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A world where bone marrow tests are replaced by blood tests. Liquid Mine's challenge to resolve pain in leukemia patients with liquid biopsy

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“Establishment of leukemia testing methods using the latest genetic analysis technology”

"Liquid biopsy" technology is currently in the spotlight worldwide. Aiming to create a tailor-made blood test for leukemia patients Liquid Mine Co., Ltd. We interviewed Mr. Tomokazu Kishimoto, the president of the company.

Spin-out from the Institute of Medical Science, University of Tokyo

Please tell us again about Liquid Mine's business outline.

We have two main technologies. One is whole genome analysis (*). Since it is known that leukemia is caused by genetic mutations, whole genome analysis is performed to accurately identify the causative gene mutations. We will identify the gene mutation that causes the onset of leukemia and lead to the treatment of leukemia. The other is technology related to leukemia monitoring tests. The conventional monitoring test is a method called bone marrow examination, in which a needle with a diameter of about 4 mm is inserted into the hip bone to collect bone marrow fluid. By utilizing Liquid Mine's technology, it is possible to replace bone marrow examination with blood examination. This is a technique called liquid biopsy, which utilizes minimally invasive liquid biopsy that places less burden on the body.

#Whole genome analysis

The process of comprehensively analyzing the genetic information of the genome, which is essential for analyzing the characteristics of organisms. A machine called a sequencer is used to read the base sequence of the DNA molecules that make up the genome (the sequence of guanine, adenine, thymine, and cytosine).

You mentioned that you are a startup from the Institute of Medical Science, the University of Tokyo.

Since around 2015, I have been researching two technologies, whole genome analysis and monitoring testing, at the Institute of Medical Science, the University of Tokyo. Around 2019, the results of my research began to appear, and I published a paper. Genomic medicine has begun to attract a lot of attention worldwide, and the founder decided to spin out with the desire to "implement this technology in society and help as many patients suffering from leukemia as possible." This is how it happened.

Mr. Kishimoto, what inspired you to join Liquid Mine in July 2020?

The first trigger was when I was contacted by the founder when I registered on the career change site. I had the experience of losing a close friend of mine to cancer, and I had always wanted to do something about cancer treatment issues.

Please tell us about any difficulties that you encountered after becoming president and representative director.

Fundraising started immediately after joining the company. There were a lot of tasks that I had never experienced before, such as communication with VCs and capital policy, and it was very difficult to challenge the investor pitch while studying on my own. While going back and forth, I received support from various VCs. Besides finance, it was also very difficult to think about what kind of pharmaceutical strategy and patent strategy we should take as a medical startup.

Genetic analysis technology is attracting attention all over the world. There are similar companies, but what is the biggest advantage of Liquid Mine among them?

Whole-genome analysis reveals hundreds to hundreds of thousands of gene mutations, although there are individual differences. However, this number also includes genetic mutations that describe a person's personality rather than a disease, such as whether hair is curly or straight, or alcohol tolerance. The process of manually judging leukemia-related mutations among hundreds of thousands of genetic mutations is very time-consuming and labor-intensive. Using our filtering technology, we believe that it is a great advantage that we can identify leukemia-related gene mutation candidates in just 3 minutes.

In terms of monitoring test technology, we believe that one of our strengths is that blood tests can replace bone marrow tests, which used to place a heavy burden on patients.

Regulatory approval and intellectual property strategy hold the key

Intellectual property strategy is the key for medical startups. What are you working on now?

Our company and the University of Tokyo have jointly applied for gene mutation filtering technology. This patent has been applied for in Japan, the United States and Europe. In addition, the University of Tokyo has applied for a patent on the intellectual property that forms the basis of our technology, and has adopted the form of granting exclusive license rights to our company. International patent applications are also planned for patents other than gene mutation filtering.

Please tell us about the regulatory approval process that Liquid Mine is working on.

Regarding the data to be obtained for obtaining pharmaceutical approval (*), the Ministry of Health, Labor and Welfare and the PMDA (Pharmaceuticals and Medical Devices Agency) (*) ask whether there is any problem in obtaining such data for obtaining pharmaceutical approval. and must be confirmed. It requires repeated discussions with the PMDA, which requires perseverance and experience. We have experienced and excellent members in charge of pharmaceutical affairs in our company, and we are proceeding with discussions with the Ministry of Health, Labor and Welfare and PMDA centering on those members.

#Pharmaceutical approval

Approval process stipulated by the Pharmaceuticals and Medical Devices Act. In order for a company to manufacture and sell pharmaceuticals and medical devices, it is necessary to apply for approval and obtain approval from the Ministry of Health, Labor and Welfare. PMDA (Pharmaceuticals and Medical Devices Agency), an independent administrative agency, is in charge of reviewing efficacy and safety.

# PMDA (Pharmaceuticals and Medical Devices Agency)

PMDA seeks prompt relief for health hazards caused by side effects of pharmaceuticals and infections mediated by biological products. It is an organization that aims to contribute to the improvement of public health through guidance and examination under a consistent system, and collection, analysis and provision of post-marketing safety information.
(Reference: https://www.pmda.go.jp/about-pmda/outline/0001.html)

Please tell us about global expansion, including overseas medical approval.

First of all, we will proceed with medical approval in Japan, but at the same time we would like to deliver it to patients in the United States and Europe. Since the bone marrow test is a common issue all over the world, there is a high need to replace it with a blood test, and after the publication of the paper, we have received inquiries from overseas. Our technology has received a certain amount of recognition overseas, so we will brush up on our business plan and regulatory strategy.

What do you think will be the key for Liquid Mine to compete in the world?

First of all, it is important to be recognized domestically. When expanding overseas, I think it is important to find good partners in each region and work closely with them to expand the business. In order to acquire overseas partners, it is necessary to improve recognition in Japan.

How do you spend your weekends and stay refreshed?

I have active sons in the 3rd and 1st grades of elementary school, so I try to refresh myself by playing outside with them as much as possible on my days off. On weekends, I spend as much time as possible with my family to refresh my mind. My sons are happy when I take them to zoos and aquariums, so I would like to cherish such times in the future.

What kind of things did you think about when you were a student?

Ever since I was a student, I vaguely wanted to start a business and become a manager. At university, I went to the Faculty of Law and aimed to become a lawyer, but in the corner of my head, I had two words: starting a business.

Building a strong organization with human resources who demonstrate value outside of their areas of expertise

What kind of people would you like to participate in?

The core members are already in place. Most importantly, I would like people who can sympathize with the mission and vision of Liquid Mine to come. The current members also decided to participate because they really wanted to do something for patients suffering from leukemia. If I had to pick one, I would be happy if someone who could entrust the CFO could participate as soon as possible, as we are planning to raise funds in the future.

How many people does your organization currently have?

There are eight employees, including outside directors. The members involved in research and development have a wealth of practical experience in genetic analysis, which is very reliable. Also, there is one member who joined the company as a new graduate after graduating from graduate school, and I am really happy that he often jumped into our company.
(*The number of employees is the number as of July 2022 when we interviewed.)

There are also people who joined the company as new graduates. Is there a message you would like to convey to current medical students?

One option is to pursue a career in medicine after completing your studies, but if you join a medical startup like ours, you will be able to learn about business while interacting with hospitals and academia. Contribute to the development of medicine while growing the company as a member of the startup. I think that kind of life will be one option.

How are you hiring?

Currently, referrals are often used. The member who is mainly in charge of pharmaceutical affairs, who joined us on July 1, decided to participate after about a year of outsourcing.

As a seed-stage Deep Tech startup, please tell us what you are devising to make it a strong organization.

At our company, if you are a researcher, you are not only doing research, but you are asked to take on various duties, such as three or four roles. I would like to create an organization in which people who actively take on challenges even if they are not in their own area of expertise are at the core.

We also place great importance on creating an environment in which employees can work comfortably. Good feedback from employees is reflected immediately. I think that startups have the impression that they work late every day and even on holidays, but I want employees to switch between on and off work, so I almost never have them work on holidays.

Aiming to be covered by health insurance by partnering with domestic testing companies

Please tell us about any past events or programs that have benefited you.

I participated in several programs, but IPAS, an intellectual property acceleration program developed by the Patent Office, was very good. The one-on-one support was very helpful for the weak parts of the patent strategy and business plan.

How do you make use of horizontal connections within the startup ecosystem?

We are connected to startup managers in various industries such as mobility and manufacturing. Even if the industry is different, there are many common concerns among business owners, so I consult with them on a case-by-case basis.

In the future, please tell us how the achievements of the leukemia monitoring test system "MyRD" will lead to overcoming cancer treatments other than leukemia.

Currently, we are focusing on leukemia, but we are considering applying the technology to diseases such as malignant lymphoma and multiple myeloma, so we are considering it as a business strategy. Application to these two types of diseases is still in the early stages of research, but we aim to put it to practical use in the next 3-5 years.

In the future, I would like to utilize cutting-edge genetic analysis to provide an optimal treatment environment for each cancer patient. We would like to implement it in society to achieve our vision of "overcoming all cancers".

Finally, please tell us about the world and goals that Liquid Mine is aiming for.

Our technology cannot be delivered to patients without the cooperation of testing companies. We are already in talks with a major domestic inspection company, but we will first accelerate this kind of business alliance. We are aiming to be covered by health insurance while promoting research and development as well as partnerships with testing companies. If insurance coverage can be realized, sales will increase dramatically, so we believe that it will be a big engine for exit.

Thank you!

Editor's comment

Bone marrow examination is widely recognized as a diagnostic method for leukemia. Liquid Mine is reviewing this common sense and trying to replace bone marrow tests with blood tests. The future in which Japanese medical startups are close to the challenges of leukemia patients around the world is just around the corner.

Liquid Mine Inc.
Address
Shibuya Dogenzaka Tokyu Building, Plug and Play Shibuya, 1-10-8 Dogenzaka, Shibuya-ku, Tokyo
CEO
Tomokazu Kishimoto
Website
http://www.liquidmine.co.jp/index.html
Daiki Nagata
He majored in space engineering as a student. He is involved in planning and managing business contests and accelerator programs and considers writing for space business media his life's work. His hobbies include road biking and watching rugby games.

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