Oragenics, Announces US-Based Drug Manufacturing Agreement to Support ONP-002 Clinical Development

Oragenics, Inc. rrecently announced it has entered into a manufacturing agreement with Sterling Pharma Solutions, an industry leading CDMO with multiple US-based development and manufacturing facilities. Oragenics has partnered with Sterling Pharma Solutions for the GMP production of its lead drug candidate, ONP-002, for the treatment of concussion.

This agreement is expected to ensure Good Manufacturing Practice (GMP)-compliant drug product supply ahead of the planned Phase IIb clinical trials which the company expects to start next year. The collaboration marks an important milestone for Oragenics as it secures domestic production capabilities to support its upcoming clinical and regulatory efforts.

“We are excited to partner with Sterling’s facility in Cary, North Carolina, to support the production of ONP-002,” said Janet Huffman, Chief Executive Officer of Oragenics. “This partnership is a critical milestone in our path forward for Phase 2b clinical trials.  This partnership reinforces our commitment to quality, efficiency, and US-based innovation and we believe this step will help streamline our clinical development strategy.”

Sterling will produce ONP-002 under strict cGMP conditions for use in Oragenics’ planned Phase 2b trials, a proof-of-concept study which will evaluate early efficacy of ONP-002 in patients with mild traumatic brain injury (mTBI).

Chad Telgenhof, Chief Commercial Officer at Sterling Pharma Solutions, said “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.”

This US-based manufacturing agreement builds upon Oragenics’ broader strategy to develop scalable, accessible, and fast-acting treatments for neurological trauma, beginning with concussion, a condition that currently has no FDA-approved pharmacological therapies.

Oragenics is a biotechnology company focused on developing intranasal therapeutics for neurological disorders. Its lead candidate, ONP-002, is being developed for the treatment of mild traumatic brain injury (mTBI), commonly known as concussion. The company’s intranasal delivery technology is designed to deliver fast, targeted, and non-invasive therapy to the brain. For more information, visit www.oragenics.com.

Sterling Pharma Solutions is a global contract development and manufacturing organization (CDMO) with more than 50 years’ experience in providing small molecule API development and manufacturing services to the pharmaceutical industry, specializing in handling challenging chemistries. Sterling manages the most complex API challenges from proof-of-concept to commercial manufacture, as well as antibody-drug conjugate (ADC) research and development bioconjugation services. Sterling has six facilities employing more than 1,350 people: its HQ in Dudley, Cramlington, UK and a site in Newcastle upon Tyne, UK; a European presence in Ringaskiddy, Co. Cork, Ireland; a dedicated bioconjugation and ADCs facility in Deeside, North Wales, UK; and two sites in the US, in Cary, North Carolina and Germantown, WI. Find out more information, visit www.sterlingpharmasolutions.com.