On November 9, 2021 Sensei Biotherapeutics, Inc. (NASDAQ: SNSE), an immunotherapy company focused on the discovery and development of next generation therapeutics for cancer, reported financial results for the third quarter ended September 30, 2021 and provided recent corporate updates (Press release, Sensei Biotherapeutics, NOV 9, 2021, View Source [SID1234594876]).
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"In the third quarter, we witnessed rapid preclinical progress with our TMAb platform, which is designed to address the challenge of resistance to checkpoint blockade. The global PD-1/PD-L1 checkpoint inhibitor market in 2020 was valued at greater than $30 billion1, yet approximately only 20-30 percent of people respond to treatment2," said John Celebi, president and chief executive officer of Sensei Biotherapeutics. "VISTA is an immune checkpoint that is widely expressed on myeloid cells within the tumor microenvironment, a hub of immunosuppressive activity, and is implicated in resistance to checkpoint blockade. VISTA has been historically difficult to address therapeutically due to the presence of a pharmacokinetic sink in the blood and unique pH-dependent biology where the pH of the tumor is more acidic than the rest of the body. We have identified a promising first product candidate, SNS-101, by characterizing a robust set of pH-selective fully human anti-VISTA antibodies. Later this week at SITC (Free SITC Whitepaper), we plan to present preclinical data demonstrating how we rationally designed SNS-101 to block VISTA at low pH within the tumor microenvironment and present initial in vivo data with SNS-101."
Mr. Celebi continued, "We also continue to advance our ImmunoPhage platform to generate new tumor-specific T-cells and are looking forward to providing more updates when we finalize the genetic design of the new ImmunoPhage backbone. Importantly, we are well funded with more than $156 million to advance our two platforms."
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1PD-1 and PD-L1 Inhibitors Market Size In 2021 – MarketWatch, 360Research.
2 Jin-Yu Sun, Resistance to PD-1/PD-L1 blockade cancer immunotherapy: mechanisms, predictive factors, and future perspectives, volume 8, Biomarker Research, 2020.
Third Quarter Highlights and Pipeline Milestones:
TMAb (Tumor Microenvironment Activated Biologics) Platform
VISTA (V-domain Ig suppressor of T cell activation) is an immune checkpoint that is implicated in resistance to PD-1/PD-L1 and correlates with poor survival across numerous cancers. In the third quarter, Sensei achieved the following milestones for this program:
In August, Sensei announced it had selected SNS-101, a potent pH-dependent product candidate that selectively blocks the interaction of VISTA with its receptor, PSGL-1, in the low pH tumor microenvironment. The identification of SNS-101 was partly based on nonclinical data from a human VISTA knock-in mouse model, which showed that TMAb antibodies significantly enhanced anti-tumor responses in combination with PD-1 blockade compared to treatment with PD-1 blockade alone.
In July, Sensei selected a CDMO for the manufacture of GMP-grade material to advance its SNS-VISTA program toward clinical studies.
In September, Sensei announced that an abstract for SNS-101 was accepted for poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) Annual Meeting being held in Washington, D.C. from November 10 – 14, 2021. Data highlighted in the poster are the first preclinical data to be presented by Sensei Bio in a scientific forum from the company’s TMAb platform.
Sensei will host a virtual science symposium on Tuesday, November 16, 2021, at 4:00 p.m. Eastern Time to discuss the potential of the VISTA checkpoint inhibitor to address current limitations of immune checkpoint therapy. The event will be hosted by Sensei’s management team and will include a presentation on VISTA biology by Robert Schreiber, Ph.D., the Andrew M. Bursky and Jane M. Bursky Distinguished Professor of Pathology and Immunology, Professor of Molecular Microbiology and co-leader of the tumor immunology program at the Siteman Comprehensive Cancer Center and Founding Director of the Center for Human Immunology and Immunotherapy Programs at the Washington University School of Medicine. A live webcast of the symposium will be available under "Events & Presentations" in the Investors section of the company’s website at www.senseibio.com. An archived replay will be available for approximately 90 days following the event.
Sensei has initiated IND-enabling studies for SNS-101. Key nonclinical studies include the generation of a broader set of in vivo efficacy data from Sensei’s human VISTA knock-in mouse models, nonclinical pharmacokinetic data, and nonclinical safety data.
VSIG4 (V-Set and Immunoglobulin Domain Containing 4) is a B7-family related protein and a potent inhibitor of T-cell activity, frequently overexpressed on tumor-associated macrophages and a potential driver of immunosuppressive macrophage polarization. VSIG4 is implicated in resistance to checkpoint blockade. Expression of VSIG4 is also found within normal tissues, presenting potential safety challenges, making VSIG4 an ideal candidate for Sensei’s TMAb platform.
Sensei has initiated its antibody discovery campaign.
Sensei plans to select a product candidate from this program in 2023.
ImmunoPhage Platform
SNS-401-NG is a potential first-in-class, multi-antigenic personalized ImmunoPhage candidate being developed in collaboration with the University of Washington designed to treat a broad range of cancers. The first proof-of concept clinical application is directed to the treatment of Merkel Cell Carcinoma (MCC), an aggressive form of skin cancer commonly driven by the Merkel Cell Polyoma Virus. Once clinical proof of concept is achieved, Sensei plans to evaluate a broader study in patients with multiple tumor types, potentially including head and neck cancer, lung cancer, melanoma, and triple negative breast cancer based on the prevalence of Phortress antigens.
Sensei is finalizing the genetic design of its next generation ImmunoPhage, which will serve as the backbone for delivery of anti-tumor antigens to the immune system.
Sensei intends to initiate IND-enabling studies for this product candidate in the second half of 2022.
Corporate
In August, Sensei strengthened its board of directors with the appointed of Kristian Humer as an independent director to its Board.
In October, the company promoted Edward van der Horst, Ph.D. to Senior Vice President, TMAb Research. The company plans to hire additional team members to extend the capabilities of its TMAb and ImmunoPhage programs.
Third Quarter 2021 Financial Results
Cash Position – Cash, cash equivalents and marketable securities were $156.7 million as of September 30, 2021, as compared to $16.6 million as of December 31, 2020. Sensei expects the current cash balance to fund operations at least into the first half of 2024.
Research and Development (R&D) Expenses – R&D expenses were $6.4 million for the quarter ended September 30, 2021, compared to $3.6 million for the quarter ended September 30, 2020. The increase in R&D expenses was primarily attributable to increased headcount to support Sensei’s research, development, and manufacturing activities.
General and Administrative (G&A) Expenses – G&A expenses were $3.9 million for the quarter ended September 30, 2021, compared to $1.8 million for the quarter ended September 30, 2020. The increase in G&A expenses was primarily attributable to higher personnel costs, including stock-based compensation expense, and costs associated with operating as a public company.
Net Loss – Net loss was $9.7 million, for the quarter ended September 30, 2021, compared to $5.4 million for the quarter ended September 30, 2020.
About SNS-101
SNS-101 is a potent, pH-dependent fully human monoclonal antibody designed to block the interaction of VISTA, a novel immune checkpoint that is expressed primarily on myeloid cells, with its receptor, PSGL-1. Selectivity is achieved because SNS-101 targets the active (i.e., protonated) VISTA present in the low pH tumor microenvironment. SNS-101 was selected based on 1) the lack of significant binding to VISTA at physiologic pH (i.e., deprotonated VISTA in the blood), and 2) its high-affinity binding to active VISTA (pH 6.0), which yielded a > 600-fold selectivity. Based on the biochemical properties of SNS-101, we anticipate tumor microenvironment selective activity for this preclinical product candidate. VISTA has been shown to be expressed in numerous tumor types, including non-small cell lung cancer (NSCLC).