The US Food and Drug Administration (FDA) has granted a fast-track designation to Invectys’ CAR-T therapy IVS-3001 for the treatment of renal cell carcinoma.
The designation was granted based on data from the drug’s investigational new drug application (IND) submission and the potential for fulfilling an unmet need for treatments for some clear cell renal cell carcinoma (RCC).
The designation is for the development of a CAR-T therapy for patients with HLA-G positive locally advanced or metastatic clear cell RCC who have failed or are intolerant to standard therapies, per the 31 July announcement.
IVS-3001 targets the immune checkpoint and tumour-specific antigen HLA-G. While HLA-G is normally expressed during pregnancy where it protects the foetus from the mother’s immune system, tumours occasionally use the same antigen to create a protective microenvironment and promote their growth, based on the press release.
IVS-3001 is an autologous CAR-T therapy, meaning that it is made out of the patient’s own cells that are subsequently modified to target HLA-G-bearing cells, per the company’s website.
Fast-track designations are granted to potential treatments that target unmet needs in serious conditions. The status helps expedite the therapy’s development and review process. There are no CAR-T therapies approved to treat RCC.
In June, the company announced the initiation of a Phase I/IIa solid tumour trial (NCT05672459) evaluating the therapy. IVS-3001 is developed in collaboration with MD Anderson and the Cell Therapy Manufacturing Centre (CTMC), under a collaboration first announced in June 2022.
Invectys previously received a $14.2m grant from the Cancer Prevention and Research Institute of Texas.
IVS-3001 is part of the company’s HLA-G platform, which also includes other therapies such as IVS-4001 and IVS-5001.
While IVS-4001 is developed as a treatment for solid tumours, IVS-5001 targets glioblastoma and other solid tumours. IVS-4001 is an anti-HLA-G monoclonal antibody and IVS-5001 is an anti-ILT4 nanobody.
Invectys also has a telomerase vaccine platform that features the multi-cancer hTERT DNA vaccine IVS-2001. The vaccine’s Phase II study (NCT03265717) was terminated due to a sponsor decision, based on a 6 July 2020 update on its ClinicalTrials.gov listing.
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