相关临床试验
9
2 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
N/A
已完成
1
11.1%
尚未招募
2
22.2%
招募中
2
22.2%
终止
4
44.4%
暂无批准数据
- Imugene's azer-cel, an allogeneic off-the-shelf CAR T therapy, demonstrated a 75% overall response rate with 55% complete response rate in patients with relapsed/refractory diffuse large B-cell lymphoma who had failed multiple prior therapies. - The first patient remains cancer-free at 15 months with additional patients showing durable responses at 2, 5, and 11 months, indicating sustained therapeutic benefit in this high-unmet-need population. - Based on these positive results and FDA Fast Track Designation, Imugene plans to meet with the FDA in Q4 2025 to discuss pivotal trial design for potential registration. - The trial is expanding to include CAR T-naïve patients with other B-cell lymphoma subtypes including primary central nervous system lymphoma and chronic lymphocytic leukemia.
- Imugene Limited received AU$5.87 million in R&D tax refunds from the Australian Government's incentive program, providing up to 48.5% refundable offset for eligible research activities. - The funding will accelerate clinical development of the company's innovative immunotherapy pipeline, including allogeneic CAR T therapy azer-cel for blood cancers and CF33 oncolytic virus therapy for solid tumors. - Imugene continues advancing multiple oncology programs including B-cell vaccine candidates, leveraging cutting-edge technology to improve cancer outcomes and transform patient care.
- A phase II trial of HER-Vaxx plus chemotherapy demonstrated a 40% survival benefit compared to chemotherapy alone in patients with HER2-overexpressing gastric cancer. - The HER-Vaxx vaccine induced strong HER2-specific IgG and IgG1 antibody responses, correlating with tumor reduction and inhibition of intracellular phosphorylation. - The vaccine's mechanism of action includes antibody-dependent cellular cytotoxicity (ADCC) and counteraction of immune tolerance effects, enhancing chemotherapy's impact. - The study suggests HER-Vaxx is safe and immunogenic, warranting further evaluation in larger trials and combination therapies for advanced gastric cancer.
