Pharma Focus Asia

Alteogen Gets FDA Approval for Orphan Drug Designation with an Antibody-Drug Conjugate for Gastric Cancer

Tuesday, August 07, 2018

Alteogen Inc. announced that it has successfully got an approval for orphan drug designation from the US Food and Drug Administration (FDA) with one of its assets (ALT-P7) for gastric cancer (designation letter 18-6439) last week. ALT-P7 is an antibody-drug conjugate (ADC) using a Trastuzumab variant form of antibody, and this approval would guarantee Alteogen the market exclusivity rights for seven years after FDA's approval of ALT-P7 for gastric cancer treatment.

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 get additional benefits, such as 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 "NexMabTM" platform technology, a proprietary next-generation site-specific conjugation methodology developed by the company. The related patents are registered in seven countries so far.

ALT-P7 is currently undergoing a first-in-human phase 1 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, Alteogen will 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 Dr. 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".

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