NYU Grossman School of Medicine recently began treating patients in a clinical trial to determine whether an antibody therapy known as LY-CoV555 can safely reduce COVID-19 severity. Sponsored by Eli Lilly and Company, this experimental treatment consists of identical copies of an antibody, a blood protein related to those that occur naturally as part of the human immune system. Designed first and foremost to assess the safety and determine if the novel treatment produces any side effects in patients hospitalized due to SARS-CoV-2, LY-CoV555 was developed with a powerful proprietary drug discovery technology used to analyze antibodies that recovered from COVID-19. Eli Lilly employed AbCellera’s platform, originating out of the University of British Columbia, to find antibodies that most tightly attached to the virus in places known to block its ability to infect human cells (neutralizing antibodies).
Beyond emergency and supportive care, there are no FDA-licensed treatment options for COVID-19. Although several organizations race for a vaccine, there are no guarantees one will work. Hence research centers are actively assessing various investigational treatments in a quest to improve care for COVID-19 patients. Mark J. Mulligan, MD, director of the Division of Infectious Diseases and Immunology and director of the Vaccine Center at NYU Langone Health, commented: “We are committed to working with our industry partners to generate scientific evidence from randomized controlled trials to meet the urgent need for treatments that reduce the severity of COVID-19 disease.”
The foundation for this powerful new antibody arose from the intellectual property out of the University of British Columbia (UBC). A UBC research team developed a new method to search immune responses more deeply than any other technology. By leveraging microfluidic technology developed out of UBC’s Michael Smith Laboratories, AbCellera was a university spinoff also leveraging advanced immunology, protein chemistry, performance computing, and machine learning in a bid to change the game for antibody therapeutics. This group is destined, TrialSite News suspects, for big things as they went on to start collaborating with the US Department of Defense via the DARPA program in 2018.
Due to their advancements in rapid, high-throughput therapeutic antibody discovery technology, DARPA invited the upstart to lead a team of partners to establish a robust technology platform for pandemic response capable of developing field ready medical countermeasures within 60 days of isolation of an unknown viral pathogen. The team participated along with the Vaccine Research Center at the National Institute for Allergy and Infectious Diseases (NIAID).
By January 28, 2020, AbCellera mobilized a pandemic response platform against the outbreak of the novel coronavirus (SARS-CoV-2) originating in Wuhan China in the ongoing collaboration with DARPA and NIAID. It was this combination that led to the basis for the eventual Lilly investigational product.
Lilly Inks Deal with AbCellera
As AbCellera made progress under the government-funded DARPA contract, Lilly intelligently inked a co-development agreement by mid-March 2020 with AbCellera based on 500+ unique antibodies isolated from one of the first US patients who recovered from COVID-19 to create antibody therapeutics for treatment and prevention of COVID-19.
Lilly Scientists Crank
Lilly scientists, operating under pandemic conditions, got right down to business leveraging the AbCellera platform produced targets. They rapidly developed the antibody in just three months after AbCellera and the Vaccine Research Center at the NIAID identified it from the sample from one of those very first COVID-19 patients. Born was the first investigational new medicine specifically designed to attack SARS-CoV-2.
LY-CoV555 was selected for this clinical trial as it was designed to interact with the “spike proteins” used by SARS-CoV-2, the virus behind the COVID-19 disease, to attach to human cell surfaces: the first step in invading cells. As viruses such as COVID-19 must enter cells to multiply, this novel treatment hopefully prevents such entry and, rather, neutralizes the virus. Commenting on this investigational product, Dr. Mulligan commented, “Antibody treatments like the one being studied here hold promise to be effective medical countermeasures against this deadly infection.”
Sponsored by Eli Lilly, the randomized, blinded, placebo-controlled, first-in-human study seeks to test the safety and tolerability of a single, intravenous dose of LY-CoV555 to hospitalized participants. The participating investigators will study how long the drug candidate lasts in the body. Those patients that are 18 to 75 that have a moderate to severe COVID-19 illness—based on National Institutes of Health (NIH) definitions—can participate in the clinical trial. Several exclusionary factors include need of intubation, pregnancy, or serious fungal infections.
In a two-stage study, the investigators dose two patients with the lowest dose of LY-CoV555 or placebo. If the drug is safe in that pair after 24 hours, six additional patients are treated. If the lowest dose level in those eight patients is well tolerated and safe, a group of eight additional patients would be randomized to receive a slightly higher dose or placebo, with the process repeating for a potential total of up to 32 patients over 29 days.
Assuming the treatment is safe at each incoming dose, Lilly plans to pivot the start of a Phase II trial, pending regulatory approval, with the possibility of investigating LY-CoV555 safety in a larger group of patients, including those that haven’t been hospitalized (e.g., milder SARS-CoV-2 cases).
Elite Research Centers
In addition to NYU Langone, Eli Lilly selected Cedars-Sinai Medical Center (Los Angeles) and Emory University (Atlanta)—elite centers known for their clinical trial expertise and capacity to rapidly initiate crucial studies. Commenting on these centers, Lilly Chief Scientific Officer and President of Lilly Research Laboratories, Daniel Skovronsky, MD, PhD, noted, “We’re pleased to partner with NYU Langone and other expert centers around the country on this study and are hopeful we can make a meaningful difference in the fight against COVID-19.
About AbCellera: Destined for Fortune?
Based in Vancouver, Canada privately held AbCellera innovates in the field of antibody discovery for therapeutics as well as immune profiling for vaccine research. By working in partnership with academia, non-profits, and industry, they work to enable and accelerate the development of new antibody therapies and new vaccines.
The UBC Spinoff
Set on a bluff over the Strait Of Georgia (an arm of the Pacific Ocean)—a place blessed with spectacular scenery and a world-class array of students and faculty—UBC is the kind of place one wouldn’t want to leave. That magical spot is where an impressive trio came together—leveraging deep, specialized, and extensive scientific expertise in highly relevant fields—to form a spinoff; one that appears to be destined for great Fortune.
One of the founding trio is the company’s CEO, Carl Hansen. Prior to spinning off AbCellera, Hansen was a professor and researcher at UBC. He was not ordinary, co-authoring over 65 manuscripts in the fields of microfluidics, immunology, genomics, and nanotechnology. Driven and holistically intelligent, he possesses an exceptional knack to identify early-stage intellectual property potential—Hansen has secured over 50 US patents as well as 63 US patent applications that are represented in 7 commercial products. Truly an impressive track record. But Mr. Hansen keeps good company. Chief Operating Officer and co-founder Ms. Veronique Lecault was a co-inventor of the high-throughput microfluidic platform, now a core to the future of AbCellera. Co-founder Kevin Heyries serves as Head of Business Development and was also at the University of British Columbia conducting post-doctoral research into high-sensitivity microfluidic digital PCR for genetic testing devices that ultimately became the basis for a commercial product. He earned his PhD from the University of Lyon.
The company’s core intellectual property (IP) centers on a single-cell platform that integrates end-to-end capabilities for therapeutic antibody discovery through a combination of technologies, such as proprietary immunizations, microfluidics, high-throughput imaging, genomics, computation, and laboratory automation. By executing ultra-deep screening of single B cells, AbCellera has unprecedented access to natural immune responses and affords the Vancouver-based venture to rapidly isolate large and diverse panels of high-quality lead antibodies from any species, including human. The company’s scientists leverage the platform for speed, screening depth, and greater specificity, helping them to perform discovery against difficult subjects such as membrane proteins, GPCRs, and ion channels. Lilly has leveraged the output of this platform for the development of LY-CoV555—it will now be put to the test at NYU Langone.
Business & Finance
AbCellera raised its first $10 million A round in 2018. It secures a whopping $105 million B round recently led by OrbiMed and current investor DCVC Bio, Founders Fund, Eli Lilly and Company, University of Minnesota, and Presight Capital. The use of funds include the expansion of capacity as well as new investments that complement and extend their proprietary antibody discovery engine.