Abcuro, Inc.

The FDA approved the first treatment for MASH in March this year. Image credit: Shutterstock/ Iurii Motov. Inventiva has secured up to €348m ($380m) in financing to help wrap up a Phase III trial for its lead, and sole, clinical asset lanifibranor in metabolic dysfunction-associated steatohepatitis (MASH). The funds will mostly go towards completing the Phase III trial (NCT04849728) for lanifibranor. Preparation for marketing approval filings and drug commercialisation also stand to benefit, as per a 14 October press release. The French biopharma will immediately receive $103.4m of the multi-tranche equity financing, with the remainder coming through future issuance phases. Inventiva also announced a further $30m that has been secured separately in milestone payments via an existing license and collaboration agreement with Chinese pharma company CTTQ. Shares in the Nasdaq-listed company were up 27% at market open on 14 October compared to the market close on 11 October. Inventiva has a market cap of $98.6m. The transaction was led by New Enterprise Associates, BVF Partners LP and Samsara BioCapital, with the participation of additional existing and new investors. Dr. Mark Pruzanski, current chairman of Corteria Pharmaceuticals and biotech Abcuro, will join Iventiva as company chairman. Srinivas Akkaraju, founder of Samsara BioCapital, will serve as a director following the deal. Four additional directors from the other four largest investors will also join the board, with at least two replacing existing directors. See Also: FDA approves Pfizer’s HYMPAVZI to treat haemophilia Cell and gene therapy approvals drive paradigm change in manufacturing Lanifibranor is Inventiva’s only clinical candidate, and the biopharma previously estimated it would need around €250m to finance its activities until Phase III topline results in MASH patients are reached. The study, called NATiV3, is expected to hit this milestone in the second half of 2026. The randomised, double-blind, placebo-controlled trial aims to assess the long-term efficacy and safety of lanifibranor in adults with biopsy-proven non-cirrhotic MASH and F2/F3 stage liver fibrosis. Around 1,000 patients are expected to enrol in the study across 494 study locations, as per a ClinicalTrials.gov entry. The trial is back on track following a halt in recruitment earlier this year due to a possible treatment-related serious adverse event (AE). The MASH treatment space has seen increased interest this year, with Madrigal Pharmaceuticals winning the first US Food and Drug Administration (FDA)-approval in the arena for Rezdiffra (resmetirom). GlobalData estimates the MASH market to reach sales of $25.7bn in 2032 across the seven major markets (7MM: US, France, Germany, Italy, Spain, the UK, and Japan). Lanifibranor is an orally administered small molecule that activates three peroxisome proliferator-activated receptor (PPAR) isoforms. These ligand-activated transcription factors are known to regulate four components of MASH, such as inflammation, fibrosis, steatosis and metabolism.  Inventiva’s pan-PPAR agonist demonstrated positive results in a Phase IIb trial, meeting primary and key secondary endpoints. Inventiva’s CEO Frederic Cren said: “This [financing] reflects the confidence of the participating investors and our partner CTTQ in the value of lanifibranor as a breakthrough therapy for patients suffering from MASH. The total proceeds from the financing will support the MASH programme and subsequent filing for marketing approval, along with preparations for the potential commercialisation of lanifibranor.”

NEWTON, Mass.--( BUSINESS WIRE )--Abcuro, Inc., a clinical stage biotechnology company developing therapies for the treatment of autoimmune diseases and cancer through precise modulation of cytotoxic T cells, today announced that Alex Martin, Chief Executive Officer, will present at the following investor conferences. Morgan Stanley 22 nd Annual Global Healthcare Conference: Presentation on September 5, 2024, at 2:35 pm E.T. Stifel Virtual Immunology and Inflammation Summit: Presentation on September 18, 2024, at 2:00 pm E.T. About Abcuro Abcuro is a clinical stage biotechnology company developing first-in-class immunotherapies for the treatment of autoimmune diseases and cancer through precise modulation of highly cytotoxic T cells. The company’s lead program is ulviprubart (ABC008) and is currently in clinical trials for inclusion body myositis (IBM) and T cell large granular lymphocytic leukemia. For more information, visit us on LinkedIn and at abcuro.com .

NEWTON, Mass.--( BUSINESS WIRE )--Abcuro, Inc., a clinical-stage biotechnology company developing therapies for the treatment of autoimmune diseases and cancer through precise modulation of cytotoxic T cells, today announced the appointment of Sarah Boyce to its Board of Directors. Ms. Boyce brings more than 25 years of global commercial leadership experience in the life sciences industry. “We are excited to welcome Sarah as a member of the Board and her experience will be instrumental as we focus on advancing ulviprubart in the ongoing Phase 3 MUSCLE trial for the treatment of inclusion body myositis,” said Mark Pruzanski, M.D., Chairman of the Board of Directors. “Sarah has extensive expertise in global product development, rare diseases and commercialization having helped bring over 20 products to market.” Ms. Boyce currently serves as the President and Chief Executive Officer of Avidity Biosciences, a publicly traded biotechnology company developing novel therapies for muscle wasting and other rare diseases. Prior to Avidity, she was President of Akcea Therapeutics and previously in her career held executive roles in business development and global operations for leading life sciences companies, including Ionis Pharmaceuticals, Forest Laboratories, Alexion Pharmaceuticals, Novartis Oncology and F. Hoffmann-La Roche AG. Ms. Boyce was named a Healthcare Technology Report Top 25 Biotech CEO in 2022 and one of the Fiercest Women in Life Sciences. She currently serves as a member of the Board of Directors at OmniAb and Contineum Therapeutics. Ms. Boyce holds a BSc (Hons) degree in microbiology from the University of Manchester, England. “I am thrilled to join Abcuro’s board at this critical point in the Company’s journey,” said Ms. Boyce. “I look forward to collaborating with the management team, providing guidance and sharing my expertise as the company progresses towards potential regulatory approval and readiness for potential commercialization.” About Abcuro Abcuro is a clinical stage biotechnology company developing first-in-class immunotherapies for the treatment of autoimmune diseases and cancer through precise modulation of highly cytotoxic T cells. The company’s lead program is ulviprubart (ABC008) and is currently in clinical trials for inclusion body myositis (IBM) and T cell large granular lymphocytic leukemia. For more information, visit us on LinkedIn and at abcuro.com .