INX-315

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). “We’re thrilled to welcome Ned, a distinguished oncologist, accomplished scientist and seasoned public servant, to our Board of Directors,” said Patrick Roberts, Pharm.D., Ph.D., Chief Executive Officer and Co-Founder of Incyclix Bio. “Ned brings unparalleled oncology expertise and experience to our Board at this important point in our growth. Ned’s passion and commitment to innovating cancer care and scientific prowess, particularly in cell cycle biology, will be invaluable as we race to bring INX-315 to patients.” “I have dedicated my career to improving the lives of people affected by cancer,” said Dr. Sharpless. “Incyclix has made exciting progress investigating the potential of its CDK2 inhibitor, INX-315, to provide treatment for patients with advanced and resistant cancer. I look forward to working with Incyclix’s experienced board and leadership team to bring this important novel treatment option to patients in need.” Dr. Sharpless is a physician, scientist, entrepreneur and former federal official, serving as Director of the National Cancer Institute from 2017 to 2022, and as Acting Commissioner of the FDA in 2019. As a federal official, he led multiple research initiatives spanning cellular immunotherapy, early cancer detection, global oncology and the use of artificial intelligence and machine learning to improve outcomes for patients affected by cancer. Prior to government, Dr. Sharpless was the Wellcome Distinguished Professor of Medicine and Director of the Lineberger Comprehensive Cancer Center at the University of North Carolina (UNC) School of Medicine. He is on the boards Karius Inc., Nucleus Radiopharma, the Eshelman Institute for Innovation, the CEO Roundtable on Cancer and the American Cancer Society; and is the co-Founder and Managing Director of Jupiter BioVentures. He was founder and board member of G1 Therapeutics, which developed the FDA-approved medicine Cosela (Trilaciclib), used to prevent chemotherapy toxicity. He is the Professor of Cancer Policy and Innovation at the UNC School of Medicine, and is a member of the American Association for Cancer Research Academy, the Association of American Physicians, the American Society for Clinical Investigation and the National Academy of Medicine. He received an MD from the UNC School of Medicine, followed by an internal medicine residency at the Massachusetts General Hospital and a hematology/oncology fellowship at the Dana-Farber/Partners Cancer Care, both of Harvard Medical School. 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 in 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. Media ContactTony Plohoros908-591-2839tplohoros@6degreespr.com

–  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 1 st quarter of 2023 RESEARCH TRIANGLE PARK, NC, USA I February 28, 2023 I 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 This email address is being protected from spambots. You need JavaScript enabled to view it. // "> This email address is being protected from spambots. You need JavaScript enabled to view it. // 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. SOURCE: Incyclix Bio