Hands Off Bayh-Dole: Biden Administration Should Not Kill This ‘Golden Goose’ of Innovation

Sometimes Congress does something right, and one example is the Bayh-Dole Act of 1980. This bipartisan patent law is widely recognized as one of the great legislative achievements of the past 60 years. It has massively boosted innovation and economic growth by incentivizing researchers and universities to commercialize their new inventions by, paradoxically, removing them from public control by the government. The Biden administration has now announced a plan to twist this law to reimpose government control over these inventions in the form of price controls. This proposal would kill this “golden goose” of innovation.

115 Organizations Call on Congress to Reauthorize PAHPA

U.S. Senator Bill Cassidy, M.D. (R-LA), ranking member of the Senate Health, Education, Labor and Pensions (HELP) Committee, released a statement highlighting the 115 organizations (including BioNJ) who have called on Congress to reauthorize the bipartisan Pandemic and All-Hazards Preparedness Act (PAHPA). The legislation strengthens our nation’s public health readiness and ensures all institutions have the tools to respond to the next health crisis or emergency.

BioNJ Joins the Council of State Bioscience Associations (CSBA) and the Biotechnology Innovation Organization at the NYSE in Honor of Biotech Month

The New York Stock Exchange welcomes the Council of State Bioscience Associations (CSBA) and the Biotechnology Innovation Organization (BIO) to the podium in celebration of Biotechnology Month. #BioNJ was thrilled to participate in the ringing of the closing bell.

Meet BioNJ’s 2024 Innovator Award Company Honorees

BioNJ revealed new details about its upcoming 31st Annual Dinner Meeting & Innovation Celebration, which is considered the kickoff event of the year for the State’s life sciences sector. The event, being held Feb. 8 at the Hilton East Brunswick, brings together hundreds of biopharma professionals, academic leaders, patient advocates, service providers, government officials and other stakeholders to honor medical innovation taking place right here in the great Garden State. As NJBIZ reported last month, Insmed chair and CEO William Lewis will be presented the Dr. Sol J. Barer Award for Vision, Innovation, and Leadership at the dinner. The evening will also include the presentation of the Heart of BioNJ Awards; an inspirational Spoken Word by Lupus Warrior Shanelle Gabriel; the opportunity to network with industry leaders; a special keynote honoring patients from around the globe; and, of course, the presentation of its Innovator Awards. Click here for the list of Honorees.

Cyclacel Pharmaceuticals Reports Fadraciclib Phase 1 Data Suggesting Efficacy Against Tumors With CDKN2A, CDKN2B and MTAP Deletions

Berkeley Heights based BioNJ Member Cyclacel Pharmaceuticals, Inc. announced interim results from its Phase 1, dose escalation 065-101 study of fadraciclib (“fadra”) in patients with advanced solid tumors and lymphoma. “As we approach the end of the year, we are excited to report that fadra continues to demonstrate anticancer activity as a single agent based on interim data reviewed to date from our 065-101 study,” said Spiro Rombotis, President and Chief Executive Officer. “The data suggest tumor sensitivity in patients with one or more of three abnormalities, CDKN2A, CDKN2B and/or MTAP deletion subject to confirmation in further studies. We believe there is great unmet medical need and industry interest in the cancer patient populations identified by these abnormalities, which are closely located on chromosome 9 and are often co-deleted.”

Soligenix Announces Top-line Results of the Phase 2a Study of SGX302 (Synthetic Hypericin) in Patients With Mild-to-Moderate Psoriasis

Princeton-based BioNJ Member Soligenix announced preliminary top-line results of its ongoing Phase 2a trial of SGX302 (synthetic hypericin) for the treatment of mild-to-moderate psoriasis. In the expanded portion of the trial (Cohort 2), an additional five patients were enrolled and the treatment guidelines for use of light activation were adjusted to allow for a more rapid escalation and higher final dose level of light than in the initial cohort (Cohort 1) of patients, which is expected to more closely mirror the way the drug will eventually be used in a "real world" clinical setting. The Cohort 2 patients were treated more aggressively than the patients enrolled in Cohort 1 during an 18-week treatment period. SGX302 therapy was well tolerated by all patients with no drug related adverse events identified.

Soligenix Announces Publication Demonstrating Complete Protection Against Filovirus Disease in Nonhuman Primate Models of Ebola and Marburg Viruses

Princeton-based BioNJ Member Soligenix announced a publication describing the preclinical efficacy of a novel, single-vial, bivalent vaccine providing 100% protection against both Sudan ebolavirus (SUDV) and Marburg marburgvirus (MARV) infections. In collaboration with University of Hawaiʻi at Mānoa (UHM), the manuscript entitled "Thermostable bivalent filovirus vaccine protects against severe and lethal Sudan ebolavirus and marburgvirus infection", has been published in Vaccine. This vaccine candidate has been previously demonstrated to be stable to high temperature storage for at least 2 years at 40 degrees Celsius (104 degrees Fahrenheit). There are currently no approved vaccines or therapeutics for either SUDV or MARV infections. Vaccines are available for Zaire ebolavirus (EBOV) infections but they provide no protection against SUDV or MARV infection. 

European Medicines Agency Validates Bristol Myers Squibb’s Application for Repotrectinib for the Treatment of Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer and NTRK-Positive Solid Tumors

Princeton-based BioNJ Member Bristol Myers Squibb announced that the European Medicines Agency (EMA) has validated its marketing authorization application for the next-generation tyrosine kinase inhibitor (TKI) repotrectinib as a treatment for ROS1 TKI-naïve and -pretreated adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) and TKI-naïve and -pretreated adult and pediatric patients 12 years and older with NTRK-positive locally advanced or metastatic solid tumors. The application was based on results from the registrational Phase 1/2 TRIDENT-1 trial (adult patients with ROS1-positiveNSCLCor NTRK-positivesolid tumors) and CARE study (pediatric patients with NTRK-positive solidtumors). Validation of the application confirms the submission is complete and begins the EMA’s centralized review procedure.

Bristol Myers Squibb Strengthens Neuroscience Portfolio With Acquisition of Karuna Therapeutics

Princeton-based BioNJ Member Bristol Myers Squibb and Karuna Therapeutics, Inc. announced that they have entered into a definitive merger agreement under which Bristol Myers Squibb has agreed to acquire Karuna for $330.00 per share in cash, for a total equity value of $14.0 billion, or $12.7 billion net of estimated cash acquired. Karuna’s lead asset, KarXT (xanomeline-trospium), is an antipsychotic with a novel mechanism of action (MoA) and differentiated efficacy and safety. Karuna’s New Drug Application (NDA) for KarXT for the treatment of schizophrenia in adults was accepted for review by the U.S. Food and Drug Administration (FDA). KarXT is also in registrational trials both for adjunctive therapy to existing standard of care agents in schizophrenia and for the treatment of psychosis in patients with Alzheimer’s disease. 

Bristol Myers Squibb Adds Premier Radiopharmaceutical Platform With Acquisition of RayzeBio

Princeton-based BioNJ Member Bristol Myers Squibb and RayzeBio, Inc. announced a definitive merger agreement under which Bristol Myers Squibb will acquire RayzeBio for $62.50 per share in cash, for a total equity value of approximately $4.1 billion, or $3.6 billion net of estimated cash acquired. RayzeBio is a clinical-stage radiopharmaceutical therapeutics (“RPT”) company with an innovation-leading position in actinium-based RPTs and a pipeline of potentially first-in-class and best-in-class drug development programs. Current pipeline programs are targeting the treatment of solid tumors, including gastroenteropancreatic neuroendocrine tumors (GEP-NETs), small cell lung cancer, hepatocellular carcinoma and other cancers. There remains a high, unmet need for more effective treatments in solid tumors, and RPTs enable a precision approach to patient treatment. RPTs bind to tumor cells and deliver targeted radiation to induce cancer cell death. 

FDA Approves Label Update for BRUKINSA® (zanubrutinib) in Chronic Lymphocytic Leukemia (CLL)

Hopewell-based BeiGene announced the U.S. Food and Drug Administration (FDA) has approved a label update for BRUKINSA® (zanubrutinib) to include superior progression-free survival (PFS) results from the Phase 3 ALPINE trial comparing BRUKINSA against IMBRUVICA® (ibrutinib) in previously treated patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL). “The ALPINE trial is the first and only study to demonstrate PFS superiority in a head-to-head comparison versus ibrutinib in CLL,” said Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene. “BRUKINSA was approved in the U.S. for CLL at the beginning of 2023, and we submitted additional data from the ALPINE PFS analysis supporting it as the BTK inhibitor of choice in CLL, solidifying it as an important treatment option for patients.”

Organon & Lilly Enter Commercialization Agreement in Europe for Two Migraine Medicines

Jersey City-based BioNJ Member Organon announced an agreement with BioNJ Member Eli Lilly and Company, with a site in Branchburg, to become the sole distributor and promoter for the migraine medicines Emgality® (galcanezumab) and RAYVOW™(lasmiditan) in Europe. Emgality, a humanized monoclonal antibody calcitonin gene-related peptide (CGRP) antagonist, is indicated for the prophylaxis of migraine in adults who have at least four migraine days per month. RAYVOW is a first-in-class serotonin 5-HT1F receptor agonist approved for the acute treatment of the headache phase of migraine attacks, with or without aura in adults. “This commercialization agreement aligns seamlessly with Organon’s suite of central nervous system treatments in our Established Brands portfolio and, most importantly, it further bolsters our offerings to women, who are disproportionately impacted by migraine,” said Kevin Ali, Organon CEO. 

Lilly Completes Acquisition of POINT Biopharma

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced the successful completion of its acquisition of POINT Biopharma Global Inc., a radiopharmaceutical company with a pipeline of clinical and preclinical-stage radioligand therapies in development for the treatment of cancer. "Next generation radioligand therapies hold great promise for delivering meaningful advances against a range of cancers and we are excited to enter this space through the addition of POINT," said Jacob Van Naarden, Executive Vice President and President, Loxo@Lilly. "We welcome POINT colleagues to Lilly and look forward to working together to build on their work as we create this new capability within Lilly. In time, I hope we can bring several new radioligand therapies to patients with cancer and improve their outcomes."

Lilly Launches End-to-End Digital Healthcare Experience Through LillyDirect™

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced LillyDirect™, a new digital healthcare experience for patients in the U.S. living with obesity, migraine and diabetes. LillyDirect offers disease management resources, including access to independent healthcare providers, tailored support, and direct home delivery of select Lilly medicines through third-party pharmacy dispensing services. "A complex U.S. healthcare system adds to the burdens patients face when managing a chronic disease. With LillyDirect, our goal is to relieve some of those burdens by simplifying the patient experience to help improve outcomes," said David A. Ricks, Lilly's Chair and CEO. "LillyDirect offers more choices in how and where people access healthcare, including a convenient home delivery option to fill Lilly medicines they have been prescribed."

EMA Gives Positive Opinion to Fexinidazole Winthrop as First Oral Treatment of Acute Form of Sleeping Sickness (rhodesiense) Found in East and Southern Africa

Bridgewater-based BioNJ Member Sanofi, DNDi and the HAT-r-ACC consortium announce the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive scientific opinion of Fexinidazole Winthrop as first oral treatment of acute form of sleeping sickness (rhodesiense). This positive opinion is for the treatment in adults and children six years of age or older and weighing at least 20 kg, of both first-stage (haemo-lymphatic) and second-stage (meningo-encephalitic) Trypanosoma brucei (T.b.) rhodesiense sleeping sickness, an acute and lethal form of this parasitic disease found in Eastern and Southern Africa. This CHMP opinion follows an application by Sanofi under Article 58 and clinical trials in Malawi and Uganda led by the non-profit medical research organization Drugs for Neglected Diseases initiative (DNDi). 

First Wave BioPharma Announces Entry into Term Sheet for Business Combination With ImmunogenX Establishing a Leading Late-Stage GI-Focused Biopharmaceutical Company

BioNJ Member First Wave BioPharma, Inc., announced that the company has signed a non-binding term sheet for a business combination with ImmunogenX, a clinical-stage biotherapeutics company developing Phase 3-ready latiglutenase, a potentially first-in-class, targeted, oral biotherapeutic for celiac disease. Pursuant to the term sheet, First Wave BioPharma will acquire ImmunogenX in an all-stock transaction with the combined company focused on advancing a GI pipeline comprised of multiple late-stage clinical assets, including latiglutenase and capeserod, which First Wave BioPharma recently in-licensed from BioNJ Member Sanofi. Following consummation of the transaction, First Wave BioPharma will continue to trade on Nasdaq under the ticker symbol “FWBI”. 

Evotec Receives US$ 2.5 m Grant to Leverage Human iPSC-derived Teratogenicity Platform for Global Health Programmes

Princeton-based BioNJ Member Evotec announced that the company has received a US$ 2.5 m grant from the Bill & Melinda Gates Foundation (“the foundation”) for its teratogenicity platform and joins the foundation’s prestigious Global Health Discovery Collaboratory (“GHDC”), a network of researchers, centres of excellence, and technology platforms working together to accelerate the discovery and translation of global health interventions. Potential teratogenicity of drug candidates, i.e., their ability to cause defects in a developing foetus, is usually assessed very late in the drug discovery process using time- and cost-intensive in vivo models. Using human induced pluripotent stem cell (“iPSC”) technology, Evotec has developed an in vitro teratogenicity platform with high-throughput capability, which enables cost effective de-risking of drug candidates early in the drug discovery process. 

Johnson & Johnson Submits Supplemental Biologics License Application and New Drug Application to U.S. FDA Seeking Approval of RYBREVANT® (amivantamab-vmjw) Plus Lazertinib for the Treatment of Patients With EGFR-Mutated Non-Small Cell Lung Cancer (NSCLC)

Raritan-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) together with a New Drug Application (NDA) seeking the approval of RYBREVANT® (amivantamab-vmjw) in combination with lazertinib for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or L858R substitution mutations, as detected by an FDA-approved test. Based on the Phase 3 MARIPOSA study, this marks the third submission from the RYBREVANT® clinical development program in four months, following sBLA submissions for MARIPOSA-2 and PAPILLON.

Janssen Submits Marketing Authorization Application to the European Medicines Agency Seeking Approval of Lazertinib, in combination With RYBREVANT®▼ (amivantamab), for the First-Line Treatment of Patients With EGFR-Mutated Non-Small Cell Lung Cancer

Raritan-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a marketing authorization application (MAA) to the European Medicines Agency (EMA) seeking approval of lazertinib, in combination with RYBREVANT®▼(amivantamab), for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with common epidermal growth factor receptor (EGFR) mutations including exon 19 deletions (ex19del) or exon 21 L858R (L858R) substitution mutations. MARIPOSA (NCT04487080) is a randomised, Phase 3 study evaluating amivantamab in combination with lazertinib compared to osimertinib in the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR ex19del or L858R substitution mutations. The MARIPOSA study met its primary endpoint, resulting in statistically significant and clinically meaningful improvement in progression-free survival (PFS) for amivantamab plus lazertinib versus osimertinib, as assessed by blinded independent central review (BICR).

GSK Enters Exclusive License Agreement With Hansoh for HS-20093

Warren-based BioNJ Member GSK and Hansoh Pharma announced that they have entered into an exclusive license agreement for HS-20093, a B7-H3 targeted antibody-drug conjugate (ADC) utilizing a clinically validated topoisomerase inhibitor (TOPOi) payload. Under the agreement, GSK will obtain exclusive worldwide rights (excluding China’s mainland, Hong Kong, Macau, and Taiwan) to progress clinical development and commercialization of HS-20093. Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: “B7-H3 is highly expressed in a broad range of solid tumours where there remains a significant need for novel treatment options. We look forward to progressing this potential new treatment across several indications and in future potential combination approaches with our established portfolio.”

Jemperli (dostarlimab) plus Zejula (niraparib) Combination Significantly Improved Progression-free Survival in Primary Advanced or Recurrent Endometrial Cancer in RUBY Part 2 Phase III Trial

Warren-based BioNJ Member GSK announced positive headline results from a planned analysis of Part 2 of the RUBY/ENGOT-EN6/GOG3031/NSGO Phase III trial investigating Jemperli (dostarlimab) plus standard-of-care chemotherapy (carboplatin and paclitaxel), followed by dostarlimab plus Zejula (niraparib) as maintenance therapy, in adult patients with primary advanced or recurrent endometrial cancer. The trial, which evaluated this combination against placebo plus chemotherapy followed by placebo, met its primary endpoint of progression-free survival (PFS), with a statistically significant and clinically meaningful benefit observed in both the overall patient population and in a subpopulation of patients with mismatch repair proficient/microsatellite stable (MMRp/MSS) tumors. Analysis of the full trial data, including the key secondary endpoint of overall survival (OS), is ongoing. OS data is immature and will continue to be followed.

Gilead and Compugen Announce Exclusive License Agreement for Novel Pre-Clinical Immunotherapy Program

BioNJ Member Gilead Sciences, with a site in Morris Plains, announced an agreement with Compugen Ltd. to exclusively license its potential first-in-class, pre-clinical antibody program against IL-18 binding protein, including the COM503 drug candidate. Compugen utilizes its broadly applicable predictive computational discovery capabilities to identify new drug targets and biological pathways for developing novel cancer immunotherapies. COM503 is a potential first-in-class, high affinity antibody which blocks the interaction between IL-18 binding protein and IL-18, thereby releasing natural IL-18 in the tumor microenvironment and inhibiting cancer growth. “We believe that this collaboration complements our strategy of developing modalities which promote immune-mediated tumor killing and may enable new combination therapies with programs in our growing oncology portfolio,” said Flavius Martin, M.D., Executive Vice President, Research, Gilead Sciences.

Novo Nordisk Enters into Research Collaborations With Omega Therapeutics and Cellarity on Novel Treatment Approaches for Cardiometabolic Diseases

Plainsboro-based BioNJ Member Novo Nordisk, Omega Therapeutics, Inc. and Cellarity Inc. announced that Novo Nordisk has entered into separate research collaborations with each company. The Omega collaboration will leverage its proprietary platform technology to develop an epigenomic controller designed to enhance metabolic activity as a part of a potential new treatment approach for obesity management. The Cellarity collaboration aims to unravel novel biological drivers of MASH and will leverage Cellarity’s platform to develop a small molecule therapy against this disease. These are the first two programs signed under the framework collaboration between Flagship Pioneering and Novo Nordisk to leverage Flagship’s bioplatform companies to develop novel treatment approaches for cardiometabolic diseases.

Novartis Signs Gene Therapy Deal With Voyager for $100 mln Upfront

East Hanover-based BioNJ Member Novartis announced it will pay $100 million upfront to Voyager Therapeutics as part of a licensing deal to develop gene therapy candidates for genetic disorders. The gene therapy developer would provide Novartis access to its RNA-based screening platform — which helps in rapid discovery of experimental gene therapies — and would also be eligible for tiered royalties on global sales of products developed using the platform. The companies would collaborate to develop a pre-clinical gene therapy candidate for Huntington's disease (HD). Voyager would advance the pre-clinical development and Novartis would be responsible for all clinical studies and commercialization for the HD candidate. Novartis would also gain access to Voyager's platform for discovery and development of potential gene therapies for treating spinal muscular atrophy.

Boehringer Ingelheim Licenses a New Compound as Part of its Commitment to People Living With Fibro-inflammatory Diseases​ from Kyowa Kirin

BioNJ Member Boehringer Ingelheim, with a site in North Brunswick, and BioNJ Member Kyowa Kirin Co. announced that they have entered into a license agreement to develop a novel, first-in-class treatment for fibro-inflammatory diseases. The new development program is part of Boehringer Ingelheim’s commitment to combat fibro-inflammatory diseases by developing breakthrough therapies, building on the company’s expertise and leadership in this disease area, to improve patient outcomes. Under the terms of the agreement, Boehringer Ingelheim will receive exclusive, worldwide rights from Kyowa Kirin to develop novel, first-in-class treatments for fibro-inflammatory diseases. Fibro-inflammatory diseases result from chronic inflammation caused by a variety of factors including persistent infections, autoimmune reactions, allergic responses and tissue injury. Examples are systemic sclerosis, inflammatory bowel disease, lung fibrosis and others. 

Boehringer Ingelheim and 3T Biosciences Enter into a Second Partnership to Develop Next-Generation Cancer Immunotherapies

BioNJ Member Boehringer Ingelheim, with a site in North Brunswick, announced

PADCEV® (enfortumab vedotin-ejfv) With KEYTRUDA® (pembrolizumab) Approved by FDA as the First and Only ADC Plus PD-1 to Treat Advanced Bladder Cancer

BioNJ Member Pfizer, with a site in Peapack, and Astellas Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has approved PADCEV® (enfortumab vedotin-ejfv, an antibody-drug conjugate [ADC]) with KEYTRUDA® (pembrolizumab, a PD-1 inhibitor) for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC). This combination is the first approved to offer an alternative to platinum-containing chemotherapy, the current standard of care in first-line la/mUC. The approval is based on results from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39), which demonstrated the combination nearly doubled median overall survival (OS) and median progression-free survival (PFS) in patients with previously untreated la/mUC compared to platinum-containing chemotherapy. 

FDA Approves Expanded Indication for KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) for the First-Line Treatment of Adult Patients With Locally Advanced or Metastatic Urothelial Cancer

Rahway-based BioNJ Member Merck & Co. announced the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate, for the treatment of adult patients with locally advanced or metastatic urothelial cancer. The FDA approved this application nearly five months ahead of the PDUFA goal date of May 9, 2024. The approval is based on data from the Phase 3 KEYNOTE-A39 trial (also known as EV-302) in 886 patients with locally advanced or metastatic urothelial cancer, which was conducted in a research collaboration with Pfizer (previously Seagen) and Astellas.

European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy for New First-Line Indications in Advanced HER2-Negative Gastric or GEJ Adenocarcinoma in Tumors Expressing PD-L1 (CPS ≥1) and Advanced Biliary Tract Cancer

Rahway-based BioNJ Member Merck & Co. announced the European Commission (EC) has approved two new indications for KEYTRUDA, Merck’s anti-PD-1 therapy, in gastrointestinal cancers: KEYTRUDA in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma in adults whose tumors express PD-L1 with a Combined Positive Score (CPS) ≥1; KEYTRUDA in combination with gemcitabine and cisplatin for the first-line treatment of locally advanced unresectable or metastatic biliary tract carcinoma (BTC) in adults. These approvals by the EC follow positive recommendations from the Committee for Medicinal Products for Human Use received in October 2023 and November 2023 and were based on overall survival (OS) results from the Phase 3 KEYNOTE-859 and KEYNOTE-966 trials, respectively.

FDA Grants Priority Review to Merck’s New Biologics License Application for V116, an Investigational, 21-valent Pneumococcal Conjugate Vaccine Specifically Designed to Protect Adults

Rahway-based BioNJ Member Merck & Co. announced the U.S. Food and Drug Administration (FDA) has accepted for priority review a new Biologics License Application (BLA) for V116, the company’s investigational 21-valent pneumococcal conjugate vaccine specifically designed to help prevent invasive pneumococcal disease and pneumococcal pneumonia in adults. The FDA grants priority review to medicines and vaccines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment or prevention of a serious condition. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action date, of June 17, 2024. The BLA for V116 is based, in part, on data from STRIDE-3, a pivotal Phase 3 trial which evaluated the immunogenicity, tolerability and safety of V116 compared to PCV20 (pneumococcal 20-valent conjugate vaccine) in adults who had not previously received a pneumococcal vaccine.

Patritumab Deruxtecan Granted Priority Review in the U.S. for Certain Patients With Previously Treated Locally Advanced or Metastatic EGFR-Mutated Non-Small Cell Lung Cancer

Rahway-based BioNJ Member Merck & Co. and Basking Ridge-based Daiichi Sankyo announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to the Biologics License Application (BLA) for patritumab deruxtecan (HER3-DXd) for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) previously treated with two or more systemic therapies. The Prescription Drug User Fee Act (PDUFA) date, the FDA action date for their regulatory decision, is June 26, 2024. The Priority Review follows receipt of Breakthrough Therapy Designation granted by the FDA in December 2021. Patritumab deruxtecan is a specifically engineered potential first-in-class HER3 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by Daiichi Sankyo and Merck & Co.

Two Phase 3 Trials of Datopotamab Deruxtecan Plus Durvalumab Initiated in Patients Across Two Breast Cancer Subtypes

The first patient has been dosed in two global, randomized Phase 3 trials evaluating the efficacy and safety of Basking Ridge-based Daiichi Sankyo and AstraZeneca’s datopotamab deruxtecan (Dato-DXd) in combination with durvalumab, AstraZeneca’s anti-PD-L1 therapy, in two types of breast cancer. Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo and AstraZeneca. TROPION-Breast04 is evaluating neoadjuvant datopotamab deruxtecan plus durvalumab followed by adjuvant durvalumab with or without chemotherapy in patients with stage II-III triple negative breast cancer (TNBC) or hormone receptor (HR) low, HER2 low or negative breast cancer. TROPION-Breast05 is evaluating datopotamab deruxtecan alone and in combination with durvalumab in patients with locally recurrent inoperable or metastatic TNBC whose tumors express PD-L1 (CPS ≥ 10).

Eisai Submits Marketing Authorization Application in Japan for Anticancer Agent TASURGRATINIB for Biliary Tract Cancer With FGFR2 Gene Fusion

Nutley-based Eisai announced that it has submitted a marketing authorization application in Japan for its in-house discovered fibroblast growth factor (FGF) receptor (FGFR1, FGFR2, FGFR3) selective tyrosine kinase inhibitor tasurgratinib succinate (generic name, development code: E7090, “tasurgratinib”) for biliary tract cancer with FGFR2 gene fusion. In Japan, tasurgratinib has received orphan drug designation for a prospective indication for unresectable biliary tract cancer with FGFR2 gene fusion by the Ministry of Health, Labour and Welfare, (MHLW). Under this system, this application will be subject to priority review. This application is based on the results of a multicenter, open-label, single-arm clinical Phase II trial (Study 201) in Japan and China conducted by Eisai. Study 201 enrolled patients with unresectable biliary tract cancer with FGFR2 gene fusion previously treated with gemcitabine-based combination chemotherapy. 

Development of Prediction Model for Brain Amyloid-Beta Accumulation Using Wristband Sensor

Oita University and Nutley-based Eisai announced the development of the world's first machine learning model to predict amyloid beta (Aβ) accumulation in the brain using a wristband sensor. This model is expected to enable screening for brain Aβ accumulation, which is an important pathological factor of Alzheimer's disease (AD), simply by collecting biological and lifestyle data from daily life. The details of this model were published in the online edition of the peer-reviewed medical journal Alzheimer's Research & Therapy. Currently, although brain Aβ accumulation can be detected by positron emission tomography (amyloid PET) and cerebrospinal fluid testing (CSF testing), the number of medical institutes able to perform those tests is limited, and the high cost and invasiveness of these tests are considered issues. 

NYC Life Sciences Firm Relocates to Thor Equities’ Lab-Ready Property in Jersey City

JLL recently announced that it has arranged a long-term lease for RegenLab USA at 95 Greene St., the new lab-ready life sciences property developed by Thor Equities Group in Jersey City. RegenLab USA, which manufactures devices for the production of regenerative cell therapy, will relocate from the Brooklyn Army Terminal in New York to occupy 15,792 square feet across the sixth floor of the recently completed property in the second quarter. The company will use the space for office, research and manufacturing of medical devices and platelet-rich plasma products. Originally built as a manufacturing plant for Colgate Palmolive, 95 Greene St. is an eight-story, 350,000-square-foot property redeveloped by Thor to meet surging demand from life science companies seeking custom space in well-located markets.

Dr. Reddy’s Acquires MenoLabs, Leading Women’s Health and Dietary Supplements Portfolio

Princeton-based Dr. Reddy’s Laboratories on Wednesday announced it will acquire women’s health and dietary portfolio MenoLabs from Amyris Inc. The MenoLabs supplements portfolio includes seven branded products designed to provide health support and address symptoms of perimenopause and menopause. The deal also includes the MenoLife health tracker app, which supports the product line and provides community, education and information to consumers regarding menopause. “The MenoLabs acquisition will serve as a catalyst to accelerate growth in this space and build upon our aspiration to lead in the fast-growing women’s nutritional and wellness markets,” Marc Kikuchi, CEO for Dr. Reddy’s in North America, said. “The acquisition complements Dr. Reddy’s U.S. self-care and wellness business portfolio of brands and addresses unmet needs of consumers for science-based, research-driven products that provide relief from the symptoms of menopause.”

Murphy to Announce Plans for AI Center in Princeton Today

Gov. Phil Murphy announced at Princeton University plans to establish a spot for generative artificial intelligence research & development in the state, numerous people told ROI-NJ. Details are limited, but such an announcement, scheduled for 11 a.m. at the school, has long been hinted at by the governor himself. Murphy mentioned it throughout his recent nine-day trip to East Asia — and, just last week, when Nokia Bell Labs announced it was staying in New Jersey, relocating to the HELIX in New Brunswick. Murphy, on that day, said the state has the science, technology, engineering & mathematics talent to compete with Silicon Valley, where so much of the AI research currently is located.

BioCentriq Secures $29.2M Investment to Accelerate Cell Therapy Innovation

BioCentriq, a Newark-based cell-based therapy contract development and manufacturing organization, raised $29.2 million in Series A funding. The company intends to use the funds to enhance its facilities, invest in advanced technologies and expand its team. The funding round marks a significant milestone in BioCentriq’s mission to accelerate delivery of innovative cell therapies by translating, optimizing and scaling processes for GMP manufacture. “We are thrilled to announce the successful completion of our latest fundraising round, which reflects the confidence of our investors in BioCentriq’s vision and capabilities,” James Park, BioCentriq chairman of the board and interim CEO, said. “This capital injection positions us strongly to continue driving innovation in cell therapy development, enabling our partners to bring transformative treatments to patients around the world.”

Johnson & Johnson CEO Discusses Branding and Leadership With Steve Adubato

Steve Adubato welcomes Joaquin Duato, Chairman of the Board and CEO of Johnson & Johnson, to talk about leadership, branding, sustainability, and the future frontiers in health innovation.

BioAegis Announces Appointment of New Chief Medical Officer

Morristown-based BioNJ Member BioAegis is pleased to announce that Howard Levy M.B.B.Ch., Ph.D., M.M.M., will assume the role of Chief Medical Officer, as they plan for execution of Phase 2 Acute Respiratory Distress Syndrome study. Dr. Levy brings a wealth of knowledge and experience in drug development, having managed multiple global clinical studies. Dr. Levy joins BioAegis with over 25 years of experience in the pharmaceutical industry with a focus on critical care therapeutic areas. He practiced as an intensivist with specialty board certification in Internal Medicine, Pulmonary and Intensive Care. Since 2010 he has advised public and private biotechnology and medical device companies on clinical and drug development strategy and execution. 

Evotec Announces CEO Transition

Princeton-based BioNJ Member Evotec SE announced that after close to 15 years of successful service, CEO Dr. Werner Lanthaler has informed the company, that he will not continue to serve until the end of his current term (March 2026), for personal reasons. Dr. Lanthaler will support a smooth and prompt transition of ongoing projects in the coming weeks. He will continue to be available as a strategic advisor to the company’s Supervisory Board, especially in the company’s activities for better access to medicines in Africa and less developed countries in Asia. The Supervisory Board has started an internal and external search for a permanent CEO. In the meantime, Dr Mario Polywka, currently Supervisory Board member and former COO of Evotec, agreed to serve as interim CEO.

CorMedix Inc. Appoints Chief Legal Officer

Berkeley Heights-based CorMedix Inc. announced they have appointed Beth Zelnick Kaufman as Executive Vice President, Chief Legal Officer and Corporate Secretary. Ms. Zelnick Kaufman has more than two decades of legal, compliance and operations experience in the life sciences industry. Prior to joining CorMedix, she most recently served as Chief Legal and Administrative Officer and Corporate Secretary of Akorn Pharmaceuticals, a specialty and generic pharmaceuticals company. Ms. Zelnick Kaufman also served in several roles at Amneal Pharmaceuticals, a publicly traded global generics, biosimilars and branded pharmaceuticals company, including roles as assistant general counsel; vice president, legal affairs and head of government affairs.

Achieving Health Equity in Life Sciences

An article by BioNJ Member Deloitte

To meet the evolving health needs of society, life sciences companies need to make health equity a social and business imperative. With a companywide commitment to achieving health equity, the industry could see stronger bottom lines and better consumer engagement — in addition to better health outcomes. Advancing health equity is, of course, the right thing to do, but it can also benefit the life sciences businesses themselves in tangible ways. Companies that invest in reaching patient populations with no previous access to their products can develop more equitable offerings and services, while potentially increasing their market size, market share, and return on investment. This can result in growth in overall margin dollars, which can be particularly important for products focused on lower-prevalence diseases.

BioNJ Market Maker, Preferred and Executive Members are invited to send articles/white papers to RBromberg@BioNJ.org to be considered for inclusion in the Thought Leadership Section.

Biotech Showcase

Hosted by Informa Connect

January 8–10, 2024 | San Francisco, CA

As a supporter of the Biotech Showcase — an all-inclusive healthcare conference devoted to providing private and micro-mid-cap biotechnology companies an opportunity to present to and meet with investors and biopharmaceutical executives — BioNJ Member companies receive a $200 discount off your registration fees. Contact RBromberg@BioNJ.org for details.

2024 Rutgers - New Brunswick Winter Career & Internship Mega Fair

Thursday, February 1, 2024 & Friday, February 2, 2024

Rutgers, New Brunswick is delighted to see your organization's interest in attending the 2024 Winter Career & Internship Mega Fair. Students and alumni from all Rutgers University campuses (New Brunswick, Camden, Newark and RBHS) from all majors are invited to attend. The event is scheduled to take place at the Jersey Mike's Arena from 11:30 a.m. to 3:30 p.m.