Sensei Biotherapeutics Provides Corporate Update and Highlights Key Upcoming Milestones
Rhea-AI Summary
Sensei Biotherapeutics (NASDAQ: SNSE) provided updates on its lead program, solnerstotug (SNS-101), a conditionally active antibody targeting VISTA in cancer treatment. The company has enrolled 45 patients in the dose expansion portion of its Phase 1/2 clinical trial, with full enrollment of approximately 60 patients expected by Q1 2025.
The trial evaluates solnerstotug both as monotherapy and in combination with Libtayo® in patients with advanced solid tumors. Most enrolled 'hot' tumor patients have either progressed on prior anti-PD-1 therapy or are PD-L1 negative. The drug continues to show good tolerability with a best-in-class pharmacokinetic profile, with dose optimization focusing on 3 and 15 mg/kg Q3W levels.
Clinical data update is expected in Q2 2025, including patient follow-up data from dose escalation cohorts. The company maintains cash runway into Q2 2026.
Positive
- Drug shows good tolerability and best-in-class pharmacokinetic profile
- Cash runway extends into Q2 2026
- Trial enrollment progressing well with 45 out of 60 patients enrolled
Negative
- Most enrolled patients have previously failed anti-PD-1 therapy or are PD-L1 negative, indicating challenging patient population
- Final efficacy data not available until Q2 2025
Insights
The Phase 1/2 clinical trial update for solnerstotug (SNS-101) reveals critical progress in VISTA-targeted immunotherapy. With 45 patients enrolled and targeting 60 patients by Q1 2025, the trial's scope is substantial for an early-phase study. The focus on "hot" tumor patients with prior PD-1 therapy resistance is strategically significant, as it addresses a important market gap in immunotherapy-resistant cancers.
The well-tolerated safety profile and optimal pharmacokinetics at 3 and 15 mg/kg Q3W doses are particularly noteworthy. The biomarker analysis strategy, combining peripheral immunophenotyping with genomic and transcriptomic analyses, demonstrates a sophisticated approach to patient stratification and response prediction.
In simpler terms: This drug is showing promise in treating cancers that have stopped responding to existing immunotherapies, with minimal side effects. The company is carefully selecting the right dose and identifying which patients are most likely to benefit from the treatment.
This update carries significant weight for Sensei's valuation prospects. The company's cash runway extending into Q2 2026 provides adequate financial cushion through critical clinical milestones. The upcoming Q2 2025 data readout represents a major catalyst that could drive stock movement, particularly given the
The strategic positioning of solnerstotug in the immunotherapy resistance space addresses a substantial unmet need and market opportunity. The focus on VISTA, a target correlated with poor survival rates, could command premium pricing if approved. The partnership with Regeneron for the Libtayo combination study adds credibility and potential partnership opportunities.
For the average investor: The company has enough money to complete its current studies and the upcoming results in Q2 2025 could significantly impact the stock price. The relatively small market cap suggests room for growth if the treatment proves effective.
- Solnerstotug (SNS-101) dose expansion arm anticipated to be fully enrolled by end of Q1 2025 -
- Clinical data update expected in Q2 2025 -
BOSTON, Jan. 08, 2025 (GLOBE NEWSWIRE) -- Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage biotechnology company focused on the discovery and development of next-generation therapeutics for cancer patients, today provided corporate updates on its lead program, solnerstotug (SNS-101) and upcoming milestones.
“2024 was a noteworthy year for Sensei and our pioneering lead program, solnerstotug. We demonstrated that solnerstotug can overcome the safety and pharmacological hurdles associated with first-generation antibodies targeting the immune checkpoint VISTA, positioning it as the first program in its class with potential to demonstrate clinically meaningful antitumor responses. Moreover, despite enrolling a predominantly ‘cold’ tumor patient population that was unlikely to respond to immunotherapy, solnerstotug demonstrated promising early signs of activity,” said John Celebi, President and Chief Executive Officer. “Looking ahead, 2025 is set to be a pivotal year as we seek to share our first significant efficacy data at optimal doses that include a ‘hot’ tumor patient population more likely to respond to immunotherapy that nonetheless has primary or acquired resistance to PD-1 inhibitors. With cash runway into the second quarter of 2026, we are positioned to advance solnerstotug through the completion of the Phase 1 portion of this study.”
Highlights and Milestones
Solnerstotug (SNS-101)
Solnerstotug is a conditionally active antibody designed to selectively target the immune checkpoint VISTA (V-domain Ig suppressor of T cell activation) within the tumor microenvironment. 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 solnerstotug (SNS-101) as both a monotherapy and in combination with Regeneron’s PD-1 inhibitor Libtayo® (cemiplimab) in patients with advanced solid tumors. Key findings and updates as of January 1, 2025 include:
- A total of 45 patients have been enrolled in the dose expansion portion of the Phase 1/2 clinical trial.
- The majority of the “hot” tumor patients enrolled in the combination dose expansion to date have progressed on a prior anti-PD-1 therapy or are PD-L1 negative, making it highly unlikely that these patients would respond upon re-challenge with anti-PD-1 alone.
- Sensei expects to complete enrollment of the dose expansion with approximately 60 patients by the end of Q1 2025.
- The Company expects to report data from evaluable patients in Q2 2025. Patient follow-up data from the dose escalation cohorts will also be presented.
- Solnerstotug continues to be well tolerated with a best-in-class pharmacokinetic profile.
- Dose optimization is now focused on dose levels of 3 and 15 mg/kg Q3W to support the Phase 2 doses in several patient populations under consideration.
- Efforts are ongoing to explore biomarker correlates of clinical benefit using peripheral immunophenotyping and tumor genomic and transcriptomic analyses.
About Sensei Biotherapeutics
Sensei Biotherapeutics (Nasdaq: SNSE) is a clinical stage biotechnology company focused on the discovery and development of next-generation therapeutics for cancer patients. Through its TMAb™ (Tumor Microenvironment Activated biologics) platform, Sensei develops conditionally active therapeutics designed to disable immunosuppressive signals or activate immunostimulatory signals selectively in the tumor microenvironment to unleash T cells against tumors. Sensei’s lead product candidate is solnerstotug, a conditionally active antibody designed to block the V-domain Ig suppressor of T cell activation (VISTA) checkpoint selectively within the low pH tumor microenvironment, where VISTA acts as a suppressor of T cells by binding the receptor PSGL-1. For more information, please visit www.senseibio.com, and follow the company on X @SenseiBio and LinkedIn.
Cautionary Note Regarding Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words and phrases such as “believe”, “designed to,” “expect”, “may”, “plan”, “potential”, “will”, and similar expressions, and are based on Sensei’s current beliefs and expectations. These forward-looking statements include expectations regarding the development and potential therapeutic benefits of Sensei’s product candidates, the timing of Sensei’s Phase 1/2 clinical trial of solnerstotug (SNS-101), including reporting of data therefrom, and its belief that its existing cash and cash equivalents will be sufficient to fund its operations into the second quarter of 2026. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the development of therapeutic product candidates, such as the risk that any one or more of Sensei’s product candidates will not be successfully developed or commercialized; the risk of delay or cessation of any planned clinical trials of Sensei’s product candidates; the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical trials, will not be replicated or will not continue in ongoing or future studies or clinical trials involving Sensei’s product candidates; the risk that Sensei’s product candidates or procedures in connection with the administration thereof will not have the safety or efficacy profile that Sensei anticipates; risks associated with Sensei’s dependence on third-party suppliers and manufacturers, including sole source suppliers, over which Sensei may not always have full control; risks regarding the accuracy of Sensei’s estimates of expenses, capital requirements and needs for additional financing; and other risks and uncertainties that are described in Sensei’s Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) on November 14, 2024 and Sensei’s other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Sensei as of the date of this release, and Sensei assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.
Investor Contact:
Michael Biega
Senior Director, Investor Relations
Sensei Biotherapeutics
mbiega@senseibio.com
Media Contact:
Joyce Allaire
LifeSci Advisors
Jallaire@lifesciadvisors.com
FAQ
When will Sensei Biotherapeutics (SNSE) complete enrollment for solnerstotug's dose expansion trial?
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