Kezar Life Sciences Discontinues Unpromising Phase 1 Solid Tumor Drug
Kezar Life Sciences Discontinues Unpromising Phase 1 Solid Tumor Drug
A total of 61 patients were enrolled across the dose-escalation and expansion portions of the study, including seven patients enrolled in the melanoma cohort of the dose-expansion portion at a dose level of 60 mg/m2.In its second-quarter earnings release, Kezar Life Sciences Inc. (NASDAQ:KZR) announced that it had dropped its phase 1 solid tumor drug.
在其第二季度收益發布中，Kezar生命科學公司（納斯達克股票代碼：KZR）宣佈，已放棄其一期實體瘤藥物。
The company said it stopped patient enrollment in the KZR-261 Phase 1 study, and clinical resources are being reallocated toward developing zetomipzomib in autoimmune hepatitis (AIH) and lupus nephritis (LN).
該公司表示，已停止KZR-261一期研究的病人登記，並將臨床資源重新分配到自體免疫性肝炎（AIH）和狼瘡性腎炎（LN）的zetomipzomib開發上。
Patients already enrolled in the study will continue to have access to KZR-261.
已經註冊該研究的患者仍將能夠使用KZR-261。
A total of 61 patients were enrolled across the dose-escalation and expansion portions of the study, including seven patients enrolled in the melanoma cohort of the dose-expansion portion at a dose level of 60 mg/m2.
該研究在劑量遞增和擴展部分中註冊了61名患者，其中包括7名在每平方米60毫克劑量擴展部分的黑色素瘤組中註冊的患者。
No objective responses have been observed in the study to date. The company adds that five patients (two with melanoma) within the dose escalation portion of the study experienced stable disease for four months or longer, of which two patients (melanoma; head and neck) experienced stable disease for twelve months or longer.
到目前爲止，該研究中未觀察到任何客觀反應。該公司補充說，研究的劑量遞增部分有五名患者（其中兩名患有黑色素瘤）經歷了四個月或更長時間的穩定疾病，其中兩名患者（黑色素瘤；頭和頸部）經歷了十二個月或更長時間的穩定疾病。
Instead, the biotech will focus on the selective immunoproteasome inhibitor called zetomipzomib.
相反，生物科技公司將專注於所謂的選擇性免疫蛋白酶體抑制劑zetomipzomib。
Kezar has enrolled all 24 patients in the phase 2 PORTOLA trial of zetomipzomib in patients with autoimmune hepatitis. Topline data are expected to be available in the first half of 2025.
Kezar已註冊了在自體免疫性肝炎患者中進行zetomipzomib的2期PORTOLA試驗的所有24名患者。拓橫數據預計在2025年上半年公佈。
A global PALIZADE Phase 2b trial of zetomipzomib in active lupus nephritis patients is expected to share topline data in mid-2026.
一項zetomipzomib全球PALIZADE第20億階段試驗，是針對活動性狼瘡性腎炎患者的試驗，預計將於2026年中期公佈拓橫數據。
"We are thrilled to announce completion of enrollment to our PORTOLA trial and look forward to sharing topline results earlier than expected in the first half of 2025," said CEO Chris Kirk.
Kezar首席執行官克里斯•柯克表示：「我們非常高興地宣佈，我們的PORTOLA試驗已完成招募，並期待在2025年上半年早於預期公佈拓橫結果。」
KZR-261 survived a pipeline restructuring in 2023, during which the biotech cut its workforce by 41% and resigned John Fowler as CEO, with Christopher Kirk appointed as the new CEO.
KZR-261在2023年的流水線重組中倖存下來，該生物科技公司將工作人員減少41％並辭去了約翰•福勒首席執行官的職務，克里斯托弗•柯克（Christopher Kirk）被任命爲新的首席執行官。
Kezar said it was also evaluating its Phase 1 trial of KZR-261 in solid tumors and expects to reduce the number of planned expansion cohorts to conserve cash resources while it evaluates safety and biologic activity in the ongoing trial.
Kezar表示，它還正在評估其KZR-261一期實體瘤試驗，並希望在評估正在進行的試驗中的安全性和生物活性的同時，減少計劃中的擴展隊列數以節約現金資源。
Initial data from its KZR-261 Phase 1 trial was expected in 2024.
其KZR-261一期試驗的初步數據預計於2024年公佈。
Price Action: KZR stock is up 1.38% at $0.58 at the last check on Wednesday.
KZR股票在上週三的最後檢查時以0.58美元的價格上漲了1.38％。
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Illustration of Phrama lab worker created with MidJourney.
藥廠實驗室工作者插圖，由MidJourney創建。