Alteogen, a Korea-based biopharmaceutical company focusing on the development and commercialization of novel anticancer drugs such as antibody-drug conjugates, has received an approval for orphan drug designation from the U.S, Food and Drug Administration (FDA) for ALT-P7 for gastric cancer ALT-P7 is an antibody-drug conjugate (ADC) using a Trastuzumab variant as the of antibody.
The approval guarantees market exclusivity for seven years after FDA approves Alteogen’s ALT-P7 for the treatment of patients with gastric cancer.
Orphan drug designation
The FDA designation of orphan drug is designed to support the development and approval of drugs for the treatment of rare diseases or life-threatening illnesses. Products designated as orphan drugs would be recognized for not only market exclusivity after FDA approval, but also to receive additional benefits, including a tax benefit of the total costs for clinical trial studies, scientific advice meetings with FDA during the development process, and waiver of marketing application user fees.
ALT-P7, a candidate ADC treatment drug for gastric and breast cancers, is an anti-cancer ADC utilizing the company’s unique NexMab™ platform technology, a proprietary next-generation site-specific conjugation methodology developed by Alteogen. The related patents are registered in seven countries so far.
Phase I trial
ALT-P7 is currently undergoing a first-in-human phase I clinical trial for breast cancer patients in Korea, after the investigational new drug (IND) approval last year from the Ministry of Food and Drug Safety (MFDS) of Korea (NCT03281824).
Alteogen is planning to start phase 2 clinical trial for breast cancer patients in 2019. Following the current breast cancer trial, the company is expected to extend the clinical development of ALT-P7 for gastric cancer as well, which already has proven efficacy in pre-clinical in vitro and in vivo studies.
“The orphan drug designation of ALT-P7 by the US FDA will accelerate the advancement of gastric cancer treatment in the US,” said Soon Jae Park, Ph.D., CEO of Alteogen.
“We believe that ALT-P7 can provide a breakthrough in the treatment of Her-2 overexpressing gastric cancer, for which there is no effective target treatment yet,” Park added.