Bryn Pharma

Jul 28, 2023

Weekly Quick Hits (Research Triangle Park) – Week of July 24, 2023 RTP’s life sciences ecosystem is bouncing back this week with the launch of a new company, Kincell Bio, as well as new financing announcements. Inceptor Bio spins out new company Kincell Bio, which aims to improve accessibility for cell therapy development and manufacturing. RedHill Biopharma and Kriya Therapeutics both announced new funding streams. By Alex Keown July 28, 2023 Quick Hits is BioBuzz’s weekly round up of all the life science news you don’t want to miss, in your region of interest. Don’t miss a beat; SUBSCRIBE to our weekly Quick Hits newsletter via LinkedIn ( BioHealth Capital Region , Greater Philadelphia , Research Triangle Park) or get it delivered to your inbox every week. Funding, Awards and Collaborations Kincell Bio Launches to Make Accessible Cell Therapy Development and Manufacturing Kincell Bio, a technology-forward contract development and manufacturing organization (CDMO) focused on cell therapies, emerged from stealth with $36 million in new funding. Based in Raleigh, Kincell is a spinout of Inceptor Bio’s CMC, manufacturing and quality organizations. Kincell offers analytical development, process development, CMC consulting and early-stage GMP manufacturing focusing on immune cell therapies, including autologous and allogeneic CAR-T, CAR-NK and CAR-M programs. The company plans to establish in-house mRNA development and additional GMP manufacturing capacity while forging trusted partnerships for viral vector and plasmid DNA supply to support all cell engineering processes. RedHill Receives Federal Funding for Opaganib Nuclear Countermeasure Development Raleigh’s RedHill Biopharma was awarded $1.7 million in U.S. Government funding, via a Small Business Innovation Research (SBIR) grant. The funds will go to the company’s development partner, Apogee Biotechnology Corporation, and will support research to further the development of opaganib as a medical countermeasure for gastrointestinal acute radiation syndrome. This grant is in addition and complementary to the multimillion dollar-valued U.S. Government Radiation and Nuclear Countermeasures Program for ARS development. Harpe Bioherbicide Awarded NSF Grant To Study Weed Resistance Agtech company Harpe BioHerbicide Solutions, Inc. secured a grant from the U.S. National Science Foundation that will fund research using its bioherbicide formulations derived from natural plant extracts to control weeds resistant to synthetic herbicides. The NSF grant totaling $275,000 was awarded to Harpe BioHerbicides as a Small Business Innovation Research (SBIR) Phase I project titled, “Safe control of herbicide-resistant weeds with a novel natural bioherbicide platform.” Harpe’s portfolio of products, which features new sites and modes of action, offer wide-spectrum control of broadleaf and grass seeds or weeds. Kriya Announces $150 Million Addition to its Series C Kriya Therapeutics, Inc., which has a significant presence in RTP, announced the addition of over $150 million in capital committed as part of its Series C financing. That brings the total Series C round to over $430 million. Proceeds from the financing will support the clinical translation of Kriya’s broad pipeline of gene therapies and continued scaling of its engineering, computational and manufacturing platforms. Since its founding in October 2019, Kriya has raised over $600 million in committed capital —and with this financing, Kriya’s cash runway is anticipated to run into late 2026. Asensus Surgical Announces $10 Million Registered Direct Offering Asensus Surgical entered into a definitive agreement for the purchase and sale of an aggregate of 23,809,524 shares of its common stock and warrants to purchase 23,809,524 shares of common stock in a registered direct offering. The shares of common stock and accompanying warrants are being sold at a combined purchase price of $0.42 per share and accompanying warrant to purchase one share of common stock. In the Clinic GeneCentric Therapeutics Data Shows Clinical Benefit of Lung Cancer Treatment Durham-based GeneCentric Therapeutics published initial results from the ongoing Piedmont study using real-world data in lung cancer to develop its novel RNA-based Antifolate Predictive Response Signature (AF-PRS), which is being co-developed as a clinical diagnostic test with LabCorp. Results showed 53% of patients that were AF-PRS(+) had extended progression-free survival versus those who were AF-PRS(-). Furthermore, the significant PFS difference was even more pronounced between AF-PRS(+) and AF-PRS(-) patients who were non-metastatic. When examining clinical response to therapy, 79% of patients demonstrating a complete response were AF-PRS(+). The retrospective analysis was published in the peer-reviewed journal Clinical Cancer Research. Humacyte Completes Phase II/II Enrolment in HAV Trial for Vascular Trauma Repair Durham-based Humacyte, Inc. completed enrollment of its Phase II/III vascular trauma trial that is expected to support a BLA filing for Humacyte’s HAV in vascular trauma repair. The HAV, an innovative regenerative medicine product candidate, is designed to provide surgeons with an off-the-shelf bioengineered human artery that has been observed to repopulate with the patient’s own cells to provide a durable, infection-resistant replacement for damaged and diseased arteries. Results from the Phase 2/3 vascular trauma trial are intended to support a BLA filing with the FDA, planned for the fourth quarter 2023. Cessation Therapeutics Will Initiate Trial of Antibody for Prevention of Fentanyl Overdose Chapel Hill-based Cessation Therapeutics received FDA clearance to initiate a clinical trial for CSX-1004, a monoclonal antibody designed specifically to prevent fentanyl overdose. The clearance follows the FDA’s review and approval of Cessation’s Investigational New Drug (IND) application and serves as a launching point for Cessation’s first-in-human clinical trials. CSX-1004 works by sequestering fentanyl molecules as they enter the bloodstream, effectively neutralizing them in the blood before they reach the brain and preventing them from exerting their harmful effects. New Products Labcorp OnDemand Offers Menopause Test to Consumers LabCorp now offers menopause testing through its Labcorp OnDemand digital health platform. Recent studies show more than 60% of women do not feel informed about menopause or the associated symptoms and only 38% of women who are approaching menopause age have discussed it with their providers. Labcorp OnDemand’s Menopause Test aims to help individuals understand hormonal factors related to menopause in order to take proactive steps to address symptoms and have more informed conversations with providers. Marius Pharmaceuticals Launches ReThink Testosterone Initiative for Patients Raleigh-based Marius Pharmaceuticals launched a disease state awareness website, ReThink Testosterone. Low testosterone, also known as male hypogonadism, affects millions of men worldwide, often impacting their overall health and well-being. However, misconceptions and stigma have created barriers to understanding and seeking appropriate treatment. ReThink Testosterone is a comprehensive online resource designed to address this gap, equipping men with knowledge to make informed decisions about their health. New Patents United Therapeutics Wins Appeal in Dry Powder Inhaler Patent Litigation United Therapeutics Corporation, which has a significant presence in Durham, announced that the United States Court of Appeals for the Federal Circuit affirmed the district court decision in the patent litigation United Therapeutics brought against Liquidia Technologies, Inc. The Federal Circuit affirmed that Liquidia’s proposed Yutrepia product infringes on United Therapeutics’ patent, U.S. Patent No. 10,716,793. As a result, the FDA cannot grant Liquidia final approval for its Yutrepia product until the 2027 expiration of the ’793 patent, except in certain circumstances. Research Roundup CoImmune Publishes Preclinical Results with SEAKER Cells in Solid Tumor Melanomas CoImmune, Inc., based in Durham, announced the publication of preclinical results with Synthetic Enzyme-Armed Killer (SEAKER) cells in solid tumor melanomas in the peer-reviewed journal Cancer Immunology Research. The published paper is entitled, “Host Interactions with Engineered T cell Micropharmacies.” The work evaluates SEAKER cells designed to target solid-tumor melanomas in syngeneic mouse models using specific targeting with T cell receptor (TCR) engineered T cells. Results demonstrate that SEAKER cells localize specifically to tumors and activate bioactive prodrugs, providing efficacy against melanoma tumors in immunocompetent hosts. Aging Process Slows When Older Mice Share Circulatory System of Young Duke researchers found that surgically joining the circulatory systems of a young and old mouse slows the aging process at the cellular level and lengthens the lifespan of the older animal by up to 10%. The longer the animals shared circulation, the longer the anti-aging benefits lasted once the two were no longer connected, according to reports. The Duke research was published in the journal Nature Aging. Researchers Discover Genetic Locations for Increased Risk of Hidradenitis Suppurativa UNC School of Medicine researchers discovered the genomic locations that contribute to the genetic risk of a chronic skin condition. The researchers homed in on genetic risk loci – or specific locations on the genome – which contribute to one’s genetic risk of developing hidradenitis suppurativa. The research was published in JAMA Dermatology. On the Hill – Regulatory and Advocacy Precision BioSciences Provides Updates on Azer-Cel FDA Meeting Durham-based Precision BioSciences, a gene editing company developing ARCUS-based in vivo gene editing and ex vivo allogeneic CAR T therapies, received final meeting minutes from its recent Type B End of Phase I meeting with the FDA for its lead investigational allogeneic CAR T therapy azercabtagene zapreleucel (azer-cel). The meeting with the FDA provided clarity and direction on azer-cel development, including a potential pathway toward registration, the company said. Based on the advice received from the FDA and clinical data shared during the May 2023 CAR T update, Precision is currently advancing discussions with multiple potential strategic partners for its cell therapy assets, including hematologic and non-hematologic applications. People on the Move Creyon Bio Expands Senior Leadership Team with Two Appointments Creyon Bio, which is developing novel gene-centric medicines, announced that Jason Ferrone and Robert Muir have joined the executive leadership team. Ferrone has been appointed as Chief Operating Officer and General Counsel and Muir has been named Chief Financial Officer. Prior to joining Creyon Bio, Ferrone co-founded Intrinsic Medicine, serving as resident and Chief Operating Officer. Prior to this, Muir served as a successful senior analyst at Berenberg and at Morgan Stanley in London. Chiesi USA CEO Appointed to ASHP Foundation Board of Directors Chiesi USA, a Cary-based specialty pharmaceutical company, announced that Jon Zwinski, CEO and General Manager at Chiesi USA, has been appointed to the American Society of Health-System Pharmacists Foundation Board of Directors. Zwinski will serve a two-year term on the board, effective June 1, 2023. The board’s first official meeting of the year will be in October at the ASHP headquarters in Bethesda, Maryland. Bryn Pharma Expands Leadership Team as it Prepares for Utuly Commercialization Privately-held Bryn Pharma expanded its leadership team with the addition of Jeff Evans, Head of Manufacturing Operations; Dr. Karen Rance, Head of Medical Affairs; Jeremy Shepler, Head of Sales and Marketing; and, Brian Tabakin, Head of Market Access. In his most recent role, Shepler served as Vice President, Area Commercial Lead, Cardiometabolic Sales for the East Area at Novo Nordisk. Prior to joining Bryn, Tabakin was Vice President, Head of Market Access for Sunovion Pharmaceuticals. Most recently, Rance served as the North American Head of Medical Affairs for ALK Abello. In his most recent role, Evans led a 130-person R&D New Product Introduction team at Johnson & Johnson.