Humanetics Corporation, a clinical-stage pharmaceutical company, has selected Lifecore Biomedical, a fully integrated CDMO, to provide a range of CDMO services to support the continued development of BIO 300 for the prevention of acute radiation syndrome. 

Per 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.

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.

“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.

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.”