CANbridge Life Sciences to be­gin CAN017 Ib/III Trial in China

BioSpectrum (Asia) - - REGULATORY NEWS -

CANbridge Life Sciences, a bio­phar­ma­ceu­ti­cal com­pany de­vel­op­ing west­ern drug can­di­dates in China and North Asia, has an­nounced that the China Na­tional Drug Ad­min­is­tra­tion (CNDA) has ap­proved the In­ves­ti­ga­tional New Drug (IND) ap­pli­ca­tion for a Phase Ib/III clin­i­cal study of CAN017 in esophageal squa­mous cell can­cer (ESCC).

The Phase Ib/ex­ten­sion study is a mul­ti­cen­tre, open la­bel study to eval­u­ate the safety, tol­er­a­bil­ity, phar­ma­coki­net­ics and pre­lim­i­nary ef­fi­cacy of CAN017 in com­bi­na­tion with chemo­ther­apy as the se­cond line treat­ment for pa­tients with lo­cally ad­vanced or metastatic esophageal squa­mous cell car­ci­noma (ESCC). ESCC is the most preva­lent form of esophageal can­cer, with 50 per cent of the cases oc­cur­ring in China.

The CAN017 IND ap­proval is a key mile­stone for CANbridge and the se­cond one this year, fol­low­ing the IND ap­proval to com­mence a trial in CAN008 in glioblas­toma mul­ti­forme (GBM) in April. CAN017 is an ErbB3 (HER3) in­hibitory an­ti­body hu­man­ized IgG1/κ ERBB3 in­hibitory an­ti­body that com­pleted a first-in-hu­man Phase I clin­i­cal trial in pa­tients with ad­vanced solid tu­mors in US pa­tients.

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