GenFleet Starts Phase Ib/II Trial of GFH009 (Highly Selective CDK9 Inhibitor) Treating Patients with Relapsed/Refractory Peripheral T-cell Lymphomas (PTCL)

GenFleet Therapeutics, a leading biotechnology company specializing in cutting-edge therapies for oncology and immunology, has announced a significant milestone in their clinical trials. The company has successfully dosed the first subject in a phase Ib/II trial of GFH009, a highly selective CDK9 inhibitor, for the treatment of relapsed/refractory peripheral T-cell lymphomas (PTCL).

This groundbreaking trial, designed to enroll a total of 95 patients, is being conducted across close to 40 hospitals in China, including renowned institutions such as the Sun Yat-Sen University Cancer Center and the First Affiliated Hospital of Zhengzhou University. The trial is open-label and single-arm, aiming to evaluate the safety and efficacy of GFH009 in PTCL patients.

GenFleet Therapeutics has already completed the dose escalation portion of the phase I trial for GFH009 monotherapy in relapsed/refractory hematological malignancies, both in China and the United States. The preliminary results have shown promising clinical efficacy and a favorable safety profile for GFH009. Notably, complete or partial responses were observed in patients with acute myeloid leukemia and lymphoma, with four PTCL patients showing clinical responses, including one patient who has been continuously treated for over 48 weeks.

PTCL is a challenging form of non-Hodgkin’s lymphoma, accounting for over 20% of new cases in China. Patients with PTCL, particularly those in subtypes other than ALK-positive ALCL, often exhibit chemo-resistance and limited response to standard treatments like autologous stem cell transplants. This trial aims to address the significant unmet medical need in recurrent/refractory PTCL patients and improve prognosis and overall survival rates.

The clinical trials of GFH009 have shown promising results in reducing the expression of proto-oncogenes such as MYC, MCL1, and PCNA in patients with hematological malignancies, including PTCL. These proto-oncogenes are associated with poor prognosis in PTCL patients. By targeting CDK9, GFH009 has demonstrated the potential to combat the disease effectively.

Dr. Yu Wang, Chief Medical Officer of GenFleet, expressed the company’s excitement about GFH009’s potential in treating hematological malignancies. Following the favorable safety profile and preliminary efficacy observed in the phase I trial, GenFleet plans to explore further studies of GFH009 monotherapy and combination therapies for patients worldwide.

GenFleet Therapeutics received IND approval in 2020 for GFH009 monotherapy to proceed into phase I trials for relapsed/refractory hematological malignancies. In 2022, the company entered into an exclusive license agreement with SELLAS Life Sciences Group, further expanding its therapeutic and diagnostic uses.

The development of GFH009 is based on targeting CDK9, a crucial kinase involved in cell cycle regulation and transcription. CDK9 activity has been linked to the overall survival rate of patients with various tumors. The preclinical research and phase I trial of GFH009 have shown promising results, including complete remission in an AML patient lasting over 8 months.

GenFleet Therapeutics is dedicated to addressing significant global unmet medical needs in oncology and immunology. With a robust pipeline of over 10 programs, the company has established itself as a leader in developing novel drug candidates, including small molecules and biologics. GenFleet has completed co-development partnerships with numerous publicly listed companies worldwide, solidifying its position as an industry leader.

With their ongoing clinical trials and plans for future studies, GenFleet Therapeutics is poised to make a significant impact on the treatment of hematological malignancies, including PTCL. Their commitment to innovative therapies and dedication to improving patient outcomes are commendable, and the results of their trials hold great promise for patients worldwide.