Through a phase I, multicenter, dose-escalation trial (NCT04588922), GFH009 (a highly selective CDK9 inhibitor) monotherapy is well tolerated with preliminary clinical activity in patients with relapsed/ refractory lymphomas. No dose limiting toxicities were observed to date. 4 lymphoma patients with different histology achieved stable disease. One patient with peripheral T cell lymphoma (PTCL) at 9 mg dose level had tumor shrinkage with tumor burden decreased by 62% after 8 weeks of treatment. The study is currently ongoing.
'We are delighted to collaborate with GenFleet in the study of GFH009 as
'GFH009 is GenFleet's first clinical-stage program treating hematologic malignancies and the company's first global multi-center clinical program granted with
First in Human (FIH) Study of GFH009, a Highly Selective Cyclin-Dependent Kinase9 (CDK9) Inhibitor, in Patients with Relapsed/Refractory (r/r) Hematologic Malignancies
ID#: 4263
Session
This is a phase I, multicenter, dose-escalation trial of GFH009 enrolling patients with relapsed/refractory acute myeloid leukemia (AML), chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) and lymphoma. In the first part of the trial, GFH009 was administered intravenously twice per week. The primary objective was to evaluate the safety of GFH009 and dose limiting toxicities (DLTs).
As of
GenFleet and
Preclinical research indicates that GFH009 is a potent and highly selective CDK9 inhibitor with the ability to reduce expression of downstream oncogenes required for rapid cellular division and protein expression through specific, short-lived inhibition of CDK9. This depletion via GFH009 inhibition of CDK9 likely deprives oncogene-addicted cancer cells of crucial survival signals, leading to senescence and death.
About GFH009 & CDK9
As the first highly selective CDK9 inhibitor entering clinical stage in
As a potent and highly selective small molecule CDK9 inhibitor, GFH009 exhibits strong apoptosis-inducing and anti-proliferative activities in multiple human cell lines and animal models of diseases. It effectively inhibits the growth of tumor in various xenograft models and significantly improves survival of tumor bearing animals.
As a family of serine & threonine kinases, cyclin-dependent kinase (CDK) family plays an important role in cell cycle regulation and transcription. CDK9 is one of the most potential targets for cancer therapeutics in the CDK family. Compared with non-selective CDK inhibitors, highly selective CDK9 inhibitors are advantageous in avoiding off-target toxicity against other CDK subtypes and reducing the risk of dose-limiting toxicity. Currently, no highly selective CDK9 inhibitors have been authorized with New Drug Application (NDA) approvals on the global market.
About
About GenFleet Therapeutics
GenFleet Therapeutics, a clinical-stage biotechnology company focusing on cutting-edge therapies, is dedicated to serving significant global unmet medical needs in oncology and immunology. Based on the deep understanding of disease biology and translational medicine, GenFleet's proprietary and fully integrated R&D platform highlights multiple cutting-edge products with novel mechanisms and global IP.
Since its inception in 2017, GenFleet has built up industry-leading capabilities and expertise in developing novel drug candidates - both small molecules and biologics. Its pipeline includes over 10 programs, many of which have entered multi-regional clinical trials across
GenFleet is expected to progress additional programs into the clinic, as well as transition from a clinical stage biotech company into a commercial stage biopharmaceutical company in the next 3-5 years.
Contact:
T: +86-13482182145
E: yzeng@genfleet.com
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