Release Date: August 08, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: Can you confirm if you have met with the FDA regarding the AXL and UPS registrational study, and what feedback have you received? Also, could you provide more details on patient compliance and safety profile? A: We have discussed mecbotamab vedotin in undifferentiated pleomorphic sarcoma with the FDA, including Project Optimus requirements and potential accelerated approval with a single-arm trial. We haven't met with the agency regarding recent patient enrollment but plan to update in the second half of the year. No new safety findings have been identified, and we focus on a more patient-compliant dosing regimen.
Q: What is your confidence level in securing a partnership deal this year, and which assets are most likely to be partnered? A: We are confident in establishing one or more partnerships this year, potentially including preclinical assets. The ADCs are receiving significant attention, and both are potential candidates for partnership.
Q: Regarding the AXL-ADC, have you observed any deepening of responses or changes in patient outcomes since the last data update? A: We have a mature dataset for mecbotamab vedotin in non-small cell lung cancer, including a CR patient. We are observing evolving data, particularly in KRAS mutation variants, and will continue to evaluate this.
Q: For the UPS study, are you still enrolling patients, and how will KRAS and AXL status influence future patient selection? A: We are not currently enrolling patients and are evaluating existing data. KRAS status shows a strong correlation with clinical benefit, and while AXL expression is beneficial, it may not be required for patient selection.
Q: Will you enroll more patients for the CTLA-4 monotherapy study at the 700-milligram dose level? A: We do not plan to further characterize monotherapy safety. Our focus is on combining with PD-1 antibodies to evaluate drug activity and safety in melanoma and lung cancer patients.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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