Lilly recently requested an emergency use authorization for LY-CoV555, an antibody treatment candidate against COVID-19. Like other COVID-19 candidates, the discovery of LY-CoV555 was heavily supported by the U.S. government. The government of Canada has also awarded millions to manufacture LY-CoV555. This blog overviews some of the government funding towards the discovery and manufacturing of LY-CoV555.
DARPA support to AbCellera
LY-CoV555 was discovered this year by AbCellera Biologics, a company based in Vancouver spun out of the University of British Columbia, in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID). AbCellera was founded in 2012 to commercialize the work of their co-founder Carl Hansen, a former professor at the University of British Columbia. Part of their focus is to develop a “rapid response” platform to quickly identify antibodies within 60 days after isolating a viral pathogen. On March 13, 2018, the Defense Advanced Research Projects Agency (DARPA) awarded AbCellera “up to USD $30 million” to establish a rapid response antibodies discovery platform.
AbCellera’s collaboration with the NIAID
Following the DARPA award, AbCellera started a partnership with the NIAID. The company added “leading researchers from the Vaccine Research Center” at the NIAID to the consortium funded by DARPA. Their goal was to “build an end-to-end platform capable of developing field-ready medical countermeasures within 60 days of a viral outbreak.”
AbCellera leveraged that platform to discover LY-CoV555. On January 28, 2020, AbCellera announced that they were mobilizing the platform funded by DARPA “to discover coronavirus-neutralizing antibodies that could ultimately be deployed to stop transmission of the 2019-nCoV outbreak.” They also explained that the NIAID was going to “test antibody candidates for prophylactic and therapeutic potency against the 2019-nCoV.” On March 12, 2020, AbCellera said that the antibodies they had sequenced were going to be screened “in collaboration” with the Vaccine Research Center (VRC) at the NIAID. A preprint posted on October 9, 2020 that reports the discovery of the LY-CoV555 antibody candidate confirms this collaboration. The preprint names Kizzmekia Corbett, Lingshu Wang, Olubukola Abiona, Barney Graham, and John Mascola as co-authors. All of them work at the NIAID, according to the affiliations disclosed in the preprint.
The manuscript reporting the discovery of the LY-CoV555 antibody also names Mark Mulligan, Meike Dittmann, and David Martinez as co-authors, all funded with extramural NIAID grants. These scientists respectively acknowledge NIAID grants AI148574, AI143639 and AI152296 in the preprint. NIAID grant AI148574 to Mulligan started in 2020 to fund the establishment of the New York University Vaccine and Treatment Evaluation Unit (NYU VTEU). The grant has two projects representing $9,666,265 in costs. NIAID grant AI143639 to Dittmann started in 2019, and has three projects with a total cost of $1,033,738. The NIAID grant AI152296 to Martinez started in 2020, and has one project representing $64,926 in cost. Prior to this Martinez had been funded by AI007151, a multi-year grant that named other scientists as principal investigators.
Collaboration between AbCellera and Lilly
Lilly came into the picture recently. On March 12, 2020, Lilly and AbCellera announced a co-development agreement to discover antibodies against SARS-CoV-2. AbCellera brought in their discovery platform funded by DARPA and Lilly their manufacturing capabilities. On June 1, 2020, both companies announced that they had dosed the first patient with LY-CoV555. The press release about the first dosed patient explains that LY-CoV555 had been identified jointly by AbCellera and their partners at the NIAID.
Funding from the Government of Canada
AbCellera has also been supported by the government of Canada. On May 3, 2020, the Minister of Innovation, Science and Industry of Canada announced a contribution of $175.6 million to AbCellera. According to the announcement, this funding was directed to “accelerating and expanding AbCellera’s capabilities to combat COVID-19.” The funding would also “support AbCellera in establishing a Good Manufacturing Practice (GMP) facility in Vancouver, B.C.” That facility “will be the first of this scale in Canada capable of going from a patient sample to manufacturing antibodies for clinical testing.”
Litigation involving patents licensed to AbCellera
Given the typical secrecy rules involving patent prosecution, the patent applications directed to LY-CoV555, if any, will probably be published in 2021. This hinders our understanding of the patent landscape around LY-CoV555, including whether the U.S. government is among the assignees or whether they disclose government funding.
There are, however, at least fifteen published patents relating to the platform AbCellera used to discover LY-CoV555. These fifteen patents are assigned to the University of British Columbia and name AbCellera CEO Carl Hansen as one of the co-inventors. They all have a priority dating back to 2010, before DARPA awarded $30 millions to AbCellera. The University of British Columbia exclusively licensed these patents to AbCellera.
This year those fifteen patents were asserted in three separate infringement complaints filed in the District Court of Delaware against Berkeley Lights, a company that recently went public. Berkeley Lights manufactures an automated system called the Beacon which can be used for antibody discovery, cell line development, synthetic biology, and cell therapy development workflows. According to news reports, several laboratories around the world are using the Beacon to identify potential antibody-based treatments against SARS-CoV-2. AbCellera alleges that the Beacon system infringes their patents.