HONG KONG – South Korea’s Bridge Biotherapeutics Inc. wrapped up the week by announcing its awaited IND clearance for its epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, BBT-176, for non-small-cell lung cancer (NSCLC) from the country’s Ministry of Food and Drug Safety (MFDS) on May 7. The company said BBT-176 exhibited strong antitumor efficacy in C797S triple mutations and showed enhanced efficacy when combined with anti-EGFR antibodies.
“We are greatly encouraged by the IND clearance of BBT-176 in South Korea,” Bridge CEO James Lee said. “Bridge will continue to focus on bringing new treatment options for patients in need of a novel NSCLC therapy.”
The inhibitor was discovered by the Korea Research Institute of Chemical Technology, with Bridge acquiring the license in December 2018. The company aims to develop it as a “next-generation therapy” to help plug the gap for the C797S mutation. The Seongnam-based company, which also has facilities in Germantown, Md., and Shanghai, applied for the MFDS clearance in December 2019, simultaneously lodging an IND application with the U.S. FDA.
Joengbin Ahn, Bridge’s director of communications, told BioWorld that “the fact that the U.S. sets a 30-business-day approval timeline, whereas Korea does not, meant that the FDA cleared our application first in January 2020, with the Korean approval coming four months later,” describing the Korean approval process as “relatively fast and smooth.”
The company is scheduling a dose-escalation study in Korea as part of a combined phase I and II study for the second half of the year, with Ahn declining to specify a more precise date. The study aims to find the maximum tolerable dose and the recommended phase II dose (RP2D) and to observe the drug’s safety, tolerability and antitumor efficacy in a group of patients with advanced NSCLC. Bridge will also be observing antitumor activity when BBT-176 is mixed with anti-EGFR antibodies.
Once the study is completed, a second dose-expansion study will take place, involving patients from both the U.S. and South Korea. During that study, the company will assess the safety, tolerability and efficacy along with the RP2D. The company will also observe detailed antitumor efficacy in the combination therapy of BBT-176 with anti-EGFR antibodies. A phase III trial will be dependent on the results of the combined phase I and II data.
Ahn also said a concern was whether the approximately 90 lung cancer patients expected to take part in the Korean study would be able to get to the clinical test sites in the midst of a small rise of COVID-19 spreading in Korea after days of single-digit cases.
The company has been also been busy in other areas, having enlisted San Francisco’s Atomwise Inc., an AI drug discovery shop, to help identify up to 13 small-molecule inhibitors of Pellino proteins and other targets in an effort to develop new therapies for inflammatory diseases in March.
Earlier, Bridge inked an agreement in July 2019 with Germany’s Boehringer Ingelheim GmbH to develop the Korean company’s phase I autotaxin inhibitor, BBT-877, for fibrosing interstitial lung diseases, including idiopathic pulmonary fibrosis. Bridge raked in up-front and near-term payments of €45 million (US$48.62 million), €1.1 billion in additional payments upon achieving certain development, regulatory and commercial milestones, and staggered royalties into the double digits from the deal.
Bridge also has a collaboration and license agreement to develop a potentially first-in-class dual agonist to treat nonalcoholic steatohepatitis and related liver disease with the country’s largest pharmaceutical company, Yuhan Corp. The company is conducting phase II trials for BBT-401, a Pellino-1 inhibitor treating ulcerative colitis.
Bridge signed a partnership with Daewoong Pharmaceutical Co. Ltd. to out-license BBT-401 in January 2019. Daewoong paid Bridge up to $40 million up front for exclusive rights to develop and commercialize the drug candidate in 22 Asian countries.
Given its previous successes in forming partnerships, Ahn said Bridge will look at using its connections to find a development partner for BBT-176, its latest potential product, with completion anticipated by 2021 or 2022.
Listed on the country’s KOSDAQ board, Bridge stock jumped 3.1% to close at ₩43,550 (US$35.578) on May 8.