āshibio raises $40 million in seed and Series A funding to advance bone and connective tissue disease therapies

– The first clinical program focuses on fibrodysplasia ossificans progressiva (FOP), a rare genetic disease that leads to extraskeletal bone formation –

– Experienced leadership team ready to accelerate pipeline development with a lead asset based on novel research –

BRISBANE, California, June 20, 2024–(BUSINESS WIRE)–āshibio, a private biotechnology company developing novel therapeutics to treat bone and connective tissue diseases, today emerged from stealth mode with $40 million in seed and Series A funding. The company was founded in 2022 by Chief Executive Officer Pankaj Bhargava, MD, and the team at MPM BioImpact, where Dr. Bhargava also serves as an entrepreneurial partner. MPM BioImpact led the Series A financing round and contributed funds from Agent Capital, YK Bioventures, and Mirae Asset Venture Investment. In connection with the financing, Preston Noon, Partner and Co-Founder of Agent Capital, joined the Board of Directors.

The funding will enable āshibio to further advance the development of several experimental therapies, including a potential treatment for fibrodysplasia ossificans progressiva (FOP), a rare genetic disorder characterized by severe and progressive heterotopic ossification (HO), a pathological condition that causes abnormal bone formation in muscles, tendons, ligaments, and other soft tissues. FOP typically begins in early childhood, is characterized by episodic and painful flare-ups, and results in severe debilitation and shortened lifespan.

“We are building a pipeline of innovative therapeutics that leverage new biological insights and novel mechanisms to treat bone and connective tissue diseases for which there are no approved treatments or for which current treatment options are inadequate,” said Dr. Bhargava. “We are grateful to our investors for recognizing the potential of our approach and supporting our development programs.”

The company’s lead program is based on the discovery that the enzyme matrix metalloproteinase-9 (MMP-9) could serve as a new target for FOP, as reported in Journal of Bone and Mineral Research in February 2024.

The 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 still has an extreme lack of heterotopic ossification (HO) and near-normal mobility. The authors found that in addition to the FOP mutation, the patient has an MMP-9 mutation that appears to protect him from disease flares and the abnormal bone formation typically seen in individuals with FOP. Further studies using MMP-9 gene knockout and pharmacological experiments confirmed that MMP-9 could serve as a new target in FOP and other more common forms of HO.

The story goes on

āshibio has licensed andecaliximab, a humanized antibody that specifically inhibits MMP-9, from Gilead Sciences, Inc. Andecaliximab has been administered to approximately 1,000 patients in previous clinical trials.

āshibio plans to initiate a Phase 2/3 trial of andecaliximab in patients with FOP in the second half of 2024. The U.S. Food and Drug Administration (FDA) granted andecaliximab an orphan drug designation for the treatment of FOP in March 2024, one month after the European Medicines Agency (EMA) granted the therapy its own orphan drug designation. The FDA also approved āshibio’s Investigational New Drug (IND) application for andecaliximab in March 2024.

Experienced management team announced
Prior to joining MPM BioImpact, Dr. Bhargava served as Head of Oncology Therapeutics at Gilead Sciences. Over the course of his career, he has also held leadership roles at several biotech companies, including Sanofi and Dicerna Pharmaceuticals, where he led development programs in oncology and rare genetic diseases.

In addition to closing Series A funding, āshibio also announced the following appointments to its leadership team:

• Victoria Smith, Ph.D., joins āshibio as Chief Scientific Officer. She has worked across multiple therapeutic areas, including oncology and autoimmune and inflammatory diseases. She previously held leadership or senior management positions at Amphivena Therapeutics, Gilead Sciences, and Arresto Biosciences, where she was co-inventor of andecaliximab.

• Deborah Wenkert, MD, joins āshibio as Chief Medical Officer. She is an experienced pediatric rheumatologist specializing in rare bone and connective tissue diseases with extensive experience in both academic and industrial settings. She previously held leadership or clinical development roles at Inozyme Pharma, PreciThera and Amgen.

“At āshibio, we are rapidly developing new therapies for serious and debilitating bone and connective tissue diseases, an area of ​​great clinical need,” commented Dr. Smith. “It is extremely gratifying to be part of such an impressive team of experienced industry leaders, clinicians and researchers dedicated to improving the lives of patients who have not been adequately helped by currently available treatment options.”

“āshibio is clearly at the forefront of drug development for heterotopic ossification and other bone and connective tissue diseases,” added Todd Foley, managing partner of MPM BioImpact and chairman of the board of āshibio. “The company is currently on track to clinical testing of its lead product and is poised to advance a number of programs that address unmet needs.”

āshibio researchers will present an update on the andecaliximab FOP program in an oral presentation and a poster presentation at the FOP Drug Development Forum in Stockholm, Sweden, on June 27-28, 2024. Company management will also present a poster at the International Conference on Children’s Bone Health, June 22-25, 2024, in Salzburg, Austria.

About āshibio
āshibio is a privately held biotechnology company developing a pipeline of novel therapeutics to treat bone and connective tissue diseases. Founded in 2022 by company CEO Pankaj Bhargava, MD, and the team at MPM BioImpact, āshibio emerged from stealth mode in June 2024 with $40 million in seed and Series A funding. The company plans to initiate a Phase 2/3 study of its lead product andecaliximab in the second half of 2024 in patients with fibrodysplasia ossificans progressiva (FOP), a rare genetic disorder characterized by progressive heterotopic ossification (HO), a pathological condition characterized by abnormal bone formation in muscle and soft tissues. For more information, visit www.ashibio.com.

About MPM BioImpact
MPM BioImpact is a leading global biotechnology investment firm with over 30 years of experience in founding and investing in innovative companies to bring breakthrough therapies to patients. Its experienced and dedicated team of investment professionals, entrepreneurs, advisors and leading scientists translate scientific discoveries into breakthrough medicines and potential cures. For more information, visit www.mpmbioimpact.com.

About Agent Capital
Agent Capital is an international life sciences investment firm that backs breakthrough healthcare companies focused on novel, differentiated therapeutics and treatments that address unmet patient needs. Agent Capital partners with scientists, entrepreneurs and other investors to develop the next generation of healthcare innovations, leveraging its industry expertise and track record to source best-in-class deals, increase value and drive successful exits. Since 2017, Agent Capital has invested in over 25 companies, most of which have entered into collaborations with major pharmaceutical companies or successfully raised additional capital in the private or public markets. For more information, visit www.agentcapital.com.

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