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Ainos Pursues Licensing Partners To Accelerate Five Candidates Of Its Low-dose Oral Interferon Formulation VELDONA To Phase 3 Trials And Commercialization
Ainos Pursues Licensing Partners To Accelerate Five Candidates Of Its Low-dose Oral Interferon Formulation VELDONA To Phase 3 Trials And Commercialization
Ainos, Inc. (NASDAQ:AIMD)(NASDAQ:AIMDW) ("Ainos", or the "Company"), a diversified medtech company focused on the development of novel point-of-care testing, low-dose interferon therapeutics, and synthetic RNA-driven preventative medicine, today announced that it is pursuing out-licensing opportunities for five new drug candidates for its low-dose oral interferon-alpha ("IFNα") formulation, VELDONA. Ainos has completed Phase 2 trials for the five new drug candidates and will work with potential partners to accelerate the candidates to Phase 3 trials and eventual commercialization of VELDONA.
The following five indications have completed Phase 2 trials. Ainos aims to enter out-licensing agreements to advance VELDONA to Phase 3 trials and commercialization.
Sjögren's syndrome (US IND No. 5700)
Aphthous Stomatitis (US IND No. 5126)
Chemotherapy-induced Stomatitis (US IND No. 5587)
Influenza (Australian ACTRNACTRN12609000976280)
Common Cold (US IND No. 5244)
The Company's product is delivered into the oral cavity as a lozenge in low (nanogram) doses. Human studies have shown that IFNα given orally is effective against viral and autoimmune diseases, without the side effects associated with high-dose injections of IFNα. Ainos has cumulatively spent nearly $40 million on developments related to the oral use of IFNα (VELDONA formulation), not including the expected expenses on clinical trials and manufacturing VELDONA. To date, 68 clinical trials have been conducted with low-dose oral IFNα. Sixty-three studies were Phase 2 trials, and three Phase 1 and two Phase 3 studies have also been conducted. Nearly 6,000 patients with one of 16 different disease indications and/or healthy volunteers participated in these trials, including a total of 4,600 subjects exposed to IFNα at a dose level ranging from three to 2,000 international units given daily for up to five years. The safety of orally administered IFNα has been consistently demonstrated in these trials.
Interferons are proteins made by host cells in response to the presence of pathogens such as viruses, bacteria, parasites, or tumor cells. They allow for communication between cells to trigger the protective defenses of the immune system that eradicate pathogens or tumors. Of the nine different families of human interferon that have been identified, interferon-alpha is the most widely studied. The US FDA has approved the use of IFNα in mega doses given by injection for treating a number of cancers, as well as Hepatitis B and C.
Ainos's low-dose oral VELDONA formulation is designed to enhance autoimmunity to resist virus damage, potentially reducing side effects and risks caused by high-dose interferon and other small molecule drugs.
Positive effects of oral VELDONA treatment have been noted across a wide range of disease indications, including:
In Sjögren's syndrome (SS) (US IND No. 5700), after 48 weeks of treatment the clinical results showed increased unstimulated whole saliva and improvement in mouth dryness and seven other SS symptoms.
In Aphthous Stomatitis (US IND No. 5126), the clinical results showed clearance of existing lesions and reduced severity of new lesions.
In Chemotherapy-induced Stomatitis (US IND No. 5587), the clinical results showed reduced severity during repeat chemotherapy.
In Influenza (Australian ACTRNACTRN12609000976280), the clinical results showed reduced incidence of moderate to severe symptoms; remission of sore throat, fever and head congestion; and significantly reduced influenza-like illness rate in three subgroups: 50 year and older, those vaccinated against seasonal flu, and males.
In Common Cold (US IND No. 5244), the clinical results showed immediate reduction of malaise and sore throat after 6 hours from initial treatment.
Chun-Hsien Tsai, Ainos' Chairman of the Board, President, and Chief Executive Officer, commented, "Low-dose oral interferon-alpha treatments have shown a promising array of potential applications through Phase 2 clinical trials. We have recently carried out studies that demonstrate VELDONA's effectiveness in protecting against symptoms associated with COVID-19 and prevention and treatment of influenza. By exploring out-licensing opportunities for our five VELDONA new drug candidates, we plan to accelerate commercialization of our VELDONA technology as rapidly as possible."
Ainos, Inc. (NASDAQ:AIMD)(NASDAQ:AIMDW) ("Ainos", or the "Company"), a diversified medtech company focused on the development of novel point-of-care testing, low-dose interferon therapeutics, and synthetic RNA-driven preventative medicine, today announced that it is pursuing out-licensing opportunities for five new drug candidates for its low-dose oral interferon-alpha ("IFNα") formulation, VELDONA. Ainos has completed Phase 2 trials for the five new drug candidates and will work with potential partners to accelerate the candidates to Phase 3 trials and eventual commercialization of VELDONA.
爱诺斯公司(纳斯达克代码:AIMD)(纳斯达克代码:AIMDW)(以下简称“公司”)是一家多元化的医疗科技公司,专注于开发新型护理点检测、低剂量干扰素疗法和合成核糖核酸驱动的预防药物。该公司今天宣布,它正在为其低剂量口服干扰素-α(“α”)配方VELDONA的五种新药候选药物寻求许可外机会。Ainos已经完成了5种候选新药的第二阶段试验,并将与潜在合作伙伴合作,加快候选药物进入第三阶段试验并最终实现VELDONA的商业化。
The following five indications have completed Phase 2 trials. Ainos aims to enter out-licensing agreements to advance VELDONA to Phase 3 trials and commercialization.
以下五种适应症已完成第二阶段试验。Ainos的目标是达成外部许可协议,将VELDONA推进到第三阶段试验和商业化。
Sjögren's syndrome (US IND No. 5700)
Aphthous Stomatitis (US IND No. 5126)
Chemotherapy-induced Stomatitis (US IND No. 5587)
Influenza (Australian ACTRNACTRN12609000976280)
Common Cold (US IND No. 5244)
SJÖGren‘s综合征(美国IND No.5700)
口腔炎(美国IND NO.5126)
化疗所致口腔炎(美国IND NO.5587)
流感(澳大利亚ACTRNACTRN12609000976280)
普通感冒(美国IND NO.5244)
The Company's product is delivered into the oral cavity as a lozenge in low (nanogram) doses. Human studies have shown that IFNα given orally is effective against viral and autoimmune diseases, without the side effects associated with high-dose injections of IFNα. Ainos has cumulatively spent nearly $40 million on developments related to the oral use of IFNα (VELDONA formulation), not including the expected expenses on clinical trials and manufacturing VELDONA. To date, 68 clinical trials have been conducted with low-dose oral IFNα. Sixty-three studies were Phase 2 trials, and three Phase 1 and two Phase 3 studies have also been conducted. Nearly 6,000 patients with one of 16 different disease indications and/or healthy volunteers participated in these trials, including a total of 4,600 subjects exposed to IFNα at a dose level ranging from three to 2,000 international units given daily for up to five years. The safety of orally administered IFNα has been consistently demonstrated in these trials.
该公司的产品以低(纳克)剂量的含片形式进入口腔。人体研究表明,口服干扰素α对病毒和自身免疫性疾病有效,没有与大剂量注射干扰素α相关的副作用。Ainos已累计花费近4,000万美元用于与口服干扰素α(VELDONA制剂)相关的开发,这还不包括临床试验和制造VELDONA的预期费用。到目前为止,低剂量口服干扰素α已经进行了68项临床试验。63项研究是第二阶段试验,也进行了三项第一阶段研究和两项第三阶段研究。近6,000名具有16种不同疾病指征之一的患者和/或健康志愿者参加了这些试验,其中包括总共4,600名受试者,他们每天给予干扰素α的剂量从3到2,000国际单位不等,最长持续5年。口服干扰素α的安全性在这些试验中得到了一致的证明。
Interferons are proteins made by host cells in response to the presence of pathogens such as viruses, bacteria, parasites, or tumor cells. They allow for communication between cells to trigger the protective defenses of the immune system that eradicate pathogens or tumors. Of the nine different families of human interferon that have been identified, interferon-alpha is the most widely studied. The US FDA has approved the use of IFNα in mega doses given by injection for treating a number of cancers, as well as Hepatitis B and C.
干扰素是宿主细胞在病毒、细菌、寄生虫或肿瘤细胞等病原体存在时产生的蛋白质。它们允许细胞之间的通信,以触发免疫系统的保护性防御,从而根除病原体或肿瘤。在已经确定的九种不同的人类干扰素家族中,干扰素-α是研究最广泛的。美国食品和药物管理局已经批准大剂量注射干扰素α用于治疗一些癌症以及乙肝和丙型肝炎。
Ainos's low-dose oral VELDONA formulation is designed to enhance autoimmunity to resist virus damage, potentially reducing side effects and risks caused by high-dose interferon and other small molecule drugs.
Ainos的低剂量口服VELDONA配方旨在增强自身免疫力,以抵抗病毒损害,潜在地减少大剂量干扰素和其他小分子药物造成的副作用和风险。
Positive effects of oral VELDONA treatment have been noted across a wide range of disease indications, including:
口服VELDONA治疗在一系列疾病适应症中都有积极的效果,包括:
In Sjögren's syndrome (SS) (US IND No. 5700), after 48 weeks of treatment the clinical results showed increased unstimulated whole saliva and improvement in mouth dryness and seven other SS symptoms.
In Aphthous Stomatitis (US IND No. 5126), the clinical results showed clearance of existing lesions and reduced severity of new lesions.
In Chemotherapy-induced Stomatitis (US IND No. 5587), the clinical results showed reduced severity during repeat chemotherapy.
In Influenza (Australian ACTRNACTRN12609000976280), the clinical results showed reduced incidence of moderate to severe symptoms; remission of sore throat, fever and head congestion; and significantly reduced influenza-like illness rate in three subgroups: 50 year and older, those vaccinated against seasonal flu, and males.
In Common Cold (US IND No. 5244), the clinical results showed immediate reduction of malaise and sore throat after 6 hours from initial treatment.
在SJÖGren‘s综合征(SS)(美国IND5700号)中,治疗48周后,临床结果显示非刺激性全唾液增加,口腔干燥和其他7种SS症状得到改善。
在口腔炎(US IND NO.5126)中,临床结果显示现有病变清除,新病变严重程度减轻。
在化疗引起的口腔炎(US IND No.5587)中,临床结果显示在重复化疗期间病情有所减轻。
在流感(澳大利亚ACTRNACTRN12609000976280)中,临床结果显示中到重度症状的发生率降低,喉咙痛、发烧和头部充血缓解,并显著降低了三个亚组的流感样疾病发生率:50岁及以上、接种季节性流感疫苗的人和男性。
在普通感冒(美国IND NO.5244)中,临床结果显示,从最初治疗起6小时后,不适和喉咙痛立即减轻。
Chun-Hsien Tsai, Ainos' Chairman of the Board, President, and Chief Executive Officer, commented, "Low-dose oral interferon-alpha treatments have shown a promising array of potential applications through Phase 2 clinical trials. We have recently carried out studies that demonstrate VELDONA's effectiveness in protecting against symptoms associated with COVID-19 and prevention and treatment of influenza. By exploring out-licensing opportunities for our five VELDONA new drug candidates, we plan to accelerate commercialization of our VELDONA technology as rapidly as possible."
爱诺仕董事局主席兼首席执行官蔡俊贤表示:“低剂量口服干扰素-α疗法在第二阶段临床试验中显示出了一系列很有前途的潜在应用。我们最近进行的研究表明,VELDONA在预防新冠肺炎相关症状和预防和治疗流感方面是有效的。通过为我们的五种候选新药探索授权外机会,我们计划尽快加快VELDONA技术的商业化进程。”
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moomoo是Moomoo Technologies Inc.公司提供的金融信息和交易应用程序。
在美国,moomoo上的投资产品和服务由Moomoo Financial Inc.提供,一家受美国证券交易委员会(SEC)监管的持牌主体。 Moomoo Financial Inc.是金融业监管局(FINRA)和证券投资者保护公司(SIPC)的成员。
在新加坡,moomoo上的投资产品和服务是通过Moomoo Financial Singapore Pte. Ltd.提供,该公司受新加坡金融管理局(MAS)监管(牌照号码︰CMS101000) ,持有资本市场服务牌照 (CMS) ,持有财务顾问豁免(Exempt Financial Adviser)资质。本内容未经新加坡金融管理局的审查。
在澳大利亚,moomoo上的金融产品和服务是通过Futu Securities (Australia) Ltd提供,该公司是受澳大利亚证券和投资委员会(ASIC)监管的澳大利亚金融服务许可机构(AFSL No. 224663)。请阅读并理解我们的《金融服务指南》、《条款与条件》、《隐私政策》和其他披露文件,这些文件可在我们的网站 https://www.moomoo.com/au中获取。
在加拿大,通过moomoo应用提供的仅限订单执行的券商服务由Moomoo Financial Canada Inc.提供,并受加拿大投资监管机构(CIRO)监管。
在马来西亚,moomoo上的投资产品和服务是通过Moomoo Securities Malaysia Sdn. Bhd. 提供,该公司受马来西亚证券监督委员会(SC)监管(牌照号码︰eCMSL/A0397/2024) ,持有资本市场服务牌照 (CMSL) 。本内容未经马来西亚证券监督委员会的审查。
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