ABM Therapeutics’ ABM-1310 Granted Fast Track Designation by the FDA Following Orphan Drug Designation

On September 26, 2023 ABM Therapeutics reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for the investigation of ABM-1310 for the treatment of Glioblastoma (GBM) patients carrying BRAF V600E mutation, following the Orphan Drug Designation for ABM-1310 to treat malignant gliomas including GBM received in July (Press release, ABM Therapeutics, SEP 26, 2023, View Source [SID1234635427]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The FDA grants Fast Track Designation to facilitate the development and expedite the review of medicines to treat serious conditions and fill an unmet medical need. Fast Track Designation is intended to bring promising medicines to patients sooner.

ABM-1310 is an investigational therapeutic candidate currently undergoing clinical development for BRAF V600E mutant solid tumors. The Fast Track Designation paves the potential path of ABM-1310 to have a significant impact on patients with BRAF V600E mutant Glioblastoma. The Fast Track Designation also reinforces ABM’s commitment to advancing this target therapy for Glioblastoma patients. ABM is ready to work closely with the FDA to expedite its development.

"We are very grateful to the FDA for recognizing the potential of our novel next-generation investigational drug ABM-1310 to help patients with brain tumors," said Zane Yang, M.D., CMO of ABM Therapeutics. "This offers ABM an interactive collaboration with the FDA to ensure ABM-1310 clinical development expeditiously with the highest standards of safety and quality."

ABM Therapeutics acknowledges the contributions of our team, partners, and investors who have played a vital role in reaching this milestone. Our mission remains to focus on developing innovative therapies for patients.