- **TCRX** has reached an agreement with the **FDA** on the **pivotal trial design for TSC-101**, which mirrors the ALLOHA™ Phase 1 trial.  **[0001783328_2227449:5]** 
- The trial design utilizes a **biologically assigned control arm** to support **relapse-free survival (RFS)** as the primary endpoint, with overall survival (OS) as a key secondary endpoint.  **[0001783328_2227449:5]** 
- The study population for TSC-101 includes patients with **AML or MDS** who are over 18 years old, undergoing first allo-HCT, and eligible for reduced intensity conditioning (RIC).  **[0001783328_2227449:5]** 
- The company expects its existing cash, cash equivalents, and marketable securities to **fund its operating plan into the second half of 2027**.  **[0001783328_2227449:2]**

TCRX Announces FDA Agreement on TSC-101 Pivotal Trial Design

- TCRX has made a strategic decision to **pause further enrollment in its solid tumor trial** and will now focus its clinical development efforts on the HEME program.  **[0001783328_2227391_1]** 
- The company is undergoing a **restructuring that includes a reduction in force of approximately 30%** of its employees, which is expected to extend its financial runway into the **second half of 2027**.  **[0001783328_2227391_1]** 
- For its lead HEME program, TSC-101, TCRX anticipates starting the **pivotal trial in the second quarter of 2026** and has finalized a new commercial-ready manufacturing process that is **five days shorter** and has decreased cost of goods.  **[0001783328_2227391_0]** **[0001783328_2227391_1]** 
- TCRX plans to file **two Investigational New Drug (IND) applications this year** for additional TCRs targeting CD45, aiming to potentially **double the addressable market** for its HEME program.  **[0001783328_2227391_2]** **[0001783328_2227391_3]**

TCRX Shifts Focus to HEME Program and Restructures Operations

- TScan Therapeutics has reached an agreement with the FDA on the pivotal study design for **TSC-101** for acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), with the pivotal trial expected to begin in **Q2 2026**.  **[1783328_0001193125-25-261612_d873161dex991.htm:0]** **[1783328_0001193125-25-261612_d873161dex991.htm:1]** **[1783328_0001193125-25-261612_d873161dex991.htm:2]** 
- The company announced a strategic prioritization to advance its heme program, pausing further enrollment in its solid tumor Phase 1 trial and shifting focus to preclinical development of in vivo-engineered TCR-Ts for solid tumors.  **[1783328_0001193125-25-261612_d873161dex991.htm:0]** **[1783328_0001193125-25-261612_d873161dex991.htm:1]** 
- This strategic shift includes a workforce reduction of approximately **30%**, or **66 employees**, and is expected to result in annual cost savings of approximately **$45.0 million** in 2026 and 2027, extending the cash runway into the **second half of 2027**.  **[1783328_0001193125-25-261612_d873161dex991.htm:0]** **[1783328_0001193125-25-261612_d873161d8k.htm:1]** **[1783328_0001193125-25-261612_d873161dex991.htm:1]** **[1783328_0001193125-25-261612_d873161dex991.htm:2]** 
- A one-time charge of up to approximately **$2.3 million** is expected in the fourth quarter of 2025 for severance-related benefits and other costs associated with the workforce reduction.  **[1783328_0001193125-25-261612_d873161d8k.htm:1]** **[1783328_0001193125-25-261612_d873161dex991.htm:2]**

TScan Therapeutics (TCRX)