IASO Bio Announces FDA Grants RMAT and Fast Track Designations to CT103A for Relapsed/Refractory Multiple Myeloma

Nanjing, Shanghai, China and San Jose, USAFebruary 13, 2023PR Newswire -- IASO Bio, a clinical-stage biopharmaceutical company dedicated to the development of innovative cell therapies, announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track (FT) designation to the company's cell therapy product CT103A for the treatment of relapsed/refractory multiple myeloma.RRMM）。

AboutCT103A

CT103A is a CAR-T cell therapy targeting B-cell maturation antigen (BCMA), which uses lentivirus as a gene vector to transfect autologous T cells. The CAR comprises a fully human scFv, CD8a hinge and transmembrane domain, 4-1BB co-stimulatory domain, and CD3ζ activation domain. Based on rigorous screening and comprehensive in vivo and in vitro functional evaluation, CT103A demonstrates potent and rapid efficacy with remarkable persistence in vivo. IASO Bio and Innovent Biologics are collaborating to develop CT103A for clinical applications in RRMM in China.

About Advanced Therapies in Regenerative Medicine (RMAT）

Regenerative Medicine Advanced Therapy (RMAT) is a significant healthcare policy in the United States under the "21st Century Cures Act" passed in December 2016. RMAT allows for faster and more streamlined approval of regenerative medicine products, such as cell and gene therapies, tissue-engineered products, and combination products. To qualify for RMAT designation, a drug under investigation must have preliminary clinical research data demonstrating positive outcomes in treating, delaying, reversing, or curing serious or life-threatening diseases, with the potential to address unmet clinical needs in the United States.

About the Fast Track (FT）

The Fast Track program allows for close interaction between companies and regulatory agencies. These interactions provide companies with the possibility of shortening the clinical trial cycles required to demonstrate the safety and efficacy of drugs, while ensuring that companies can prepare all necessary data and documents in a timely and complete manner to meet regulatory approval requirements. For drugs granted Fast Track designation, marketing application materials can be submitted in phases on a rolling basis, without waiting until all data is complete, allowing regulatory agencies to conduct an early dynamic review of the application materials.

About IASO Bio

IASO Bio is a clinical-stage biopharmaceutical company dedicated to the development of innovative cell therapies. With a foundation of innovation in the development of hematological tumor cell-based drugs and antibody drugs, the company is expanding into solid tumors and autoimmune diseases. IASO Bio possesses a complete, end-to-end platform capability spanning early discovery, regulatory submission, clinical development, and commercial production. Its multiple technology platforms include a fully human antibody discovery platform, a high-throughput CAR-T drug optimization platform, a universal CAR technology platform, a manufacturing technology platform, and a clinical translational research platform.

The company currently has 10 drug candidates at various stages of development. The most advanced candidate, Ixmyelocel-T injection, has had its New Drug Application (NDA) accepted by the National Medical Products Administration (NMPA) and granted priority review status. It has also received approval from the U.S. FDA for registration in clinical trials to treat relapsed/refractory multiple myeloma. This product has been designated as a "Breakthrough Therapy" by the NMPA and granted "Orphan Drug Designation (ODD)" by the FDA. In addition to multiple myeloma, the Investigational New Drug (IND) application for Ixmyelocel-T injection for an expanded indication—antibody-mediated Neuromyelitis Optica Spectrum Disorder (NMOSD)—has been approved by the NMPA. Another innovative candidate developed in-house, CT120 (a fully human CD19/CD22 dual-target CAR-T cell injection), has entered the clinical research stage for treating CD19/CD22-positive relapsed/refractory B-cell Non-Hodgkin Lymphoma (B-NHL) and relapsed/refractory acute B lymphoblastic leukemia (B-ALL). It has also been granted "Orphan Drug (ODD)" designation by the FDA.

IASO Bio has successively reached BD licensing or R&D cooperation agreements with overseas cell therapy companies Sana Therapeutics, Cabaletta Bio, and Umoja Biopharma based on the clinically validated fully human CAR structure or sequence. It is actively exploring the development of next-generation cell therapy products. With its strong management team, innovative product pipeline, in-house GMP manufacturing, and robust clinical development capabilities, IASO Bio aims to provide transformative, curative, and affordable innovative therapies to meet unmet medical needs of patients in China and around the world.

For more information, please visit the company's official website: www.iasobio.com or LinkedIn account: www.linkedin.com/company/iasobiotherapeutics.