T-Plex-200-A0201/204-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

Discovery of a MAGE-A4-specific TCR-T therapy candidate for multiplex treatment of solid tumors (SITC 2024) - "MAGE-A4-specific TCR-T cells also displayed in vivo efficacy in reducing tumor burden in xenograft mouse models. Conclusions The autologous MAGE-A4-specific TCR-T therapy candidate TSC-202-A0201 has been advanced to IND-enabling studies to be added to TScan's Immunobank of TCRs, with the ultimate goal of being used in a multiplex approach known as T-Plex as a best-in-class immunotherapy strategy for treating patients with solid tumors."

IO biomarker • Colon Cancer • Colorectal Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD8 • MAGEA4

Preclinical models for T-Plex, a customized multiplexed TCR-T cell therapy addressing intra-tumor antigen and HLA heterogeneity (SITC 2024) - "As TScan's ImmunoBank grows, customized T-Plex products can be tailored to specifically address more patients' unique tumors. Ethics Approval Studies involving mice were approved by the IACUC committee at Explora Biolabs (Protocol # EB17-010-301), and adhered to high ethical standards concerning animal welfare."

Heterogeneity • Preclinical • Oncology • Solid Tumor • HLA-A • HLA-B • HLA-C • PRAME

Initial data from a phase 1, first-in-human clinical trial for T-Plex, a multiplexed, enhanced T cell receptor-engineered T cell therapy (TCR-T) for solid tumors. (ASCO 2024) - P, P1 | "Initial data indicate that the combination of HLAs and targets in the ImmunoBank results in ≥1 TCR-T match for the majority of solid tumor patients evaluated to date, and many patients qualify for multiplexed TCR-T treatment. LOH testing can prevent selection and treatment with a TCR-T that would not confer benefit. The proportion of patients eligible for multiplexing is expected to increase as the ImmunoBank grows."

Clinical • IO biomarker • P1 data • Oncology • Solid Tumor • HLA-A • HLA-B • HLA-C • PRAME

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 Upcoming Presentations at the 2024 American Society of Clinical Oncology Annual Meeting (GlobeNewswire) - "TScan Therapeutics...announced the acceptance of two abstracts for poster presentation at the upcoming 2024 American Society of Clinical Oncology (ASCO) Annual Meeting being held May 31 - June 4 in Chicago, IL as well as virtually."

P1 data • Trial status • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Myelodysplastic Syndrome • Solid Tumor

Trial in Progress: A Phase 1, First in Human Clinical Trial for T-Plex, a Multiplexed, Enhanced T Cell Receptor-Engineered T Cell Therapy (TCR-T) for Solid Tumors (ASGCT 2024) - "Secondary endpoints are rates and durations of response, and exploratory endpoints measure T cell activation and persistence. The goal of the ImmunoBank is to enable up to 80% of patients with common solid tumors to qualify for multiplexed TCR-T therapy."

Clinical • IO biomarker • P1 data • Cervical Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD4 • HLA-A • HLA-C • PRAME • TGFB1

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

Non-Clinical Development of T-Plex Component TSC-201-B0702: A TCR-T Cell Therapy Directed to a Novel HLA-B*07:02 Restricted MAGE-C2 Epitope for the Treatment of Solid Tumors (ASGCT 2024) - "TSC-201-B0702 exhibits high specificity and potency against MAGE-C2-positive, HLA-B*07:02 tumor cells with no projected allo- or off-tumor reactivity. Based on these results, an IND for the clinical development of TSC-201-B0702 has been filed with the aim of incorporating TSC-201-B0702 in the ongoing T-Plex Phase 1 clinical trial master protocol. Plain Language Summary: T cells are designed to recognize cells that are infected with pathogens and eliminate them, but given the right tools, they can also recognize and eliminate rogue cells giving rise to cancer."

Clinical • Oncology • Solid Tumor • CD34 • CD8 • DHFR • HLA-B • IFNG • TGFB1

TScan Therapeutics Announces Upcoming Presentations at the American Society of Gene and Cell Therapy 27th Annual Meeting (GlobeNewswire) - "TScan Therapeutics...announced the acceptance of one abstract for oral presentation and four abstracts for poster presentation at the upcoming American Society of Gene and Cell Therapy (ASGCT) 27th Annual Meeting being held May 7-11 in Baltimore, MD as well as virtually."

Trial status • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Myelodysplastic Syndrome • Solid Tumor

Trial in progress: A phase 1, first in human clinical trial for T-Plex, a multiplexed, enhanced T cell receptor-engineered T cell therapy (TCR-T) for solid tumors (AACR 2024) - "Secondary endpoints are rates and durations of response and exploratory endpoints measure T cell activation and persistence. Two additional TCR-Ts are on track to be added to the ImmunoBank, which could allow 50-80% of common solid tumor patients to qualify for multiplexed TCR-T therapy."

Clinical • IO biomarker • P1 data • Cervical Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD4 • HLA-A • HLA-C • PRAME • 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 | 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

TScan Therapeutics Presents Phase 1 Trial Design for Solid Tumor Program at the Society for Immunotherapy of Cancer 38th Annual Meeting (GlobeNewswire) - "TScan Therapeutics, Inc...announced the presentation of six posters at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting....TScan’s Phase 1 solid tumor clinical trial is designed to assess customized, multiplexed TCR-T as a way to overcome tumor heterogeneity and HLA loss of heterozygosity. First generation TCR-T, targeting single antigens, has shown encouraging response rates (typically 30-50%), but has often shown short durations of response (3-4 months)....TScan is developing TSC-201-B0702, a TCR-T cell therapy that targets this epitope, with plans to file an IND by the end of the year. TCR-Ts targeting MAGE-C2 could potentially be used to treat up to 50% of melanoma patients, 25% of patients with head and neck cancers, and 50% of patients with NSCLC in the United States....'In addition to filing an IND for TSC-201-B0702, we also anticipate filing an IND for TSC-204-A0101 by the end of 2023'."

Clinical protocol • IND • Anal Carcinoma • Cervical Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

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

Overcoming tumor heterogeneity – Clinical trial assays to prospectively assign patients customized multiplexed TCR-T cell therapy in Phase 1 (SITC 2023) - "Importantly, HLA-A/B/C alleles were almost always lost together, indicating that HLA loss most frequently occurs through haplotype loss, informing a strategy to direct multiplexed TCR-T to the remaining HLA haplotype. Conclusions Overall, these data highlight the importance of a multiplexed TCR-T cell therapy targeting various intact tumor antigens presented on intact HLA alleles in order to effectively address solid tumors."

Clinical • Heterogeneity • P1 data • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • HLA-B • HLA-C • PRAME

Trial in progress: product characteristics and clinical trial design for T-Plex, a multiplexed, enhanced T cell receptor-engineered T cell therapy for solid tumors (SITC 2023) - P=N/A | "Primary endpoints include safety and feasibility, secondary endpoints are rates and durations of response and exploratory endpoints measure T cell persistence. Three additional TCR-Ts are on track to be added to the ImmunoBank in 2023, that could allow 50–80% of common solid tumor patients to qualify for multiplexed TCR-T therapy."

Clinical • IO biomarker • Oncology • Solid Tumor • CD4 • HLA-A • HLA-C • TGFB1

TScan Therapeutics Announces Upcoming Presentations at the 38th Society for Immunotherapy of Cancer Annual Meeting (GlobeNewswire) - "TScan Therapeutics, Inc...announced the acceptance of six abstracts at the upcoming Society for Immunotherapy of Cancer (SITC) Annual Meeting, being held from November 1-5, 2023, both in San Diego, CA and virtually."

P1 data • Preclinical • Trial status • Oncology • 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 | 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

Product characteristics and clinical trial design for T-Plex: Multiplexed, enhanced T cell receptor engineered T cell therapy for solid tumors. (ASCO 2023) - "Four additional TCR-Ts are on track to be added to the ImmunoBank in 2023 which makes 50-80% of patients with common solid tumors eligible for multiplexed TCR-T therapy."

Clinical • IO biomarker • Oncology • Solid Tumor • CD4 • HLA-A • HLA-C • TGFB1

TScan Therapeutics Announces Upcoming Trial in Progress Poster Presentation at the 2023 American Society of Clinical Oncology Annual Meeting (GlobeNewswire) - "TScan Therapeutics...announced that the Company will be presenting a Trial in Progress (TIP) poster at the upcoming 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, being held from June 2-6, 2023, at McCormick Place in Chicago, Illinois and online."

Trial status • 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 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