Release Date: October 31, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: How reliable are changes in IgE and TC from the healthy volunteer study for KT-621, and how do they compare to previous studies? A: Nello Mainolfi, CEO, explained that the main goal of the phase one study is to demonstrate predictable PK and safety. The study uses a direct biomarker, protein levels, which is more reliable than downstream biomarkers. Changes in IgE and TC are modest in healthy volunteers, and while they provide some insight, the primary focus is on safety and PK. The expected changes are in line with previous studies, but the data can be noisy.
Q: With the focus on immunology, are there any savings from oncology that will be redeployed? A: Bruce Jacobs, CFO, stated that there are savings from not pursuing certain oncology clinical development plans. However, most of these savings will be reinvested into the immunology pipeline, including both disclosed and undisclosed programs. The overall cash runway guidance remains unchanged.
Q: Have you made comparisons between KT-621 and Dupilumab in preclinical models? A: Nello Mainolfi, CEO, confirmed that comparisons have been made. In preclinical models, KT-621 showed potent inhibition of relevant pathways and greater in vivo activity compared to KT-294. The focus has been on T2 biomarkers and disease outcomes in asthma models rather than ear thickness in atopic dermatitis models.
Q: What are the potential benefits of a degrader approach for STAT6 compared to small molecule inhibitors? A: Nello Mainolfi, CEO, explained that degrading STAT6 offers a more complete blockade of the pathway compared to inhibitors, which face challenges with PK and PD correlation. The degrader approach is catalytic and does not require such correlation, potentially offering a more profound impact on pathway blockade.
Q: What are the potential on-target or off-target adverse events for KT-621 at high doses? A: Nello Mainolfi, CEO, stated that preclinical studies have not shown any adverse events even at high doses. KT-621 is highly selective, and no off-target activity is expected. Genetic studies also support the safety of STAT6 degradation, with knockout mice being normal and fertile.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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