MBRX Moleculin Biotech

Moleculin completes dosing in Part A of MIRACLE Phase 2/3 trial for Annamycin in R/R AML

Moleculin announced completion of dosing for the full randomized, double-blind n=90 Part A population of the pivotal MIRACLE trial evaluating Annamycin plus cytarabine versus cytarabine plus placebo in adults with R/R AML. The company remains on track for a comprehensive Part A data readout in Q1 2027 to support Annamycin dose selection for Part B, with the final population expected to show an approximately 50/50 split between patients who failed 7+3 chemotherapy and venetoclax-based regimens.

Moleculin: Peer-reviewed pooled analysis shows no cardiotoxicity for Annamycin

A peer-reviewed publication in Frontiers in Cardiovascular Medicine reports a pooled analysis of 90 patients across five trials (AML and STS) showing no clinical or subclinical cardiotoxicity for Annamycin at cumulative doses exceeding traditional anthracycline limits. Independent Cleveland Clinic review found no change in LVEF or other cardiac markers. This supports continued development of Annamycin in the MIRACLE Phase 2/3 trial for r/r AML without the cardiotoxicity limitations of conventional anthracyclines.

Moleculin presents Annamycin preclinical pancreatic cancer data at AACR

New preclinical data presented at AACR show Annamycin's antitumor activity in pancreatic cancer models is partially mediated by CD8+ T cells, suggesting it may turn immunologically cold tumors hot and support future combination approaches. This is separate from the ongoing pivotal MIRACLE Phase 2/3 trial of AnnAraC in relapsed/refractory AML, which remains the primary focus.

Moleculin Biotech Granted Mexican Patent No. 436849 for Lung-Targeted Liposomal Annamycin Until 2040

The Mexican Patent Office granted Patent No. 436849 protecting Moleculin's proprietary lung-targeted liposomal formulation of Annamycin through November 23, 2040. This expands the company's international IP estate for the next-generation anthracycline, which is currently in the pivotal MIRACLE Phase 2/3 trial for relapsed/refractory AML and being explored for soft tissue sarcoma lung metastases.

Moleculin: MIRACLE Part A 90-patient unblinded readout Dec 2026–Feb 2027

Positive interim data from the first 45 patients in Part A showed CR rates at least three times higher than control. The trial is on track to complete 90-patient enrollment in September 2026, with the unblinded efficacy readout scheduled for December 2026 to February 2027 to support optimal-dose selection and Part B initiation in 1H 2027.

Moleculin Biotech: Atlantic Health to run Ph1B/2 Annamycin pancreatic cancer study

Moleculin will supply Annamycin and maintain the IND for a new investigator-initiated Phase 1B/2 single-arm trial of Annamycin in third-line advanced pancreatic cancer. Atlantic Health will conduct the study, which is expected to run from 2026 into 2030. The trial is funded by Atlantic Health and adds a new indication to Annamycin’s development program.