Innovent Receives an Approval from FDA to Initiate Clinical Trials for its Anti-CD47 Monoclonal Antibody IBI-188
Innovent Biologics announced that its IND application for IBI-188, a fully human anti-CD47 monoclonal antibody (mAb) drug candidate, has been approved by the US Food & Drug Administration (FDA) to initiate clinical trials for patients with advanced malignancies and lymphomas.
IBI-188 is the second Innovent molecule to be approved for clinical trials by the FDA. In January, 2018 the FDA IND for IBI308 (Sintilimab, an anti-PD-1 antibody) was also approved. Innovent is the first Chinese biopharmaceutical company to receive clinical trial approval for a CD47 monoclonal antibody from the FDA.
As one of the key targets in the field of anti-tumor immunotherapy, CD47 monoclonal antibody has become a highly researched therapeutic target across the world. Currently, a few CD47 advanced programs are in phase I and II clinical stage outside China. This IND approval demonstrates the significant progress Innovent has made to bring cancer treatments to global markets.
“Innovent, a China based company, was established with an ambition to serve global patient needs. We have been exploring the most advanced research areas and adhere to international innovative R&D and production standards. The FDA IND approval of anti-CD47 monoclonal antibody is an affirmation of our efforts and allow us to further advance Innovent’s innovative programs. We hope that through our efforts, China’s “smart” biologics will play a role on the international stage,” said Michael Yu, Founder, Chief Executive Officer and Chairman.