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March 24, 2020 Bioscience Notebook

New Haven biotechs ramp up trials, R&D; COVID-19 at-home test advances

PHOTO | CONTRIBUTED BioXcel CEO Vimal Mehta
By Natalie Missakian

As the coronavirus pandemic brings much of Connecticut’s economy to a halt, New Haven-area biotechnology firms are still moving forward on clinical trials and R&D for drugs to treat cancer and other illnesses, including COVID-19, officials said Monday.

Gov. Ned Lamont has included bioscience companies on a list of essential businesses exempt from his “Stay Safe, Stay at Home” executive order, allowing them to continue on-site operations during the pandemic, although area biotech leaders said many employees are working remotely.

Dawn Hocevar, president and CEO of bioscience booster organization BioCT, said she heard from several CEOs over the weekend worried that their companies would be forced to shut down their labs. 

“That was the biggest concern that the industry had, not just for companies that are doing COVID-19 work, but for companies that are working on cancer [treatments] and clinical trials — things that can’t stop,” Hocevar said.

While some pharmaceutical companies around the country have temporarily halted clinical trials in the wake of the virus, Hocevar said as of Monday she’d heard no reports of local companies’ trials being shuttered. “Everybody’s still moving forward,” she said.

In a news release, New Haven’s BioXcel Therapeutics said it was still planning to report results of clinical trials on its drug for agitation by the middle of this year.

“Despite the current situation with COVID-19, we remain on track with the enrollment of our SERENITY studies,” CEO Vimal Mehta said in the release.

Randy Teel, vice president of corporate development for Arvinas Inc., said as of Monday the coronavirus crisis has had “no meaningful impact” on its two clinical trials underway for drugs to treat advanced forms of breast and prostate cancer. 

“The safety of our patients and the staff at our clinical trial sites is the most important factor in our planning,” Teel told New Haven BIZ. “We are monitoring the COVID-19 pandemic, and working very closely with our sites and partners as the trials progress.”

At Biohaven Pharmaceuticals, which has several ongoing trials around the country on experimental drugs for diseases ranging from Alzheimer’s to ALS, CEO Vlad Coric said that most of its studies are in the advanced stages, limiting the impact on recruiting volunteers.

He said that while disruptions are being seen at some of its clinical trial sites, “this varies by geographical region.” 

Some biotech industry observers have predicted more stalled trials in the future if health-care workers become consumed with treating coronavirus patients on an emergency basis.

“We are working with the sites to amend protocols to best meet the needs of the current situation,” said Coric. “We cannot yet anticipate what each new day will bring, so must remain flexible.”

The pandemic intensified in the U.S. just as Biohaven headed to market last week with its newly approved migraine drug, Nurtec. Coric said the company’s sales team continues to market the drug remotely via telemedicine, social media, direct-to-consumer advertising and other electronic means. 

“In many geographies, our field sales team is working via virtual meetings to interact with physicians shipping samples or utilizing other approaches,” he said. 

New Haven oncology biotech Kleo Pharmaceuticals had been planning a mid-2020 launch of human testing on its multiple myeloma treatment at Dana Farber Cancer Institute in Boston — Kleo’s first clinical trial — when the pandemic hit. 

“Given what experts are saying about the peak of the pandemic, we believe we will be able to start the trial on time,” CEO and President Doug Manion said. 

Manion also said Tuesday that Kleo has identified a potential drug that can be tested against COVID-19 and has shared the information with potential government, philanthropic and private investors.

He said all non-lab employees have been working remotely for a few weeks and the company is staggering lab employee hours to limit possible exposure to the virus.

At-home test advances

Numerous other companies around the region are working to tackle the coronavirus, from ramping up ventilator manufacturing to developing vaccines and test kits.

On Tuesday, Branford diagnostics firm Isoplexis announced it was working with the Institute for Systems Biology on “mapping functional immune responses at the single-cell level to study COVID-19.”

“Through our unique functional analysis of each cell, we can unlock further understanding of how COVID-19 interacts with the immune system,” CEO and co-founder Sean Mackay said in a statement. 

Bioscience entrepreneur Jonathan Rothberg said this week his Guilford-based startup Homodeus Inc. has received Institutional Review Board (IRB) approval for Covid Detect, a rapid, at-home test for COVID-19 which would be as simple to use as a home pregnancy test.  

New Haven BIZ  first reported Rothberg’s work on developing the test earlier this month.

The approval green lights the company to begin clinical testing and can “streamline FDA approval down the line,” a company spokeswoman said Tuesday. 

More than 60 Homodeus team members and volunteers are working on developing the test, according to Rothberg.  He said the company has been in discussions with Yale New Haven Hospital and the University of Pennsylvania to test the effectiveness of the at-home test. It plans to scale to mass production in five to eight weeks. 

“The team is working around the clock to have the test ready in weeks, not months, for the public,” the spokeswoman said. “Clinical trials are set to begin very shortly.”

Meanwhile, medtech companies like Medtronic, which has a manufacturing presence in North Haven, and Guilford’s BioMed Devices Inc. are ramping up production of ventilators to meet surging demand, according to news reports. 

More than 250 Medtronic employees are dedicated to producing the ventilators at the company’s Galway, Ireland facility, according to the Minneapolis/St. Paul Business Journal. The company told the publication it hopes to double that number by transferring  employees from other facilities.

Contact Natalie Missakian at news@newhavenbiz.com

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