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KDDF-201412-08 Development of a novel EGFR-targeted antibody(Oncology, Protein) [06.25.2015]

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Development and Market Objectives

The objective of this study is to determine the safety, tolerability, and the recommended phase II dose, and to investigate the potential efficacy of the recommended phase II dose in target disease indication through expansion study. A rationale for development strategy and competitiveness compared with other drugs will be established through translation study.

Unmet Medical Need & Target Patients

Current EGFR-targeted antibodies have low response rate and recurrence problem and it is highly in need for therapeutics with higher response rate and prolonged efficacy. In phase 1 clinical study GC1118 is open for the stage IV patients with solid tumors who failed in standard therapy or other EGFR-targeted therapeutics. The ultimate target patients are stage IV colorectal cancer patients including those refractory to other EGFR-targeted antibodies and stage IV gastric cancer who failed in standard therapy.

Status

An underlying mechanism for superior tumor inhibitory effect of GC1118 to other EGFR-targeted antibodies was provided by efficacy and mechanism study. Furthermore potential use of GC1118 for Erbitux-failed patients was also implicated in Erbitux-resistant animal model. We’re planning to have a proof of concept data through phase 1 clinical trial including expansion study.

A Dose escalation study has been completed and indicated that GC1118 is tolerable and safe.  Recommended phase II dose has been determined. An overall response rate was encouraging where partial response was observed at the RP2D level. An expansion study has begun to further determine the safety as well as efficacy in the specific subsets of target patients. The expansion study is expected to be completed on Aug. 2017.

Intellectual Property

Antibodies specifically binding to the epidermal growth factor receptor, patent registered in KR, US, others (11 nations) including BR, CA are under review

Epitopes of epidermal growth factor receptor surface antigen and use thereof, patented in PCT/KR and under review in 15 other nations

Competitive Advantages

Potent inhibition on a broad range of EGFR ligands including high affinity ligands implicated in Erbitux resistance and formation of tumor vasculature

Strong tumor suppression in Erbitux-resistant model

Superior growth inhibitory activity on tumor xenografts with K-Ras mutation compared with other EGFR-targeted antibodies

Indication

Oncology

Research Period

2015.4.27-2017.8.26

Company

Green Cross Corporation

Developmental Stage

Phase1

Additional Information

Contact Information

Contact
Address Company Name: Green Cross Corporation
WebSite Homepage: http://www.greencross.com Contact Person: Heejung Cho
E-mail: chohj2012@greencross.com Contact: +82-31-260-9104

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