Incyclix Bio Announces FDA Clearance of IND Application for INX-315 in Patients With Advanced or Metastatic Cancer
Incyclix Bio, LLC recently announced the US 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, PharmD, PhD, 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).
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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