No. 2023.53

Rebirthel Co., Ltd.
Developing a novel allogeneic T cell therapy with cytotoxic T lymphocytes
regenerated from induced pluripotent stem cells (iPSCs)
Creation Core Kyoto Mikuruma 448-5
Kajii-cho, Kamigyo-ku, Kyoto
602-0841 Japan
https://rebirthel.com/en/

Founded in 2019
Founder & CTO: KAWAMOTO Hiroshi MD PhD
President & CEO: KAJIKAWA Masunori
No. of employees: 8
Type of Ownership: Private
Primary stock exchange: N/A

October 2023: Preparing the first clinical trial
conducted in humans for acute myeloid leukemia toevaluate safety and efficacy.
Venture Valuation (VV) interviewed, Mr. Kajikawa Masunori, President & CEO.

VV:

There are reports that the use of iPSCs in regenerative medicine potentiallycauses the formation of tumors. Please explain what your solution is.

Kajikawa:

It is known that contamination of undifferentiated iPSCs causes the formation oftumors. Those cells have not yet acquired a specific structure and function justlike mature cells do. It is essential to eliminate them for successful iPSC-derived
cell therapy.
Led by our founder, Prof. Kawamoto of Kyoto University, we have learned how tocontrol and check the quality of cells to eradicate undifferentiated iPSCs.
Furthermore, we have constantly controlled the quality of IPSCs-divided cell
preparation used for cell therapy in a year-long safety test.

VV:

Your novel allogeneic iPSC-derived T cell therapy technology will be an advanced
cancer treatment. How do you position your technology in the cancer treatment
field?

Kajikawa:

To treat various cancers, we need a greater variety of treatments that include
non-cell therapies and cell therapies. Our technology is for the cell therapy fieldthat consists of autologous and allogeneic. (see the chart on the next page)
Autologous cell therapy is a treatment in which patient-derived T cells arestrengthened ex vivo by activation or genetic modification and introduced backinto the patient. The process of autologous cell therapy is known to be timeconsuming, costly, and heterogeneous in quality.

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Allogeneic T cell therapies are currently TCR (T Cell Receptor), in which ourtechnology is classified, and CAR (Chimeric Antigen Receptor). CAR technology
is an artificial receptor to recognize tumor cell surface antigens. It is noteffective for solid tumors.
Meanwhile, our allogenic TCR therapy uses pluripotent stem cell as a material
and TCR therapy is transduced to recognize cancer antigens. It is applicable toany cancer including solid cancer.

VV:

Among various allogeneic approaches that other companies are developing, yourtechnology excels in suppression of immune rejection, antigen specificity, andinduction of antigen specific T cells.

Kajikawa:

Those fields are our intellectual property. The chart below illustrates the processof transduction, differentiation, mass-production, and frozen stock to provide
off-the-shelf T cells to patients. We already have patented technologies at eachcritical step in all schemes.
We have the advantage of producing large quantity of T cells to make our therapy
available to patients suffering from cancer at affordable prices and delivered
without delay.

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No. 2023.53

VV:Your first target of the in-house pipeline projects is acute myeloid leukemia. Why
not a solid cancer?

Kajikawa:

Our vision is to pioneer a new era of cancer treatment. For the purpose of that,
we understand that solid cancer is the must targeted field.
However, as this is a brand-new cancer treatment, we selected acute myeloid
leukemia to demonstrate the safety and efficacy of our technology. CAR T-celltherapy has become a promising treatment for various types of blood cancer likeleukemia.

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No. 2023.53

VV:

On the pipeline chart above, you are listing several partnering business projects
for cancer and infectious diseases. What is your business development plan?

Kajikawa:

We intend to submit an IND (Investigational New Drug) application in Japan when
the first-in-human clinical trial for acute myeloid leukemia will start in late 2025.
Raising funds of US$ 20 to 30 million is our objective.
Currently we are proactively in discussions with pharma and biotech companies
as well as investors worldwide for licensing and collaboration opportunities. Any
inquiries and suggestions are welcome.

VV Comments after the interview:
A report on the market of cell therapies published on August 20221 mentions that
more than 250 companies in the world are engaged in the development of morethan 1,200 early and late-stage T cell therapies. Over 6,800 patents are related
to CAR-T therapy. TCR therapies and others such as TIL (Tumor Infiltrating
Lymphocyte) therapy have been demonstrating continued innovation.
Considerable funding is indispensable. The same report points out that “… to fundproduct development initiatives in this domain, capital investments worth USD 30billion have been made by various private and public sector investors in the last
few years. Driven by the ongoing pace of innovation in this field, sufficientfinancial support from investors and encouraging clinical results, the T-cell
immunotherapy market is anticipated to witness substantial growth in the mid tolong-term.”
CAR-T therapy is working in liquid tumors but not the solid tumors representing
approximately 90 percent of adult human cancers2. Rebirthel’s allogeneic T celltherapy for treatment of solid tumors will be a significant breakthrough for thecancer treatment field. An affordable price and speedy delivery to patients are apathway to democratizing cancer care.

Contact

Mariko Hirano, m.hirano (at) venturevaluation.com
Venture Valuation specializes in independent assessment and valuation oftechnology-driven companies in growth industries, such as the Life Sciences(Biotech, Pharma, and Medtech), ICT, Femtech, Nanotech, Cleantech andRenewable Energy. In addition to valuation products, Venture Valuation offers
high-quality, focused information services like the Global Life Sciences Database,
Biotechgate.com and this “Let’s Interview Series” with companies with1
2

https://www.rootsanalysis.com/reports/t-cell-therapies-market/261.html
https://themedicinemaker.com/discovery-development/completing-the-cell-therapy-revolution

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No. 2023.53

interesting technologies and services. We select and interview thriving companies
and organizations especially in Switzerland and Japan.

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T +41 (43) 321 86 60 | F +41 (43) 321 86 61 | www.venturevaluation.com | www.biotechgate.com