On October 11, 2022 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate"), a clinical-stage precision oncology company, reported an update from the ongoing global Phase 1 KN-8701 trial evaluating KIN-2787, an investigational pan-RAF inhibitor, in patients with BRAF-altered solid tumors and/or who have NRAS mutant melanoma (Press release, Kinnate Biopharma, OCT 11, 2022, https://investors.kinnate.com/news-releases/news-release-details/kinnate-biopharma-inc-announces-recent-corporate-updates [SID1234621929]).

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Key monotherapy updates to date include:

Enrolled patients with BRAF Class I, II and III alterations, and/or who have NRAS mutant melanoma, into six KIN-2787 dose levels: 25 mg bid, 50 mg bid, 100 mg bid, 200 mg bid, 300 mg bid and 400 mg bid.

KIN-2787 cleared the predicted efficacious dose at 300 mg bid.

Enrollment in the dose escalation portion continues; currently at the 400 mg bid dose with the maximum tolerated dose not yet determined.

KIN-2787 achieved meaningful exposures that were dose proportional and exceeded the predicted efficacious thresholds based on preclinical models.

Encouraging initial clinical responses observed thus far.
Initial site activation was slower than expected due to COVID-19. This has resulted in a limited number of efficacy evaluable patients to-date in the relevant population at the predicted efficacious dose. The company anticipates sharing detailed dose escalation data with additional efficacy evaluable patients in the first half of 2023.

Subsequent to the KIN-2787 data release, the company will announce the next pipeline program, which is anticipated to enter the clinic in 2023.

As of September 30, 2022, Kinnate’s total cash and cash equivalents and investments were approximately $262 million, exclusive of its China joint venture Kinnjiu’s cash, and is expected to fund current operations into mid-2024.

Nima Farzan, chief executive officer, Kinnate Biopharma Inc., commented, "We are encouraged by what we are seeing in the clinic with KIN-2787 monotherapy thus far. Enrollment in the dose escalation portion of the trial is ongoing at sites globally, with increasing momentum. In addition, with $262 million cash on hand and a cash runway into mid-2024, we remain well-capitalized to progress our portfolio of precision oncology programs. We look forward to announcing the next program from our discovery engine, which we expect to enter the clinic next year."

KN-8701 Clinical Trial Background

KN-8701 is an ongoing, global Phase 1 clinical trial (NCT04913285) evaluating KIN-2787, a pan-RAF inhibitor, in patients with advanced solid tumors harboring BRAF Class I, II and III alterations, and/or who have NRAS mutant melanoma. The trial is actively enrolling patients at 24 sites across the globe. KN-8701 contains a two-part dose escalation phase: in Part A1, KIN-2787 is being evaluated as a monotherapy across BRAF alterations and tumor types and Part A2 is evaluating KIN-2787 in combination with binimetinib, a MEK inhibitor, in NRAS mutant melanoma. Part B, the dose expansion phase, will evaluate KIN-2787 at a selected dose in three cohorts: melanoma, non-small cell lung cancer and other advanced or metastatic solid tumors, each driven by BRAF Class II or Class III alterations.