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New Study for Treatment of Acute Myeloid Leukemia

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Moleculin Biotech, Inc. today announced that it has received allowance from the Polish Department of Registration of Medicinal Products (URPL), as well as the requisite Ethics Committee approval, to proceed with its Phase 1/2 clinical trial in Poland of Annamycin (L-ANN) in combination with Cytarabine (Ara-C) in the treatment of subjects with acute myeloid leukemia (AML) who are refractory to or relapsed after induction therapy.

The Phase 1/2 L-ANN /ARA-C combination (AnnAraC) trial (MB-106), an open label trial, builds on the safety and dosage data from the two successfully concluded single agent Annamycin AML Phase 1 trials (MB-104 and MB-105) in the U.S. and Europe and the preclinical data discussed below. The study is expected to commence patient enrollment in the first half of 2022.

Walter Klemp, Chairman and Chief Executive Officer of Moleculin commented, “We are pleased with the positive feedback from the URPL and are excited to take another step toward initiating this important trial. Bolstered by the encouraging data seen to-date, we believe the combination of Annamycin with Cytarabine has the ability to synergistically improve activity against AML. With this allowance to proceed now in hand, our team is working to get this trial up and running as quickly and efficiently as possible. Based on the continued support received from local physicians in Poland for this AnnAraC trial, we believe we will be able to remain on track to get the trial underway this quarter and build momentum with patient recruitment. We are also working to potentially expand this trial to additional countries in Europe to help further accelerate the rate of recruitment.”

Importantly, Annamycin has also demonstrated a lack of cardiotoxicity in multiple human clinical trials, including ongoing trials for the treatment of relapsed or refractory AML and soft tissue sarcoma (STS) lung metastases. Annamycin is the Company’s next-generation anthracycline that has been shown in animal models to accumulate in the lungs at up to 30-fold the level of doxorubicin, as well as demonstrating the ability to avoid the multidrug resistance mechanisms that typically limit the efficacy of doxorubicin and other currently prescribed anthracyclines.  Furthermore, based on additional preclinical animal data from sponsored research, Annamycin in combination with Cytarabine demonstrated a 68% improvement in the median overall survival (OS) compared to Annamycin as a single agent and a 241% increase in OS compared to Cytarabine alone. These data were recently presented at the 62nd Annual Meeting & Exposition of the American Society for Hematology (“ASH”) under the title: “High Efficacy of Liposomal Annamycin (L-ANN or Annamycin) in Combination with Cytarabine in Syngeneic p53-null AML Mouse Model.”

In January 2022, the Company reported that it had received an updated independent safety review of certain preliminary data for the first 30 patients in its three Phase 1 clinical trials with Annamycin targeting AML (MB-104 and MB-105) and the metastases of soft tissue sarcoma to the lungs (STS Lung) or MB-107, which concluded there was no evidence of cardiotoxicity. Based on the preliminary data seen in the fifth and final dose escalation cohort of the MB-105 trial, the Company reported Annamycin demonstrated an overall response rate (ORR) of 60%. This included two partial responses (PRs) and one complete response with incomplete recovery of neutrophils and/or platelets (CRi). Upon safely reaching the RP2D of 240 mg/m2 in the MB-105 trial, the Company concluded recruitment for the trial.

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