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KDDF-201709-60 Combination Therapy of Novel Drug Candidate for Proliferation and Reinvigoration of T cells with Pembrolizumab (anti-PD-1) in Clinical Trial(Oncology, Protein) [2019-08-29]

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

Development and Market Objectives

Genexine, Inc. and NeoImmuneTech are collaborating together for development of Hyleukin-7, an investigational T cell amplifier which is in the stage of early clinical development. Hyleukin-7 enhances T cell mediated immune response by increasing absolute counts of T cells and its functionality. The safety and anti-tumor activity of Hyleukin-7 in combination with pembrolizumab (an anti-PD-1 therapy) is to be tested in patients with triple-negative breast cancer (TNBC). The trial aims to study Hyleukin-7’s effect on the efficacy of pembrolizumab by enhanced antitumor T-cell immunity and increased tumor infiltrated lymphocytes count.

Unmet Medical Need & Target Patients

-  Target Patients: Patients with metastatic, triple-negative breast cancer (mTNBC)

-  Unmet Medical Need: Patients with mTNBC have limited treatment options and may be relatively low responders to immunotherapy drugs.

Status

- Preparing for IND submission in Korea and plans to initiate patient enrollment at the end of 2018

Intellectual Property

(1)   Patent status of Hyleukin-7 product

- Granted : Korea

- Filed and pending : USA, China, Japan, Europe, Canada, Brazil, India, Russia, Indonesia

 

(2)   Patent status of Hyleukin-7 formulation

- Filed and pending : USA, Taiwan, China, Korea

 

Competitive Advantages

- In Phase 1 clinical study, Hyleukin-7 showed increase in absolute lymphocyte counts, as well as CD4/CD8 T cells especially naïve and memory T cells while the numbers of regulatory T cells that are known to hinder anti-cancer effect stay comparable. This result suggests that Hyleukin-7 has potential to be a new drug for T cell based immune therapy.

Contact & Company Overview

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