Sensei Biotherapeutics, Inc. is a clinical-stage biopharmaceutical company which focuses on the discovery, development, and delivery of next generation immunotherapies for the treatment of cancer and infectious diseases. The company was founded in 1999 and is headquartered in Rockville, MD.
Clinical Trials
4
0 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
1999
Completed
2
50.0%
Terminated
1
25.0%
Withdrawn
1
25.0%
No approval data available
- The advanced endometrial cancer pipeline is expanding rapidly, with immunotherapies, targeted agents, and antibody-drug conjugates (ADCs) driving a more competitive and biomarker-driven market. - Merck's Phase III TroFuse-005 trial met its primary endpoints of overall survival and progression-free survival for the investigational TROP2-directed ADC sacituzumab tirumotecan in advanced or recurrent endometrial cancer. - Genmab's rinatabart sesutecan (Rina-S) achieved a 50.0% confirmed objective response rate, including two complete responses, in heavily pretreated advanced endometrial cancer patients. - The global endometrial cancer market is forecast to grow from USD 30.60 billion in 2025 to USD 40.66 billion by 2031, at a CAGR of 4.86%.
- Sensei Biotherapeutics acquired Faeth Therapeutics and secured $200 million in concurrent private placement financing to advance PIKTOR, an investigational all-oral combination targeting the PI3K/AKT/mTOR pathway. - PIKTOR demonstrated a 47% overall response rate in a Phase 1b trial with response-evaluable patients averaging four prior lines of therapy, including three complete responses. - The combined company plans to advance PIKTOR through key clinical milestones, including topline Phase 2 data in endometrial cancer and initiation of Phase 1b trials in breast cancer by year-end 2026. - The acquisition positions the company to address the longstanding challenge of balancing efficacy and tolerability in PI3K pathway inhibition through multi-node targeting.
- Sensei Biotherapeutics is discontinuing development of solnerstotug, its sole clinical-stage asset targeting VISTA, despite achieving 50% six-month progression-free survival in anti-PD-L1 resistant patients. - The company is implementing workforce reductions and exploring strategic alternatives including asset sale, merger, or complete wind-down of operations. - The decision comes just weeks after presenting positive Phase I dose expansion data at ESMO 2025 and announcing plans for Phase II studies in 2026. - Sensei has faced multiple setbacks in recent years, including previous workforce cuts and abandonment of other clinical programs like SNS-301.
- Sensei Biotherapeutics reported Q2 2025 financial results with $28.6 million in cash to fund operations into Q2 2026, while advancing its lead cancer immunotherapy solnerstotug. - The company completed enrollment of 64 patients in its Phase 1/2 dose expansion cohort, including 41 patients with PD-(L)1 resistant tumors, with full data expected by year-end 2025. - Solnerstotug demonstrated favorable safety profile in combination with cemiplimab without significant additional toxicity, positioning the VISTA-targeting therapy for multiple Phase 2 studies. - Clinical data from the dose expansion cohort will be presented at the European Society for Medical Oncology Congress in October 2025, marking a key milestone for the program.
- Sensei Biotherapeutics will present clinical data from the Phase 1 dose expansion cohort of solnerstotug, a pH-selective anti-VISTA antibody, at ESMO Congress 2025 in Berlin. - The study evaluates solnerstotug alone and in combination with cemiplimab in patients with advanced solid tumors resistant to prior PD-(L)1 therapy. - Solnerstotug is designed to selectively block the VISTA checkpoint within the low pH tumor microenvironment to unleash T cells against tumors. - The presentation will be delivered by Dr. Kyriakos Papadopoulos on October 17, 2025, highlighting results from this novel immunotherapy approach.
• Solnerstotug, a conditionally active monoclonal antibody targeting VISTA, showed a 14% overall response rate in PD-L1 resistant tumors, nearly triple the expected response rate for PD-L1 rechallenge. • Notable responses included a durable complete response in a Merkel cell carcinoma patient and a partial response in a microsatellite instability-high colorectal cancer patient who had previously progressed after checkpoint therapy. • The Phase 1/2 trial demonstrated a favorable safety profile with no dose-limiting toxicities, positioning solnerstotug as a potential new treatment option for patients with limited alternatives beyond chemotherapy.
• Sana Biotechnology's HIP-modified islet cells demonstrated immune evasion and C-peptide production in a Type 1 Diabetes patient without immunosuppression. • The positive Phase 1 data supports the potential of Sana's hypoimmune (HIP) cell platform, leading to increased price targets from analysts. • A single patient in the trial showed stable C-peptide levels 4 weeks post-injection, indicating the HIP cells' survival and function without triggering an immune response. • Sana Biotechnology's progress in Type 1 Diabetes treatment has been recognized, potentially setting a more favorable stage for its stock performance.
