On November 8, 2022 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), an immuno-oncology company focused on the discovery and development of next generation therapeutics for cancer patients, reported financial results for the third quarter ended September 30, 2022 and provided recent business updates (Press release, Sensei Biotherapeutics, NOV 8, 2022, View Source [SID1234623430]).

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"We believe VISTA has tremendous potential as an immune checkpoint target and have prioritized the advancement of SNS-101 toward clinical studies. This has been a productive quarter in that regard highlighted by robust and differentiated preclinical data, which we believe demonstrate the potential of SNS-101 to avoid poor pharmacokinetics from target-mediated drug disposition and lower the risk of cytokine release syndrome, while significantly enhancing the anti-tumor effects of PD-1 blockade. These data, coupled with the progress of our SNS-102 program targeting VSIG4, also support the biological rationale for Sensei’s conditionally active approach as a mechanism for achieving selective activation in the tumor microenvironment. We believe our TMAb platform has the potential to unlock previously undruggable immune targets by avoiding on-target/off-tumor effects that have thwarted previous efforts to inhibit targets such as VISTA," said John Celebi, President and Chief Executive Officer of Sensei Biotherapeutics. "With cash runway into the first quarter of 2025, Sensei is well positioned to advance multiple programs and achieve critical near-term milestones, including the anticipated submission of an IND for SNS-101 in the first half of 2023."

Highlights and Milestones

SNS-101

Sensei continues to advance SNS-101, a conditionally active antibody targeting the immune checkpoint VISTA (V-domain Ig suppressor of T cell activation), which is implicated in resistance to PD-1/PD-L1 therapy and correlates with poor survival across numerous cancers. Recent updates for SNS-101 include:

On Friday, November 11, 2022, Sensei will present new preclinical data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting, being held in Boston, MA.
The Company presented preclinical data at the Sixth Annual CRI-ENCI-AACR International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper): Translating Science into Survival which demonstrated SNS-101’s favorable pharmacokinetic (PK) profile in single-dose mouse and non-human primate (NHP) models, and evidence of enhanced anti-tumor effects in combination with anti-PD-1 antibodies in mice. Additionally, SNS-101 demonstrated a superior cytokine release profile compared to a non-pH-sensitive VISTA antibody.
The Company intends to present new data from a multi-dose pharmacokinetic (PK) and toxicology model in non-human primates in the first half of 2023.
Over the last quarter, Sensei completed GMP manufacturing of SNS-101 bulk drug substance and projects sufficient drug product for its planned Phase 1/2 clinical trial.
The Company is exploring ways to leverage SNS-101’s high selectivity for the tumor microenvironment through other modalities.
Sensei remains on track to submit an Investigational New Drug application (IND) for SNS-101 in the first half of 2023.
SNS-102

Sensei is advancing several pH-sensitive antibodies targeting VSIG4 (V-Set and Immunoglobulin Domain Containing 4), a B7-family related protein that is a potent inhibitor of T cell activity and is frequently overexpressed on tumor-associated macrophages. The Company intends to optimize toward a pH-dependent, high-affinity inhibitory antibody that binds VSIG4 selectively in the tumor microenvironment without affecting healthy tissue.

On Thursday, November 10, 2022, Sensei will present a poster at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting detailing an enhanced mechanistic understanding of VSIG4 to inform future antibody development.
The Company has identified eight parental pH-selective VSIG4 antibodies, and a lead antibody set is currently undergoing further optimization.
Sensei remains on track to select a product candidate for SNS-102 in 2023.
SNS-103

Sensei is advancing conditionally active antibodies targeting ENTPDase1 (ecto-nucleoside triphosphate diphosphohydrolase-1, also known as CD39), the upstream, rate-limiting enzyme that leads to the breakdown of extracellular ATP and the production of immunosuppressive adenosine. The Company began screening the first set of parental antibodies in September 2022 and remains on track to select a product candidate in 2023.

Corporate Updates

On Monday, November 21, 2022, Sensei will host a virtual KOL webinar "Lessons from VISTA: New Strategies to Address an Important Immune Checkpoint." Robert Schreiber, Ph.D., a globally recognized expert on the immune system’s role in anti-cancer immunity, will present on VISTA’s role in immunosuppression, and Sensei management will provide a review of the SNS-101 program.
Sensei will present at the 13th Annual Jefferies Global Healthcare Conference, being held in London, United Kingdom, on Thursday, November 17, 2022, at an updated time of 8:00 a.m. GMT.
Consistent with the Company’s prioritization of its TMAb platform, Sensei has suspended development efforts related to its ImmunoPhage platform, including its SNS-401-NG product candidate. As a result, the Company now plans to focus all its resources and efforts on developing conditionally active antibodies through its TMAb platform.
Third Quarter 2022 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $116.6 million as of September 30, 2022, as compared to $147.6 million as of December 31, 2021. Sensei expects its current cash balance to fund operations into the first quarter of 2025.

Research and Development (R&D) Expenses: R&D expenses were $9.2 million for the quarter ended September 30, 2022, compared to $6.4 million for the quarter ended September 30, 2021. The increase in R&D expenses was primarily attributable to increased manufacturing and early development activities for the Company’s lead program SNS-101, partially offset by a decrease in clinical trial expenses.

General and Administrative (G&A) Expenses: G&A expenses were $4.8 million for the quarter ended September 30, 2022, compared to $3.9 million for the quarter ended September 30, 2021. The increase in G&A expense was primarily attributable to external professional services.

Net Loss: Net loss was $13.4 million for the quarter ended September 30, 2022, compared to $9.7 million for the quarter ended September 30, 2021.