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KDDF-201408-02 Novel HER2 targeted therapeutic antibody against Gastric Cancer(Oncology, Protein) [12.05.2014]

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Development and Market Objectives

By successfully completing optimization studies for efficacy, pharmacokinetics and single-dose toxicity studies of an innovative antibody drug targeting HER2 for the treatment of patient with gastric cancer, our final objective is to enter preclinical development.

Unmet Medical Need & Target Patients

Gastric cancer is third leading cause of cancer deaths worldwide, and the fifth most common cancer, with a 5-year survival rate for progressive gastric cancer patients at diagnosis of only 7%. HER2 is overexpressed in 22% of gastric cancer patients and is known to be involved in the development and progress of malignant growth. The blockbuster breast cancer treatment Herceptin was approved as a targeted treatment for HER2 overexpression in gastric cancer patients but compared to existing chemotherapy, the average survival rate is only extended for 2.7 months and the response rate is 47%, indicative of a limited effect. Therefore, new drugs that can increase the survival and response rates of gastric cancer patients with HER2 overexpression are urgently needed.

Status

· Confirmation of correlation between anti-proliferation activity of antibody and HER2 expression level and anti-proliferative activity in Herceptin-resistant cancer cells by in intro profiling.

· Confirmation of synergistic anti-tumor activity of novel antibody in combination with Herceptin in human gastric cancer xenograft and patient-derived xenograft (PDX) models.

· Establishment of CHO-based production cell lines.

· Conduction of pharmacokinetics (PK) and dose-range finding (DRF) in cynomolgus monkey.

· Studies for mechanism of action and biomarker development

Intellectual Property

• National patent registered (10-1453462, HER specific-binding antibody): Specific CDR listed antibody and/or antigen binding fragment and pharmaceutical composition which includes use for preventing or treating breast cancer or gastric cancer.
•National patent applied (10-2014-0109642, HER specific-binding antibody): CDR listing, antibody with specificity for the CDR3 area in light and heavy chains and/or its antigen binding fragment and pharmaceutical composition which includes its use for preventing or treating breast cancer or gastric cancer.
•PCT application (PCT/KR2014/004317, HER specific-binding antibody): Combined antibody with a specific CDR listing and/or antigen binding fragment and pharmaceutical composition which includes its use for preventing or treating breast cancer or gastric cancer.

· The patent has been applied in 10 national phases (HER2 specific-binding antibody): Combined antibody with a specific CDR listing and/or antigen binding fragment and pharmaceutical composition which includes its use for preventing or treating breast cancer or gastric cancer.

Competitive Advantages

•Limited therapeutic options are available for the treatment of patients with gastric cancer, so there is a big potential for clinical development and a large market size.
• Novel anticancer activity based on distinct mechanism of action compared to the existing antibody therapeutics.
•Shows superior anticancer efficacy in combination with Herceptin compared to Herceptin single treatment and combination treatment of Herceptin and Perjeta.
•Shows anticancer activity in some HER2-positive and Herceptin-resistant cancer cells.

Indication

Gastric cancer

Research Period

Nov, 2014 ~ May, 2016

Company

Abclon

Developmental Stage

Candidate

Additional Information

Contact Information

Contact
Address Company Name: AbClon Inc.
WebSite Homepage: http://www.abclon.com Contact Person: Bong-Kook Ko, Deputy Director
E-mail: bkko@abclon.com Contact: +82-2-2109-1286

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