TC-510 / Adaptimmune - LARVOL DELTA

A Phase 1/2 Trial of TC-510 In Patients With Advanced Mesothelin-Expressing Cancer (clinicaltrials.gov) - P1/2 | N=6 | Active, not recruiting | Sponsor: TCR2 Therapeutics | Trial completion date: Dec 2027 ➔ Oct 2028 | Trial primary completion date: Nov 2023 ➔ Oct 2028

Metastases • Trial completion date • Trial primary completion date • Biliary Cancer • Breast Cancer • Cholangiocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Hepatology • Lung Cancer • Malignant Pleural Mesothelioma • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • Triple Negative Breast Cancer • MSLN

A Phase 1/2 Trial of TC-510 In Patients With Advanced Mesothelin-Expressing Cancer (clinicaltrials.gov) - P1/2 | N=6 | Active, not recruiting | Sponsor: TCR2 Therapeutics | Recruiting ➔ Active, not recruiting | N=140 ➔ 6 | Trial primary completion date: Jun 2025 ➔ Nov 2023

Enrollment change • Enrollment closed • Metastases • Trial primary completion date • Biliary Cancer • Breast Cancer • Cholangiocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Hepatology • Lung Cancer • Malignant Pleural Mesothelioma • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • Triple Negative Breast Cancer • MSLN

Functional enhancement of mesothelin-targeted TRuC-T cells by a PD1-CD28 chimeric switch receptor. (PubMed, Cancer Immunol Immunother) - "T cells expressing a mesothelin (MSLN)-specific T cell receptor fusion construct (TRuC), called TC-210, have demonstrated robust antitumor activity in preclinical models of mesothelioma, ovarian cancer, and lung cancer. These data demonstrate that integration of a PD1-CD28 CSR into TRuC-T cells improves effector function, resistance to exhaustion, and prolongs persistence. Based on these findings, TC-510 is currently being evaluated in patients with MSLN-expressing solid tumors."

IO biomarker • Journal • Lung Cancer • Mesothelioma • Oncology • Ovarian Cancer • Solid Tumor • CD28 • MSLN • PD-1

Adaptimmune Reports Second Quarter Financial Results and Business Update (Adaptimmune Press Release) - "The Phase 1/2 clinical trial for TC-510 for people with MPM, ovarian cancer, pancreatic cancer, colorectal cancer, or triple negative breast cancer is ongoing in the dose-escalation phase. Initial data readouts are anticipated this year to enable further directional decisions for TC-510....Adaptimmune plans to be IND-ready in late 2023 with a PRAME targeted TCR T-cell therapy....A clinical trial is expected to initiate in 2024 (indications remain to be determined). An IND for CD70 is planned for 2024. Afami-cel: Adaptimmune plans to complete BLA submission in Q4 2023...Agreed confirmatory evidence plan with FDA: Cohort 2 of the SPEARHEAD-1 trial will act as confirmatory evidence for full approval, enrollment in Cohort 2 has completed."

BLA • IND • New trial • P1/2 data • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Malignant Pleural Mesothelioma • Mesothelioma • Oncology • Ovarian Cancer • Pancreatic Cancer • Sarcoma • Solid Tumor • Synovial Sarcoma • Triple Negative Breast Cancer

TCR² Therapeutics Reports Fourth Quarter and Full-Year 2022 Financial Results and Provides Corporate Update (GlobeNewswire) - "First data readout from the Phase 1 trial with TC-510 for patients with ovarian, malignant pleural mesothelioma, pancreatic, colorectal, or triple-negative breast cancer anticipated in the second half of 2023."

P1 data • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Malignant Pleural Mesothelioma • Mesothelioma • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • Triple Negative Breast Cancer

TCR² Therapeutics Announces Pipeline Priorities for 2023 (GlobeNewswire) - "gavo-cel Phase 2 clinical trial now focused on ovarian cancer cohort with first meaningful durability data expected in 2H 2023. Second-generation enhanced programs TC-510 and TC-520 prioritized with TC-510 Phase 1 clinical trial ongoing and first meaningful objective response data expected in 2H 2023. Company to be streamlined with approximately 40 percent reduction in workforce."

P1 data • P2 data • Gynecologic Cancers • Ovarian Cancer • Solid Tumor

TCR² Therapeutics Reports Second Quarter 2022 Financial Results and Provides Corporate Update (GlobeNewswire) - "TCR2 initiated the Phase 1 dose escalation portion of the Phase 1/2 clinical trial of TC-510, its first enhanced mesothelin-targeted TRuC-T cell that co-expresses a PD-1:CD28 chimeric switch receptor. Enrollment is ongoing and the Company expects to report on initial safety, efficacy and translational data from at least one of the Phase 1 dose escalation cohorts of the Phase 1/2 clinical trial in the second half of 2022; Pipeline: Initiate IND-enabling studies for TC-520, an enhanced CD70 targeting TRuC-T cell program, in 2022."

P1/2 data • Oncology • Solid Tumor

A Phase 1/2 Trial of TC-510 In Patients With Advanced Mesothelin-Expressing Cancer (clinicaltrials.gov) - P1/2 | N=115 | Recruiting | Sponsor: TCR2 Therapeutics

New P1/2 trial • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Hepatology • Lung Cancer • Malignant Pleural Mesothelioma • Mesothelioma • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • Triple Negative Breast Cancer • MSLN

TCR² Therapeutics Reports Fourth Quarter 2021 Financial Results and Provides Corporate Update (GlobeNewswire) - "Anticipated Milestones - TC-510: Report initial safety, efficacy and translational data from at least one of the Phase 1 dose escalation cohorts of the TC-510 Phase 1/2 clinical trial in the second half of 2022."

P1 data • Oncology

TCR² Therapeutics Announces 2022 Strategic Priorities and Anticipated Milestones (GlobeNewswire) - "TC-510: TRuC-T cell targeting mesothelin-positive solid tumors: IND filing and clearance anticipated in 1H 2022; Initial safety, efficacy and translational data from Phase 1 dose escalation anticipated in 2H 2022; Allogeneic TRuC-T cells: Preclinical data from and selection of lead allogeneic TRuC-T cell candidate anticipated in 2022; Autologous TRuC-T cells: Preclinical data from TRuC-T cells targeting novel antigens and enhancements anticipated in 2022."

IND • Preclinical • Oncology • Solid Tumor

TCR² Therapeutics Reports Third Quarter 2021 Financial Results and Provides Corporate Update (GlobeNewswire) - "Anticipated Milestones: TCR2 anticipates the identification of the recommended Phase 2 dose (RP2D) in 4Q21; TCR2 plans to file an IND for TC-510, the first enhanced TRuC-T cell (targeting mesothelin with a PD1xCD28 switch), in the first quarter of 2022; TCR2 anticipates initiation of IND-enabling studies for TC-520, an enhanced CD70 targeting TRuC-T cell program in 2022; TCR2 plans to select a lead candidate for its allogeneic program in 2022; TCR2 anticipates production of clinical trial material from ElevateBio BaseCamp in anticipation of demand from the Phase 2 expansion trial of gavo-cel in 2022."

IND • Trial status • Oncology • Solid Tumor

TCR² Therapeutics Announces Expansion of U.S. Manufacturing Capacity (GlobeNewswire) - "TCR2 Therapeutics...announced today the expansion of its manufacturing capacity by exercising an option on a second clean room at ElevateBio BaseCamp which adds to the buildout of clinical and commercial supply currently underway at its Rockville, MD, facility. The timing of the additional supply at ElevateBio BaseCamp aligns with an anticipated 2022 increase in demand from the Phase 2 clinical trial of gavo-cel for mesothelin-expressing solid tumors as well as the start of a Phase 1 clinical trial for TC-510, a mesothelin TRuC-T cell enhanced with a PD1xCD28 switch."

Commercial • Oncology • Solid Tumor