NIAID Continues Funding for Bolder BioTechnology's BBT-059 as Radiation Countermeasure
Key Insights
NIAID (search) has exercised its option to continue funding the preclinical development of BBT-059, an IL-11 analog, as a radiation medical countermeasure.
The contract aims to complete GMP manufacturing and preclinical safety studies to enable an Investigational New Drug Application filing with the FDA.
BBT-059 promotes bone marrow regeneration and accelerates platelet and neutrophil recovery in preclinical models of Acute Radiation Syndrome (search).
Bolder BioTechnology (search), Inc. has announced that the National Institute of Allergy and Infectious Diseases (NIAID (search)), a part of the National Institutes of Health (NIH), has exercised its option to fund the second year of contract NIH-BAA-75N93023C00011, focusing on the advanced development of BBT-059 as a radiation medical countermeasure. The contract supports dosing up to 48 hours post-exposure to radiation.
The primary objectives of this two-year contract include completing Good Manufacturing Practice (GMP) manufacturing, conducting preclinical safety studies, and undertaking other essential activities required to file an Investigational New Drug (IND) Application with the United States Food and Drug Administration (FDA). This filing is a crucial step towards initiating human trials for BBT-059.
The total value of the contract is $3,079,369. The receipt of the full contract award is dependent on the continued achievement of specific technical and business milestones.
Addressing Acute Radiation Syndrome
Acute Radiation Syndrome (search) (ARS) encompasses a range of illnesses that arise following exposure to high doses of ionizing radiation within a condensed timeframe. This type of exposure could occur in scenarios such as accidents at nuclear power plants or the detonation of nuclear weapons.
Bone marrow, responsible for generating new blood cells, is particularly vulnerable to radiation. Individuals acutely exposed to high radiation doses often develop bone marrow aplasia, leading to severe neutropenia (search) (low neutrophil count) and thrombocytopenia (search) (low platelet count) within weeks of exposure. A significant number of these individuals succumb to infections due to neutrophil deficiency or uncontrolled bleeding resulting from platelet deficiency.
BBT-059's Potential
BBT-059 has demonstrated the ability to promote bone marrow regeneration, accelerate the recovery of platelets and neutrophils, and enhance survival rates in preclinical models of ARS. These findings suggest that BBT-059 could be a valuable therapeutic intervention for individuals affected by acute radiation exposure.
Bolder BioTechnology (search) is a clinical-stage biotechnology company specializing in the development of protein therapeutics for human diseases, utilizing advanced protein engineering and bioconjugation technologies to create safer and more effective treatments.