GenFleet Therapeutics Announces GFH009 Granted with FDA Fast Track, Orphan Drug Designations for Treating R/R Peripheral T-cell Lymphomas and Acute Myeloid Leukemia
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The FDA's decision to grant both fast track and orphan drug designations to GFH009 for the treatment of r/r PTCL and r/r AML is a significant milestone for GenFleet Therapeutics. These designations are pivotal in the oncology field as they expedite the review process and provide potential market exclusivity, which can be crucial for the success of new therapies targeting rare and serious conditions. The observed clinical responses and safety profile in the early trials of GFH009 suggest a promising therapeutic potential for patients with limited treatment options. The continuous treatment of a PTCL patient for over 66 weeks is particularly noteworthy, indicating sustained response and tolerability.
From a research perspective, the progression of GFH009 into Phase II studies in both China and the US highlights its potential efficacy in treating hematological malignancies. The significant reduction in the expression of proto-oncogenes like MYC and MCL1 during Phase I trials indicates a strong biological rationale for its mechanism of action as a CDK9 inhibitor. Moreover, the combination trial of GFH009 with venetoclax and azacitidine in the US for r/r AML patients is an innovative approach, potentially addressing the complexity of AML treatment by targeting multiple pathways. The complete response in the first patient enrolled at the safety dose level without dose-limiting toxicities is an encouraging sign for the ongoing trials.
For investors and stakeholders, the FDA's designations for GFH009 could be a harbinger of GenFleet's growth potential in the oncology market. The designations not only enhance the company's reputation but also improve the drug's chances of a successful market entry. Given the global prevalence of PTCL and AML, which remain areas with high unmet medical needs, a successful entry of GFH009 into the market could lead to substantial revenue generation. Furthermore, GenFleet's pipeline advancements, including GFH925's NDA acceptance and priority review in China, underscore the company's strategic focus on innovation and may attract further investments and partnerships.
GenFleet is conducting a multi-center, open-label, single-arm study of GFH009 for the treatment of r/r PTCL in close to 40 sites in
GenFleet's partner Sellas Life Sciences is currently undertaking a Phase II trial in the US for SLS009 (GFH009) in combination with venetoclax and azacitidine for treating r/r AML patients. The first patient enrolled at the safety dose level has achieved complete response. No dose-limiting toxicities were observed; significant anti-leukemic effects, marked by a decrease of
"Leading projects in GenFleet's pipeline made significant strides in registrational efforts over the past year. GFH925 was granted with NDA acceptance, priority review and two breakthrough therapy designations in
Fast Track Designation is a process designed by the FDA to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Programs with FTD are eligible for more frequent interactions with FDA to discuss the candidate's development plan, as well as a rolling review of NDA or BLA to facilitate Accelerated Approval and Priority Review if relevant criteria are met. Besides, the benefits provided by ODD include assistance in the drug development process, tax credits for qualified clinical costs, exemptions from certain FDA fees and seven years of marketing exclusivity.
About CDK9 and GFH009
As a family of serine & threonine kinases, the cyclin-dependent kinase (CDK) family plays an important role in cell cycle regulation and transcription; CDK9 activity is inversely correlated with the overall survival rate of patients with multiple tumors. Data from phase I trial and the preclinical research of GFH009 were posted at the 2002 Annual Meeting of the American Society of Hematology. GFH009 monotherapy is well tolerated with preliminary clinical activity in patients with relapsed/ refractory lymphomas.
According to preclinical research, GFH009 reduces the expression of downstream oncogenes required for rapid cellular division and protein expression through specific, short-lived inhibition of CDK9. With more than 100 times selectivity over other CDK subtypes, this depletion via GFH009 inhibition of CDK9 likely deprives oncogene-addicted cancer cells of crucial survival signals, leading to senescence and death. GFH009 also exhibits strong anti-proliferative activities in multiple human cell lines, effectively inhibits the growth of tumor in various xenograft models and significantly improves survival of tumor bearing animals.
GenFleet received IND approval in 2020 for the GFH009 monotherapy to proceed into phase I trial treating patients with r/r hematological malignancies. In 2022, GenFleet and SELLAS Life Sciences Group (Nasdaq: SLS) entered into an exclusive license agreement across all therapeutic and diagnostic uses worldwide outside of
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