Approval gives green light to study of WP1066 for treatment of pediatric brain cancer

HOUSTON, TX, USA I November 12, 2019 I 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, announced that the FDA has approved a request for Investigational New Drug (“IND”) status for its drug candidate WP1066 to be used in a Phase 1 clinical trial for the treatment of children with recurrent or refractory malignant brain tumors.  The request was made by physician researchers at Emory University, including Dr. Tobey MacDonald, Professor of the Department of Pediatrics at Emory University School of Medicine, Director of Pediatric Neuro-Oncology at Aflac Cancer and Blood Disorders Center and Principle Investigator for this clinical trial.  The trial will be conducted at the Aflac Cancer and Blood Disorders Center at Children’s Healthcare of Atlanta.

“This FDA approval gives a green light for Emory University to begin an important clinical trial to explore a new approach to treating pediatric brain cancer,” commented Walter Klemp, Moleculin’s Chairman and CEO.  “WP1066 is currently in a clinical trial for adult patients with glioblastoma and melanoma metastases to the brain at MD Anderson Cancer Center, and this is a logical extension of that research.  WP1066 is an inhibitor of the activated form of a protein called STAT3, a target that has been implicated in a wide range of highly resistant cancers.  Preclinical research at Emory University indicated that WP1066 had a significant anti-tumor effect on medulloblastoma cell lines, so there is a lot of encouragement regarding the opportunity to provide new hope for treating this rare condition.”

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. The Company’s clinical stage drugs are: Annamycin, a Next Generation Anthracycline, designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML, WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic cancer and hematologic malignancies, and WP1220, an analog to WP1066, for the topical treatment of cutaneous T-cell lymphoma. Moleculin is also engaged in preclinical development of additional drug candidates, including additional Immune/Transcription Modulators, as well as compounds capable of Metabolism/Glycosylation Inhibition.

For more information about the Company, please visit http://www.moleculin.com.

SOURCE: Moleculin Biotech