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Lucy Chard
2 Aug 2023

CAR-T therapy for renal cell carcinoma gains fast track approval

Joining the strong number of cancer therapies being approved in 2023 is the CAR-T cell therapy from Invectys, the clinical-stage immuno-oncology company.

Invectys focuses on developing novel therapies for advanced cancers, and their latest therapy is no exception, using revolutionary technology to target HLA-G, an immune checkpoint and tumour-specific antigen that is often overlooked. 

The HLA-G molecule is normally only expressed during pregnancy, with the purpose of protecting the foetus from the mother’s immune system. In cancer however, tumours can commandeer HLA-G to create a protected environment for them to thrive in, guarding against the natural immune system, allowing them to grow uninhibited. 

The new product, IVS-3001, has been granted Fast Track Designation from the US FDA, for use in patients with HLA-G positive locally advanced or metastatic clear cell renal cell carcinoma (RCC) who have previously failed or are intolerant to pre-existing RCC therapies. The therapy is an autologous CAR-T therapy, forged from the patient’s own cells, modified to target HLA-G-bearing cells and will work to boost the body’s natural defences, enabling it to better fight against cancerous growth. The approval will aid in progressing cancer therapeutics, increasing options for patients, and ultimately leading to improved patient outcomes. 

Fast Track designation is granted to revolutionary treatments aiming to fulfil an unmet need in serious medical conditions, in this case, HLA-G positive locally advanced or metastatic clear cell renal cell carcinoma that has been unresponsive to treatment. IVS-3001 is the first CAR-T therapy to be approved for RCC treatment. 

The Fast Track designation for IVS-3001 was based on compelling data from the submission from Invectys to the Investigational New Drug Application (IND). Data is being collected from a Phase I/IIa clinical trial into solid tumours (NCT05672459) started in June 2023, with support from the MD Anderson and the Cell Therapy Manufacturing Centre (CTMC) for the development of the therapy. 

“We are thrilled to receive the FDA’s Fast Track designation for IVS-3001,” commented Jake Kushner, CEO of Invectys. “This recognition further validates the potential of our CAR-T cell therapy in revolutionising cancer treatment for patients with solid tumours. 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.”

Pharmaceutical Technology. FDA fast-tracks Invectys’ CAR-T therapy for renal cell carcinoma. [Date Accessed 02/08/2023].
Invectys Cancer Immunotherapeutics. FDA Grants Fast Track designation to IVS-3001, a CAR-T Cell Therapy in the Treatment of Renal Cell Carcinoma. Date Accessed [02/08/2023]. 

Lucy Chard
Digital Editor - Pharma

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