Neoantigen Cancer Vaccine Candidate Reports Positive Response Rate

A biopharmaceutical company developing personalized cancer immunotherapies announced the first results from its ongoing Phase 1/2a clinical trial for GEN-009, a neoantigen vaccine candidate. 

This first-in-human study of the GEN-009 cancer vaccine was last updated on May 7, 2019. 

This small study of 99 participants is being conducted in two parts in adult patients with cutaneous melanoma, non-small cell lung cancer, squamous cell carcinoma of the head and neck, urothelial carcinoma, or renal cell carcinoma. 

“To date, we have analyzed full immune response data from 3 patients following their priming series of 3 vaccinations and have detected immune responses to 93 percent of the total administered neoantigens, a response rate that would be best-in-class if seen across the full vaccinated cohort,” said Tom Davis, M.D., Genocea Biosciences, Inc.’s Chief Medical Officer. 

These 3 patients are from the Phase 1/Part A of the GEN-009 study.

These are patients with no evidence of disease, but a high likelihood of relapse.

Genocea employs its ATLAS™ platform for patient-specific neoantigen selection, using each patient’s own T cells to identify the neoantigens to which each patient mounts anti-tumor cytokine responses. 

“We are studying a diverse group of patients and, despite this variability, we are seeing consistently broad immune responses, including ex vivo CD8+ T cell responses, which have not previously been detected after monotherapy with a neoantigen vaccine,” said Dr. Davis, in a press release.   

Neoantigen-based cancer vaccines have recently shown marked therapeutic potential in both preclinical and early-phase clinical studies, said these researchers in 2018.   

However, significant challenges remain in the effective identification of immunogenic neoepitopes and the efficient and safe delivery of the subunit vaccine components for eliciting potent and robust anticancer T cell responses. 

First clinical data from Part B of the trial is expected to be available in 2020 and is to be completed in 2022, said the Company.