solnerstotug (SNS-101) / Sensei Biotherap - LARVOL DELTA

Results from a phase I expansion cohort of solnerstotug (pH-selective anti-VISTA antibody) combined with cemiplimab in patients with advanced solid tumors resistant to prior PD-(L)1 therapy (ESMO 2025) - P1/2 | "Mono and combination regimens were well tolerated. RECIST responses and prolonged stable disease associated with tumor shrinkage demonstrate encouraging signs of durable activity in both acquired and primary IO resistant tumors, outcomes that are notably better than expected for IO monotherapy rechallenge alone."

Clinical • Metastases • P1 data • Microsatellite Instability • Oncology • Solid Tumor • MSI

Sensei Biotherapeutics Announces Initiation of Strategic Review to Maximize Shareholder Value (GlobeNewswire) - "...Board of Directors has determined, after extensive consideration of the Company’s development pipeline and current market conditions, to discontinue development of solnerstotug and initiate a comprehensive review of strategic alternatives aimed at maximizing shareholder value. The Company is exploring a range of strategic alternatives that may include, among other options, a sale of assets, licensing arrangements, collaborations, a sale of the Company, a business combination, a merger, or an orderly wind-down of operations....'Our role now is to steward the Company and its assets with care, including an orderly wind-down of the ongoing Phase 1/2 clinical trial and preservation of shareholder value.'"

Discontinued • Trial termination • Bladder Cancer • Breast Cancer • Cervical Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Head and Neck Cancer • Kidney Cancer • Merkel Cell Carcinoma • Non Small Cell Lung Cancer • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Renal Cell Carcinoma • Sarcoma • Thyroid Gland Carcinoma

Sensei Biotherapeutics Reports New Clinical Results Highlighting Durable Progression Free Survival Data for Solnerstotug in PD-(L)1 Resistant Tumors at the ESMO Congress 2025 (GlobeNewswire) - "6-month progression-free survival (PFS) of 50% in the higher 15 mg/kg dose cohort compares favorably to historical PD-(L)1 refractory settings. All clinical responses, including a complete response, observed in the higher 15 mg/kg dose cohort....Data support advancement to Phase 2 studies, currently being planned in Non-Small Cell Lung Cancer and Merkel Cell Carcinoma....Sensei is planning two Phase 2 studies to begin in 2026...."

MSI-H • New P2 trial • P1 data • Colorectal Cancer • Esophageal Cancer • Merkel Cell Carcinoma • Microsatellite Instability • Non Small Cell Lung Cancer

SNS-101-2-1: A Study of SNS-101 (Anti VISTA) Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=98 | Active, not recruiting | Sponsor: Sensei Biotherapeutics, Inc. | Recruiting ➔ Active, not recruiting | N=169 ➔ 98

Enrollment change • Enrollment closed • Monotherapy • Bladder Cancer • Breast Cancer • Cervical Cancer • Colon Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Genito-urinary Cancer • Head and Neck Cancer • Kidney Cancer • Lung Cancer • Melanoma • Merkel Cell Carcinoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Refractory Ovarian Cancer • Renal Cell Carcinoma • Sarcoma • Skin Cancer • Solid Tumor • Thyroid Gland Carcinoma • Uterine Cancer

Sensei Biotherapeutics Reports Second Quarter 2025 Financial Results and Provides Corporate Update (GlobeNewswire) - "Clinical Program Highlights: Full dose expansion data, including 6-month progression free survival (PFS), from the Phase 1/2 study continues to be expected by year-end 2025. Enrollment in the Phase 1/2 dose expansion cohort is complete with a total of 64 patients, including: 10 'cold' MSS CRC patients in the monotherapy arm; 54 patients in the cemiplimab combination arm consisting of 10 'cold' MSS CRC patients and 44 'hot' tumor patients. 41/44 patients in the 'hot' tumor cohort had received and progressed on a prior PD-(L)1 inhibitor."

P1/2 data • Colorectal Cancer

Sensei Biotherapeutics to Present Clinical Data from the Phase 1 Dose Expansion Cohort of Solnerstotug at the ESMO Congress 2025 (GlobeNewswire) - "Sensei Biotherapeutics...announced today that clinical data from the dose expansion cohort of the Phase 1/2 trial of solnerstotug alone and in combination with Libtayo (cemiplimab), Regeneron’s PD-1 inhibitor, will be presented in a mini oral session at the European Society for Medical Oncology (ESMO) Congress 2025, being held October 17-21, 2025 in Berlin, Germany."

P1/2 data • Solid Tumor

Sensei Biotherapeutics Reports Full Year 2024 Financial Results and Update on Clinical Progress (GlobeNewswire) - "Clinical Progress and Outlook: Target enrollment (n=60) in the dose expansion cohort has been achieved. Full expansion data expected by year-end 2025."

P1/2 data • Trial status • Bladder Cancer • Melanoma • Merkel Cell Carcinoma • Non Small Cell Lung Cancer • Ovarian Cancer • Pancreatic Cancer • Renal Cell Carcinoma • Sarcoma

Sensei Biotherapeutics Reports Favorable Preliminary Dose Expansion Data for Solnerstotug in PD-(L)1 Resistant Tumors (GlobeNewswire) - P1/2 | N=169 | NCT05864144 | Sponsor: Sensei Biotherapeutics, Inc. | "Phase 1 Dose Expansion Preliminary Results:...14% ORR (3 patients) and 62% DCR (disease control rate) (13 patients) among 21 evaluable PD-(L)1 resistant 'hot' tumor patients. Durable complete response (CR) in a MCC patient treated with 15 mg/kg solnerstotug + cemiplimab. Patient continues on treatment at 42+ weeks....Partial response (PR) at Week 12 in a MCC patient treated with 15 mg/kg solnerstotug + cemiplimab. Patient continues on treatment at 12+ weeks....Partial response (PR) at Week 36 in an MSI-H CRC patient treated with 15 mg/kg solnerstotug + cemiplimab. Patient had durable stable disease (SD) through the course of treatment before converting to a PR at Week 36. Patient continues on treatment at 36+ weeks....Sensei plans to initiate a Phase 2 study in Q1 2026..."

New P2 trial • P1 data • Colorectal Cancer • Head and Neck Cancer • Melanoma • Merkel Cell Carcinoma • Microsatellite Instability • Non Small Cell Lung Cancer • Renal Cell Carcinoma

Sensei Biotherapeutics Provides Corporate Update and Highlights Key Upcoming Milestones (GlobeNewswire) - "Sensei Biotherapeutics, Inc...provided corporate updates on its lead program, solnerstotug (SNS-101) and upcoming milestones....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."

Enrollment status • P1/2 data • Bladder Cancer • Breast Cancer • Head and Neck Cancer • Kidney Cancer • Melanoma • Merkel Cell Carcinoma • Non Small Cell Lung Cancer • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer

Sensei Biotherapeutics Reports Third Quarter 2024 Financial Results and Recent Business Highlights (GlobeNewswire) - "SNS-101:...Patient enrollment is advancing in the dose expansion portion of the Phase 1/2 study...the Company expects to report clinical data across two dose levels in multiple tumor types in the first half of 2025...Sensei is announcing an organizational restructuring to streamline operations and focus resources on advancing the clinical development of SNS-101. The Company will close its research site in Rockville, Maryland and reduce its workforce by approximately 46 percent, with most of the headcount reductions in the Company’s preclinical research and development group. These changes are anticipated to extend cash runway into the second quarter of 2026."

Commercial • P1/2 data • Oncology • Solid Tumor

Sensei Biotherapeutics to Present at Two Upcoming Scientific Conferences (GlobeNewswire) - "Conference and Presentation Details: [1] Selectively Targeting VISTA in the Tumor-Microenvironment with SNS-101, a Conditionally Active Monoclonal Antibody; [2] Spatial proteomic profiling of VISTA and PSGL-1 interactions across cancer indications"

Clinical • Oncology

BRGSF-HIS mice as a predictive tool for safety assessment of biologics (ESMO 2024) - P1/2 | "Altogether, the data suggest that CD34-reconstituted BRGSF-HIS mice could be used as a predictive tool to investigate immunotherapies' safety."

Preclinical • Oncology • CD34

Sensei Biotherapeutics Reports Second Quarter 2024 Financial Results and Recent Business Highlights (GlobeNewswire) - "Clinical Highlights and Milestones - SNS-101:...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....Patient enrollment is advancing in the dose expansion portion of the Phase 1/2 study. The Company is on track to report initial data from the dose expansion cohorts and hold an end-of-Phase 1 meeting with the FDA by the end of 2024."

Enrollment status • FDA event • P1 data • Solid Tumor

Initial results from a first-in-human phase 1 study of SNS-101 (pH-selective anti-VISTA antibody) alone or in combination with cemiplimab in patients with advanced solid tumors. (ASCO 2024) - P1/2 | "In the mono arm, 1 pembrolizumab-resistant HPV+ H&N pt at 15 mg/kg had tumor regression of 17%. pH selective SNS-101, both alone and in combo with cemi, has been safely administered at doses that are ~50x higher than doses where severe CRS was observed with prior VISTA agents. Both mono and combo therapy have been generally well tolerated. Early signs of clinical activity were observed in both the acquired and primary PD-1 resistant tumor settings."

Clinical • Combination therapy • Metastases • P1 data • Anemia • Colon Cancer • Cough • Dermatitis • Dermatology • Fatigue • Hematological Disorders • Immunology • Metabolic Disorders • Oncology • Respiratory Diseases • Solid Tumor

Sensei Biotherapeutics Presents Promising Clinical Data from Phase 1 Dose Escalation Study of SNS-101 (GlobeNewswire) - P1/2 | N=169 | NCT05864144 | Sponsor: Sensei Biotherapeutics, Inc. | "As of the April 30, 2024 data cutoff, SNS-101 demonstrated preliminary evidence of promising clinical activity in multiple tumor types, including: One microsatellite stable (MSS) endometrial cancer patient that received SNS-101 plus cemiplimab had a confirmed partial response (59% decrease) and remains on study at 30+ weeks....One MSS colorectal cancer (CRC) patient that received SNS-101 plus cemiplimab remained on study for 18 weeks and had tumor regression of 27%....One pembrolizumab-resistant renal cell carcinoma patient that received SNS-101 plus cemiplimab remained on study for 12 weeks and had tumor regression of 18%. One pembrolizumab-resistant human papillomavirus (HPV)+ head and neck cancer patient that received SNS-101 as monotherapy remained on study for 12 weeks and had tumor regression of 17%."

P1 data • Colorectal Cancer • Endometrial Cancer • Head and Neck Cancer • Renal Cell Carcinoma

Sensei Biotherapeutics Reports First Quarter 2024 Financial Results and Recent Business Highlights (GlobeNewswire) - "SNS-101: Patient enrollment is ongoing for both the monotherapy and combination dose expansion arms....The Company expects to report initial data from the dose expansion cohorts and hold an end-of-Phase 1 meeting with the FDA by the end of 2024."

FDA event • P1 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology

Sensei Biotherapeutics to Present Topline Clinical Data from the SNS-101 Phase I Dose Escalation Study at the 2024 ASCO Annual Meeting (GlobeNewswire) - "Sensei Biotherapeutics...announced that topline clinical data from the monotherapy and combination 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), will be presented in a poster presentation at the upcoming 2024 American Society of Clinical Oncology (ASCO) Annual Meeting..."

P1 data • Solid Tumor

Sensei Biotherapeutics to Participate in Canaccord Genuity’s Horizons in Oncology Virtual Conference (GlobeNewswire) - "Sensei Biotherapeutics, Inc...announced that Company management will participate in a panel titled ‘KRAS and VISTA - Better Approaches for Key Targets’ at Canaccord Genuity’s Horizons in Oncology Virtual Conference on Monday, April 15th at 2:00 p.m. ET. The panel will feature Dr. Shiraj Sen, M.D., Ph.D., Medical Oncologist and Director of Clinical Research at NEXT Oncology-Dallas. Dr. Sen is an investigator on the ongoing Phase 1/2 clinical trial for SNS-101."

Clinical • Bladder Cancer • Breast Cancer • Head and Neck Cancer • Kidney Cancer • Melanoma • Non Small Cell Lung Cancer • Ovarian Cancer • Prostate Cancer • Sarcoma • Solid Tumor

VISTA checkpoint inhibition by pH-selective antibody SNS-101 with optimized safety and pharmacokinetic profiles enhances PD-1 response. (PubMed, Nat Commun) - "In syngeneic tumor models utilizing human VISTA knock-in mice, SNS-101 shows in vivo efficacy when combined with a PD-1 inhibitor, modulates cytokine and chemokine signaling, and alters the tumor microenvironment. In summary, SNS-101, currently in Phase I clinical trials, emerges as a promising therapeutic biologic for a wide range of patients whose cancer is refractory to current immunotherapy regimens."

Checkpoint inhibition • Journal • PK/PD data • Oncology • PD-1

Sensei Biotherapeutics Announces Nature Communications Publication Describing Mechanism of Action of SNS-101 Selectively Targeting the Active Form of VISTA within the Tumor Microenvironment (GlobeNewswire) - "The paper details the mechanism and characteristics of SNS-101, a novel pH-sensitive monoclonal antibody. SNS-101 was shown to bind to a novel epitope of VISTA that is remodeled under low pH conditions, switching VISTA into an active state that engenders extensive T-cell suppression. SNS-101 is designed to block VISTA by inhibiting its interaction with PSGL-1 on T-cells resulting in T-cell activation. Subsequently, in various preclinical models, SNS-101 was shown to mitigate CRS risk and maintain a favorable pharmacokinetic and safety profile, all of which had thwarted the clinical development of first generation, non-pH sensitive anti-VISTA antibodies."

Preclinical • Oncology • Solid Tumor

VISTA checkpoint inhibition by pH-selective antibody SNS-101 with optimized safety and pharmacokinetic profiles enhances PD-1 response (Nature, Nat Commun) - "Structural and biochemical analyses confirmed the pH-selectivity and unique epitope targeted by SNS-101. These properties confer favorable pharmacokinetic and safety profiles on SNS-101. In syngeneic tumor models utilizing human VISTA knock-in mice, SNS-101 shows in vivo efficacy when combined with a PD-1 inhibitor, modulates cytokine and chemokine signaling, and alters the tumor microenvironment."

Preclinical • Oncology

VISTA checkpoint inhibition by pH-selective antibody SNS-101 with optimized safety and pharmacokinetic profiles enhances PD-1 response (Nature, Nat Commun) - "Structural and biochemical analyses confirmed the pH-selectivity and unique epitope targeted by SNS-101. These properties confer favorable pharmacokinetic and safety profiles on SNS-101. In syngeneic tumor models utilizing human VISTA knock-in mice, SNS-101 shows in vivo efficacy when combined with a PD-1 inhibitor, modulates cytokine and chemokine signaling, and alters the tumor microenvironment."

Preclinical • Oncology

Sensei Biotherapeutics to Present New Preclinical Data at Upcoming Scientific Conferences (GlobeNewswire) - "Sensei Biotherapeutics...announced that the company will present preclinical data on its conditionally active immuno-oncology programs at upcoming scientific conferences."

Preclinical • Oncology

Sensei Biotherapeutics Reports Full Year 2023 Financial Results and Recent Business Highlights (GlobeNewswire) - P1/2 | N=169 | NCT05864144 | Sponsor: Sensei Biotherapeutics, Inc. | "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....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."

P1/2 data • Oncology • Solid Tumor

A Study of SNS-101 (Anti VISTA) Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=169 | Recruiting | Sponsor: Sensei Biotherapeutics, Inc. | N=129 ➔ 169

Combination therapy • Enrollment change • Metastases • Monotherapy • Bladder Cancer • Breast Cancer • Cervical Cancer • Colon Cancer • Colorectal Cancer • Endocrine Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatology • Kidney Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Refractory Ovarian Cancer • Renal Cell Carcinoma • Sarcoma • Solid Tumor • Thyroid Gland Carcinoma • Uterine Cancer