Patient assistance programs, government initiatives towards cancer awareness, prevalence of cancer, and the subsequent rise in R&D initiatives and cancer-related clinical trials are the primary factors pushing advancements in the field of cancer treatment. Today, several global pharmaceutical firms are working to develop various cancer treatment options.
Sensei Biotherapeutics, a US-based biopharmaceutical firm aimed at discovery, development and delivery of immuno-oncology treatments, reportedly announced the dosing of the first patient in its Phase 1/2 clinical study for SNS-301. The study assesses the efficacies of SNS-301 in ASPH-positive head as well as neck cancer patients who previously have been given immune checkpoint inhibitors.
The company’s candidate, SNS-301 is the first-ever immunotherapy candidate that uses bacteriophage viral vector that targets the human ASPH (aspartate β-hydroxylase). This is also the first program from the company to enter clinical development through its proprietary platform of drug discovery.
The Phase 1/2 clinical study is an open-label, multicenter trial that is designed to evaluate the immunogenicity, preliminary efficacy and safety of SNS-301 when combined with pembrolizumab.
The trial would specifically include ASPH-positive patients who have locally advanced metastatic/recurrent or unresectable squamous cell head and neck cancer and are presently receiving nivolumab or pembrolizumab.
The company hopes to register about 30 patients in this two-stage study with primary efficacy endpoints that includes duration of response, objective response rate and multiple secondary endpoints that measure immune responses.
Consulting Chief Medical Officer at Sensei Biotherapeutics, Ildiko Csiki, M.D., Ph.D., stated that the company is thrilled to advance SNS-301 in a phase 1/2 clinical study for head and neck cancer, a disease that has heavy unmet medical demand. The company has earlier demonstrated dose-dependent ASPH specific immunogenicity, which encouraged a favorable safety profile and clinical activity in ASPH positive patients via proof-of-concept studies along with SNS-301.
Csiki further added that targeting ASPH signifies a new strategy for cancer therapy and the company believes that SNS-301 could potentially have wide applications across a broad variety of cancers when its unique mechanism is coupled with checkpoint inhibition. The company looks forward to delivering preliminary outcomes at a major medical conference in 2020.