Sensei Biotherapeutics Inc.

• Sensei Biotherapeutics Inc.
• Health-Care

SNSE

We are a clinical-stage immunotherapy company engaged in the discovery and development of next-generation therapies with an initial focus on treatments for cancer. Our proprietary ImmunoPhage platform is a powerful, self-adjuvanted and highly differentiated immunotherapy approach that is designed to utilize bacteriophage to induce a robust, focused and coordinated innate and adaptive immune response. We are engineering our ImmunoPhage product candidates to directly target antigen presenting cells, or APCs, and modulate the tumor microenvironment, or TME, through the targeted use of nanobodies which further enhances therapeutic activity. We believe our ImmunoPhage platform has the potential to deliver personalized, off-the-shelf product candidates tailored to a patient’s specific tumor. The versatility of our ImmunoPhage platform allows us to design product candidates in a modular fashion, based on a cocktail of common and patient-specific antigens built from our proprietary library of ImmunoPhages, which we refer to as Phortress.

We are currently conducting an ongoing 30-patient Phase 1/2 clinical trial of our lead product candidate, SNS-301, in combination with the PD-1 inhibitor pembrolizumab, as a potential treatment for squamous cell carcinoma of the head and neck, or SCCHN. As of December 10, 2020, we have enrolled 11 patients in the trial, of which ten patients were evaluable for efficacy. We have observed disease control in seven of the patients evaluable for efficacy, including one patient with a partial response, or PR, and two patients who have achieved longstanding stable disease, or SD, for greater than 36 weeks following treatment. Treatment with SNS-301 has generally been well tolerated. We anticipate reporting topline data from this trial by the end of 2021. If the results of this trial are positive, subject to feedback from the U.S. Food and Drug Administration, or FDA, we intend to initiate a randomized, registration-enabling trial for SNS-301. We are leveraging the insights from our experience with SNS-301 to expand our development pipeline to include SNS-401 for the treatment of Merkel cell carcinoma, or MCC, as well as a human monoclonal antibody, or mAb, program targeting the novel immune checkpoint VISTA, or V-set immunoglobulin domain suppressor of T cell activation.

Monoclonal antibodies targeting the programmed cell death protein 1, or PD-1, and its related ligand, or PD-L1, have emerged as one of the most promising classes of therapeutics for the treatment of cancer. However, in a majority of patients they generally fail to produce meaningful results. Drugs utilizing PD-1 blockade have been approved by the FDA to treat at least 20 different types of cancer and, in 2019, generated sales of approximately $19.4 billion worldwide. By 2024, the total global market for drugs utilizing PD-1 blockade is estimated to exceed $36 billion. Two of the most common reasons for non-response to PD-1 blockade treatment include a lack of tumor infiltrating lymphocytes, or TILs, or the presence of alternate immunosuppressive mechanisms such as VISTA. To address these mechanisms of non-response to PD-1 blockade, there has been considerable focus on the development of therapies that induce the body’s immune system to mount a response towards tumor antigen targets. Our ImmunoPhage platform is designed to address the challenges of converting PD-1 blockade non-responsive tumors into responsive ones by triggering the generation of tumor antigen-specific T cells and circumventing immunosuppressive pathways.

Pioneering work with bacteriophage led to our discovery of their utility as a powerful, self-adjuvanted immunotherapy platform. The foundation of ImmunoPhage is the bacteriophage lambda, or lambda phage, which we selected for its native immunostimulatory capabilities, large and tractable genome, and tolerability profile. The highly immunogenic nature of bacteriophage promotes a balanced, coordinated and robust response by both the innate and the cellular and humoral components of the adaptive immune system. We believe that the unique features of bacteriophage, including the ability to generate both T cell responses and B cell mediated antibody responses, give it the potential to be used in the development of differentiated treatments for cancer.

The modularity of the ImmunoPhage platform allows for personalized, dynamic substitution of particular phage components to optimize patient therapy. Our creation of a phage cocktail expressing multivalent antigens along with the integration of nanobody technology is designed to enhance the utility, precision and therapeutic activity of our product candidates. This allows for an adaptive clinical trial design, which we have discussed with the FDA. To date, we have constructed over 25 unique ImmunoPhage configurations in-house in accordance with current good manufacturing practices, or cGMP, and we are continuing to expand our Phortress library of ImmunoPhages. 

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