Kinnate Biopharma Inc. Receives Fast Track Designation from the U.S. Food and Drug Administration for KIN-2787, an Investigational Pan-RAF Inhibitor

On September 21, 2022 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate"), a clinical-stage precision oncology company, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Kinnate’s investigational pan-RAF inhibitor, KIN-2787, for treatment of patients with BRAF Class II or III alteration-positive and/or NRAS mutation-positive stage IIb to IV malignant melanoma that is metastatic or unresectable (Press release, Kinnate Biopharma, SEP 21, 2022, View Source [SID1234621300]).

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!

According to the FDA, Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fulfill an unmet medical need. A therapeutic candidate that receives Fast Track designation is eligible for more frequent interactions with the FDA to discuss the candidate’s development plan and, if relevant criteria are met, eligibility for Accelerated Approval and Priority Review.

KIN-2787 is an orally available, potent and selective small molecule pan-RAF inhibitor being evaluated in KN-8701 (NCT04913285), an ongoing Phase 1 global clinical trial in patients with solid tumors harboring BRAF alterations or who have NRAS mutant melanoma. Unlike currently available treatments that target only Class I BRAF kinase mutations, Kinnate has designed KIN-2787 to target Class II and Class III BRAF alterations, where it has the potential to be a first-line targeted therapy, in addition to covering Class I BRAF alterations, and as a potential treatment for NRAS mutation-positive melanoma.

The company previously announced that the FDA granted Orphan Drug Designation (ODD) for KIN-2787 for the treatment of stage IIb-IV melanoma. An ODD is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the U.S.