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Moleculin Completes Enrollment in Early-Stage Cancer Study

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Moleculin Biotech, Inc. MBRX announced that it has completed enrollment in the proof-of-concept clinical study evaluating its p-STAT3 inhibitor candidate, WP1220, as a topical treatment of cutaneous T-cell lymphoma (“CTCL”), a form of skin cancer.

The study site is currently in Poland and will evaluate WP1220 to observe the potential of the candidate in treating CTCL. The company states that immunotherapies, including checkpoint inhibitors like Bristol-Myers’ BMY Opdivo and Merck’s MRK Keytruda are the major players in the oncology market. However, the company believes there are certain non-responsive tumors where checkpoint inhibitors have lower efficacy. It states that research has shown that a combination of a STAT3 inhibitor and a checkpoint inhibitor immunotherapy might result in better results in non-responsive tumors.

Another company developing treatment for CTCL is Soligenix , which is evaluating its pipeline candidate, SGX301, in a pivotal phase III study.

Apart from WP1220, the company has five other candidates in its pipeline in pre-clinical or early-stage development.

The company is developing its lead pipeline candidate, annamycin, as a potential treatment for relapsed/refractory acute myeloid leukemia (“AML”) in phase I/II studies. Interim data from the ascending-dose study has shown no significant adverse events and the company is proceeding with the evaluation of a higher dose of the candidate.

In April this year, the FDA granted a Fast Track Designation to annamycin for treating relapsed or refractory AML. The candidate also enjoys an orphan drug status for addressing AML.

In March, Moleculin announced positive interim safety and efficacy results from the phase I/II studies on annamycin for treating AML, conducted both in the United States and Europe.

Annamycin is also being evaluated in pre-clinical studies for treating metastatic lung cancer. In April 2019, the company announced that annamycin significantly improved the survival rate in an aggressive form of triple negative breast cancer metastasized to the lungs in animal models.

Annamycin, an anthracycline, is currently being evaluated in two phase I/II studies for treating relapsed/refractory AML. On approval, the new patents will provide a protection of 20 years for annamycin. In July, the company filed for new patents, covering the production and reconstitution of annamycin.

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