Neldaleucel (MT-601) - (APOLLO)

March 18, 2026: Marker Therapeutics, Inc. (NASDAQ: MRKR) reported 2025 corporate updates and year-end financial results, highlighting multiple upcoming clinical catalysts.

MT-601 (APOLLO Phase 1; lymphoma; NCT05798897): An August 2025 update (also presented at ASH Dec 2025) showed a 66% objective response rate (8/12) in relapsed non-Hodgkin lymphoma with 50% complete responses and durability ranging 3–24 months; 78% ORR (7/9) in Hodgkin lymphoma. Safety was favorable across 100×10^6–400×10^6 cells, with no dose-limiting toxicities and no ICANS. The trial has moved into dose expansion enrolling anti-CD19 CAR-relapsed DLBCL at 400×10^6 cells. Additional patient data and FDA feedback on study design are expected in Q2 2026, with an APOLLO data update also anticipated in Q2 2026.

MT-601 (pancreatic cancer): Cited a January 2026 Nature Medicine publication reporting favorable safety and up to 84.6% disease control rate when combined with frontline chemotherapy. Marker expects to initiate a company-sponsored pancreatic cancer clinical program in Q2 2026.

MT-401 Off-the-Shelf (RAPID Phase 1; AML/MDS): Ongoing evaluation of a four-antigen MAR-T therapy; no new data reported here.

Operations: Manufacturing collaboration with Cellipont Bioservices for MT-601 cGMP production; technical transfer expected to complete in Q2 2026. Cash/restricted cash of $17.0M as of Dec 31, 2025; runway projected through Q4 2026.