Oragenics, Inc., a Tampa, Florida-based biotech company developing intranasal therapeutics for brain-related conditions, announced it has signed a manufacturing agreement with Sterling Pharma Solutions to produce its lead drug candidate, ONP-002, for the treatment of concussion.
Sterling, a contract development and manufacturing organization (CDMO) with multiple U.S. facilities, will manufacture ONP-002 under current Good Manufacturing Practice (cGMP) standards at its site in Cary, North Carolina, the companies said. The partnership is intended to ensure clinical trial supply ahead of Oragenics’ planned Phase IIb trials, expected to begin next year.
“We are excited to partner with Sterling’s facility in Cary, North Carolina, to support the production of ONP-002,” Oragenics CEO Janet Huffman said in a statement. “This partnership is a critical milestone in our path forward for Phase IIb clinical trials. This partnership reinforces our commitment to quality, efficiency, and U.S.-based innovation and we believe this step will help streamline our clinical development strategy.”
The upcoming Phase IIb study will evaluate the early efficacy of ONP-002 in treating mild traumatic brain injury (mTBI), according to the announcement.
Chad Telgenhof, chief commercial officer at Sterling, added: “We are pleased to be partnering with Oragenics for the GMP production of its lead molecule for clinical trials. Our scientific expertise in CNS therapies and our ability to meet critical timelines will support the continued path to market for this transformative drug candidate.”
Oragenics said the manufacturing agreement aligns with its strategy to advance scalable, accessible therapies for neurological trauma. Currently, there are no FDA-approved pharmacological treatments for concussion, according to Oragenics.
In June, Sterling Pharma Solutions also partnered with Kivu Bioscience to produce cGMP-quality material for Phase 1 clinical trials of Kivu’s lead oncology antibody-drug conjugate (ADC) candidate. The partnership includes process familiarization, analytical development, process optimization, and scale-up activities in preparation for cGMP manufacturing at Sterling’s bioconjugation facility in Deeside, U.K.