Home / News / FDA Grants Fast Track designation to IVS-3001, Invectys’ CAR-T Cell Therapy in the Treatment of Renal Cell Carcinoma

FDA Grants Fast Track designation to IVS-3001, Invectys...

FDA Grants Fast Track designation to IVS-3001, a CAR-T Cell Therapy in the Treatment of Renal Cell Carcinoma


Houston, TX, USA, July 31, 2023 – Invectys, Inc., a clinical-stage immuno-oncology company focused on developing novel therapies for advanced cancers, is pleased to announce the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its revolutionary product, IVS-3001. This significant milestone marks a crucial step forward in advancing cancer treatment options and improving patient outcomes.

IVS-3001 is a cutting-edge CAR-T cell immunotherapy that targets the rarely exploited immune checkpoint and tumor-specific antigen known as HLA-G. This molecule, typically expressed only during pregnancy, protects the fetus from the mother’s immune system. However, in cancer, HLA-G can be utilized by tumors to create a protective microenvironment, evading the immune system, and promoting tumor growth. By targeting this mechanism, IVS-3001 aims to reinvigorate the body’s natural defense to combat cancer effectively.

The Fast Track designation to IVS-3001 was based on the compelling data from the Investigational New Drug Application (IND) submission, and the potential for addressing the unmet need in patients with HLA-G positive locally advanced or metastatic clear cell renal cell carcinoma (RCC) who have failed or are intolerant to standard RCC therapies.

Fast Track designation is a critical regulatory designation designed to expedite the development and review process for therapies that address unmet medical needs in serious conditions.

“We are thrilled to receive the FDA’s Fast Track designation for IVS-3001,” said Dr. Jake Kushner, CEO of Invectys. “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.”

For more information on Invectys, Inc. and its revolutionary CAR-T cell immunotherapy, please visit www.invectys.com.

About Invectys
Inspired by ideas from the world-renowned Pasteur Institute in Paris, Invectys, Inc. has two wholly owned subsidiaries, Invectys, S.A.S (Paris), which is focused on scientific research and innovation and Invectys USA, Inc. (Houston), whose lead product is the development of a first-in-human HLA-G /CAR-T initiative. Invectys USA, Inc. has received a grant of $14.2 million from the Cancer Prevention and Research Institute of Texas (Grant ID DP200034) to help fund its HLA-G CAR-T program.

Invectys, Inc. Media Contact:
Rosie Williams