Soon-to-be public biopharma firm moves to Fort Collins, submits new drug application for COVID treatment

Dan Mika

FORT COLLINS — A biopharmaceutical firm that intends to go public in the next month or so is seeking clearance to start trials for a possible treatment to inhibit the COVID-19 virus from replicating itself in an infected person, its first major move since moving to Fort Collins.

In a statement, Cytocom Inc. said it submitted an Investigational New Drug Application to the U.S. Food and Drug Administration for its drug candidate CYTO-205, which is thought to help patient immune systems maintain the correct levels of cytokine release when fighting infection or illness.

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The company said that the drug candidate has reduced the replication of COVID-19 in lung cells cultured in a lab.

Cytokines are one way that an immune system is signaled to produce an immune response. However, if too many cytokines are generated in what’s called a cytokine storm, the body could start attacking healthy, non-threatening cells that form tissues for the lungs, heart and other organs.

A fraction of patients who had severe COVID-19 or died from the disease showed signs of a cytokine storm, suggesting that an overactive immune response could be one of the reasons COVID can threaten people who were healthy prior to contracting the virus.

The trial would be a Phase II study, which is designed to test if a drug is safe and effective for sick patients.

“To date, research has provided compelling rationale for the potential CYTO-205 could have as both a therapeutic intervention and as a prophylactic agent to reduce the spread of the disease,” CEO Michael Handley said in a statement.

If approved, the trial would begin recruiting up to 75 COVID-19 patients with mild symptoms who are at risk of developing life-threatening symptoms. Cytocom expects the trial to begin in April, assuming that it is cleared by federal regulators, and would end the study in April 2022.

Cytocom was first established in a suburb of Orlando, Florida, and announced last October that it would go public by acquiring Buffalo, New York-based Cleveland BioLabs Inc. (Nasdaq: CBLI) in an all-stock deal. The acquisition is subject to approval by Cleveland BioLabs’ shareholders.

The company moved into its head offices in the CSU Research Foundation building in December and will maintain its other offices in Maryland and Florida after the merger is complete.

In a separate announcement, Cytocom said it had signed an agreement with contract clinical trial manager ICON plc (Nasdaq: ICLR) to manage the Phase III study of CYTO-201, a Crohn’s disease treatment that uses similar anti-inflammatories to manage the gastrointestinal malady.

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