Market News
Global Anti-Radiation Drugs Market- Recent Developments
Clinical Developments
- On September 06, 2023, Humanetics Corporation, a clinical-stage specialty pharmaceutical company, announced that the company was awarded with a 5-year contract from the Department of Defense (DOD) to develop its drug, BIO 300, as a medical countermeasure to prevent bodily harm caused by acute exposure to radiation. The contract is in the form of an Other Transaction Authority (OTA) for Prototype Agreement. It includes a base period of US$ 20 million for activities required to gain U.S. Food and Drug Administration (FDA) Emergency Use Authorization for the use of BIO 300 under a potential military emergency. The OTA agreement provides options for the DOD to fund all activities required to bring BIO 300 to full FDA approval.
- On February 15, 2023, RedHill Biopharma Ltd., a specialty biopharmaceutical company, announced the positive outcome of a scheduled Type B meeting with the U.S. Food and Drug Administration (FDA) for the development of opaganib for Acute Radiation Syndrome (ARS) in which the FDA provided guidance on opaganib's developmental pathway to potential approval under the Animal Rule
- In March 2022, Tanner Pharma Group, an international distributor of essential medicines, announced that it had significantly increased its inventory of Leukine (sargramostim, yeast-derived rhuGM-CSF) to be held in Europe. This action is being taken in partnership with Leukine’s owner, Partner Therapeutics (PTx), in response to the ongoing war in Ukraine and escalating potential for incidents that could require rapid deployment of medical interventions to treat radiation or chemical exposure.
- In February 2022, Partner Therapeutics, Inc. (PTx), a commercial biotech company, announced the publication of two pivotal studies that provided the basis for approval of Leukine (sargramostim, yeast-derived rhu GM-CSF) to improve survival in patients exposed to myelosuppressive doses of radiation (Hematopoietic syndrome of acute radiation syndrome H-ARS). The first study, “Sargramostim (rhu GM-CSF) Improves Survival of Non-Human Primates with Severe Bone Marrow Suppression after Acute, High-Dose, Whole-Body Irradiation” (Clayton, et al.) was published in Radiation Research. The second study, “Efficacy of Delayed Administration of sargramostim up to 120 hours Post Exposure in a Nonhuman Primate Total Body Radiation Model” (Zhong, et al.), was published in International Journal of Radiation Biology.
Acquisition, Partnerships, and Funding
- On September 12, 2023, University of Nebraska–Lincoln, National Strategic Research Institute and the University of Nebraska Medical Center, had received a US$ 24.5 million award from the Defense Health Agency to advance development of an acute radiation syndrome prophylactic. The University of Nebraska research team will develop a first-of-its-kind treatment aimed at protecting U.S. troops from the effects of acute radiation syndrome.
- On July 11, 2023, Pluri, a Israeli company engaged in the development of human placental adherent stromal cells for commercial use in disease treatment, signed a three-year US$ 4.2m contract with the U.S. National Institute of Allergy and Infectious Diseases (NIAID) and the US Department of Defense (DoD) to develop its cell therapy avoplacel (PLX-R18) to treat haematopoietic acute radiation syndrome or radiation poisoning.
- In November 2022, Researchers with The Ohio State University Comprehensive Cancer Center –Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James) had entered a federal cooperative agreement, valued up to US$ 9.42 million, that will help to further develop Ohio State’s biodosimetry technology to discover noninvasive biomarkers for radiation exposure – work that will have national security applications