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.”
Sources:
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].
Related News
-
News Pfizer forges ahead with blood cancer therapy after approval from FDA
Pfizer gains accelerated approval from the US FDA for their new bispecific antibody therapy for multiple myeloma, set to address an unmet need for patients. -
News Women in Pharma: Marketing for the other half in healthcare
In our new monthly series, we interview women from across the pharmaceutical industry and supply chain to discuss the importance of gender diversity in healthcare, the workplace, and beyond. This instalment highlights not only the importance of ma... -
News CPHI Podcast Series: The ripple effects of nearshoring in pharma
In the most recent instalment of the CPHI Podcast Series, Digital Editor Lucy Chard is joined by Sandra Sánchez y Oldenhage, President and CEO of PharmAdvice, to discuss nearshoring and reshoring in the pharmaceutical industry, and the subs... -
News Bringing the pharmaceutical supply chain closer to home
The pharmaceutical supply chain has encountered numerous disruptions in the last few years, impacting procurement, manufacturing, packaging, and distribution operations within the pharmaceutical industry. Read about the rise in calls for near/resh... -
News Alzheimer's drug donanemab deemed effective in landmark clinical trial
Results from the TRAILBLAZER-ALZ 2 Randomised Clinical Trial into the use of donanemab to treat early symptoms of Alzheimer’s disease have been analysed. -
News Humira biosimilars at discounted prices to meet market demand for accessible treatment
Several biosimilars to AbbVie’s monoclonal antibody therapeutic Humira were launched by various pharmaceutical giants this week in the US, with more expected to be released by the end of the year as the patent expires. -
News President Biden's executive order to increase access to contraception
In the USA, President Joe Biden will be signing an executive order to expand access to contraception. -
News CPHI North America 2023: from the experts – Sharp Services
Throughout CPHI North America (Philadelphia, PA; April 25–27, 2023), we caught up with some of the exhibiting organisations to ask what the show brings to the North American pharmaceutical sector, and what is driving industry innovation in this r...
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance