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Articles from Incyclix Bio

Incyclix Bio Granted U.S. FDA Fast Track Designation for INX-315 to Treat CCNE1-Amplified Platinum-Resistant/Refractory Ovarian Cancer
Fast Track designation highlights potential of INX-315 to address unmet need for patients with recurrent advanced/metastatic cancer
By Incyclix Bio · Via GlobeNewswire · April 29, 2025
Incyclix Bio Announces Publication in Nature Communications Highlighting Biomarkers of Response to CDK2 Inhibition
RESEARCH TRIANGLE PARK, N.C., Feb. 13, 2025 (GLOBE NEWSWIRE) -- Incyclix Bio, LLC, a next-generation cell cycle control company developing INX-315, a novel, potent and selective CDK2 inhibitor for the treatment of advanced and resistant cancer, today announced the publication of a peer-reviewed article in Nature Communications. The publication titled, “Discrete vulnerability to pharmacological CDK2 inhibition is governed by heterogeneity of the cancer cell cycle” identifies biomarkers for response to INX-315 and highlights the potential of INX-315 to overcome resistance to CDK4/6 inhibitors in certain cancers.
By Incyclix Bio · Via GlobeNewswire · February 13, 2025
Incyclix Bio Announces Interim Clinical Data from the Phase 1/2 Clinical Trial of INX-315 in Patients with CDK4/6 Inhibitor Resistant ER+/HER2- Breast Cancer or CCNE1-Amplified Solid Tumors
INX-315 was safe and well tolerated in monotherapy dose escalation
By Incyclix Bio · Via GlobeNewswire · December 13, 2024
Incyclix Bio Announces Clinical Trial Collaboration and Supply Agreement with Lilly to Evaluate INX-315 in Combination with Verzenio® (abemaciclib) and Fulvestrant in HR+/HER2- Breast Cancer
INX-315, a potential best-in-class CDK2 inhibitor, to be evaluated in combination with Verzenio® (abemaciclib) and fulvestrant
By Incyclix Bio · Via GlobeNewswire · November 18, 2024
Incyclix Bio Expands Board of Directors with Appointment of Norman E. Sharpless, MD
RESEARCH TRIANGLE PARK, N.C., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Incyclix Bio, LLC, a next-generation cell cycle control company developing INX-315, a novel, potent and selective CDK2 inhibitor for the treatment of advanced and resistant cancer, today announced the appointment of Norman E. “Ned” Sharpless, MD, to the Company’s Board of Directors as an independent director. Dr. Sharpless is a physician, scientist and entrepreneur who has led tremendous progress in cancer research and care serving in several leadership roles, including Director of the National Cancer Institute (NCI) and Acting Commissioner of the US Food and Drug Administration (FDA).
By Incyclix Bio · Via GlobeNewswire · November 12, 2024
Incyclix Bio Announces Abstract Accepted for Presentation at 2024 San Antonio Breast Cancer Symposium
RESEARCH TRIANGLE PARK, N.C., Nov. 04, 2024 (GLOBE NEWSWIRE) -- Incyclix Bio, LLC, a next-generation cell cycle control company developing INX-315, a novel, potent and selective CDK2 inhibitor for the treatment of advanced and resistant cancer, today announced the acceptance of an abstract for a poster presentation at the 2024 San Antonio Breast Cancer Symposium (SABCS) taking place in San Antonio, Texas, from December 10-13, 2024.
By Incyclix Bio · Via GlobeNewswire · November 4, 2024
Incyclix Bio Appoints Dr. Andrew Beelen as Vice President of Clinical Development
RESEARCH TRIANGLE PARK, N.C., Aug. 20, 2024 (GLOBE NEWSWIRE) -- Incyclix Bio, LLC, a next-generation cell cycle control company developing INX-315, a novel, potent and selective CDK2 inhibitor for the treatment of advanced and resistant cancer, today announced the appointment of Andrew Beelen, MD, as Vice President of Clinical Development. Dr. Beelen will be responsible for progressing the clinical development of INX-315 and brings a wealth of experience and expertise to this pivotal leadership role.
By Incyclix Bio · Via GlobeNewswire · August 20, 2024
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
By Incyclix Bio · Via GlobeNewswire · February 28, 2023