Alteogen's Kadcyla biobetter gains edge in gastric cancer with FDA orphan designation
"Market exclusivity for seven years in the area of gastric cancer in the U.S. means a lot to us," Alteogen CEO Park Soon Jae told BioWorld. "ALT-P7 is Herceptin-based ADC, where the competition is very high for the treatment of breast cancer. But for gastric cancer, we will take a unique position after approval from FDA and we can market that in the U.S."
Alteogen noted additional benefits, including tax benefit of the total costs for clinical trial studies, scientific advice meetings with the FDA during the development process and a waiver of marketing application fees.
The company is conducting a first-in-human phase I trial of ALT-P7 in Korea targeting HER2-positive breast cancer, after gaining an IND approval from the Ministry of Food and Drug Safety (MFDS) in Korea last year. That trial is expected to be completed by end of this year.
"Based on the promising result so far, we are planning phase II trial for breast and gastric cancer in 2019. With a proper collaborating partner, phase II can also be conducted in the U.S.," Park said, adding, "It is very likely that phase III for gastric cancer will be conducted in the U.S. and Korea."
The ADC drug uses Alteogen's Nexmab platform, which is a site-specific drug conjugation technology. The technology's patent is registered in seven countries, including the U.S., Japan and Korea.
Alteogen notes that HER2 is overexpressed in 20 percent to 25 percent of breast cancer patients and in 10 percent to 15 percent of gastric cancer patients.
ALT-P7 was developed as a biobetter of Kadcyla (trastuzumab, Roche Holding AG), approved for use in breast cancer in the U.S. in 2013. Kadcyla has not been approved in gastric cancer.
Alteogen is hoping to position its product as a safer and better alternative to Kadcyla, thanks to its Nexmab technology. While Kadcyla, like other first-generation ADCs, was developed in a non-site-specific manner, Alteogen's drug was developed using the metal ion binding motif of the Nexmab technology to create site-specific conjugation.
"We also submitted another patent related with Nexmab conjugation technology which further reinforces the improvement of the current site-specific technology," Park said.
Gastric cancer has become the fourth deadliest cancer, after lung, liver and colorectal cancer, taking the lives of 754,000 people in 2015.
Founded just a decade ago, Daejeon-based Alteogen has five other drugs in the pipeline. ALT-P1, a long-acting human growth hormone, has completed phase II testing in adult growth hormone deficiency (GHD) patients in Korea and is set to enter a phase II trial for pediatric GHD patients in 2019.
The long-acting factor Vlla, ALT-Q2, is still in the early development stage. ALT-Q5, an ADC candidate targeting ovarian cancer, will enter preclinical testing in 2019.
Alteogen joined hands with the U.S.'s Lynkogen Inc. in mid-July to develop a GLP-1 mimetic and alpha-1 antitrypsin (A1AT) fusion targeting nonalcoholic steatohepatitis and metabolic diseases. Clinical trials are expected to start in two years' time. (See BioWorld, July 11, 2018.)
Two biosimilars are in the works, including ALT-L2, referencing Herceptin (trastuzumab/Roche Holding AG), which completed phase I trials and is currently in phase III studies in Korea. For that drug, Alteogen has collaborated with Dutch company Linxis BV for the supply, and with China's Qilu Pharmaceutical Co. Ltd. to co-develop and commercialize the drug.
Alteogen will seek to file an IND application for a clinical trial next year of ALT-L9, potentially the world's first biosimilar of Eylea (aflibercept/Regeneron Pharmaceuticals Inc.). It plans to launch the follow-on version in Japan and China in 2022 after Eylea's patents expire.
The Korean firm also has its Nexp fusion technology, a platform that uses DNA recombination and human alpha-1 antitrypsin protein to increase the half-life of biologics.