Startup Genome launched the first cohort of the Global Hypergrowth Tokyo late-stage scaling program in March 2024 in partnership with the Tokyo Metropolitan Government. The initiative aims to propel the best Tokyo tech companies into successful global commercialization and expansion into international target markets.

The program addresses a significant support gap for fast-growing startups, recognizing them as drivers of economic growth and competitiveness, and creators of sustainable jobs and societal wellbeing. In its inaugural cohort, Hypergrowth provides 21 companies from Tokyo with access to global mentors, expert scaling advice from leading executives, go-to market support, and connections to potential new customers and investors.

The companies selected represent a variety of sub-sectors, including Deep Tech, Life Sciences, and AI, and have raised close to $100 million in total funding as they look to expand overseas.

In this article series, Startup Genome introduces the cohort companies, exploring the groundbreaking technologies each startup is developing to make a positive impact on the world.

Nagasaki-based SCM BioMedica Co., Ltd. is revolutionizing cancer treatment to create a future without fear. Established in 2023, the company is dedicated to advancing SCM therapy, an innovative form of cancer immunotherapy.

Yoshimasa Tanaka, CEO, established PD-1 immune checkpoint inhibitors in 2000, and has been focusing on the development of SCM therapy to augment the therapeutic efficacy of PD-1 inhibitors. SCM therapy integrates PD-1 immune checkpoint inhibitors with specific biologics and is designed to target both the priming and effector phases of immune responses against cancer. Importantly, SCM therapy promotes the efficient generation of stem cell memory T cells and central memory T cells, which subsequently differentiate into effector memory T cells and tumor-specific effector T cells.

Startup Genome spoke to SCM BioMedica for a look into its groundbreaking technology, biggest challenges, and future innovations.

Yoshimasa Tanaka (YT): Currently, in Japan, approximately one in two people will develop cancer at least once in their lifetime, and about half of cancer patients die as a result of the disease. Until about 10 years ago, standard treatments for cancer primarily included surgery, radiotherapy, and chemotherapy. In 2000, I developed the world’s first PD-1 immune checkpoint inhibitor. Following non-clinical trials in animal models, the PD-1 immune checkpoint inhibitor was launched as an anticancer drug in 2014. At present, PD-1 immune checkpoint inhibitors are increasingly becoming the first-line treatment for many types of cancer. PD-1 immune checkpoint inhibitors demonstrate higher efficacy and fewer side effects compared to conventional standard therapies. Over the past decade, pharmaceutical companies have been developing combination therapies that integrate PD-1 immune checkpoint inhibitors with chemotherapy. However, traditional chemotherapies have negative effects on immune effector cells, limiting the overall efficacy of such combination therapies. In response to this challenge, our company has focused not only on the effector phase but also on the priming phase of the immune response. Through the use of structured clinical management (SCM) therapy, we have successfully increased the number and enhanced the activation of antitumor immune effector cells in mice models. This innovation allows for the maximization of the antitumor effects of PD-1 immune checkpoint inhibitors.

YT: SCM therapy consists of three agents, two of which have already been commercialized. However, the remaining biologic must be prepared by ourselves. To date, we have successfully established a manufacturing method at the laboratory scale. In the seed round, our primary objective will be to outsource the production to a Contract Development and Manufacturing Organization to establish large-scale manufacturing processes and develop a formulation protocol. Following this, in the Series A round, it will be necessary to conduct non-clinical trials using the non-GMP-manufactured biologic.

In the Series B round, we will proceed with GMP-compliant manufacturing to obtain the investigational drug for clinical trials. Finally, in the Series C round, we plan to conduct Phase I/IIa clinical trials to evaluate the efficacy and safety of SCM therapy for cancer. As we move forward with the development of SCM therapy through the seed rounds, securing sufficient development funds will be essential. To that end, we aim to engage in discussions and consultations with venture capital firms to secure the necessary funding for the development process.

YT: SCM therapy utilizes three biologics, all of which were developed in Japan. Among these, I developed the the PD-1 immune checkpoint inhibitor in 2000. Another biologic was discovered in 1995 by one of our company’s research collaborators. As a result, we possess extensive knowledge regarding these two molecules, giving us a competitive advantage that other companies cannot easily match. The use of these three agents in SCM therapy enables not only the activation of immune effector cells during the effector phase, but also promotes the differentiation of early memory T cells by acting on the priming phase. Consequently, SCM therapy exerts effects on both the activation and logistics of immune effector T cells, which enhances therapeutic efficacy in a highly efficient manner.

YT: Startup Genome has introduced us to a number of mentors & investors from the US that has been very helpful.

YT: It is often said that the origins of chemotherapy lie in the development of chemical warfare agents during World War I. Specifically, chemotherapy is believed to have originated from the application of mustard gas as an alkylating agent for cancer treatment. Given this historical background, it cannot be denied that chemotherapy for cancer has traditionally focused on improving overall survival and disease-free survival, often at the expense of addressing the patient's quality of life, which has been regarded as an inevitable trade-off. However, the advent of PD-1 immune checkpoint inhibitors has demonstrated the possibility of developing cancer treatments that are highly effective while causing minimal side effects. At SCM BioMedica, our goal is to develop cancer therapies that are both highly efficacious and low in adverse effects, and to implement these innovations into society. By doing so, we aim to contribute to the enhancement of human health and wellbeing.