Release Date: March 03, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: Could you share the latest progress on how you are mitigating the AST elevation and proteinuria issue related to Emi-Le? How might this increase your confidence in maintaining the dose intensity at a higher dose level? A: AST does not result in meaningful dose delays, typically only about a week if it occurs. Proteinuria primarily causes dose delays at the highest dose range. We've amended the protocol to include prophylactic measures like ACE inhibitors and ARBs to minimize proteinuria. If proteinuria occurs but is asymptomatic, we can maintain dosing by reducing the dose instead of delaying it. We're testing this approach in the clinic to maintain dose intensity.
Q: Regarding your dose expansion criteria of having patients with one to four prior lines of therapy, what's your sense of the distribution of patients that you might be getting? A: It's too early to determine the distribution of patients with fewer versus more prior lines of therapy. However, our inclusion criteria ensure that patients with more than four prior lines are excluded from expansion.
Q: How are you currently thinking about establishing the final biomarker cutoff for B7H4 high? A: We expect the final biomarker cutoff to capture roughly 40% to 50% of the TNBC population. It would be surprising if it falls outside this range.
Q: Could you give us clarity on when we could expect some of the expansion cohort data up to 67 milligrams? Are you exploring other dosing intervals? A: We are not providing specific timing for the expansion cohort data release. We are continuing to explore different dosing schedules, but they are limited to the three we've previously shared.
Q: With the Pfizer program now discontinued, have you spoken to any KOLs who have been on both the Pfizer study and yours? How do they compare the two agents? A: Investigators have not shared confidential data from Pfizer. However, we were informed that Pfizer was not pursuing their B7H4 in TNBC post-topo, which led several sites to join our study as it was seen as a promising opportunity and the only option for their patients.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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