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Dyadic Announces Publication of C1 Monoclonal Antibody in Nonhuman Primate Study in Nature Communications

Dyadic Announces Publication of C1 Monoclonal Antibody in Nonhuman Primate Study in Nature Communications

Dyadic宣布在《自然通讯》上发表非人灵长类研究中的C1单克隆抗体
Dyadic ·  03/26 00:00
  • The first trial using a C1 produced monoclonal antibody provides equivalent protection against SARS-CoV-2 in hamster and nonhuman primate models compared to monoclonal antibody produced in CHO.
  • 与在CHO中产生的单克隆抗体相比,使用C1产生的单克隆抗体的第一项试验在仓鼠和非人灵长类动物模型中提供了对SARS-CoV-2的同等保护。

JUPITER, Fla., March 26, 2024 — Dyadic International, Inc. ("Dyadic" or the "Company") (NASDAQ: DYAI), a global biotechnology company focused on building innovative microbial protein production platforms today announced the online publication of the manuscript "Filamentous fungus-produced human monoclonal antibody provides protection against SARS-CoV-2 in hamster and nonhuman primate models" in Nature Communications ("Springer-Nature"), an international journal publishing peer-reviewed research in all fields of science and technology.

佛罗里达州朱庇特,2024年3月26日——专注于构建创新微生物蛋白生产平台的全球生物技术公司Dyadic International, Inc.(“DYADIC” 或 “公司”)(纳斯达克股票代码:DYAI)今天宣布在《自然通讯》上在线发表《丝状真菌产生的人类单克隆抗体为仓鼠和非人类灵长类动物模型提供SARS-CoV-2防护》手稿(《Springer-Nature》),这是一本国际期刊,发表了所有科学和技术领域的同行评审研究。

"These results demonstrate that the C1-expression system is promising as a technology platform for human monoclonal antibody (HuMab) development and production for preventive and therapeutic medicines," said Prof. Albert Osterhaus of Hannover University of Veterinary Medicine, Germany and of CR2O, a Dutch CRO. "The study characterized the in vitro activity of a monoclonal antibody (mAb) produced by C1 cells (designated "HuMab 87G7′′) and demonstrated its protective efficacy for both prophylactic and therapeutic applications in hamsters and non-human primates without causing antibody-mediated enhanced virus replication. Those are significant findings, in the sense that the demonstration of HuMab 87G7 in animal models against SARS-CoV-2 provided protection, especially with the raising concerns related to emerging infectious diseases in a changing world."

德国汉诺威兽医大学和荷兰CR2O的阿尔伯特·奥斯特豪斯教授说:“这些结果表明,C1表达系统有望成为预防和治疗药物的人类单克隆抗体(HumAb)开发和生产的技术平台。”“该研究的特点是 体外 由C1细胞(指定为 “HumaB 87G7′”)产生的单克隆抗体(mAb)的活性,在不引起抗体介导的增强病毒复制的情况下,在仓鼠和非人类灵长类动物的预防和治疗应用中均具有保护作用。这些都是重要的发现,从某种意义上说,HumaB 87G7在动物模型中针对SARS-CoV-2的演示提供了保护,尤其是在人们对不断变化的世界中出现的传染病的担忧日益增加的情况下。”

"These studies, led by Dr. Osterhaus and now published in a peer reviewed publication highlight the advantages of our C1-expression system in developing and producing human monoclonal antibodies against infectious and other diseases. A mounting body of evidence, from both ourselves and an expanding community of scientists worldwide, supporting the use of Dyadic's C1 expression system as a versatile production platform. Our platform enables rapid development and manufacturing of human vaccines, monoclonal antibodies, and various therapeutic proteins crucial for both preventive and therapeutic interventions in infectious, autoimmune, inflammatory, neurogenerative, oncology, and other disease domains," said Mark Emalfarb, Dyadic International's President, and CEO. "We believe that our C1 platform offers numerous advantages, such as streamlined vaccine and antibody development, increased production yields, reduced costs, and adaptability to emerging virus variants, which are critical for preparedness and response to infectious and other diseases. The transformative impact of these findings is further amplified with the recently reported top-line safety and reactogenicity results from Dyadic's first human vaccine clinical trial."

“这些研究由奥斯特豪斯博士领导,现已发表在同行评审的出版物中,突显了我们的C1表达系统在开发和生产针对传染病和其他疾病的人类单克隆抗体方面的优势。来自我们自己和全球不断扩大的科学家社区的大量证据支持使用Dyadic的C1表达系统作为多功能生产平台。我们的平台可以快速开发和制造人类疫苗、单克隆抗体和各种治疗蛋白,这些蛋白对于传染性、自身免疫、炎症、神经生成、肿瘤学和其他疾病领域的预防和治疗干预至关重要。” Dyadic International总裁兼首席执行官Mark Emalfarb说。“我们认为,我们的C1平台具有许多优势,例如简化疫苗和抗体开发、提高产量、降低成本以及对新兴病毒变种的适应性,这些对于防备和应对传染病和其他疾病至关重要。Dyadic的首次人体疫苗临床试验最近报告的顶级安全性和反应原性结果进一步放大了这些发现的变革性影响。”

"We expect the efficacy of monoclonal antibodies observed in hamsters and non-human primates, combined with the safety data in our DYAI-100 Phase 1 clinical trial to accelerate the global adoption and commercialization of the C1 technology across various human and animal health applications," Mr. Emalfarb concluded.

埃马尔法布总结说:“我们预计,在仓鼠和非人类灵长类动物身上观察到的单克隆抗体的功效,加上我们 DYAI-100 1 期临床试验中的安全数据,将加速 C1 技术在各种人类和动物健康应用中的全球采用和商业化。”

To view the online publication of "Filamentous fungus-produced human monoclonal antibody provides protection against SARS-CoV-2 in hamster and nonhuman primate models", please visit nature communications or follow the link below:

要查看 “丝状真菌产生的人类单克隆抗体在仓鼠和非人灵长类动物模型中提供针对SARS-CoV-2的保护” 的在线出版物,请访问自然通讯或点击以下链接:

About Dyadic International, Inc.

关于 Dyadic International,

Dyadic International, Inc. is a global biotechnology company focused on building innovative microbial protein production platforms to address the growing demand for global protein bioproduction, and to develop and manufacture prophylactic, therapeutic, and nutritional biopharmaceutical products for human and animal health and wellness.

Dyadic International, Inc. 是一家全球生物技术公司,专注于建立创新的微生物蛋白生产平台,以满足对全球蛋白质生物生产不断增长的需求,并开发和制造用于人类和动物健康和保健的预防、治疗和营养生物制药产品。

Dyadic's gene expression and protein production platforms are based on the highly productive and scalable fungus Thermothelomyces heterothallica (formerly Myceliophthora thermophila). Our lead technology, C1-cell protein production platform, is based on an industrially proven microorganism (named C1), which is currently used to speed development, lower production costs, and improve performance of biologic vaccines and drugs at flexible commercial scales for the human and animal health markets. Dyadic has also developed the Dapibus filamentous fungal based microbial protein production platform to enable the rapid development and large-scale manufacture of low-cost proteins, metabolites, and other biologic products for use in non-pharmaceutical applications, such as food, nutrition, and wellness.

Dyadic 的基因表达和蛋白质生产平台基于高产量和可扩展的真菌 Thermothelomyces heterot以前是 myceliophthora thermophila)。 我们的领先技术——C1细胞蛋白生产平台基于一种经过工业验证的微生物(名为C1),该微生物目前用于加快开发、降低生产成本并以灵活的商业规模改善人类和动物健康市场的生物疫苗和药物的性能。Dyadic还开发了基于Dapibus丝状真菌的微生物蛋白生产平台,以实现低成本蛋白质、代谢物和其他生物产品的快速开发和大规模生产,用于食品、营养和保健等非药物应用。

With a passion to enable our partners and collaborators to develop effective preventative and therapeutic treatments in both developed and emerging countries, Dyadic is building an active pipeline by advancing its proprietary microbial platform technologies, including our lead asset DYAI-100 COVID-19 vaccine candidate, as well as other biologic vaccines, antibodies, and other biological products.

Dyadic热衷于使我们的合作伙伴和合作者能够在发达国家和新兴国家开发有效的预防和治疗方法,正在通过推进其专有的微生物平台技术(包括我们的主要资产 DYAI-100 COVID-19 候选疫苗以及其他生物疫苗、抗体和其他生物制品)来建立活跃的产品线。

To learn more about Dyadic and our commitment to helping bring vaccines and other biologic products to market faster, in greater volumes and at lower cost, please visit www.dyadic.com.

要了解有关Dyadic以及我们致力于帮助更快、更大批量和更低成本将疫苗和其他生物产品推向市场的承诺,请访问 www.dyadic.com

Safe Harbor Regarding Forward-Looking Statements

关于前瞻性陈述的安全港

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including those regarding Dyadic International's expectations, intentions, strategies, and beliefs pertaining to future events or future financial performance, such as the success of our alternative protein business, our internal programs and third-party collaborations. Actual events or results may differ materially from those in the forward-looking statements because of various important factors, including those described in the Company's most recent filings with the SEC. Dyadic assumes no obligation to update publicly any such forward-looking statements, whether because of new information, future events or otherwise. For a more complete description of the risks that could cause our actual results to differ from our current expectations, please see the section entitled "Risk Factors" in Dyadic's annual reports on Form 10-K and quarterly reports on Form 10-Q filed with the SEC, as such factors may be updated from time to time in Dyadic's periodic filings with the SEC, which are accessible on the SEC's website and at www.dyadic.com.

本新闻稿包含1933年《证券法》第27A条和1934年《证券交易法》第21E条所指的前瞻性陈述,包括与Dyadic International与未来事件或未来财务业绩有关的预期、意图、战略和信念,例如我们的替代蛋白业务、内部计划和第三方合作的成功。由于各种重要因素,包括公司最近向美国证券交易委员会提交的文件中描述的因素,实际事件或结果可能与前瞻性陈述中的事件或结果存在重大差异。无论是由于新信息、未来事件还是其他原因,Dyadic都没有义务公开更新任何此类前瞻性陈述。要更完整地描述可能导致我们的实际业绩与当前预期不同的风险,请参阅Dyadic向美国证券交易委员会提交的10-K表年度报告和10-Q表季度报告中标题为 “风险因素” 的部分,因为这些因素可能会在Dyadic向美国证券交易委员会提交的定期文件中不时更新,这些文件可在美国证券交易委员会的网站和上网查阅 www.dyadic.com

Contact:
Dyadic International, Inc.
Ping W. Rawson
Chief Financial Officer
Phone: (561) 743-8333
Email: ir@dyadic.com

联系人:
Dyadic 国际有限公司
Ping W. Rawson
首席财务官
电话:(561) 743-8333
电子邮件: ir@dyadic.com

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