Bristol Myers Squibb Licenses Xencor’s Xtend™ Technology to Extend Half-Life of SARS-CoV-2 Neutralizing Antibody Combination

Compiled and translated by | Fan Dongdong

Recently, Xencor and Bristol-Myers Squibb signed a licensing agreement for the use of Xtend XmAb technology, under which Bristol-Myers Squibb will utilize Xencor's technology to extend the half-life of its SARS-CoV-2 neutralizing monoclonal antibody combination therapy.

Bristol-Myers Squibb's progress in the field of COVID-19 treatment has been relatively slow. Xencor, its partner in this collaboration, is a clinical-stage biopharmaceutical company dedicated to developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases. Upon signing of the agreement, Bristol-Myers Squibb will obtain non-exclusive rights to Xencor’s Xtend Fc technology. The company hopes this technology will extend the half-life of novel SARS-CoV-2 antibody combination therapies intended for the treatment or prevention of COVID-19.

The SARS-CoV-2 mAb Duo was originally discovered by researchers at Rockefeller University, and Bristol-Myers Squibb obtained a license for the therapy in February of this year. Currently, researchers at Rockefeller University Hospital are conducting a Phase 1 clinical trial to evaluate the appropriate dosing and safety profile of this antibody combination. If a low-dose subcutaneous formulation of the two antibodies proves effective, Bristol-Myers Squibb will be able to manufacture large quantities of the therapeutic product at a relatively low cost in a rapid and easy-to-administer format.

Bristol-Myers Squibb plans to rapidly advance into registration trials upon completion of Phase I. As part of the NIH ACTIV-2 trial, Phase 2 and Phase 3 trials will evaluate the therapy in outpatients with COVID-19. If successful, Bristol-Myers Squibb aims to introduce this antibody combination therapy to low- and middle-income countries. To date, the high manufacturing costs of antibodies and the treatment challenges associated with intravenous administration have largely limited the clinical use of existing therapies.

Under the terms of the agreement, Bristol-Myers Squibb will be solely responsible for supporting and advancing the research, development, regulatory filings, and commercialization of the SARS-CoV-2 mAb Duo. Should the therapy be successfully manufactured and marketed in the future, Xencor will be eligible to receive royalties on net sales of products containing these antibodies. The specific financial details of the licensing transaction remain confidential.

Bristol-Myers Squibb's antibody combination therapy lags significantly behind the progress of companies with similar treatments, such as Eli Lilly and Regeneron. Currently, the anti-SARS-CoV-2 antibodies from both companies have received Emergency Use Authorization (EUA) from the FDA. Eli Lilly's bamlanivimab generated $871 million in revenue in the fourth quarter of 2020. However, laboratory testing revealed that bamlanivimab monotherapy does not protect against emerging coronavirus variants as effectively as the bamlanivimab and etesevimab combination therapy, prompting the U.S. government to halt its use in multiple states where variant strains are prevalent.

Consequently, the FDA has revoked the Emergency Use Authorization for bamlanivimab monotherapy. Eli Lilly’s combination therapy, along with Regeneron’s casirivimab and imdevimab combination therapy, have been authorized for the treatment of mild to moderate COVID-19. Despite the first-mover advantage held by Eli Lilly and Regeneron, and the approval of multiple vaccines for COVID-19 prevention, Bristol-Myers Squibb has nevertheless decided to enter the competition.

Reference Source:

1.Bristol Myers taps Xencor's half-life tech for COVID-19 antibody

2.Bristol Myers Squibb : Xencor and Bristol Myers Squibb Enter License Agreement for Use of Xtend™ XmAb® Technology in SARS-CoV-2 Neutralizing Monoclonal Antibody Combination for the Treatment of COVID-19