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Genosco/Yuhan Announce Results from Phase 1/2 Study of YH25448, a 3rd-Generation EGFR-TKI, in Advanced NSCLC to be Presented at ASCO 2018

(May 16, 2018)

CAMBRIDGE, Mass.--(BUSINESS WIRE)--#AACR18--Genosco, a clinical-stage biotechnology company focused in immunology and oncology, today announced that the abstract from a Phase 1/2 study evaluating YH25448 (GNS-1480) in patients with advanced Non-Small Cell Lung Cancer (NSCLC) is now available on the website of the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting. YH25448 (GNS-1480), Genosco’s 3rd-generation EGFR-TKI candidate partnered for clinical development and commercialization with Yuhan Corporation, is an oral, potent, irreversible EGFR-TKI that is highly selective for activating (EGFRm) and T790M resistance mutations.


“We are encouraged by the safety and efficacy results shown in these data and look forward to the presentation of the full data set which will inform the future clinical trials,” said Jong Sung (John) Koh, Ph.D., Genosco CEO.

Results from an open-label, multi-center Phase 1/2 study of YH25448 (GNS-1480) for patients with advanced NSCLC with or without CNS metastases will be presented in a poster session (Abstract 9033) by Byoung Chul Cho, M.D., Ph.D., Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea, at ASCO in Chicago. The poster (#356) is titled YH25448, a 3rd-generation EGFR-TKI, in patients with EGFR-TKI-resistant NSCLC: Phase I/II study results and will be presented in the Lung Cancer—Non-Small Cell Metastatic session on Sunday, June 3, 2018, 8:00 AM – 11:30 AM CT.

A total of 105 patients with EGFRm advanced NSCLC with acquired resistance to EGFR-TKIs with or without brain metastasis were enrolled in a Phase 1/2 study with dose-escalation and expansion cohorts.



   

Key findings at the time of data cut-off include:

       
Objective Response Rate (ORR) - Evaluable patients   (n=91)   64%
ORR - T790M-positive patients   (n=76)   67%
ORR - T790M-negative patients   (n=15)   47%
ORR – patients with Brain metastases   (n=9)   56%
YH25448 (GNS-1480) was generally well tolerated with no dose-limiting toxicities observed. AEs of grade 3 or higher were observed in 5% of the patients.
 

Updated data will be presented at ASCO.

About YH25448
YH25448 (GNS-1480) is an oral, potent, highly mutant-selective and irreversible, investigational 3rd-generation EGFR-TKI that penetrates the blood-brain barrier (BBB). It targets the activating EGFR mutations Del19 and L858R, as well as the T790M mutation, while sparing wild type. EGFR mutations are present in approximately 10-15% of NSCLCs. YH25448 (GNS-1480) is being evaluated in advanced NSCLC as both first- and second-line treatments.

About Genosco
Located in Cambridge, MA, Genosco is a clinical-stage biotechnology company focusing on developing and commercializing novel immunology and oncology treatments to improve the lives of patients. Genosco’s core competence comes from its expertise in generating selective kinase inhibitors that include candidates that target EGFRm+ (NSCLC), SYK (Autoimmune diseases) and FLT3/AXL (AML) and other conditions. The company is enrolling patients in a Phase 1 study of SKI-G-801 for AML and expects to initiate a Phase 2 study of SKI-O-703 in ITP and RA in 2018. In 2015, Genosco partnered globally with Yuhan Corporation for development and commercialization of YH25448 (GNS-1480), a 3rd-generation EGFR-TKI, for treatment of NSCLC currently in Phase 2 clinical trials. Genosco was founded in 2008 as a subsidiary company of Oscotec, Inc, (KOSDAQ: 039200), South Korea. For more information, please visit www.genosco.com.

About Yuhan Corporation
Yuhan Corporation (CEO, Jung Hee Lee) is a globally operating, leading pharmaceutical company in South Korea. Founded in 1926 by Dr. Ilhan New, the company is engaged in research and development (R&D), drug manufacturing, CMO business, marketing and distribution of a broad spectrum of pharmaceutical and healthcare products. R&D strategies of Yuhan Corporation revolve around, first and the foremost, the patient needs. This patient-centered approach has directed the focus of Yuhan R&D on two critical areas of unmet medical needs; oncology and metabolic diseases. For more information, please visit www.yuhan.co.kr.


Contacts

Genosco Contact
David Kim
Manager
[email protected]
or
Media Contact:
LaVoieHealthScience
Sharon Correia, 617-412-8779
VP, Integrated Communications
[email protected]


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