STELLA PHARMA CORPORATION announced today that our Company has entered into a Development and Collaboration Agreement (“the Agreement”) with TAE LIFE SCIENCES US, LCC (“TLS”Head office: USA, California, CEO: Robert Hill) for the development and commercialization of Borofalan (10B) “BPA” in Europe and the US to be used in BNCT (Boron Neutron Capture Therapy) for head and neck cancer※1 as a primary indication.
1.Background of the collaboration
Founded under the umbrella of TAE Technologies, an US nuclear fusion company, TLS is an unlisted US
biotechnology company working on BNCT by developing a low energy accelerator-based neutron
irradiation system (“Alphabeam™”) and the next generation BNCT drugs, other than BPA. TLS
concentrates its business with great effort on Europe and the US toward the global BNCT market
expansion, and already decided to introduce Alphabeam™ in Italy..
Our Company received the manufacturing and marketing approval in Japan for the world’s first BNCT
drug (Product name: Steboronine®, hereafter “the BPA drug”) in March 2020 for unresectable recurrent
or unresectable advanced head and neck cancer.
Our Company and TLS both recognize that the BPA drug, already used in clinical sites in Japan, is a
world-leading drug for the expansion of BNCT. We also believe in the growth potential and the
importance of an early entry in the European and US market. This led to the Agreement with the target
of quickly realizing the commercialization of the BPA drug.
２.Main contents of the collaboration
The Agreement focuses on joint development and commercialization, which includes the
implementation of clinical trials using BPA developed by our company and Alphabeam™, that TLS will
introduce to medical institutions in the development region agreed with us.
The collaboration includes extensive international cooperation across the USA and Europe with clinical
trials anticipated to begin in 2026. Subject to the confirmation of the relevant authority, Stella Pharma is
expected to obtain marketing the approval for the BPA drug, and TLS will be granted with an exclusive
sales right in the region at the commercialization stage.
Furthermore, TLS will be responsible for the development of the medical equipment part and the
implementation of clinical trials, while our Company will supply the investigational drug and be
responsible for developing boron drugs based on existing products complying with the laws and
regulations of the relevant region.
Although the initial regions are Europe and the US, both companies agree on gradually expanding the
target countries. In addition to head and neck cancer, we are aiming to expand the target indications,
to include glioma※2, meningioma ※3, angiosarcoma※4 and solid thoracic malignant tumors※5, for
which clinical trials are being conducted in Japan.
To expand the BNCT market, we will also provide the BPA as an investigational drug to medical
institutions that use BNCT system from other manufacturers than TLS. After the marketing approval,
however, TLS and Stella Pharma will cooperate in supplying the approved drug.
３.Overview of TLS
Corporate site: https://taelifesciences.com/
4.Schedule
Board of Directors Resolution: November 14, 2024 JST
Agreement Execution: November 13, 2024 PST (November 14, 2024 JST)
5.Outlook.
Although this conclusion will impact our financial results for the current fiscal year (ending March 2025)
only minimally, this alliance will contribute to our medium- and long-term financial results and the
improvement of our corporate value. At this point, the impact on our future financial results has not
been determined, but if any disclosure requiring change arises, it will be disclosed promptly.
６.Others
TLS’s news release on this.
https://taelifesciences.com/tae-life-sciences-and-stella-pharma-announce-strategic-agreement-for-development-and-commercialization-of-bpa-for-bnct-cancer-therapy-in-the-usa-and-europe
※1 Head and neck cancer
Head and neck cancer is a group of cancers that develop below the brain, ranging from the cranial
base to the collarbone (such as the ear, nose, mouth, jaw and throat areas). The head and neck areas
contain organs necessary for everyday activities, and therefore there is a need for the establishment
of treatment that can both control the cancer and preserve such functions after the treatment.
BNCT is a treatment in which radiation destroys cancer cells only, and is therefore expected to
control the cancer while having less impact on peripheral normal tissues and their functions
※2 Glioma
Glioma is a sort of malignant tumor that develops in the brain and comprises approximately 30% of
primary brain tumors. According to the malignancy, they are classified into four stages (grade I -IV).
Glioma of grades III and IV are called glioblastoma. Malignant glioma including glioblastoma are also
today considered as difficult to treat.
※3 Meningioma
Meninges are thin layers of tissue protecting the brain and spinal cord. In the inner side of these
inner layers the brain tumor meningioma develops. Most meningiomas are benign (WHO grade I, but
the highly malignant (WHO grade II and III) can also infiltrate the brain, cerebral blood vessels and
skull, leading to repeated recurrences. Furthermore, they can develop metastasis into the lungs and
other organs. Recurrences are treated with surgery or external X-ray irradiation, but several
limitations still exist and therefore, there is no effective treatment established yet.
※4 Angiosarcoma
Angiosarcoma is cancer that develops endothelial cells of blood vessels. It can occur anywhere in the
body but mostly occurs in the skin.
※5 Thoracic solid malignant tumors
Esophageal cancer, non-small cell lung cancer, breast cancer, malignant soft tissue sarcoma occurring
in thoracic area, malignant pleural mesothelioma, etc.
