Annamycin

Annamycin shows promise against Ara-C and Venetoclax resistant AML, with no cardiotoxicity and improved organotropism. It synergizes with Ara-C, achieving a 60% CRc rate in relapsed/refractory AML patients. Preclinical studies highlight its efficacy and safety, suggesting potential for durable disease eradication and immune-memory induction.

New findings reveal Annamycin's significant activity against Venetoclax-resistant AML, with a 60% CR/CRi rate in relapsed/refractory patients, surpassing historical rates. Annamycin combined with Ara-C shows promise, with median overall survival of 11.6 months in second-line therapy. Moleculin Biotech advances Annamycin in Phase 3 trials for R/R AML, aiming to address unmet treatment needs.

Moleculin Biotech amends Phase 3 MIRACLE trial protocol with FDA, accelerating unblinding of preliminary primary efficacy data and safety/tolerability at 45 subjects, aiming for potential accelerated approval of Annamycin in combination with cytarabine for relapsed or refractory AML.

Moleculin Biotech amends Phase 3 MIRACLE trial protocol with FDA, accelerating unblinding of preliminary efficacy data for Annamycin in R/R AML treatment, with first subject expected in Q1 2025.

Moleculin Biotech amends Phase 3 MIRACLE trial protocol with FDA, accelerating unblinding of preliminary efficacy data at 45 subjects for Annamycin in R/R AML treatment, aiming for potential accelerated approval and strategic partnering.

Moleculin Biotech amended its Phase 3 MIRACLE trial protocol to unblind preliminary efficacy and safety data at 45 subjects, aiming for accelerated Annamycin approval for relapsed/refractory AML. The trial, targeting first subject treatment by Q1 2025, adapts design based on FDA feedback, with data expected by H2 2025.

Moleculin Biotech receives IRB approval for Phase 3 MIRACLE trial of Annamycin + Cytarabine for R/R AML, aiming for first subject treated in Q1 2025.

Moleculin Biotech received IRB approval for its Phase 3 MIRACLE trial evaluating Annamycin + Cytarabine for relapsed/refractory AML, aiming for first subject enrollment in Q1 2025.