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IMUNON Announces Site Activation for IMNN-101 Phase 1 Vaccine Study

IMUNON Announces Site Activation for IMNN-101 Phase 1 Vaccine Study

IMUNON 宣布激活 IMNN-101 第 1 期疫苗研究的场地
Imunon ·  05/13 12:00

Proof-of-concept study for Imunon's first vaccine utilizing its proprietary PlaCCine platform is now open for enrollment

Imunon首款利用其专有PlacCine平台的疫苗的概念验证研究现已开放报名

Topline results expected this year

预计今年的头条业绩

LAWRENCEVILLE, N.J., May 13, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug development company focused on developing non-viral DNA-mediated immunotherapy and next-generation vaccines, today announced that DM Clinical Research in Philadelphia is the first site activated and ready for patient recruitment for its Phase 1 study with IMNN-101 in a seasonal Covid-19 vaccine. DM Clinical Research is an integrated national network of clinical trial sites focused on delivering advanced, preventive medicine to underserved communities. It won the 2023 Best Clinical Trial Network at the annual Vaccine Industry Excellence (ViE) Awards held during the World Vaccine Congress Washington, the leading global vaccine congress.

新泽西州劳伦斯维尔,2024年5月13日(GLOBE NEWSWIRE)——专注于开发非病毒DNA介导免疫疗法和下一代疫苗的临床阶段药物开发公司IMUNON, Inc.(纳斯达克股票代码:IMNN)今天宣布,费城的DM临床研究是第一个启动并准备招募患者参与季节性Covid-19疫苗的 IMNN-101 1期研究的研究基地。DM Clinical Research是一个综合的全国性临床试验场所网络,致力于为服务不足的社区提供先进的预防性药物。它在全球领先的疫苗大会华盛顿世界疫苗大会期间举行的年度疫苗行业卓越(ViE)奖中获得了2023年最佳临床试验网络奖。

A second site at a tertiary center in Boston, MA is expected to be activated in the next few weeks.

马萨诸塞州波士顿三级中心的第二个站点预计将在未来几周内启用。

Top line data from the trial are anticipated by year-end. IMNN-101 utilizes the company's PlaCCine platform, a proprietary mono- or multi-valent DNA plasmid that regulates the expression of key pathogen antigens and is delivered via a novel synthetic DNA delivery system.

预计该试验的主要数据将于年底公布。IMNN-101 利用该公司的 PlacCine 平台,这是一种专有的单价或多价 DNA 质粒,可调节关键病原抗原的表达,并通过一种新的合成 DNA 递送系统输送。

"We are delighted to initiate the first trial at two sites to evaluate IMNN-101 as a superior next generation vaccine candidate in human subjects. I'd like to congratulate the IMUNON team on the timely achievement of this important milestone," said Michael Tardugno, Executive Chairman of IMUNON. "We look forward to demonstrating proof-of-concept for our PlaCCine technology and providing data in the fourth quarter. Along with improved durability, PlaCCine's attributes and competitive advantages are key to attracting potential partners to continue development and to expand its potential to other infectious diseases where there are limited options or significant drawbacks to current options," he added.

“我们很高兴在两个地点启动第一项试验,评估 IMNN-101 是人类受试者中卓越的下一代候选疫苗。我要祝贺IMUNON团队及时实现这一重要里程碑。” IMUNON执行主席迈克尔·塔尔杜尼奥说。“我们期待在第四季度演示我们的PlacCine技术的概念验证并提供数据。除了提高耐用性外,PlacCine的特性和竞争优势是吸引潜在合作伙伴继续开发以及将其潜力扩展到其他选择有限或当前选择存在重大缺陷的传染病的关键,” 他补充说。

As currently planned, the Phase 1 study will be conducted in the United States and will enroll 24 subjects evaluating three escalating doses of IMNN-101. For this study, IMMN-101 has been designed to protect against the SARS-CoV-2 Omicron XBB1.5 variant, in accordance with the FDA's Vaccines and Related Biological Products Advisory Committee's June 2023 announcement of the framework for updated COVID-19 doses. The primary objectives of the study are to evaluate safety and tolerability of the vaccine in healthy adults. Secondary objectives include evaluating the ability of the IMNN-101 vaccine to elicit neutralizing antibody responses, cellular responses and their associated durability. Based on reported preclinical data, durability of immune protection is expected to be superior to published mRNA vaccine data.

按照目前的计划,第一阶段研究将在美国进行,并将招收24名受试者,评估三种递增剂量的 IMNN-101。在这项研究中,根据美国食品药品管理局疫苗及相关生物制品咨询委员会 2023 年 6 月发布的 COVID-19 更新剂量框架,IMMN-101 旨在防止 SARS-CoV-2 Omicron XBB1.5 变体。该研究的主要目标是评估疫苗在健康成年人中的安全性和耐受性。次要目标包括评估 IMNN-101 疫苗引发中和抗体反应的能力、细胞反应及其相关的耐久性。根据报告的临床前数据,免疫保护的耐久性有望优于已发布的mRNA疫苗数据。

IMUNON's preclinical work with prototype PlaCCine vaccines has shown promise:

IMUNON对原型PlacCine疫苗的临床前研究显示出希望:

  • Immunogenicity and protection in non-human primates exceeding 95%, which is comparable to mRNA vaccines. These characteristics and excellent stability of the vaccine at workable temperatures (up to one year at 4°C and one month at 37°C) suggest superior commercial handling and distribution properties compared with mRNA vaccines.
  • PlaCCine vaccines have advantages in T-cell responses, safety, compliance and manufacturing flexibility compared with viral or other DNA or protein vaccines.
  • 非人灵长类动物的免疫原性和保护性超过95%,与mRNA疫苗相当。与mRNA疫苗相比,疫苗在可工作温度(4°C时长达一年,37°C时长达一个月)下的这些特性和出色的稳定性表明,与mRNA疫苗相比,具有优异的商业处理和分销特性。
  • 与病毒或其他DNA或蛋白质疫苗相比,Placcine疫苗在T细胞反应、安全性、合规性和生产灵活性方面具有优势。

About IMUNON

关于 IMUNON

IMUNON is a clinical-stage biotechnology company focused on advancing a portfolio of innovative treatments that harness the body's natural mechanisms to generate safe, effective and durable responses across a broad array of human diseases, constituting a differentiating approach from conventional therapies. IMUNON is developing its non-viral DNA technology across its modalities. The first modality, TheraPlas, is developed for the coding of cytokines and other therapeutic proteins in the treatment of solid tumors where an immunological approach is deemed promising. The second modality, PlaCCine, is developed for the delivery of DNA-coded viral antigens that can elicit a strong immunological response. This technology may represent a promising platform for the development of vaccines in infectious diseases.

IMUNON是一家处于临床阶段的生物技术公司,专注于推进一系列创新疗法,利用人体的自然机制对各种人类疾病产生安全、有效和持久的反应,这是一种与传统疗法不同的方法。IMUNON正在开发其各种模式的非病毒DNA技术。第一种模式,TheraPlas,专为在实体瘤治疗中编码细胞因子和其他治疗蛋白而开发,在实体瘤治疗中,免疫学方法被认为很有希望。第二种模式,PlacCine,专为输送经DNA编码的病毒抗原而开发,可引起强烈的免疫学反应。这项技术可能为传染病疫苗的开发提供一个前景光明的平台。

The Company's lead clinical program, IMNN-001, is a DNA-based immunotherapy for the localized treatment of advanced ovarian cancer currently in Phase 2 development. IMNN-001 works by instructing the body to produce safe and durable levels of powerful cancer-fighting molecules, such as interleukin-12 and interferon gamma, at the tumor site. Additionally, the Company is entering a first-in-human study of its COVID-19 booster vaccine (IMNN-101). We will continue to leverage these modalities and to advance the technological frontier of plasmid DNA to better serve patients with difficult-to-treat conditions. For more information on IMUNON, visit www.imunon.com.

该公司的主要临床项目 IMNN-001 是一种基于 DNA 的免疫疗法,用于晚期卵巢癌的局部治疗,目前处于二期开发阶段。IMNN-001 的工作原理是指示人体在肿瘤部位产生安全耐用的强效抗癌分子,例如白介素-12 和干扰素伽玛。此外,该公司正在对其 COVID-19 加强疫苗(IMNN-101)进行首次人体研究。我们将继续利用这些模式,推进质粒DNA的技术前沿,以更好地为难以治疗的患者提供服务。有关 IMUNON 的更多信息,请访问 www.imunon.com

Forward-Looking Statements

前瞻性陈述

IMUNON wishes to inform readers that forward-looking statements in this news release are made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, but not limited to, statements regarding the Company's IND application, expectations regarding the Phase 1 clinical study of IMNN-101, including with respect to enrollment for the study and reporting of data, the potential efficacy and safety profile of our PlaCCine platform, potential partnering opportunities, and the Company's plans and expectations with respect to its development programs more generally, are forward-looking statements. We generally identify forward-looking statements by using words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances). Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, uncertainties relating to unforeseen changes in the course of research and development activities and in clinical trials; the uncertainties of and difficulties in analyzing interim clinical data; the significant expense, time and risk of failure of conducting clinical trials; the need for IMUNON to evaluate its future development plans; possible actions by customers, suppliers, competitors or regulatory authorities; and other risks detailed from time to time in IMUNON's filings with the Securities and Exchange Commission. IMUNON assumes no obligation, except to the extent required by law, to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise.

IMUNON希望告知读者,本新闻稿中的前瞻性陈述是根据1995年《私人证券诉讼改革法》的 “安全港” 条款做出的。除历史事实陈述外,所有陈述均为前瞻性陈述,包括但不限于有关公司IND申请的陈述、对IMNN-101 1期临床研究的预期,包括研究注册和数据报告、我们的PlacCine平台的潜在疗效和安全性、潜在的合作机会以及公司对其开发计划的总体计划和预期。我们通常使用诸如 “可能”、“将”、“期望”、“计划”、“预期”、“估计”、“打算” 等词语和类似表达(以及其他提及未来事件、条件或情况的词语或表达)来识别前瞻性陈述。请读者注意,此类前瞻性陈述涉及风险和不确定性,包括但不限于与研发活动和临床试验中不可预见的变化相关的不确定性;分析中期临床数据的不确定性和困难;进行临床试验的重大费用、时间和失败风险;IMUNON评估其未来发展计划的必要性;客户、供应商、竞争对手或监管机构可能采取的行动;以及其他详细的风险不时出现在IMUNON向美国证券交易委员会提交的文件中。除非法律要求,否则IMUNON没有义务更新或补充由于后续事件、新信息或其他原因而变得不真实的前瞻性陈述。

Contacts:
IMUNON LHA Investor Relations
Jeffrey W. Church Kim Sutton Golodetz
609-482-2455 212-838-3777
jchurch@imunon.com kgolodetz@lhai.com
联系人:
IMUNON LHA 投资者关系
杰弗里 W. 丘奇 金·萨顿·戈洛德茨
609-482-2455 212-838-3777
jchurch@imunon.com kgolodetz@lhai.com

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Source: Imunon, Inc.

资料来源:Imunon, Inc.

译文内容由第三方软件翻译。


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