On March 1, 2023 Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported the first subject has been treated in Italy in the Company’s Phase 1/2 trial evaluating Annamycin in combination with Cytarabine (Ara-C) for the treatment of subjects with AML who are refractory to or relapsed after induction therapy (MB-106) (Press release, Moleculin, MAR 1, 2023, View Source [SID1234627988]).

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"We continue to be highly encouraged by the data demonstrated from the successfully concluded Annamycin single agent trials and the no evidence of cardiotoxicity seen to date. We remain very optimistic in Annamycin’s potential to be an important treatment for refractory or relapsed AML in combination with Cytarabine. We are pleased to commence subject dosing in Italy and are continuing our efforts to bring additional sites online and build momentum in enrollment. We are committed to driving the development of Annamycin for the treatment of AML and look forward to continuing our evaluations of Annamycin in combination with Ara-C," commented Walter Klemp, Chairman and CEO of Moleculin.

Annamycin is the Company’s next-generation anthracycline that has been designed to be non-cardiotoxic and has been shown in animal models to accumulate in the lungs at up to 30-fold the level of doxorubicin (a commonly prescribed anthracycline), as well as demonstrating the ability to avoid the multidrug resistance mechanisms that typically limit the efficacy of doxorubicin and other currently prescribed anthracyclines. Annamycin is currently in development for the treatment of relapsed or refractory AML and STS lung metastases and the Company believes it may have the potential to treat additional indications.

The Phase 1/2 MB-106 trial is an open label trial that builds on the safety and dosage data from the two successfully concluded single agent Annamycin AML Phase 1 trials, MB-104 and MB-105, conducted in the U.S. and Europe, respectively. Highlights from the final data demonstrated in the MB-105 study include:

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MB-105 demonstrated 80% overall response rate (ORR) in final cohort for treatment of relapsed/refractory acute myeloid leukemia (R/R AML).

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Final reported results showed one CRi (complete response with incomplete recovery of peripheral blood count) and three PRs (Partial Response).

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The responses in the MB-105 trial were seen in subjects 62-73 years of age and the CRi was from a subject 65 years of age.

The clinical study report for MB-105 has been finalized and the Company expects to publish detailed data in a paper or publication in the near future.

Data so far have resulted from treatment with Annamycin as a single agent, however, additional preclinical animal data from sponsored research demonstrated Annamycin in combination with Cytarabine had 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.1

Annamycin currently has Fast Track Status and Orphan Drug Designation from the US Food and Drug Administration (FDA) for the treatment of STS lung metastases and the treatment of relapsed or refractory AML. For more information about the MB-106 Phase 1/2 trial, visit clinicaltrialsregister.eu and reference EudraCT 2020-005493-10 or clinicaltrials.gov and reference NCT05319587.

1 Zal T, Zielinski R, Grela K, Cardenas-Zuniga R, Skora S, Fokt I, Zal A, Andreeff M, Gil L Shephard R, Priebe W, High Efficacy of Liposomal Annamycin (L-ANN) in Combination with Cytarabine in Syngeneic p53-Null AML Mouse Model, Blood (2020) 136 (Supplement 1): 6-7. View Source