āshibio Secures $40M in Seed and Series A Funding for Bone and Connective Tissue Therapies

Ashibio, a biotechnology company focused on novel treatments for bone and connective tissue disorders, has announced its emergence from stealth mode with $40 million in seed and Series A financing. The company was founded in 2022 by CEO Pankaj Bhargava, M.D., alongside the team at MPM BioImpact. The Series A financing was led by MPM BioImpact, with additional contributions from Agent Capital, YK Bioventures, and Mirae Asset Venture Investment. In conjunction with the funding, Preston Noon from Agent Capital has joined Ashibio's Board of Directors.

The funding will be used to advance the development of several investigational therapies, including a potential treatment for fibrodysplasia ossificans progressiva (FOP). FOP is a rare genetic condition that causes severe and progressive heterotopic ossification (HO), where abnormal bone forms in muscles, tendons, and other soft tissues. The disease typically begins in early childhood, leading to episodic, painful flare-ups, severe debilitation, and reduced lifespan.

Dr. Pankaj Bhargava expressed gratitude to the investors for their support, emphasizing the company's goal to develop innovative therapies for bone and connective tissue disorders with no approved treatments or inadequate existing options. Ashibio's lead program focuses on using the matrix metalloproteinase-9 (MMP-9) enzyme as a novel target for FOP. Research published in the Journal of Bone and Mineral Research in February 2024 highlighted a unique case of a 35-year-old FOP patient with minimal heterotopic ossification and nearly normal mobility. This patient has an additional MMP-9 mutation that appears to protect against the typical flare-ups and abnormal bone formation associated with FOP. Further studies confirmed that targeting MMP-9 could be a promising strategy for treating FOP and other forms of HO.

Ashibio has licensed andecaliximab, a humanized antibody that specifically inhibits MMP-9, from Gilead Sciences. Andecaliximab has already been tested in approximately 1,000 patients in previous clinical trials. The company plans to initiate a Phase 2/3 trial of andecaliximab in the latter half of 2024 for FOP patients. The U.S. FDA designated andecaliximab an Orphan Drug for FOP treatment in March 2024, shortly after the European Medicines Agency (EMA) issued a similar designation. The FDA has also approved Ashibio's Investigational New Drug (IND) application for andecaliximab.

Ashibio has also announced the appointment of key members to its senior leadership team. Victoria Smith, Ph.D., has joined as Chief Scientific Officer, bringing extensive experience from Amphivena Therapeutics, Gilead Sciences, and Arresto Biosciences. Deborah Wenkert, M.D., has been appointed Chief Medical Officer. She is a seasoned pediatric rheumatologist specializing in rare bone and connective tissue disorders, with prior roles at Inozyme Pharma, PreciThera, and Amgen.

Dr. Smith emphasized the importance of developing therapeutics for severe bone and connective tissue disorders, highlighting the experienced and dedicated team at Ashibio. Todd Foley, managing partner at MPM BioImpact and Chair of Ashibio's Board of Directors, noted that the company is at the forefront of drug development for heterotopic ossification and related pathologies, with a robust pipeline addressing significant unmet medical needs.

Ashibio will present updates on the andecaliximab FOP program at the FOP Drug Development Forum in Stockholm, Sweden, on June 27-28, 2024, and at the International Conference on Children’s Bone Health in Salzburg, Austria, from June 22-25, 2024.