Marker Therapeutics, Inc. is a clinical-stage immuno-oncology company, which engages in the development and commercialization of novel cell-based immunotherapies and peptide-based vaccines for the treatment of hematological malignancies and solid tumor indications. The company was founded on October 22, 1991 and is headquartered in Houston, TX.
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- Baylor College of Medicine researchers published results in Nature Medicine showing Multi-Antigen Targeted T cells achieved an 84.6% disease control rate when combined with frontline chemotherapy in pancreatic cancer patients. - The Phase 1/2 clinical study demonstrated a median overall survival of 14.1 months and median duration of response of 7.5 months for patients achieving partial or complete responses. - Infused T cells remained detectable in patients 12 months post-treatment and were found at higher frequencies in patients who responded to the investigational therapy. - Marker Therapeutics plans to advance this technology as MAR-T cells with clinical initiation of their pancreatic cancer program anticipated in the first half of 2026.
- Marker Therapeutics successfully treated the first patient in its Phase 1 RAPID study with MT-401-OTS, an off-the-shelf multi-antigen recognizing T cell therapy targeting acute myeloid leukemia and myelodysplastic syndromes. - The initial patient received 100x10⁶ cells and showed no treatment-related adverse events after 28 days of monitoring, consistent with the favorable safety profile of MAR-T cell therapies. - The off-the-shelf approach aims to accelerate treatment delivery to as fast as 72 hours using commercially available donor material, potentially addressing manufacturing bottlenecks in personalized cell therapies. - The company's lead lymphoma program MT-601 has demonstrated a 66% objective response rate with durable complete responses in non-Hodgkin lymphoma patients in the ongoing APOLLO study.
- Marker Therapeutics' Phase 1 APOLLO study shows lymphodepletion significantly improves expansion and persistence of MT-601 MAR-T cells in lymphoma patients, potentially enhancing anti-tumor activity. - Early clinical data reveals promising efficacy with 78% objective response rate and 44.4% complete response rate in patients who relapsed after or are not candidates for anti-CD19 CAR-T therapy. - The non-genetically modified MAR-T cell approach targets six different tumor antigens, demonstrating excellent safety with no dose-limiting toxicities while potentially offering manufacturing advantages over current engineered T cell therapies.
• FibroBiologics has unveiled a new 10,000-square-foot laboratory facility in Houston that will bring manufacturing operations in-house and accelerate development of fibroblast-based therapeutics for chronic diseases. • The expanded facility will increase the company's research capabilities, reduce reliance on external partners like Charles River Laboratories, and enable FibroBiologics to streamline its supply chain for cell therapy products. • With 240+ patents issued and pending, FibroBiologics plans to hire additional researchers to support its growing pipeline of candidates targeting multiple chronic disease indications using its proprietary fibroblast technology.
• Marker Therapeutics' lead MAR-T cell therapy MT-601 (neldaleucel) demonstrated a 78% objective response rate in lymphoma patients who relapsed after anti-CD19 CAR-T therapy, with 44.4% achieving complete responses. • The company secured over $13 million in non-dilutive funding from CPRIT and NIH to support clinical programs for pancreatic cancer and lymphoma, while also raising $16.1 million through a private placement. • MT-601 showed a favorable safety profile with no immune-effector cell associated neurotoxicity syndrome and only one case of Grade 1 cytokine release syndrome reported in the Phase 1 APOLLO trial.
- Afamitresgene autoleucel (afami-cel; Tecelra) received FDA approval for unresectable or metastatic synovial sarcoma, marking the first engineered cell therapy approval for a solid tumor. - MAGEA4, the target of afami-cel, is expressed in various solid tumors, including NSCLC, head and neck squamous cell carcinoma, and melanoma, making it a target for T-cell therapies. - Early-phase studies of IMA401, a MAGEA4/8-directed bispecific T-cell engager, and MT-601, a multi-tumor-associated antigen-specific T-cell agent, show promising response rates in solid tumors and lymphoma, respectively.
