SOLA Biosciences Japan Receives $40 Million Grant to Advance ALS Gene Therapy

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Keizo Koya

Boston — SOLA Biosciences Japan GK has received a grant of approximately 6 billion yen over five years from the Japan Agency for Medical Research and Development to advance SOL-257, an experimental gene therapy for amyotrophic lateral sclerosis.

SOLA Biosciences Japan is the wholly owned Japanese subsidiary of Boston-based SOLA Biosciences Inc. The grant was awarded under AMED’s Strengthening Program for Pharmaceutical Startup Ecosystem.

SOL-257 is designed to restore the structure and function of misfolded TDP-43, a protein associated with ALS. SOLA said TDP-43 becomes mislocalized, misfolded and aggregated in motor neurons in approximately 97% of ALS cases, contributing to neurodegeneration and loss of normal protein function.

The therapy was developed using SOLA’s proprietary JUMP70 platform, which is designed to use the cell’s natural protein quality-control machinery to selectively identify disease-associated misfolded proteins while preserving normal proteins.

The platform combines a disease-specific targeting domain with a protein quality-control activation domain that engages HSP70, a molecular chaperone involved in protein repair and removal.

SOLA said SOL-257 is designed to target misfolded TDP-43 and promote restoration of proper protein folding and function. The company is developing the therapy as a potential disease-modifying treatment for ALS.

Under the AMED-supported program, SOLA Japan will serve as a development hub and work with the company’s U.S. team as well as academic institutions, clinical development organizations, manufacturing partners and investors.

The program is supported by Curie.Bio, an AMED-registered venture capital firm, as lead investor, with The University of Tokyo Edge Capital Partners participating as a follow-on investor.

SOLA plans to use the funding to advance SOL-257 toward human proof-of-concept studies in both the United States and Japan and establish a foundation for broader global clinical development.

“We are deeply honored to receive this support from AMED and feel a profound responsibility to advance SOL-257 as efficiently and rigorously as possible,” said Keizo Koya, Founder, CEO and President of SOLA Biosciences Inc. and SOLA Biosciences Japan GK. “For ALS patients and their families, time is extremely important. We will continue working closely with researchers, clinicians, investors, manufacturing partners, and pharmaceutical collaborators in Japan and the United States to bring an innovative new treatment to patients as quickly as possible.”

“This AMED award gives us an important opportunity to build a truly integrated Japan-U.S. development platform,” said Yuta Inokuchi, COO of SOLA Biosciences Japan GK. “Our goal is to combine Japan’s scientific, clinical, and manufacturing strengths with SOLA’s global development capabilities and create a strong path from innovative science to meaningful benefit for patients.”

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