TSC-203-A0201 / TSCan Therap - LARVOL DELTA

TScan Therapeutics Reports Third Quarter 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - Solid Tumor Program: Actively screening, enrolling, and dosing patients across the TCR-T therapy candidates; Update on solid tumor program expected by the end of 2024; Investigational new drug (IND) filing for TCR targeting MAGE-A4 on HLA-A*02:01 (TSC-202-A0201) planned by the end of the year; Response data for multiplex therapy anticipated in 2025."

IND • P1 data • Trial status • Oncology • Solid Tumor

First Patient Receives TCR-T Therapy in Multiplexed Study Screening Patients With Melanoma, Cervical Cancer and More (CGTLive) - "Screening is underway for participants with solid tumors to receive T-Plex, a multiplexed T-cell receptor-engineered T-cell (TCR-T) therapy, with 1 participant having received 1 Singleplex therapy so far in a phase 1 study (NCT05973487) with no acute toxicities....TSCAN-002 is a master protocol currently containing 6 TCR-Ts from a growing collection of TCR-Ts, called the ImmunoBank. Three TCR-Ts target MAGE-A1 across different HLA types, one targets MAGE-C2, one targets PRAME, and one targets HPV16."

Trial status • Cervical Cancer • Gynecologic Cancers • Head and Neck Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

TScan Therapeutics Announces First Patient Dosed in Phase 1 Clinical Trial Evaluating TCR-T Therapy for the Treatment of Solid Tumors (GlobeNewswire) - "TScan Therapeutics, Inc...today announced that the first patient has been dosed in the Company’s Phase 1 trial evaluating TCR-T therapy for the treatment of solid tumors. The patient, diagnosed with metastatic melanoma, was dosed with TSC-203-A0201 targeting the cancer-associated antigen PReferentially expressed Antigen in MElanoma (PRAME)....TScan’s Phase 1 clinical trial is designed to assess the safety and feasibility of T-Plex, autologous customized TCR-T therapy targeting multiple peptide/human leukocyte antigens (HLA) targets in participants with antigen-positive, locally advanced, unresectable or metastatic solid tumors."

Trial status • Melanoma • Oncology • Skin Cancer • Solid Tumor

TScan Therapeutics Provides Clinical Pipeline Update and Highlights Near-Term Priorities (GlobeNewswire) - "Phase 1 solid tumor clinical study has been initiated; first three patients expected to be dosed in early May 2024. More than 40 patients have completed all biomarker testing in the screening protocol across a broad array of tumor types. 60% of patients qualify for at least one TCR-T in the ImmunoBank and approximately 30% are eligible for multiplex therapy (T-Plex), potentially enabling rapid enrollment into the treatment protocol upon disease progression. Patients have been identified across all six TCR-T cohorts with dosing expected to commence early May. Initial data on patients from both singleplex and multiplex cohorts expected in the second half of 2024....Long-term duration of response data for multiplex therapy anticipated in 2025."

P1 data • Trial status • Solid Tumor

A Basket Study of Customized Autologous TCR-T Cell Therapies in Patients With Locally Advanced (Unresectable) or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: TScan Therapeutics, Inc. | Initiation date: Nov 2023 ➔ Feb 2024

IO biomarker • Metastases • Pan tumor • Trial initiation date • Anal Carcinoma • Cervical Cancer • Colorectal Cancer • Cutaneous Melanoma • Gastrointestinal Cancer • Head and Neck Cancer • Infectious Disease • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Oropharyngeal Cancer • Ovarian Cancer • Penile Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Vaginal Cancer • Vulvar Cancer • HLA-A • HLA-C • PRAME

A Basket Study of Customized Autologous TCR-T Cell Therapies in Patients With Locally Advanced (Unresectable) or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: TScan Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Pan tumor • Anal Carcinoma • Cervical Cancer • Colorectal Cancer • Cutaneous Melanoma • Gastrointestinal Cancer • Head and Neck Cancer • Infectious Disease • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Oropharyngeal Cancer • Ovarian Cancer • Penile Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Vaginal Cancer • Vulvar Cancer • HLA-A • HLA-C • PRAME

TScan Therapeutics Announces FDA Clearance of Investigational New Drug Application for TSC-203-A0201 Targeting PRAME (PRNewswire) - "TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biopharmaceutical company focused on the development of T cell receptor (TCR)-engineered T cell therapies (TCR-T) for the treatment of patients with cancer, today announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for TSC-203-A0201, a TCR-T targeting PReferentially expressed Antigen in Melanoma (PRAME)....A screening protocol to identify eligible patients has already been initiated and clinical trial start-up activities are underway to initiate clinical development for all four TCR-Ts in the ImmunoBank. We are excited about the potential to help patients with these prevalent solid tumors, where a high unmet need for effective treatments remains, and are on-track to treat the first patient with a TScan TCR-T and report preliminary data by the end of 2023."

Clinical data • IND • Melanoma • Oncology • Skin Cancer • Solid Tumor

TScan Therapeutics Reports Second Quarter 2023 Financial Results and Provides Corporate Update (GlobeNewswire) - "Solid Tumor Program: Anticipates further expansion of the ImmunoBank with the recent filing of an IND for TSC-203-A0201, an HLA-A*02:01-restricted TCR targeting PRAME, and IND filings for two additional TCRs by year-end; Plans to initiate Phase 1 solid tumor clinical study in the second half of 2023 and anticipates sharing preliminary data by the end of 2023; Expects to report initial multiplexed therapy data for its first combinations of TCR-Ts under T-Plex, as well as response data for singleplex cohorts, in 2024."

IND • New P1 trial • P1 data • Oncology • Solid Tumor

TScan Therapeutics Reports First Quarter 2023 Financial Results and Provides Corporate Update (GlobeNewswire) - "Upcoming Anticipated Milestones...Anticipates further expansion of the ImmunoBank by filing INDs for two additional TCR-Ts (TSC-200-A0201 targeting HPV16 and TSC-203-A0201 targeting PRAME) by the middle of 2023, and two more TCR-Ts by year end. Plans to initiate Phase 1 solid tumor clinical study in the second half of 2023 and anticipates sharing preliminary singleplex data for the most advanced TCRs by the end of 2023. Expects to report initial multiplexed therapy data for its first combination of TCR-Ts under T-Plex, as well as response data for initial singleplex cohorts, in 2024. Anticipates T-Plex duration of response data and singleplex response data for additional TCR-Ts in 2025."

Clinical data • IND • New P1 trial • Oncology • Solid Tumor

Discovery of TSC-203-A02: A PRAME-specific TCR-T cell therapy candidate for the treatment of solid tumors (SITC 2022) - "PRAME 425–434 -specific TCR-T cells were also able to control tumor growth in vivo following infusion into immunodeficient mice implanted with PRAME-expressing xenografts. Conclusions Based on its demonstrated activity in vitro and in vivo , this autologous TCR-T cell therapy candidate, TSC-203-A02, has been advanced to IND-enabling studies."

Cutaneous Melanoma • Melanoma • Oncology • Ovarian Cancer • Solid Tumor • CD8 • PRAME

TScan Therapeutics Presents Preclinical Data for Solid Tumor Program at the 37th Society for Immunotherapy of Cancer Annual Meeting (GlobeNewswire) - "Using TScan’s proprietary ReceptorScan platform, TCRs specific for five different A*02:01 epitopes in PRAME were discovered by screening over 800 million naïve CD8+ T cells from 16 healthy donors to identify over 5,000 relevant TCRs. PRAME425-433-specific TCRs demonstrated superior recognition of a PRAME-expressing cell line compared to TCRs for the other four epitopes....Safety assessment demonstrated that few off-target peptides were recognized by these lead TCRs, minimal alloreactivity was observed to 110 allotypes tested, and no reactivity to normal primary human cells was found. PRAME425-433-specific TCR-T cells were able to control tumor growth in vivo following infusion into immunodeficient mice implanted with PRAME-expressing xenografts....The Company has advanced several candidate PRAME425-433 TCRs into IND-enabling studies and plans to file an IND for TSC-203-A2 in 2023."

IND • Preclinical • Oncology • Solid Tumor

TScan Therapeutics Reports Third Quarter 2022 Financial Results and Provides Business Update (GlobeNewswire) - "The Company plans to progress IND-enabling studies for its solid tumor programs and submit IND applications for two MAGE-A1 TCRs (TSC-204-A2 and TSC-204-C7) by the end of 2022; The Company plans to file INDs for HPV (TSC-200-A2) and PRAME (TSC-203-A2) in the first half of 2023 with two additional INDs to be filed by the end of 2023. The Company expects to release preliminary clinical safety data for the most advanced TCRs by the end of 2023."

IND • Oncology • Solid Tumor

TScan Therapeutics Announces Upcoming Poster Presentations at the 37th Society for Immunotherapy of Cancer Annual Meeting (GlobeNewswire) - "TScan Therapeutics...announced the acceptance of two abstracts at the upcoming Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting, being held from November 8–12, 2022, at the Boston Convention and Exhibition Center in Boston, MA."

Preclinical • Oncology • Solid Tumor

TScan Therapeutics Reports Full Year 2021 Financial Results and Highlights Key 2022 Priorities (GlobeNewswire) - "Initiate Phase 1 umbrella trial for TSC-100 following submission of clinical protocol to IRBs for the initial study sites, with plans to enroll patients in the first half of 2022...Progress IND-enabling studies for the TSC-200 series and submit two IND applications during the second half of 2022. These are expected to include TSC-200 for HPV and TSC-204 for MAGE-A1; In 2023, the Company plans to release initial clinical data for the TSC-200 series TCRs, as well as file further INDs for additional programs in this series."

Clinical data • IND • New P1 trial • Hematological Malignancies • Oncology • Solid Tumor

TScan Outlines 2022 Priorities as Programs Enter Clinic (GlobeNewswire) - "Following the IND submissions and pending acceptance by the FDA, the Company expects to initiate Phase 1 clinical trials for TSC-100 and TSC-101 in the first half of 2022, with preliminary data expected in the second half of 2022....TScan plans to present initial preclinical data on the TSC-2xx series at a medical meeting in the first half of 2022. TScan plans to progress IND-enabling studies for the TSC-2xx series and submit multiple IND applications during the second half of 2022."

IND • New P1 trial • P1 data • Preclinical • Hematological Malignancies • Oncology • Solid Tumor

TScan Therapeutics Establishes Facility to Manufacture T Cell Receptor Engineered T Cell Therapies (GlobeNewswire) - "TScan Therapeutics...announced that it has completed the construction of a state-of-the-art GMP manufacturing facility to manufacture Phase I/II TCR-T therapies. This facility will support the manufacturing of TScan’s two lead liquid tumor candidates, TSC-100 and TSC-101, designed to eliminate residual leukemia and prevent relapse after hematopoietic cell transplantation for patients with hematological malignancies, as well as solid tumor candidates TSC-200, TSC-201, TSC-202 and TSC-203, designed to treat patients with solid tumors including head and neck, cervical, anal, melanoma and non-small cell lung cancers."

Commercial • Anal Carcinoma • Cervical Cancer • Head and Neck Cancer • Hematological Malignancies • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor