アプタマー アフェレシス 核酸医薬の開発|タグシクス・バイオ株式会社

News Release

CAGE Bio and TAGCyx announced execution of a license agreement for development and commercialization of TAGX-0003 for the treatment of immunodermatology diseases mediated by the IFN-γ pathway

CAGE Bio Inc. (hereinafter “CAGE Bio”), a biotechnology company focused on developing innovative therapies for infection, inflammation and immunology and TAGCyx Biotechnologies Inc. (hereinafter “TAGCyx”), a biotechnology company developing DNA aptamer drugs based on its proprietary artificial nucleic acid base pair technology, announce execution of a license agreement for development of TAGX-0003, for the targeted treatment of alopecia areata and vitiligo by dermatological application.

TAGX-0003, developed by TAGCyx, is a DNA aptamer possessing potent interferon gamma (IFN-γ) antagonistic activity. TAGX-0003 has shown effectiveness in a humanized animal model of alopecia areata. Applying CAGE Bio’s innovative proprietary ionic liquid formulation technology to TAGX-0003, both parties confirmed TAGX-0003 can penetrate into the skin enabling a non-invasive, efficacious and safe treatment for dermatological diseases in which IFN-γ is implicated.

Under this agreement, CAGE Bio will receive an exclusive worldwide license, excluding Japan, to develop and commercialize the drug.  TAGCyx will receive an upfront payment, development and sales milestone payments and sales related royalties.  Alopecia and vitiligo present a significant social burden affecting the lives of millions of people and represent multibillion-dollar global market opportunities.

PeptiStar Inc. (hereinafter “PeptiStar”), a technology-based Contract Development and Manufacturing Organization (CDMO) for peptide and oligonucleotide drugs will manufacture TAGX-0003 for clinical trials and possible future commercialization.

 

Dr. Nitin Joshi, CEO of CAGE Bio stated “There is a critical unmet need for easy-to-use treatment options for highly visible diseases such as alopecia and vitiligo.  We are excited to partner with the TAGCyx and Peptistar teams to develop an innovative, first-of-its-kind approach to improve the lives of patients struggling with the medical and social burdens of these conditions. We believe that bringing the DNA-aptamer science from TAGCyx together with our ionic liquid platform will help us accomplish this goal.”

Dr. Chizuko Koseki, CEO of TAGCyx said “We were impressed to see the results that our very potent midsize DNA aptamer penetrated into hair follicles in the human skin when formulated in CAGE Bio’s ionic liquid formulation technology. I am pleased we could execute the license agreement with CAGE Bio upon completion of a productive research collaboration and the project will now be advanced to human clinical trials by CAGE Bio. We believe TAGX-0003 will be an efficacious and safe treatment for alopecia and vitiligo patients. We have selected PeptiStar as our CDMO partner to manufacture TAGX-0003, as we are convinced by their excellent facility and the oligonucleotide production capability of their team.”

Dr. Yutaka Kameyama, CEO of PeptiStar said “We are pleased to support this project as the Active Pharmaceutical Ingredient (API) manufacturing CDMO in collaboration with CAGE Bio and TAGCyx. Process development and manufacturing of TAGX-0003 will be implemented in our facilities in Osaka, Japan. We have cGMP production facilities for oligonucleotides with advanced equipment, technologies, and quality management system for manufacturing and scaling-up the production of TAGX-0003 to support all stages of the product.”

 

CAGE Bio Inc. (https://www.cagebio.com/ )

CAGE Bio, based in San Carlos, CA and Fort Worth, TX, is a clinical stage startup company exploiting its proprietary ionic liquid formulation platform to develop products for infection, inflammation, and immunology. CAGE Bio has in-licensed technology developed by a research team led by Prof. Samir Mitragotri from the University of California, Santa Barbara.

 

TAGCyx biotechnologies Inc.  (http://tagcyx.com/en/ )

TAGCyx, based in Tokyo, Japan, is a biotech company exploiting its proprietary Xenoligo® technology platform, allowing high functional oligonucleotide drug discovery. TAGCyx have invented artificial nucleic acid base-pair technology that enables to produce high affinity and selective DNA aptamers “Xenoligo®”. Xenoligo® is a trade mark registered by TAGCyx Biotechnologies Inc.

 

PeptiStar Inc. (https://peptistar.com)

PeptiStar, based in Osaka, Japan, is a CDMO (Contract Development and Manufacturing Organization) for peptide and oligonucleotide APIs. PeptiStar is a technology-based company that provides its customers with high value-added services through its innovative manufacturing technologies.