Major Molecular Response (MMR)
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Terns Pharmaceuticals (TERN) Update / Briefing Transcript
2025-09-03 21:30
Summary of Terns Pharmaceuticals (TERN) Investor Webinar Company and Industry Overview - **Company**: Terns Pharmaceuticals - **Industry**: Pharmaceuticals, specifically focusing on treatments for Chronic Myeloid Leukemia (CML) Core Points and Arguments 1. **Introduction of TURN701**: Terns Pharmaceuticals is developing TURN701, a next-generation oral allosteric BCR ABL inhibitor for CML treatment, which is expected to have a best-in-class profile [3][4][5] 2. **Unmet Medical Need in CML**: Despite advancements with first and second-generation TKIs, approximately 40% of CML patients switch therapies within five years due to inadequate response or side effects [6][7] 3. **Market Dynamics**: Osiminib, the first allosteric BCR ABL inhibitor, has gained significant market share, achieving 15% in frontline therapy within two quarters of its launch and projected peak sales of $3 billion [7][8] 4. **Efficacy and Safety Comparison**: TURN701 aims to improve upon osiminib's efficacy, safety, and convenience, with a focus on achieving higher Major Molecular Response (MMR) rates and a better safety profile [9][10][19] 5. **Clinical Data and Study Design**: The CARDINAL Phase I study is evaluating TURN701 in patients who have failed or are intolerant to prior TKIs, with a focus on dose escalation and safety [11][12][24] 6. **Target Coverage and Selectivity**: TURN701 demonstrates higher target coverage and selectivity compared to osiminib, which may lead to better clinical outcomes [20][22][24] 7. **Regulatory Pathway**: Terns plans to initiate pivotal studies for TURN701 in both second-line and frontline settings, aiming for a broad indication across all lines of CML therapy [41][42] Important but Overlooked Content 1. **Patient Population Insights**: The majority of patients in Phase I studies have high leukemia burden and lack efficacy to their last TKI, indicating a challenging treatment landscape [28][30] 2. **Safety Profile**: Early data from TURN701 shows no dose-limiting toxicities (DLTs) up to 500 mg, contrasting with osiminib, which has reported significant adverse events [23][24][63] 3. **Market Adoption Predictions**: The anticipated shift in treatment dynamics suggests that a significant portion of newly diagnosed patients may start on allosteric TKIs, potentially changing the standard of care in CML [38][39][40] 4. **Long-term Safety Data**: There is a need for ongoing collection of long-term safety data to further differentiate TURN701 from existing therapies [24][63] This summary encapsulates the key points discussed during the Terns Pharmaceuticals investor webinar, highlighting the company's strategic focus on TURN701 and its potential impact on the treatment landscape for CML.