Moleculin Reports 2023 Annamycin Trial Progress and Upcoming 2024 Milestones

Moleculin Biotech, a pharmaceutical firm focused on developing treatments for challenging tumors and viruses, has reported promising preliminary data from its 2023 Annamycin clinical trials. The company is advancing towards pivotal Phase 2B/3 studies and has outlined its anticipated milestones for 2024.

In the MB-106 AML Phase 1B/2 trial, which combines Annamycin with Cytarabine for acute myeloid leukemia (AML) patients, recruitment has reached 67%. The preliminary findings indicate a 40% complete response (CR) rate and a 47% CR/CRi rate among 15 intent-to-treat subjects. Notably, the first subject treated in the first line AML group achieved a complete response, with no relapses observed to date.

The company also reported results from the MB-107 trial, which evaluates Annamycin as a monotherapy for soft tissue sarcoma lung metastases. The Phase 1B data showed a median overall survival of 11 months for heavily pre-treated subjects. Moreover, across multiple studies involving 62 subjects, no cardiotoxicity was detected, as confirmed by an independent expert's assessments.

Moleculin's CEO, Walter Klemp, highlighted the company's progress, emphasizing the potential of Annamycin as a second-line therapy for AML and its ability to broaden patient access to anthracyclines, a significant treatment class for AML and advanced soft tissue sarcoma.

Looking ahead to 2024, Moleculin plans to conduct an in-depth review and present topline data from the MB-106 trial in the first half of the year, followed by an End of Phase 2 meeting with regulatory authorities. The company anticipates identifying and initiating the next phase of development by mid-2024 and transitioning into a pivotal program by late 2024 or early 2025.

For the STS Lung Mets program, Moleculin expects to release final data from the MB-107 trial in the second half of 2024 and to initiate a first-line STS study with an investigator-initiated trial in late 2024 or early 2025.

In addition to Annamycin, Moleculin is engaged in the development of other drug candidates, such as WP1066, which is being evaluated for the treatment of brain tumors and pediatric brain tumors in collaboration with academic institutions. The company aims to finalize agreements for trials and report results from formulation efforts and investigator-initiated studies in 2024.

Moleculin Biotech is committed to expanding its pipeline with innovative treatments, including next-generation anthracyclines like Annamycin and Immune/Transcription Modulators such as WP1066. The company's focus on hard-to-treat conditions underscores its dedication to improving patient outcomes and addressing unmet medical needs.