Notice of the Execution of a Contract with the Japan Agency for Medical Research and Development

NanoCarrier and Axcelead Establish PrimRNA, a New Company Involved in the Development of mRNA Therapeutics

April 23, 2021
NanoCarrier Co., Ltd.
Axcelead, Inc.

NanoCarrier Co., Ltd. (President and CEO: Tetsuhito Matsuyama, “NanoCarrier”) and Axcelead, Inc. (President & CEO:Tomoyuki Fujisawa, “Axcelead”) today announced that they have established PrimRNA, Inc. (“PrimRNA”), and concluded a research and development consignment contract with the Japan Agency for Medical Research and Development (“AMED”) concerning research to develop mRNA therapeutics using NanoCarrier technology, which was selected for AMED’s Cyclic Innovation for Clinical Empowerment () grant program.

PrimRNA will make full use of Axcelead’s extensive drug discovery experience and network, aiming to create the world’s first mRNA therapeutics to treat articular cartilage discovered by NanoCarrier. The aim of the project (“the Project”) recently selected for is to establish GMP-compliant production of the mRNA therapeutics and conduct an investigator-initiated Phase I clinical trial in 2024 to determine verify safety and the recommended dose of the mRNA therapeutics.

Cyclic Innovation for Clinical Empowerment () grant program
of Japan Agency for Medical Research and Development (AMED)

(Vicle: Maximum of 1 billion yen per research proposal)

Project title: Development of mRNA therapeutics for disease-modifying treatment of osteoarthritis
Principal investigator: PrimRNA Inc.
Participating institutions:
 Tokyo Medical and Dental University
  Professor Keiji Itaka, M.D., Ph.D. (Department of Biofunction Research)
  Professor Hideyuki Koga, M.D., Ph.D.(Department of Joint Surgery and Spots Medicine)
 The University of Tokyo
  Professor Sakae Tanaka, M.D., Ph.D. (Department of Orthopaedic Surgery Faculty of Medicine)
Purpose of the Project:
mRNA therapeutics is a new modality of drug discovery with a wide range of potential applications. However, there are still only a few clinical trials in the world for other therapeutic mRNA drugs than vaccines. The project aims to treat articular cartilage with mRNA therapeutics for the first time in the world. There are more than 10 million symptomatic patients with OA in Japan, which is predicted to continue increasing as the population ages. Although OA treatment is currently focused on symptomatic relief, mRNA can provide an option for early intervention.

NanoCarrier and Axcelead will be fully committed to creating new value for mRNA medicines by promoting the practical application of mRNA therapeutics, a new modality, and creating a new market with domestic technology in the field of regenerative medicine.

This will not have a direct impact on earnings for the fiscal year ending in March 2022.
Forecasts for the fiscal year ending in March 2022 will be announced in the section on the forecasts for the fiscal year ending in March 2022 included in the financial results report for the fiscal year ended in March 2021, due to be released on May 13.

■About PrimRNA, Inc.
Establishment︓ April 1, 2021
Address: Ohnoya-Kyobashi Bldg 1-4-10 Kyobashi,Chuo-ku, Tokyo, 104-0031, Japan
Management: President & CEO Tomoyuki Fujisawa (Axcelead, Inc. President and CEO)
 Director, Head of R&D Tetsuo Yoshida(NanoCarrier Co., Ltd. Head of Research)
 Director Tomoya Kurihara(NanoCarrier Co., Ltd. Head of Legal & IP)

■About NanoCarrier Co., Ltd.
NanoCarrier is a clinical-stage pharmaceutical company specialized in drug discovery and clinical development mainly of anti-cancer drugs using polymeric micelles (micellar nanoparticles technology), NanoCarrier’s proprietary drug delivery system (DDS). The DDS is a system which efficiently delivers active ingredients to the site of the disease, maximizing a drug’s efficacy whilst minimizing side effects and it can also be applied to nucleic acid therapeutics, which has gained new attention as a new therapeutic modality. NanoCarrier will contribute to the health and wellbeing of people by expanding beyond the cancer therapy domain into regenerative medicine using mRNA and by providing new therapies based on new technologies.
For more information on NanoCarrier, please visit the company’s website at https://www.nanocarrier.co.jp/

■About Axcelead, Inc.
Axcelead is a group of companies that develops a drug discovery platform business centered on Axcelead Drug Discovery Partners, Inc. (“ADDP”), Japan’s first integrated drug discovery solution provider, which took over Takeda’s drug discovery platform business in 2017. Axcelead, is the flagship portfolio company of Drug Discovery Gateway Fund, which was jointly established by Whiz Partners, Inc., and Takeda Pharmaceutical Company, Co., Ltd., in 2018, with the aim of promoting the drug discovery ecosystem in Japan and will make various contributions to healthcare broadly and globally. For more information on Axcelead, please visit the company’s website at https://www.axcelead-hd.com/.

■Contact
NanoCarrier Co., Ltd.
Ohnoya-Kyobashi Bldg 1-4-10 Kyobashi,Chuo-ku, Tokyo, 104-0031, Japan
Contact form: https://www.nanocarrier.co.jp/contact/

Axcelead, Inc.
26-1, Muraoka-Higashi 2-chome, Fujisawa, Kanagawa 251-0012, Japan
Contact form: hd_contact@axcelead.com