多機(jī)制協(xié)同抗癌療法公布臨床試驗(yàn)結(jié)果；創(chuàng)新減重組合療法獲積極進(jìn)展…… | 一周盤點(diǎn)

本期看點(diǎn)：

1. 抗體偶聯(lián)藥物（ADC）micvotabart pelidotin 用于治療復(fù)發(fā)/轉(zhuǎn)移性頭頸部鱗狀細(xì)胞癌（R/M HNSCC）的1期臨床 試驗(yàn)結(jié)果積極， 與pembrolizumab聯(lián)合用于一線或二線及以上（1L/2L+）的患者時(shí)，客觀緩解率（ORR）達(dá)71%，疾病控制率（DCR）為100% 。

2. 線粒體 質(zhì)子載體TLC-6740聯(lián)用 GLP-1/GIP受體雙重激動(dòng)劑tirzepatide治療肥胖，在一項(xiàng)早期臨床試驗(yàn)中使受試者 24周平均減重13.3%，且 呈持續(xù)線性減重趨勢， 未導(dǎo)致瘦體重流失。

Micvotabart Pelidotin（MICVO）：公布1期臨床試驗(yàn)數(shù)據(jù)

Pyxis Oncology公司宣布，其ADC療法micvotabart pelidotin（MICVO，原名PYX-201）用于治療復(fù)發(fā)/轉(zhuǎn)移性頭頸部鱗狀細(xì)胞癌的1期臨床試驗(yàn)取得了積極的初步數(shù)據(jù)。MICVO以微管抑制劑（優(yōu)化的auristatin）作為有效載荷，能靶向腫瘤細(xì)胞外基質(zhì)（ECM）中的非細(xì)胞性結(jié)構(gòu)成分——纖連蛋白B結(jié)構(gòu)域（Extradomain-B Fibronectin，EDB+FN），通過直接殺傷癌細(xì)胞、降低細(xì)胞外基質(zhì)密度、抑制血管生成及激活抗腫瘤免疫，實(shí)現(xiàn)多機(jī)制協(xié)同抗癌。該藥已獲美國FDA授予的快速通道資格，用于鉑類和PD-（L）1抑制劑治療后疾病進(jìn)展的R/M HNSCC患者。

此次公布的結(jié)果顯示，MICVO單藥用于2L+ R/M HNSCC患者，確認(rèn)的ORR為46%，DCR為92%。MICVO與pembrolizumab聯(lián)合用于1L/2L+患者時(shí)，ORR提升至71%，DCR為100%。安全性方面，MICVO總體耐受良好，未觀察到4級(jí)ADC有效載荷治療相關(guān)不良事件，也沒有觀察到5級(jí)不良事件。

TLC-6740：公布1b/2a期聯(lián)合治療試驗(yàn)數(shù)據(jù)

OrsoBio公司宣布，其新型口服、肝臟靶向的線粒體質(zhì)子載體TLC-6740在一項(xiàng)為期24周的1b/2a期臨床試驗(yàn)中取得了積極的頂線數(shù)據(jù)。該研究評(píng)估了TLC-6740聯(lián)合GLP-1/GIP受體雙重激動(dòng)劑tirzepatide治療肥胖的效果。TLC-6740是一種新型口服藥物，通過選擇性作用于肝臟線粒體，增加能量消耗，旨在促進(jìn)減重并改善代謝健康，包括改善胰島素敏感性和脂質(zhì)代謝。該藥正在開發(fā)用于肥胖、糖尿病和代謝功能障礙相關(guān)脂肪性肝炎（MASH）等疾病。

此次公布的結(jié)果顯示，在55名非糖尿病肥胖成人（平均BMI為37.5 kg/m2）中，聯(lián)合治療組（tirzepatide 5 mg+TLC-6740 180 mg）24周平均減重13.3%，較單用tirzepatide組患者（8.8%）額外多減重4.5%（約5.1公斤，相對(duì)提升51%，p=0.018）。此外，單藥組在24周時(shí)體重下降趨于平臺(tái)期，而聯(lián)合組仍呈持續(xù)線性減重趨勢。此外，TLC-6740聯(lián)合tirzepatide的治療顯著改善了患者的胰島素敏感性、肝臟健康和體成分，且未導(dǎo)致瘦體重流失。安全性方面，TLC-6740聯(lián)用tirzepatide的安全性和耐受性良好，胃腸道不良反應(yīng)與tirzepatide單藥治療相當(dāng)。

SAB-142：公布1期臨床試驗(yàn)數(shù)據(jù)

SAB BIO公司公布了其在研人類抗胸腺細(xì)胞免疫球蛋白療法SAB-142的積極1期臨床試驗(yàn)結(jié)果。SAB-142是一種人類多克隆免疫球蛋白，旨在治療自身免疫性1型糖尿病。該藥物可針對(duì)多種殺傷胰島β細(xì)胞的免疫細(xì)胞，調(diào)節(jié)它們的活性，從而起到保護(hù)胰島β細(xì)胞的作用。

此次公布的數(shù)據(jù)顯示，SAB-142耐受性良好，未引發(fā)血清?。?/68），且無任何抗藥抗體（ADA）相關(guān)不良事件（0/68），即使在再次給藥的健康受試者中亦如此，表明其免疫原性極低或無免疫原性。所有受試者均未發(fā)生藥物相關(guān)嚴(yán)重不良事件（SAE），大多數(shù)不良反應(yīng)為輕度、短暫的1級(jí)類流感癥狀及輸注部位反應(yīng)。藥效學(xué)方面，作為與靶點(diǎn)結(jié)合的標(biāo)志，SAB-142誘導(dǎo)了短暫性淋巴細(xì)胞減少（100%受試者），但1–3天內(nèi)即恢復(fù)至基線，恢復(fù)速度遠(yuǎn)快于其他免疫調(diào)節(jié)藥物，支持其在門診環(huán)境中的長期重復(fù)使用。

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