On November 9, 2020 Sensei Biotherapeutics, Inc., a clinical-stage biopharmaceutical company developing next generation immunotherapies for the treatment of cancer and infectious diseases, reported new data from its ongoing Phase 1/2 clinical trial of SNS‑301, Sensei’s lead program from its ImmunoPhage platform, in patients with Locally Advanced Unresectable or Metastatic/Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN) (Press release, Sensei Biotherapeutics, NOV 9, 2020, View Source [SID1234570532]). The data were presented in a poster session at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 35th Anniversary Annual Meeting.
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"These promising new data build upon the initial safety and efficacy data for SNS-301 in patients with ASPH-positive SCCHN and provide additional confidence that SNS-301, when combined with checkpoint inhibition, has the potential to provide long-term benefit as 2nd and later line treatment for patients," said Marie-Louise Fjällskog, M.D., Ph.D., Chief Medical Officer of Sensei Biotherapeutics. "These results, including a partial response in an advanced SCCHN patient with a PD-L1 negative tumor, as well as translational data demonstrating a shift from an immune desert to an inflamed phenotype, represent a notable achievement for Sensei, further validating our unique phage-based platform approach."
The multi-center Phase 1/2 clinical trial is designed to assess the safety, efficacy and immunogenicity of SNS-301 in SCCHN patients that did not achieve tumor reductions on anti-PD-1/PD-L1 therapy alone. As of the data cutoff date of October 6, 2020, eleven patients were enrolled in the study and enrollment is ongoing. Key highlights from the poster titled "Early Safety and Efficacy of a Phase 1/2 Multi-Center Trial of SNS-301 Added to Pembrolizumab in Patients with Advanced Squamous Cell Carcinoma of the Head and Neck" are:
Disease control in 6 of 9 patients evaluable for efficacy, including:
One patient with PD-L1 negative disease achieved a partial response (PR) with a tumor reduction of 43% at week 12 and was confirmed at week 18. Immunohistochemical staining of this patient’s tumor pre- and post-treatment demonstrated clear increases in CD8 density and PD-L1 expression on CD8 T cells and macrophages. This patient also achieved a clear serological response.
One patient achieved a stable disease (SD) for more than 4 months following progressive disease (PD) after 10 months of PD-1 blockade treatment prior to study entry.
Two patients achieved SD for 36+ weeks.
Of the three patients that had PD as their best response, two had PD on single agent PD1 blockade when entering the study.
SNS-301 was well tolerated with no dose-limiting toxicities and observed adverse events (AEs) have primarily been either Grade 1 or 2 and mostly unrelated to treatment.
Nanostring analysis of tumors from patients with a partial response, stable disease, and progressive disease was generally concordant with clinical effect, including across immune parameters such Th1 markers, IFN-gamma, Granzyme B, and CD8 T cells.
In addition to the new safety and efficacy data presented today, Sensei also presented a trial-in-progress (TIP) poster describing the design of the ongoing Phase 1/2 clinical trial of SNS-301 in combination with pembrolizumab in SCCHN patients.
About SNS-301
SNS-301 is a first-in-class cancer immunotherapy designed to overcome immune tolerance and induce robust and durable antigen-specific humoral and cellular responses. It is a bio-engineered, inactivated bacteriophage virus expressing a fusion protein of native bacteriophage GPD (Glyceraldehyde-3-phosphate dehydrogenase) protein and a selected domain of aspartate β-hydroxylase (ASPH). Expression of ASPH is uniquely upregulated in more than 20 different types of cancer and expression levels in various tumors are generally inversely correlated with disease prognosis. ASPH signaling is related to cancer cell growth, cell motility and invasiveness, occurs through the Notch pathway and is implicated in the epithelial to mesenchymal transition (EMT).