Pharma Focus America

FDA Grants Fast Track Designation to CAR-T Cell Therapy IVS-3001 for Renal Cell Carcinoma Treatment

Monday, July 31, 2023

Invectys, a clinical-stage immuno-oncology company focusing on developing innovative therapies for advanced cancers, has exciting news to share. The U.S. Food and Drug Administration (FDA) has recently granted Fast Track designation to their revolutionary product, IVS-3001. This designation is a significant milestone in the advancement of cancer treatments and the potential improvement of patient outcomes.

IVS-3001 is a cutting-edge CAR-T cell immunotherapy that targets a specific immune checkpoint and tumor-specific antigen known as HLA-G. Unlike other therapies, IVS-3001 addresses HLA-G, which is usually present during pregnancy to protect the fetus from the mother's immune system. However, in cancer, this molecule can be exploited by tumors to create a protective environment, evading the immune system and promoting tumor growth. By targeting HLA-G, IVS-3001 aims to boost the body's natural defense system to effectively combat cancer.

The Fast Track designation was granted to IVS-3001 based on compelling data from the Investigational New Drug Application (IND) submission. It offers hope for patients with HLA-G positive locally advanced or metastatic clear cell renal cell carcinoma (RCC) who have not responded well to standard RCC therapies.

Fast Track designation is a regulatory status that expedites the development and review process for therapies that address unmet medical needs in serious conditions.

Dr. Jake Kushner, CEO of Invectys, expressed his enthusiasm, stating, We are thrilled to receive the FDA’s Fast Track designation for IVS-3001. This recognition further validates the potential of our CAR-T cell therapy in revolutionizing cancer treatment for patients with solid tumors. The dedicated team at Invectys, as well as our partners, are committed to bringing this innovative therapy to the clinic and making a meaningful difference in the lives of cancer patients.

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