Pharma Focus Asia

GenFleet and BeiGene Announce Trial Partnership for Phase Ib/II Study of GFH009 (CDK9 Inhibitor) and BRUKINSA® (Zanubrutinib) Combination Therapy for Diffuse Large B Cell Lymphoma

Friday, March 29, 2024

GenFleet Therapeutics, a pioneering clinical-stage biotech company focusing on innovative therapies in oncology and immunology, has announced a collaboration with BeiGene Switzerland GmbH for a clinical trial and supply agreement. This partnership aims to initiate a phase Ib/II multicenter trial to investigate the combination of GFH009, a CDK9 inhibitor, and BRUKINSA® (zanubrutinib), a BTK inhibitor, in treating diffuse large B-cell lymphoma (DLBCL). The trial, led by renowned institutions such as the Henan Cancer Hospital and Fudan University Shanghai Cancer Center, has already dosed its first patient.

Under this agreement, GenFleet will conduct an open-label, single-arm, and multi-center study across ten hospitals in China to assess the safety and efficacy of the combination therapy among relapsed/refractory DLBCL patients. BeiGene will provide clinical drug supplies of BRUKINSA® for this trial. This marks the first combination trial led by a Chinese biotech, focusing on the combination of a CDK9 inhibitor and BTK inhibitor to target DLBCL.

DLBCL constitutes a significant portion of the approximately 100,000 newly diagnosed non-Hodgkin's lymphoma cases reported annually in China by the National Cancer Center. Despite the global standard of care being R-CHOP, a substantial proportion of DLBCL patients progress into the relapsed/refractory stage, necessitating more effective treatments.

The efficacy of GFH009 in treating peripheral T-cell lymphoma and acute myeloid leukemia has already advanced to phase II trials in China and the U.S., respectively. Encouraging responses, including complete or partial remissions and significant downregulation of anti-apoptotic proteins, have been observed in numerous patients.

Preclinical studies have also demonstrated GFH009's anti-proliferative effects across various tumor cell lines. Treatment with GFH009 led to increased expression of apoptosis markers in a dose-dependent manner. Moreover, combining CDK9 inhibitor treatment with BTK inhibitor showed accelerated induction of key proteins involved in cancer-cell killing mechanisms.

Jiong Lan, Ph.D., Chief Executive Officer of GenFleet, expressed enthusiasm about the collaboration, highlighting the potential of GFH009 and the recognition of GenFleet's research capabilities by BeiGene. GFH009's promising monotherapy trial results, coupled with BRUKINSA®'s global approvals, inspire hopes for innovative therapies in relapsed/refractory DLBCL patients.

GFH009, a CDK9 inhibitor, targets the cyclin-dependent kinase family, crucial for cell cycle regulation and transcription. Its phase I trial data, along with preclinical research, indicate promising clinical activity in relapsed/refractory lymphomas.

BRUKINSA® (zanubrutinib) is a BTK inhibitor designed to provide complete and sustained inhibition of the BTK protein, demonstrating efficacy in inhibiting malignant B cells across disease-relevant tissues with differentiated pharmacokinetics compared to other approved BTK inhibitors.

This collaboration reflects GenFleet's commitment to advancing novel therapeutic options in oncology and immunology, aiming to address unmet medical needs and improve patient outcomes.



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