Sensei Biotherapeutics is developing a pipeline of medicines that work by “awakening” the immune system to defend and defeat cancer and infectious diseases. Sensei’s most advanced program is SNS-301, a vaccine that targets Aspartyl beta Hydroxylase (ASPH) in Phase 1/2 studies of advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN). ASPH is overexpressed in many types of cancer, including both hematologic and solid tumors.

 

APPROACH/TARGET
INDICATION
DISCOVERY
PRECLINICAL
PHASE 1
PHASE 2
PHASE 3
SNS-301
ASPH; HPV- specific E6/E7
1st Line Head & Neck Cancer
in combination with pembrolizumab
 
 
 
 
 
 
  • PD-1 blockade has been approved for several years in the treatment of advanced SCCHN after platinum-containing chemotherapy, but the objective response rate has been reported to be modest at 13% to 18% with progression-free survival (PFS) of two months and overall survival (OS) of eight months.
  • The addition of SNS-301 has the potential to enhance PD-1 blockade activity.
  • We also intend to use an ImmunoPhage cocktail targeting the E6/E7 antigens of HPV, in combination with SNS-301, in HPV-positive patients in our ongoing trial of SNS-301.
Head & Neck Cancer Neoadjuvant
in combination with durvalumab
 
 
 
 
 
 
  • We will evaluate the safety and efficacy of SNS-301 in combination with durvalumab for patients with locally advanced, resectable SCCHN in the neoadjuvant setting.
SNS-401
Cocktail with MCPyV
Merkel Cell Carcinoma
 
 
 
 
 
 
  • First custom MCC vaccine consisting of Merkel Cell Polyoma Virus (MCPyV) epitopes together with other patient-specific antigens.
  • MCC is a rare but highly aggressive neuroendocrine carcinoma of the skin in which MCPyV infection and chronic exposure to ultraviolet radiation are key risk factors.
  • Although systemic PD-1/PD-L1 inhibition therapy is associated with a high overall response rate, prolonged durable responses, and good tolerability in advanced-stage MCC, refractory PD-1/PD-L1 inhibitor disease remains a significant unmet medical need with an aggressive clinical course.
SNS-VISTA
VISTA
Solid Tumors
 
 
 
 
 
 
  • VISTA is an immunoregulatory receptor and is highly expressed on various immune system cells including neutrophils, monocytes, macrophages, basophils, and dendritic cells.
  • VISTA blockade appears to dramatically modulate the tumor microenvironment toward a state that favors an immune system response, resulting in improved T cell effector function and anti-tumor activity.
Nanobodies & Antibodies
Various
 
 
 
 
 
Discovery & validation of multiple antibodies & nanobodies utilizing ImmunoPhage platform
  • Proprietary nanobodies, derived from alpacas, are antibody-like structures that consist of a single monomeric variable domain located on the heavy chain.
  • We are developing nanobodies targeted to immune checkpoints and other immune-stimulatory molecules that can be packaged into the phage as immunomodulatory payloads to enhance immunogenicity.
ImmunoPhage
Antibody

SNS-301

SNS-301 is a first-in-class ImmunoPhage™ that is being studied in a Phase 1/2 clinical trial. Early data with SNS-301 as a monotherapy and in combination with immune checkpoint inhibitors have demonstrated that it has generally been well tolerated, shows improvements in disease biomarkers and has the potential to generate a robust, dose-dependent antigen-specific CD8+ T cell and B-cell response. Sensei Bio is currently conducting a Phase 1/2 trial of SNS-301 in combination with Keytruda™ (pembrolizumab) in head and neck cancer patients who did not achieve tumor reductions on anti-PD-1/PD-L1 therapy alone (NCT04034225).

Sensei Bio has an active clinical collaboration with AstraZeneca to evaluate the combination of SNS-301 and IMFINZI® (durvalumab) in patients with the following cancers:

  • Locally-advanced head and neck cancer in the neoadjuvant setting in conjunction with neoadjuvant chemotherapy (i.e. prior to surgical resection).
  • ASPH+ patients with various locally-advanced unresectable or metastatic/recurrent solid tumors

SNS-401

SNS-401 is an ImmunoPhage™ cocktail against Merkel Cell Carcinoma, an aggressive type of skin cancer, driven by the Merkel Cell Carcinoma Polyoma Virus, in collaboration with investigators at the University of Washington. The University of Washington is one of the premier cancer centers worldwide for the research and treatment of Merkel Cell Carcinoma. Researchers there have mapped the B- and T-cell epitopes of the Merkel Cell Polyoma Virus.

SNS-VISTA

Sensei is developing an antibody-based therapeutic targeting V-domain Ig suppressor of T cell activation (VISTA), currently in lead identification, in conjunction with Adimab. VISTA is a novel immune checkpoint that is expressed primarily on myeloid cells; it has been shown in multiple experimental mouse tumor models to be highly complementary to the PD-1/PD-L1 pathway.  In addition, preclinical studies have shown that VISTA is implicated in PD-1/PD-L1 resistance and that therapeutic intervention has the potential to be effective as a monotherapy and synergistic with PD-1/PD-L1 inhibition in vivo.

About Head and Neck Cancer

Head and neck cancers include cancers in the larynx, throat, lips, mouth, nose, and salivary glands.  Head and neck cancer is the sixth most common malignancy worldwide, accounting for approximately 6% of all cancer cases, and is responsible for an estimated 1% to 2% of all cancer deaths. An estimated 650,000 cases of head and neck cancer are diagnosed annually worldwide, including approximately 50,000 cases in the United States. Tobacco use, heavy alcohol use, and infection with human papillomavirus (HPV) increase the risk of head and neck cancers1. Although five-year overall survival (OS) is good for patients diagnosed with localized (83.7%) or locoregionally advanced (64.2%) squamous cell carcinoma of the head and neck (SCCHN), the cancer often recurs distantly. Recurrent or de novo metastatic SCCHN is virtually incurable and the five-year survival is 38.5%2. Extending patients’ survival is, therefore, an important treatment goal.

1 Head and Neck Cancers, NCI, 2017
2 Squamous Cell Carcinoma of the Head and Neck, Decision Resources Disease Landscape and Forecast 2018

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