On May 9, 2024 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage immuno-oncology company focused on the discovery and development of next-generation therapeutics for cancer patients, reported financial results for the first quarter ended March 31, 2024, and provided corporate updates (Press release, Sensei Biotherapeutics, MAY 9, 2024, View Source [SID1234643017]).

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"Building upon our initial data for SNS-101, which we believe support a favorable and potentially best-in-class clinical safety and PK profile, we now look forward to sharing topline dose escalation data at ASCO (Free ASCO Whitepaper) in June and initial dose expansion data in the fourth quarter of this year," said John Celebi, President and Chief Executive Officer. "Looking ahead, we are squarely focused on advancing patient enrollment in the dose expansion cohorts, which are intended to generate additional supportive data and optimize the Phase 2 trial design for SNS-101. With cash runway into the fourth quarter of 2025, we believe we are in a strong position to build on both our clinical momentum on behalf of the patients we aim to serve and our scientific advances, as illustrated by our recent publication in Nature Communications."

Highlights and Milestones

SNS-101

SNS-101 is a conditionally active antibody harnessing the acidic tumor microenvironment to selectively target the immune checkpoint VISTA (V-domain Ig suppressor of T cell activation). VISTA is implicated in numerous cancer indications and its expression correlates with low survival rates. Sensei is conducting a multi-center Phase 1/2 clinical trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of SNS-101 as both a monotherapy and in combination with Regeneron’s PD-1 inhibitor Libtayo (cemiplimab) in patients with advanced solid tumors. Recent updates include:

Sensei has completed enrollment in the dose escalation portion of the Phase 1/2 clinical trial of SNS-101, enrolling 16 patients in the monotherapy arm and 18 patients in the combination arm.
In the monotherapy dose escalation arm, patients have cleared all planned dosing cohorts of 0.3, 1, 3, 10, and 15 mg/kg.
In the combination dose escalation arm, patients have cleared all planned dosing cohorts of 3, 10, and 15 mg/kg of SNS-101 plus Libtayo.
There have been no dose limiting toxicities (DLT) observed across both the monotherapy and the combination arms.
Sensei will present topline clinical data from the monotherapy and combination dose escalation portion of its Phase 1/2 trial of SNS-101 in a poster presentation at the upcoming 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place in Chicago, IL, from May 31 – June 4, 2024.
Title: Initial results from a first-in-human phase 1 study of SNS-101 (pH-selective anti-VISTA antibody) alone or in combination with cemiplimab in patients with advanced solid tumors
Presenter: Dr. Shiraj Sen
Session Type: Poster Session
Session Title: Developmental Therapeutics—Immunotherapy
Date and Time: Saturday, June 1, 2024, at 9:00 a.m. – 12:00 p.m. CDT
Abstract Number: 2600
Patient enrollment is ongoing for both the monotherapy and combination dose expansion arms.
In the monotherapy dose expansion arm, Sensei is enrolling patients with microsatellite stable (MSS) colorectal cancer (CRC) at a dose level of 15 mg/kg.
In the combination dose expansion arm, Sensei is enrolling patients with MSS CRC, Head and Neck (H&N) cancer, non-small cell lung cancer (NSCLC), and melanoma at a dose level of 15 mg/kg plus Libtayo.
The solid tumor types were selected to focus the cancer indications on a basket of more commonly occurring histologies, including both "hot" (NSCLC, H&N, Melanoma) and "cold" (CRC) tumors where the company believes SNS-101 has potential to provide clinical benefit based on VISTA biology and supporting preclinical data. Additional tumor types and doses may be considered for both the monotherapy and combination expansion arms.
The Company expects to report initial data from the dose expansion cohorts and hold an end-of-Phase 1 meeting with the FDA by the end of 2024.
In April 2024, Sensei published a peer-reviewed research paper in Nature Communications describing the mechanism of action of SNS-101 selectively targeting the active form of VISTA within the tumor microenvironment.
In March 2024, the company presented SNS-101 data at Keystone Symposia’s Cancer Immunotherapy: Beyond Immune Checkpoint Blockade and Overcoming Resistance.
In February, Sensei presented at the 10th Annual Immuno-Oncology 360 Conference (IO360).
Corporate Updates

In January 2024, Sensei announced the appointment of Ron Weitzman, M.D., F.A.C.P., as part-time Chief Medical Officer.
In January 2024, Sensei announced a realignment of its resources to fully support the Phase 1/2 clinical trial of SNS-101. As a result, Sensei has paused IND-enabling work on its preclinical-stage TMAb programs, including SNS-102 (VSIG4), SNS-103 (CD39) and SNS-201 (VISTAxCD28). Preclinical work to characterize selected lead antibodies, including their mechanisms of action, and target biology is expected to continue throughout 2024.
As a result of this realignment of resources Sensei’s cash runway now extends into the fourth quarter of 2025.
First Quarter 2024 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $58.1 million as of March 31, 2024, as compared to $65.8 million as of December 31, 2023. The decrease is due to cash used to fund operations. Sensei expects its current cash balance to fund operations into the fourth quarter of 2025.

Research and Development (R&D) Expenses: R&D expenses were $4.9 million for the quarter ended March 31, 2024, compared to $5.2 million for the quarter ended March 31, 2023. The decrease in R&D expenses was primarily attributable to lower manufacturing-related expenses and lower costs related to preclinical research, primarily offset by higher expenses associated with clinical trials.

General and Administrative (G&A) Expenses: G&A expenses were $3.8 million for the quarter ended March 31, 2024, compared to $5.8 million for the quarter ended March 31, 2023. The decrease in G&A expense was primarily attributable to decreased cost for external professional services.

Net Loss: Net loss was $8.0 million for the quarter ended March 31, 2024, compared to $10.2 million for the quarter ended March 31, 2023.