NILK-2301

NILK-2301 is a fully human bispecific antibody designed in the κλ body format, featuring a common heavy chain and two different light chains (one kappa and one lambda). It targets CEACAM5 on tumor cells via its kappa light chain arm and CD3ε on T-cells via its lambda light chain arm. The molecule incorporates the "LALAPA" mutation to abrogate FcγR binding, reducing off-target effects. NILK-2301 acts as a T cell engager by redirecting T cells to eliminate CEACAM5-expressing cancer cells through T-cell activation, proliferation, cytokine release, and cytotoxicity. Preclinical studies demonstrated potent activity against colorectal, gastric, and lung cancer cell lines expressing CEACAM5 with high specificity (no binding to other CEACAM family members or normal colon epithelial cells). In vivo models showed significant tumor growth delay in colon and pancreatic adenocarcinoma. The drug is being developed for solid tumors—especially CEA-positive cancers such as metastatic colorectal cancer—and has entered Phase I clinical trials. Developers report favorable pharmacokinetics (projected human half-life ~13 days) and tolerability in preclinical models[1][3][4][6].

Other names

NILK-2301NILK2301NILK 2301NI-2301NI2301NI 2301