TCRX - TScan Therapeutics Announces 2024 Clinical Plans and Highlights Recent Progress | Benzinga
Reported positive initial data from Phase 1 heme program at the 65th American Society of Hematology (ASH) Annual Meeting
Clearance of INDs for four TCR-Ts, including a TCR-T for PRAME, in support of use of multiple TCRs in combination for the solid tumor clinical trial
Entered a collaboration with Amgen to identify novel targets in Crohn's Disease
Closed underwritten public offering with net proceeds of $140.6 million, funding operations into 2026
WALTHAM, Mass., Jan. 04, 2024 (GLOBE NEWSWIRE) -- 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 its 2024 clinical pipeline plans and highlighted recent corporate achievements.
"2023 was a pivotal year for TScan, most recently marked by the Phase 1 heme malignancies data presented at the ASH Annual Meeting on six treatment arm patients and four control arm patients. We are encouraged to see complete donor chimerism and MRD negativity achieved and maintained in all six treated patients, with a median follow-up of over six months," said Gavin MacBeath, Ph.D., Chief Executive Officer. "Over the course of the year we also continued to build our ImmunoBank for the treatment of solid tumors. We have now cleared INDs for four TCRs, including TCRs for PRAME, HPV16, and MAGE-A1, and have regulatory clearance to treat patients with multiple TCRs sequentially in our Phase 1 study. Additionally, we submitted INDs for two additional TCRs in December and the 30-day review period with the FDA is ongoing. We look forward to dosing the first patient in the Phase 1 solid tumor clinical study in the first quarter and reporting clinical data, initially on patients treated with singleplexed therapy, and then on patients treated with multiplexed therapy, in 2024."
"The data from our heme program presented at ASH is a true testament to the progress we made over the past year. We have now enrolled and dosed patients up to the third and final dose level with no DLTs observed to date and no safety signals thus far, indicating that the third dose level will likely be the recommended Phase 2 dose," added Debora Barton, M.D., Chief Medical Officer. "We plan to activate additional sites and provide clinical updates at major medical meetings throughout the year. Upon establishing the recommended Phase 2 dose, we plan to open expansion cohorts at that dose to further characterize safety and evaluate translational and efficacy endpoints."
2023 Key Achievements and Recent Company Highlights
Heme Malignancies Program: TScan's two lead TCR-T cell therapy candidates, TSC-100 and TSC-101, are designed to treat residual disease and prevent relapse in patients with acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), or myelodysplastic syndromes (MDS) undergoing hematopoietic cell transplantation (HCT) (NCT05473910).
- Recently presented initial Phase 1 clinical results at the 65th American Society of Hematology (ASH) Annual Meeting. Highlights from the poster included:
- No relapses have occurred in six of six treatment-arm patients, four with follow-up past six months; one of four control-arm patients relapsed at six months and two others required clinical intervention for increasing mixed chimerism.
- No patient-derived ...
- No relapses have occurred in six of six treatment-arm patients, four with follow-up past six months; one of four control-arm patients relapsed at six months and two others required clinical intervention for increasing mixed chimerism.