Moleculin Reports 2023 Annamycin Trial Data and 2024 Phase 2B/3 Plans

Moleculin Biotech, Inc., a clinical-stage pharmaceutical company focused on developing new treatments for tough-to-treat tumors and viruses, has shared promising updates on their Annamycin clinical trials at the end of 2023. The company aims to proceed to pivotal Phase 2B/3 trials by the end of 2024. Annamycin is designed as a next-generation anthracycline to overcome drug resistance with minimal cardiotoxicity, positioning it as a potential 2nd line therapy for acute myeloid leukemia (AML).

In the ongoing Phase 1B/2 clinical trial (MB-106) evaluating Annamycin combined with Cytarabine (Ara-C), preliminary data shows significant responses in AML patients. Among the evaluable patients, there was a 40% complete response (CR) rate and 47% CR/CR with incomplete hematologic recovery (CRi) rate among the intent to treat population (N=15). Of those dosed per protocol (N=13), the results were even more encouraging, showing a 46% CR rate and 54% CR/CRi rate. Additionally, the first patient treated as a 1st line therapy achieved CR, and no relapses have been reported among the MB-106 participants.

Also, noteworthy is the MB-107 study for STS Lung Mets, which focuses on soft tissue sarcoma lung metastases. The median overall survival for heavily pre-treated patients in the Phase 1B was extended to 11 months, with Phase 2 results still progressing. This trial enrolled patients with a median of four prior therapies, suggesting the potential for Annamycin in a heavily pre-treated population.

The 2024 outlook includes major milestones: an in-depth review and top-line data release for the MB-106 AML trial in the first half, an End of Phase 2 meeting with FDA or European equivalent, and initiation of a pivotal program in late 2024 or early 2025. For the STS Lung Mets trial, the final data readout is expected in the second half of 2024, followed by commencing a 1st line STS study.

Moleculin is also developing other drug candidates, including WP1066 and WP1122. WP1066, an immune and transcription modulator, is aimed at treating glioblastomas, pediatric brain tumors, and other cancers. Anticipated agreements with Northwestern University are expected to advance WP1066 into new trials early in 2024. WP1122, a prodrug of 2-deoxy-D-glucose, is shown to have enhanced antiviral activity compared to its monotherapy, and future trials to test its efficacy in brain tumors and other cancers are in discussion.

Moleculin’s 2023 progress and plans for 2024 reflect a robust pipeline aiming to bring new, effective therapies to patients with severe and hard-to-treat conditions. As ongoing trials continue to yield data, the company looks forward to potentially transformative treatments in the near future.