On February 22, 2023 Fapon Biopharma, an innovative biotech company, reported that its Investigational New Drug (IND) application of FP002, an anti-CD47 monoclonal antibody drug candidate, has been approved by FDA for clinical trials (Press release, Fapon Biopharma, FEB 22, 2023, View Source [SID1234634116]).
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FP002 is a humanized anti-CD47 IgG4 monoclonal antibody, developed and patented by Fapon Biopharma. It binds strongly to the CD47 protein on the surface of tumor cells, and weakly to human red blood cells. This novel antibody does not cause hemagglutination. It has proven to be safe, and in comparison with similar products, have shown better efficacy in multiple tumor models in preclinical research. In demonstrating stronger anti-tumor efficacy and higher reliability, FP002 shows great potential in becoming the best-in-class drug worldwide.
Under this IND, the Company intends to initiate a single-armed, dose escalation and dose expansion study to investigate the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) activity of FP002 in subjects with advanced malignancies. Apart from the FDA submission, it has also been submitted for IND application in China.
"The FDA approval to commence our clinical trial for FP002 is a significant milestone for Fapon Biopharma," said Vincent Huo, President of Fapon Biopharma. "This is our first project that includes IND application in both China and the US. With our cutting-edge technology platform and a competitive pipeline, we are committed to enabling more reliable and affordable biologics for patients all over the world."