-Grant of orphan drug designation suggesting the preclinical data were accepted by the FDA and showing the
promise for treating gastric cancer with IMC002
-IND submission by the end of 2022 is on track both in China and US
July 19, 2022, Shanghai and Suzhou, China-Immunofoco, a leading company developing innovative cell therapy drugs, announces that 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.
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.”
About Immunofoco
Immunofoco is a clinical-stage biotech company, devoted to bringing revolutionary immune cell drugs to patients with solid tumors. The operation started in September 2020, with the founding members combined the mavens from the industry, academia, business, and medical professions, and the executive committees had their hands on all the critical activities in advancing the NDA approval of the first CAR-T drug in China.
We draw our attention to the clinical barriers of the solid tumors, and have established our competitive, patented R&D pipelines. To overcome the toxicity risks in solid tumor treatments, we have adopted firstly the strategy of “curing the solid tumors by treating them as hematologic malignancies” and have established the Peri Cruiser® platform to further reduce the potential toxicity risks of CAR-T treatment. Based on that, additional technology platforms been used to further armor the CAR-T or as combination therapy to enhance the efficacy, thus we can achieve the breakthrough of solid tumor treatment.
With the mission of pursuing breakthroughs in solid tumor treatments with immune cell therapies, we are working with internal and external industry talents, to bring survival benefits to patients with solid tumors.
