Establishment and Investment in AlphaNavi Pharma Corporation, a Carve-Out Venture Company from Dainippon Sumitomo Pharma Co.

Kyoto University Innovation Capital Corporation ("Kyoto iCAP"; Headquarters: Sakyo-ku, Kyoto; President: Koji Murota) and Dainippon Sumitomo Pharma Co. ("AlphaNavi"; Headquarters: Sakyo-ku, Kyoto; President: Yoshihiro Oyamada), a carve-out venture company from Dainippon Sumitomo Pharma, through a third-party allocation of new shares.

For AlphaNavi's Round A third-party allotment of approximately 900 million yen in total, a coalition of investors, including Kyoto iCAP, Shinsei Capital Partners, SMBC Venture Capital Co. Ltd. and Dainippon Sumitomo Pharma Co.

AlphaNavi is a carve-out venture company from DSP, established in January 2019 by two DSP employees with support from Kyoto iCAP. DSP-2230 (development code), which was discovered in-house and is being developed for neuropathic pain, will be carved out by DSP with the aim of promoting research and development for neuropathic pain diseases such as those associated with genetic mutations through collaboration with outside parties AlphaNavi is a DSP AlphaNavi has licensed the rights to manufacture, develop, and market DSP-2230 from DSP, and aims to commercialize DSP-2230 as a therapeutic agent for the treatment of pediatric extremity pain seizures and other disorders.

Pediatric Limb Pain Seizures is a rare disease with a high unmet medical need. A research group led by Professor Emeritus Akio Koizumi of Kyoto University Graduate School of Medicine and Professor Tsutomu Takahashi of Akita University Graduate School of Medicine discovered a Japanese family with a characteristic condition of periodic pain attacks triggered by cold or fatigue from infancy, and named the condition pediatric limb pain attacks. They also found that the pain attacks were caused by a single nucleotide mutation in the SCN11A gene (Nav1.9), which is a voltage-gated sodium channel, and that this mutation causes abnormal excitation of the channel localized in peripheral nerves, leading to the onset of pain.

AlphaNavi plans to enter into a joint research agreement with Professor Emeritus Koizumi for non-clinical studies of DSP-2230 to further clarify the efficacy and characteristics of DSP-2230 for diseases with high unmet medical needs, such as pediatric extremity pain attacks, and to promote clinical development.

Kyoto iCAP highly evaluated AlphaNavi's management philosophy of bringing new therapeutic agents to pain patients for whom existing drugs are inadequately effective as soon as possible and the potential of the company's pipeline, and provided support including business development such as implementation of carve-outs even before the company was established. DSP hopes that the carve-out of DSP-2230 and open innovation through industry-academia collaboration with academia, centered on AlphaNavi, will promote the research and development of DSP-2230 based on a new development strategy and contribute to the treatment of diseases with high unmet medical needs. We are looking forward to this.

Professor Emeritus Koizumi, AlphaNavi's Scientific and Technical Advisor, stated. Pediatric Limb Pain Syndrome occurs mainly in early childhood and adolescence, and its severe pain can significantly impair quality of life. We hope that AlphaNavi's work will help us identify new patients.

Professor Takahashi, Professor Emeritus Koizumi's co-research partner, stated, "Now that the cause of pediatric limb pain seizures, which is ineffective with existing pain medications, has been elucidated, the practical application of a therapeutic drug that blocks the function of the causative gene is the most promising therapeutic development. Now that we have identified the cause of pediatric limb pain attacks, for which existing pain medications are ineffective, the practical application of a therapeutic agent that blocks the function of the causative gene is considered the most promising therapeutic development.

AlphaNavi's Representative Director, Mr. Oyamada, stated, "In recent years, it has become clear worldwide that pain is caused by mutations in voltage-gated sodium channels. AlphaNavi is committed to the rapid and efficient development of DSP-2230 through collaboration between industry, government and academia, with a focus on patients and their families. AlphaNavi hopes to advance the development of DSP-2230 quickly and efficiently through collaboration between industry, government, and academia, with a focus on patients and their families.

Overview of AlphaNavi Pharma, Inc.

Establishment	January 2019
Business	Research and development of selective voltage-dependent sodium channel inhibitors such as DSP-2230
Head Office Location	36-1 Yoshidahonmachi, Sakyo-ku, Kyoto, Japan (in the International Science Innovation Building, Kyoto University)
President & CEO	Yoshihiro Oyamada
Osaka Office	33-94 Enoki-cho, Suita City, Osaka, Japan (Dainippon Sumitomo Pharma Research Institute Co.)

 

(Reference)

[About the carve-out]
A carve-out is when a company carves out a portion of its business and spins it off as one of its outside businesses with a combination of outside capital to establish the independent business as a new venture.

About DSP-2230
DSP-2230 is a selective voltage-gated sodium channel inhibitor with a novel mechanism discovered by DSP. Non-clinical studies using a neuropathic pain model have shown that DSP-2230 exhibits excellent analgesic effects and does not cause central nervous system or cardiac side effects, which are problems with existing drugs. The agent is being developed for the treatment of neuropathic pain, and Phase I studies have been completed in the United States, the United Kingdom, and Japan.

[About Pediatric Limb Pain Seizures.
Pediatric Limb Pain Attack Syndrome is a pain attack in the limbs of infants and toddlers induced by cold or fatigue, and it has been elucidated that the pain attack is caused by a mutation in the gene "SCNA11A". For details, please refer to the Kyoto University announcement below.
http://www.kyoto-u.ac.jp/ja/research/research_results/2016/160527_1.html

About Dainippon Sumitomo Pharma Co.
Dainippon Sumitomo Pharma's corporate philosophy is to contribute broadly to society by creating new value based on research and development for the betterment of people's health and prosperity. To realize this philosophy and to deliver innovative and useful pharmaceutical products to people in Japan and around the world, we are fully committed to research and development of new drugs. We have designated neuropsychiatry, oncology, and regenerative/cellular medicine, where there are significant unmet medical needs, as priority research areas, with the aim of discovering innovative drugs.