CT-P73 / Celltrion - LARVOL DELTA

Samsung Bioepis and Celltrion Aim for Blockbuster New Drug Development (Business Korea) - "Celltrion aims to advance a total of nine biobetter ADC candidate substances and four multi-antibody candidate substances into clinical trials by 2028, with improved therapeutic efficacy and safety compared to original pharmaceuticals. Three ADC candidate substances—CT-P70, CT-P71, and CT-P73—have already entered the clinical trial phase."

Licensing / partnership • Colorectal Cancer • Gastric Cancer • Gastroesophageal Cancer • Non Small Cell Lung Cancer

Celltrion accelerates ADC drug development with new strategies and partnerships (Chosun Biz) - "CT-P70 started clinical phase 1 with the first dosing in stomach cancer patients on July 15, and the goal is to receive accelerated approval from the U.S. Food and Drug Administration (FDA) as a second-line treatment for gastric esophageal cancer by 2030....CT-P73 targets the tissue factor, a protein involved in blood coagulation that is overexpressed in tumors, and IND approval application is expected in September of this year."

FDA approval • IND • Esophageal Cancer • Gastric Cancer

Celltrion Presents Preclinical Findings on ADC Candidate CT-P73 at World ADC Asia Summit (Korea IT Times) - "Celltrion revealed the preclinical findings of CT-P73, which targets solid tumors such as cervical cancer, head and neck cancer, and colorectal cancer, in a poster presentation at the summit....In preclinical studies, CT-P73 demonstrated a favorable therapeutic index, showing low toxicity and superior efficacy. It also confirmed advantageous pharmacokinetic properties due to the stability of its linker. Furthermore, CT-P73 is expected to exhibit a bystander effect, destroying surrounding cancer cells, and excellent tumor penetration. Based on these findings, Celltrion plans to submit an investigational new drug (IND) application for CT-P73 to regulatory authorities both domestically and internationally as early as this year....Looking forward, Celltrion aims to submit IND applications for 13 candidates, including nine in the ADC field and four for multispecific antibodies, by 2028."

IND • Preclinical • Cervical Cancer • Colorectal Cancer • Head and Neck Cancer • Solid Tumor

Celltrion, next-generation ADC new drug 'CT-P70' US FDA phase 1 IND approval…New drug development company leaps forward, follow-up IND also proceeds sequentially [Google translation] (Celltrion Press Release) - "Celltrion announced on the 5th that it has received approval for an investigational new drug (IND) plan for phase 1 clinical trials of its antibody - drug conjugate (ADC )-based anticancer drug 'CT-P70' from the U.S. Food and Drug Administration (FDA)....Celltrion plans to begin patient administration this year, and the global phase 1 clinical trial will target cancer patients to confirm safety and the maximum tolerated dose (MTD) through a stepwise dose escalation, and comprehensively evaluate pharmacokinetics, immunogenicity, and initial efficacy....Meanwhile , starting with the IND approval of CT-P70, Celltrion plans to sequentially submit a total of four INDs this year, including CT-P71, CT-P72, and CT-P73, to begin clinical trials of its next generation new drug pipeline."

IND • Colon Cancer • Gastroesophageal Cancer • Non Small Cell Lung Cancer