference that attracts more than 100 of the region’s movers and shakers for a half-day of dynamic speakers and topics that are important to start-up and early stage biotech company leaders. RBC seeks to provide an educational environment for biotechnology and related businesses, to help them establish and maintain their businesses and to leverage their technologies.

Genesis 2022

December 7, 2022

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

Princeton Chemical & Biological Engineering Graduate Student Symposium Networking Fair

December 9, 2022

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

New Jersey Academic Drug Discovery Consortium on Infectious Diseases

December 16, 2022

The New Jersey Academic Drug Discovery Consortium is delighted to host the 2022 annual meeting at the Institute for Life Science Entrepreneurship taking place on Friday, December 16 from 8:00 a.m. - 3:00 p.m. There will be presentations, networking opportunities, lunch, and poster sessions. Speakers include a keynote from David Perlin, CSO and SVP, from the Center for Discovery and Innovation and professor of medical sciences at the Hackensack Meridian School of Medicine; a scientific program featuring Jun Wang, Ph.D., and Purnima Bhanot, Ph.D., from Rutgers University, Thomas Dick from CDI-Hackensack Meridian, David Olsen from Merck, and a special presentation from Erin Duffy, Ph.D., CSO of CARBX.

Biotech Showcase: The Investor Conference for Innovators

January 9-11, 2023

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

Partner Spotlight

Email KMinton@BioNJ.org to connect you to this partner. 

For more information reach out to Save@BIO.org.

Please contact BioNJ with any questions.

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

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