SAN FRANCISCO and SAN DIEGO, Jan. 17, 2023 (GLOBE NEWSWIRE) -- Kinnate Biopharma Inc. (Nasdaq: KNTE) (“Kinnate”), a clinical-stage precision oncology company, today announced 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)-related conferences.

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 Meeting webpage: https://conferences.asco.org.

About Kinnate Biopharma Inc.

Kinnate Biopharma Inc. is a clinical-stage precision oncology company focused on expanding on the promise of targeted therapies for those battling cancer. The company is developing medicines for known oncogenic drivers where there are no approved targeted drugs and to overcome the limitations of marketed cancer therapies, such as non-responsiveness or acquired and intrinsic resistance. Kinnate has two lead clinical programs being studied in solid tumors with RAF, NRAS and FGFR-driven alterations, and is rapidly progressing a pipeline of additional small molecule drug candidates as part of the Kinnate Discovery Engine. The company is driven by the urgency and knowledge that patients are waiting for new, effective cancer medicines.  For more information, visit Kinnate.com and follow us on LinkedIn.

Forward Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. These forward-looking statements include, without limitation, statements regarding the potential benefits of KIN-3248, the trial design of KN-4802, our intention to make presentations at ASCO and the anticipated timing of KIN-3248 clinical data. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are also intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and trends. Such expectations and projections may never materialize or may prove to be incorrect. These forward-looking statements are subject to a number of risks, uncertainties, assumptions and other factors, including risks related to recently transitioning to operating as a clinical-stage biopharmaceutical company with a limited operating history; our ability to raise additional capital to finance our operations; our ability to discover, advance through the preclinical and clinical development of, obtain regulatory approval for and commercialize our product candidates; the novel approach we are taking to discover and develop drugs; our ability to timely file and obtain approval of investigational new drug applications for our planned clinical trials; the potential for any clinical trial results to differ from our preclinical study results; negative impacts of the COVID-19 pandemic on our business, including ongoing and planned clinical trials and preclinical studies; competition in our industry; regulatory developments in the United States and other countries; our ability to attract, hire and retain highly skilled executive officers and employees; difficulties in managing our growth; our ability to protect our intellectual property; reliance on third parties to conduct our ongoing and planned preclinical studies and clinical trials, and to manufacture our product candidates; general economic and market conditions; and other risks. These and other risks, uncertainties, assumptions and other factors are further described under the heading “Risk Factors” in our Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2022 that we have filed with the Securities and Exchange Commission (the “SEC”), as well as in our subsequent filings we make with the SEC. New risk factors emerge from time to time and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements. Investors should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Our forward-looking statements speak only as of the date of this release, and except as required by law, we undertake no obligation to update publicly any forward-looking statements for any reason in the future.

Investor & Media Contact:

Priyanka Shah | Priyanka.Shah@kinnate.com | +1-908-447-6134

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