On August 3, 2023 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 second quarter ended June 30, 2023, and provided recent business updates (Press release, Sensei Biotherapeutics, AUG 3, 2023, View Source [SID1234633776]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The second quarter of 2023 was momentous for Sensei as we moved expeditiously from the FDA’s clearance of our SNS-101 trial in April to the enrollment of six patients by the end of July. We’re encouraged by the rapid clinical enrollment activity we’ve observed so far, which suggests that we may be able to accelerate the start of the combination arm of this study," said John Celebi, President and Chief Executive Officer of Sensei Biotherapeutics. "We’re grateful for the efforts of the clinical investigators, patients, and families without whom this clinical trial would not be possible."

Highlights and Milestones

SNS-101

Sensei’s lead investigational candidate is SNS-101, a conditionally active antibody targeting the immune checkpoint VISTA (V-domain Ig suppressor of T cell activation), which is implicated in numerous cancer indications and whose expression correlates with low survival rates.

Recent updates for SNS-101 include:

An Investigational New Drug (IND) application for SNS-101 was cleared by the U.S. Food and Drug Administration (FDA) in April 2023. The cleared starting dose of 0.3 mg/kg was substantially higher than other anti-VISTA antibodies.
On June 1, 2023, Sensei reported the first patient dosed in the dose escalation portion of the SNS-101 multi-center Phase 1/2 clinical trial. To date, Sensei has enrolled a total of 6 patients, clearing its first patient cohort at 0.3 mg/kg and its second patient cohort at 1.0 mg/kg, and is currently dosing patients in its third cohort at 3.0 mg/kg.
As a result of the pace of enrollment to date, Sensei expects to dose the first patient in combination with Regeneron’s PD-1 inhibitor Libtayo (cemiplimab) in Q4 2023.
Sensei now expects to report initial pharmacokinetic (PK) and safety data by year-end 2023, and topline monotherapy data and initial combination data for the Phase 1/2 clinical trial in 2024.
On June 27, 2023, Sensei provided an overview of SNS-101 and its Phase 1/2 clinical trial in a virtual KOL event entitled "A New VISTA for Cancer Care: Exploring SNS-101’s Potential as a Transformative Treatment Option for Patients with Solid Tumors." A link to the event recording can be accessed on the Sensei website. For this event, Sensei welcomed James Gulley, M.D., Ph.D., Co-Director of the Center for Immuno-Oncology, and Clinical Director at the National Cancer Institute (NCI), part of the National Institutes of Health, to provide an overview of today’s immuno-oncology treatment landscape and discuss NCI’s Cooperative Research & Development Agreement (CRADA) with Sensei, which includes ongoing research to further elucidate the role of VISTA in immune checkpoint resistance, research to expand the potential of SNS-101 as a combination therapy beyond anti-PD-1, and NCI serving as a clinical site for the SNS-101 Phase 1/2 clinical trial.
Other TMAb Platform Updates

Through its Tumor Microenvironment Activated biologics (TMAb) platform, Sensei is advancing several conditionally active antibody programs, including SNS-102 targeting VSIG4 (V-Set and Immunoglobulin Domain Containing 4), SNS-103 targeting ENTPDase1 (ecto-nucleoside triphosphate diphosphohydrolase-1, also known as CD39) and a recently initiated bispecific antibody program.

Recent updates include:

Sensei has completed lead optimization for its programs SNS-102 (targeting VSIG4) and SNS-103 (targeting CD-39) and is currently characterizing potential lead antibodies for each program. Sensei remains on track to select product candidates for both SNS-102 and SNS-103 in 2023.
Sensei’s early discovery bispecific antibody program has generated an initial set of conditionally active bispecific antibodies that are currently being characterized.
Upon successful candidate selection, Sensei expects to advance one product candidate to IND-enabling studies.
Additional Updates

Robert Schreiber, Ph.D., Professor of Pathology & Immunology and Director of the Center for Human Immunology and Immunotherapy Programs at Washington University, has been appointed Chair of Sensei’s Immuno-Oncology Advisory Board. Dr. Schreiber was largely responsible for defining the concept of cancer immunoediting and his research focuses on elucidating the biochemistry and molecular cell biology of immune responses to developing and established tumors. He is an expert on VISTA, the target of Sensei’s lead program SNS-101, and his laboratory at Washington University in St. Louis, MO has partnered with Sensei to support the continued clinical development of SNS-101.

Second Quarter 2023 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $78.8 million as of June 30, 2023, as compared to $107.1 million as of December 31, 2022. The decrease is due to cash used to fund operations and $7.8 million relating to shares repurchased within the period. Sensei expects its current cash balance to fund operations into the second half of 2025.

Research and Development (R&D) Expenses: R&D expenses were $4.8 million for the quarter ended June 30, 2023, compared to $6.4 million for the quarter ended June 30, 2022. The decrease in R&D expenses was primarily attributable to lower personnel costs due to the Company’s December 2022 restructuring, lower expense relating to lab supply purchases and lower manufacturing-related expenses, partially offset by increased expense relating to outside research fees and higher expense associated with clinical trials.

General and Administrative (G&A) Expenses: G&A expenses were $5.4 million for the quarter ended June 30, 2023, compared to $4.3 million for the quarter ended June 30, 2022. The increase in G&A expense was primarily attributable to external professional services, including $1.56 million of non-recurring expenses associated with stockholder activism related to our 2023 annual meeting of stockholders, partially offset by lower recruiting expense.

Net Loss: Net loss was $9.4 million for the quarter ended June 30, 2023, compared to $10.5 million for the quarter ended June 30, 2022.