Hartford Business Journal

www.HartfordBusiness.com • June 1, 2020 • Hartford Business Journal 15 ers and bioscience experts say. New York-based Pfizer, in partner- ship with German pharmaceutical company BioNTech, is creating four COVID-19 mRNA vaccines and an antiviral drug under a larger develop- ment 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 hu- man clinical trials ongoing in Germa- ny and at medical research universi- ties in New York, Ohio and Maryland. Burkhardt says all successful vac- cines stimulate the immune system to produce antibodies against an antigen to ensure that people who are vacci- nated 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 Gro- ton, 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 manufac- turing 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, Burkhardt says, has already accelerated COVID-19 vaccine devel- opment 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 Septem- ber, that would be great," Burkhardt said of a best-case scenario for a coronavirus vaccine. "There are so many players investing, I am hope- ful 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 — discov- ered 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 au- thorization 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 corona- viruses that cause SARS and CO- VID-19 are genetically similar. Protein Sciences' Research Park- way 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 repur- posed 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 con- ducted 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 CO- VID-19 infection because it provoked an immune response and afforded partial protection in animal studies. Just 25 miles north, immunother- apy startup CaroGen, based in UCo- nn'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 Medi- cine'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 mil- lion 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 po- tential 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 de- veloped candidates because Rose is a pioneer in the field of vaccine develop- ment. 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 be- cause this virus is not going away." CT's bioscience industry takes on coronavirus These are some of the Connecticut-based or affiliated biopharmaceutical companies working to combat the COVID-19 coronavirus outbreak. COVID-19-related projects Company Vaccines Treatments/therapies Alexion Pharmaceuticals (New Haven) ü BioHaven (New Haven) ü BioSig Technologies (Westport) ü CaroGen (Farmington) ü IsoPlexis (Branford) ü Kleo Pharmaceuticals (New Haven) ü Pfizer (Groton) ü ü Protein Sciences (Meriden)/Sanofi ü ü Source: HBJ research FOCUS: HEALTH CARE Paul Pescatello is the executive director of the Connecticut Bioscience Growth Council. CaroGen CEO Bijan Almassian in his UConn incubator lab in Farmington. PHOTO | STEVE LASCHEVER PHOTO | CONTRIBUTED

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