AbCellera, Vir find partners for COVID-19 mAb manufacturing capacity

Two start-ups partner for COVID-19 mAb manufacturing muscle

The race to create antibody-based treatments for COVID-19 gained momentum this week as two start-ups linked up with biopharma companies for mAb development expertise and manufacturing capacity.

Eli Lilly and Co. (NYSE:LLY) will co-develop antibodies discovered by AbCellera Biologics Inc., and Biogen Inc. (NASDAQ:BIIB) will manufacture antibodies from Vir Biotechnology Inc. (NASDAQ:VIR).

Vir also has a development and manufacturing partnership for COVID-19 mAbs with WuXi Biologics Inc. (HKEX:2269).

In addition to AbCellera and Vir, at least six other companies including Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and academic groups have launched COVID-19 antibody programs (see “COVID-19: A Growing List of New Vaccines and Therapies”).

“It is important to find antibodies that are absolutely dialed-in to the pandemic strain itself.”

Ester Falconer, AbCellera

Manufacturing will be the rate-limiting factor for rapidly moving mAbs from discovery into clinical trials.

Regeneron already has large-scale antibody manufacturing capabilities, and president and CEO Leonard Schleifer stated in a televised White House meeting on March 2 that the company can start producing 200,000 doses per month of an investigational COVID-19 antibody therapy in August.

AbCellera and Vir, on the other hand, had to turn to partners to scale up manufacturing capacity.

Lilly and AbCellera could start Phase I trials of candidate COVID-19 antibodies in June, according to the companies.

Vir has not disclosed a manufacturing timetable for its COVID-19 antibodies, though it said it usually takes four to six months for WuXi Biologics to manufacture an investigational antibody product for clinical testing.

From sample to antibodies in one week

AbCellera has been preparing pandemic response capabilities since 2018, when it signed a deal with the U.S. Defense Advanced Research Projects Agency (DARPA) to rapidly discover antibodies as part of the agency’s Pandemic Prevention Platform (P3).

So far, AbCellera has identified hundreds of antibodies that could neutralize the SARS-CoV-2 virus that causes COVID-19.

The company received a blood sample from one of the first patients in the U.S. known to have recovered from COVID-19 and within a week identified hundreds of antibodies that could be used to create a product with therapeutic and/or protective properties.

“We reached out to our network to obtain a sample, and from a single donor sample we were able to screen over 5 million immune cells and have a collection of 500 unique antibodies so far,” Ester Falconer, head of R&D at AbCellera, told BioCentury.

“Not all antibodies are created equal.”

George Scangos, Vir

While other companies are developing antibody therapies based on samples from patients who have recovered from SARS, a coronavirus that is closely related to COVID-19, Falconer said, “We believe the best approach is to get very specific antibodies directly from patients who have been infected with and recovered from the pandemic strain.” She added, “There is similarity between them, but they are different viruses. It is important to find antibodies that are absolutely dialed-in to the pandemic strain itself.”

Researchers at the Vaccine Research Center, part of NIH’s National Institute for Allergy and Infectious Diseases (NIAID), will screen the antibodies AbCellera has discovered for potency to neutralize the virus.

At the same time, AbCellera and Lilly will be assessing the antibodies to determine which are most suitable for manufacturing and development, Falconer said.

AbCellera and Lilly expect to select antibodies, manufacture them, complete preclinical tests and start a Phase I trial within four months. It would be the first AbCellera-discovered product to enter a clinical trial.

The partnership with Lilly is critical to shrinking development timelines from the years it usually takes to the months that are required to respond to an outbreak, Falconer said. “It’s one thing to have a very large collection of probably potent neutralizing antibodies that will be suitable for a therapeutic. It really takes a partner to step up to take on development and manufacturing.”

AbCellera and Lilly will “equally share initial development costs towards a product,” the companies said. After initial development, Lilly “will be responsible for all further development, manufacturing and distribution,” as well as global regulatory activities.

Vir enters deal with Biogen

Vir has isolated and identified mAbs that bind to SARS-CoV-2, the virus that causes COVID-19, from individuals who had survived infection with SARS.

It announced a partnership on March 12 with Biogen for the development and clinical manufacturing of human mAbs to treat COVID-19. Vir CEO George Scangos served as CEO of Biogen from 2010 to 2017, and chairs a BIO committee that is coordinating the biotech industry’s COVID-19 responses.

Under a letter of intent signed by the two companies, Biogen would be responsible for cell line development, process development and clinical manufacturing activities to develop antibodies discovered by Vir. Financial terms were not disclosed.

Vir also has a separate collaboration with WuXi Biologics, announced in February, under which WuXi will be responsible for cell line development, process and formulation development, and initial manufacturing for clinical development of COVID-19 mAbs. The deal gives WuXi Biologics commercialization rights in Greater China.

Vir’s mAb discovery capabilities stem from its 2017 acquisition of Swiss company Humabs BioMed S.A.

Scangos emphasized the importance of Humabs for Vir in a 2018 interview. “Not all antibodies are created equal,” he said. “We have capabilities now in place to create sophisticated, high-affinity antibodies that cover a broad range of viral and bacterial serotypes, and that is one of our key strengths at Vir.”

The Humabs technology has already proven itself in the fight against another emerging pathogen, Ebola.

Teams at Humabs and the Institute for Research in Biomedicine (IRB) isolated and characterized mAb114. The mAb was demonstrated to reduce mortality from Ebola by 34% in a trial conducted in the Democratic Republic of the Congo and is being offered to patients there, along with the REGN-EB3 mAb from Regeneron (see “Two Ebola Therapies Best ZMapp in Congo Trial”).

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