Vaxart Provides Update on its Oral COVID-19 Vaccine Program

Vaxart 提供其口服 COVID-19疫苗计划的最新信息

2020-04-01 13:30:18 BioSpace

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Five COVID-19 Vaccine Candidates in Preclinical Testing Development Services to Enable Manufacture of cGMP Vaccine at Emergent BioSolutions have Started SOUTH SAN FRANCISCO, Calif., March 31, 2020 (GLOBE NEWSWIRE) -- Vaxart, Inc., a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, today announced it had produced five COVID-19 vaccine candidates for testing in its preclinical models. Each of the COVID-19 vaccine constructs is based on a different coronavirus antigen combination, and Vaxart expects to advance the best performing vaccine to manufacturing for clinical trials. “The effectiveness of Vaxart’s oral vaccine technology has been demonstrated in clinical trials. Developing a vaccine to meet this current public health threat is very important to all of us at Vaxart,” said Sean Tucker, Ph.D., chief scientific officer of Vaxart. “Our scientists have been working tirelessly to develop these 5 different vaccine constructs, and this evaluation in our preclinical models will allow us to select the most potent candidate for clinical testing.” In January, Vaxart initiated a program to develop a COVID-19 vaccine based on its VAASTTM platform. On March 18, Vaxart announced that it had entered into an agreement with Emergent BioSolutions Inc. (“Emergent”) for development services in preparation for the cGMP production of the Vaxart vaccine. Development services have started and, if Vaxart elects to proceed with cGMP manufacturing, Emergent is expected to produce bulk cGMP vaccine for use in a Phase 1 clinical study that Vaxart currently expects to initiate early in the second half of 2020. “We believe an oral vaccine administered using a room temperature-stable tablet would provide enormous logistical advantages in large vaccination campaigns,” said Wouter Latour, MD, chief executive officer of Vaxart Inc. “Perhaps more importantly, we recently demonstrated that our oral H1 influenza vaccine protects against respiratory infection based on mucosal immunity, the first line of defense for “mucosal” viruses like influenza and this new coronavirus. We believe this puts Vaxart in a unique position to develop an effective vaccine that protects the population from COVID-19.” About Coronavirus CDC is responding to a pandemic of respiratory disease spreading from person-to-person caused by a novel (new) coronavirus. The disease has been named “coronavirus disease 2019” (abbreviated “COVID-19”). This situation poses a serious public health risk. The federal government is working closely with state, local, tribal, and territorial partners, as well as public health partners, to respond to this situation. COVID-19 can cause mild to severe illness; most severe illness occurs in older adults. About Vaxart Vaxart is a clinical-stage biotechnology company primarily focused on developing oral recombinant protein vaccines based on its proprietary oral vaccine platform. Vaxart’s vaccines are designed to generate broad and durable immune responses that protect against a wide range of infectious diseases and may also be useful for the treatment of chronic viral infections and cancer. Vaxart’s vaccines are administered using a convenient room temperature-stable tablet, rather than by injection. Vaxart believes that tablet vaccines are easier to distribute and administer than injectable vaccines and have the potential to significantly increase vaccination rates. Vaxart’s development programs include oral tablet vaccines that are designed to protect against coronavirus, norovirus, seasonal influenza and respiratory syncytial virus (RSV), as well as a therapeutic vaccine for human papillomavirus (HPV). For more information, please visit www.vaxart.com. Note Regarding Forward-Looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Vaxart’s strategy, prospects, plans and objectives, results from preclinical and clinical trials, commercialization agreements and licenses, beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as “believe,” “could,” “potential,” “will” and other words and terms of similar meaning. Examples of such statements include, but are not limited to, statements relating to Vaxart’s ability to develop and commercialize its product candidates and clinical results and trial data (including plans with respect to the proposed coronavirus vaccine program); Vaxart’s intention to continue its efforts to advance its oral tablet seasonal flu vaccine; and Vaxart’s expectations with respect to the important advantages it believes its oral vaccine platform can offer over injectable alternatives, particularly for mucosal pathogens such as norovirus, flu and RSV, as well as coronaviruses such as SARS, MERS and SARS-Cov-2. Vaxart may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Vaxart makes, including, for example, Vaxart’s product candidates may not be approved by the FDA or non-U.S. regulatory authorities; even if approved by the FDA or non-U.S. regulatory authorities, Vaxart’s product candidates may not achieve broad market acceptance; Vaxart may experience manufacturing issues and delays due to events within, or outside of, Vaxart’s control, including the recent outbreak of COVID-19; and other risks described in the “Risk Factors” sections of Vaxart’s Quarterly and Annual Reports filed with the SEC. Vaxart does not assume any obligation to update any forward-looking statements, except as required by law. Contact Brant Biehn Vaxart Inc 650 550 3500 IR@vaxart.com
五名 COVID-19疫苗预检候选人 为紧急生物解决方案生产 cGMP 疫苗而开展的开发服务已经启动 加州圣弗朗西斯科.、2020年3月31日( GLOBE NEWSWIRE )-Vaxart , Inc .,一家临床阶段生物技术公司,开发口服重组疫苗,由片剂而非注射给药,今天宣布已经生产了5种 COVID-19疫苗候选疫苗,用于临床前模型的检测。COVID-19疫苗的每一种构建都是基于不同的冠状病毒抗原组合, Vaxart 希望将性能最好的疫苗推进到临床试验制造中。 “ Vaxart 口服疫苗技术的有效性已在临床试验中得到证明。Vaxart 首席科学官员 SeanTucker 博士说:“研制疫苗以应对当前的公共健康威胁对我们所有人都非常重要。”“我们的科学家一直在不知疲倦地开发这5种不同的疫苗结构,我们的临床前模型中的这种评估将使我们能够选择最有潜力的临床试验候选人。” 今年1月, Vaxart 启动了一个基于 VAASTTM 平台开发 COVID-19疫苗的项目。3月18日, Vaxart 宣布,它已与 Emeragent BioSolutions Inc .(“ Emeragent ”)签订了开发服务协议,为 Vaxart 疫苗的 cGMP 生产做准备。开发服务已经开始,如果 Vaxart 选择继续进行 cGMP 生产, Emergant 预计将生产批量 cGMP 疫苗,用于 Vaxart 目前预计将于2020年下半年启动的第1期临床研究。 Vaxart Inc .首席执行官 Wouter Latour 医学博士表示:“我们相信,使用室温稳定平板电脑接种的口服疫苗将在大型疫苗接种活动中提供巨大的后勤优势。”我们最近证明,我们的口服 H1流感疫苗可以预防基于粘膜免疫的呼吸道感染,这是流感等“粘膜”病毒和这种新型冠状病毒的第一道防线。我们相信,这使 Vaxart 处于一个独特的位置,能够开发一种有效的疫苗,保护人们免受 COVID-19的感染。” 关于冠状病毒 疾病预防控制中心(CDC)正在应对由新型冠状病毒引起的从人到人的呼吸道疾病大流行。该疾病已命名为“2019年冠状病毒病”(简称“ COVID-19”)。这种情况造成严重的公共卫生风险。联邦政府正与州、地方、部落和领土伙伴以及公共卫生伙伴密切合作,以应对这种情况。COVID-19可导致轻度到重度疾病;大多数严重疾病发生在老年人身上。 关于 Vaxart Vaxart 是一家临床阶段生物技术公司,主要致力于基于其专有口服疫苗平台开发口服重组蛋白疫苗。Vaxart 的疫苗旨在产生广泛和持久的免疫反应,以防止广泛的传染病,也可能有助于治疗慢性病毒感染和癌症。Vaxart 的疫苗使用方便的室温稳定药片而不是注射。Vaxart 认为片剂疫苗比注射疫苗更容易分发和管理,有可能显著提高疫苗接种率。Vaxart 的开发计划包括口服片剂疫苗,旨在预防冠状病毒、诺病毒、季节性流感和呼吸道合胞病毒( RSV ),以及人类乳头瘤病毒(人乳头状瘤病毒(HPV))的治疗性疫苗。详情请访问 www.vaxart.com 。 有关前瞻性陈述的附注 本新闻稿载有涉及重大风险及不明朗因素的前瞻性陈述。所有声明,除历史事实陈述外,包括在本新闻稿中关于 Vaxart 的战略、前景、计划和目标、临床前和临床试验的结果、商业化协议和许可、管理层的信念和期望都是前瞻性陈述。这些前瞻性陈述可能伴随着“相信”、“能够”、“潜力”、“意愿”等词语,以及具有类似含义的词语和术语。此类声明的示例包括但不限于关于 Vaxart 开发和商业化其产品候选者的能力以及临床结果和试验数据的声明(包括关于拟议冠状病毒疫苗计划的计划); Vaxart 打算继续努力推进其口服片剂季节性流感疫苗;以及 Vaxart 对其口服疫苗的重要优势的期望,它相信其口服疫苗平台可以提供比注射替代品更好的替代品,特别是针对粘膜病原体,如 Norovirus 、流感和 RSV ,以及冠状病毒,如 SARS 、 MERS 和 SARS-Cov-2。Vaxart 可能无法实际实现计划、实施意图或满足前瞻性陈述中披露的预期或预测,您不应过度依赖这些前瞻性陈述。实际结果或事件可能与前瞻性声明中披露的计划、意图、预期和预测存在重大差异。各种重要因素可能导致实际结果或事件与 Vaxart 做出的前瞻性陈述存在重大差异,例如, Vaxart 的产品候选者可能无法获得 FDA 或非美国监管机构的批准;即使获得 FDA 或非美国监管机构的批准,Vaxart 的产品候选者可能无法获得广泛的市场认可;由于 Vaxart 控制范围内或之外的事件,包括最近 COVID-19的爆发, Vaxart 可能会遇到制造问题和延迟,以及在提交给 SEC 的 Vaxart 季度和年度报告的“风险因素”部分中描述的其他风险。除法律要求外, Vaxart 不承担任何更新任何前瞻性声明的义务。 联系人 Brant Biehn Vaxart 公司 650,550,3500 IR @ vaxart.com

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