바이오스펙테이터

바이오스펙테이터 Jongwon Jang 기자

On August 23, Alteogen announced that it will soon initiate a phase I clinical trial for ALT-P7, a novel antibody-drug conjugate (ADC) targeting the human epidermal growth factor receptor 2 (HER-2) gene for treating HER2-positive breast cancer at the Samsung Medical Center (SMC), following approval by the SMC’s Institutional Review Board.

The Ministry of Food and Safety Drug Safety approved the phase I trial for Alteogen’s ALT-P7 on June 15.

This trial is an open-label, dose-escalating, phase I clinical study to evaluate the safety, tolerability, and pharmacokinetics of ALT-P7 in a total of 42 patients with HER2-positive, advanced or refractory breast cancer who are unresponsive to the current standard therapy.

Company officials stated that the launch of this phase I study represents a meaningful event for the local company who developed the ADC product.

ADC is a complex molecule composed of an antibody linked to a biologically active cytotoxic chemotherapy. The aim of developing ADC is to target and kill only cancer cells. Due to this targeting, the drug has low side effects and gives a wider therapeutic window than that afforded by the chemotherapeutic agents. ALT-P7 is a long-acting Herceptin biobetter.

The CEO of Alteogen, Park Soon-jae, commented "A green light to launch the phase I trial for the ADC product not only gives us a boost on the global market, but also opens a new era for local developers. With its proprietary NexMabTM ADC technology, we will further expand the indications of ALT-P7 to gastric cancer whose market size is estimated at 4 trillion won".

Listed on Korea’s KOSDAQ (Korean Securities Dealers Automated Quotation) in December 2014 through a public offering, Alteogen is a biopharmaceutical company devoted to developing monoclonal antibody biobetter with its proprietary ADC technology (NexMabTM), coupled with the development of long-acting biobetters.