SNS-301 / Sensei Biotherap - LARVOL DELTA

Safety and efficacy of SNS-301 plus pembrolizumab in patients with advanced squamous cell carcinoma of the head and neck (SCCHN). (ASCO 2023) - P1/2 | "The combination of SNS-301 and pembrolizumab was well-tolerated with few treatment-related TEAEs. Importantly, pts treated with SNS-301 + pembrolizumab did not demonstrate ASPH-specific antibody or T-cell responses. Based on insufficient immunologic and clinical activity, the trial was terminated early."

Clinical • Metastases • Dermatology • Head and Neck Cancer • Oncology • Pain • Pruritus • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD8

[VIRTUAL] Early Safety and Efficacy of a Phase 1/2 Open-Label, Multi-Center Trial of SNS-301 Added to Pembrolizumab in Patients with Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN) (SITC 2020) - P1, P1/2 | "Additional efficacy and immunological analyses are ongoing. Conclusions Early data show that the combination of SNS-301 and pembrolizumab has manageable toxicity and capacity to achieve long-term disease stability and objective tumor responses."

Clinical • P1/2 data • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD8

[VIRTUAL] Safety/efficacy of a phase I/II study of SNS-301 added to pembrolizumab in patients with ASPH+ locally advanced unresectable or metastatic/recurrent squamous cell carcinoma of the head and neck (SCCHN). (ASCO 2020) - P1/2 | "Anti-PD-1 antibodies such as pembrolizumab and nivolumab can induce durable clinical responses in 13-16% SCCHN patients. Early safety/efficacy warrant further evaluation of this combination therapy. Trial will be proceeding to full enrollment after the safety run-in is completed. Research Funding: None"

Clinical • IO Biomarker • P1/2 data • Head and Neck Cancer • Oncology • Pain • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD8

[VIRTUAL] SNS-301 added to pembrolizumab in patients (Pts) with ASPH+ advanced squamous cell carcinoma of the head & neck (SCCHN) (ESMO 2020) - P1, P1/2 | "Pts are required to have ASPH+ SCCHN, actively receiving pembrolizumab or nivolumab for ≥12 weeks, & have a best response of stable disease (SD) or first evidence of progressive disease (PD). Funding: Sensei Biotherapeutics, Inc. Clinical trial identification: NCT04034225; July 16, 2019."

Clinical • IO biomarker • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD8

Characterization of antigen specific immune responses from a first-in-human study evaluating the anti-ASPH cancer vaccine SNS-301 in biochemically relapsed prostate cancer patients (SITC 2018) - P1; "Conclusions In this phase I setting, the SNS-301 vaccine induced vibrant and durable antigen-specific immune responses, which generally correlated with biochemical responses. Based on these cumulative results, a multi-site phase 2 efficacy clinical trial will commence enrollment in the 2nd half of 2018."

Clinical • IO biomarker • P1 data • Gastrointestinal Cancer • Hepatocellular Cancer • Prostate Cancer

Final Results from a Phase I Clinical Trial Evaluating the Safety, Immunogenicity, and Anti-Tumor Activity of SNS-301 in Men with Biochemically Relapsed Prostate Cancer (ESMO 2018) - P1; "SNS-301 appears safe and well tolerated when administered intradermally at doses up to the RP2D of 3X1011 particles. The vaccine induces vibrant antigen-specific immune responses and demonstrates provocative signals of anti-tumor activity. Based on these results, a multi-site phase 2 efficacy clinical trial will commence enrollment in the 2nd half of 2018."

Clinical • P1 data • Prostate Cancer

[VIRTUAL] Early Safety and Efficacy of a Phase 1/2 Open-Label, Multi-Center Trial of SNS-301 Added to Pembrolizumab in Patients with Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN) (SITC 2020) - P1, P1/2 | "Additional efficacy and immunological analyses are ongoing. Conclusions Early data show that the combination of SNS-301 and pembrolizumab has manageable toxicity and capacity to achieve long-term disease stability and objective tumor responses."

Clinical • P1/2 data • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD8

Phase 1 open-label trial to evaluate the safety and immunogenicity of PAN-301-1, a novel nanoparticle therapeutic vaccine, in patients with biochemically relapsed prostate cancer. (ASCO 2018) - P1; "PAN-301-1 is safe when administered intradermally at doses up to 3E11 particles, induces antigen-specific humoral and cellular immune responses and has provided preliminary indications of efficacy in the reduction of PSA or PSA doubling time."

Clinical • P1 data • Prostate Cancer

[VIRTUAL] Update on safety and efficacy of a phase 1/2 of SNS-301 added to pembrolizumab in patients with advanced squamous cell carcinoma of the head and neck (SCCHN). (ASCO 2021) - P1/2 | "The combination of SNS-301 and pembrolizumab was well-tolerated and resulted in encouraging clinical efficacy in pts not expected to respond to PD-1 blockade alone . Translational data suggest cellular response to SNS-301 and transformation of a poorly inflamed tumor to an immunologically active tumor in a responding pt (PR) . Based on these data, an additional cohort will start enrolling PD-1 blockade naïve pts with LA/met SCHNN in the front-line setting."

Clinical • IO biomarker • P1/2 data • Head and Neck Cancer • Immunology • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD8 • PD-L1

SNS-301 Monotherapy in High Risk MDS and CMML (clinicaltrials.gov) - P2; N=0; Withdrawn; Sponsor: Sensei Biotherapeutics, Inc.; N=20 ➔ 0; Not yet recruiting ➔ Withdrawn

Clinical • Enrollment change • Monotherapy • Trial withdrawal • Chronic Myelomonocytic Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

SNS-301-2-2: Addition of SNS-301 to Checkpoint Inhibitor Treatment in Metastatic/Recurrent SCCHN (clinicaltrials.gov) - P1/2; N=23; Terminated; Sponsor: Sensei Biotherapeutics, Inc.; N=60 ➔ 23; Trial completion date: Aug 2022 ➔ Jun 2021; Recruiting ➔ Terminated; Terminated by the sponsor

Checkpoint inhibition • Clinical • Enrollment change • Trial completion date • Trial termination • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Sensei Biotherapeutics Announces Prioritization of Next-Generation Multi-Antigenic ImmunoPhage Platform, Monoclonal Antibody and Nanobody Programs (Sensei Biotherapeutics Press Release) - "Discontinuation of first-generation, single-antigen phage SNS-301 program upon analysis of clinical activity and antigen specific T-cell data....Sensei has decided to reprioritize its pipeline and refocus resources. Sensei anticipates sharing full SNS-301 clinical data and the results of specific B and T cell response data at a future scientific conference."

Discontinued • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma of Head and Neck

SNS-301 + Pembrolizumab well Tolerated as Treatment of Squamous Cell Carcinoma of the Head and Neck - P1/2, N=60; "The data will be presented as a poster (#6029; ASCO 2021) by Alain Algazi, M.D...taking place virtually June 4 - 8, 2021."

Clinical data

Sensei Biotherapeutics Announces New Clinical Data from the Ongoing Phase 1/2 Combination Trial of SNS-301 in Patients with Squamous Cell Carcinoma of the Head and Neck (GlobeNewswire) - P1/2, N=60; NCT04034225; Sponsor: Sensei Biotherapeutics, Inc; “An analysis of anti-tumor activity was conducted in 12 patients who did not achieve an objective response to prior treatment with PD-1 blockade (Cohort A). No patients were evaluable from Cohort B as of the cut-off date. 67% (n=8/12) of patients achieved stable disease (SD) or partial response (PR), including: One patient with PD-L1 negative tumor who achieved a tumor reduction of 71% that is still ongoing after 11 months of therapy…Sensei expects to report these data as part of the larger dataset planned by the end of 2021. Sensei also plans to add a third cohort by the end of 2021 to evaluate SNS-301 with HPV-specific E6/E7 ImmunoPhage.”

P1/2 data • Trial status • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma of Head and Neck

Sensei Biotherapeutics Reports First Quarter 2021 Results and Provides Business Update (GlobeNewswire) - "Anticipated Pipeline Milestones and Events: American Society for Clinical Oncology (ASCO) 2021 conference: An abstract titled: 'Update on Safety and Efficacy of a Phase 1/2 Study of SNS-301 and Pembrolizumab in Patients with Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)' has been accepted for poster presentation at the 2021 ASCO Annual Meeting taking place virtually from June 4-8, 2021; Phase 1/2 Topline Data Readout on Track: Sensei remains on track to report a substantial subset of data from the Phase 1/2 study by the end of 2021."

P1/2 data • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma of Head and Neck

Sensei Biotherapeutics Reports Full Year 2020 Results and Provides Business Update (GlobeNewswire) - "Sensei expects to announce multiple updates from its SNS-301 program: Initiation of a Phase 2 study in the neoadjuvant setting in combination with durvalumab; Commencement of an additional cohort of the ongoing Phase 1/2 study of HPV-specific E6/E7 ImmunoPhage in combination with SNS-301 and pembrolizumab; Announcement of a large subset of data from the Phase 1/2 study in combination with pembrolizumab for the treatment of locally advanced unresectable or metastatic SCCHN."

New P2 trial • P1/2 data • Trial status • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma of Head and Neck

Addition of SNS-301 to Checkpoint Inhibitor Treatment in Metastatic/Recurrent SCCHN (clinicaltrials.gov) - P1/2; N=60; Recruiting; Sponsor: Sensei Biotherapeutics, Inc.; N=30 ➔ 60; Trial completion date: Feb 2022 ➔ Aug 2022; Trial primary completion date: Feb 2021 ➔ Aug 2021

Checkpoint inhibition • Clinical • Enrollment change • Trial completion date • Trial primary completion date • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Sensei Biotherapeutics Announces $30 Million Financing to Advance Clinical Pipeline of Oncology Therapeutics and Proprietary ImmunoPhage Platform (Businesswire) - "Sensei Biotherapeutics, Inc...announced the successful closing of a $30 million Series B financing...Sensei’s lead ImmunoPhage product candidate, SNS‑301, is being evaluated in a Phase 1/2 trial for the treatment of locally advanced unresectable or metastatic squamous cell carcinoma of the head and neck (SCCHN) in combination with pembrolizumab...topline results from this trial are expected by the end of 2021...Sensei is also advancing two preclinical programs generated from its platform, including SNS-401, an ImmunoPhage cocktail for the treatment of merkel cell carcinoma, and SNS‑VISTA, a monoclonal antibody targeting V-domain Ig suppressor of T cell activation..."

Financing • P1/2 data • Preclinical • Head and Neck Cancer • Merkel Cell Carcinoma • Oncology • Squamous Cell Carcinoma of Head and Neck

Sensei Biotherapeutics Reports Early Data from Phase 1/2 Clinical Trial of SNS-301 in Combination with Pembrolizumab in Advanced Head and Neck Cancer Patients at ESMO 2020 (Businesswire) - P1/2, N=30; NCT04034225; Sponsor: Sensei Biotherapeutics, Inc; “SNS‑301 in combination with pembrolizumab was well tolerated with a favorable safety profile...Of the 9 patients evaluable as of the publication date, 6 remain on study. Of these: One patient with PD-L1 negative disease and stable disease on pembrolizumab upon study entry was converted to a partial response with a tumor reduction of 43%. One patient with progressive disease upon study entry was converted to stable disease. Four patients with stable disease upon study entry remain stable, with 2 of these patients on study for 8 months or more….Based on these data, Sensei plans to enroll all 30 patients for this study. An additional study in neoadjuvant SCCHN patients is planned to begin early next year in combination with Imfimzi® (durvalumab).”

Enrollment status • New trial • P1/2 data • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Sensei Biotherapeutics Presents Additional Data from Phase 1/2 Clinical Trial of SNS-301 at the Society for Immunotherapy of Cancer (SITC) Annual Meeting (Businesswire) - P1/2, N=30; NCT04034225; Sponsor: Sensei Biotherapeutics, Inc; “Disease control in 6 of 9 patients evaluable for efficacy, including: One patient with PD-L1 negative disease achieved a partial response (PR) with a tumor reduction of 43% at week 12 and was confirmed at week 18. Immunohistochemical staining of this patient’s tumor pre- and post-treatment demonstrated clear increases in CD8 density and PD-L1 expression on CD8 T cells and macrophages. This patient also achieved a clear serological response….SNS-301 was well tolerated with no dose-limiting toxicities and observed adverse events (AEs) have primarily been either Grade 1 or 2 and mostly unrelated to treatment.”

P1/2 data • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma of Head and Neck

Sensei Biotherapeutics Announces $28.5 Million Financing To Advance Clinical Pipeline and Immunophage Platform Targeting Multiple Cancers (Businesswire) - "Sensei Biotherapeutics...announced the completion of a $28.5 million equity financing. The financing was co-led by Cambrian Biopharma and H&S Ventures, along with participation from new investors Future Ventures, Christian Angermayer’s Apeiron Investment Group, and Presight Ventures, Apeiron’s U.S. arm...The proceeds from the Series AA financing will enable the further development of SNS-301 and enable the advancement of Sensei’s pipeline of novel immunotherapies based on its Immunophage platform, which combines a vaccine’s ability to generate antigen-specific B- and T-cells with payloads of immunomodulatory nanobodies."

Financing • Oncology

Aspartate β-hydroxylase as a target for cancer therapy. (PubMed, J Exp Clin Cancer Res) - "The PAN-301-1 vaccine against ASPH has already been tested in a phase 1 clinical trial in patients with prostate cancer. In summary, ASPH is a promising target for anti-tumor and anti-metastatic therapy based on inactivation of catalytic activity and/or immunotherapy."

IO Biomarker • Journal • Review • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Sensei Biotherapeutics completes acquisition of Alvaxa Biosciences, a camelid antibody therapeutics company (Businesswire) - "Sensei Biotherapeutics, Inc...announced the acquisition of Alvaxa Biosciences, Inc., a camelid antibody therapeutics company with technology licensed from Fred Hutchinson Cancer Research Center....Its most advanced program, SNS-301, is currently enrolling patients in Phase 2 clinical trials."

Enrollment open • M&A • Oncology

SNS-301 Monotherapy in High Risk MDS and CMML (clinicaltrials.gov) - P2; N=20; Not yet recruiting; Sponsor: Sensei Biotherapeutics, Inc.; Initiation date: Jan 2020 ➔ Apr 2020

Clinical • Monotherapy • Trial initiation date

SNS-301 Monotherapy in High Risk MDS and CMML (clinicaltrials.gov) - P2; N=20; Not yet recruiting; Sponsor: Sensei Biotherapeutics, Inc.

Clinical • Monotherapy • New P2 trial