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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 ·  2024/12/12 16:16

Moomoo AI 已提取核心訊息

Aditxt's subsidiary Adimune has successfully completed preclinical efficacy and safety studies for its ADI-100 immune modulation therapeutic platform. The company plans to submit Clinical Trial Application/IND applications in H2 2025 for first-in-human trials targeting Type 1 Diabetes, Psoriasis, and Stiff-Person Syndrome, with the latter in collaboration with Mayo Clinic.Preclinical studies demonstrated ADI-100's ability to achieve antigen-specific tolerization without compromising immune system functionality. In Non-Obese Diabetic mice, the therapy prevented hyperglycemia in 70% of treated subjects, with protection lasting over 300 days. Safety studies confirmed no detectable plasmid persistence, no anti-plasmid antibodies formation, and no significant adverse effects.The therapy represents a potential paradigm shift in autoimmune disease treatment, targeting a market valued at $84.12 billion. ADI-100 consists of two DNA molecules designed to restore immune tolerance through precision immune reprogramming, potentially eliminating the need for immunosuppressants. GMP drug substances have been manufactured and stability studies are currently underway.
Aditxt's subsidiary Adimune has successfully completed preclinical efficacy and safety studies for its ADI-100 immune modulation therapeutic platform. The company plans to submit Clinical Trial Application/IND applications in H2 2025 for first-in-human trials targeting Type 1 Diabetes, Psoriasis, and Stiff-Person Syndrome, with the latter in collaboration with Mayo Clinic.Preclinical studies demonstrated ADI-100's ability to achieve antigen-specific tolerization without compromising immune system functionality. In Non-Obese Diabetic mice, the therapy prevented hyperglycemia in 70% of treated subjects, with protection lasting over 300 days. Safety studies confirmed no detectable plasmid persistence, no anti-plasmid antibodies formation, and no significant adverse effects.The therapy represents a potential paradigm shift in autoimmune disease treatment, targeting a market valued at $84.12 billion. ADI-100 consists of two DNA molecules designed to restore immune tolerance through precision immune reprogramming, potentially eliminating the need for immunosuppressants. GMP drug substances have been manufactured and stability studies are currently underway.
Aditxt的子公司Adimune已經成功完成了其ADI-100免疫調節治療平台的臨牀前療效和安全性研究。公司計劃在2025年下半年提交臨牀試驗申請/IND申請，用於針對1型糖尿病、銀屑病和僵人綜合症的首次人體試驗，其中後者與梅奧診所合作。臨牀前研究表明，ADI-100能夠實現抗原特異性耐受，同時不影響免疫系統的功能。在非肥胖糖尿病小鼠中，該療法在70%的治療對象中有效預防了高血糖，保護效果持續超過300天。安全性研究確認未檢測到質粒持久性，沒有抗質粒抗體形成，也沒有顯著的不良反應。該療法代表了自身免疫疾病治療的潛在範式轉變，針對的市場價值爲841.2億美元。ADI-100由兩種DNA分子組成，旨在通過精準免疫重編程恢復免疫耐受，潛在地消除對免疫抑制劑的需求。GMP藥物成分已經生產，並且穩定性研究目前正在進行中。
Aditxt的子公司Adimune已經成功完成了其ADI-100免疫調節治療平台的臨牀前療效和安全性研究。公司計劃在2025年下半年提交臨牀試驗申請/IND申請，用於針對1型糖尿病、銀屑病和僵人綜合症的首次人體試驗，其中後者與梅奧診所合作。臨牀前研究表明，ADI-100能夠實現抗原特異性耐受，同時不影響免疫系統的功能。在非肥胖糖尿病小鼠中，該療法在70%的治療對象中有效預防了高血糖，保護效果持續超過300天。安全性研究確認未檢測到質粒持久性，沒有抗質粒抗體形成，也沒有顯著的不良反應。該療法代表了自身免疫疾病治療的潛在範式轉變，針對的市場價值爲841.2億美元。ADI-100由兩種DNA分子組成，旨在通過精準免疫重編程恢復免疫耐受，潛在地消除對免疫抑制劑的需求。GMP藥物成分已經生產，並且穩定性研究目前正在進行中。
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