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
FTH-PIK-101, SNS-101, Solnerstotug, and SNS-103. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
FTH-PIK-101 FDA Regulatory Events
FTH-PIK-101 is a drug developed by Sensei Biotherapeutics for the following indication: in patients with HR+/HER2- advanced breast cancer.
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:
- FTH-PIK-101
- Announced Date:
- May 5, 2026
- Indication:
- in patients with HR+/HER2- advanced breast cancer.
Announcement
Sensei Biotherapeutics, Inc announced today that the first patient was dosed in Study FTH-PIK-101 (NCT07558733), a Phase 1b/2 trial of PIKTOR in patients with HR+/HER2- advanced breast cancer..
AI Summary
Sensei Biotherapeutics announced that the first patient has been dosed in Study FTH-PIK-101 (NCT07558733), a multi-center, dose-escalation Phase 1b/2 trial testing PIKTOR in patients with HR+/HER2- advanced or metastatic breast cancer. The study will evaluate PIKTOR given with fulvestrant and/or other anticancer therapies, focusing on safety, recommended dosing, and early signs of benefit.
PIKTOR is an investigational, all-oral combination that targets multiple nodes in the PI3K/AKT/mTOR pathway. It pairs serabelisib, which inhibits PI3K-alpha, with sapanisertib, which inhibits mTORC1 and mTORC2. By blocking several pathway points at once, the approach aims to prevent cancer cells from rerouting growth signals around single-node inhibitors.
This dosing milestone advances Sensei’s clinical development program for PIKTOR, which also includes an ongoing Phase 2 study in advanced endometrial cancer. The trial’s early results will guide further development decisions.
Read Announcement
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:
- October 17, 2025
- Indication:
- Suppressor of T cells by binding the receptor PSGL-1
Announcement
Sensei Biotherapeutics, Inc. announced 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).
Read Announcement- 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
- Target Action Date:
- Q2 2025
- Estimated Target Date Range:
- April 1, 2025 - June 30, 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
- Target Action Date:
- Q1 2025
- Estimated Target Date Range:
- January 1, 2025 - March 31, 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:
- 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:
- 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
Solnerstotug FDA Regulatory Events
Solnerstotug is a drug developed by Sensei Biotherapeutics for the following indication: in PD-(L)1 Resistant Tumors.
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:
- Solnerstotug
- Announced Date:
- October 17, 2025
- Indication:
- in PD-(L)1 Resistant Tumors
Announcement
Sensei Biotherapeutics, Inc announced 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 Phase 1/2 dose expansion results for solnerstotug, a monoclonal antibody targeting the VISTA checkpoint. The study enrolled patients whose tumors had progressed on PD-(L)1 therapy.
At the 15 mg/kg dose, solnerstotug combined with cemiplimab yielded a 6-month PFS of 50%, versus 24% at 3 mg/kg and 10–20% historically. All clinical responses, including a complete response in a Merkel cell carcinoma patient, were in the 15 mg/kg group, with five responses in PD-(L)1 resistant tumors.
Treatment was well tolerated. Six mild, manageable grade 1 cytokine release syndrome cases occurred, all in the 15 mg/kg group, and no new safety signals were seen across dose expansion.
These data support advancing solnerstotug to planned Phase 2 studies in non-small cell lung cancer and Merkel cell carcinoma.
Read Announcement- Drug:
- Solnerstotug
- Announced Date:
- September 23, 2025
- Indication:
- in PD-(L)1 Resistant Tumors
Announcement
Sensei Biotherapeutics, Inc. announced that it will host a virtual key opinion leader (KOL) event on Monday, October 20, 2025 at 8:00 AM ET featuring company leadership and Kyriakos Papadopoulos, MD (Co-Director of Clinical Research at START, San Antonio), who will discuss the unmet need and current treatment landscape for immunotherapy-resistant solid tumors.
AI Summary
Sensei Biotherapeutics, a clinical-stage biotech focused on next-generation cancer therapies, will host a virtual key opinion leader (KOL) event on Monday, October 20, 2025 at 8:00 AM ET. The session will feature company leadership alongside Kyriakos Papadopoulos, MD, Co-Director of Clinical Research at START in San Antonio.
Dr. Papadopoulos will address the unmet need in treating immunotherapy-resistant solid tumors and review current treatment approaches. The event will also cover Sensei’s plans for Phase 2 studies and share data from the full Phase 1/2 dose expansion cohort, including insights presented at the European Society for Medical Oncology (ESMO) oral session on Friday, October 17.
A live question-and-answer segment will follow the presentations. Interested attendees can register online to join this in-depth discussion on advancing therapies against resistant solid tumors.
Read Announcement
SNS-103 FDA Regulatory 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
