🔒CT bioscience companies among global leaders in COVID-19 vaccine, treatment development

As Connecticut continues to face one of the world’s deadliest COVID-19 outbreaks, the state’s bioscience industry has aggressively turned its focus to developing new breakthrough vaccines and treatments for the novel coronavirus.

Some of the more than 150 vaccine candidates and countless antiviral treatments in production globally are being developed by Connecticut-based or affiliated biopharmaceutical companies.

For example, a COVID-19 vaccine created by global pharmaceutical giant Pfizer, which has roughly 200 of its 5,000 Groton employees dedicated to coronavirus-related projects, was the first to reach human clinical trials in the U.S., and could be available for emergency use as early as this fall, according to John Burkhardt, the Groton lab’s site director and vice president of global drug safety research and development.

Meriden’s Protein Sciences, a division of French pharmaceutical company Sanofi, is modifying previous development work on a SARS vaccine to expedite a potential COVID-19 vaccine. The 100-employee Connecticut homegrown bioscience company also has the manufacturing capacity to produce large quantities of the vaccine if it proves effective.

Other COVID-19 vaccines and treatments in Connecticut’s research and development pipeline are being studied by Farmington-based CaroGen; Biohaven, Alexion and Kleo Pharmaceuticals in New Haven; IsoPlexis in Branford; BioSig Technologies in Westport; and Shelton’s NanoViricides.

On separate fronts, The Jackson Laboratory for Genomic Medicine in Farmington is making, administering and analyzing coronavirus tests, while medtech giant Medtronic, which has a large manufacturing facility in North Haven, is sharing the design specs for one of its in-demand ventilators.

“From viral treatment, to vaccines, to testing, we are involved in all of it, which is really incredible,” said Paul Pescatello, executive director of the Connecticut Bioscience Growth Council. “Connecticut is front and center on the COVID-19 vaccine and treatment front.”

Pescatello and drugmakers say Connecticut bioscience companies have been able to accelerate COVID-19 vaccine and treatment-related activities, in part, because the industry here has experience developing immunotherapies for cancer and infectious diseases. There’s also a greater willingness among bioscience companies to collaborate and pool knowledge and resources due to the economic and human suffering caused by the coronavirus outbreak.

The efforts are part of a worldwide push to pool funding and resources to develop and manufacture effective vaccines for the global population.

In Washington, D.C., the Trump administration has tasked a newly created program dubbed Operation Warp Speed — which ties together all major federal, medical, military and other oversight entities — with developing 300 million COVID-19 vaccine doses by January.

Warp Speed has identified and invested more than $1 billion in COVID-19 vaccine candidates being developed by Sanofi, AstraZeneca, Moderna and Johnson and Johnson.

COVID-19 vaccine and treatment developments are moving at unprecedented speeds, according to Pescatello and Burkhardt, who say the bioscience community needs “multiple winners” to provide enough vaccines for the global population.

“It shows the great research capability and expertise we have in Connecticut that companies could pivot and turn to putting an army of researchers to work on the coronavirus and on COVID-19 vaccines,” Pescatello said. “It’s really amazing how much innovation and creativity is going on here in Connecticut.”

Pfizer’s “Operation Lightspeed”

Two promising COVID-19 vaccine candidates in the U.S. are being developed by Pfizer and Boston biotech company Moderna, area drug makers and bioscience experts say.

New York-based Pfizer, in partnership with German pharmaceutical company BioNTech, is creating four COVID-19 mRNA vaccines and an antiviral drug under a larger development program known internally as “Operation Lightspeed,” Burkhardt said. The initiative was coined by CEO Albert Bourla, who recently told Forbes Magazine that Pfizer is willing to spend $1 billion this year to develop and manufacture a COVID-19 vaccine that it doesn’t know yet will work.

Pfizer currently has coronavirus human clinical trials ongoing in Germany and at medical research universities in New York, Ohio and Maryland.

All successful vaccines stimulate the immune system to produce antibodies against an antigen to ensure that people who are vaccinated develop immunity to a specific viral infection. But Pfizer’s mRNA vaccine, which is being worked on in the company’s 2.8-million-square-foot medical research laboratory in Groton, is unique because it can be made synthetically in a batch setting rather than requiring live cells. That makes it more amenable to scale-up manufacturing than other “traditional vaccine approaches,” he said.

The downside is that no company has successfully developed a mRNA vaccine, according to Forbes.

“We are taking all four vaccines into clinical studies now to see if one or two produce a more robust immune response than the others,” Burkhardt said. “We really won’t know until we get the data.”

Pfizer’s Groton lab has about 200 full- and part-time workers focused on its two-pronged approach of developing a vaccine and an antiviral treatment to combat COVID-19, he said. (Before the COVID-19 outbreak, the 160-acre complex had about 5,000 workers, and up to 3,000 on site a day.)

In particular, the Groton site is working to ensure safety and formulation of Pfizer’s COVID-19 vaccine candidates. It's also involved in developing an antiviral drug discovered at Pfizer's California lab. Burkhardt says the antiviral drug is on pace to start the first phase of clinical studies in the third quarter, and estimated it could obtain emergency use authorization for treatment in 2021.

“This is a big mission of the Groton site, which is excellent in chemistry, excellent in scale-up of chemical synthesis, formulation and clinical supply manufacturing, safety and metabolism of these drugs,” he said.

Pfizer, Burkhardt says, has already accelerated COVID-19 vaccine development by several months thanks to a close partnership with the Food and Drug Administration and by testing multiple candidates at once. The fast start, he added, means Pfizer could potentially produce up to 10 million doses of a vaccine by year-end, and 200 million doses in 2021.

“Of course if it could be September, that would be great,” Burkhardt said of a best-case scenario for a coronavirus vaccine. “There are so many players investing, I am hopeful there will be multiple winners, because that’s what we need.”

Scientists at Pfizer’s Groton lab are also heavily involved in developing an antiviral drug — that would be used in a hospital and administered intravenously to patients — discovered at the company’s California lab. Burkhardt says the antiviral drug is on pace to start the first phase of clinical studies in the third quarter, and could obtain emergency use authorization for treatment in 2021.

Protein Sciences, CaroGen in the race

Protein Sciences and CaroGen are both developing COVID-19 vaccines by using the same platforms they developed in the wake of the global SARS epidemic in the early 2000s. That’s possible because the coronaviruses that cause SARS and COVID-19 are genetically similar.

Protein Sciences’ Research Parkway lab in Meriden is playing a key role in Paris-based Sanofi’s initial development work on two COVID-19 vaccine candidates, according to Clement Lewin, head of Sanofi’s Biomedical Advanced Research and Development Authority (BARDA) office. One of the candidates, he said, could begin phase one clinical trials in the fourth quarter. Sanofi is also collaborating with pharmaceutical partner Regeneron to test a repurposed rheumatoid arthritis drug — Kevzara — as a possible treatment for critically ill COVID-19 patients.

Since February, Protein Sciences, known for its eggless flu vaccine, has been leveraging work it conducted on a SARS vaccine in 2002 that never made it to market and was abandoned when the outbreak subsided. Sanofi, which acquired Protein Sciences for $750 million in 2017, has said it’s optimistic the vaccine candidate could prevent COVID-19 infection because it provoked an immune response and afforded partial protection in animal studies.

Just 25 miles north, immunotherapy startup CaroGen, based in UConn’s Technology Incubation Program (TIP) building in Farmington, is using previous SARS vaccine work done by co-founder Dr. John Rose, who is now director of the Yale School of Medicine’s molecular virology program, to develop a COVID-19 vaccine.

CaroGen CEO Bijan Almassian said the project rebooted in February under the leadership of Rose, who still chair’s the company’s scientific advisory board. CaroGen is providing scientific input and has assigned its head of immunology to the project.

Almassian said the vaccine is being tested in mice and other animals as the company moves “cautiously” toward a potential clinical phase. CaroGen, though, will need to raise up to $25 million to advance its COVID-19 vaccine to the end of an initial clinical trial.

Connecticut Innovations, the state’s quasi-public venture capital arm, and a major financial backer of CaroGen, has invested up to $2 million for the company’s vaccine project with Yale, and is willing to invest more if other investors come on board.

Almassian says the company is currently in talks with several potential corporate investors.

“We don’t want to chase the front-runners because they are not easy to catch,” Almassian said. “These are companies backed by the government and the private sectors, and sitting on hundreds of millions of dollars in cash. They are moving very fast.”

But Almassian is confident that CaroGen’s vaccine platform could close the gap on other globally developed candidates because Rose is a pioneer in the field of vaccine development. CaroGen’s virus-based vaccine candidate can also be quickly altered if COVID-19 mutates or modifies, throwing other platforms in limbo.

“We are behind, but that’s fine,” he said. “Not all the front-runners get to finish, and even if they do finish we believe there is a worldwide market because this virus is not going away.”