Contract to support manufacturing and a Phase 1 clinical trial
ROCKVILLE, Md., May 18, 2021 — Integrated BioTherapeutics Inc. (IBT), a Maryland biotechnology company specializing in emerging infectious diseases, announced today the receipt of a contract valued at up to $16.3 million from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to develop IBT-T03H, a monoclonal antibody for treatment of Marburg virus disease (MVD). MVD is caused by either of two marburgviruses, Marburg virus and Ravn virus, and has reemerged several times since it was initially described in 1967. IBT-T03H, discovered in collaboration with the University of Maryland, has been shown in preclinical studies to be protective against both Marburg and Ravn virus.
The contract, including all options, supports formulation development, process development, preclinical safety studies, manufacturing, and a first-in-human dose ranging study of IBT-T03H in a Phase 1 clinical trial. This award supports NIAID’s mission to develop medical countermeasures against emerging infectious diseases and high priority biological threat agents.
Marburg and Ravn viruses are closely related to Ebola virus, and similarly cause a potentially fatal viral hemorrhagic fever. An outbreak of MVD caused by Marburg virus occurred as recently as 2017, and the largest outbreak occurred in 2005 in Uganda, in which a 90% case fatality rate was observed. The related Ravn virus also caused outbreaks in 1987, 1998-2000, and 2007 with case fatality rates reaching 83%. Ravn virus has sometimes co-circulated with Marburg virus during outbreaks. There are no approved therapeutics for the treatment of MVD.
“The experience of the 2014-2017 Ebola virus disease outbreak and current COVID-19 pandemic are reminders of the importance of investing in countermeasures for potential future epidemics,” said Dr. M. Javad Aman, President and Chief Scientific Officer of IBT. “The timely award of this contract is a crucial step toward preparedness against future outbreaks of MVD with potentially disastrous consequences for Africa and the world.”
“IBT has an outstanding product candidate which has shown efficacy in animal models of MVD and is positioned well for entry into the clinical phase of testing,” said Dr. Gary S. Nabors, Executive Vice President and Chief Development Officer.
Prior studies that led to the discovery and development of IBT-T03H were supported by grants R41-AI47929 and R01-AI126587 from NIAID.
About Integrated BioTherapeutics:
IBT develops vaccines and immunotherapies for bacterial and viral infectious diseases. The Company’s lead vaccine product, IBT-V02 is a first-in-class multi-component vaccine against Staphylococcus aureus. Supported by CARB-X and by Novo Holdings’ Repair Impact Fund, IBT-V02 is currently undergoing cGMP manufacturing and IND-enabling studies, with initiation of clinical trials anticipated in late 2021. IBT’s immunotherapeutic pipeline includes monoclonal antibodies for the treatment of the array of viruses that cause hemorrhagic fever. IBT is also developing product candidates for the treatment of S. aureus, anthrax, and Clostridium difficile, based on its proprietary Infection Site Targeted Antitoxin Antibody (ISTAb) technology. Learn more about IBT’s pipeline at https://www.integratedbiotherapeutics.com.
IBT Bioservices, the contract research division of IBT, offers in vitro assays and animal models to enable lead-to-candidate selection and eventual progression to IND and clinical development. Learn more about IBT Bioservices at http://www.ibtbioservices.com or email us at firstname.lastname@example.org.
CONTACT: Integrated BioTherapeutics Inc.
Gary S. Nabors, Ph.D.
EVP and Chief Development Officer
Phone (240) 539-3060
Source: Integrated BioTherapeutics Inc.