Marker Therapeutics, Inc. (Nasdaq: MRKR) has reported promising preliminary results from its Phase 1 APOLLO study investigating MT-601, now officially named neldaleucel, in patients with refractory lymphomas who have relapsed after anti-CD19 CAR-T cell therapy.
The multi-center trial demonstrated an impressive 78% objective response rate among the first nine patients treated, with 44.4% achieving complete responses. The therapy also exhibited a favorable safety profile, with no cases of immune-effector cell associated neurotoxicity syndrome (ICANS) and only one case of Grade 1 cytokine release syndrome (CRS) observed.
"Preliminary data from our Phase 1 APOLLO study showed encouraging safety and efficacy results in lymphoma patients who relapsed after anti-CD19 CAR-T cell therapy," said Juan Vera, M.D., President and Chief Executive Officer of Marker Therapeutics. "With a 78% objective response rate and favorable safety profile, we believe MT-601 has the potential to provide a transformative treatment option for this patient population."
MT-601: A Novel Approach to T Cell Therapy
MT-601 represents Marker's lead multi-antigen recognizing (MAR)-T cell therapy, a platform that differs significantly from conventional CAR-T approaches. Unlike genetically engineered T cell therapies, MAR-T cells are developed through selective expansion of tumor-specific T cells from a patient's or donor's blood.
The technology enables recognition of hundreds of different epitopes within up to six tumor-specific antigens, potentially reducing the likelihood of tumor escape mechanisms. This approach may offer several advantages over current engineered T cell therapies, including easier and less expensive manufacturing processes and an improved safety profile.
The United States Adopted Name (USAN) council and International Nonproprietary Names (INN) expert committee recently approved "neldaleucel" as the nonproprietary name for MT-601.
Expanding Clinical Programs
Beyond lymphoma, Marker is advancing MT-601 for metastatic pancreatic cancer, with clinical program launch anticipated in the second half of 2025. This expansion is supported by $2 million from the National Institute of Health (NIH) Small Business Innovation Research (SBIR) program and $9.5 million from the Cancer Prevention & Research Institute of Texas (CPRIT).
Additionally, the company is preparing to initiate a clinical program for MT-401-OTS, an "off-the-shelf" product for patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS). This allogeneic approach utilizes cells manufactured from healthy donors, with a cellular inventory already established and ongoing efforts to expand.
Financial Position Strengthened
Marker has bolstered its financial position through both non-dilutive funding and a strategic private placement. In December 2024, the company announced a $16.1 million private placement with participation from both new and existing investors, including Blue Owl, New Enterprise Associates (NEA), and Aisling Capital.
As of December 31, 2024, Marker reported cash and cash equivalents of $19.2 million, which the company believes will fund operating expenses into the first quarter of 2026, with potential for further extension through additional anticipated grant funding.
For the fiscal year 2024, Marker reported research and development expenses of $13.5 million, compared to $10.4 million in 2023, reflecting increased investment in clinical programs. General and administrative expenses decreased to $4.2 million from $7.5 million in the previous year. The company reported a net loss of $10.7 million for 2024, compared to $8.2 million for 2023.
Looking Forward
Marker continues to enroll additional participants in the Phase 1 APOLLO trial and expects to report further data in the second half of 2025. The company has also announced plans to share additional insights during a webinar scheduled for the second quarter of 2025.
"We also strengthened our financial position through a strategic private placement and additional non-dilutive funding from the NIH and CPRIT. As we move further into 2025, our focus remains on cash preservation and disciplined execution to maximize the impact of our clinical programs," said Dr. Vera.
The company's approach to developing non-genetically modified T cell therapies represents a distinctive strategy in the competitive cellular therapy landscape, potentially offering new options for patients with limited treatment alternatives.
