Pharma Focus Asia

GenFleet Therapeutics' GFH009 Granted FDA Fast Track and Orphan Drug Designations for Lymphomas and Leukemia

Friday, January 12, 2024

GenFleet Therapeutics, a biotechnology company focused on developing advanced therapies in oncology and immunology, recently announced that the U.S. Food and Drug Administration (FDA) has granted two additional designations for SLS009 (GFH009). GFH009, a highly selective CDK9 inhibitor, has received fast track and orphan drug designations from the FDA for treating adult patients with relapsed/refractory (r/r) peripheral T-cell lymphomas (PTCL) and r/r acute myeloid leukemia (AML). Currently, two phase II studies are actively underway in China and the U.S., focusing on r/r PTCL and r/r AML, respectively. Previous studies have shown positive results, with numerous subjects achieving complete or partial responses and demonstrating a superior safety profile and efficacy of GFH009.

GenFleet is conducting a multi-center, open-label, single-arm study of GFH009 for the treatment of r/r PTCL at close to 40 sites in China. The study is progressing into Phase II after completing safety confirmation in Phase Ib. During the dose escalation in Phase I, significant reductions in the expression of proto-oncogenes such as MYC and MCL1 were observed in patients with hematological malignancies, including PTCL. Four PTCL patients exhibited clinical responses, and one patient has been continuously treated for over 66 weeks.

GenFleet's partner, Sellas Life Sciences, is currently conducting a Phase II trial in the U.S. for SLS009 (GFH009) in combination with venetoclax and azacitidine for treating r/r AML patients. The first patient enrolled at the safety dose level achieved a complete response, with no observed dose-limiting toxicities. A substantial number of subjects demonstrated significant anti-leukemic effects, marked by a notable decrease in bone marrow blasts.

Dr. Yu Wang, Chief Medical Officer of GenFleet, expressed appreciation for the progress made in the past year. GFH925 received NDA acceptance, priority review, and two breakthrough therapy designations in China, while GFH009 received FDA fast track and orphan drug designations for two indications. Dr. Wang emphasized the challenges and opportunities in their forward-thinking strategy and anticipated more advancements in their pipeline in the coming year.

The FDA's Fast Track Designation expedites the review of drugs for serious conditions with unmet medical needs. Drugs with this designation are eligible for more frequent interactions with the FDA, facilitating Accelerated Approval and Priority Review. Orphan Drug Designation provides benefits such as assistance in drug development, tax credits for clinical costs, exemptions from certain FDA fees, and seven years of marketing exclusivity.

GFH009, a CDK9 inhibitor, has demonstrated promising results in preclinical research and phase I trials, showing well-tolerated monotherapy with clinical activity in patients with relapsed/refractory lymphomas. With over 100 times selectivity over other CDK subtypes, GFH009's inhibition of CDK9 reduces the expression of downstream oncogenes, hindering rapid cellular division and protein expression. This specific inhibition likely deprives cancer cells of crucial survival signals, leading to senescence and death. GenFleet received IND approval in 2020 for GFH009 monotherapy, and in 2022, an exclusive license agreement was established with SELLAS Life Sciences Group for all therapeutic and diagnostic uses worldwide outside of Greater China.



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