Release Date: February 26, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: Can you elaborate on the mechanism for the cleavage of the T-cell engager and its efficiency in the tumor microenvironment? A: Mika Derynck, Executive Vice President, Therapeutic Area Head Oncology, explained that the Pro extend masking technology used in their T-cell engagers is efficiently cleaved in the tumor microenvironment. This is evidenced by the activity observed in both the HER2 and PSMA programs, which show tumor-specific cleavage without significant peripheral toxicity. The technology is also used in an approved hemophilia drug, demonstrating its efficiency in a high protease environment.
Q: What additional steps are needed to start the Eclipse trial for hepatitis Delta, and what is the estimated timing for enrollment completion? A: Mark Eisner, Executive Vice President and Chief Medical Officer, stated that they are on track to initiate the Eclipse program in the first half of the year. The team is working urgently to start the trials, and they expect efficient patient recruitment due to the high unmet need in hepatitis Delta and compelling phase 2 data.
Q: What are the go/no-go criteria for the hepatitis B program, and what would be attractive to a potential development partner? A: Mark Eisner mentioned that they are looking for a 30% functional cure in the triplet therapy and 20% in the doublet, based on KOL interactions. These criteria are considered clinically meaningful, and they plan to partner the program after obtaining functional cure data.
Q: Given the strong safety profile in phase one studies of other programs, do you see a read-through to 5,525, and will you escalate doses more aggressively? A: Marianne De Backer, CEO, indicated that learnings from previous programs will inform the 5,525 study. Mark Eisner added that EGFR is broadly expressed in normal tissue, making it a rigorous test for their dual masking technology. They expect to be efficient in conducting the study, leveraging insights from earlier programs.
Q: What gives you confidence that higher doses of 5,500 will produce deeper, more durable PSA responses? A: Mark Eisner explained that the PSMA program is still in early dose escalation, showing compelling early signs of efficacy and safety. They anticipate deeper and more sustained efficacy as they escalate the dose, supported by the platform's validated ability to unmask molecules in the tumor while maintaining a high safety profile.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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