May 9, 2022

Phase I clinical trial initiated for
HER2-targeted CAR-T cell therapy BP2301
Tokyo, Japan - May 9, 2022/ -- BrightPath Biotherapeutics (TSE Growth 4954), a clinicalstage biopharmaceutical company focused on developing novel immunotherapeutics, today
announced that the start of an investigator initiated phase I clinical trial testing the safety andefficacy of BP2301, a HER2 CAR-T cell product genetically modified with non-viral vectors , inpatients with HER2-positive recurrent or progressive bone and soft tissue sarcomas andgynecologic malignancies at Shinshu University Hospital. BP2301 has been developed
collaboratively by BrightPath and Shinshu University.
Pharmaceuticals and Medical Devices Agency (PMDA) accepted the clinical trial notificationand the investigator initiated clinical trial of BP2301 starts as of May 6, 2022. Japan Agency
for Medical Research and Development (AMED) gives financial supports for this clinical trial,using one of AMED’s programs called the “Project for Regenerative/Cellular Medicine andGene Therapies.”
BP2301 is an autologous chimeric antigen receptor T(CAR-T) cell product targeting HER2protein that is highly expressed in various types of solid tumors. CAR-T cell therapy has been
approved globally with the excellent clinical performance in treatment of hematologicalmalignancies. BP2301 is expected to open an opportunity to apply CAR-T cell therapy for alarger number of patients with solid tumors.
In general, solid tumors are more complex than hematologic tumors and have evolved multiple
mechanism to keep them immunosuppressive. This has limited the use of CAR-T cells to treat
solid tumors. CAR-T cells get exhausted and cannot perform durable anti-tumor function in theimmunosuppressive tumor microenvironment. To overcome the T cell exhaustion barrier in solidtumors, we developed a new approach using piggyBac transposon system to manufacture CART cells together with Professor Yozo Nakazawa, Department of Pediatrics, Shinshu University
School of Medicine, and Professor Shigeki Yagyu, Shinshu University-Innovative Research &Liaison Organization. BP2301 exhibits a dominant fraction of stem cell memory-like T cells(Tscm)that are less exhausted, having continual proliferation capacity and ability of self-renewal,
and long-lived in vivo.

BP2301 is a promising solution to enhance resistance to T cell exhaustion

and to achieve long-lasting anti-tumor effects against solid tumors. This novel method rests on
the non-viral gene transfer method established by Professor Nakazawa.

1About BrightPath:
BrightPath Biotherapeutics is an immuno-oncology focused biotech company dedicated toimproving treatment and clinical outcomes for patients through cancer vaccine, therapeutic
antibodies, and cell therapy that harness the immune system to fight cancer.
BrightPath’s clinical-stage product, GRN-1201 is a new cancer vaccine in phase 2 trial inpatients with melanoma and lung cancer in US. BP2201 in-collaboration with RIKEN, Japan is
an iPSC (induced pluripotent stem cell)-derived NKT therapy and the phase 1 trial is currently
ongoing in Japan.
BrightPath’s broad pipeline of immunotherapy includes several potentially first-in-class and bestin-class clinical and preclinical candidates in cancers with high unmet medical need.
BrightPath has been a pioneer in immunotherapy by cancer vaccine and has expanded its
expertise in the tumor microenvironment and immune cell development as well as antibodyengineering. This innovative approach has resulted in a diversified proprietary portfolio ofcancer vaccine, therapeutic antibody, and immune-cell therapy.
Based in Tokyo, Japan, BrightPath is listed on Tokyo Stock Exchange in Japan. For more
information, visit www.brightpathbio.com
Forward-Looking Statements:
This news release contains forward-looking statements that are based on the current
expectations and beliefs of BrightPath. All statements, other than statements of historical fact,
are statements that could be deemed forward-looking statements. BrightPath cautions thatthese forward-looking statements do not guarantee our future financial results but involve risks
and uncertainties that could cause actual results to differ materially from those discussed in theforward-looking statements. These forward-looking statements speak only as of the date of thispress release and BrightPath assumes no duty to update forward-looking statements, except as
may be required by law.
Investor and Media Contact:
Director of Corporate Management
irpr@brightpathbio.com
www.brightpathbio.com

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