Evaxion Biotech A/S, a firm specializing in AI-driven immunology vaccines, recently published data from its Phase 1 dose escalation study of the EVX-01 personalized cancer vaccine for metastatic melanoma showing almost 70% clinical response from patients.

The study, published in the Journal for ImmunoTherapy of Cancer (an open-access journal), showed that 8 out of 12 patients (67%) demonstrated objective clinical response to the vaccine, including six partial and two complete responses. EVX-01 did not cause vaccine-related serious adverse events in patients who also received anti-PD1 therapy.

EVX-01 targets neoantigens, which are antigenic sequences from cancer mutations displayed on the surface of cancer cells. This allows the immune system to recognize and eliminate malignant cells. Because neoantigen profiles vary among cancer patients, EVX-01 is tailored to the unique characteristics of each patient’s tumor and immune system, representing a novel and personalized approach to cancer treatment.

Evaxion presented comprehensive immune data from its ongoing Phase 2 study of EVX-01 at the recent American Society for Clinical Oncology (ASCO) meeting, according to the news release. The data presented there showed that 71% of administered neoantigens induced a specific T-cell response. There was also a positive correlation between the neoantigen prediction score from Evaxion’s AI platform and the observed immune response.

"This publication provides a clear conclusion to our Phase 1 study, with peer-reviewed validation of our reported outcomes," said Christian Kanstrup, CEO of Evaxion, in a press release. "We are very impressed with EVX-01 achieving a 67% objective response rate in the trial. This is encouraging as it verifies a true reduction in tumor burden following dosing and compares favorably with historical data from anti-PD-1 monotherapy trials. With the encouraging data from our ongoing Phase 2 study of EVX-01 presented at this year’s annual ASCO meeting, we are on track to report our one-year readout in the third quarter of this year."

Source: Evaxion press release. June 17, 2024.