This section highlights FDA-related milestones and regulatory updates for drugs developed by Sensei Biotherapeutics (SNSE).
Over the past two years, Sensei Biotherapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
SNS-101 and SNS-103. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
SNS-101 - FDA Regulatory Timeline and Events
SNS-101 is a drug developed by Sensei Biotherapeutics for the following indication: Suppressor of T cells by binding the receptor PSGL-1.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SNS-101
- Announced Date:
- March 28, 2025
- Indication:
- Suppressor of T cells by binding the receptor PSGL-1
Announcement
Sensei Biotherapeutics, Inc. provided corporate updates.
AI Summary
Sensei Biotherapeutics, Inc. provided key corporate updates during their recent announcement. In Q4, the company restructured its operations to better concentrate on advancing their lead product candidate, solnerstotug, for cancer treatment. They streamlined processes and focused resources to enhance clinical progress and cost management.
The company also made significant leadership appointments by naming Josiah Craver as Senior Vice President of Finance and Principal Financial and Accounting Officer, and Dr. Ron Weitzman as part-time Chief Medical Officer. Additionally, Sensei shared that they have achieved full enrollment in their Phase 1/2 dose expansion cohort for solnerstotug, with final data expected by the end of 2025, and confirmed a cash runway into the second quarter of 2026. These updates underscore their commitment to optimizing internal processes and advancing their innovative therapeutic strategy.
Read Announcement- Drug:
- SNS-101
- Announced Date:
- March 27, 2025
- Indication:
- Suppressor of T cells by binding the receptor PSGL-1
Announcement
Sensei Biotherapeutics announced initial results from the dose expansion portion of its Phase 1/2 trial evaluating solnerstotug (formerly SNS-101), a conditionally active monoclonal antibody targeting VISTA (V-domain Ig suppressor of T cell activation).
AI Summary
Sensei Biotherapeutics announced promising initial results from the dose expansion portion of its Phase 1/2 trial for solnerstotug (formerly SNS-101). This conditionally active monoclonal antibody targets VISTA, a protein that suppresses T cell activation, and aims to treat patients with tumors resistant to PD-(L)1 therapies. In early tests, solnerstotug produced an overall response rate of 14% in a group of hard-to-treat, PD-(L)1 resistant “hot” tumors—nearly three times higher than historical response rates for PD-(L)1 rechallenge. Notably, one Merkel Cell Carcinoma patient experienced a durable complete response, while additional patients achieved partial responses. All patients showing tumor shrinkage remain on treatment, suggesting the potential for prolonged benefits. These initial outcomes underscore the antibody’s promise in addressing a significant unmet need for patients who have progressed on standard immunotherapy treatments.
Read Announcement- Drug:
- SNS-101
- Announced Date:
- January 8, 2025
- Indication:
- Suppressor of T cells by binding the receptor PSGL-1
Announcement
Sensei Biotherapeutics, Inc. provided corporate updates on its lead program, solnerstotug (SNS-101) and upcoming milestones.
AI Summary
Sensei Biotherapeutics, Inc. provided an update on its lead program, solnerstotug (SNS-101), a conditionally active antibody targeting the VISTA immune checkpoint in the tumor microenvironment. The company is currently enrolling patients for the dose expansion portion of its Phase 1/2 clinical trial. Approximately 45 patients have been enrolled so far, and the expected enrollment target is around 60 patients by the end of Q1 2025. Clinical data from evaluable patients is anticipated in Q2 2025, with additional follow-up data from the dose escalation cohorts expected. The trial is testing solnerstotug both as a monotherapy and in combination with a PD-1 inhibitor, focusing on both "hot" and "cold" tumor patient populations. This update marks a key milestone as Sensei aims to demonstrate clinically meaningful antitumor responses while moving forward with its clinical development efforts.
Read Announcement- Drug:
- SNS-101
- Announced Date:
- January 8, 2025
- Estimated Event Date Range:
- April 1, 2025 - June 30, 2025
- Target Action Date:
- Q2 - 2025
- Indication:
- Suppressor of T cells by binding the receptor PSGL-1
Announcement
Sensei Biotherapeutics, Inc. announced that Clinical data update expected in Q2 2025
AI Summary
Sensei Biotherapeutics recently announced that a clinical data update for its lead candidate, solnerstotug (SNS-101), is expected in Q2 2025. This update comes as part of the ongoing Phase 1/2 clinical trial evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of solnerstotug in patients with advanced solid tumors.
The dose expansion portion of the study is planned to be fully enrolled, with approximately 60 patients expected by the end of Q1 2025. The upcoming data will offer early insights into solnerstotug’s performance, particularly in showing its potential to generate meaningful antitumor responses in patient populations that have shown resistance to other immunotherapies.
Read Announcement- Drug:
- SNS-101
- Announced Date:
- January 8, 2025
- Estimated Event Date Range:
- January 1, 2025 - March 31, 2025
- Target Action Date:
- Q1 - 2025
- Indication:
- Suppressor of T cells by binding the receptor PSGL-1
Announcement
Sensei Biotherapeutics, Inc. announced that Solnerstotug (SNS-101) dose expansion arm anticipated to be fully enrolled by end of Q1 2025 -
AI Summary
Sensei Biotherapeutics has announced that the dose expansion arm of its Phase 1/2 clinical trial for Solnerstotug (SNS-101) is expected to be fully enrolled with approximately 60 patients by the end of Q1 2025. This arm of the study is designed to include patients who are more likely to respond to immunotherapy, including those with “hot” tumors and resistance to PD-1 inhibitors.
The company also plans to release updated clinical data in Q2 2025. Solnerstotug is a next-generation conditionally active antibody focused on targeting the immune checkpoint VISTA, which plays a key role in the tumor microenvironment. By advancing the enrollment and subsequent data reporting, Sensei aims to demonstrate promising antitumor activity and pave the way for further clinical development of this novel cancer therapy.
Read Announcement- Drug:
- SNS-101
- Announced Date:
- May 23, 2024
- Indication:
- Suppressor of T cells by binding the receptor PSGL-1
Announcement
Sensei Biotherapeutics, Inc. today reported encouraging clinical data from the dose escalation portion of its Phase 1/2 trial of SNS-101, a conditionally active, human monoclonal antibody targeting the immune checkpoint VISTA (V-domain Ig suppressor of T cell activation).
AI Summary
Sensei Biotherapeutics, Inc. reported encouraging results from the dose escalation phase of its Phase 1/2 trial testing SNS-101, a conditionally active, human monoclonal antibody targeting the VISTA immune checkpoint. The trial explored a once-every-three-weeks dosing schedule, which showed promising signs of clinical activity in patients with advanced solid tumors, including microsatellite stable colorectal and endometrial cancers that have historically been unresponsive to immunotherapy.
Results indicated that SNS-101 was well tolerated at its highest planned dose with no dose limiting toxicities and displayed a favorable pharmacokinetic profile with linear elimination kinetics. These findings suggest that the conditionally active, pH-selective approach may overcome previous barriers associated with VISTA-targeted treatments. The promising clinical signals have supported plans to progress further into the dose expansion stage of the trial.
Read Announcement- Drug:
- SNS-101
- Announced Date:
- April 4, 2024
- Indication:
- Suppressor of T cells by binding the receptor PSGL-1
Announcement
Sensei Biotherapeutics, Inc announced the publication of a peer-reviewed research paper in Nature Communications. The research was conducted by scientists at Sensei Biotherapeutics in collaboration with genOway and the laboratory of Dr. Robert Schreiber at the Washington University, St. Louis School of Medicine.
AI Summary
Sensei Biotherapeutics, Inc. announced that its peer-reviewed research paper has been published in Nature Communications. The study was performed by Sensei’s own scientists in collaboration with genOway and Dr. Robert Schreiber’s laboratory at Washington University in St. Louis School of Medicine. This publication highlights their innovative approach in developing SNS-101, a pH-sensitive monoclonal antibody designed to selectively target the active protonated form of VISTA, a protein known for suppressing T-cell activation in the tumor microenvironment. By specifically binding to a remodeled epitope under low pH conditions, SNS-101 works to trigger T-cell activation while reducing risks like cytokine release syndrome. The research not only deepens the understanding of VISTA’s role in immune regulation but also supports the potential for SNS-101 to offer a safer, more effective treatment option in immuno-oncology.
Read Announcement
SNS-103 - FDA Regulatory Timeline and Events
SNS-103 is a drug developed by Sensei Biotherapeutics for the following indication: Active monoclonal antibody targeting ecto-nucleoside triphosphate diphosphohydrolase-1 (ENTPDase1).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SNS-103
- Announced Date:
- September 4, 2024
- Indication:
- Active monoclonal antibody targeting ecto-nucleoside triphosphate diphosphohydrolase-1 (ENTPDase1)
Announcement
Sensei Biotherapeutics, Inc. announced that preclinical data on SNS-103 will be presented in a poster session at the CRI-ENCI Eighth International Immunotherapy Conference, being held September 8-11, 2024, at the Gaylord National Resort & Convention Center in National Harbor, MD.
AI Summary
Sensei Biotherapeutics, Inc. announced that its preclinical data on SNS-103 will be featured in a poster session at the CRI-ENCI Eighth International Immunotherapy Conference. The conference will be held from September 8-11, 2024, at the Gaylord National Resort & Convention Center in National Harbor, MD.
The poster, scheduled for presentation on Sunday, September 8, 2024, from 12:05 to 2:05 p.m. EDT, is titled “Pre-clinical characterization of monoclonal antibodies targeting CD39 activity in the acidic tumor microenvironment.” Dr. F. Donelson Smith, Senior Director of Biologics Discovery & Early Development, will present the findings. SNS-103 is a conditionally active monoclonal antibody aimed at targeting CD39 to disrupt immunosuppressive signals in the tumor microenvironment. By sharing these preclinical insights, Sensei Biotherapeutics highlights its commitment to advancing next-generation cancer immunotherapies.
Read Announcement
