BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a China-based biotechnology company, has entered into a clinical research and drug supply cooperation agreement with fellow Chinese firm GenFleet Therapeutics. The partnership will kick off a Phase Ib/II clinical trial to evaluate the safety and efficacy of a combination regimen featuring BeiGene’s Bruton’s tyrosine kinase (BTK) inhibitor, Brukinsa (zanubrutinib), alongside GenFleet’s CDK9 inhibitor, GFH009, in patients with diffuse large B-cell lymphoma (DLBCL). The open-label, single-arm study has already enrolled its first patient.
Preclinical and Phase I data indicate that GFH009, by specifically targeting CDK9 protein, can effectively reduce downstream oncogene expression, inhibit the rapid division and protein synthesis of cancer cells, and significantly curtail the proliferation of various blood cancer cell lines. The drug has received fast-track status and orphan drug designation (ODD) in the U.S. for the treatment of peripheral T-cell lymphoma and acute myeloid leukemia, respectively. Notably, U.S.-based Sellas (NASDAQ: SLS) secured a USD 150 million licensing agreement with GenFleet in April 2022, acquiring global development and commercialization rights for GFH009 outside of Greater China.
Brukinsa, for its part, has garnered regulatory approval for multiple indications across 70 markets worldwide, including the U.S., China, the EU, the UK, Canada, South Korea, and Switzerland.- Flcube.com
