CT-P70 / Celltrion - LARVOL DELTA

Celltrion announced on December 4 that its antibody-drug conjugate (ADC) based anticancer drug candidate, CT-P70, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) (The Asia Business Daily) - "The FDA is reported to have granted Fast Track designation after comprehensively evaluating the fact that the target patient group is at high risk with limited treatment options using existing methods, as well as the potential shown by the initial development data of CT-P70."

Fast track • Solid Tumor

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

ADC candidate substance CT-P70 for second-line treatment of gastroesophageal cancer has been conducting Phase 1 clinical trials since July, targeting accelerated approval in 2030. (Business Korea)

Approval • Gastroesophageal Cancer

Celltrion confirms ADC candidates suppress tumors in lung, colon, stomach models (Chosun Biz) - "In particular, in experiments with cancer cells resistant to tyrosine kinase inhibitors (TKIs), a targeted therapy used for non-small cell lung cancer with mutations in the epidermal growth factor receptor (EGFR), which is highly expressed in several cancer types, CT-P70 reduced cancer cell survival and blocked tumor growth. Similar anticancer effects were confirmed in other solid tumors such as colorectal and gastric cancers."

Preclinical • Colorectal Cancer • Gastric 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

[Approval/Clinical] Celltrion ADC New Drug 'CT-P70' Enters Domestic Phase 1 [Google translation] (HIT News) - "The global phase 1 clinical trial of 'CT-P70', a new antibody-drug conjugate (ADC) drug substance currently under development by Celltrion, will also begin in Korea....On the 2nd, the company received approval from the Ministry of Food and Drug Safety for a phase 1 clinical trial plan to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and initial efficacy of CT-P70 in adult patients with advanced solid tumors. The research team plans to confirm dose escalation and dose expansion through this study, which is the first human application clinical trial."

New P1 trial • 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

Celltrion files IND with FDA for CT-P70, advancing global ADC cancer drug strategy (Korea Biomedical Review) - "Celltrion said it has submitted an investigational new drug (IND) application to the U.S. FDA for its novel antibody-drug conjugate (ADC) cancer therapy, CT-P70. This marks the first concrete step in executing its new global drug development strategy outlined at the J.P. Morgan Healthcare Conference 2025....CT-P70 is an ADC cancer treatment targeting various solid tumors, including non-small cell lung cancer (NSCLC), colorectal cancer, and gastric cancer."

IND • Colorectal Cancer • Gastric Cancer • Non Small Cell Lung Cancer

Celltrion unveils strategic vision for advancing its innovative drug pipeline at the 43rd Annual J.P. Morgan Healthcare Conference (PRNewswire) - "Celltrion, Inc...today announced its innovative drug development strategy in the rigorous and cutting-edge field of novel drug therapeutics at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco, California...Celltrion's Chairman Jung-Jin Seo and Chief Executive Officer Jin-Seok Seo outlined new drug developments including its next-generation antibody drug conjugate (ADC) platform, with two biobetter ADC candidates CT-P70 and CT-P71...In addition, the company announced its plan to develop dual-payload ADCs that incorporate two distinct payloads with complementary mechanisms of action, aiming to deliver a more potent cytotoxic response to cancer cells. The company also plans to focus on developing multispecific antibodies that selectively target cancer cells or are activated only under specific conditions...Mr. Seo outlined IND submission timelines of its novel drug pipeline with plans to develop 13 new drugs by 2028, including 9 ADCs and 4 multispecific antibodies."

IND • Pipeline update • Bladder Cancer • Non Small Cell Lung Cancer • Oncology

Celltrion Announces New Drug Development Strategy at JPM Conference in the US [Google translation] (Hankyung) - "Celltrion Group Chairman Seo Jung-jin and Celltrion Business Division CEO Seo Jin-seok will announce their new drug development strategy at the world's largest pharmaceutical and bio investment event, the '2025 JP Morgan Healthcare Conference' (JPM)...Here, Celltrion will present the actual development results of its new drug pipeline, including ADC anticancer drugs such as 'CT-P70' and 'CT-P71'....It also plans to reveal the development schedule for a total of 13 new drug pipelines, including 9 ADC new drugs and 4 multi-antibody new drugs by 2028."

Pipeline update • Solid Tumor

Celltrion, Equipped with CDMO Competitiveness… 'Leaping to Global Big Pharma with 10 Trillion Won in Sales by 2027' [Google translation] (Nate) - "Celltrion is taking a leap forward to solidify its position as a global big pharma by entering into antibody-drug conjugate (ADC) new drug development and contract development and manufacturing (CDMO) businesses...Celltrion plans to disclose ADC new drug substances within the year and accelerate development with the goal of commercializing them in 2029...Celltrion is developing two solid cancer ADC candidates (CT-P70 and CT-P71) in collaboration with PinoBio...Both treatments are undergoing non-clinical studies and are planning to enter full-scale clinical trials starting next year."

New trial • Pipeline update • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

PinoBio, Celltrion Develop '2 ADC New Drugs' Preclinical Results Disclosure [Google translation] (HIT News) - "One of the new drug candidates revealed, 'CT-P70', is a cell growth factor receptor (cMET)-targeting ADC targeting solid cancers such as non-small cell lung cancer (NSCLC). 'CT-P71', also revealed, targets solid cancers such as bladder cancer and targets Nectin-4....Both treatments are undergoing non-clinical studies and have demonstrated excellent tumor suppression efficacy and excellent safety."

Preclinical • Bladder Cancer • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor

Celltrion Unveils New Cancer Drug Candidates at World ADC Conference [Google translation] (Korea Duty Free News) - "Biotech company Celltrion has revealed promising preclinical results for two novel cancer treatments at the World ADC 2024 conference in San Diego, marking its strategic shift toward new drug development...The company presented data for CT-P70 and CT-P71, both antibody-drug conjugates (ADCs) designed to target solid tumors. CT-P70 aims to treat non-small cell lung cancer by targeting cMET, while CT-P71 focuses on bladder cancer by targeting Nectin-4."

Preclinical • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Celltrion, first public disclosure of development results of two new anticancer drugs at World ADC [Google translation] (Medipana) - "On the afternoon of the 5th (local time), Celltrion announced the non-clinical study results of two ADC new drug pipelines currently under development, 'CT-P70' and 'CT-P71', drawing attention from many participants....CT-P70 showed efficacy in tumor suppression in cMET-expressing lung and stomach cancers in vitro and in vivo, and also confirmed sufficient safety in toxicity tests....CT-P71 showed efficacy in tumor suppression of bladder cancer, breast cancer, and lung cancer in non-clinical studies, and showed excellent safety in toxicity tests....The new pipeline disclosed at World ADC this time utilized 'PBX-7016', an ADC platform of ADC specialist Pino Bio discovered through open innovation."

Preclinical • Bladder Cancer • Breast Cancer • Gastric Cancer • Lung Cancer