TSC-200-A0201 / TSCan Therap - LARVOL DELTA

TSCAN-002: A Basket Study of Customized Autologous TCR-T Cell Therapies in Patients With Locally Advanced (Unresectable) or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=840 | Active, not recruiting | Sponsor: TScan Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Pan tumor • Anal Carcinoma • Cervical Adenocarcinoma • Cervical Cancer • Colorectal Cancer • Cutaneous Melanoma • 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-002: A Basket Study of Customized Autologous TCR-T Cell Therapies in Patients With Locally Advanced (Unresectable) or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=840 | Recruiting | Sponsor: TScan Therapeutics, Inc. | N=100 ➔ 840

Enrollment change • Anal Carcinoma • Cervical Adenocarcinoma • Cervical Cancer • Colorectal Cancer • Cutaneous Melanoma • 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 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

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

TScan Therapeutics Announces 2024 Clinical Plans and Highlights Recent Progress (GlobeNewswire) - "Upcoming Anticipated Milestones...Solid Tumor Program: (i) Initiated Phase 1 solid tumor clinical study and expects to dose the first patient in the first quarter of 2024; (ii) 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; (iii) Plans to continue to build ImmunoBank with additional IND filings throughout 2024; (iv) Long-term duration data for multiplexed therapy anticipated in 2025."

IND • 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. | 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

Non-clinical development of T-Plex component TSC-200-A0201: a natural HPV16 E7-specific TCR-T cell therapy for the treatment of HPV16-positive solid tumors (SITC 2023) - "Conclusions TSC-200-A0201 exhibits high specificity and potency. Based on these results, TSC-200-A0201 has been cleared by the U. S. FDA for clinical development and has been incorporated in the T-Plex Phase 1 clinical trial master protocol."

Clinical • IO biomarker • Cervical Cancer • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD34 • CD8 • DHFR • HLA-A • IFNG • TGFB1

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 | Not yet recruiting | Sponsor: TScan Therapeutics, Inc.

Metastases • New P1 trial • 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

TScan Therapeutics Announces FDA Clearance of Investigational New Drug Application for TSC-200-A0201 Targeting HPV16 to Treat Solid Tumors (GlobeNewswire) - "TScan Therapeutics, Inc...announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for TSC-200-A0201, a TCR-T targeting human papillomavirus 16 (HPV16)....'Clinical trial start-up activities are ongoing, and we anticipate initial data for the most advanced TCRs in this program by the end of this year'....' We are continuing to build our ImmunoBank and anticipate additional IND filings in 2023 and 2024'."

Clinical data • IND • 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

TScan Therapeutics Announces 2023 Clinical Plans and Highlights Recent Progress (GlobeNewswire) - "Clinical Plans and Expected Milestones: In the hematologic malignancies program, the Company expects to enroll the first two cohorts in the Phase 1 umbrella trial (NCT05473910) for TSC-100 and TSC-101 in the first half of 2023 and to report top-line data by the end of 2023. Additionally, the Company expects to share prevention of relapse data in 2024. In the solid tumor program, the Company plans to file INDs for HPV (TSC-200-A0201) and PRAME (TSC-203-A0201) in the first half of 2023 with two additional INDs to be filed by the end of 2023; expects preliminary clinical data for the most advanced TCRs by the end of 2023. The Company expects to report initial multiplex therapy data for this program in 2024."

Clinical data • IND • P1 data • Hematological Malignancies • Myelodysplastic Syndrome • 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 Reports Second Quarter 2022 Financial Results and Highlights Recent Progress (GlobeNewswire) - "Anticipated Near-Term and Upcoming Catalysts: The Phase 1 umbrella trial (NCT05473910) for TSC-100 and TSC-101 is now open, and the Company will provide an update by the end of 2022...The Company plans to progress IND-enabling studies for its solid tumor programs and submit IND applications for two TCRs by the end of 2022. These are expected to include TSC-200-A2 for HPV and TSC-204-C7 for MAGE-A1, which was the subject of a recent publication in Cell; The Company plans to file additional INDs for its solid tumor programs, as well as release initial clinical data for TCRs in this series, by the end of 2023."

IND • P1 data • Hematological Malignancies • Oncology • Solid Tumor

TScan Therapeutics Announces Publication in Cell Highlighting the Discovery of Tumor Antigens and TCRs for the Treatment of Solid Tumors Using Foundational Screening Technology (GlobeNewswire) - P2 | N=30 | NCT02919683 | "TScan Therapeutics, Inc...announced the publication of a peer-reviewed article...in the journal Cell....Single cell analysis revealed that tumor-infiltrating CD8 T cells that expanded upon treatment with checkpoint blockade exhibited specific and identifiable gene expression signatures....In one responding patient, two different T cell clones recognized the same novel C*07:02-restricted epitope on the cancer/testis antigen MAGE-A1, and both TCRs exhibited strong anti-cancer activity....'This specific TCR-T cell therapy candidate, TSC-204-C07, is highly active in preclinical models. We look forward to bringing it to patients in the first half of next year, along with TSC-200-A2, our first TCR candidate for HPV-16'."

P2 data • Head and Neck Cancer • Oncology • Oral Cancer • Solid Tumor

Discovery of TSC-200-A02: A Natural HPV16 E7-Specific TCR-T Cell Therapy Candidate for the Treatment of HPV-Positive Solid Tumors (ASGCT 2022) - "Using TScan’s proprietary ReceptorScan platform, we discovered 453 putative HPV16 E711-19-specific TCRs by screening 681 million naïve CD8+ T cells from 15 unique healthy donors. We have advanced the resulting autologous TCR-T cell therapy candidate, TSC-200-A02, to IND-enabling studies. These results validate the use of ReceptorScan, in conjunction with SafetyScan, as a way to rapidly identify naturally occurring, high affinity TCRs that are suitable for clinical development."

Anal Carcinoma • Cervical Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Oncology • Solid Tumor • CD4 • CD8 • HLA-A • TGFBR2

TScan Therapeutics Presents Preclinical Data at the American Society of Gene and Cell Therapy 25th Annual Meeting (GlobeNewswire) - "Treatment with TCR-200-A02 showed significant inhibition of tumor growth in immunocompromised mice inoculated with HPV positive tumor cell lines....TSC-204-C07 displayed strong cytotoxicity and cytokine secretion in response to HLA-C*07:02 positive cell lines that expressed MAGEA1 but not a cell line that lacked MAGEA1 expression, indicating no risk of off-tumor reactivity....TCR-200-A02, for the treatment of HPV-positive solid tumors, on track for IND submission in 2H22....TCR directed to a novel C*07:02-restricted epitope of MAGEA1, TSC-204-C07, on track for IND submission in 2H22."

IND • Preclinical • Oncology • Solid Tumor

TScan Therapeutics to Host Virtual KOL Event to Discuss its Solid Tumor Program Strategy and Highlights from the ASGCT 25th Annual Meeting (GlobeNewswire) - "TScan Therapeutics, Inc....announced that the Company will host a virtual key opinion leader (KOL) event, to discuss highlights from its presentations at the American Society of Gene & Cell Therapy (ASGCT) 25th Annual Meeting as well as its solid tumor program on Thursday, May 19, 2022, at 4:30 p.m. ET....The event will provide an in-depth review of the oral and poster presentations related to solid tumor TCR-T therapy candidates, TSC-200-A02 for HPV16, and TSC-204-C07 for MAGE-A1, as well as TScan’s approach to potentially overcome antigen heterogeneity and HLA loss with multiplexed TCR-T."

Clinical • Oncology • Solid Tumor

TScan Therapeutics Announces Upcoming Presentations at the 25th American Society of Gene and Cell Therapy Annual Meeting (GlobeNewswire) - "The lead TCR showed comparable preclinical activity to a therapeutic TCR from NCI, that has previously shown a 50% objective response rate in a Phase I clinical trial. No allo-reactivity was observed for the HLAs tested and only a few putative off-targets were identified using our genome-wide SafetyScan platform....The resulting TCR-T cell therapy candidate, TSC-200-A02, is expected to complete IND-enabling studies in the second half of 2022."

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

TScan Therapeutics Reports Second Quarter 2021 Financial Results and Highlights Recent Company Progress (GlobeNewswire) - “Solid Tumor Programs: TScan’s TSC-200 series of TCR-T therapy candidates include a combination of known targets, such as HPV16 for TSC-200 and PRAME for TSC-203, as well as targets that are novel antigens for TCR-T therapy, such as for TSC-201 and TSC-202. Present additional preclinical data of TSC-200 series during the first half of 2022. Complete three IND-enabling studies for TSC-200 series and submit subsequent IND applications to FDA during the second half of 2022. A fourth IND is also planned for the first half of 2023…Research and development expenses for the second quarter 2021 were $10.8 million, compared to $4.5 million for the second quarter 2020.”

Commercial • IND • Preclinical • Oncology • Solid Tumor