On January 17, 2023 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate"), a clinical-stage precision oncology company, reported the poster presentation of the design and rationale of a Phase 1 trial-in-progress (KN-4802, NCT05242822) evaluating the Company’s investigational pan-FGFR inhibitor, KIN-3248, at two upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)-related conferences (Press release, Kinnate Biopharma, JAN 17, 2023, View Source [SID1234626297]).

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KIN-3248 is an irreversible, small molecule pan-FGFR inhibitor designed to address primary FGFR2 and FGFR3 oncogenic alterations, and those predicted to drive acquired resistance to current FGFR-targeted therapies, including gatekeeper, molecular brake, and activation loop mutations observed in cancers such as intrahepatic cholangiocarcinoma (ICC) and urothelial carcinoma (UC). In preclinical studies, KIN-3248 demonstrated inhibitory activity across a wide range of clinically relevant mutations that drive primary disease and acquired resistance to other FGFR inhibitors.

The KN-4802 clinical trial (NCT05242822) is a 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. Dose escalation (Part A) 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 initial dose escalation data anticipated in the second half of 2023.

Poster Presentation Details

ASCO Gastrointestinal Cancers Symposium, January 19-21, 2023
San Francisco, Calif. and Online

Title: First-in-Human Phase 1/1b Study Evaluating KIN-3248, a Next-Generation, Irreversible Pan-FGFR Inhibitor, in Patients With Advanced Cholangiocarcinoma and Other Solid Tumors Harboring FGFR2 and/or FGFR3 Gene Alterations
Author: James Harding, MD
Abstract Number: TPS637
Poster Board: P6
Session Type and Track: Trials in Progress Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract
Session Date/Time: Friday, January 20, 2023 | 12:00 p.m. – 1:30 p.m. PT

ASCO Genitourinary Cancers Symposium, February 16-18, 2023
San Francisco, Calif. and Online

Title: First-in-Human Phase 1/1b Study Evaluating KIN-3248, a Next‑Generation, Irreversible Pan-FGFR Inhibitor, in Patients With Advanced Urothelial Carcinoma and Other Solid Tumors Harboring FGFR2 and/or FGFR3 Gene Alterations
Author: Benjamin Garmezy, MD
Abstract Number: TPS593
Poster Board: P16
Session Type and Track: Trials in Progress Poster Session, Urothelial Carcinoma
Session Date: February 17, 2023 |12:30 p.m. PT

For additional information, visit the ASCO (Free ASCO Whitepaper) Meeting webpage: View Source