On April 28, 2023 Kirilys Therapeutics, Inc., a multi-asset biotechnology company founded by investment firm Catalys Pacific and supported by Lightspeed Venture Partners, reported the Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for a Phase 1 clinical study of KRLS-017, a potentially best in class reversible small molecule inhibitor of Cyclin Dependent Kinase 7 (CDK7) (Press release, Kirilys Therapeutics, APR 28, 2023, View Source [SID1234638426]).
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CDK7 plays a key role in control of both cell cycle and gene transcription, and dysregulation of CDK7 has been documented as a negative prognostic indicator across a broad spectrum of tumor types. The Phase 1 clinical trial of KRLS-017 is planned as a monotherapy, open-label, safety and PK/PD study for patients with treatment refractory solid tumors. The primary objective of the Phase 1a dose escalation portion of the trial is to evaluate safety and tolerability of KRS-017. Following establishment of a recommended Phase 2 dose and schedule from Phase 1a, Kirilys plans an indication-specific cohort expansion that will include breast, ovarian and potentially other transcriptionally active tumor types to evaluate anti-tumor activity.