Humanetics Partners with Lifecore Biomedical to Advance BIO 300 for Acute Radiation Syndrome Prevention
Minneapolis-based drug development company, Humanetics Corporation, with funding support from the U.S. Department of Defense, has engaged Lifecore Biomedical to provide CDMO services for BIO 300, a novel radioprotective agent aimed at preventing acute radiation syndrome.
The collaboration involves technology transfer, formulation development, gap assessment, pilot batch filling, and analytical method work to support BIO 300's advancement, which is under late-stage clinical development for mitigating impaired pulmonary function in COVID-19 patients and protecting cancer patients from radiation therapy side effects.
Lifecore Biomedical, Inc. (“Lifecore”), a fully integrated contract development and manufacturing organization (“CDMO”), and Humanetics Corporation (“Humanetics”), an advanced clinical-stage pharmaceutical company, today announced that Humanetics has selected Lifecore to provide a range of CDMO services to support the continued development of BIO 300 for the prevention of acute radiation syndrome. Under the terms of the agreement, Lifecore will conduct technology transfer of the existing fill and finish process for BIO 300, including formulation development, gap assessment, and filling of a pilot batch. Lifecore will also undertake analytical method work including feasibility assessments designed to estimate future development work for the product candidate.
“This relationship represents another important example of the momentum that we are generating at Lifecore as we execute against our strategic growth plan. Humanetics’ BIO 300 is the exact type of promising, cutting-edge biopharmaceutical product that we strive to support, and we are gratified to have been selected by the company to provide these services,” said Paul Josephs, chief executive officer of Lifecore. “Additionally, this collaboration between two Minnesota-based life science companies helps shine a spotlight on the impressive medical innovation that is coming out of our state, and we are thrilled to be able to support the important work being advanced by Humanetics.”
“We are excited about working with Lifecore in our own backyard, showcasing the exceptional talent and innovation Minnesota has to offer,” said Ronald Zenk, chief executive officer of Humanetics. “Results of this collaboration will help provide critical protection against exposure to radiation for warfighters, First Responders and civilian populations worldwide.”
In addition to the acute radiation syndrome program, BIO 300 is currently in late-stage clinical development for the mitigation of impaired pulmonary function in COVID-19 patients recently discharged from the hospital. Humanetics recently announced promising data from a Phase 2 clinical trial of BIO 300. The compound is also in development for oncology applications to protect cancer patients from unintentional side effects caused by radiation therapy.
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