Mitsubishi Gas Chemical and Veritas In Silico Announce Joint Research Agreement for Drug Discovery and Establishment of Manufacturing Methods for Nucleic Acid Drugs

  Mitsubishi Gas Chemical Company, Inc. (MGC; Head Office: Chiyoda-ku, Tokyo Japan; President: Yoshinori Isahaya) and Veritas In Silico Inc. (VIS; Head Office: Shinagawa-ku, Tokyo Japan; CEO: Shingo Nakamura) have entered into a Joint Research Agreement with the aim at discovering innovative nucleic acid drugs and establishing manufacturing methods based on QbD^*1.
 MGC and VIS have been in ongoing discussions and deliberations regarding business cooperation related to nucleic acid drugs since December 2023 and working to enhance the feasibility of the collaboration through the signing of MOU announced in the press release dated October 9, 2024, titled " MGC and Veritas In Silico Sign MOU for Joint Venture in the Development of RNA-Targeted Pharmaceuticals." These discussions have led to the signing of an agreement.

 MGC and VIS will collaborate on drug discovery of nucleic acid drugs targeting long-chain RNA^*2 to obtain development candidates of ASO^*3 and establish manufacturing methods through QbD-based approaches in 3 years of scheduled researching term. In this Joint Research, MGC will establish the manufacturing methods for ASO development candidates based on QbD principles and VIS will acquire the ASO development candidates based on QbD principles, utilizing its proprietary drug discovery platform, ibVIS®.
 The concept of QbD will be adopted from the early stages of research, and the development of ASO manufacturing methods and processes will be advanced in parallel with drug discovery research. By adopting the concept of QbD from the early stages of research, MGC and VIS aim to establish manufacturing methods that meet the quality and reliability requirements for commercial manufacturing, as well as to acquire highly active and low-toxicity compounds, enabling a swift transition to pre-clinical and clinical phases.

 In its medium-term management plan, “Grow UP 2026,” MGC has designated “medical and food” as priority focus areas and is actively advancing various initiatives within these domains. These efforts fall under MGC’s core strategy, “Build new value through innovation,” which is a pivotal component of the broader objective to “Strengthen the resiliency of our business portfolio” outlined in the plan. In addition, MGC has experience and expertise in GMP manufacturing^*4, including the production of antibody drugs. MGC views nucleic acid drugs as a market with future growth potential and, while exploring the possibilities of CDMO business^*5, invested in VIS in 2017 and has been discussing business cooperation with VIS regarding nucleic acid drugs since December 2023.

 VIS has identified ASO compounds as intellectual property and has obtained a patent in Japan. Currently, VIS is conducting in-house research to obtain more efficient and active ASOs. To date, VIS has partnered with several pharmaceutical companies and has conducted joint drug discovery research on small molecule drugs targeting mRNA, utilizing its unique drug discovery platform, ibVIS®, which consists of various drug discovery technologies optimized for mRNA targets. This drug discovery platform is also applicable to nucleic acid drugs, and VIS aims to utilize it in this Joint Research to achieve research outcomes in a relatively short period of time.

 MGC and VIS together promote the collaborative research based on QbD principles and aim to business development of the oligonucleotide therapeutics with utilizing ibVIS® platform provided by VIS.

*1 QbD: Abbreviation for Quality by Design. A concept that incorporates considerations for ensuring product quality from the design stage through to manufacturing.
*2 Long-chain RNA: Refers to RNA molecules that are approximately 300 base pairs or longer, playing a crucial role in protein synthesis and other cellular functions. Examples include mRNA, pre-mRNA, and long non-coding RNA.
*3 ASO: Abbreviation for Antisense Oligonucleotide. A type of nucleic acid drug. Consisting of single stranded DNA or RNA, it binds to mRNA and primarily functions to regulate protein synthesis.
*4 GMP manufacturing: GMP stands for Good Manufacturing Practice. It is a set of guidelines designed to ensure the quality, safety, and efficacy of pharmaceuticals and quasi-drugs throughout all stages of production, from raw material procurement through manufacturing, quality control, and distribution.
*5 CDMO business: CDMO stands for Contract Development and Manufacturing Organization. It refers to a business that provides contract manufacturing services for pharmaceutical development.

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【Reference】　For more details about Veritas In Silico Inc.: https://www.veritasinsilico.com/en/