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KDDF-201803-05 Development of novel third generation best-in-class EGFR TKI YH25448 for NSCLC(Oncology, Chemical) [2019-10-25]

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Ongoing Project
Section Lead
Generation
Lead
Optimization
Preclinical Phase I Phase II Phase III

Development and Market Objectives

Clinical development of a third generation EGFR TKI, YH25448 (Lazertinib) for NSCLC and licensing out for global development

Unmet Medical Need & Target Patients

[Unmet medical needs]

Limited treatment option available for patients with brain metastases which occur in approximately 50% of NSCLC patients in 3 years after diagnosis

High incidence of side effects related to insufficient selectivity of a compound over wild-type EGFR (rash, diarrhea, and interstitial lung disease) and undesired off-target activities (QT prolongation and hyperglycemia) of metabolites

 

[Target Patients]

1st-line therapy: EGFR del19, L858R mutation-positive advanced and metastatic NSCLC patients

2nd-line therapy: EGFR T790M mutation-positive metastatic NSCLC patients who progressed after 1st or 2nd-generation EGFR TKI

Status

Dosing regimen: oral, once daily

Phase 2 study (1st-line and 2nd-line) is ongoing

Phase 3 study will be commenced in 2019

Intellectual Property

Strong, world-wide IP rights secured

PCT/KR2015/010784: patent was granted in USA and pending in other countries

Competitive Advantages

Excellent clinical efficacy in brain metastasis patients due to high BBB penetration

Very good clinical safety and tolerability due to excellent selectivity of YH25448 and its metabolite

Favorable safety profile of YH25448 due to high selectivity over wild-type EGFR leading to successful development for combination therapy 

Contact & Company Overview

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