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RedHill Biopharma's Positive Opaganib Results Indicate Reduction in Venetoclax Resistant Cells
Prnewswire· 2025-12-15 12:00
Core Insights - Resistance to venetoclax, a $2.5 billion therapy for Chronic Lymphocytic Leukemia (CLL), is becoming a significant therapeutic challenge as leukemic cells persist despite combination therapies [1][3] - New in vivo studies indicate that the addition of opaganib, a potent sphingosine kinase 2 (SPHK2) inhibitor, to venetoclax can reduce CLL cell counts by 50% compared to controls, suggesting its potential as an add-on therapy for venetoclax-resistant CLL [1][2] - Opaganib has demonstrated a favorable safety and tolerability profile in over 470 clinical trials and is being evaluated for multiple indications, including oncology and viral infections [1][9] Company Overview - RedHill Biopharma Ltd. is a specialty biopharmaceutical company focused on the development and commercialization of drugs for gastrointestinal diseases, infectious diseases, and oncology [12] - The company promotes the FDA-approved drug Talicia for treating Helicobacter pylori infections and is advancing several late-stage clinical programs, including opaganib [12][13] - Opaganib is currently undergoing a Phase 2 clinical trial in combination with darolutamide for advanced prostate cancer, highlighting its broad therapeutic potential [1][7] Product Insights - Venetoclax, approved by the FDA in 2016, is a first-in-class BCL-2 inhibitor that has become a cornerstone of CLL therapy, achieving sales of approximately $2.5 billion in 2024 [3] - Opaganib is a first-in-class, orally administered drug with anticancer, anti-inflammatory, and antiviral activities, targeting multiple indications including various cancers and viral diseases [6][10] - The drug has received orphan-drug designations from the FDA for cholangiocarcinoma and neuroblastoma, indicating its potential in treating rare diseases [7]
Gilead Sciences (GILD) Conference Transcript
2023-02-14 17:22
Gilead Sciences (GILD) Conference Summary Company Overview - Gilead Sciences is focusing on building a sustainable pipeline, particularly in HIV, virology, oncology, and inflammation [3][4] Key Products and Pipeline Trodelvy - Trodelvy has received approvals for triple-negative breast cancer and bladder cancer, with recent approval for HR positive HER2 negative breast cancer [5][6] - The strategy includes expanding indications and moving into earlier treatment lines, with ongoing studies in triple-negative and HR positive HER2 negative breast cancer, as well as non-small cell lung cancer [7][8] - Revenue trajectory for Trodelvy is positive, with expectations for continued growth [9] Non-Small Cell Lung Cancer - Comparison with AstraZeneca's TROP-two highlights differences in linker technology and payload, which may affect efficacy and safety profiles [10][11] - Gilead's hydrolyzable linker and moderately toxic payload are expected to provide a differentiated profile in lung cancer treatment [12][13] - Ongoing trials are similar in size and patient population to AstraZeneca's, but with key differences in patient selection criteria [15][16] TIGIT Development - Data presented at ASCO indicates that TIGIT adds value to PD-1 inhibitors in non-small cell lung cancer, with a promising PFS improvement [18][19] - Ongoing trials are designed to assess the efficacy of TIGIT in combination therapies [20][21] Cell Therapy - Kite, a Gilead subsidiary, is positioned as a leader in cell therapy, with a focus on optimizing CAR T technology and reducing delivery times [22][23] - Partnerships, including with Galapagos, are being leveraged to enhance cell therapy offerings [24][25] Magrolimab - Magrolimab is being developed for both solid tumors and hematological malignancies, with ongoing Phase III trials for MDS and AML [27][28] - The company is focused on safety and efficacy, with a patented dosing approach to minimize adverse effects [30][31] Oral COVID Treatment - Gilead is conducting trials for its oral COVID treatment, with sample sizes of approximately 2,300 for high-risk and 1,900 for standard-risk patients [37][38] - The company acknowledges challenges in recruiting patients and adapting to the evolving pandemic landscape [34][36] Lenacapavir and Inflammation Programs - Gilead is advancing multiple candidates in the inflammation space, including oral beta-seven, IRAK4, and TYPO2 programs, with Phase II studies expected in the next year or two [48][49] - The focus is on developing best-in-class differentiated molecules for various inflammatory indications [50] Additional Insights - Gilead is committed to adapting its strategies based on evolving market conditions and patient needs, particularly in the context of the COVID-19 pandemic and competitive landscape [34][36][41] - The company is actively monitoring and adjusting its clinical trial designs to ensure robust data collection and analysis [38][41] This summary encapsulates the key points discussed during the conference, highlighting Gilead's strategic focus, product pipeline, and ongoing developments in various therapeutic areas.