Zai Lab Limited ZLAB and NovoCure Limited NVCR revealed additional data on Saturday from the Phase 3 PANOVA-3 trial of Tumor Treating Fields (TTFields) therapy for pancreatic cancer.The data were presented at the 2025 American Society of Clinical Oncology Annual Meeting.The Phase 3 PANOVA-3 trial evaluated the use of TTFields therapy concomitantly with gemcitabine and nab-paclitaxel as a first-line treatment for unresectable, locally advanced pancreatic adenocarcinoma compared to gemcitabine and nab-paclita ...

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]

Core Insights - Theriva Biologics announced positive topline outcomes from the VIRAGE Phase 2b clinical trial for VCN-01 in combination with standard-of-care chemotherapy for metastatic pancreatic ductal adenocarcinoma (PDAC) patients [1][3] Company Overview - Theriva Biologics is a diversified clinical-stage company focused on developing therapeutics for cancer and related diseases, with its lead product candidate being VCN-01, an oncolytic adenovirus [10][11] Clinical Trial Results - The VIRAGE trial involved 96 newly-diagnosed metastatic PDAC patients, showing that patients receiving 2 doses of VCN-01 plus chemotherapy had a median overall survival (OS) of 14.8 months compared to 11.6 months for those receiving chemotherapy alone [2] - In the primary endpoint analysis, patients treated with VCN-01 followed by chemotherapy had a median OS of 10.8 months, while those receiving only chemotherapy had a median OS of 8.6 months [5] - The trial demonstrated increased progression-free survival (PFS) and duration of response (DoR) in the VCN-01 treatment group, with median PFS of 7.0 months compared to 4.6 months for the control group [5] Safety Profile - VCN-01 was well-tolerated, with adverse events being transient and reversible, consistent with prior clinical trials [3][4] - The most common adverse events included pyrexia, flu-like illness, and elevated transaminases, which were less frequent after the second dose of VCN-01 [3] Future Directions - The positive data from the VIRAGE trial is expected to facilitate engagement with industry partners and support the design of a Phase 3 confirmatory trial [3][4]