On July 19, 2022, Shanghai and Suzhou, China-Immunofoco, a leading company developing innovative cell therapy drugs, reported the innovative CAR-T candidate, IMC002, an autologous Claudin 18.2 specific cell therapy has been granted orphan drug designation (ODD) by the U.S. Food and Drug Administration (FDA), for the indication of gastric cancer (Press release, Immunofoco, JUL 19, 2022, View Source;c=show&id=27 [SID1234628620]).

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ODD is granted to drugs intended to treat rare diseases with a patient population less than 200,000 in the United States. Orphan drug designation qualifies sponsors for incentives such as tax credits for qualified clinical trials, exemption from user fees, and potential 7-years market exclusivity after approval.

IMC002 is an autologous CAR-T cell therapy based on an anti-claudin 18.2 VHH antibody with high specificity, with no cross-reactivity to Claudin 18.1. Preclinical data have shown that IMC002 is safe and efficacious, with superior safety profiles compared to product candidate of the same kind, indicating a higher dosage window in clinic setting.

"We are encouraged by the grant of ODD designation, which means the preclinical data were accepted bythe FDA and our data demonstrate the promise of treating gastric cancer with IMC002", said Crystal Sun, founder and CEO of Immunofoco, "we are going to submit IND applications both in China and U.S. and will move forward the clinical development as quickly as we can, thus the patients could benefit from this innovative therapy as early as possible."