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AI-Designed Cancer Vaccine Shown to Act Against Melanoma

T-cells and cancer cells

Killer T-cells surround a cancer cell (NICHD, Flickr)

26 May 2023. Results of a small clinical trial show most patients with melanoma receiving a personalized therapeutic vaccine with an approved immunotherapy reduced at least some of their tumors. Evaxion Biotech A/S, a company in Copenhagen, Denmark and developer of the vaccine, plans to present the findings on 3 June at the upcoming American Society for Clinical Oncology or ASCO meeting in Chicago.

Evaxion Biotech designs personalized therapies for cancer and infectious diseases, including treatments for bacterial infections becoming resistant to conventional antibiotics. The company says its technology uses generative prediction models from artificial intelligence to create precision medicine treatments that invoke the immune system. For cancer therapies, Evaxion says it starts with a tissue sample from a patient’s tumor biopsy to identify the cancer-causing mutation, then uses its A.I. models to determine the contents of neoantigens, unique sequences of amino acids or peptides on the surface of tumor cells that act as vaccine targets.

Neoantigens represent not only properties of the tumor, but also characteristics of the patient’s personal chemistry. The company says its models can design vaccines with multiple targets where tumors are quickly mutating, and predict as well the likelihood of neoantigen targets to invoke T-cell responses from the immune system. Evaxion says it manufactures personalized cancer vaccines generating T-cell responses targeting those precise antigens, given with standard cancer treatments. The company says vaccines used in the reported clinical trial took eight weeks to produce.

All participants show T-cell responses

The early-stage clinical trial is recruiting patients in Italy with melanoma, an aggressive skin cancer that metastasized, or spread to the lymph nodes or to other parts of the body. Participants are given the approved immune checkpoint inhibitor drug pembrolizumab that blocks tumors from suppressing the immune system, as well as Evaxion’s experimental personal vaccine code-named EVX-01. The study team is evaluating participants for two years, looking for full or partial clinical responses to the treatments, immune system responses, and any adverse effects. The team is comparing participants’ responses to historical data of metastatic melanoma patients treated with pembrolizumab alone or going untreated. The study has no placebo or comparison group.

At the ASCO meeting, Evaxion is reporting interim data from the trial that began in July 2022. All of the 12 patients enrolled, says the company, exhibit T-cell responses from the personalized neoantigens, with more than half (58%) of the neoantigens inducing an immune response. Eight of the 12 patients, or two-thirds, exhibit at least some clinical improvement, with two of the eight participants showing a complete response, indicating disappearance of all known disease. Evaxion says any adverse events from the EVX01 treatments are rated mild or moderate.

“EVX-01 was well tolerated,” says Evaxion Biotech CEO Per Norlén in a company statement, “and induced a higher objective response rate than previously reported for standard of care treatment.” Norlén adds that “EVX-01 induced a broad immune response that correlated with clinical outcome, which is very encouraging for the further development of Evaxion’s personalized cancer vaccine programs.”

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