Shanghai-based biotech GenFleet Therapeutics has announced that its investigational drug SLS009 (GFH009) has received fast-track status from the US FDA for the treatment of recurrent/refractory adult peripheral T-cell lymphoma (PTCL) patients. This CDK9 inhibitor was previously awarded an orphan drug designation (ODD) by the FDA in mid-October, highlighting its potential in addressing unmet medical needs.
Clinical Study and Efficacy Data
The Sino-US multi-center Phase I study for GFH009 as a monotherapy in recurrent/refractory hematological tumors has successfully concluded the dosage escalation phase. Clinical data indicates that GFH009 can significantly reduce the expression of proto-oncogenes such as MYC and MCL1 in patients with hematological tumors like PTCL. Notably, clinical efficacy has been observed in 4 PTCL patients (36.4%), including one patient who continued treatment for over 56 weeks and remains under treatment.
Phase Ib/II Study Initiation
A Phase Ib/II study for GFH009 as a monotherapy in recurrent/refractory PTCL patients has been initiated in China, involving nearly 40 centers. This study aims to further evaluate the safety and efficacy of GFH009 in this patient population.
Licensing Deal with SELLAS Life Sciences Group
In April 2022, US-based biopharma Sellas Life Sciences Group Inc., (NASDAQ: SLS) secured all therapeutic and diagnostic usage rights outside the Greater China market for GFH009 through a USD 150 million licensing deal. This agreement underscores the global potential of GFH009 and positions SELLAS to advance its development and commercialization outside of Greater China.-Fineline Info & Tech
