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M701—EpCAM×CD3

Name: Injectable humanized recombinant anti-EpCAM and anti-CD3 bispecific antibody

Intro: Intro:Using in house IP protected YBODY® format, Our second bispecific antibody under CDE review in China, clinical studies planned to initiate in 2018, target patient population includes EpCAM positive colorectal and ovarian cancer induced ascites

Advantages: extensive preclinical studies have demonstrated high potency, manageable toxicities, long half life, less immunogenecity, robust manufacturing process and high stability

Market potential: Few direct competition in the same drug class. No competition from EpCAM monoclonal antibodies. Supply of first bispecific antibody Removab targeting EpCAM developed by Trion has been halted due to high immunogenecity.

Targeting to EpCAM and CD3

EpCAM( Epithelial Cell Adhesion Molecule )gene loci is at chromosome 2p21, MW 40kD, transmembrane glycoprotein. It functions as cell adhesion molecule. The wide expression in diverse cancer types, including skin, esophageal,gastric, colorectal, prostate, lung, ovarian close to 100%, breast cancer 73%,kidney cancer 51.8%,  liver cancer 14. EpCAM monoclonal antibody has not shown efficacy towards these cancers.

        Leveraging on YZY Biopharm in house proprietary Y-BODY platform, M701 bispecific antibody is designed to bind tumor cells through anti-EpCAM and immune cells through CD3 and FcgR.  Close contact of immune cells and tumor cells induced by M701 can cause effective tumor cell lysis and T cell stimulation.  With Fc builtin, M701 is stable and has long half life. Manufacturing process was developed quickly through established development platform.

M701 cytotoxicity
  • M701 has been shown to have more potent lysis activity towards colorectal, gastric tumor cell lines than monoclonal anti-EpCAM antibody through extensive in vitro and in vivo studies. Survival has been prolonged through NOD-SCID animal models using very low dose.

  • The indications for M701 are ovarian, colorectal,breast and gastric cancers and ascites induced by EpCAM positive tumors.
  • IND was filed in 2016. Phase I is planned for 2018 second half.