IASO Bio's FUCASO Receives Orphan Drug Designation from Saudi FDA for Relapsed/Refractory Multiple Myeloma

Multiple Myeloma (MM) is the second most common hematological malignancy globally. According to Globocan data, the global incidence rate of multiple myeloma was 1.8 per 100,000 in 2022, with a 5-year prevalence rate of 6.8 per 100,000. Despite advances in current anti-myeloma treatments, MM remains largely incurable and prone to multiple relapses, often developing resistance to various drug classes, posing significant treatment challenges. Therefore, for the treatment of relapsed or refractory MM, there is still an urgent need for new therapeutic options beyond existing anti-myeloma therapies to achieve deep and durable responses.

FUCASO (Equecabtagene Autoleucel Injection) is a CAR-T cell therapy targeting B-cell maturation antigen (BCMA). It uses lentivirus as a gene vector to transfect autologous T cells. The CAR comprises a fully human scFv, CD8α hinge and transmembrane domain, 4-1BB co-stimulatory molecule, and CD3ζ activation domain. Based on stringent molecular structure screening and comprehensive in vivo and in vitro functional evaluation, Fucaso...^®With rapid and potent efficacy, as well as remarkable persistence in the body, it can provide patients with deep and sustained remission, continuously safeguarding patients with multiple myeloma.

IASO Bio, established in 2017, is a leading biopharmaceutical company focused on the research, development, manufacturing, and commercialization of innovative cell therapies. The company builds its innovation foundation on the development of hematological tumor cell-based drugs and expands into autoimmune diseases and antibody-based therapeutics, possessing comprehensive end-to-end capabilities from early drug discovery, clinical development, regulatory submission to commercialization. IASO Bio currently has over 10 innovative drug candidates at various stages of development, including the world’s first fully human CAR-T product, Ixcellen (generic name: Equecabtagene Autoleucel Injection), which was independently developed by IASO Bio and targets BCMA.^®) was approved for marketing by the China National Medical Products Administration (NMPA) in June 2023, for the treatment of adult patients with relapsed or refractory multiple myeloma (R/RMM) who have progressed after at least three prior lines of therapy (including at least one proteasome inhibitor and one immunomodulatory agent). Its frontline indication for treating 2-3 line multiple myeloma (MM) has entered Phase III clinical trials. In addition, Ixalocel injection has received multiple Investigational New Drug (IND) approvals in both China and the United States for various autoimmune diseases.

Simultaneously, the bispecific (CD19/CD22) product CT120 for lymphoma is about to enter Phase II clinical trials. Another product targeting GPRC5D for the treatment of relapsed or refractory multiple myeloma, IASO118, has received IND approval in China. In addition to cell therapy products, the company's fully human anti-CD19 antibody product, IASO-782, has obtained IND clearance in both China and the United States for the treatment of multiple autoimmune diseases, while further indications for additional autoimmune conditions are still under exploration. The company has successively entered into global business development licensing or research collaborations with overseas cell therapy companies Sana Therapeutics, Cabaletta Bio, and Umoja Biopharma, actively exploring the development of next-generation cell therapy products. Relying on its strong management team, innovative pipeline, in-house GMP manufacturing, and advanced clinical development capabilities, IASO Bio is fully committed to bringing transformative, accessible innovative therapies and the hope of a cure to patients in China and around the world. For more information, please visit the company’s official website: www.iasobio.com or LinkedIn page: www.linkedin.com/company/iasobiotherapeutics.