TSC-204-C0702 / 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

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 Reports First Quarter 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - "Solid Tumor Program...Phase 1 solid tumor clinical study has been initiated; first patient dosed in early May, with three additional patients enrolled and manufacturing underway. Initial data expected in the second half of 2024. Additional investigational new drug (IND) filings planned to continue to expand the ImmunoBank. Long-term duration of response data for multiplex therapy anticipated in 2025."

P1 data • Trial status • Anal Carcinoma • Cervical Cancer • Head and Neck Cancer • Melanoma • Oncology • Oropharyngeal Cancer • Ovarian Cancer • Penile Cancer • Rectal Cancer • Solid Tumor • Squamous Cell Carcinoma • Vulvar Cancer

Nonclinical Development of T-Plex Component TSC-204-A0101: A Natural TCR-T Cell Therapy for the Treatment of MAGE-A1- and HLA-A*01:01-Positive Cancers (ASGCT 2024) - "TSC-204-A0101 exhibits high specificity and potency against MAGE-A1- and HLA-A*01:01-positive tumor cells with no projected allo- or off-tumor reactivity. Based on these results, an IND for the clinical development of TSC-204-A0101 has been filed with plans in place to incorporate TSC-204-A0101 in TScan's ongoing T-Plex clinical trial master protocol."

Oncology • Solid Tumor • CD34 • CD8 • DHFR • TGFB1

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

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 Three Investigational New Drug Applications for the Treatment of Solid Tumors (GlobeNewswire) - "TScan Therapeutics, Inc....announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) applications for T-Plex, TSC-204-A0201, and TSC-204-C0702....With these INDs cleared, TScan is now working to open a multicenter Phase 1 clinical trial to establish the safety, preliminary efficacy, and feasibility of repeat dosing of multiplexed TCR-T. The trial will include patients with non-small cell lung cancer, melanoma, head and neck cancer, ovarian cancer, and cervical cancer....'We are now engaged in study start-up activities and look forward to sharing initial clinical data for the most advanced TCRs in this program by the end of 2023.'"

IND • New P1 trial • P1 data • Cervical Cancer • Gynecologic Cancers • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Skin Cancer • Solid Tumor

TScan Therapeutics Announces FDA Clearance of Three Investigational New Drug Applications for the Treatment of Solid Tumors (GlobeNewswire) - "'We are continuing to build our ImmunoBank, with four more IND filings anticipated in 2023'....In the Phase 1 trial design, each TCR-T will initially be evaluated as singleplex therapy at two successive dose levels. Once single agent safety is established, each TCR becomes eligible for combination with any other TCR that has passed this threshold. The protocol has an interval 3+3 design, potentially allowing for a rapid path to multiplexing. The trial design also features a screening protocol, which pre-identifies patients whose tumors have a combination of targets and HLAs that would qualify them for the interventional study. The screening protocol is expected to initiate in Q2 2023."

Clinical protocol • IND • Cervical Cancer • Gynecologic Cancers • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Skin Cancer • 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 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 a Novel C07:02-Resticted Epitope on MAGE-A1 and Pre-Clinical Development of an Enhanced TCR-T Cell Therapy Candidate for the Treatment of Solid Tumors (ASGCT 2022) - "We have advanced the resulting autologous TCR-T cell therapy candidate, TSC-204-C07, to IND-enabling studies. These results validate the use of TargetScan to identify relevant tumor antigens and TCRs from the expanded T cell repertoires of patients exhibiting strong and durable responses to immune checkpoint blockade."

Preclinical • Head and Neck Cancer • Immune Modulation • Inflammation • Oncology • Solid Tumor • CD4 • CD8 • HLA-C • MAGEA1 • TGFBR2

Multiplexed TCR-T Cell Therapy: A Strategy to Enhance the Efficacy of Engineered T Cell Therapy (ASGCT 2022) - "However, when TCR LD8-3 and SK-MEL-5 cells were co-cultured with TSC-204-C07 and A101D, the cytotoxic activity of TCR LD8-3 was synergistically enhanced...These findings support the hypothesis that multiplexed TCR-T has the potential to overcome antigen heterogeneity not only through independent targeting of different cancer cell populations, but also by cytokine-mediated T cell enhancement. We are currently conducting in vivo studies to confirm the synergistic effect of multiplexed TCR-T cell therapy and designing trials to test this hypothesis clinically."

Clinical • Oncology • Solid Tumor • HLA-B • HLA-C • MAGEA1 • PRAME

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) - "A TCR directed to a novel C*07:02-restricted epitope of MAGEA1 was identified as a potential driver of the anti-tumor response. These results suggest that TargetScan can identify relevant tumor antigens and TCRs from expanded T cell repertoires of patients exhibiting strong and durable responses to checkpoint therapy, thereby providing suitable TCRs for clinical development. The Company has advanced this TCR-T to IND enabling studies as TSC-204-C07."

Preclinical • Oncology

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