FDA has Authorized Use of Antibody-Rich COVID-19 Therapy Derived from Convalescent Patients
Under Collaboration BioBridge Global Will Be Using XBiotech's COVID-19 Antibody Test to Identify the Convalescent Blood Products
AUSTIN, Texas, Aug. 24, 2020 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) announced today that the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for COVID-19 Convalescent Plasma (CCP) as a COVID-19 treatment, opening the door for XBiotech's antibody screening technology used to identify CCP. XBiotech collaborated with BioBridge Global to develop a test to accurately detect human antibodies present in patient blood that specifically attack the COVID-19 virus. BioBridge Global, which provides blood products to hospitals through its subsidiary, the South Texas Blood & Tissue Center, is using XBiotech's test to identify human bloods from patients that have recovered from COVID-19—so called convalescent plasma. BioBridge utilizes the convalescent plasma to produce naturally immune blood products as treatment for patients hospitalized with the virus.
While XBiotech's testing technology will be used as the first step in the production of anti-COVID-19 convalescent blood products, XBiotech has also used the convalescent blood samples supplied by BioBridge to identify the precise genetic information present in individuals producing these natural antibodies against COVID-19. The Company recently announced it had in fact successfully discovered candidate True Human therapeutic antibodies based on this effort.
The decision by the FDA to approve use of convalescent plasma (or blood with natural anti-COVD-19 antibodies from patients that recovered from the infection) comes from the Agency's extensive review of scientific data developed over the past several months. These preliminary findings show that convalescent plasma is safe and effective in treating COVID-19, such that a 35% better survival rate has been observed in patients 30 days after receiving plasma treatment. Furthermore, there have been approximately 70,000 patients treated to date with no concerning safety signals.
This data strongly supports XBiotech's approach and technology for identifying therapeutic antibodies—which it does for a variety of diseases—from convalescent blood. By identifying and manufacturing the actual antibodies from convalescent patients, the Company is able to produce candidate drug products with highly concentrated purified antibody. This approach allows the Company to harness the body's immune response to the virus and make targeted therapies that could potentially be safe and effective.