Alivexis, Inc. (headquartered in Tokyo, Japan, “Alivexis”) and Melodia Therapeutics AG (headquartered in Basel, Switzerland, “Melodia”), a company established by Forty51 Ventures, announced today that they have entered into an exclusive license agreement for the worldwide development, manufacturing, and commercialization of Alivexis’ MDI-0151, a novel Cathepsin C inhibitor with best-in-class potential. MDI-0151 is an innovative clinical candidate identified in Alivexis’ MOD-A discovery program.

Melodia will rapidly initiate IND-enabling activities for MDI-0151 to prepare for a Phase 1/Phase 2a study in various refractory inflammatory diseases caused by excessive activation of neutrophils, such as ANCA-associated Vasculitis and several other relevant diseases in the context of neutrophils.  Patients suffering from these diseases have a high unmet medical need.

Alivexis and Melodia will leverage their respective expertise in drug discovery research and development with the aim of obtaining clinical Proof of Concept in these indications.
Under the terms of the agreement, Alivexis grants Melodia worldwide rights to develop, manufacture, and commercialize MDI-0151 and will receive from Melodia an upfront payment and development and sales milestone payments totaling up to approximately $275 million (JPY 42.7 billion[1]), and will be entitled to receive royalties on net sales of any marketed product. In addition, Alivexis is eligible to receive a number of warrants to subscribe for Melodia’s common shares.

S. Roy Kimura,D., CEO of Alivexis, commented on the deal: “I am pleased to announce the signing of our licensing and clinical partnership with Melodia for our MOD-A Cathepsin C inhibitor program. This event marks a significant milestone for Alivexis and serves as validation of our drug discovery R&D team and platform, our proprietary pipeline of discovery programs, and our business model involving the use of our cutting-edge platform to accelerate clinical candidate discovery for diseases with high unmet need. This is the first of many licensing and collaboration agreements that we anticipate from our maturing portfolio of IND-ready candidate molecules in our pipeline and our unique and proven discovery platform. We are confident that the Melodia team will be able to take our candidate molecule through clinical trials and ultimately help many patients in need suffering from chronic inflammatory diseases.”

Melodia’s founding shareholder Forty51 Ventures commented on the deal: “We are extremely pleased to in-license and continue the development of MDI-0151. We consider that this asset from Alivexis has best-in-class, blockbuster potential. Melodia aims to develop the program in a variety of underserved indications in the field of immunology. Further announcements will follow shortly as Melodia advances this program expeditiously.”

About MDI-0151
MDI-0151 is a clinical candidate compound from the Alivexis’ discovery program MOD-A, focused on Cathepsin C inhibition. Cathepsin C, also known as dipeptidyl peptidase-1 (DPP-1), is an enzyme responsible for the activation of a group of proteases that play an important role in the destruction of tissues by neutrophils. As inhibition of Cathepsin C is believed to have little effect on the immune function of neutrophils, MDI-0151 may effectively treat various immune and inflammatory diseases while not compromising the immune system.

About Alivexis, Inc.
Headquarter：Daiichi Hibiya Building 7F, Shimbashi 1-18-21, Minato-ku, Tokyo 105-0004, Japan
Representative directors: S. Roy Kimura, Ph.D., CEO / Kazuki Ohno, Dr. Eng. COO
Established: August 8, 2016
URL： https://alivexis.com
Business Description: A network-based drug discovery company utilizing cutting-edge technologies.

About Melodia Therapeutics AG
Headquarter：Basel, Switzerland
Founding shareholder: Forty51 Advisors AG
Established: December 2023
URL： https://www.melodiatx.com
Business Description: A biotech company focused on developing therapies for neutrophil-driven diseases.

[1] *USD/JPY conversion rate: 155

Melodia Therapeutics and Alivexis Sign Exclusive License Agreement for Cathepsin C Inhibitor Program MOD-A(PDF)