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Sensei Biotherapeutics (NasdaqGM:SNSE) Update / Briefing Transcript
2025-10-20 13:02
Summary of Sensei Biotherapeutics Conference Call Company Overview - **Company**: Sensei Biotherapeutics (NasdaqGM:SNSE) - **Event Date**: October 20, 2025 - **Focus**: Update on Solnestretug, a VISTA-targeting antibody in immuno-oncology Key Points Industry Context - **Immuno-Oncology**: The call marks a significant milestone for the field, particularly regarding VISTA-targeting therapies, which have not previously demonstrated progression-free survival data in PD1-resistant tumors [2][56] Clinical Data and Findings - **Solnestretug**: - Represents the first progression-free survival data for any VISTA-targeting antibody [2] - Demonstrated clinical activity, durability, and tolerability, suggesting a differentiated mechanism of action [2] - Designed to selectively reverse immunosuppression in the tumor microenvironment, avoiding systemic toxicity [4][6] - **Clinical Trials**: - Phase one dose escalation showed no dose-limiting toxicity, reaching a top dose of 15 mg/kg [7][8] - Combination therapy with cemiplimab was well tolerated, with a six-month progression-free survival rate of 37% for patients previously treated with immunotherapy [15][21] - Notably, 50% of patients receiving the 15 mg/kg dose had a six-month progression-free survival [16][21] Safety Profile - **Adverse Events**: - Low-grade cytokine release syndrome was the only notable class-related adverse event, with no grade 3 or 4 adverse events attributed to Solnestretug [12][48] - The safety profile was consistent with that of single-agent cemiplimab, indicating a well-tolerated regimen [48][56] Market Opportunity - **Commercial Potential**: - PD1-targeted therapies generate over $45 billion annually, with significant unmet needs in secondary resistance cases [4][5] - VISTA's expression across various cancer types presents a broad therapeutic potential [5] Future Plans - **Phase Two Studies**: - Planned initiation in early 2026, focusing on hot tumor settings and potentially leading to accelerated approval in the PD1-resistant population [25][29] - Two-study approach: one randomized study in non-small cell lung cancer and a single-arm study in Merkel cell carcinoma [26][27] Regulatory Considerations - **FDA Engagement**: - Ongoing discussions with the FDA regarding phase two study design and potential for breakthrough therapy designation [54] Conclusion - **Overall Impact**: - Solnestretug represents a significant advancement in immuno-oncology, offering a new therapeutic path for patients with secondary resistance to existing therapies [56][57] - **Future Outlook**: - The company is optimistic about the potential of Solnestretug to redefine treatment options in the immuno-oncology landscape [57]
Why Is Nano-Cap BioLineRx Stock Surging On Friday?
Benzinga· 2025-05-30 17:58
Core Insights - BioLineRx Ltd is presenting new data from the CheMo4METPANC Phase 2 trial at the 2025 American Society of Clinical Oncology Annual Meeting, which evaluates a combination of motixafortide, cemiplimab, and standard chemotherapies for first-line pancreatic cancer [1] Group 1: Clinical Trial Results - The pilot phase of the trial showed that four out of eleven patients remained progression-free after more than one year [2] - The overall response rate (ORR) was 64% (7 out of 11), and the disease control rate (DCR) was 91% (10 out of 11), significantly higher than historical rates of 23% and 48% for gemcitabine and nab-paclitaxel [5] - The trial is the first large, multi-center, randomized study evaluating motixafortide with a PD-1 inhibitor and first-line PDAC chemotherapies, with full enrollment expected by 2027 [6] Group 2: Patient Outcomes - Two patients with metastatic pancreatic cancer (mPDAC) underwent definitive treatment, with one achieving complete resolution of liver lesions and the other showing a sustained partial response [3] - An increase in CD8+ T-cell tumor infiltration was observed across all eleven patients treated with the motixafortide combination, indicating a potential immune response [4] Group 3: Company Financials and Market Response - BioLineRx has reduced its operating expense run rate by over 70% starting January 1, 2025, due to the transfer of the APHEXDA program and the shutdown of U.S. commercial operations [7] - The company raised gross proceeds of $10 million in financing and reaffirmed its cash runway through the second half of 2026 [7] - Following these developments, Jones Trading upgraded BioLineRx from Hold to Buy with a price target of $12, and the stock price increased by 42.7% to $5.41 [8]