On November 7, 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 third quarter ended September 30, 2023, and provided recent business updates (Press release, Sensei Biotherapeutics, NOV 7, 2023, View Source [SID1234637162]).
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"The third quarter of 2023 was marked by significant progress, culminating in the presentation of favorable clinical data supporting our belief that our lead investigational candidate SNS-101 is a potentially transformative treatment in the oncology space with a best-in-class safety and pharmacokinetic profile," said John Celebi, President and Chief Executive Officer of Sensei Biotherapeutics. "Clinical data to-date support our capability to execute on the promise and development of conditionally active antibodies, and we believe we are well-capitalized to advance SNS-101 clinically toward our near-term business and scientific milestones."
Highlights and Milestones
SNS-101
SNS-101 is 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. 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:
Enrollment as of November 6, 2023:
A total of 17 patients have been treated with SNS-101 across various dose levels, with 14 patients in the monotherapy arm and three patients in the combination arm.
In the monotherapy dose escalation arm, patients are enrolling at a dose level of 15 mg/kg after clearing dose levels of 0.3, 1, 3, and 10 mg/kg.
In the combination dose escalation arm, three patients have been enrolled in the first cohort which has cleared a dose level of 3.0 mg/kg SNS-101 + Libtayo.
On November 3, 2023, Sensei reported initial data from the monotherapy dose-escalation portion of the Phase 1/2 clinical trial for SNS-101 in a late-breaker poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 38th Annual Meeting, showing that SNS-101 has a potential best-in-class safety and pharmacokinetic profile, including, as of the safety cutoff date of October 3, 2023:
Safety, cytokine expression and pharmacokinetic data were presented for seven patients from the first three monotherapy cohorts, all of which have cleared the dose-limiting toxicity assessment period.
A total of 11 adverse events (including one serious adverse event not considered related to SNS-101) were reported in five patients, with no dose-limiting toxicities observed. Only one adverse event (Grade 2 dermatitis acneiform) was considered related to SNS-101.
There were no instances of cytokine release syndrome and no significant changes in key inflammatory cytokines over time, consistent with preclinical studies.
Pharmacokinetic data demonstrate dose-proportional exposure consistent with lack of target mediated drug disposition, no notable accumulation with repeat dosing, and linear elimination kinetics of SNS-101, in concordance with preclinical data.
On October 23, 2023, Sensei presented a trial-in-progress poster from the Phase 1/2 clinical trial for SNS-101 at the European Society for Medical Oncology Congress (ESMO) (Free ESMO Whitepaper) 2023.
On September 21, 2023, Sensei presented new preclinical data reinforcing SNS-101’s pharmacokinetic profile, safety characteristics, and mechanism of action at the Seventh Annual CRI-ENCI-AACR International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper): Translating Science into Survival (CICON).
Anticipated milestones for the SNS-101 Phase 1/2 clinical trial include:
Initial safety and pharmacokinetic data for the combination dose escalation arm of SNS-101 and Libtayo in Q1 2024
Topline data for the SNS-101 monotherapy dose escalation arm in Q2 2024
Topline data for the combination dose escalation arm of SNS-101 and Libtayo in 2024
Additional TMAb Pipeline and 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 SNS-201, a VISTAxCD28 bispecific antibody.
Recent updates:
Sensei has selected a lead candidate for SNS-201, a conditionally active VISTAxCD28 bispecific antibody, supporting a mechanism focused on conditional activation of CD28 within low pH environments, such as the tumor microenvironment. CD28 is a major costimulatory pathway for T cells. Based on preclinical data of SNS-201 and a prototype molecule, Sensei believes SNS-201 has the potential to conditionally activate CD28 under low pH conditions, such as those found in the tumor microenvironment, leading to stimulation of T cell activation in the tumor while minimizing off-tumor toxicity.
Sensei has selected a lead candidate for SNS-102, a conditionally active antibody that potently blocks the interaction of VSIG4 with its novel counter-receptor and is 585-fold more selective for VSIG4 at low pH conditions. A counter-receptor has been provisionally identified and confirmation is in progress.
Sensei is continuing to evaluate two potential antibodies as potential lead candidates for SNS-103 (targeting CD39).
Upon successful candidate selection, Sensei expects to advance one product candidate toward early manufacturing activities and single-dose toxicology studies.
In August 2023, Sensei published a review article describing its pH-sensitive antibody engineering efforts, entitled "Conditionally Active, pH-Sensitive Immunoregulatory Antibodies Targeting VISTA and CTLA-4 Lead an Emerging Class of Cancer Therapeutics," in Antibodies, an international, peer-reviewed journal.
Corporate Updates
On November 1, 2023, Sensei announced the announced the appointment of Stephanie Krebs, MS, MBA, as Chief Business Officer.
Upcoming Events
Sensei will participate in the Jefferies London Healthcare Conference in London, UK from November 14-16, 2023.
Sensei will present at the Protein & Antibody Engineering Summit (PEGS-EU) in Lisbon, Portugal on Tuesday, November 14, 2023, at 5:00 p.m. CET.
Third Quarter 2023 Financial Results
Cash Position: Cash, cash equivalents and marketable securities were $72.0 million as of September 30, 2023, as compared to $107.1 million as of December 31, 2022. The decrease is due to cash used to fund operations and $9.8 million relating to shares repurchased during the nine months ended September 30, 2023. 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 $3.8 million for the quarter ended September 30, 2023, compared to $9.2 million for the quarter ended September 30, 2022. The decrease in R&D expenses was primarily attributable to lower manufacturing-related expenses, lower personnel costs due to the Company’s December 2022 restructuring and lower expense relating to lab supply purchases, partially offset by higher expense associated with clinical trials.
General and Administrative (G&A) Expenses: G&A expenses were $3.9 million for the quarter ended September 30, 2023, compared to $4.8 million for the quarter ended September 30, 2022. The decrease in G&A expense was primarily attributable to decreased personnel costs due to the Company’s December 2022 restructuring and lower expense related to directors and officers insurance.
Net Loss: Net loss was $7.1 million for the quarter ended September 30, 2023, compared to $13.4 million for the quarter ended September 30, 2022.