This section highlights FDA-related milestones and regulatory updates for drugs developed by TScan Therapeutics (TCRX).
Over the past two years, TScan Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
TSC-100 and TSC-101. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
TSC-100 - FDA Regulatory Timeline and Events
TSC-100 is a drug developed by TScan Therapeutics for the following indication: Solid tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TSC-100
- Announced Date:
- March 5, 2025
- Indication:
- Solid tumors
Announcement
TScan Therapeutics, provided a business update.
AI Summary
TScan Therapeutics provided a business update highlighting progress in its clinical programs and financial strength. The company presented updated data from its ALLOHA™ Phase 1 heme trial at the 66th ASH Annual Meeting, showing promising results with only 2 of 26 treated patients relapsing compared to 4 of 12 in the control group. Additional two-year relapse data is expected by the end of the year, reinforcing the potential of this therapy. In its solid tumor program, the IND application for TSC-202-A0201 targeting MAGE-A4 on HLA-A*02:01 was cleared by the FDA, now contributing to a total of seven TCR-T therapy candidates in the PLEXI-T Phase 1 trial. TScan also completed a $30 million registered direct offering at a 37% premium, ensuring that cash and marketable securities will fund operations into the first quarter of 2027.
Read Announcement- Drug:
- TSC-100
- Announced Date:
- December 9, 2024
- Indication:
- Solid tumors
Announcement
TScan Therapeutics, Inc. announced that updated results from the ongoing ALLOHA™ Phase 1 trial of TSC-100 and TSC-101 will be presented during an oral session at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition.
AI Summary
TScan Therapeutics, Inc. announced that updated results from its ongoing ALLOHA™ Phase 1 trial of TSC-100 and TSC-101 will be presented during an oral session at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition. The trial focuses on patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and myelodysplastic syndrome (MDS) who have undergone allogeneic hematopoietic cell transplantation with reduced intensity conditioning. Early data show that event-free survival significantly favors the treatment arm, and there is a trend toward a lower probability of relapse when compared to control patients.
The treatments, designed to eliminate residual disease and prevent relapse, were well-tolerated at all studied dose levels with no dose-limiting toxicities observed. These encouraging results suggest TSC-100 and TSC-101 could offer a promising new approach for addressing relapse in high-risk transplant patients.
Read Announcement- Drug:
- TSC-100
- Announced Date:
- May 29, 2024
- Indication:
- Solid tumors
Announcement
TScan Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to TSC-100 and TSC-101, the Company's two lead TCR-T therapy candidates for the treatment of heme malignancies (NCT05473910).
AI Summary
TScan Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its two leading T cell receptor (TCR)-engineered therapy candidates, TSC-100 and TSC-101. This designation aims to accelerate the development and review of these promising treatments for hematologic malignancies such as acute myeloid leukemia, acute lymphoblastic leukemia, and myelodysplastic syndrome. The RMAT program offers intensive FDA guidance, enabling early discussions on surrogate endpoints and potential pathways for accelerated approval. By targeting specific antigens, TSC-100 and TSC-101 are designed to eliminate residual malignant or pre-malignant cells post-transplant while sparing donor cells, addressing a critical need in transplant patients who face high relapse rates. This milestone reflects TScan’s commitment to advancing innovative therapies that could significantly improve outcomes in hard-to-treat blood cancers.
Read Announcement
TSC-101 - FDA Regulatory Timeline and Events
TSC-101 is a drug developed by TScan Therapeutics for the following indication: Solid Tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TSC-101
- Announced Date:
- May 29, 2024
- Indication:
- Solid Tumors
Announcement
TScan Therapeutics, Inc announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to TSC-100 and TSC-101, the Company's two lead TCR-T therapy candidates for the treatment of heme malignancies (NCT05473910)..
AI Summary
TScan Therapeutics, Inc. announced that the FDA has granted RMAT designation to its two lead TCR-T therapy candidates, TSC-100 and TSC-101, for treating hematologic malignancies. The therapies are being developed to help patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and myelodysplastic syndrome (MDS) who receive allogeneic hematopoietic cell transplants. RMAT designation is a special FDA program that speeds up the review and development of promising regenerative medicine therapies for serious conditions. The designation supports TScan’s strategy to use engineered T cell receptors to target and eliminate residual malignant cells after a transplant while keeping donor cells intact. This milestone reflects the potential of TSC-100 and TSC-101 to address significant unmet needs in the treatment of these challenging blood cancers, and TScan looks forward to continued collaboration with the FDA.
Read Announcement
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