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KDDF-201509-15 Nonclinical studies of novel antibody TJO-054 for treatment of wet AMD(Others, Protein) [01.26.2016]

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Development and Market Objectives

First-in-class anti-VEGFR2 antibody for treatment of wet AMD
1) Nonclinical study of ocular PK/toxicity and IND approval for Phase 1 clinical trial
2) Manufacturing the material TJO-054 for clinical study phase 1
3) Pre-formulation study to develop the high concentration antibody product suitable for intravitreal injection
 

Unmet Medical Need & Target Patients

1) Wet age-related macular degeneration (wet AMD) is the leading cause of severe vision loss in people over age 60.
2) Anti-VEGF-A therapy, Lucentis® and Eylea®, for neovascular AMD has become a standard treatment for neovascular AMD. However, developments of new treatments are needed due to induction of unresponsiveness to some patients with current treatment.
3) Taejoon’s TJO-054 aims to target wet AMD patients including the non-responders to current anti-VEGF-A drugs.
 

Status

1) Nonclinical efficacy test shows that TJO-054 has inhibitory effects of wet AMD.
2) Safety of TJO-054 has been approved in a phase 1 clinical study of systemic administration to solid cancer patients.
3) We are planning to get IND approval of phase 1 clinical trial for ocular administration.
4) It is shown that TJO-054 is the only antibody that possesses cross-species cross reactivity for rodents in the scope of all the VEGFR-2/KDR targeting antibodies. Thus, TJO-054 can evaluate efficacy and safety in rodent models and can easily find availability for expanding indications by translational research.

Intellectual Property

1) Taejoon Pharm. possesses global commercial/business rights of TJO-054 for ocular indication (including wet AMD) by a license contract with original developer.
2) It is expected to apply for additional patents once TJO-054 confirms any new mechanism or newly high concentration formulation is developed for suitable ocular administration.
 

Competitive Advantages

1) TJO-054 is a fully human monoclonal antibody to bind VEGFR-2/KDR on abnormal vasculature related to new angiogenesis diseases including wet AMD and cancers.
2) In choroidal neovascularization, the main cause of wet AMD, VEGFR2 signaling by not only VEGF-A but also VEGF-C, -D is also important. However, current anti-VEGF drugs (Lucentis® and Eylea®) cannot block VEGFR2 signaling by VEGF-C and –D. In contrast, TJO-054 is able to block VEGF signaling by VEGF-C, -D as well as VEGF-A, thus expects to improve the efficacy as well as reduce unresponsiveness compared to current treatments.

Indication

Macular Degeneration

Research Period

Jan. 1, 2016 ~ Jun. 30, 2018

Company

Taejoon Pharmaceutical Co., Ltd.

Developmental Stage

Preclinical

Additional Information

Contact Information

Contact
Address Company Name: Taejoon Pharmaceutical Co., Ltd.
WebSite Homepage: http://www.taejoon.co.kr/en Contact Person: Dong Hyeon Kim (Ph.D., Development Team)
E-mail: kimdh@taejoon.co.kr Contact: +82-2-799-0160

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