Kirilys Therapeutics Announces FDA Clearance of IND Application for KRLS-017, a reversible inhibitor of CDK7 for Oncology

Phase 1 clinical study will evaluate the safety, pharmacokinetics, and preliminary efficacy of KRLS-017 in treatment refractory solid tumors

San Francisco, CA, April 28, 2023 — Kirilys Therapeutics, Inc., a multi-asset biotechnology company founded by investment firm Catalys Pacific and supported by Lightspeed Venture Partners, today announced 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).

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.


About Kirilys Therapeutics, Inc.
Kirilys Therapeutics, Inc. is a private, preclinical-stage biopharmaceutical company committed to the development of multiple precision oncology assets. Kirilys’ initial asset is KRLS-017, a novel CDK7 inhibitor with the potential to improve the treatment of multiple cancers. Kirilys is headquartered in San Francisco, CA. For more information about Kirilys, please visit


About Catalys Pacific
Catalys Pacific is a life sciences venture capital firm focusing on early-stage investments. The firm’s mission is to provide healthcare solutions for patients worldwide through the creation of and investment in biotech companies. Catalys Pacific is led by a global team versed in working closely with its partners in academia, biotech, venture capital and the pharmaceutical industry worldwide with an emphasis in Japan. The firm maintains offices in Tokyo and Kanagawa (Shonan Health Innovation Park), Japan and in San Francisco, California. For more information about Catalys Pacific, please visit


About Lightspeed Venture
Partners. Lightspeed Venture Partners is a multi-stage venture capital firm focused on accelerating disruptive innovations and trends in the Enterprise, Consumer, and Health sectors. Over the past two decades, the Lightspeed team has backed hundreds of entrepreneurs and helped build more than 400+ companies globally. Lightspeed and its affiliates currently manage $10.5B across the global Lightspeed platform, with investment professionals and advisors in Silicon Valley, Israel, India, China, Southeast Asia, and Europe. For more information, please visit