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Incyclix Bio Announces FDA Clearance of Investigational New Drug Application for INX-315 in Patients with Advanced or Metastatic Cancer

  • INX-315 is a novel, potent and selective inhibitor of CDK2 with compelling pre-clinical efficacy and safety data
  • First-in-human, Phase 1/2 study of INX-315 in patients with ER+/HER2- breast cancer who have progressed on a CDK4/6i regimen and CCNE1-amplified solid tumors that have progressed on standard of care treatment
  • Incyclix expects to initiate the study during the 1st quarter of 2023

Research Triangle Park, N.C. – February 28, 2023 – Incyclix Bio, LLC, a next-generation cell cycle control company, today announced that the U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for the Company’s lead compound, INX-315, a novel, potent and selective CDK2 inhibitor. The Phase 1/2 first-in-human study (INX-315-01) will evaluate the safety, pharmacokinetics (PK), and preliminary antitumor activity of INX-315 in patients with advanced/metastatic cancers.

“CDK2 is a known driver of cancer cell proliferation and a target with broad clinical potential,” said Patrick Roberts, Pharm.D., Ph.D., Chief Executive Officer and Co-Founder of Incyclix Bio. “The approval of our IND for INX-315 is a significant milestone in our mission to advance the care of cancer patients through the development of precision treatments that regain cell cycle control.”

INX-315-01 is a first-in-human, Phase 1/2 open-label, dose-escalation and dose-expansion study that will enroll patients with ER+/HER2- breast cancer that has progressed on a prior CDK4/6i regimen and patients with CCNE1-amplified solid tumors that have progressed on standard of care treatment. The study will be conducted in the United States and Australia. For additional information and to find a participating clinical site, email clinicalinfo@incyclixbio.com or visit www.clinicaltrials.gov (identifier NCT05735080).

About Incyclix Bio

Incyclix Bio is a next-generation cell cycle control company advancing precision treatments that target the aberrant proliferation driving many cancers. The company’s lead compound, INX-315, is a potent and selective cyclin-dependent kinase 2 (CDK2) inhibitor entering clinical development. Incyclix Bio is a scientific leader in understanding cyclin-dependent kinases (CDKs) and their role in the cell cycle as attractive therapeutic targets across many tumor types, including ovarian, breast and lung cancers. Headquartered in Research Triangle Park, NC, Incyclix Bio is founded by pioneers in CDK inhibitor discovery, research and development. For more information, visit incyclixbio.com.


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