Ongoing Study:
MB-107: Phase 1B/2 Study of Annamycin in STS Lung Mets in the United States
Multi-Center, Open-Label, Single-Arm Study of Liposomal Annamycin for the Treatment of Subjects with Soft-Tissue Sarcomas (STS) with Pulmonary Metastases
Preliminary Phase 1B Data Demonstrated No Cardiotoxicity1
and Demonstrated Clinical Activity2
Study Highlights:
Enrolling: ~25 Subjects in Phase 2 portion
Treatment Period: Single dose every 21 days
RP2D: 360mg/m2 (protocol provides for a reduction to 330 mg/m2 after the first 3 patients treated if warranted based on tolerability)
Phase 1B Concluded: RP2D determined to be 360mg/m2
Phase 2 Recruitment Open: Expansion at 360 mg/m2 with option to decrease to 330 mg/m2
For complete study details, please view the study listing on ClinicalTrials.gov Identifier: NCT04887298
1: Moleculin Biotech, Inc. (2024). Form 10-K for the fiscal year ended December 31, 2024. https://moleculin.com/sec-filings/. For updates on Annamycin and its lack of cardiotoxicity, see subsequent disclosures in Forms 8-K, 10-Q, and 10-K.
2: Data are preliminary. Defined as stable disease or better. As of August 12, 2022, preliminary data demonstrated 12 of 14 patients measured had SD after two cycles of Annamycin.
Annamycin Demonstrates Efficacy in STS Lung Metastases
Demonstrated Stable Disease After Two Treatment Cycles
Demonstrated Improvement with Dose ≤ 330 mg/m2 and Fewer Prior Therapies
