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Home > News > FDA News > Fast Track Designation from the U.S. Food and Drug Administration for KIN-3248, an Investigational Pan-FGFR Inhibitor

Fast Track Designation from the U.S. Food and Drug Administration for KIN-3248, an Investigational Pan-FGFR Inhibitor

Author: Magicure Date: 2023-02-15

Kinnate Biopharma Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Kinnate’s investigational pan-FGFR inhibitor, KIN-3248, for the treatment of patients with unresectable, locally advanced or metastatic cholangiocarcinoma (CCA) harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other alterations, who have received at least one prior systemic therapy.

As a more and more common digestive tract tumor, cholangiocarcinoma CCA  is used to transport digestive fluid from the liver to the bile ducts of the gallbladder and small intestine, which means that this tumor is generally diagnosed late and difficult to receive surgical treatment in time.

First of all, introduce FGFR, whose full name is Fibroclast Growth Factor Receptor. Its mechanism of action is to participate in cell proliferation, differentiation, migration and survival as a member of tyrosine kinase family. When FGFR is over-expressed, the FGFR signal pathway is activated, which will lead to normal cell carcinogenesis. RAS-RAF-MAPK and SATAHE PI3K-AKT are the main signal pathways.

FGFR contains four receptor subtypes (FGFR1,2,3 and 4). FGFR2 is the most common subtype of FGFR family, and the detection rate of FGFR2 as the most important therapeutic target in patients with cholangiocarcinoma is 15-20%. FGFR2 mutation is quite exclusive, and many statistical results confirm that FGFR2 does not coexist with other mutation types.

About KIN-3248

KIN-3248, as a new generation of irreversible small molecule panFGFR inhibitor, has the characteristics of high selectivity, irreversibility and strong effect. KIN-3248 plans to develop treatment for primary FGFR2/3 gene changes and solid tumors resistant to FGFR2/3 targeted therapy. In preclinical studies, KIN-3248 showed inhibitory activity in a wide range of clinically relevant mutations, which would lead to primary disease and acquired resistance to other FGFR inhibitors.

The KN-4802 clinical trial (NCT05242822) is an ongoing multi-center, open-label, two-part study of approximately 120 patients to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of KIN-3248 in adults with advanced tumors harboring FGFR2 and/or FGFR3 gene alterations.

In dose escalation (Part A), the trial will determine the recommended dose and schedule of KIN-3248 for further evaluation in patients with FGFR2 and/or FGFR3 gene alteration-driven cancers. 

Dose expansion (Part B) will assess the safety and efficacy of KIN-3248 at the recommended dose and schedule in FGFR inhibitor naïve and FGFR inhibitor pretreated patients with cancers driven by FGFR2 and/or FGFR3 gene alterations, including ICC, UC, and other advanced or metastatic solid tumors in adults.

This trial is currently enrolling across multiple sites in the U.S. and Taiwan, with additional sites expected globally. Initial dose escalation data is anticipated in the second half of 2023.

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