Fort Collins’ soon-to-be newest public company looks to use opioid treatments to fight COVID, cancer

FORT COLLINS — A small pharmaceutical company that recently relocated to Fort Collins is betting that an anti-addiction medicine that’s been around for decades could be repurposed to fight COVID, cancer and spur a new wave of immunity-focused treatments.

In a matter of months, Cytocom Inc. went from a startup with a stalled research portfolio into a company that is soon to become Northern Colorado’s newest public company through a reverse merger and with four conditions that its drug candidate is ready to begin pivotal Phase III trials.

The company is helmed by CEO Mike Handley, a Colorado State University graduate who previously was chief executive for local pharmaceutical companies Armis Biopharma Inc. and Aletheia Therapeutics Corp. from 2012 to the fall of 2019.

In an interview with BizWest, Handley said he was recruited by an investment banking contact to do a turnaround of Orlando-based oncology company Immune Therapeutics Inc. After spending some time managing Immune’s finances, he came across Cytocom, which was spun off in 2014 and was at the time dormant.

Handley was intrigued by its portfolio of drug candidates and joined the company last April and immediately set about moving its headquarters to Fort Collins, raising venture funding and launching acquisitions of contract research firm ImQuest Life Sciences Inc. and Cleveland BioLabs Inc. (Nasdaq: CBLI). Both of those deals are subject to final closes, which are expected this spring.

Once it closes the acquisition of the publicly-traded Cleveland BioLabs, Cytocom will take over that company’s spot on the Nasdaq.

“It was a tremendously busy past nine, 10 months, but very rewarding and successful so far,” he said.

Using opioid treatments to manage immunity

Cytocom’s main drug of focus is naltrexone, which is currently approved for use in treating alcoholism and opioid addiction. It’s a similar compound to naloxone, the generic name for Narcan used in treating people with life-threatening opioid overdoses.

Naltrexone works by inhibiting the receptors that help a person in getting high. The drug was mainly researched at high doses of 50 to 100 milligrams each, mainly to stop those feelings of euphoria. 

But researchers at Penn State University made initial findings in 2011 that suggested lower doses of naltrexone reduced inflammation in Crohn’s Disease patients, a disease that researchers don’t fully understand the cause of but believe the pain is derived from an overactive immune system.

That is where the research thesis of Cytocom comes in: Handley and his team believe that naltrexone in doses smaller than 10 milligrams can modulate a patient’s immune system, spurring it to fight off infections that it doesn’t immediately recognize or keeping it from being so active that it attacks healthy cells.

“The data supports that this small molecule has a novel mechanism of action at a low dose, which just happens to one-tenth of the approved dose,” he said.

That would allow naltrexone to take on other established therapies in the market, such as the Crohn’s treatment Humira. Sales for that treatment were more than $4.2 billion in the U.S. alone last year.

The inhibition of overly-aggressive immune behavior is the reason why Cytocom thinks naltrexone could be used in treating COVID-19. 

It’s thought that some severe cases of COVID are caused by the immune system overreacting and causing inflammation in the lungs and elsewhere in the body. Cytocom has submitted an application to the U.S. Food and Drug Administration to begin trials to see if using naltrexone can keep patients from developing severe reactions. While an approval for use in general populations would take months and the rate of vaccinations are increasing across the U.S., having that treatment could be helpful for people who cannot take a COVID shot due to allergy concerns or because they refuse it.

Starting trials on multiple fronts

So far, Cytocom has passed Phase II trials for naltrexone use for patients with Crohn’s, fibromyalgia and multiple sclerosis, and has a different drug candidate for pancreatic cancer ready for Phase III studies. The company plans to finish those studies and gain approval to begin selling those treatments within the next 24 to 36 months in the U.S., and is looking to start selling some treatments for infectious diseases to developing markets within the next quarter.

Repurposing naltrexone is in many ways similar to the story of messenger RNA, or mRNA, which is the mechanism of action in use for the Pfizer and Moderna COVID shots. That technology teaches cells to produce a harmless portion of a protein found on the virus, which the immune system then recognizes as a threat and destroys it, learning to fight off future infections in the process.

Messenger RNA as a technology has been around for decades as a way to, in theory, teach an immune system how to properly respond to a disease or condition. But only until the world started to face COVID did it get the wide-scale research needed to prove that it could be a game-changer not just in fighting the pandemic, but for use in fighting other maladies.

Handley is selling potential investors on those treatments, along with a new way of thinking about treatment for a range of diseases where the immune system is thought to be key.

“We’re seeing kind of a renaissance of drug discovery and development and treatment of diseases by just taking an advantage of what our immune system should be good at, which is, destroying cancers, wiping out infections,” he said.

© 2021 BizWest Media LLC

FORT COLLINS — A small pharmaceutical company that recently relocated to Fort Collins is betting that an anti-addiction medicine that’s been around for decades could be repurposed to fight COVID, cancer and spur a new wave of immunity-focused treatments.

In a matter of months, Cytocom Inc. went from a startup with a stalled research portfolio into a company that is soon to become Northern Colorado’s newest public company through a reverse merger and with four conditions that its drug candidate is ready to begin pivotal Phase III trials.

The company is helmed by CEO Mike Handley, a Colorado State University graduate who previously was chief executive for local pharmaceutical companies Armis Biopharma Inc. and Aletheia Therapeutics Corp. from 2012 to the fall of 2019.

In an interview with BizWest, Handley said he was recruited by an investment banking contact to do a turnaround of Orlando-based oncology company Immune Therapeutics Inc. After spending some time managing Immune’s finances, he came across Cytocom, which was spun off in 2014 and was at the time dormant.

Handley was intrigued by its portfolio of drug candidates and joined the company last April and immediately set about moving its headquarters to Fort Collins, raising venture funding and launching acquisitions of contract research firm ImQuest Life Sciences Inc. and Cleveland BioLabs Inc. (Nasdaq: CBLI). Both of those deals are subject to final closes, which are expected this spring.

Once it closes the acquisition of the publicly-traded Cleveland BioLabs, Cytocom will take over that company’s spot on the Nasdaq.

“It was a tremendously…