As a fair-skinned, freckled person (my mom says she painted them on me while I slept), and one who has a family history of skin cancers and melanoma, the news on February 19 that Iovance Biotherapeutics’ AMTAGVITM received U.S. Food and Drug Administration (FDA) accelerated approval to treat melanoma was welcome news to me and the over 5,000 Canadians who are diagnosed with it each year – of which 1,250 are expected to die from it. (Canadian cancer organizations report on this differently. The numbers vary from almost 7,000 to almost 10,000.)
Melanoma is the deadliest form of skin cancer. According to Iovance’s announcement, AMTAGVI is a tumour-derived autologous (the cells come from the patient) T-cell immunotherapy indicated for the treatment of adult patients with unresectable (unable to be removed with surgery) or metastatic melanoma and the first and the only one-time, individualized T-cell therapy to receive FDA approval for a solid tumour cancer. AMTAGVI offers a new cell therapy approach using patient-specific T cells called tumour infiltrating lymphocyte (TIL) cells. When the body detects cancer, the immune system automatically creates TILs to locate, attack and destroy the cancer. TIL cells are able to recognize distinctive tumour markers on the cell’s surface; however, when cancer overtakes the body, TILs have so far been unable to stop the cancer cells.
Iovance’s CEO says the company has big plans.
“The accelerated approval of AMTAGVI™ is the first step in realizing Iovance’s ambition to usher in the next generation of cell therapy by bringing this breakthrough to patients with advanced solid tumors,” said Frederick Vogt, Ph.D., J.D., Interim Chief Executive Officer and President of Iovance. “Given the significant unmet needs in the advanced melanoma community, we are proud to offer a personalized, one-time therapeutic option for these patients. We are continuing our development efforts to address additional unmet medical needs in patients with solid tumor cancers, making our novel cell therapies available to more patients with melanoma and other types of cancers.”
Steven Rosenberg, M.D., Ph.D., Chief, Surgery Branch, National Cancer Institute, and a TIL and immunotherapy pioneer, is also quoted in the release, sharing his excitement.
“This landmark FDA approval reflects significant advancements in TIL cell therapy since we initially showed that TIL cells isolated from patients with metastatic melanoma could be expanded in the lab and returned to the patient to mediate cancer regression. This approval is transformative for the entire research field and supports continued investigation of TIL cell therapy across additional types of solid tumors.”
In addition to what this means to melanoma patients, the industry is watching closely. Genetically modified immune cells have achieved outstanding therapeutic effects in blood cancers, but solid tumours are the next mountain to summit.
There are several challenges to overcome with solid tumours, according to industry sources, for example:
- On-target, off-tumor toxicity
This means that engineered immune cells are targeting healthy tissue with the same protein target meant for cancer cells. Obviously this is bad.
- T-cell exhaustion
Solid tumours are stronger and more resistant to therapy, and our body’s naturally occurring T cells lose their efficacy as they become tired fighting cancerous cells. Chimeric antigen receptor (CAR) T cells, used successfully in blood cancers, experience the same exhaustion.
- Crossing the blood-brain barrier
The blood-brain barrier, an obstacle specific to brain cancers, is a protective layer that lines the inner surfaces of the blood vessels inside the brain. It’s integral to how the brain and nervous system work together and controls what goes in and out of the brain. The blood-brain barrier prevents healthy T cells and other immune cells from reaching the central nervous system and the brain.
Other companies are racing to develop therapies to treat solid tumours. Turnstone Biologics was borne out of research developed in Canada. The company is developing “next-generation TIL therapies by selecting the most potent (meaning able to mediate an anti-tumor response) and tumor-reactive T cells, which [they] refer to as Selected TILs […] for potential treatment across multiple solid tumors.” Turnstone’s work is based on the research and expertise of its founding scientists, Drs. John Bell (Ottawa Hospital Research Institute), Brian Lichty (McMaster University) and David Stojdl (Turnstone, formerly Children’s Hospital of Eastern Ontario). Turnstone has offices in La Jolla, California, and Ottawa, Ontario.
In October 2023, Dr. Shana Kelley (University of Toronto, Northwestern University) gave a TEDx Talk on TILs. Hear what she has to say about these special immune cells that can identify cancer cells and eradicate them, and the challenges of finding them in a tube of blood that contains 25,000,000,000 cells. Watch it below.
Stacey Johnson
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