On November 10, 2026 Moleculin Biotech, Inc. (Nasdaq: MBRX) ("Moleculin" or the "Company") reported new preclinical data showing that its lead drug candidate, Annamycin (naxtarubicin), combined with PD-1 immune checkpoint blockade, extended survival in pancreatic cancer models beyond that achieved with either agent alone. The findings will be presented today by Waldemar Priebe, PhD, of The University of Texas MD Anderson Cancer Center, in an oral presentation at the 6th Annual Marie Skłodowska-Curie Symposium on Cancer Research and Care organized by Moffitt Cancer Center, being held November 8-11, 2026 in Tampa, Florida.
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The presentation, titled "Targeting pancreatic cancer with Annamycin and turning immune cold tumor into hot tumor," is scheduled for November 10th at 2:45 p.m. ET during the symposium’s gastrointestinal and urologic malignancies session.
In a syngeneic, immunocompetent KPC mouse model of advanced pancreatic ductal adenocarcinoma, treatment with liposomal Annamycin (L-ANN) in combination with PD-1 checkpoint blockade significantly increased survival compared with cohorts treated with either agent alone. The result has been reconfirmed in a second, independent experiment. Pancreatic cancer is among the tumor types least responsive to immune checkpoint inhibitors such as pembrolizumab and nivolumab, in large part because its tumor microenvironment is immunologically "cold," with few infiltrating T cells. The Company believes these data support the evaluation of Annamycin in combination with approved PD-1 inhibitors in pancreatic cancer and, potentially, in other tumors where efficacy of checkpoint inhibitors is limited by an immunologically cold microenvironment.
The combination result builds on a series of findings from Dr. Priebe’s laboratory. Topoisomerase II alpha (TOP2A) is elevated in pancreatic cancer, and its expression correlates with shorter overall survival and higher rates of metastasis; yet approved topoisomerase II -targeting agents such as doxorubicin have not proven effective in the disease. Pharmacokinetic studies show that Annamycin achieves substantially higher and more sustained exposure in pancreatic tissue than doxorubicin at the same dose, offering a potential explanation. In treated tumors, Annamycin was measured at high concentrations, accompanied by evidence of DNA damage consistent with topoisomerase II targeting and by significantly increased infiltration of both CD8+ cytotoxic T cells and CD4+ helper T cells. Inhibiting CD8+ T cells in treated animals shortened survival, demonstrating that these cells are functional contributors to Annamycin’s antitumor activity rather than bystanders. These data extend results presented at the AACR (Free AACR Whitepaper) Annual Meeting in April 2026 and at the AACR (Free AACR Whitepaper) Conference on Pancreatic Cancer in September 2026, which demonstrated Annamycin’s activity across human orthotopic and syngeneic pancreatic cancer models, including liver metastasis models, and first identified the contribution of CD8+ T cells to its antitumor effect.
"In April we showed Annamycin reaches pancreatic tumors in animal models and shrinks them. In September we showed the immune system is part of why. These data close the loop: when you pair Annamycin with a checkpoint inhibitor the animals live longer than with either drug alone," said Walter Klemp, Chairman, President and Chief Executive Officer of Moleculin. "This combination logic presents an exciting opportunity for potentially enabling immuno-oncology approaches in pancreatic cancer, and it comes with an additional benefit as Annamycin, in contrast to doxorubicin, has been shown to avoid cardiotoxicity in preclinical and clinical studies. While our immediate priority remains the MIRACLE trial in AML and its Q1 2027 data readout, this body of work continues to expand the strategic value of Annamycin well beyond AML."
"Topoisomerase II is a validated but effectively undrugged target in pancreatic cancer, not because the target is wrong but because doxorubicin does not appear to reach the pancreas and consequently pancreatic cancer in sufficient concentration. We have successfully demonstrated in preclinical models that Annamycin does," said Dr. Priebe. "What we did not anticipate is that once it is there, its action increases tumor infiltration of functional CD8+ and CD4+ T lymphocytes, and that is what makes the combination with checkpoint blockade work."
The pancreatic cancer research described in this release is preclinical, which may not be predictive of clinical outcomes. The Company is currently planning to sponsor an investigator initiated clinical trial of Annamycin for the treatment of pancreatic cancer in 2027.
(Press release, Moleculin, NOV 10, 2026, View Source [SID1234674563])