NEW YORK – BostonGene will conduct genomic analysis to identify best responders to Transgene's investigational, bespoke cancer vaccine, TG4050, within two ongoing trials, the companies said on Tuesday.
The studies, both Phase I, are evaluating the personalized vaccine's safety, tolerability, and activity as a treatment for patients with ovarian cancer and head and neck cancer. The single-arm, ovarian cancer trial will enroll 13 patients who have previously received first-line treatment following surgery. The head and neck cancer trial will randomize patients with human papillomavirus-negative squamous cell carcinoma who are at a high risk for relapse following surgery to receive TG4050 either at the time of disease recurrence or at the time of primary treatment completion.
Earlier this year, Transgene said it would work with NEC to advance TG4050 in these trials. NEC would use its artificial intelligence-based Neoantigen Prediction System to identify the most responsive neoantigen sequences for each patient's tumor, and Transgene would use its proprietary myvac platform to develop a virus-based vaccine against the selected neoantigens, under that alliance. The immunotherapy vaccine is designed to target up to 30 patient-specific neoantigens.
Now, BostonGene will use its genomic and transcriptomic analysis platform to identify predictors of response to TG4050. Specifically, BostonGene will identify significant somatic alterations, gene expression, and tumor heterogeneity to assess factors that may mediate response to the vaccine. BostonGene will present these insights in a comprehensive Tumor Portrait Report, ideally shedding light on the oncogenic state and immunogenicity of each patient's tumor.
"BostonGene's advanced [next-generation sequencing] analysis of … cancer patients provides excellent profiling that we believe will add important insight into the understanding of each patient's tumor environment and how it reflects on the clinical outcomes of our treatment," Osamu Fujikawa, NEC's senior VP, said in a statement.