相关临床试验
11
1 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
进行中（未招募）
1
9.1%
已完成
10
90.9%
暂无批准数据
- Akamis Bio's NG-350A combined with chemoradiotherapy achieved a 50% composite response rate in the first 10 patients with mismatch repair-proficient locally advanced rectal cancer, doubling the expected 25% rate from standard treatment alone. - The Phase 1b FORTRESS study demonstrated no serious adverse events related to NG-350A, with the oncolytic immunotherapy designed to drive intratumoral expression of a CD40 agonist antibody. - Results could enable more patients to pursue organ-preserving "watch-and-wait" protocols instead of life-altering rectal surgery, particularly important as colorectal cancer becomes the leading cause of cancer death in patients under 50. - The encouraging preliminary data provides clinical proof of concept for NG-350A's potential to advance the standard of care for the approximately 30,000 patients diagnosed annually with this condition in the US.
- The oncolytic virus therapy landscape has expanded steadily over the past decade, with over 100 companies worldwide pursuing clinical or preclinical programs developing 110+ oncolytic virus drugs. - Key market drivers include growing cancer incidence in hard-to-treat solid tumors, increasing understanding of cancer biology, advancements in viral engineering, and rising adoption of personalized medicine approaches. - Leading companies such as Candel Therapeutics, Oncolytics Biotech, and CG Oncology are advancing promising therapies like CAN-2409, Pelareorep, and CG0070 through Phase III clinical trials. - Recent developments include innovative combination approaches, with Imugene and JW Therapeutics collaborating on CF33-CD19 with CAR-T therapy, and multiple FDA designations granted including Fast Track and RMAT status.
- The FDA has granted fast track designation to NG-350A, an oncolytic immunotherapy developed by Akamis Bio, for treating mismatch repair-proficient locally advanced rectal cancer. - NG-350A is designed to drive intratumoral expression of a CD40 agonist monoclonal antibody, activating antigen-presenting cells and recruiting T cells to deliver potent anti-tumor immune responses. - The therapy is being evaluated in the phase 1b FORTRESS trial combining NG-350A with chemoradiotherapy in approximately 30 patients with locally advanced rectal cancer. - Patients with mismatch repair-proficient tumors represent approximately 90% of locally advanced rectal cancer cases, highlighting a significant unmet medical need for new therapeutic approaches.
- Akamis Bio has enrolled the first patient in its Phase 1b FORTRESS trial evaluating NG-350A in combination with standard chemoradiotherapy for locally advanced rectal cancer. - NG-350A is a systemically administered immunotherapy designed to drive intratumoral expression of CD40 agonist antibodies, potentially enhancing immune response against both primary and metastatic tumors. - The FORTRESS trial builds on promising results from the earlier CEDAR study, which showed significantly higher complete response rates when combining Akamis Bio's immunotherapy with standard chemoradiotherapy.
