INX-315

Fast Track designation highlights potential of INX-315 to address unmet need for patients with recurrent advanced/metastatic cancerRESEARCH TRIANGLE PARK, N.C., April 29, 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 that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for INX-315 for the treatment of CCNE1-amplified platinum-resistant/refractory ovarian cancer. “The FDA’s decision to grant Fast Track designation for INX-315 reflects the best-in-class potential of our CDK2 inhibitor, the strength of our preclinical and early clinical data and the urgency to address significant unmet need in patients with CCNE1-amplified platinum-resistant/refractory ovarian cancer,” said Patrick Roberts, PharmD, PhD, Chief Executive Officer and Co-Founder of Incyclix Bio. “We look forward to working closely with the FDA to advance the clinical development of INX-315 to bring it to patients as soon as possible.” The FDA grants Fast Track designation to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Treatments that receive Fast Track designation may benefit from more frequent interactions with the FDA throughout development. In addition, the Fast Track program allows for eligibility for Accelerated Approval and Priority Review, if relevant criteria are met. Amplification of CCNE (cyclin E1 and E2) occurs in a broad range of solid tumors and in a significant subset of patients with high-grade serous ovarian cancer (HGSOC). CCNE1-amplification is also correlated with resistance to platinum-based chemotherapy, creating an area of high unmet need in patients with the most common type of ovarian cancer. INX-315 is a novel, potent and selective CDK2 inhibitor that is being evaluated in INX-315-01, an ongoing first-in-human Phase 1/2 clinical trial to evaluate its safety, tolerability, pharmacokinetics (PK) and preliminary antitumor activity in patients with recurrent advanced/metastatic cancer. INX-315 is an investigational drug product and has not been approved by the FDA. More information on the trial can be found at clinicaltrials.gov (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 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 Contact:Tony Plohoros908-591-2839tplohoros@6degreespr.com

INX-315, a potential best-in-class CDK2 inhibitor, to be evaluated in combination with Verzenio® (abemaciclib) and fulvestrant Combination therapy to be evaluated as part of ongoing Phase 1/2 study in patients with HR+/HER2- metastatic breast cancer Incyclix will sponsor the trial and Lilly will provide Verzenio Incyclix plans to initiate combination cohorts with INX-315 in fourth quarter of 2024 RESEARCH TRIANGLE PARK, N.C., Nov. 18, 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 a clinical trial collaboration and supply agreement with Eli Lilly and Company (Lilly) for supply of its CDK4/6 inhibitor Verzenio® (abemaciclib) for use in combination with INX-315 and fulvestrant for treatment of patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer who progressed on a prior CDK4/6i regimen. “We are pleased to enter this clinical trial collaboration with Lilly as it marks another milestone in our commitment to bring INX-315 to patients with advanced cancer,” said Patrick Roberts, Pharm.D., Ph.D., Chief Executive Officer and Co-Founder of Incyclix Bio. “Previous studies of Verzenio plus fulvestrant have demonstrated clinical benefit in patients with HR+, HER2- breast cancer who had disease progression on or after prior treatment with a CDK4/6 inhibitor. We are excited to explore how the addition of our CDK2 inhibitor, INX-315, to this combination can improve clinical outcomes for patients with advanced breast cancer.” Under the terms of the agreement, Lilly will provide abemaciclib to Incyclix Bio, who will conduct and sponsor the combination study. Incyclix and Lilly will retain all development and commercial rights to their respective compounds, including as monotherapy or as combination therapies. 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