LakePharma signs partnership to manufacture COVID-19 vaccine candidate in Hopkinton
Photo | Grant Welker
LakePharma, a Hopkinton-based firm, was acquired by Curia.
The biotech company LakePharma has signed a partnership agreement with a North Shore therapeutics company to jointly develop a potential COVID-19 vaccine and produce it at its Hopkinton facility.
LakePharma is planning to manufacture commercial quantities of Beverly-based Akston Biosciences' vaccine candidate, which is scheduled to begin early clinical trials later this month, the two firms announced Tuesday. Akston's potential vaccine isn't yet ready for market but has one potentially major advantage to those that are: It has been shown to be shelf-stable for weeks at up to 95 degrees. Other drugs need to be kept very cold, and in some cases require health facilities to have special freezers on hand.
LakePharma, which opened its 70,000-square-foot Hopkinton facility in 2018, is providing contract manufacturing services for its partners like Akston while also looking into potentially developing its own COVID-19 vaccine that will work similar to the one it's creating with Akston Bioscience, Chief Manufacturing Officer John Manzello said.
[Related: Lakepharma aiding in coronavirus antibody and diagnostic development]
LakePharma is what's known as a contract research, development, and manufacturing organization, or a CDMO, a type of firm that contributes to the development of partners' therapeutic or diagnostic products. The company, whose headquarters are in Silicon Valley, says it has so far contributed to the development of more than 200 such products.
Most industry CDMO’s are equally busy using their manufacturing capacity towards COVID-19 based programs of one variety or another, Manzello said, and that COVID effort now includes LakePharma.
"Our employees are very excited about working towards a COVID vaccine — our partners and potentially our own — as those efforts represent a chance to dramatically affect global society," he said.
Hua Tu, LakePharma's president and CEO, said in a statement the company brings to the partnership experience in developing SARS-CoV-2 proteins, as the coronavirus is formally known, and its manufacturing facility in Hopkinton can quickly scale up a fast production of the vaccine.
The potential vaccine differs from those from Moderna of Pfizer, which began public use in December, not only in the temperatures it can remain viable in but also in how it fends off the virus. Akston's vaccine uses what's called a fusion protein, which includes multiple genes joined together, using small pieces of the virus itself to train the body to fight it. Moderna and Pfizer's vaccines use messenger RNA, or mRNA, which uses a protein to trigger an immune response in the body, to prepare it to fight off the vaccine.
[Related: UMass Medical School students to aid Worcester vaccination effort]
Akston has used its fusion protein platform for other drugs, including autoimmune disease therapies, vaccines and insulin drugs, including one insulin products that needs to be taken only once a week, unlike the more common daily or twice-daily products, and which anchors insulin to an antibody in a similar way that Akston has developed its coronavirus vaccine.
Akston already had a relationship with LakePharma's West Coast-based research-and-development operations and decided to call on the company for its Hopkinton facility, said Todd Zion, Akston's president and CEO. Akston's own facility is able to handle earlier-stage drug preparation but not the later-stage and commercial-use products later on.
Akston's facility in the Netherlands is planning to start a trial in a few weeks, Zion said, with a parallel process in the United States about a month behind. The company doesn't yet have a timetable for when the vaccine could reach the market, but Akston sees a major potential despite so many vaccines already being distributed worldwide. That's due to the vaccine's ability to be stored at room temperature and the potential need for booster vaccines periodically.
Akston and LakePharma should be able to make billions of doses a year of the vaccine, Zion said.
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