Accelerating the development of new formulations
for hematological diseases designed to:
GreenJay Therapeutics, Inc. (GreenJay) is a late-stage pharmaceutical company based in Houston, Texas, focused on reformulation of drugs to improve clinical outcomes. The Company has developed a new intravenous (IV) formulation of busulfan which we believe will reduce toxicity risks to the patient. Busulfan currently is used as a pretreatment related to stem cell transplantation. Current IV formulations of busulfan on the market contain a “Class 2” solvent, for which the FDA recommends strict dose limits due to the severe chemical effects. The current drug busulfan contains this solvent at levels that substantially exceed (by approximately 1000x) the recommended permissible daily exposure (“PDE”), exposing patients to severe effects.
Our new formulation, Bulanta ™, removes this solvent, which we believe will reduce the toxicity of therapy without reducing efficacy. Regulatory approval of this new formulation is being pursued through the NDA 505(b)(2) regulatory pathway.
The current product on the market, IV busulfan, is marketed as a conditioning agent for Chronic Myelogenous Leukemia (CML) in the USA, European Union and Japan. Additionally, the current product is being used “off label” in a variety of other cancers requiring stem cell transplants.
According to the National Cancer Institute (“NCI”) there were an estimated 8.930 new cases and 1,319 deaths from CML in the United States in 2023. Only a fraction of these cases received stem cell transplants and were treated with IV busulfan. However, based on available manufacturing data, we are aware that there is substantial off-label use in other cancer indications. We intend to investigate these indications after receiving regulatory approval in CML.
We believe that the removal of the Class 2 solvent from the excipients to create our new product, Bulanta TM , will improve therapies, supplant existing use of busulfan, and expand use in CML and, ultimately, other indications. GreenJay will first seek FDA registration of its new product, Bulanta TM , for use in CML, through the 505(b)(2) regulatory pathway in the USA. We will also explore the requirements to obtain regulatory approval in the European Union and Japan either directly or through a commercial partner.
After regulatory approval, GreenJay intends to investigate the use of Bulanta in other cancers, including acute myelogenous leukemia (“AML”) and other cancer types.
GreenJay was founded in 2022 by three entrepreneurs who currently serve as members of its Board of Directors. The Company operates virtually and engages highly skilled experts to assist with regulatory, manufacturing and preclinical activities.
GreenJay Therapeutics Successfully Completes More than $1 Million in its Seed Round of Financing