Lacutamab Clinical Development and Regulatory Pathway - Lacutamab is a First-in-Class antibody targeting KIR3DL2 for CTCL treatment, with potential to transform CTCL care [15, 16] - TELLOMAK Phase 2 data demonstrated clinical benefit in Mycosis Fungoides (MF) and Sézary Syndrome (SS), supporting potential accelerated approval in SS and Phase 3 initiation [16, 19] - The company is progressing towards potential confirmatory Phase 3 initiation in SS and MF, with the protocol submitted to the FDA [16, 19] - The company plans to file a BLA based on Phase 2 data once Phase 3 is underway, targeting potential accelerated approval in 2027 [17] CTCL Market Landscape and Commercial Opportunity - CTCL comprises 71% of T-cell lymphomas, with Mycosis Fungoides (MF) being the largest subtype (64%) and Sezary Syndrome (SS) accounting for 5% [25] - Real-world data indicates a CTCL prevalence of approximately 20,000 patients in the US, with MF affecting 12,436 patients and SS affecting 1,100 patients [113] - In MF, only 25% of patients receive systemic therapy, indicating a significant untapped market [119] - The company estimates Lacutamab could achieve peak sales of up to $150 million with accelerated approval in SS, potentially growing to $500 million with US approval in MF, and exceeding $500 million with further market expansion [161] Lacutamab Clinical Trial Results and Safety Profile - In SS patients post-Mogamulizumab, TELLOMAK Phase 2 study showed a Global ORR of 42.9% [65] - In MF patients, TELLOMAK Phase 2 study showed a Global CBR of 86% and a Skin response of 29% [74] - Lacutamab demonstrated a favorable safety profile in CTCL, with a low discontinuation rate of 6.3% in SS and 5.6% in MF [84]