Moleculin Biotech’s Annamycin shows 80% response rate in Phase 1 AML trial

Moleculin Biotech provided an update on its clinical programs evaluating Annamycin for the treatment of relapsed or refractory acute myeloid leukemia – AML – and soft tissue sarcoma – STS – lung metastases. Key updates made during the presentation include: 80% overall response rate in final cohort – n=5 – of the European trial of Annamycin as a single agent for the treatment of relapsed/refractory acute myeloid leukemia with one complete response with incomplete recovery of peripheral blood count and three Partial Responses. Of 42 subjects in the company’s Annamycin clinical trials, 100% demonstrated no signs of cardiotoxicity. In two Annamycin clinical trials, 32 subjects have been, as allowed by the trial protocol, safely treated above the current FDA lifetime maximum anthracycline dose with up to 1800 mg/m2 of Annamycin treatment with no evidence of cardiotoxicity. Based on additional preclinical animal data from sponsored research, Annamycin in combination with Cytarabine demonstrated a 68% improvement in the median overall survival vs. Annamycin as a single agent and a 241% increase in OS compared to Cytarabine alone. The company has begun screening in Poland for a Phase 1b/2 clinical trial using Annamycin in combination with Cytarabine for the treatment of R/R AML. The company is looking to expand this trial into other countries in Europe to potentially improve recruitment rates. Annamycin currently has Fast Track Status and Orphan Drug Designation from the FDA for the treatment of STS lung metastases and the treatment of relapsed or refractory AML.