On May 10, 2022 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 first quarter ended March 31, 2022, and provided recent corporate updates (Press release, Sensei Biotherapeutics, MAY 10, 2022, View Source [SID1234614052]).

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"We continue to make significant progress in the development of our TMAb platform, which is designed to address the challenge of resistance to checkpoint blockade. New preclinical data show that SNS-101, our anti-VISTA antibody, binds selectively in low-pH environments to inhibit tumor growth, offering high potential for therapeutic benefit while avoiding the pharmacokinetic sinks and on-target, off-tumor toxicities that have made multiple immune targets difficult to drug," said John Celebi, president and chief executive officer of Sensei Biotherapeutics. "Importantly, we have extended our cash runway into the first quarter of 2025 by prioritizing near-term milestones for SNS-101 and other TMAb programs, while also continuing to optimize our ImmunoPhage platform."

Highlights and Milestones

TMAb (Tumor Microenvironment Activated Biologics) Platform

SNS-101

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

In April 2022 Sensei presented preclinical data demonstrating that SNS-101 had a favorable pharmacokinetic profile in a single-dose mouse model. Notably, pH-selective SNS-101 demonstrated a long mean residence time in the blood, indicating a lack of significant target-mediated drug disposition and clearance in non-malignant tissues.
SNS-101 demonstrated synergistic anti-tumor activity in vivo in combination with anti-PD-1 in a MC38 syngeneic tumor model in human VISTA knock-in mice.
SNS-101 has demonstrated great manufacturing productivity to date and Sensei anticipates reviewing pharmacokinetic and toxicology data from its single dose non-human primate studies in mid-2022.
Sensei has initiated GMP manufacturing for SNS-101 and remains on track to submit an IND in the first half of 2023.
SNS-102

Sensei intends to select a product candidate and initiate IND-enabling studies in 2023 for SNS-102, a monoclonal antibody targeting VSIG4 (V-Set and Immunoglobulin Domain Containing 4), a B7-family related protein that is frequently overexpressed on tumor-associated macrophages.
VSIG4 is a potent inhibitor of T-cell activity and potential driver of immunosuppressive macrophage polarization. Given its expression within normal tissues and the resulting potential safety challenges, Sensei believes that VSIG4 is an ideal candidate for development through its TMAb platform.
Sensei has generated the first set of parental tumor-selective antibodies targeting VSIG4 aimed at developing an inhibitory antibody with high selectivity for VSIG4 in the tumor microenvironment versus normal tissue environments.
SNS-103

Sensei remains on track to select a product candidate in 2023 for SNS-103, a monoclonal antibody targeting ENTPDase1 (ecto-nucleoside triphosphate diphosphohydrolase-1, also known as CD39), the upstream, rate-limiting enzyme leading to the breakdown of extracellular ATP.
ImmunoPhage Platform and SNS-401-NG

Sensei is optimizing its ImmunoPhage platform to offer a potentially transformative approach to generating new T cells to fight cancer, with potential to address multiple tumor types. Current work in this platform area extending into 2023 is focused on SNS-401-NG, a potential first-in-class, multi-antigenic bacteriophage designed to deliver anti-tumor antigens to the immune system. Sensei believes that a measured approach to development will position the company to advance the most potent ImmunoPhage product candidate when ready.

Corporate

In April 2022, Robert Pierce, M.D., Chief R&D Officer, presented an update on SNS-101 at the World Vaccine Congress, held April 18-21, 2022, in Washington DC.
In March 2022, Sensei announced the appointment of William Ringo as Chair of the Board of Directors.
In January 2022, Sensei announced the promotions of Erin Colgan to Chief Financial Officer and Robert Pierce, M.D., to Chief R&D Officer.
First Quarter 2022 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $136.2 million as of March 31, 2022, as compared to $147.6 as of December 31, 2021. Sensei expects the current cash balance to fund operations into the first quarter of 2025.

Research and Development (R&D) Expenses: R&D expenses were $7.5 million for the quarter ended March 31, 2022, compared to $3.4 million for the quarter ended March 31, 2021. 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 $5.0 million for the quarter ended March 31, 2022, compared to $4.6 million for the quarter ended March 31, 2021, with the increase mainly driven by franchise tax increases. The company is focused on carefully managing the growth of G&A expenses in the near term.

Net Loss: Net loss was $12.4 million, for the quarter ended March 31, 2022, compared to $8.0 million for the quarter ended March 31, 2021.