Moleculin Reports Positive Annamycin Trial Results for STS Lung Metastases

Moleculin Biotech has announced encouraging efficacy data from its U.S. Phase IB/II trial (MB-107) of Annamycin in treating soft tissue sarcoma (STS) lung metastases. The trial showed a 59.4% clinical benefit rate, with one partial response and 18 cases of stable disease. Participants receiving two Annamycin cycles showed improved progression-free survival (PFS) and overall survival (OS). At the recommended 330 mg/m² dose, patients had a median PFS of 105 days and OS of 13.5 months, outperforming typical second-line treatments. Those with fewer prior therapies achieved even better outcomes—PFS of 127 days and OS of 19.9 months. No cardiotoxicity was observed. Annamycin holds FDA Fast Track and Orphan Drug designations for AML and STS, with EMA orphan status as well. CEO Walter Klemp noted the drug’s potential as a meaningful treatment for STS lung mets. The EMA recently approved a pivotal Phase IIB/III trial of Annamycin with cytarabine for AML.

10-06-2025