Bridge Biotherapeutics Files Investigational New Drug Application for BBT-176, an EGFR TKI for NSCLC

SEONGNAM,South Korea,Dec. 20,2019 -- Bridge Biotherapeutics Inc.,a clinical stage biotech company headquartered in Seongnam,announced that the company filed an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) and the Ministry of Food and Drug Safety (MFDS) in Korea to initiate phase I/II study of BBT-176,a clinical candidate of targeted lung cancer therapy.

BBT-176,a novel epidermal growth factor receptor - tyrosine kinase inhibitor (EGFR-TKI) is designed to inhibit EGFR with C797S mutations,which arise as Tagrisso (osimertinib) resistant mutations following Tagrisso treatment in non-small cell lung cancer (NSCLC). BBT-176 exhibited strong antitumor efficacy in xenograft models harboringC797S triple mutations including Del19/T790M/C797S and L858R/T790M/C797S.Furthermore,BBT-176 displayedmarkedly enhanced efficacy when combined with anti-EGFR antibodies.

Since the EGFR C797S mutationwas reported 3 years ago,as the first evidence of Tagrisso resistance,no major breakthroughs have been achieved to target the clinically relevant mutant variant that impedes covalent bond formation with irreversible EGFR inhibitors.[i]

The company plans to initiate dose escalation studies in advanced NSCLC patients in Korea next year and to develop further clinical studies in bothKoreaandthe US afterwards. In the Phase I/II study with NSCLC patients,the safety,tolerability and efficacy of the candidate will be observed.

"We are proud of the IND submission for BBT-176,which has shown a potential to be developed as a highly mutant-selective,fourth-generation EGFR-TKI for NSCLC treatment," stated James Lee,CEO of Bridge Biotherapeutics."Our team will make our best effort to develop novel targeted lung cancer therapy inhibiting C797S EGFR mutation."

BBT-176 was discovered by Korea Research Institute of Chemical Technology (KRICT),a Korean government research institute,and was licensed to Bridge Biotherapeutics in December 2018 for the worldwide exclusive right for further development.

Lung cancer is the leading cause of cancer death,accounting for about one-fifth of all cancer deaths. It is split into NSCLC and small cell lung cancer (SCLC) and NSCLC accounts for approximately 85% of all lung cancers. Overall,across 8 major countries including the U.S.,5 EU countries,China and Japan,the total NSCLC population as of 2015 is assumed 2million and the incidence of NSCLC is expected to increase at an annual growth rate of 3.1% from 2015 to 2025.[ii]

[i] Grabe et al.,C797S Resistance: The Undruggable EGFR Mutation in Non-Small Cell Lung Cancer?,ACS Med. Chem. Lett. 2018,9,779−782

[ii] Non-small cell lung cancer (NSCLC) - Global Drug Forecast and Market Analysis to 2025,GlobalData

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About Bridge Biotherapeutics

Bridge Biotherapeutics Inc.,based inSouth Korea,US andChinais a clinical stage biotech company founded in 2015. Bridge Biotherapeutics is engaged in the discovery and development of novel therapeutics,focusing on therapeutic areas with high-unmet needs,such as ulcerative colitis,fibrotic diseases,and cancers.BBT-401,the first-in-class Pellino-1 inhibitor for treatment of ulcerative colitis,is currently in Phase II in the US,and BBT-877,an autotaxin inhibitor to treat various fibrosing interstitial lung diseases including idiopathic pulmonary fibrosis (IPF),was licensed to Boehringer-Ingelheim for further development inJuly 2019with potential license value more than1.1 billion euro.BBT-176,a potent targeted cancer therapy for non–small cell lung cancer (NSCLC) is also in development. Bridge Biotherapeutics is a resident company of JLABS @Shanghai.

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