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KDDF-201212-12 Preliminary non-clinical study of a therapeutic antibody candidate for the treatment of cholangiocarcinomas(Oncology, Protein) [03.05.2013]

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Development and Market Objectives

Our developmental goal is to analyze the pharmacokinetics, single-dose toxicity, and antitumor activities of Ab417 human anti-L1CAM monoclonal antibody that cross-reacts with rodent L1CAM. We aim to conduct single-dose toxicity tests in mice and carry out research to optimize antitumor efficacy using mouse models of human bile duct cancers. Our immediate goal is to enter the pre-clinical stage.

Unmet Medical Need & Target Patients

(1) Target patients include those with intrahepatic bile duct cancer, extrahepatic bile duct cancer and gallbladder cancer.
(2) The survival rate for bile duct cancer patients is less than 5 percent. Although bile duct cancer is not as prevalent as many other types of cancer, the 5-year overall survival rate is among the lowest, after pancreatic, lung and liver cancer.
(3) As of 2012, only 13 out of 144 clinical tests being conducted worldwide on bile duct cancer are EGFR/VEGFR targeted therapy tests. In order to improve bile duct cancer treatment, various targeted therapies must be further developed.

Status

We conducted PK, single-dose toxicity and in vivo efficacy studies. We plan to perform repeated-dose toxicity study in monkeys.

Intellectual Property

(1) A novel monoclonal antibody specific to the L1CAM, A hybridoma producing the same and a method producing the same (licensed number 0756051, license date 2007.08.30).

(2) A composition for treating L1CAM-expressing cancer comprising an inhibitor of activity or expression of L1CAM and anticancer agent (application number 2008-0118921, application date: 2008.11.27 PCT/KR2009/007056).

(3) A pharmaceutical composition for treating cholangiocarcinoma, a method for inhibiting growth or invasion of cholangiocarcinoma and a method for treating cholangiocarcinoma.

Country of Application

Date of Application

Application Number

Date of Registration

Registration Number

Australia

2009-03-12

2007288620

2012-12-13

2007288620

Brazil

2009-02-25

0715844-0

   

Canada

2009-02-23

2,661,669

   

China

2009-04-21

200780039170.9

2013- 06-26

ZL200780039170.9

Europe

2009-02-27

07793649.0

2013-11-27

2054083

Indonesia

2009-02-23

W00200900471

   

India

2009-03-06

474/MUMNP/2009

   

Philippines

2009-02-23

1-2009-500353

   

Japan

2009-02-23

2009-525498

   

Mexico

2009-02-23

MX/A/2009/002064

2012-04-09

297926

USA

2009-02-20

12/438,354

2012-04-10

8153122

Vietnam

2009-03-23

1-2009-00568

   

Korea

2007-07-01

2007-0084868

2009.12.07

931976


(4) Humanized antibody against human L1CAM and method for preparing the antibody
(application number 10-2012-00092965, application date 2012.8.24)

(5) Antibodies specifically binding to L1CAM in humans and mice, and use thereof (application number: 10-2011-0130590, application date: 2012.11.16).

Competitive Advantages

(1) Currently holding patents for targets of bile duct cancer treatment and antibodies.

(2) Antibody binding to both human and mouse L1CAM provides efficient testing of toxicity, PK, and efficacy in mouse models.

(3) Bile duct cancer therapeutics are categorized as orphan drugs, reducing the time for clinical studies and leading to faster market penetration.

(4) The L1CAM targeting antibody may have applications in bile duct cancers as well as the treatment of other tumors expressing L1CAM.

Indication

Oncology

Research Period

Feb. 15, 2013-Dec. 14, 2014

Company

Kangwon Nat. Univ.

Developmental Stage

Lead Optimization

Additional Information

Contact Information

Contact
Address Company Name: Kangwon National University, College of Biomedical Sciences, Department of Systems and Immunology
WebSite Homepage: http://www.kangwon.ac.kr/english/main/main.php Contact Person: Professor Hong, Hyo Jeong
E-mail: hjhong@kangwon.ac.kr Contact: +82-33-250-8381

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