Summary of the Oncology Innovation Summit - CellCuity Fireside Chat Company Overview - **Company**: CellCuity - **Focus**: Development of a platform to quantify signaling pathway activity in live tumor cells, specifically targeting the PI3K AKT mTOR pathway, referred to as the PAM pathway, which is a significant oncogenic pathway and represents a large untapped drug development opportunity in solid tumors [4][5] Key Assets and Studies - **Lead Asset**: Gadotelisib, a pan-PI3K inhibitor - **Ongoing Studies**: - Phase 3 study in second-line patients with ER-positive, HER2-negative advanced breast cancer, data expected in Q3 for wild type cohort and Q4 2025 for PIK3CA mutant cohort [5][6] - Phase 3 study for first-line HR-positive, HER2-negative advanced breast cancer, enrollment expected to begin this quarter [6] - Phase 1b study in prostate cancer for metastatic castration-resistant prostate cancer, top-line data expected later this month [6] Differentiation in the Market - **Mechanism of Action**: Unlike other inhibitors that target single components of the PAM pathway, CellCuity's approach addresses multiple targets, which is crucial due to feedback loops that can lead to adaptive resistance [9][10] - **Potency**: Gadotelisib is reported to be 300 times more potent than other approved single-target PAM inhibitors and is the only drug effective in both tumor cells with and without PIK3CA mutations [11][12] Clinical Expectations and Comparisons - **Hazard Ratio (HR)**: A hazard ratio of 0.5 or below is considered compelling for the upcoming phase 3 wild type data [20] - **Comparative Studies**: Previous studies have shown HRs ranging from 0.59 to 0.68, with no study reporting an HR below 0.5 in similar patient populations [20][21] - **Phase 1b Data**: In the phase 1b study, 60% of patients had an objective response, with 49% progression-free at 12 months, indicating favorable results compared to existing therapies [38][39] Safety Profile - **Adverse Events**: Gadotelisib has shown a lower incidence of hypoglycemia compared to other drugs in the class, with a discontinuation rate of 4% in early studies versus over 26% for other drugs [48][49] - **Patient Tolerance**: Preliminary data suggests good tolerance among patients, with no discontinuations due to adverse events related to hypoglycemia [48][49] Market Opportunity and Administration - **Efficacy vs. Safety**: The primary factors influencing physician decisions will be efficacy and safety, with convenience being a secondary consideration [51] - **Infused vs. Oral Drugs**: Infused drugs are more common in oncology, and while oral drugs offer convenience, they can lead to compliance issues due to side effects [54][55] - **Financial Considerations**: Infused drugs may have less cumbersome reimbursement processes compared to oral drugs, which can expose patients to high co-pays [54][55] Conclusion - The upcoming data in Q3 and Q4 is highly anticipated, with expectations for significant insights into the efficacy and safety of CellCuity's lead asset, gadotelisib, in treating advanced breast cancer and prostate cancer [56]