As per the agreement, GenFleet will carry out the open-label, single-arm, and multicentre study across ten hospitals in China. The trial aims to evaluate the safety and efficacy of the combination therapy in patients with relapsed/refractory DLBCL.
In a landmark development for lung cancer treatment, National Medical Products Administration (NMPA), has accepted the New Drug Application (NDA) for GFH925. This is the first time an NDA for a KRAS G12C inhibitor has been accepted in China. The NMPA has also granted GFH925 a priority review designation. Additionally, GFH925 holds Breakthrough Therapy Designations for advanced NSCLC (non-small cell lung cancer) and colorectal carcinoma patients.
GFH375/VS-7375 is an orally bioavailable, potent and selective small molecule KRAS G12D (ON/OFF) inhibitor. Preclinical models demonstrate strong tumor regression as a single agent and support approaches in combination with Verastem Oncology’s RAF/MEK clamp avutometinib as well as other rational combinations across KRAS G12D-driven cancers. KRAS G12D represents 26% of all KRAS mutations, making it the most prevalent KRAS mutation in human cancer.
GenFleet Therapeutics's GFH312 is a small molecule inhibitor of receptor-interacting serine/threonine protein-1(RIP1) kinase, a key regulator of the TNF- downstream. GenFleet is the first Chinese company that moves RIPK1 inhibitor development into clinical stage.
A Phase Ib/II trial will analyse GFH018 in combination with a PD-1 inhibitor for advanced solid tumour patients. The other study is a Phase II trial of GFH018, a PD-1 inhibitor along with immunochemotherapy and radiotherapy to treat locally advanced and unresectable non-small cell lung cancer (NSCLC) patients.
In retrospect, China’s rise in biopharma may seem inevitable: If nothing else, the sheer size of the population spells a boon for both drug research and sales. But the world didn’t always see it that way.
It's been a big year for the long undruggable target. The first inhibitor — Lumakras sotorasib from Amgen Inc. — reached the market in May under the accelerated approval pathway for non-small cell lung cancer (NSCLC), and Amgen and Mirati both revealed strong proof of concept in colorectal cancer at this month’s European Society for Clinical Oncology (ESMO) Congress.
Shanghai-based GenFleet has been developing GFH925 as a treatment for non-small cell lung cancer and other solid tumors.
