FDA Grants Orphan Drug Designation to Gastric Cancer Treatment, ALT-P7

This US Food and Drug Administration (FDA) has granted an orphan drug designation to Alteogen Inc.’s ALT-P7 for the treatment of patients with gastric cancer.

ALT-P7 is an antibody-drug conjugate (ADC) that utilizes a Trastuzumab variant form of antibody. The potential anti-cancer ADC treatment utilizes the company’s "NexMab^TM" platform technology, which is a “next-generation site-specific conjugation methodology developed by the company,” according to the announcement.

"The orphan drug designation of ALT-P7 by the FDA will accelerate the advancement of gastric cancer treatment in the United States," said Soon Jae Park, PhD, CEO of Alteogen, in a recent statement. "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.”

Currently, ALT-P7 is undergoing a first-in-human phase 1 clinical trial for patients with breast cancer in Korea. The primary outcome measure for the trial is a determination of maximum tolerated dose (MTD) and the dose level showing dose-limiting toxicity (DLT), or determination of recommended phase 2 dose (RP2D) as an alternative to MTD establishment. Secondary outcome measures for the trial include: incidence of treatment-emergent adverse events, a pharmacokinetics test, an immunogenicity test as measured in the timeframe of 4 weeks and an efficacy test as measured at the end of cycle 2; each cycle is 21 days.

For the trial, 7 groups of patients will receive varying doses of ALT-P7. Doses include: 0.3 mg/kg, 0.6 mg/kg, 1.2 mg/kg, 2.4 mg/kg, 3.6 mg/kg, 4.8 mg/kg, and 5.4 mg/kg. Patients will be administered the treatment on day 1 of each 3-week cycle.

The trial is currently enrolling an anticipated 30 participants; December 31, 2018, is the estimated primary completion date. Plans for a phase 2 clinical trial for breast cancer patients is in the works for 2019.

Additionally, Alteogen will extend the clinical development of ALT-P7 for gastric cancer as well, following the current breast cancer trial, which already has proven efficacy in pre-clinical in vitro and in vivo studies.