Global contract development and manufacturing organization (CDMO), Sterling Pharma Solutions has signed an agreement with Moleculin Biotech, Inc., to support the company’s expanded development efforts for its potential COVID-19 treatment, WP1122.

Moleculin is a clinical-stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumours and viruses. The company is preparing to submit a request to the US Food and Drug Administration (FDA) for Investigational New Drug (“IND”) status for WP1122.

The agreement will see Sterling undertaking final purification of the product at its site in Cary, North Carolina. It will also help ensure a reliable supply of the drug for preclinical studies and the anticipated clinical trials.

“In light of the added complexity surrounding drug production during the current COVID-19 pandemic, we wanted to make sure we had a reliable source of drug supply located here in the US,” commented Walter Klemp, Chairman and CEO of Moleculin. “We are expanding our planned preclinical studies for the IND, so our contract with Sterling Pharma Solutions helps us cover this increased demand in combination with our expected use in clinical trials.”

Mat Minardi, President of US Operations at Sterling Pharma Solutions added: “It’s a privilege to support companies at such a pivotal time for the pharma sector. The COVID-19 pandemic has brought into sharp focus the importance of innovative companies like Moleculin in the search for potential therapies.

“Our experience and expertise with carbohydrate chemistry, flexibility and ability to respond quickly and scale to Moleculin’s needs are key to this project and we look forward to collaborating with their team over the coming years.”

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 and viruses. 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, being studied for brain tumors, pancreatic cancer and hematologic malignancies; and WP1220, an analog to WP1066, being studied 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, such as WP1122. Moleculin has the exclusive worldwide rights (subject to certain territories for which it has issued sublicenses) to all of the above technologies.

On the other hand,  Sterling Pharma Solutions is a contract development and manufacturing organisation (CDMO) with world-class facilities in both the UK and the US. Sterling has over 50 years’ experience in delivering comprehensive small molecule services spanning pre-clinical development to full commercial cGMP manufacturing.

Widely recognized for its expertise in complex, hazardous chemistry and its service-oriented customer experience, Sterling is a proven and trusted partner to the world’s most innovative biotechs and leading pharmaceuticals.