Matica Bio Signs CDMO Agreement with Calidi for Oncolytic Virus Therapy in the U.S.

Support for U.S. FDA IND Application

Matica Biotechnology (Matica Bio), the U.S. subsidiary of CHA Biotech, announced on November 3 that it has signed a commercial project contract for contract development and manufacturing organization (CDMO) services with Calidi Biotherapeutics (Calidi), a U.S.-based biotechnology company.

Matica Biotechnology

Under this agreement, Matica Bio will support Calidi’s development of 'CLD-401' by providing analytical development (AD), process development (PD), and GMP manufacturing, as well as assisting with the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA). The contract amount and detailed project information remain undisclosed as per mutual agreement between the two companies. There is also potential for additional contracts if the FDA approves the IND.

Calidi is a biotechnology company developing next-generation targeted oncolytic virus therapies. The company possesses proprietary technology that maximizes the anti-cancer effects of oncolytic viruses using allogeneic stem cells as a platform.

'CLD-401' is a targeted oncolytic virus therapy utilizing the vaccinia virus, designed for intravenous administration to circulate throughout the body and act on metastatic cancer sites. In addition to directly destroying cancer cells, it induces an immune priming effect that helps T cells and NK cells attack tumors by triggering an immune response.

Calidi’s stem cell-loaded oncolytic virus therapy 'CLD-201', currently under development as a treatment for soft tissue sarcoma, has also been granted Fast Track designation by the FDA.

Paul Kim, CEO of Matica Bio, stated, "As more biotechnology companies develop oncolytic virus-based therapies, demand for highly skilled cell and gene therapy (CGT) CDMO services is also increasing. Matica Bio supports the entire drug development process from early research to clinical and commercial stages for cell and gene therapies, leveraging our rapid and flexible manufacturing capabilities, process and analytical development expertise, and viral vector technology, including oncolytic viruses."

Eric Poma, CEO of Calidi, said, "Matica Bio not only has its own platform for viral vectors, but also possesses the capabilities to support every stage of drug development, including GMP manufacturing and regulatory compliance. We expect to accelerate the development of oncolytic virus therapies in collaboration with Matica Bio."

This content was produced with the assistance of AI translation services.