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Aditxt | 8-K: Current report

Aditxt | 8-K: Current report

Aditxt | 8-K：重大事件
美股SEC公告 ·  12/13 05:16

Moomoo AI 已提取核心信息

Aditxt announced that its subsidiary Adimune has successfully completed preclinical efficacy and safety studies for ADI-100, an antigen-specific gene therapy for immune modulation. The therapy demonstrated potential in treating Type 1 Diabetes, Psoriasis, and Stiff-Person Syndrome without impairing overall immune responsiveness.Preclinical data showed ADI-100's ability to reverse hyperglycemia, restore islet cell mass, and transfer protective immune modulation in diabetes models. It also prevented hyperglycemia in 70% of treated mice for over 300 days when combined with checkpoint inhibitors. Toxicology studies confirmed the therapy's safety, with no significant adverse effects observed.Adimune aims to submit a Clinical Trial Application/Investigational New Drug application in H2 2025 to initiate first-in-human trials. The company views ADI-100 as a potential paradigm shift in autoimmune disease treatment, targeting a market valued at $84.12 billion. Adimune's progress positions it as a frontrunner in developing innovative therapies for autoimmune diseases.
Aditxt announced that its subsidiary Adimune has successfully completed preclinical efficacy and safety studies for ADI-100, an antigen-specific gene therapy for immune modulation. The therapy demonstrated potential in treating Type 1 Diabetes, Psoriasis, and Stiff-Person Syndrome without impairing overall immune responsiveness.Preclinical data showed ADI-100's ability to reverse hyperglycemia, restore islet cell mass, and transfer protective immune modulation in diabetes models. It also prevented hyperglycemia in 70% of treated mice for over 300 days when combined with checkpoint inhibitors. Toxicology studies confirmed the therapy's safety, with no significant adverse effects observed.Adimune aims to submit a Clinical Trial Application/Investigational New Drug application in H2 2025 to initiate first-in-human trials. The company views ADI-100 as a potential paradigm shift in autoimmune disease treatment, targeting a market valued at $84.12 billion. Adimune's progress positions it as a frontrunner in developing innovative therapies for autoimmune diseases.
Aditxt宣布其子公司Adimune已成功完成针对ADI-100的临床前疗效和安全性研究，这是一种特异性针对抗原的基因疗法，用于免疫调节。这种疗法在治疗1型糖尿病、银屑病和僵人综合症方面显示出潜力，并未损害整体免疫应答能力。临床前数据表明，ADI-100能够逆转高血糖，恢复胰岛电芯质量，并在糖尿病模型中转移保护性免疫调节。与检查点抑制剂联用时，它还在70%的处理小鼠中预防了高血糖，持续超过300天。毒理学研究证实了该疗法的安全性，未观察到显著的不良反应。Adimune计划于2025年下半年提交临床试验申请/研究新药申请，以启动首个人体试验。该公司将ADI-100视为自身免疫疾病治疗的潜在范式转变，目标市场估值为841.2亿美元。Adimune的进展使其在开发创新自身免疫疾病疗法方面处于领先地位。
Aditxt宣布其子公司Adimune已成功完成针对ADI-100的临床前疗效和安全性研究，这是一种特异性针对抗原的基因疗法，用于免疫调节。这种疗法在治疗1型糖尿病、银屑病和僵人综合症方面显示出潜力，并未损害整体免疫应答能力。临床前数据表明，ADI-100能够逆转高血糖，恢复胰岛电芯质量，并在糖尿病模型中转移保护性免疫调节。与检查点抑制剂联用时，它还在70%的处理小鼠中预防了高血糖，持续超过300天。毒理学研究证实了该疗法的安全性，未观察到显著的不良反应。Adimune计划于2025年下半年提交临床试验申请/研究新药申请，以启动首个人体试验。该公司将ADI-100视为自身免疫疾病治疗的潜在范式转变，目标市场估值为841.2亿美元。Adimune的进展使其在开发创新自身免疫疾病疗法方面处于领先地位。
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