Moleculin Reports Positive In Vivo Efficacy of Annamycin in Lung Metastatic Sarcoma Models

Data presented at the International Association for the Study of Lung Cancer (IASLC) 2024 World Conference on Lung Cancer highlighted significant findings regarding Annamycin, a drug under development by Moleculin Biotech, Inc. Annamycin demonstrated promising results in preclinical studies for treating primary and metastatic lung cancer.

Annamycin, developed by Moleculin Biotech, showcased its potential in inhibiting tumor growth and extending survival rates in orthotopic lung cancer models. Importantly, it has been noted for its non-cardiotoxic properties, a significant advantage over doxorubicin (DOX), a commonly prescribed anthracycline, which has limitations due to its cardiotoxic effects. The research and findings were presented through a poster titled "Annamycin: Opening New Doors for Organotropic Targeting of Primary and Metastatic Lung Cancer" by Waldemar Priebe, PhD, and his team.

The data presented indicated that Annamycin maintains high uptake and retention in the lung parenchyma of animal models, unlike DOX, which suffers from low lung uptake. Specifically, Annamycin reached lung concentrations that were 10 to 30 times higher than those of DOX. This significant concentration difference correlates with Annamycin's consistent efficacy in orthotopic and experimental lung metastatic models of various cancers, including sarcoma, breast, and colon cancer.

Moreover, preclinical tests confirmed that Annamycin has a superior cardiac safety profile compared to DOX. No cardiotoxicity was observed in animal models treated with Annamycin, a finding that aligns with ongoing clinical trials where no cardiac toxicity has been noted.

Walter Klemp, the Chairman and CEO of Moleculin, emphasized the importance of these findings. He pointed out that Annamycin consistently shows activity against various cancer types, including therapy-resistant cancers, such as soft tissue sarcoma lung metastases. This positions Annamycin as a potentially valuable treatment option for patients with primary or metastatic lung cancers. Klemp expressed confidence in Annamycin's ability to address significant unmet medical needs across a broad spectrum of cancers, citing the growing body of encouraging clinical data from ongoing studies.

The promising results of Annamycin in these preclinical studies justify further translational research to evaluate its effectiveness in patients, both as a standalone treatment and in combination with existing therapies. This ongoing research is vital as Moleculin continues to progress with clinical trials for Annamycin in treating relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases. Annamycin has received Fast Track Status and Orphan Drug Designation from the FDA for AML and STS, and similar designations from the European Medicines Agency (EMA) for AML.

Moleculin Biotech, Inc., a clinical-stage pharmaceutical company, focuses on developing novel treatments for challenging tumors and viruses. The company's leading program, Annamycin, is designed to overcome multidrug resistance and eliminate the cardiotoxicity associated with traditional anthracyclines. In addition to Annamycin, Moleculin is developing other therapeutic candidates, such as WP1066, an immune/transcription modulator targeting various cancers, and WP1122, aimed at treating pathogenic viruses and specific cancer indications.

These developments mark a significant step forward in the fight against hard-to-treat cancers, offering hope for more effective and safer treatment options for patients.