āshibio, a privately held biotechnology company developing novel therapeutics for treating bone and connective tissue disorders, exited stealth mode with $40 million in seed and Series A financing. MPM BioImpact led the Series A round, with contributing funds from Agent Capital, YK Bioventures, and Mirae Asset Venture Investment. In connection with the funding, Agent Capital Partner and Co-Founder Preston Noon have joined the Board of Directors.
The company was launched in 2022 by Chief Executive Officer Pankaj Bhargava, M.D., and the team at MPM BioImpact, where Dr. Bhargava is also an entrepreneur partner.
This funding will enable āshibio to continue to advance development of several investigative therapies including a potential treatment for fibrodysplasia ossificans progressiva (FOP), a rare genetic disease characterized by severe and progressive heterotopic ossification (HO) – which is a pathological condition that causes abnormal bone formation in muscles, tendons, ligaments and other soft tissues. AndFOP typically starts in early childhood, is characterized by episodic and painful flare-ups, and leads to severe debilitation and shortened life span.
The company’s lead program is based on a discovery that the matrix metalloproteinase-9 (MMP-9) enzyme could serve as a novel target for FOP, as published in Journal of Bone and Mineral Research in February 2024. This research described the case of a unique 35-year-old patient who carries the classic genetic mutation of FOP (ACVR1 R206H, present in over 95% of patients), but has extreme lack of heterotopic ossification (HO) and near normal mobility. And the authors determined that the patient has an MMP-9 mutation in addition to the FOP mutation that appears to protect him from flare-ups and the abnormal bone formation typically seen in individuals with FOP. More studies with MMP-9 gene knockout and pharmacological experiments confirmed that MMP-9 may serve as a novel target in FOP and other more common forms of HO.
āshibio has licensed andecaliximab, a humanized antibody that specifically inhibits MMP-9, from Gilead Sciences. And andecaliximab has been administered to about 1,000 patients in previous clinical trials.
āshibio plans on initiating a Phase 2/3 trial of andecaliximab in the second half of 2024 in patients with FOP. And the U.S. Food and Drug Administration (FDA) designated andecaliximab an Orphan Drug for the treatment of FOP in March 2024, one month after the European Medicines Agency (EMA) issued its own Orphan Drug Designation for the therapy. The FDA cleared āshibio’s Investigational New Drug (IND) application for andecaliximab in March 2024.
Before joining MPM BioImpact, Dr. Bhargava was the Oncology Therapeutic Area Head at Gilead Sciences. And he has also held executive positions at multiple biotech companies during his career, including Sanofi and Dicerna Pharmaceuticals, where he led development programs for oncology and rare genetic diseases.
āshibio also revealed the following appointments to its senior leadership team:
1.) Victoria Smith, Ph.D. joins āshibio as Chief Scientific Officer – She worked across several therapeutic areas including oncology, and autoimmune and inflammatory diseases. And she has previously held executive or senior positions at Amphivena Therapeutics, Gilead Sciences, and Arresto Biosciences, where she was a co-inventor of andecaliximab.
2.) Deborah Wenkert, M.D. joins āshibio as Chief Medical Officer – She is an experienced pediatric rheumatologist, specializing in rare bone and connective tissue disorders, with extensive experience in both academic and industry settings. She has previously held executive or clinical development positions at Inozyme Pharma, PreciThera, and Amgen.
KEY QUOTES:
“We are building a pipeline of innovative therapeutics that leverage emerging biology and novel mechanisms to impact bone and connective tissue disorders that have no approved treatments or where current treatment options are inadequate. We are grateful to our investors for recognizing the promise of our approach and for supporting our development programs.”
– Dr. Bhargava
“At āshibio, we are rapidly advancing novel therapeutics for severe and debilitating bone and connective tissue disorders, an area of great clinical need. It is extremely gratifying to be a part of such an impressive team of seasoned industry executives, clinicians, and researchers who are devoted to improving the lives of patients who have not been adequately served by currently available treatment options.”
– Dr. Smith
“āshibio is clearly at the forefront of drug development in heterotopic ossification and other bone and connective tissue pathologies. The company is now on a clinical path for its lead asset and is poised to advance a pipeline of programs that address unmet needs.”
– Todd Foley, managing partner at MPM BioImpact and Chair of the āshibio Board of Directors
