EnGeneIC Pty Ltd, a Sydney-based biotechnology company and leader in innovative cancer therapies, has announced the successful dosing of the first patient in its open-label, multicentre, Phase I/IIa clinical trial at Mater Hospital, Sydney. The trial (ENG19) is an essential next step in progressing EnGeneIC’s novel platform technology through the clinic and to market.

总部位于悉尼的生物技术公司、创新型癌症疗法领域的领导者 EnGeneIC 有限公司宣布，其在悉尼 Mater 医院进行的开放标签、多中心、I/IIa 期临床试验中成功为第一名患者给药。该试验（ENG19）是推动 EnGeneIC 的新型平台技术走向临床和市场的重要下一步。

It will assess the safety and efficacy of EGFR-targeted EDVTM (EnGeneIC Dream Vector) nanocells carrying the super-cytotoxic drug PNU-159682, together with EDVs loaded with an immune-stimulating adjuvant in patients with advanced solid tumours expressing Epidermal Growth Factor Receptor (EGFR)..

它将评估携带超强细胞毒性药物PNU-159682的EGFR靶向EDVTM（EnGeneIC梦幻载体）纳米细胞与装载免疫刺激佐剂的EDV在表达表皮生长因子受体（EGFR）的晚期实体瘤患者中的安全性和有效性。

This groundbreaking study targets patients for whom second-line therapy is no longer working or for whom first- and/or second-line treatments are not appropriate. The trial will focus on EGFR-positive cancers that are difficult to treat and have a poor prognosis, including but not limited to non-small cell lung cancer (NSCLC), mesothelioma, kidney and bladder cancer, pancreatic cancer, head and neck cancer, medullary thyroid cancer, and triple-negative breast cancer..

这项开创性的研究针对二线治疗不再有效或一线和/或二线治疗不合适的患者。试验将专注于那些难以治疗且预后较差的EGFR阳性癌症，包括但不限于非小细胞肺癌（NSCLC）、间皮瘤、肾癌和膀胱癌、胰腺癌、头颈癌、甲状腺髓样癌以及三阴性乳腺癌。

Professor Fran Boyle and Dr. Luke Ardolino are Investigators for the trial at the Mater Hospital. Commenting on the significance of this trial, Professor Boyle said: “We are thrilled to be part of this innovative study, which has the potential to offer new hope to patients suffering from aggressive EGFR-expressing cancers.

Mater医院的弗兰·博伊尔教授和卢克·阿尔多利诺博士是该试验的研究者。博伊尔教授在评论这项试验的重要性时说：“我们很高兴能参与这项创新研究，它有可能为患有表达EGFR的侵袭性癌症患者带来新的希望。

The treatment combines cutting-edge technology with a promising therapeutic approach, which has the potential to change the way we treat these challenging cancers.”.

该治疗结合了尖端技术和富有前景的治疗方法，有潜力改变我们治疗这些棘手癌症的方式。

As part of the expansion of the trial, EnGeneIC will open recruitment at Frankston Hospital, Victoria, this month under the guidance of Principal Investigator, Professor Vinod Ganju before adding further Australian sites. Additionally, the trial will be launched internationally at Curie Oncology in Singapore, where Dr.

作为试验扩展的一部分，EnGeneIC 将于本月在维多利亚州弗兰克斯顿医院开启招募工作，由首席研究员文诺德·甘朱教授指导，随后将增加更多的澳大利亚试验地点。此外，该试验还将在新加坡的居里肿瘤学中心国际启动，那里的医生。

Su Pin Choo will lead the study and EnGeneIC collaborator, Singapore Advanced Medicine (SAM, Dr. S. K. Djeng) will serve as EnGeneIC’s local representative, as required by the Health Sciences Authority, Singapore..

周素嫔将领导这项研究，EnGeneIC 的合作者新加坡高级医学（SAM，邓世凯博士）将根据新加坡卫生科学局的要求，担任 EnGeneIC 的当地代表。

Dr Himanshu Brahmbhatt, co-CEO of EnGeneIC commented: “The EDV nanocell therapy is a globally unique technology that stimulates a complete orchestra of anti-tumor responses, individual to every patient. In early clinical studies, even patients who had exhausted all treatment options have responded. Most anti-cancer therapies are designed to hit only one tumor specific target, but the difficulty lies in the fact that as the cancer progresses, it becomes highly heterogeneous resulting in some cells escaping the therapy.

EnGeneIC公司的联合首席执行官希曼舒·布拉姆巴特博士评论道：“EDV纳米细胞疗法是一项全球独特的技术，能够激发针对每位患者个体的全方位抗肿瘤反应。在早期的临床研究中，即使是对所有治疗方案均已无效的患者也产生了反应。大多数抗癌疗法设计时仅针对一个特定的肿瘤靶点，但难点在于，随着癌症的进展，它变得高度异质化，导致部分癌细胞逃脱了治疗。”

This means that the multi-drug and/or immunotherapy-resistant tumor keeps coming back.”.

这意味着对多种药物和/或免疫疗法产生耐药性的肿瘤会不断复发。"

“In this clinical trial, we aim to identify which cancer indications show a favourable outcome. This trial will accelerate the development of this potentially life-changing treatment for patients, by EnGeneIC’s engagement with a committed group of investigators and clinical sites. It is a huge step for us as we take EDV therapy forward in larger, defining, clinical trials for these unresponsive low survival cancers,” he added..

“在这项临床试验中，我们旨在确定哪些癌症适应症显示出良好的结果。通过EnGeneIC与一群专注的研究人员和临床试验点的合作，这项试验将加速这种潜在改变生命的治疗方法的发展。这是我们推进EDV疗法在更大规模、更具决定性的临床试验中针对这些难治性低生存率癌症迈出的重要一步，”他补充道。

EnGeneIC's EDV nanocells form the backbone of the company's ongoing commitment to revolutionise cancer therapy by utilising advanced nanotechnology to improve both the precision and efficacy of treatments to stimulate an anti-tumor immune response and to overcome the drug resistance that plagues successful treatment of low survival tumour types..

EnGeneIC的EDV纳米细胞构成了该公司持续致力于通过利用先进的纳米技术来革新癌症治疗的基石，这些技术旨在提高治疗的精准性和有效性，刺激抗肿瘤免疫反应，并克服困扰低存活率肿瘤类型成功治疗的耐药性问题。

For more information about the trial or to inquire about participation, please visit www.engeneic.com or contact Stephen Parker whose details are listed below. The trial is registered on the Australia and New Zealand clinical trial site https://www.anzctr.org.au/ACTRN12625000203459.aspx

欲了解有关试验的更多信息或咨询参与事宜，请访问 www.engeneic.com 或联系下面列出详细信息的斯蒂芬·帕克。该试验在澳大利亚和新西兰临床试验网站上注册，网址为 https://www.anzctr.org.au/ACTRN12625000203459.aspx 。

About EnGeneIC

关于EnGeneIC

EnGeneIC is a clinical stage biopharmaceutical company focused on developing novel cancer therapies based on its proprietary platform of EnGeneIC Dream Vector (EDV) nanocells. These nanocells are designed to deliver highly potent drugs directly to cancer cells, providing targeted treatment while minimizing damage to healthy tissue and at the same time stimulate a powerful anti-tumour innate and adaptive immune response.

EnGeneIC是一家处于临床阶段的生物制药公司，专注于基于其专有的EnGeneIC Dream Vector（EDV）纳米细胞平台开发新型癌症疗法。这些纳米细胞旨在将高效药物直接递送至癌细胞，提供靶向治疗，同时最大限度地减少对健康组织的损害，并激发强大的抗肿瘤先天性和适应性免疫反应。

The company’s approach aims to improve the quality of life and extend survival for cancer patients by offering new and more effective therapies for hard-to-treat cancers..

该公司的方法旨在通过为难治性癌症提供新的更有效的疗法，改善癌症患者的生活质量并延长生存期。

For media inquiries, please contact:

媒体咨询，请联系：

Stephen Parker

斯蒂芬·帕克

Business Operations

商业运营

sparker@engeneic.com

sparker@engeneic.com

Source: globenewswire.com

来源：globenewswire.com