Lifecore Biomedical Selected by Humanetics for BIO 300 CDMO Services

• Lifecore Biomedical will provide CDMO services to Humanetics Corporation for the development of BIO 300, a drug for preventing acute radiation syndrome.

• The agreement includes technology transfer, formulation development, gap assessment, and pilot batch filling.

Lifecore Biomedical, Inc. has been selected by Humanetics Corporation to provide contract development and manufacturing (CDMO) services for BIO 300, a drug candidate aimed at preventing acute radiation syndrome. The agreement marks a step forward in the continued development of BIO 300, which is also being evaluated for additional clinical applications.

Under the terms of the collaboration, Lifecore will conduct a technology transfer for BIO 300’s existing fill-finish process. The scope of work includes formulation development, gap assessment, and the filling of a pilot batch. Lifecore will also carry out feasibility assessments for analytical methods, which will help estimate future development requirements for the product candidate.

Commenting on the partnership, Paul Josephs, chief executive officer of Lifecore, stated: “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.”

In addition to its application in radiation protection, BIO 300 is in late-stage clinical development for mitigating impaired pulmonary function in COVID-19 patients and is also being explored for oncology applications. Humanetics recently announced promising data from a Phase 2 clinical trial of the drug.

The collaboration highlights the growing life sciences sector in Minnesota, with both companies headquartered in the state. Ronald Zenk, chief executive officer of Humanetics, emphasized the significance of this local partnership, noting that the results of the collaboration could provide essential protection for warfighters, first responders, and civilian populations worldwide.