GenFleet Therapeutics Announces GFH009 Granted with FDA Fast Track, Orphan Drug Designations for Treating R/R Peripheral T-cell Lymphomas and Acute Myeloid Leukemia

GenFleet Therapeutics, a clinical-stage biotechnology company developing cutting-edge therapies in oncology and immunology, announced that U.S. Food and Drug Administration (FDA) has recently granted another two designations for SLS009 (GFH009). GFH009 (highly selective CDK9 inhibitor) so far has received both fast track and orphan drug designations from the FDA for the treatment of adult patients with relapsed/refractory (r/r) peripheral T-cell lymphomas (PTCL) and r/r acute myeloid leukemia (AML). At present, two phase II studies are actively underway in China and the US, focusing on the treatment of r/r PTCL and r/r AML respectively. Numerous subjects in GFH009 studies achieved complete or partial responses, and superior safety profile & efficacy of GFH009 was observed in previous studies.

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 China. The study is currently progressing into Phase II, following the completion of safety confirmation in Phase Ib. During the dose escalation portion of Phase I, the data demonstrated significant reduction in expression of proto-oncogenes such as MYC, MCL1 among patients with hematological malignancies including PTCL; clinical responses were observed in four PTCL patients, and one of these PTCL patients has been under continuous treatment for over 66 weeks.

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 50% or more in bone marrow blasts, were observed in a substantial number of subjects.

"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 China; GFH009 received FDA fast track and orphan drug designations for two indications. The forward-thinking strategy in GenFleet's pipeline buildup brings immense challenge as well as opportunities for our innovation. We appreciate recognition of supervisory bodies and collaborative efforts of business partners both in China and the US. As we step into new year, we are looking forward to more registrational advancements of our pipeline." stated by Yu Wang, M.D.,Ph.D., Chief Medical Officer of GenFleet.

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 Greater China (the Chinese mainland, Hong Kong, Macau and Taiwan). 

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