Why Is Cancer-Focused Tyra Biosciences Stock Falling On Friday?
Why Is Cancer-Focused Tyra Biosciences Stock Falling On Friday?
On Thursday, Tyra Biosciences, Inc. (NASDAQ:TYRA) released clinical proof-of-concept data for TYRA-300 in patients with metastatic urothelial (mUC) cancer from its ongoing SURF301 Phase 1/2 study.
週四,泰拉生物科技公司(納斯達克:TYRA)發佈了關於其進行中的SURF301階段1/2研究中TYRA-300在轉移性泌尿上皮癌(mUC)患者中的臨床概念證明數據。
These data will be presented at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics.
這些數據將在分子靶點和癌症治療研討會上進行展示,該研討會由歐洲癌症研究組織、新華保險和美國癌症研究協會共同舉辦。
TYRA-300 is a potential first-in-class, investigational, oral, FGFR3-selective inhibitor designed to avoid the toxicities associated with the inhibition of FGFR1, FGFR2, and FGFR4 while being agnostic for the FGFR3 gatekeeper mutations.
TYRA-300是一種潛在的首家研究性口服FGFR3選擇性抑制劑,旨在避免與FGFR1、FGFR2和FGFR4抑制相關的毒性,同時在FGFR3門控突變方面保持中立。
Also Read: BofA Upgrades Tyra Biosciences As Investors Focus On Preclinical Data Amid High Benchmarks Set By Johnson & Johnson's Drug
也可閱讀:BofA升級 Tyra Biosciences,投資者關注先期數據,儘管約翰遜&約翰遜藥品制定了高標準。
As of Aug. 15, the data cutoff date, 41 patients were enrolled in the Phase 1 portion of the SURF301 Phase 1/2 study.
截至8月15日的數據截止日期,SURF301研究的1/2期中,有41名患者參與了1期研究部分。
The enrolled patient population was heavily pre-treated. Treatment with TYRA-300 was evaluated across six dose levels, ranging from 10 mg to 120 mg once daily (QD).
參與的患者人群均經過了重度治療。TYRA-300的治療在6個劑量水平進行評估,從每日10毫克到120毫克不等。
Preliminary PK/PD analysis in 41 patients as of the data cutoff date: TYRA-300 plasma concentrations indicate adequate target coverage at ≥ 90 mg QD, with ongoing pharmacokinetic characterization.
截至數據截止日期,41名患者的初步PK/PD分析顯示:TYRA-300血漿濃度表明在每日≥90毫克的劑量下有充分的靶標覆蓋,同時進行中的藥代動力學特徵描述。
In patients with FGFR3+ mUC who received doses ≥ 90 mg QD, anti-tumor activity was observed in all patients:
接受每日≥90毫克劑量的FGFR3陽性mUC患者中,所有患者觀察到抗腫瘤活性:
- 6 out of 11 (54.5%) patients at ≥ 90 mg QD achieved a partial response, 3 of which are still ongoing.
- 5 out of 10 (50%) patients at 90 mg QD achieved a partial response.
- 1 out of 1 (100%) patient at 120 mg QD achieved a partial response.
- For all patients at ≥ 90 mg QD (PR + stable disease), a 100% disease control rate (DCR) was achieved.
- 在≥90毫克每日一次的11名患者中,有6名(54.5%)達到了部分緩解,其中3名仍在進行中。
- 在90毫克每日一次的10名患者中,有5名(50%)達到了部分緩解。
- 在120毫克每日一次的1名患者中,100%達到了部分緩解。
- 對於所有≥90毫克每日一次的患者(部分緩解 + 穩定疾病),實現了100%的疾病控制率(DCR)。
TYRA-300 has demonstrated favorable interim safety results:
TYRA-300已經展示了良好的中期安全性結果:
- Preliminary data from SURF301 suggest TYRA-300 to be generally well-tolerated, with infrequent FGFR2- and FGFR1-associated toxicities.
- In doses from 10 mg up to 120 mg QD, there were 4 (10%) serious adverse events related to TYRA-300, one dose-limiting toxicity (DLT) of grade 3 diarrhea at 90 mg QD, and one grade 3 treatment-related adverse event leading to discontinuation of treatment (90 mg QD).
- 來自SURF301的初步數據表明TYRA-300通常耐受良好,FGFR2-和FGFR1相關毒性發生不頻繁。
- 在從10毫克到120毫克每日一次的劑量中,與TYRA-300相關的4例(10%)嚴重不良事件,90毫克每日一次導致1例DLT(3級腹瀉),以及1例3級治療相關的不良事件導致停止治療(90毫克每日一次)。
The 120 mg QD dose was the highest dose evaluated, and no DLTs were reported.
120毫克每日一次的劑量是最高評估的劑量,未報告DLT。
Price Action: TYRA stock is down 18.4% at $23.34 at last check Friday.
價格走勢:TYRA股票在上週五最新數據顯示下跌18.4%,報23.34美元。
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Image created using artificial intelligence via Midjourney.
圖像由Midjourney通過人工智能創建。
譯文內容由第三人軟體翻譯。