Agenus Loses More Than 50% Value On Thursday - Here's Why
Agenus Loses More Than 50% Value On Thursday - Here's Why
Agenus Inc. (NASDAQ:AGEN) stock is trading lower on Thursday, with a session volume of 6.29 million, according to data from Benzinga Pro.
根據Benzinga Pro的數據，Agenus Inc.（納斯達克股票代碼：AGEN）股價週四走低，交易量爲629萬。
The company announced the results of its end-of-Phase 2 (EOP2) meeting with the FDA to advance its immunotherapy combination, botensilimab (BOT) and balstilimab (BAL), for adult patients with relapsed/refractory microsatellite-stable colorectal cancer (r/r MSS CRC) with no active liver metastases (NLM).
該公司公佈了與美國食品藥品管理局舉行的第二階段末（EOP2）會議的結果，以推進其免疫療法組合博騰西利單抗（BOT）和巴爾斯蒂利單抗（BAL），適用於復發/難治性微衛星穩定性結直腸癌（r/r MSS CRC）的成年患者，無活性肝轉移（NLM）。
The FDA discouraged the accelerated approval pathway and advised against submitting these results to support an Accelerated Approval based on its view that objective response rates may not translate to survival benefits.
美國食品和藥物管理局不鼓勵採用加速批准途徑，並建議不要提交這些結果來支持加速批准，因爲美國食品和藥物管理局認爲客觀的回覆率可能不會轉化爲生存益處。
Agenus previously disclosed data from the Phase 1 trial, which showed an overall response rate (ORR) of 23% in the 77 MSS mCRC patients without active liver metastases, with a median follow-up of 13.6 months.
Agenus此前披露了1期試驗的數據，該試驗顯示，在77名沒有活動性肝轉移的MSS mCRC患者中，總緩解率（ORR）爲23％，中位隨訪時間爲13.6個月。
The estimated 6-month, 12-month, and 18-month overall survival (OS) rates were 86%, 71%, and 62%, respectively. The estimated median OS was 21.2 months.
估計的6個月、12個月和18個月的總存活率（OS）分別爲86％、71％和62％。估計操作系統中位數爲21.2個月。
Topline interim data from the Phase 2 trial show trends consistent with the Phase 1 study, including an ORR of 19.4% and a 6-month survival rate of 90% for the BOT 75mg/BAL combination.
來自2期試驗的主要中期數據顯示趨勢與1期研究一致，包括BoT 75mg/BAL組合的ORR爲19.4％，6個月的存活率爲90％。
The safety profile was manageable, and no new signals were observed.
安全狀況是可控的，沒有觀察到新的信號。
Agenus plans to explore opportunities to partner in the U.S. to accomplish a successful Phase 3 trial.
Agenus計劃探索在美國合作的機會，以成功完成第三階段試驗。
In addition to the progress in the U.S., Agenus is advancing its efforts to bring BOT/BAL to patients in Europe.
除了在美國取得的進展外，Agenus還在努力將BOT/BAL帶給歐洲患者。
Engagements with the European Regulatory Authority to explore registration paths are scheduled for later this summer.
計劃於今年夏天晚些時候與歐洲監管局合作探索註冊途徑。
These discussions aim to align on the regulatory path for approval of the BOT/BAL combination in Europe.
這些討論旨在協調歐洲批准BOT/BAL合併的監管路徑。
Agenus continues to pursue opportunities for BOT/BAL development in earlier lines of CRC and other tumor types where BOT/BAL has demonstrated clinical activity, such as lung, melanoma, and pancreatic cancers.
Agenus繼續在早期的結直腸癌和BOT/BAL已顯示出臨床活性的其他腫瘤類型（例如肺癌、黑色素瘤和胰腺癌）中尋找BOT/BAL開發的機會。
The company expects to present data from some of these programs at future medical congresses, including BOT/BAL in sarcoma at the European Society for Medical Oncology in September 2024.
該公司預計將在未來的醫學大會上公佈其中一些項目的數據，包括2024年9月在歐洲腫瘤內科學會舉行的肉瘤中的BOT/BAL。
Price Action: AGEN shares are down 53.20% at $8.27 at the last check on Thursday.
價格走勢：在週四的最後一次支票中，AGEN股價下跌53.20％，至8.27美元。