ALPHAGLIO: Development of a novel treatment for glioblastoma

Glioblastoma multiforme (GBM) is a highly aggressive and common type of brain tumor, causing severe neurological issues and significantly reducing patients' quality of life. Unfortunately, the current standard of care (SoC) for GBM, which involves surgery, radiation therapy, and chemotherapy, has limited success, with a median survival of only 14-16 months and a low overall survival rate. Blue Wave Therapeutics is tackling this challenging medical issue with a groundbreaking approach. They are developing a novel treatment called ARAspheres, aiming to be the next-generation solution for relapsed or refractory GBM and other related brain conditions. ARAspheres consists of alpha-particle emitting nanospheres, representing a significant advancement over existing therapies. The innovative treatment involves a single implantation and a unique mechanism of action, providing a more effective and potentially less side-effect-prone option for patients. The current standard treatments for GBM have significant limitations, leading to tumor relapse in 80% of cases and death in 70% of patients within two years. Blue Wave's ARAspheres, on the other hand, offers a promising alternative. The treatment consists of biopolymer spheres that bind specifically to tumor cells, delivering a radionuclide to irradiate and eliminate the cancerous cells. This groundbreaking solution not only presents a new option for primary and recurrent GBM patients but also has the potential to be used in combination with the current standard of care, providing a more efficient and improved quality of life for GBM patients. In essence, Blue Wave's innovative approach addresses a critical unmet medical need and opens up new possibilities for the treatment of this devastating disease.

Glioblastoma multiforme (GBM) is the most commonly occurring malignant primary brain tumor. Due to its aggressive nature, a diagnosis with GBM results in severe neurological deficit and reduction in patients’ quality of life and the disease can be rapidly fatal. GBM is responsible for ~200,000 worldwide deaths per year, including nearly 15,000 in EU and 9,000 in the US, having a median survival of 14-16 months, a 2-year overall survival rate of less than 30% and a 5-year survival rate of less than 10%. The current standard of care (SoC) for GBM consists of surgical resection to remove the primary tumor, usually followed four to eight weeks later by external beam radiation therapy and adjuvant chemotherapy. Despite the complex treatment algorithm, prognosis remains poor, resulting in tumor relapse in 80% of cases and death in 70% of patients within 2 years. Therefore, GBM remains a serious unmet medical need. Blue Wave Therapeutics is developing a novel treatment with potential to become the next generation treatment for relapsed or refractory primary or secondary GBM or brain metastases. With ALPHAGLIO, Blue Wave seeks to deliver the first alpha-particle emitting nanospheres for GBM treatment and achieve greater effectiveness and fewer side effects than existing therapies. Both the single implantation and the mechanism of action represent a substantial innovation for the treatment of these deadly diseases. The shortcomings of the current SoC for GBM creates a significant opportunity for a novel, first-in-class targeted therapy to become successful in this indication. Our innovative drug is comprised of tumor-binding biopolymer spheres that chelate a radionuclide that will irradiate and kill the tumor cells. Therefore, our ground-breaking solution will constitute a new treatment option for primary and recurrent GBM patients that can also be combined with the SoC, providing an efficient alternative to improve the quality of life of GBM patients.