AI-Guided Personalised Cancer Vaccine Designated Fast Track by FDA
Danish biotech Evaxion’s personalised cancer vaccine, dubbed EVX-01, has been granted fast track designation by the US Food and Drug Administration (FDA) for a combination trial with MSD’s Keytruda.
The fast track designation will mean that the drug’s review process will be expedited by the inclusion of more frequent liaison with the FDA and more support given to the drug’s development.
Evaxion’s CEO, Per Norlén, said: ”We are extremely pleased that our cancer vaccine candidate EVX-01 has received the FDA fast track designation, as it enables a potentially faster approval of the vaccine.”
The FDA fast track designation is reserved for developing drugs that treat serious health conditions or meet a currently unmet clinical need.
EVX-01 and Keytruda Clinical Trials
EVX-01 has completed its phase I/IIa clinical trials and is entering phase IIb to study the safety and efficacy of the drug on patients with metastatic melanoma. The new trial will examine the effect of the immunotherapy in collaboration with MSD in Europe, the US, and Australia.
“Receiving a green light from the FDA is a tremendous boost for our personalized cancer vaccine program,” said Erik Heegaard, Chief Medical Officer at Evaxion.
He continued: “EVX-01 is already actively enrolling patients in Australia, and the FDA approval expands our ability to move forward quickly with our lead program in malignant melanoma.”
MSD’s PD-1 checkpoint inhibitor Keytruda (pembrolizumab) will be trialled in combination with EVX-01. Keytruda is a humanised monoclonal antibody therapy which blocks signals that decrease the effect of the immune system against cancer.
PIONEER AI-Guided Platform for Immunotherapy Development
Evaxion developed their peptide-based cancer vaccine using their proprietary artificial intelligence (AI) platform PIONEER, which enables the rapid discovery of patient-specific neoantigens.
The AI-guided platform simulates the human immune system and creates tailored predictive models which are used to develop Evaxion’s immunotherapies. In tandem with gene analysis of the patient’s specific cancer, PIONEER generates immunotherapies which should complement their immune system.
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