Sensei Biotherapeutics Announces First Patient Dosed in Phase 1/2 Clinical Trial of SNS-301 in Patients with ASPH-Positive Head and Neck Cancer

GAITHERSBURG, Md.–(BUSINESS WIRE)–Sensei Biotherapeutics, Inc., a clinical-stage biopharmaceutical company developing precision immuno-oncology therapies, today announced the dosing of the first patient in its Phase 1/2 clinical trial evaluating SNS-301 in patients with ASPH‑positive head and neck cancer who have previously received immune checkpoint inhibitors. SNS-301 is a first-in-class immunotherapy candidate utilizing a bacteriophage viral vector that targets human aspartate β‑hydroxylase (ASPH), and is the company’s first program to enter clinical development from its proprietary drug discovery platform.

The Phase 1/2 clinical trial is a multicenter, open-label trial designed to evaluate the safety, preliminary efficacy and immunogenicity of SNS-301 in combination with pembrolizumab. The study will include ASPH‑positive patients with locally advanced unresectable or metastatic/recurrent squamous cell head and neck cancer currently receiving pembrolizumab or nivolumab. Sensei expects to enroll approximately 30 patients in this two-stage trial with primary efficacy endpoints including objective response rate, duration of response, and multiple secondary endpoints measuring immune responses.

“We are pleased to advance SNS-301 into a Phase 1/2 clinical trial in head and neck cancer, an indication that continues to have a high unmet medical need. We have previously demonstrated dose-dependent ASPH-specific immunogenicity, encouraging clinical activity and a favorable safety profile in ASPH‑positive patients through proof-of-concept studies with SNS-301,” said Ildiko Csiki, M.D., Ph.D., consulting Chief Medical Officer of Sensei Biotherapeutics. “Targeting ASPH represents a novel strategy for treating cancer and we believe that SNS-301 has potentially broad applicability across a wide variety of cancers with its unique mechanism combined with checkpoint inhibition. We look forward to providing preliminary results at a major medical meeting in 2020.”

About SNS-301

SNS-301 is a first-in-class immunotherapy candidate utilizing a bacteriophage viral vector that targets human aspartate β-hydroxylase (ASPH), a cell surface enzyme that is normally expressed during fetal development. Expression of ASPH is upregulated in more than 20 different types of cancer and is related to cancer cell growth, invasiveness, and is inversely correlated with poor disease prognosis. SNS-301 is designed to overcome self-tolerance and induce robust and durable humoral and cellular immune responses that are specific to ASPH. SNS-301 is delivered through intradermal injection and avoids time consuming and uncomfortable infusions, greatly facilitating ease of use.

About Sensei Biotherapeutics

Sensei Biotherapeutics is a clinical-stage biopharmaceutical company focused on the discovery, development and delivery of precision immuno-oncology therapies to transform the cancer treatment landscape. The company is using its proprietary drug discovery platform to study and understand the tumor microenvironment and identify a new class of cancer immunotherapies that act through new biology and differentiated mechanisms. The company brings together scientific leaders in biology, immunology, and oncology along with a highly experienced management team and scientific advisors. . For more information, please visit www.senseibio.com.

Contacts

Media:
Kathryn Morris

The Yates Network

914-204-6412

[email protected]

Investors:
Julie Seidel

Stern Investor Relations, Inc.

212-362-1200

[email protected]