TScan Therapeutics Updates TSC-101 Trial Results
TScan Therapeutics announced updated results from the ongoing ALLOHA Phase 1 trial of TSC-101 in patients with heme malignancies undergoing allogeneic hematopoietic cell transplantation, HCT. The data is being featured in a poster presentation at the 67th American Society of Hematology, ASH, Annual Meeting and Exposition. Key Presentation Highlights: Relapse-free survival and overall survival were improved in the treatment arm relative to the control arm; All 3 TSC-101-treated patients that reached two years of follow-up remained relapse-free as of the data cutoff, compared to 1 of 4 patients in the control arm, consistent with effective elimination of residual cancer cells post-HCT and durable remission with TSC-101 infusion; TSC-101 infusions were well-tolerated at all dose levels, with no dose-limiting toxicities. Observed adverse events were similar across the treatment and control arms and were generally consistent with post-HCT adverse events; Mixed chimerism or relapses following TSC-101 infusions were found to be significantly associated with greater ex vivo expansion of TCR-T cells during the manufacturing process
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- Clinical Advancement: GT Biopharma has advanced its GTB-3650 clinical trial to Cohort 4, where patients are receiving a dosing of 10μg/kg/day, indicating potential efficacy against resistant blood cancers, with further results expected in Q1 2026.
- Safety Confirmation: Six patients across Cohorts 1, 2, and 3 have successfully completed treatment with GTB-3650, establishing the therapy's safety profile at escalating doses without any dose-limiting toxicities, thereby enhancing confidence in the clinical trial.
- Dose Escalation Plan: The trial is designed to include seven cohorts, with plans to enroll two patients per cohort, escalating doses from 1.25μg/kg/day to potentially 100μg/kg/day, demonstrating the company's ongoing commitment to efficacy and patient care.
- Therapeutic Prospects: GT Biopharma is also advancing GTB-5550, with regulatory submission for human trials expected in late December 2025 or January 2026, further expanding its market opportunities in cancer treatment.

- Clinical Trial Progress: GT Biopharma has advanced its GTB-3650 clinical trial to Cohort 4, where patients are receiving a dosing of 10μg/kg/day, indicating enhanced safety and potential efficacy in combating resistant blood cancers.
- Treatment Protocol Optimization: The therapy follows a continuous infusion schedule structured as two-week treatment periods followed by two-week rest intervals, which is expected to improve patient adherence and treatment outcomes over a four-month duration.
- Market Potential: Targeting CD33-positive acute myeloid leukemia and high-risk myelodysplastic syndrome, GTB-3650 represents a significant complement to traditional therapies, potentially unlocking substantial market opportunities for the company.
- Future Outlook: The company plans to share its next trial update in Q1 2026, and as dosing escalates, GTB-3650 is expected to approach higher efficacy ranges, further advancing its clinical development trajectory.

- Significant Efficacy: Among patients treated with TSC-101, 100% (3/3) remained relapse-free at the two-year follow-up, compared to only 25% (1/4) in the control group, highlighting TSC-101's potential in treating acute myeloid leukemia (AML).
- Good Safety Profile: No dose-limiting toxicities were observed at any dose level of TSC-101, indicating excellent tolerability among patients and laying a solid foundation for future clinical applications.
- Clinical Trial Progress: The company plans to initiate a pivotal study in the second quarter of 2026 to further validate the efficacy of TSC-101 and expand indications to address unmet medical needs.
- Market Opportunity: With increasing treatment demands for AML and MDS patients, TScan anticipates significantly increasing the addressable patient population by expanding its hematologic malignancies program, enhancing its competitive position in the market.
- Significant Efficacy: In the ALLOHA™ Phase 1 trial, 100% of patients treated with TSC-101 remained relapse-free at the two-year follow-up, compared to only 25% in the control group, highlighting TSC-101's potential in treating hematologic malignancies.
- Good Safety Profile: TSC-101 showed no dose-limiting toxicities at all dose levels, indicating its safety for clinical use and laying a solid foundation for further research and market introduction.
- Market Opportunity: TScan plans to expand its hematologic malignancies program in 2026, aiming to double the addressable patient population with new product candidates to meet the growing market demand.
- Manufacturing Efficiency Improvement: The new commercial-ready manufacturing process reduces production time from 17 days to 12 days, significantly enhancing production efficiency and supporting future market expansion and product supply.
- Clinical Progress: GT Biopharma has successfully completed the safety review for its GTB-3650 Phase 1 trial, with all six patients treated across the cohorts showing no safety or tolerability issues, indicating strong tolerability of the therapy for relapsed blood cancers.
- Dose Advancement: The company is now advancing to Cohort 4, where patients will receive a dose of 10μg/kg/day, which is believed to be closer to the clinical efficacy threshold, potentially enhancing treatment outcomes and driving further clinical trial progress.
- Patient Recruitment: GT Biopharma is actively screening patients for Cohort 4 and anticipates initiating dosing in the coming weeks, which will provide critical clinical data updates in the first quarter of 2026, further boosting investor confidence.
- Technology Platform: GTB-3650 employs the company's proprietary TriKE platform technology, aiming to target cancer cells by stimulating patients' natural killer cells, demonstrating potential in treating acute myeloid leukemia and high-risk myelodysplastic syndrome.
- Clinical Progress: GT Biopharma has successfully completed the safety review for its GTB-3650 Phase 1 trial, with all six participants showing no safety or tolerability issues at progressively higher doses, indicating the therapy's potential in treating relapsed blood cancers.
- Dose Advancement: The company has moved into Cohort 4, where patients will receive a dose of 10μg/kg/day, which is expected to be closer to the clinical efficacy threshold, potentially enhancing treatment outcomes and improving patient prognosis.
- Patient Recruitment: GT Biopharma is actively screening patients for Cohort 4 and anticipates initiating dosing in the coming weeks, which will provide a more comprehensive clinical update in the first quarter of 2026.
- Technology Platform: GTB-3650 employs the company's proprietary TriKE platform technology, aiming to target cancer cells by stimulating patients' natural killer cells, showcasing innovative potential in treating acute myeloid leukemia and high-risk myelodysplastic syndrome.





