Marker Therapeutics (MRKR) Update / Briefing Transcript

Summary of Marker Therapeutics (MRKR) Update - August 26, 2025 Company Overview - Company: Marker Therapeutics - Focus: Development of MT-601, a T cell therapy for relapsed lymphoma, utilizing Marf T cell technology Key Points and Arguments Clinical Study Update - Study: Phase I APOLLO study of MT-601 in relapsed lymphoma - Participants: Patients with non-Hodgkin lymphoma, heavily pretreated with a median of five prior lines of treatment [16][40] - Results: - Complete Response (CR) rate of 50% and Overall Response Rate (ORR) of 66% in heavily pretreated patients [16] - Durability of responses: Three patients in complete response for over a year, five patients with clinical responses lasting more than six months [17] - In patients receiving the highest dose of 400 million cells, ORR was 78% and CR was 11% [18] Technology and Mechanism - Technology: Marf T cell technology developed at Baylor College of Medicine, capable of recognizing multiple tumor-associated targets without genetic modification [7][9] - Manufacturing: Collaboration with Cellipont for future pivotal studies and commercial launch, with a vein-to-vein time of 20-25 days [10][11] Safety Profile - Safety Observations: Excellent safety profile with no dose-limiting toxicities (DLTs) reported, and only mild cytokine release syndrome (CRS) observed [20] - Comparison to CAR T therapies: MT-601 does not require genetic modification, potentially reducing long-term risks associated with CAR T therapies [21] Competitive Landscape - Current Treatments: - Bispecific antibodies and CAR T therapies are the main treatments for DLBCL, but they have limitations in efficacy and durability [26][27] - Unmet needs persist for patients relapsing after CAR T or those ineligible for CAR T due to toxicity [26] - Potential Positioning: MT-601 could fill significant unmet needs in the treatment landscape, particularly for patients with DLBCL who have failed other therapies [31] Future Directions - Next Steps: Focus on dose expansion in DLBCL CAR relapse and bispecific relapse patients, aiming for pivotal study foundation [35] - Regulatory Strategy: Plans for accelerated approval based on strong clinical data and addressing high unmet medical needs [48] Additional Insights - Patient Experiences: Several case studies highlighted patients achieving complete metabolic responses after multiple prior therapies with minimal toxicity [24][25] - Long-term Vision: Potential to move MT-601 into earlier lines of treatment as more data becomes available [49] Important but Overlooked Content - Manufacturing Process: Emphasis on the autologous nature of the product and the strategic collaboration for manufacturing [10][11] - Clinical Context: The discussion on the overall survival rates for DLBCL CAR relapse patients, which is approximately five months, highlights the significance of the observed response durations with MT-601 [40] This summary encapsulates the critical aspects of the Marker Therapeutics update, focusing on the clinical study results, technology, safety profile, competitive landscape, and future directions.