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SPM-011

What is SPM-011?

SPM-011 is a boron-containing drug for BNCT developed by STELLA PHARMA.

Challenges of BNCT

One of the reasons why BNCT has not been widely used was the need for boron isotope enrichment technology to produce the chemical entity.

Boron isotope enrichment technology

In nature, boron stably exists in two types: 10B (mass number 10) and 11B (mass number 11), and 10B exists only about 20% of boron. The neutron-induced fission reaction used by BNCT to destroy cancer cells is a reaction that occurs only in 10B, and this reaction does not occur in 11B. Boron isotope enrichment technology separates and concentrates only this 10B to a high concentration, and is an indispensable technology for the success of BNCT owned only by our parent company Stella Chemifa in Japan. And we are the only company in the world equipped with the technology necessary to develop drugs exclusively for BNCT.

Development status of SPM-011

As of March 2021

Head and neck cancer : Obtained marketing and manufacturing approval, then launched (Product name: STEBORONINE® 9000 mg/300 mL for infusion)
Recurrent malignant glioma : SAKIGAKE comprehensive evaluation consultation underway
Recurrent malignant meningioma : Phase II study in Japan underway (As an investigator-initiated clinical trial)
Malignant melanoma and angiosarcoma : Phase I study in Japan underway