AstraZeneca planlama to start a phase 1 clinical trial of a COVID-19 antibody therapy within two months. The commitment follows the signing of a deal that grants AstraZeneca an exclusive license to six anti-SARS-CoV-2 antibodies identified by researchers at Vanderbilt University.
In April, AstraZeneca outlined a multipronged approach to the discovery of antibodies against the pandemic coronavirus. After receiving the genetic sequences of antibodies identified by Vanderbilt and the Chinese Academy of Sciences, AstraZeneca embarked on a preclinical evaluation that saw it whittle 1,500 prospects down to two molecules that it plans to move into the clinic.
AstraZeneca plans to start testing the two-antibody combination within two months, suggesting an early August start date. The timeline is in keeping with the plans AstraZeneca outlined in April when it set its sights on entering the clinic between July and September.
The two antibodies AstraZeneca plans to test first in humans target different parts of the receptor-binding domain found on the SARS-CoV-2 spike protein. AstraZeneca thinks hitting two targets may increase efficacy and mitigate the risk that the virus will develop resistance against the therapy.
AstraZeneca has entered into an agreement with the Defense Advanced Research Projects Agency (DARPA) to test that hypothesis. DARPA will support the production of antibodies for testing in phase 1 and the trial itself, boosting AstraZeneca’s hopes of being in the clinic within two months.
With Eli Lilly having already initiated dosing in a clinical trial of its AbCellera-partnered antibody, the timeline puts AstraZeneca just behind the front-runners. However, even if more advanced programs generate positive results, the need for an unprecedentedly broad response against a viral pathogen means there could be room for multiple treatments.
AstraZeneca has consistently highlighted the potential for antibodies to prevent infections with the coronavirus, notably in high-risk people who need extra protection to complement a vaccine and individuals who are ineligible for vaccination. Like its peers, AstraZeneca also sees therapeutic uses for its antibodies but it is putting the prophylactic application front and center.
“By combining two monoclonal antibodies that bind to distinct parts of the SARS-CoV-2 spike protein into what potentially could be a single preventative therapy, we hope to improve its effectiveness in neutralizing the virus,” AstraZeneca Executive Vice President Mene Pangalos said in a statement.
AstraZeneca is advancing toward that goal in parallel to other companies. Regeneron is targeting a mid-June start date for a clinical trial of its cocktail of anti-SARS-CoV-2 antibodies, and companies including Amgen and GlaxoSmithKline are also involved in efforts to join Eli Lilly in the clinic.
