On May 21, 2026 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), reported that an abstract featuring pooled cardiac safety data for its lead drug candidate Annamycin (also known as "L-Annamycin" or "naxtarubicin"), has been accepted for poster presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 29 – June 2, 2026, in Chicago, Illinois. Access the abstract here.
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The abstract, titled "Cardiac safety of L-annamycin at high cumulative anthracycline exposure: Pooled analysis," will be presented in a poster session focused on Symptom Science and Palliative Care.
Presentation Details:
Session Type: Poster Session – Symptom Science and Palliative Care
Presentation Date and Time: May 30, 2026, 1:30 PM – 4:30 PM CDT
Location: Poster Board #8
The abstract presents pooled cardiac safety analyses from sponsor- and investigator-initiated clinical trials evaluating Annamycin (also known as "L-Annamycin" or "naxtarubicin") in patients with acute myeloid leukemia (AML) and soft tissue sarcoma.
Key findings include:
Independent cardiac safety review conducted in 90 patients treated with L-Annamycin across five completed clinical trials
Source-verified pre-and-post-treatment left ventricular ejection fraction (LVEF) assessments available for 78 patients
Median cumulative L-Annamycin dose of 660 mg/m2 (95% CI, 645-690; range, 210-2,970 mg/m2), with most cumulative doses exceeding conventional lifetime anthracycline limits
No statistically significant change in LVEF from baseline to final assessment (mean difference, -0.12%; 95% CI, -1.34 to 1.09; p = 0.84)
No correlation observed between cumulative L-Annamycin dose and change in LVEF (p = 0.12)
No correlation observed between patient age and change in LVEF (p = 0.73)
Independent review of serial ECGs, cardiac biomarkers, cardiac adverse events, and available global longitudinal strain measurements demonstrated no evidence of drug-induced cardiotoxicity
"Acceptance of these findings at ASCO (Free ASCO Whitepaper) highlights the growing body of evidence supporting the differentiated safety profile of Annamycin," said Walter Klemp, Chairman and CEO of Moleculin. "These data continue to support the potential for Annamycin to provide effective anthracycline therapy without the traditional cumulative dose limitations associated with cardiotoxicity. We believe these findings further strengthen the rationale for our ongoing pivotal Phase 2b/3 MIRACLE trial in AML patients."
Anthracyclines remain among the most widely used chemotherapy agents but are limited by cumulative dose-dependent cardiotoxicity. Annamycin is designed to avoid multidrug resistance mechanisms while potentially eliminating the cardiotoxicity commonly associated with currently prescribed anthracyclines.
Previously reported results from the Company’s Phase 1b/2 study evaluating Annamycin in combination with cytarabine as second-line therapy in AML demonstrated:
50% complete remission (CR) rate
60% composite complete remission (CRc) rate
Median overall survival of 12.39 months (95% CI, 2.07-13.96) in the intent-to-treat population
The ASCO (Free ASCO Whitepaper) Annual Meeting is one of the largest and most influential gatherings of oncology professionals worldwide, featuring cutting-edge research and advances in cancer treatment. For more information, please visit asco.org.
(Press release, Moleculin, MAY 21, 2026, View Source [SID1234665934])