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Inhibrx Biosciences Provides Progress Updates on the INBRX-106 Program and the Expansion Cohorts of the ozekibart (INBRX-109) Program
Prnewswire· 2025-12-16 22:00
Core Insights - Inhibrx Biosciences, Inc. announced updates on its clinical trials for INBRX-106 and ozekibart, focusing on oncology therapeutics [1] INBRX-106 Clinical Trials - The Phase 2 portion of the INBRX-106 trial has recruited 46 out of 60 patients, with expected completion of enrollment in Q1 2026 [2] - The trial targets patients with unresectable or metastatic head and neck squamous cell carcinoma (HNSCC) who have not received prior systemic therapy and have tumor PD-L1 CPS expression ≥ 20 [2] - Primary endpoint is overall response rate, with secondary endpoints including duration of response, progression-free survival, and safety [2] - Data maturity for HNSCC and NSCLC trials is anticipated in H2 2026 to assess the efficacy of INBRX-106 in combination with Keytruda [4] Ozekibart Clinical Trials - Enrollment for the Phase 1/2 trial of ozekibart in combination with FOLFIRI for advanced colorectal cancer has been completed with 44 patients [5] - Ozekibart showed good tolerability and durable responses, with progression-free survival data expected in Q2 2026 [5] - The trial for ozekibart in combination with irinotecan and temozolomide for Ewing sarcoma is expected to complete enrollment in Q2 2026, with plans to discuss accelerated approval with the FDA in H2 2026 if trends continue [6] Product Descriptions - INBRX-106 is a hexavalent sdAb-based therapeutic candidate targeting OX40, currently being investigated for HNSCC and NSCLC [7] - Ozekibart is a tetravalent DR5 agonist antibody designed to induce tumor-biased cell death, with a BLA filing expected in early Q2 2026 [8] Company Overview - Inhibrx Biosciences focuses on developing a pipeline of novel biologic therapeutic candidates using advanced protein engineering methods [9]
Inhibrx Reports Third Quarter 2025 Financial Results
Prnewswire· 2025-11-14 11:00
Core Insights - Inhibrx Biosciences, Inc. reported financial results for Q3 2025, highlighting the completion of the sale of INBRX-101 to Sanofi S.A. and the spin-off of Inhibrx as a standalone entity [1][4] - The company has two ongoing clinical programs, with positive topline results from the registrational trial of ozekibart (INBRX-109) in chondrosarcoma [2][9] - Inhibrx plans to submit a biologics license application to the U.S. FDA in Q2 2026 [6] Recent Corporate Highlights - On October 23, 2025, Inhibrx announced positive topline results from its trial of ozekibart in chondrosarcoma, demonstrating significant improvement in median progression-free survival compared to placebo [2][6] - Interim data from expansion cohorts in colorectal cancer and Ewing sarcoma show high response and disease control rates in heavily pretreated patients [6] Financial Results - As of September 30, 2025, Inhibrx had cash and cash equivalents of $153.1 million, down from $186.6 million as of June 30, 2025 [6] - Research and development expenses for Q3 2025 were $28.5 million, a decrease from $38.9 million in Q3 2024, primarily due to reduced process development and manufacturing activities [6][7] - General and administrative expenses were $5.3 million in Q3 2025, down from $7.9 million in Q3 2024, attributed to decreased legal and personnel-related expenses [6][7] - The net loss for Q3 2025 was $35.3 million, or $2.28 per share, compared to a net loss of $43.9 million, or $2.84 per share, in Q3 2024 [6][7] Summary of Financial Performance - Total revenue for Q3 2025 was $1.3 million, compared to $0.1 million in Q3 2024 [7] - Total operating expenses for Q3 2025 were $33.8 million, down from $46.8 million in Q3 2024 [7] - The company reported total liabilities of $140.6 million as of September 30, 2025, with stockholders' equity at $36.8 million [7]
Inhibrx Biosciences Reports Positive Topline Results from its Registrational Trial of Ozekibart (INBRX-109) in Chondrosarcoma and Provides Updates on Colorectal Cancer and Ewing Sarcoma Expansion Cohorts
Prnewswire· 2025-10-23 20:05
Core Insights - Inhibrx Biosciences announced positive topline results from the ChonDRAgon study, demonstrating the efficacy of ozekibart (INBRX-109) in treating advanced or metastatic chondrosarcoma, achieving a statistically significant improvement in median progression-free survival (PFS) compared to placebo [1][2][6] Chondrosarcoma Study Results - The ChonDRAgon study met its primary endpoint, showing a 52% reduction in the risk of disease progression or death with ozekibart, resulting in a median PFS of 5.52 months versus 2.66 months for placebo [2][6] - Ozekibart is the first investigational therapy to show a significant PFS benefit in a randomized trial for chondrosarcoma, a condition lacking approved systemic treatments [2][6] - Key secondary endpoints indicated a disease control rate of 54% for ozekibart compared to 27.5% for placebo, along with improvements in pain and physical function [3][6] Safety Profile - Ozekibart was generally well tolerated, with common treatment-related adverse events including fatigue, constipation, and nausea. The incidence of treatment-related hepatic adverse events was 11.8% compared to 4.5% in the placebo group [4][10] - Hepatotoxicity was managed effectively through patient selection and monitoring, resulting in a low overall incidence of severe liver-related adverse events [4][10] Expansion Cohorts - Inhibrx is conducting expansion cohorts for ozekibart in combination with FOLFIRI for colorectal cancer and with irinotecan and temozolomide for Ewing sarcoma, showing promising early results [6][15] - Initial results from the colorectal cancer trial indicated a 23% overall response rate and a 92% disease control rate in a heavily pretreated patient population [7][8] - For Ewing sarcoma, the combination therapy showed a 64% overall response rate and a 92% disease control rate among evaluable patients [9][10] Future Plans - The company plans to file a Biologics License Application (BLA) for ozekibart in Q2 of 2026, aiming to expedite its availability to patients [6][10] - Detailed results from the ChonDRAgon study will be presented at the Connective Tissue Oncology Society Annual Meeting on November 14, 2025 [5][6]