TScan Therapeutics Secures FDA Agreement on Key Study Design for TSC-101 and Reveals Strategic Focus to Propel TSC-101 Development While Extending Cash Runway Through H2 2027
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Nov 03 2025
0mins
Should l Buy TCRX?
Source: Newsfilter
Regulatory and Clinical Updates: TScan Therapeutics has reached an agreement with the FDA on the pivotal study design for TSC-101, focusing on treating acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), while pausing enrollment in its solid tumor trial to prioritize hematologic malignancies.
Workforce Reduction and Financial Strategy: The company is implementing a 30% workforce reduction to streamline operations and extend its cash runway into the second half of 2027, anticipating annual cost savings of approximately $45 million.
Manufacturing Process Improvements: TScan has developed a commercial-ready manufacturing process that shortens production time and reduces costs, which will be utilized in upcoming trials and is expected to enhance patient outcomes.
Upcoming Milestones: The company plans to present updated clinical data at the ASH Annual Meeting in December 2025 and aims to launch the pivotal trial for TSC-101 in Q2 2026, alongside submitting IND applications for additional TCR-T candidates.
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy TCRX?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
Analyst Views on TCRX
Wall Street analysts forecast TCRX stock price to rise
7 Analyst Rating
5 Buy
2 Hold
0 Sell
Moderate Buy
Current: 0.934
Low
3.00
Averages
5.50
High
7.00
Current: 0.934
Low
3.00
Averages
5.50
High
7.00
About TCRX
TScan Therapeutics, Inc. is a clinical-stage biotechnology company. The Company is focused on developing a robust pipeline of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer. The Company’s lead TCR-T therapy candidates, TSC-100 and TSC-101, are in development for the treatment of patients with hematologic malignancies to prevent relapse following allogeneic hematopoietic cell transplantation. The Company is also developing multiple TCR-T therapy product candidates for the treatment of solid tumors. The Company has developed and continues to build its ImmunoBank with TCRs across different targets and human leukocyte antigens types to enable customized multiplex TCR-T therapy. Its solid tumors programs include TSC-200, TSC-201, TSC-202, TSC-203, and TSC-204. Its hematologic malignancies programs include TSC-100, TSC-101, and TSC-102.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
GT Biopharma Advances GTB-3650 Clinical Trial to Cohort 4 with 10μg/kg/day Dosing
- 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.
See More
GT Biopharma Advances GTB-3650 Clinical Trial to Cohort 4 with 10μg/kg/day Dosing
- 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.
See More
TScan Reports 100% Relapse-Free Survival in AML Patients Treated with TSC-101 at Two-Year Follow-Up
- 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.
See More
TScan's TSC-101 Shows Significant Efficacy in Cancer Treatment
- 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.
See More
GT Biopharma Completes Safety Review for GTB-3650 Phase 1 Trial
- 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.
See More
GT Biopharma Completes Safety Review for GTB-3650 Phase 1 Trial
- 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.
See More
GT Biopharma Advances GTB-3650 Clinical Trial to Cohort 4 with 10μg/kg/day Dosing
- 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.
See More
GT Biopharma Advances GTB-3650 Clinical Trial to Cohort 4 with 10μg/kg/day Dosing
- 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.
See More
TScan Reports 100% Relapse-Free Survival in AML Patients Treated with TSC-101 at Two-Year Follow-Up
- 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.
See More
TScan's TSC-101 Shows Significant Efficacy in Cancer Treatment
- 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.
See More
GT Biopharma Completes Safety Review for GTB-3650 Phase 1 Trial
- 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.
See More
GT Biopharma Completes Safety Review for GTB-3650 Phase 1 Trial
- 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.
See More
