FDA Grants Orphan Drug Status to Beactica's BEA-17 for Glioblastoma Treatment

Beactica Therapeutics, a Swedish precision oncology company, announced today that the U.S. FDA has designated BEA-17 as an orphan drug for the treatment of glioblastoma (GBM). BEA-17 is a first-of-its-kind small molecule degrader of the epigenetic enzyme LSD1 and its co-factor CoREST. LSD1 overexpression has been linked to the development of a number of cancers, including GBM. There are currently no approved GBM treatments that target this enzyme.

Publish Date: 01-02-2023 Source: Beactica Therapeutics

Glioblastoma (GBM), also known as Glioblastoma multiforme, is the most aggressive primary malignancy of the central nervous system (CNS) in adults, with a median age of diagnosis of 65 years. In newly diagnosed GBM, the standard of care includes maximally safe surgical resection, followed by concurrent radiotherapy and temozolomide (TMZ) and six-monthly cycles of adjuvant TMZ. Treatment options are limited when tumors progress after first-line therapy, and recurrent GBM (rGBM) management remains challenging. GBM recurrence is inevitable after a median survival time of 32–36 weeks due to a lack of uniform definition and criteria for tumor recurrence; institutional variability in treatment philosophy; and the heterogeneous nature of the disease, including the location of recurrence and distinct mechanisms believed to contribute to known subtypes of GBM. More than 90% of patients with glioma showed recurrence at the original tumor location, and that multiple lesions developed in 5% after treatment. Second, although less common, GBM may also recur by developing new parenchymal lesions that fail to exhibit continuous growth patterns, intraventricular spread, or dissemination.

The incidence of Glioblastoma (GBM) ranges from 2.8 to 3.2 cases per 100,000 population in the USA, among which 70 to 80% are recurrent cases.

However, the current Glioblastoma (GBM) treatment market share, market uptake, and attribute analysis concerning the most potential emerging therapies (VB11, DSP-7888, AV-GBM-1, etc..) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.

In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for the Glioblastoma (GBM) treatment. The key companies in the advanced development stage are VBL Therapeutics, Sumitomo Pharma Oncology, Inc., Aivita Biomedical, Inc., etc., targeting GBM.

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook forecast report on Glioblastoma (GBM) to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2021 to 2032.

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