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KDDF-201509-07 Clinical Phase IIa Trial with Tanibirumab, a Novel Anti-Cancer Antibody Therapeutics, in Recurrent Glioblastoma Patients(Oncology, Protein) [01.15.2016]

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Development and Market Objectives

Phase I clinical study of tanibirumab, a fully human monoclonal antibody, for advanced and metastatic cancer patients were completed and it showed its strong tolerability and safety profile. With those results, phase 2a clinical study of tanibirumab for recurrent glioblastoma (GBM) will be done at Australia to evaluate safety and preliminary efficacy. Phase 2b clinical study will be followed for efficacy evaluation and predictive biomarker finding on tanibirumab for recurrent glioblastoma.

Unmet Medical Need & Target Patients

Glioblastoma covers 15 % of all brain tumors and 45 % of malignant brain tumors. New cases of glioblastoma occur in approximately 2~3 persons per each 100,000 every year and it is the third leading cause of youth (age of 15-35) death by cancer. The incidence rate of glioblastoma has been increased 1.5 % annually.

The current standard therapy for glioblastoma is surgery, radiation and chemotherapy with temodal (temozolomide). It showed about 14 months of median overall survival, but most of patients are recurred within two years. The 5 year survival rate of glioblastoma is less than 3 %. Currently, there is little option for the recurrent glioblastoma patient. Avastin which gave benefit of edema relief to patient was approved at 2009 as an orphan drug for recurrent glioblastoma but was failed at phase 3 clinical study in patients with newly diagnosed glioblastoma recently.

Tanibirumab blocks Vascular endothelial growth factor/ Vascular endothelial growth factor receptor-2 (VEGF/VEGFR-2) signal pathway similar to avastin, but it can also block VEGF-C and VEGF-D binding to VEGFR-2 in addition to VEGF-A. Thus, it is expected to give more benefit to recurrent glioblastoma patient. It is also expect that this study will give a clue about predictive biomarker for the target grouping of patients who will get benefit by tanibirumab.

Status

The phase I clinical study of tanibirumab, an anti-cancer antibody therapeutic agent, was completed for advanced and metastatic tumor patients during 2011-2013. It showed no DLT(dose-limiting toxicity) up to 24 mg/kg and no neutralization positive subject. The pharmacodynamics biomarker also showed expected trends. By the results of phase I clinical study, phase 2a clinical trial for recurrent glioblastoma patients has been conducted in Australia from Feb. 2016 to evaluate safety, pilot efficacy, pharmacokinetics, and pharmacodynamics of the drug for recurrent glioblastoma patients.

Intellectual Property

Patent registered

- The patent has been registered for 22 countries (Registered Countries: South Korea, Japan, Singapore, China, Australia, Canada, EU(15 Countries), United States of America)

- Title of Patent: Human Monoclonal Antibody Neutralizing Vascular Endothelial Growth Receptor and Use Thereof.

 

Patent Roll

No.

Registration No.

Registration Date

Country

1

10-883430

2009.02.05

Korea

2

5086430

2012.09.14

Japan

3

157597

2013.04.30

Singapore

4

101802003

2013.02.13

China

5

2007354976

2014.06.26

Australia

6

2691159

2014.07.29

Canada

7

2158217

2014.01.15

EU(15 Countries)

8

9150650

2015.10.06

USA

9

9249219

2016.02.02

USA

10

9249220

2016.02.02

USA

 

Scope of rights

1. ScFv and IgG molecules neutralizing vascular endothelial cell growth factor receptor (VEGFR) with combinations of 19 species in the light chain variable region, including the light chain of Tanibirumab as well as the heavy chain variable region 

2. Composition of the molecule for the inhibition of angiogenesis in paragraph 1

3. Composition of the molecule for cancer treatment containing molecule in paragraph 1

 

Competitive Advantages

1.A strong market cap exists in the field of angiogenesis inhibitors.
2.Tanibirumab is a fully human antibody therapeutic agent, the most suitable antibody type for therapeutic application in humans.
3.Tanibirumab showed minor side-effects and lower toxicity than competitors, which is due to the high level of specificity with high binding affinity to the vascular endothelial growth factor receptor-2 (VEGFR-2), a primary regulator of angiogenesis. 
4.Tanibirumab is expected to show the efficacy in several indications such as Her2-negative breast cancer, in which competitors have not showed the significant efficacy.
5.Tanibirumab showed the efficacy in an avastin-resistant tumor model and is anticipated that it gives a solution to overcome the avastin-resistance. 
6.Tanibirumab is the only therapeutic antibody containing cross-species reactivity for VEGFR-2 in rodents which is available in translational research opportunities and in selection of optimal indications. As a result, it is expected to increase the success rate in clinical trials.

Indication

Recurrent Glioblastom

Research Period

2016.1.1-2018.12.31

Company

PharmAbcine, Inc.

Developmental Stage

PhaseⅡ

Additional Information

Contact Information

Contact
Address Company Name: PharmAbcine, Inc.
WebSite Homepage: http://www.pharmAbcine.com Contact Person: Sang Ryeol Shim
E-mail: srshim@pharmabcine.com Contact: +82-43-235-2017 (Ext.3041)

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