Release Date: March 06, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: Can you provide details on the expected data update for CX-2051 in the first half of 2025? A: Sean McCarthy, CEO, stated that the initial update will include a characterization of the safety profile and an assessment of antitumor activity, including pharmacodynamic markers and potentially tumor shrinkage. They are optimistic about the progress, given the challenges faced by previous systemic EpCAM strategies.
Q: Regarding CX-801, what is the timeline for moving to the KEYTRUDA combination, and how does it relate to the data update? A: Sean McCarthy, CEO, mentioned that they are progressing well with the CX-801 study and are currently in the fourth dose level. They anticipate initiating the KEYTRUDA combination in the second half of 2025, likely before presenting any data, which is expected by the end of the year.
Q: How many of the seven-dose cohorts for CX-2051 are predicted to be within the therapeutically active range? A: Sean McCarthy, CEO, explained that starting from dose level 3, they predict entering the therapeutically active range based on preclinical modeling. A significant number of patients will have been treated with doses in this range by the time data is shared.
Q: Is there any expectation of differential activity in CX-2051 based on KRAS status or liver metastases? A: Sean McCarthy, CEO, clarified that there is no known connection between KRAS status or liver metastases and EpCAM expression. They are enrolling a broad patient population to characterize the drug across the full CRC population.
Q: What is the rationale for prioritizing CRC for the EpCAM ADC, and have you seen signals outside CRC? A: Sean McCarthy, CEO, emphasized that CRC was chosen due to its high and consistent EpCAM expression, significant unmet need, and the known responsiveness of CRC to topo-1 inhibition. The study is focused entirely on metastatic CRC patients.
Q: What is the bar for success in the CX-2051 study, particularly in late-line CRC? A: Sean McCarthy, CEO, noted that the bar is low in fourth-line CRC, with current treatments showing single-digit response rates. Any evidence of RECIST responses would be considered a success, and they are also looking for tumor stabilization and pharmacodynamic activity.
Q: Where might the Phase 1a CRC data for CX-2051 be presented, and how many more dose levels are planned? A: Sean McCarthy, CEO, stated that they are keeping options open for data presentation. They are currently in the seventh dose level and will continue to escalate if cleared, with the therapeutic active range based on preclinical modeling.
Q: Is there published literature to guide what level of EpCAM expression would be beneficial in the CX-2051 trial? A: Sean McCarthy, CEO, confirmed that EpCAM expression is well-documented in literature, particularly in colorectal cancer, and they anticipate their clinical results will validate this.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
This article first appeared on GuruFocus.Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.