Sensei Biotherapeutics Reports Full Year 2023 Financial Results and Recent Business Highlights

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– Updated dose escalation data from SNS-101 clinical study supports favorable and potentially best-in-class safety and PK profile both as monotherapy and in combination with PD-1 blockade –

– Topline efficacy and biomarker data for both monotherapy and combination arms of dose escalation study now expected in Q2 2024, ahead of previous guidance –

– Strong balance sheet with cash runway into fourth quarter of 2025 –

BOSTON, Feb. 28, 2024 (GLOBE NEWSWIRE) — Sensei Biotherapeutics, Inc. (NASDAQ:SNSE), a clinical stage immuno-oncology company focused on the discovery and development of next-generation therapeutics for cancer patients, today reported financial results for the full year 2023, and provided corporate updates.

“2023 saw the entry of our differentiated anti-VISTA antibody, SNS-101, into clinical development,” said John Celebi, President and Chief Executive Officer. “Initial data revealed in November, and updated today, support a favorable and potentially best-in-class clinical safety and PK profile, consistent with preclinical studies, thus overcoming major hurdles associated with prior efforts to drug VISTA. We believe SNS-101 is now the first anti-VISTA therapy to reach pharmacologically relevant dose levels in a clinical study, and we are looking forward to an exciting year for Sensei. Based on the rapid pace of enrollment, we now plan to share topline efficacy and biomarker data for both monotherapy and combination arms in the second quarter of 2024, which is ahead of previous guidance. Looking ahead, part of management’s attention in 2024 will be directed toward preparations for an end-of-Phase 1 meeting with FDA in the fourth quarter of 2024 and defining the paths we intend to follow over the next several years to maximize the value of SNS-101 and our additional novel product candidates.”

Highlights and Milestones

SNS-101

SNS-101 is a conditionally active antibody harnessing the acidic tumor microenvironment to 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:

As of February 23, 2024:

A total of 33 patients have been treated with SNS-101 +/- Libtayo in the dose escalation phase of this study.

In the monotherapy dose escalation arm, 16 patients have been enrolled and cleared all planned dosing cohorts of 0.3, 1, 3, 10, and 15 mg/kg.
In the combination dose escalation arm, 17 patients have been enrolled and cleared the first two planned dosing cohorts of 3 and 10 mg/kg + Libtayo. The third cohort at a dose level of 15.0 mg/kg of SNS-101 plus Libtayo is enrolling.

Patient enrollment has started for the recently announced monotherapy dose expansion arm in patients with microsatellite stable (MSS) colorectal cancer (CRC) at a dose level of 15 mg/kg.
The combination dose expansion arm will commence once the safety monitoring committee reviews the third combination dose escalation cohort.
SNS-101 +/- Libtayo has been well tolerated in both the monotherapy and combination dose escalation cohorts with no dose-limiting toxicities observed.

In the monotherapy dose escalation arm, 13/16 patients (81%) experienced at least one treatment-emergent adverse event (TEAE), with the majority of adverse events (AEs) Grade 1 or 2.
In the combination dose escalation arm, 10/17 patients (59%) experienced at least one TEAE, with the majority of AEs Grade 1 or 2.

SNS-101 has demonstrated potentially best-in-class pharmacokinetics, with linear elimination kinetics and dose-proportional increases in exposure across monotherapy and combination cohorts. There was no notable difference in pharmacokinetics between monotherapy and combination dosing. The pharmacokinetic data support once every 3-week dosing for SNS-101.
As a result of rapid enrollment, Sensei now expects to report both topline monotherapy and combination dose escalation data in Q2 2024.
Initial data for the SNS-101 dose expansion cohorts is expected by the end of 2024.

In January 2024, Sensei announced plans to enroll up to 40 additional patients in both monotherapy and in combination with Libtayo in specific tumor types to further optimize the design of the Phase 2 trial.

In the monotherapy dose expansion arm, Sensei plans to enroll up to 10 patients with MSS CRC at a dose level of 15 mg/kg.
In the combination dose expansion arm, Sensei plans to enroll up to 30 patients with MSS CRC, head and neck cancer (H&N), non-small cell lung cancer (NSCLC), and melanoma.
The initially selected solid tumor types are focused on a basket of more commonly occurring histologies, including both “hot” (NSCLC, H&N, Melanoma) and “cold” (CRC) tumors. All patients with “hot” tumors enrolling into the expansion arm are expected to have been previously treated with a PD-1/L1 checkpoint inhibitor. Additional tumor types and doses may be considered for both the monotherapy and combination expansion arms.

Sensei presented supporting SNS-101 data at numerous medical meetings throughout 2023:

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) 38th Annual Meeting, showing that SNS-101 has a potential best-in-class safety and pharmacokinetic profile.
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) 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: Translating Science into Survival (CICON).
In February 2023, preclinical data presented at the Keystone Symposia on Next-Generation Antibody Therapeutics included crystal structure analysis further elucidating SNS-101’s mechanism of action, showing that the antibody directly blocks the pH-dependent interaction between VISTA and PSGL-1.

In February 2024, Sensei co-authored a publication discussing the development of a preclinical in vivo model to assess cytokine release syndrome (CRS).
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.
In June 2023, Sensei hosted a KOL event featuring James Gulley, M.D., Ph.D., Co-Director of the Center for Immuno-Oncology at the National Cancer Institute (NCI) entitled “A New Vista for Cancer Care: Exploring SNS-101’s Potential as a Transformative Treatment Option for Patients with Solid Tumors”.
Sensei announced two collaborations key to the development of SNS-101 and the Phase 1/2 clinical trial:

A Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), executed in February 2023, is designed to further demonstrate the role of VISTA in checkpoint resistance and will enable Sensei to explore SNS-101’s potential as a combination therapy beyond anti-PD-1. The NCI will also participate …

Full story available on Benzinga.com


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