On April 18, 2022 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate"), a biopharmaceutical company focused on the discovery and development of small molecule kinase inhibitors for difficult-to-treat, genomically defined cancers, reported that the first patient has commenced treatment in its Phase 1 KN-4802 (NCT05242822) clinical trial evaluating its lead Fibroblast Growth Factor Receptor (FGFR) product candidate, KIN-3248 (Press release, Kinnate Biopharma, APR 18, 2022, View Source [SID1234612401]). KIN-3248 is a next-generation pan-FGFR inhibitor being developed for the treatment of intrahepatic cholangiocarcinoma (ICC) and urothelial carcinoma (UC), as well as other solid tumors.
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"With the dosing of the first patient in our Phase 1 trial of KIN-3248, we are excited to further advance the development of this next-generation therapy which we believe is unique among FGFR inhibitors and has the potential to offer a new targeted therapy option for cancer patients with FGFR-altered tumors," said Richard Williams, MBBS, PhD, Chief Medical Officer of Kinnate. "We are grateful for the contribution of all the participants in this multi-center trial and for the support of our clinical collaborators at each trial site."
KIN-3248 is an irreversible, small molecule pan-FGFR inhibitor that has been developed to address both 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 ICC and 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 (PK), and preliminary efficacy of KIN-3248 in adults with advanced tumors harboring FGFR2 and/or FGFR3 gene alterations. The dose escalation portion (Part A) of 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. The dose expansion phase (Part B) of the trial 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 selected adult solid tumors.
"Successfully treating ICC and UC patients with FGFR2 and/or FGFR3 gene alteration-driven cancers remains a significant unmet need in cancer care. KIN-3248 brings a unique approach to potentially address the shortcomings of existing therapies in specific patient populations with primary FGFR2 and/or FGFR3 oncogenic alterations, including those patients with gatekeeper, molecular brake, and activation loop mutations," said Benjamin Garmezy, MD, Assistant Director of Genitourinary Research for Sarah Cannon Research Institute at Tennessee Oncology. "We are proud to be the first site to treat a patient with KIN-3248 and look forward to working with Kinnate to continue enrollment in this important Phase 1 trial."