Circle Pharma's CID-078: A New Frontier In Cancer Treatment As First Patients Enter Phase 1 Trial

Circle Pharma, Inc., a clinical-stage biopharmaceutical firm focused on pioneering a new wave of macrocycle therapies, has announced that it has successfully dosed the first patient cohort in the Phase 1 trial of CID-078. This innovative oral cyclin A/B RxL inhibitor represents a first-in-class treatment option. The trial aims to assess the efficacy of CID-078 in patients suffering from advanced solid tumors, particularly those characterized by heightened E2F transcription factor activity. This includes conditions such as small cell lung cancer, triple-negative breast cancer, and ER+ HER-2- breast cancer, especially in cases following CDK 4/6 inhibitor therapy.

CID-078 is engineered to specifically block critical protein-to-protein interactions associated with cyclins A and B, proteins that play a significant role in the growth and survival of cancer cells. This research initiative is rooted in foundational studies conducted in the laboratory of William G. Kaelin Jr., MD, a Nobel Laureate and the Chair of Circle Pharma’s Scientific Advisory Board. Dr. Kaelin's work highlighted the concept of synthetic lethality achieved by disrupting cyclin function in contexts where cell cycle control is compromised and E2F activity is elevated.

David J. Earp, JD, Ph.D., CEO of Circle Pharma, said in a statement, “We are thrilled that the IND for CID-078 was cleared at the end of the 30-day regulatory review period and that CID-078 has now moved into human dosing at a consortium of world class cancer centers. This will allow our investigators to generate clinical proof-of-concept data which will inform CID-078’s potential impact in settings of high unmet medical need as well as validate Circle Pharma’s proprietary MXMO™ macrocycle platform for difficult-to-drug targets in cancer and other serious diseases.”

Geoffrey Shapiro, MD, Ph.D., senior vice president, Development Therapeutics at Dana-Farber Cancer Institute and professor of medicine at Harvard University, mentioned, “Disrupting the ability of E2F-driven cancer cells to turn off E2F at the appropriate time in the cell cycle has been shown to selectively induce apoptosis. Until now there hasn’t been a selective therapeutic agent to exploit this observation and so I am extremely excited to see Circle Pharma’s cyclin A/B RxL inhibitor move into the clinic.”

All patients participating in this cohort are being treated at The START Center for Cancer Research in Grand Rapids, MI. Additional clinical sites currently accepting patients include The START Center for Cancer Research in West Valley City, UT, and NEXT Oncology in San Antonio, TX. More sites are expected to open in the near future.

Circle Pharma's Phase 1 clinical trial (NCT06577987) is an open-label, multi-center study focused on dose escalation and expansion, with plans to enroll up to 100 participants. The trial aims to assess the safety, pharmacokinetics, and pharmacodynamics of CID-078, along with its initial anti-tumor effects on solid tumors. Preliminary safety and anti-tumor results from this Phase 1 study are anticipated to be released in 2025.