Innovent Sells CAR T-Cell Stake to IASO Bio for 18% Equity

Fucaso, a chimeric antigen receptor (CAR) T-cell therapy targeting B-cell maturation antigen (BCMA), is now under the global commercial rights of IASO Biotechnology (IASO Bio) following a transfer from Innovent Biologics. The agreement allows Innovent to acquire an 18% stake in IASO Bio, although the financial terms of the deal were not disclosed. This strategic move enhances IASO Bio's portfolio, allowing it to further develop and commercialize Fucaso.

Last month, China's National Medical Products Administration (NMPA) approved Fucaso as a fourth-line therapy for treating relapsed and/or refractory multiple myeloma (r/r MM). This approval is a significant milestone for the therapy, which has also received investigational new drug (IND) application approval for treating r/r MM patients with up to two prior therapy lines who are refractory to Revlimid (lenalidomide).

Beyond its approval in China, Fucaso has received multiple designations from the US Food and Drug Administration (FDA) including orphan drug, breakthrough therapy, and fast track designations for treating r/r MM. These accolades reflect the therapy's potential to address unmet medical needs in this patient population. Moreover, Fucaso has obtained an IND approval from the FDA, facilitating further clinical trials and potential expansions of its therapeutic indications.

IASO Bio aims to explore additional applications for Fucaso, including its use in treating refractory generalized myasthenia gravis. Both China and the U.S. have granted IND approvals for this new indication, suggesting a promising future for the therapy in treating various diseases.

The cell and gene therapy market, which is projected to grow significantly and reach over $81 billion by 2029, has recently experienced increased regulatory scrutiny. The FDA initiated a safety probe into CAR T-cell therapies in November 2023, highlighting the need for additional safety measures. The agency also proposed adding boxed warnings for secondary T-cell malignancies to all approved CAR-T therapies. These developments underscore the importance of balancing innovation with patient safety in this rapidly evolving field.

Despite these safety concerns, the CAR T-cell therapy sector continues to attract substantial investments and partnerships. In December 2023, AstraZeneca acquired Gracell Biotechnologies for $1.2 billion, adding a dual BCMA and CD19 targeting CAR-T cell therapy to its portfolio. This therapy, GC01F, is under investigation for multiple indications, including multiple myeloma and systemic lupus erythematosus (SLE). Another significant deal occurred in November 2023, when Novartis entered into a licensing agreement potentially worth over $1 billion with Legend Biotech Ireland for its delta-like ligand protein 3 (DLL3)-targeting CAR-T cell therapies.

These high-profile deals indicate robust interest and confidence in the CAR-T cell therapy market, despite the challenges and regulatory hurdles it faces. The continued development and commercialization of therapies like Fucaso demonstrate the sector's potential to address complex diseases and improve patient outcomes.

As the cell and gene therapy industry continues to evolve, the collaborative efforts between companies like Innovent Biologics and IASO Bio will be crucial in advancing the field and bringing innovative treatments to market. The ongoing research and development, coupled with strategic partnerships, are likely to drive significant advancements in the treatment of various challenging diseases, offering new hope to patients worldwide.