FDA Allows Resumption Of BioNTech/MediLink Therapeutics Partnered Phase 1 Study For Cancer Drug With Lower Dose
FDA Allows Resumption Of BioNTech/MediLink Therapeutics Partnered Phase 1 Study For Cancer Drug With Lower Dose
The FDA has lifted the partial clinical hold on MediLink Therapeutics' Phase 1 trial for BNT326/YL202, a HER3-targeting antibody-drug conjugate (ADC).
美連生物製藥的BNT326/YL202第一階段試驗，針對HER3的抗體藥物聯合物（ADC）的部分臨床暫停已經被FDA解除。
This decision, announced on August 15, follows the submission of a complete response that includes data analysis, updated documentation, and additional risk mitigation measures, the company reported in an SEC filing.
該公司在提交包括數據分析、更新文檔和其他風險緩解措施的完整回應後，於8月15日宣佈了這個決定。該公司在提交的證券文件中提到此事。
The MediLink-sponsored trial evaluates the early-stage antibody-drug conjugate product candidate BNT326/YL202 as a later-line treatment in heavily pre-treated patients with advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer or HR+/HER2-negative breast cancer.
美連生物贊助的試驗評估了早期的抗體藥物聯合物候選品BNT326/YL202，作爲晚期治療重度預處理的EGFR突變非小細胞肺癌或HR+/HER2陰性乳腺癌的後線治療。
The FDA has shared with MediLink concerns that BNT326/YL202 may, at higher doses, expose human subjects to an unreasonable and significant risk of illness or injuries.
FDA與MediLink分享了他們的擔憂，即BNT326/YL202在更高的劑量下可能會讓人類受到不合理和重大的疾病或傷害風險。
Also Read: Pfizer, BioNTech's COVID-19/Flu Combo Vaccine Fails To Meet Key Goal In Late-Stage Study.
此前消息：輝瑞、biontech的新冠疫苗兼流感疫苗組合在晚期研究中未能達到關鍵目標。
Initially paused in June 2024, the clinical trial will resume recruitment, focusing on dose levels not exceeding 3 mg/kg, where the treatment has shown a manageable safety profile and encouraging clinical activity.
最初在2024年6月暫停，此次臨床試驗將恢復招募，重點關注劑量不超過每千克3毫克，這是該治療的安全性能可控且臨床活性令人鼓舞的劑量水平。
The hold stemmed from concerns over dose-dependent treatment-related adverse events (TRAEs), notably a decrease in neutrophil count (neutropenia) and a rise in mucositis cases.
這次暫停是由於治療相關不良事件（TRAEs）與劑量有關而引起的關注，尤其是中性粒細胞計數（中性粒細胞減少症）的降低和口腔炎例增加。
Both conditions are known risks associated with established chemotherapies and can lead to severe infections.
這兩種病況是與已建立的化療治療有關的已知風險，並且可能導致嚴重的感染。
Neutropenia is typically managed through dose adjustments, treatment interruptions, or prophylactic measures like recombinant granulocyte colony-stimulating factors (G-CSFs), depending on the patient's individualized risk.
根據患者個體化風險，通常通過劑量調整、治療中斷或預防措施（如重組粒細胞集落刺激因子（G-CSFs））來管理中性粒細胞減少症。
In response to these safety concerns, MediLink and BioNTech SE (NASDAQ:BNTX) took proactive measures.
針對這些安全問題，美連生物和biontech採取了積極措施。
These included halting patient enrollment in dose cohorts above 3 mg/kg and reducing doses for enrolled participants at higher levels.
這包括停止劑量高於每千克3毫克的患者隊列的招募，並減少接受更高劑量的參與者的劑量。
With the FDA's approval, MediLink and BioNTech are set to resume clinical development under the revised guidelines, ensuring patient safety while exploring the potential of BNT326/YL202.
在FDA的批准下，美連生物和biontech將按照修訂後的指南恢復臨床開發，確保患者的安全性，並探索BNT326/YL202的潛力。
Price Action: BNTX stock is up 1.10% to $86.13 at the last check on Monday.
BNTX股票在週一上漲1.10%，報86.13美元。
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譯文內容由第三人軟體翻譯。