On January 6, 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 continued advancement of the company’s ongoing clinical trial, KN-8701, to include patients with NRAS-mutant melanoma and planned 2022 milestones for its product candidates, including KIN-2787, an orally available small molecule pan-RAF inhibitor being developed for the treatment of patients with lung cancer, melanoma, and other solid tumors (Press release, Kinnate Biopharma, JAN 6, 2022, View Source [SID1234598387]). The company also updated its cash position as of December 31, 2021.

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"We have built a solid clinical foundation in 2021 with initial data from our ongoing first-in-human trial of KIN-2787 expected in the third quarter of 2022 and are pleased to announce that we will be expanding the trial to include patients with NRAS-mutant melanoma both in monotherapy and in combination with binimetinib," said Nima Farzan, Chief Executive Officer of Kinnate. "We are leveraging the power of the Kinnate Discovery Engine to potentially improve outcomes of cancer patients and overcome the limitations of current targeted therapies. Our goal is to generate one IND filing a year and in 2022 we expect Phase 1 initiation for our second program, KIN-3248, a Fibroblast Growth Factor Receptor inhibitor candidate, in the first half of the year subject to IND clearance by the FDA."

NRAS-mutant melanoma is an adjacent population to RAF-driven solid tumors where signaling is highly CRAF-dependent. Approved BRAF inhibitors that target BRAF Class I alterations are not effective in NRAS-mutant melanoma. Currently there is no approved targeted therapy approved for this population. The company’s preclinical data supports development of KIN-2787 in combination with binimetinib in NRAS-mutant melanoma. In vitro data indicates meaningful and synergistic combination benefit of KIN-2787 with binimetinib in NRAS-mutant melanoma cells. In in vivo xenograft models of NRAS-mutant melanoma, treatment with KIN-2787 in combination with binimetinib was well tolerated and resulted in significant tumor growth inhibition, including tumor regressions at clinically relevant twice-daily (BID) doses of KIN-2787 and binimetinib, respectively. The addition of NRAS-mutant melanoma patients meaningfully expands the potential market opportunity for KIN-2787 as the NRAS-mutant melanoma population represents approximately 25% of advanced and metastatic melanoma patients and is largely discrete from those melanoma patients with BRAF Class I, II or III alteration-driven disease.

Key 2021 Highlights

In collaboration with Guardant Health, announced initial findings from a BRAF kinase alteration genomic landscape and real-world clinical outcomes study with preliminary analyses suggesting that the prevalence of Class II and III alterations across patients with advanced and metastatic solid tumors is higher than previously understood. Among the nearly 6,000 patients who were identified as having BRAF alteration-positive cancers, approximately 55% were found to be harboring Class II and III alterations in over 25 common adult solid tumors, including Non-Small Cell Lung Cancer, Melanoma, Colorectal Cancer, Prostate Cancer and Breast Cancer.

Announced the first patient dosed in a Phase 1 trial evaluating KIN-2787 and detailed the two-part Phase 1 trial design for KN-8701 (NCT04913285), a first-in-human, multicenter, non-randomized, open-label, Phase 1 trial of KIN-2787 in adult patients with BRAF-mutant advanced and metastatic solid tumors.

Presented data at major medical meetings including:

details of the two-part Phase 1 trial design for KN-8701 at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper);
preclinical data on the KIN-3248 program at the JCA-AACR Precision Cancer Medicine International Conference; and
preclinical data from the KIN-2787 program at American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
Closed a $35 Million Series A financing to establish a Chinese joint venture, Kinnjiu Biopharma Inc. ("Kinnjiu"), led by OrbiMed Asia Partners, with participation from OrbiMed Private Investments and Foresite Capital. Kinnjiu has an exclusive license to develop and commercialize Kinnate’s currently most advanced kinase inhibitor candidates in Greater China.

Expanded the organization to 61 full-time employees as of December 31, 2021, of which 46 were engaged in research and development activities, and announced key appointments to the Board of Directors and executive team.

Announced the addition of Kinnate to the NASDAQ Biotechnology Index and the Russell 2000 Index.

Key Upcoming 2022 Milestone Targets

KIN-2787 Program

Initial monotherapy data from the ongoing KN-8701 Phase 1 trial expected in the third quarter of 2022.
Initiation of the combination portion of KN-8701 to study KIN-2787 with binimetinib in NRAS-mutant melanoma expected in the first half of 2022 with initial data expected by year end 2022.
Initiation of a Phase 1 trial in Greater China by Kinnjiu expected in mid-2022.
KIN-3248 Program

Initiation of a Phase 1 trial expected in the first half of 2022 subject to Investigational New Drug ("IND") clearance by the U.S. Food and Drug Administration ("FDA").
Early Discovery Pipeline

Goal to generate one IND filing a year from the Kinnate Discovery Engine.
Announcement of the next pipeline target expected in the second half of 2022.
Financial

Updated cash, cash equivalents and investments as of December 31, 2021 of approximately $324.9 million (exclusive of Kinnjiu’s cash), which is expected to fund current operations, including initiation of multiple registrational studies, into the second half of 2023.