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Societal CDMO Inks Manufacturing and Packaging Agreement with NCI

Contract is for the manufacture and packaging of ammonium tetrathiomolibdate capsules to support clinical development of the compound.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Societal CDMO, a contract development and manufacturing organization (CDMO) dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development, has been awarded a new manufacturing and packaging task order agreement by the National Cancer Institute’s Division of Cancer Treatment and Diagnosis (DCTD). The new contract is an individual task order of more than $400,000 for the manufacture and packaging of ammonium tetrathiomolibdate (ATTM) capsules to support clinical development of the compound.

Under terms of the new task order award, Societal CDMO will develop and provide DCTD with a scalable manufacturing and packaging process for cGMP production of 100 mg ATTM capsules. This work will include production and packaging of an initial engineering batch of ATTM, followed by production and packaging of a larger cGMP batch of the capsules including a 36-month shelf-life stability study. ATTM acts to interfere with intestinal uptake of copper when administered with meals and binds plasma copper when taken between meals. Based on this mechanism of action, the compound is believed to have potential to enhance the activity of platinum-based antitumor agents.

“We are pleased to support the NCI and the important research its scientists are undertaking on behalf of cancer patients. By delivering cGMP batches of ATTM to the DCTD, we will be playing an important role in activities designed to advance the battle against cancer, which aligns well with Societal CDMO’s mission and our tagline of ‘Bringing Science to Society,’” said David Enloe, CEO of Societal CDMO. “It is validating to be chosen by the NCI to execute this work and we strongly value the trusted relationship we have established with a number of groups within the National Institutes of Health in recent years. We look forward to delivering the high-quality process and product that our customers expect from Societal CDMO.”

This project is funded in whole or in part with Federal funds from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N98019D00058, Task Order 75N91022F00002. The content of this press release is solely the responsibility of Societal CDMO and does not necessarily represent the official views of the National Cancer Institute.

Visit Societal CDMO at CPhI NA booth 1908.

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