Stella Pharma Corporation
The BNCT Field Pioneer

Stella Pharma is a pharmaceutical company specializing in the research and development of drug products for boron neutron capture therapy (BNCT). As the primary purpose, the company has been aiming to expand and also gain recognition of BNCT as a novel modality of cancer treatment.

Its unrelenting effort and passion for research have earned Steboronine^®, the boron drug that Stella Pharma has been distributing since 2020, the tag of the world-first BNCT drug. At present, it is in charge of sales and marketing of the drug in Japan. At the same moment, the company strives to disseminate BNCT from the cradle of a formally approved treatment.

Steboronine^® is a pre-mixed drug product for intravenous injection, containing borofalan (10B) as an active pharmaceutical ingredient (API). This borofalan (10B) will be over 99 percent of its isotopic enrichment owing to the fact that only 10B boron brings about nuclear reactions toward thermal neutrons in BNCT, while natural boron consists of 80 percent of 11B isotopes and 20 percent of 10B isotopes. This is why natural boron hardly functions in BNCT. Steboronine^®’s arrival on the market was certainly a game-changer for BNCT. It is widely recognized as a radiation therapy that only calls for single irradiation in each treatment. Moreover, it has a positive impact on those who struggle with recurrent head and neck cancer after standard radiation therapy. BNCT can be a practical option for them.

The boron drug for BNCT must utilize a specific isotope, known as 10B, among stable isotopes. 10B also needs to undergo further isotopic enrichment. Stella Pharma, to this end, has made significant progress in its drug development process by partnering with a company capable of manufacturing high-quality and highly enriched pure 10B. The development successfully ended up fulfilling over 99 percent of its isotopic enrichment and marketing the high-grade boron drug.

“We are the ones who have been performing a leading role in realizing commercialization of boron drug as well as BNCT, ahead of the world. In a sense, we carried out this challenging project through all the collaborative work with device companies even from the early stage of research,” says Koki Uehara, COO, Stella Pharma.

At present, BNCT is approved for those with head and neck cancer. Stella Pharma is diligently working towards expanding its indications by leveraging the potential of Steboronine^®. Additionally, the company has strategic plans to initiate overseas business operations in the upcoming years. The phase II study of BNCT involved 21 head and neck cancer patients, and the post-treatment response rate was 71.4 percent at the 90-day mark. In Japan, patients with head and neck cancer who are applied to BNCT are supposed to have no treatment alternatives. Amongst them, one may not physically stand for a surgical operation, and another may be the one whose QOL deteriorates due to surgery. Concerning such patients, there were actual cases where BNCT diminished a tumor at first, and the tumor turned into resectable.

The company is also developing diagnostic imaging, FBPA-PET, to visualize the internal distribution status of the boron drug. In such a way, Stella Pharma intends to keep providing the next-generation BNCT as well. At present, it is planning a clinical trial that combines FBPA-PET and BNCT.

Stella Pharma waves the banner of its managerial philosophy, more like its motto, stating ‘For a precious and irreplaceable life’. Besides the conventional treatment for cancer, offering a new modality of cancer treatment as BNCT surely corresponds to its philosophy. The company strongly believes that BNCT can be, or even has been, an effective option for those who struggle against cancer—even for those who are engaged in medical services.