The trial will be conducted in patients with peripheral artery disease and with intermittent claudication at 15 research centers, including University of Colorado Anschutz Medical Campus.
One study is a phase Ib/II trial of GFH018 with PD-1 inhibitor treating patients with advanced solid tumors; the other study is a phase II trial of GFH018, PD-1 inhibitor with concurrent chemoradiotherapy treating patients with locally advanced & unresectable NSCLC. GenFleet has completed a phase I trial of GFH018 monotherapy treating solid tumors in early 2022, and the data will soon be published in relevant international medical conference.
The clinical data of GFH925 dose escalation part of the phase I trial (NCT05005234), currently conducted by Innovent, will be released as a poster at ASCO held from June 3-7th.
We are pleased that GFH009, one of the leading assets in our first-in-class portfolio, will now be developed and commercialized on a worldwide basis
Bringing in over two decades of experiences in the pharmaceutical industry, Dr. Li was involved in numerous programs of approved drugs and diagnostics. His expertise ranges from process development, quality control validation, scale-up manufacturing to other core technologies related with the upstream & downstream sectors of the industry and led various teams to develop preclinical and clinical batches of different monoclonal antibodies, therapeutic vaccines and recombinant protein products.
This round of financing is led by Huagai Capital, with participation by new investors including Suxin Venture Capital, Cherami Investment Group, ABC International, DYEE Capital, Qiaojing Eastern Investment, Baidu Venture, and Wenzhou Capital. Existing investors including CDH Venture and Growth Capital, Lake Bleu Capital, HM Capita, Panlin Capital, Shanjin Asset also participated. Start Point Advisors act as the sole financial advisor.
This multi-center trial the first POC (proof of concept) study designed by GenFleet and it's also the company's third program involving global research sites. GFH018 demonstrated excellent safety profile in phase I trial. Preclinical data also suggested antitumor effects of low-dose GFH018 in combination with PD-1 inhibitors.
Designed to enroll over 100 patients with late stage NSCLC and gastrointestinal cancer, the study will evaluate the safety/tolerability/efficacy and characterize the pharmacokinetics profile of GFH925
