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KDDF-201210-14 Completion of phase II clinical trial with Tanibirumab, a Novel Anti-cancer Therapeutic Antibody(Oncology, Protein) [01.17.2013]

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Development and Market Objectives

The safety and tolerability of the monoclonal antibody Tanibirumab with be examined in Phase1 in targets of patients with advanced or metastatic cancers. subsequently, the safety and tolerability of the drug will be further examined in phase 2a Clinical trial in Patients  with recurrent brain tumors (glioblastoma, GBM) If successful, additional disease application study will be conducted in the global market.

Unmet Medical Need & Target Patients

● Glioma is a type of malignant tumor that accounts for 60% of all primary brain tumors. Except radiotherapy, no specific  treatment currently exist. In particular, Gliobalstomas (GBM) are classified as the most malignant,  and are often highly resistant to radiotherapy and chemotherapy. Major reasons for a lack of effective treatment options include a poor understanding of neurobiology and the fact that drug delivery is hampered by the blood- brain barrier.
 
● Despite rapid development over the past 30 years and the introduction of new anti-cancer drug Temozolomide, the median overall survival rate for patients with GBM is only 14.6 months with some patients exhibiting significant resistant to Temozolomide. Thus, GBM remains a largely incurable disease and the development of novel anti-cancer drug is urgently needed.
 
● The majority of existing anti-cancer are unable to pass through the blood-brain barrier and their efficancy remains are not to be. Verified The unmet medical needs for the treatment of GBM can be summarized as follows. ① Development of novel therapeutic strategies. ② Development of drugs that are effective in lowering resistance to Temozolomide. ③ Development of personalized treatments for patients who exhibit different clinical benefits

Status

Tanibirumab an anti-cancerdrug candidate is currently in phase 1 clinical trial for patients with advanced or metastatic cancers in Korea. This phase 1 is excepted to be completed by the second half of 2013.

Intellectual Property

Registration
 Date
Registration
 No.
Applicant Title
2009.02.05 10-0883430
(Korea)
PharmAbcine
/KRIBB
HUMAN MONOCLONAL ANTIBODY NEUTRALIZING VASCULAR ENDOTHELIAL GROWTH FACTOR RECEPTOR AND USE THEREOF
2012.09.14 5086430
(Japan)
PharmAbcine
/KRIBB
HUMAN MONOCLONAL ANTIBODY NEUTRALIZING VASCULAR ENDOTHELIAL GROWTH FACTOR RECEPTOR AND USE THEREOF
2012.12.05 2012113000071360
(China)
PharmAbcine
/KRIBB
HUMAN MONOCLONAL ANTIBODY NEUTRALIZING VASCULAR ENDOTHELIAL GROWTH FACTOR RECEPTOR AND USE THEREOF

Patent registration has been completed in Korea, Japan and China. The patent application is currently under review in the us, Canada, Australia, singapore and at the European Patent Office

● 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

●  A strong market cap exists in the field of angiogenesis inhibitors.
●  Tanibirumab is a fully human antibody therapeutic agent, the most suitable antibody type for therapeutic application in humans
●  Due to selective binding affinity to the vascular endothelial growth factor receptor-2 (VEGFR-2) a primary regulator of tumor angiogenesis, minor side-effects are anticipated. In addition, due to its IgG1 subtype, it is expected to exhibit enhanced therapeutic efficacyvia antibody dependent cell mediated cytotoxicity(ADCC)
●  It is the only therapeutic antibody containing cross species reactivity for VEGFR-2 in rodents Translational research opportunities are therefore available and selection of optimal indications can be determined. As a result, the success rate in clinical trials is expected to increase.
●  Through process development, the yield has been improved (> 1.5 g/L).

Indication

Oncology

Research Period

Jan. 02, 2013 ~ Dec. 31, 2014

Company

PharmAbcine

Developmental Stage

Clinical phase 1 MAD

Additional Information

Contact Information

Contact
Address Company Name: PharmAbcine
WebSite Homepage: http://www.pharmabcine.com Contact Person: Sung-Woo Kim, Manager
E-mail: swkim1017@gmail.com Contact: 042-863-2017 (ext 103)

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Clinical Phase IIa Trial with Tanibirumab, a Novel Anti-Cancer Antibody Therapeutics, in Recurrent Glioblastoma Patients Project view
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