Pittsburgh biotech firm ‘milestone’ will help it speed Covid-19 therapy to clinical trial 


By Paul J. Gough  – Reporter, Pittsburgh Business Times

Apr 28, 2020, 5:17pm EDT

A Pittsburgh biotech firm’s newly announced partnership with an England-based pharmaceutical manufacturer will allow the company to bring its drug candidate into clinical trials to see if it will be an effective therapy for Covid-19.

CytoAgents Inc., a two-year-old company based in Pittsburgh, is collaborating with Quotient Sciences of Nottingham, England, to allow for rapid development of CytoAgent’s drug candidate GP1681 for Phase I and II clinical trials in 2020. Quotient will help develop and supply the pills to be used in the trials from its Philadelphia-region facility in Garnet Valley, Pa.

The drug candidate developed by CytoAgents doesn’t treat Covid-19 per se but instead addresses an underlying illness caused by Covid-19, an excessive immune response that turns the body against not only the virus but also against healthy cells. This immune response, called a cytokine storm, is becoming a major complication of Covid-19 and other respiratory diseases like influenza, SARS and MERS.

“It triggers an inflammation that leads to respiratory distress,” said CytoAgent CEO Teresa Whalen. The drug candidate fine tunes the immune response, much like immunotherapy works to change the cellular response to cancer.

CytoAgents initially focused its efforts at startup on a drug candidate that would address influenza, which is another infectious respiratory disease that can trigger the potentially deadly cytokine storm. GP1681 was isolated as a new chemical entity from another drug, Beraprost, which was developed in Asia to treat pulmonary hypertension. The same drug candidate that was going to be used in clinical trials for influenza will be used for Covid-19; it’s in the regulatory process for the additional clinical trial.

Whalen said that GP1681 could be incredibly useful as a therapy beyond Covid-19 if it does well, because the symptoms are similar between respiratory diseases.

“Our mission to is to create a powerful, lasting solution not just for the current crisis but any respiratory epidemic,” Whalen said.

Even before the Covid-19 pandemic, CytoAgents has attracted the interest of the Pittsburgh investment community. It’s a portfolio company of Blue Tree Allied Angel, and has received support of the Pittsburgh Life Sciences Greenhouse, Innovation Works and others. It’s prerevenue and has a small staff but works with an advisory board and regulatory and drug development consulting firms.

The partnership with Quotient is an important step in the development of the Covid-19 drug candidate.

“This is definitely a big milestone for the company,” Whalen said. “The collaboration with Quotient will ensure that we continue to reach our target to go into clinical human trials in the summer. This is a key partnership for us.”

Another big factor: The drug candidate has been well studied in its previous form and found to be effective and well tolerated. It’s also stable on the shelf for years, so it could be stockpiled for the future if it is successful.

The next step is evaluating locations for trial as well as receiving FDA approval to expand the medication’s investigational new drug status beyond influenza to Covid-19.

“We are very fortunate in that we have more than one option ready and willing to run our trials for us,” Whalen said Tuesday. “We’re just evaluating what the best solution for us will be.”