RB-601 / Novatim Immune Therap, Radiance Biopharma - LARVOL DELTA

A First-In-Human, Multicenter, Open-Label Phase I/II Investigational Study to Evaluate the Safety, Tolerability, Pharmacokinetics, And Preliminary Efficacy of KY-0301 as monotherapy or combined with other anticancer agents in Patients with advanced Solid Tumors (ChiCTR) - P1/2 | N=120 | Recruiting | Sponsor: Shanghai East Hospital; Novatim Immune Therapeutics (Zhejiang) Co., Ltd.

New P1/2 trial • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Head and Neck Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • ALK • BRAF • HER-2 • KRAS • MET • MSI • NTRK • PD-L1 • ROS1

Radiance Biopharma Signs Exclusive License For ‘First In Class’ c-Met/EGFR Targeted Nano Antibody ADC (GlobeNewswire) - "Under the terms of the Exclusive License, Radiance will pay NOVATIM an upfront payment of USD$15 million, and up to $150 million in potential development and regulatory milestone payments and over $1 Billion in potential commercial milestone payments....An Investigational New Drug (IND) application for RB-601 has been cleared by China's regulatory agency...NMPA. RB-601 is currently being investigated by NOVATIM in a Phase 1 clinical trial in advanced solid tumors in China."

Licensing / partnership • Trial status • Solid Tumor

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