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KDDF-201904-23 Evaluation of cancer-targeted oncolytic adenovirus GM103(Oncology, Genetics) [2019-10-01]

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Ongoing Project
Section Lead
Generation
Lead
Optimization
Preclinical Phase I Phase II Phase III

Development and Market Objectives

Main objective of this research is to perform several critical preclinical evaluation of cancer-targeted oncolytic adenovirus candidate material (GM103) to prepare sufficient data for non-clinical trial. In detail, we are aiming to (1) compare in vitro therapeutic efficacy of GM103 with competitor oncolytic virus products, (2) study pharmacokinetic and biodistribution profile of GM103, (3) perform in-depth mode-of-action analysis, (4) determine the feasibility of expanding the indication of GM103 for different cancer types, (5) evaluate the therapeutic efficacy of GM103 in combination with immune checkpoint inhibitors, and (6) establish CMC and mass production protocol.

Unmet Medical Need & Target Patients

· Target Patients: Patients with solid tumors that are easily accessible by needle for local administration

 

· Unmet Medical Need

1) Tumor cells induce immunosuppression and are capable of escaping immune surveillance, thus limiting the therapeutic efficacy of conventional immunotherapeutics

2) Highly active angiogenesis and vascularization in tumor milieu promotes rapid proliferation and metastasis of tumor.

3) Conventional chemotherapeutics lack cancer specificity, thus leading to poor safety profile and insufficient therapeutic efficacy.

Status

· Comparative evaluation of GM103 against competing oncolytic viruses in vitro

· Evaluation of distribution and pharmacokinetic profile of GM103

· In-depth mode-of-action evaluation (in vitro and in vivo)

· Target disease indication expansion study

· Evaluation of GM103 and immune checkpoint inhibitor combination therapy regimen

· Establish CMC and mass production protocol

Intellectual Property

•  Patents granted in Korea (3), US (1), EU (1), Japan (1), German (1), Singapore (1) and India (1)

•  Patent applications filed in Korea (1), US (1), EU (1) and China (1)

Competitive Advantages

Most competitor products have been developed to target one aspect of lung cancer. In sharp contrast, GM103 in combination with immune checkpoint inhibitor can function can simultaneously target and regulate multiple survival- and metastasis-related signaling pathways of the tumor as well as inducing robust antitumor immune response, ultimately fulfilling unmet needs of patients with locally accessible solid tumors.

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