-- Proof-of-concept for monoclonal antibody protection against SARS-CoV-2 infection demonstrated in preclinical models including non-human primates --
-- Goal to initiate Phase 1 clinical trial of lead candidate IDB003 in third quarter 2020 --
PALO ALTO, Calif., July 15, 2020 (GLOBE NEWSWIRE) -- IDBiologics, Inc., a private biotechnology company developing human monoclonal antibodies (mAbs) for the treatment and prevention of serious infectious diseases, today announced that the peer-reviewed publication Nature has published results demonstrating the ability of ultra-potent monoclonal antibodies to completely neutralize the SARS-CoV-2 virus. These ultra-potent antibodies neutralize the SARS-CoV-2 virus with similar potencies as monoclonal antibodies already published in peer-reviewed journals. Vanderbilt Vaccine Center (VVC) researchers, including Dr. James Crowe, developed ultra-fast methods for discovering highly-potent antiviral human monoclonal antibodies and validating their ability to protect small animals and non-human primates.
Earlier this year, IDBiologics licensed IDB003, one of the monoclonal antibodies identified in Dr. Crowe’s lab, and is developing it to treat SARS-CoV-2, the virus causing the COVID-19 illness. IDBiologics intends to initiate a Phase 1 clinical trial of IDB003 in the third quarter this year.
“In the race to target and neutralize SARS-CoV-2, we are extremely excited to be heading quickly towards the clinic with a best-in-class and highly-potent human antibody,” said Kenneth Kelley, executive chairman of IDBiologics. “We believe that with VVC’s superior antibody candidates and IDBiologics’ team of experienced antibody developers, IDB003 has the potential to be among the first and best monoclonal antibody medicines for treatment of those stricken with COVID-19 and for prevention among those who cannot be vaccinated.”
Scientists at VVC developed the ability to identify and isolate individual antibody-producing B cells to target specific viral proteins. Dr. Crowe and his collaborators ultimately identified thousands of antibodies that bind to the SARS-CoV-2 Spike protein and block human angiotensin-converting enzyme (hACE2) receptor binding. Since SARS-CoV-2 enters the human body by binding to hACE2, the ability of these antibodies to block hACE2 receptor binding essentially neutralizes the ability of SARS-CoV-2 to infect cells in vitro.
“Our approach to quickly identifying thousands of antibodies from donated blood of recovered COVID-19 patients, and then selecting those that are highly potent in neutralizing the SARS-CoV-2 virus, is remarkable in its speed and scope,” said Dr. James Crowe, founder of IDBiologics. “We believe that the ability of these monoclonal antibodies to neutralize the virus is an early, yet powerful proof-of-concept towards developing a potential therapeutic against SARS-CoV-2.”
IDBiologics plans to file an Investigational New Drug (IND) application to allow human testing to begin in the third quarter of 2020. The Company has partnered with multiple contract manufacturing organizations to provide sufficient supply of clinical material. In addition to developing monoclonal antibodies against SARS-CoV-2, IDBiologics is developing a portfolio of monoclonal antibodies directed at influenza and Zika viruses.
About the Results Published in Nature
The Nature article was published in the on-line first edition today and provides further evidence that a monoclonal antibody has potential as a therapeutic against SARS-CoV-2. From a panel of monoclonal antibodies (mAbs) targeting the Spike (S) glycoprotein isolated from the B cells of recovered COVID-19 patients, the authors identified several monoclonal antibodies that exhibited potent neutralizing activity against the wild type or native SARS-CoV-2 (not a pseudovirus). The most potent monoclonal antibodies fully block the binding of the SARS-CoV-2 Spike (S) protein to the hACE2 receptor. By blocking the binding of SARS-CoV-2 to its receptor, hACE2, these monoclonal antibodies block virus entry into cells. Key highlights from the preclinical research include:
- Complete protection against SARS-CoV-2 infection in rhesus macaques challenged with the live virus
- Binding sites of neutralizing monoclonal antibodies are not sites where variants have been detected; there is no evidence of potential resistance to these monoclonal antibodies
About IDB003
IDB003 was identified in the lab of Dr. James Crowe, a co-founder of IDBiologics and with the Vanderbilt Vaccine Center. IDB003 was selected from a set of ultra-potent monoclonal antibodies as one of the best performers in preclinical studies, and was licensed exclusively to IDBiologics. The Company plans to file an Investigational New Drug (IND) application for IDB003 and initiate a Phase 1 clinical trial in the third quarter of 2020.
About IDBiologics
IDBiologics is a private biotechnology company focused on the development of human monoclonal antibodies for the treatment and prevention of serious infectious diseases. The Company was founded in 2017 and seeded by Vanderbilt University Medical Center (VUMC) in response to the repeated threats of epidemics around the world including Ebola in West Africa and Zika in the Americas, and the successful demonstration of monoclonal antibodies as potential treatments. IDBiologics is developing a portfolio of monoclonal antibodies against SARS-CoV-2, influenza and Zika viruses.
Source: IDBiologics, Inc.