KY-0301 / Novatim Immune Therap - LARVOL DELTA

A First-in-human Study of KY-0301 in Patients With Advanced Solid Tumors. (clinicaltrials.gov) - P1/2 | N=212 | Not yet recruiting | Sponsor: Novatim Immune Therapeutics (Zhejiang) Co., Ltd.

Monotherapy • New P1/2 trial • Non Small Cell Lung Cancer • Oncology • Solid Tumor

The world’s first nano bispecific ADC—KY-0301—has been approved by the FDA for clinical trials [Google translation] (bydrug.pharmcube.com) - "On December 5, 2024, Keyi (Zhejiang) Pharmaceutical Technology Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) officially approved the clinical trial application (IND) for KY-0301, the world's first nano bispecific antibody ADC. This is the eighth clinical trial approval obtained by Keyi Pharmaceuticals and the second innovative drug pipeline of Keyi Pharmaceuticals to enter the U.S. clinical stage."

IND • New trial • Oncology • Solid Tumor

A promising MET-EGFR bispecific nanobody-drug conjugate therapy for multiple solid tumours (ESMO 2024) - "KY-0301 was engineered with lower EGFR affinity (161-fold) and EGFR arm truncation, with the aim of reducing EGFR-driven toxicity in normal tissues. KY-0301 showed higher internalization rates than AZD9592 in HCT116 and NCI-H1975. Preclinical data has demonstrated promising efficacy and safety of KY-0301 in tumors expressing MET and EGFR, including but not limited to NSCLC, colorectal cancer, pancreatic cancer and kidney cancer."

Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Kidney Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Renal Cell Carcinoma • Solid Tumor • EGFR • MET