Pharma Focus Asia

ABM Therapeutics Announces US FDA Orphan Drug Designation to ABM-1310

Thursday, August 03, 2023

ABM Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ABM-1310, an innovative small molecule BRAF inhibitor. This designation is specifically intended for the treatment of individuals afflicted by glioblastoma (GBM) and who carry the BRAF V600 mutation.

ABM-1310 is an orally administered medication with remarkable characteristics. It boasts high selectivity for BRAF mutations, excellent water solubility, and an ability to effectively permeate the blood-brain barrier. Currently, ABM-1310 is undergoing Phase I clinical trials at multiple medical sites across the United States and China.

ABM-1310 has exhibited strong potential as an anticancer agent, while also demonstrating a favourable safety profile in patients with advanced BRAF V600 mutant solid tumours, including brain tumours like GBM and other gliomas. Promising results have emerged from the interim findings of the U.S. Phase I study.

Glioblastoma (GBM) is exceptionally challenging and aggressive brain tumour to manage. Its intricate tumorigenesis and resistance to standard therapies contribute to the complexity of treatment. Conventional approaches like surgical resection, radiation, and chemotherapy have shown limited efficacy. With few treatment options available after the disease has progressed, the development of more effective treatments is in high demand.

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