本期看点：

1. Zymeworks公司公布了其抗体偶联药物（ADC）ZW191的1期临床试验新数据， 该药在 铂类耐药 卵巢癌（PROC）及子宫内膜癌患者中展现出显著的抗肿瘤活性。

2. Aptose Biosciences公司公布了tuspetinib联用标准剂量的venetoclax和azacitidine（TUS+VEN+AZA）三联疗法治疗新确诊的急性髓系白血病（AML）患者的1/2期试验的新数据。

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ZW191：公布1期临床试验的新数据

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Zymeworks公司公布了其ADC疗法ZW191的1期临床试验新数据。ZW191靶向叶酸受体α（FRα），该靶点在约75%的高级别浆液性卵巢癌和约70%的肺腺癌中表达。ZW191具有独特的设计，可高效进入FRα阳性细胞，并释放Zymeworks开发的具旁观者效应的载荷——拓扑异构酶I抑制剂ZD06519。

此次公布的结果显示，ZW191在铂类耐药卵巢癌及子宫内膜癌患者中展现出显著的抗肿瘤活性。截至2026年3月9日的数据，在疗效可评估的PROC患者中，FRα阳性与阴性肿瘤患者的确认客观缓解率（cORR）分别达到78.6%和47.4%，疾病控制率（DCR）分别为100.0%和89.5%；整体PROC人群的cORR为58.8%。FRα阴性子宫内膜癌患者的cORR为40.0%，DCR为80.0%。两癌种队列的缓解出现较早且随时间加深，中位缓解持续时间尚未达到，中位无进展生存期（PFS）为7.6个月。此外，该药物具备良好的耐受性特征和较宽的治疗窗口，支持继续开展临床开发。

Tuspetinib：公布1/2期联合治疗试验数据

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Aptose Biosciences公司公布了其针对新确诊的急性髓系白血病患者开展的1/2期TUSCANY试验的新数据。这些患者接受了不同剂量的tuspetinib联用标准剂量的venetoclax和azacitidine。该三联疗法正在被开发作为一种安全且不依赖于特定突变的一线治疗方案，用于治疗那些无法接受诱导化疗的新确诊AML患者，这些患者具有多样的突变。

此次公布的结果显示，32名AML患者接受了TUS+VEN+AZA三联疗法，其中29名疗效可评估患者的复合完全缓解率（CRc）达到86.2%；在获得完全缓解（CR）或部分血液学恢复的完全缓解（CRh）的患者中，微小残留病灶（MRD）阴性率达86.4%，所有给药患者的MRD阴性率为62.5%。具有不同遗传特征（包括TP53突变、复杂核型和未突变FLT3）的AML患者，在安全实现治疗缓解的同时，也达到了MRD阴性。安全性方面，tuspetinib与标准剂量的VEN/AZA联用耐受性良好，未发生与治疗相关的死亡、QTc间期延长、CPK升高或分化综合征，且其药代动力学特性未受联合用药、抗真菌药或食物的显著影响。

KT-621：公布1期临床试验数据

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Kymera Therapeutics公司公布了其在研口服、潜在“first-in-class”的STAT6降解剂KT-621在健康日本成年人中进行的1期临床研究结果。该公司此前已报告KT-621在非日本健康志愿者及中重度特应性皮炎患者中的1期临床数据。在这些研究中，KT-621使受试者血液和皮肤中的STAT6快速、深度且持续地降解，并显著降低疾病相关2型炎症生物标志物，特应性皮炎以及共病哮喘和过敏性鼻炎的临床终点和患者报告结局显著改善，安全性良好。

此次公布的结果显示，KT-621展现出良好的药代动力学（PK）特征，包括吸收迅速、血浆暴露量呈剂量比例增加，以及在血液中快速且持续地降解STAT6。在第7天时，两种剂量水平下，STAT6的中位降解率均≥98%。此外，在两种剂量下，该药物的耐受性和安全性均良好。总体而言，这些在日本健康成人中获得的结果与在非日本成人及特应性皮炎患者中观察到的结果相当，进一步支持了KT-621作为慢性2型炎症性疾病新型口服疗法的潜力。

参考资料：

[1] Kymera Therapeutics Presents Phase 1 Data in Healthy Japanese Adults for KT-621, a First-in-Class Oral STAT6 Degrader, at the Japanese Dermatological Association Annual Meeting. Retrieved June 18, 2026, from https://www.globenewswire.com/news-release/2026/06/12/3310977/0/en/kymera-therapeutics-presents-phase-1-data-in-healthy-japanese-adults-for-kt-621-a-first-in-class-oral-stat6-degrader-at-the-japanese-dermatological-association-annual-meeting.html

[2] Celldex Presents Positive First-in-Human Results from Phase 1 Study of Novel Bispecific CDX-622 at the European Academy of Allergy and Clinical Immunology Annual Meeting. Retrieved June 18, 2026, from https://www.globenewswire.com/news-release/2026/06/14/3311438/24180/en/celldex-presents-positive-first-in-human-results-from-phase-1-study-of-novel-bispecific-cdx-622-at-the-european-academy-of-allergy-and-clinical-immunology-annual-meeting.html

[3] Zymeworks Presents New Phase 1 Data for Folate Receptor Alpha-Targeting ADC ZW191 at ESMO Gynaecological Cancers Congress 2026. Retrieved June 18, 2026, from https://www.globenewswire.com/news-release/2026/06/14/3311472/0/en/zymeworks-presents-new-phase-1-data-for-folate-receptor-alpha-targeting-adc-zw191-at-esmo-gynaecological-cancers-congress-2026.html

[4] Aptose Presents Safety, Response, and MRD Clinical Data from TUSCANY Phase 1/2 Clinical Trial of Tuspetinib Triplet Therapy in Newly Diagnosed AML at the 2026 EHA Congress in Oral Presentation. Retrieved June 18, 2026, from https://www.globenewswire.com/news-release/2026/06/15/3311704/35575/en/aptose-presents-safety-response-and-mrd-clinical-data-from-tuscany-phase-1-2-clinical-trial-of-tuspetinib-triplet-therapy-in-newly-diagnosed-aml-at-the-2026-eha-congress-in-oral-pr.html

[5] Bambusa Therapeutics Presents Positive Preliminary Multiple Ascending Dose Phase 1 Data for BBT002 at the European Academy of Allergy & Clinical Immunology (EAACI) Annual Congress 2026. Retrieved June 18, 2026, from https://www.prnewswire.com/news-releases/bambusa-therapeutics-presents-positive-preliminary-multiple-ascending-dose-phase-1-data-for-bbt002-at-the-european-academy-of-allergy--clinical-immunology-eaaci-annual-congress-2026-302799221.html

[6] Context Therapeutics Announces Positive Interim Efficacy and Safety Results from Ongoing Phase 1 Clinical Trial for CTIM-76. Retrieved June 18, 2026, from https://www.globenewswire.com/news-release/2026/06/15/3311621/0/en/context-therapeutics-announces-positive-interim-efficacy-and-safety-results-from-ongoing-phase-1-clinical-trial-for-ctim-76.html

[7] Enterome presents Phase 1/2 iNHL interim data at EHA demonstrating durable OncoMimics™-induced CD8 T cell responses and clinical activity. Retrieved June 18, 2026, from https://www.enterome.com/news-events/enterome-presents-phase-1-2-inhl-interim-data-at-eha-demonstrating-durable-oncomimics-induced-cd8-t-cell-responses-and-clinical-activity/

[8] Marea Therapeutics Presents Phase 1 Data Supporting Potential Best-in-disease Profile of MAR002 for the Treatment of Acromegaly at ENDO 2026. Retrieved June 18, 2026, from https://www.mareatx.com/press-releases/marea-therapeutics-presents-phase-1-data-supporting-potential-best-in-disease-profile-of-mar002-for-the-treatment-of-acromegaly-at-endo-2026/

[9] 英矽智能与衡泰生物的合作达成首个临床里程碑，AI 驱动的 NLRP3 抑制剂 ISM8969 完成 I 期临床试验首例受试者给药. Retrieved June 18, 2026, from https://www.prnasia.com/story/537494-1.shtml

[10] Positive results from the Phase Ib clinical study of NeuroRestore ACD856, under development for Alzheimer’s. Retrieved June 18, 2026, from https://www.alzecurepharma.se/en/positive-results-from-the-phase-ib-clinical-study-of-neurorestore-acd856-under-development-for-alzheimers/

[11] HCW Biologics Announces Positive Results for Preliminary Human Data Readout for Phase 1 Clinical Trial Evaluating IL-2 Based Fusion Immunotherapeutic, HCW9302 Monotherapy, in Alopecia Areata. Retrieved June 18, 2026, from https://www.globenewswire.com/news-release/2026/06/16/3312406/0/en/hcw-biologics-announces-positive-results-for-preliminary-human-data-readout-for-phase-1-clinical-trial-evaluating-il-2-based-fusion-immunotherapeutic-hcw9302-monotherapy-in-alopeci.html

[12] Nectin Therapeutics Reports Encouraging Phase 1 Results for NTX1088 in Combination with Keytruda® (pembrolizumab) at ASCO 2026. Retrieved June 18, 2026, from https://www.prnewswire.com/news-releases/nectin-therapeutics-reports-encouraging-phase-1-results-for-ntx1088-in-combination-with-keytruda-pembrolizumab-at-asco-2026-302803053.html

[13] Lexeo Therapeutics Announces Publication in JAMA Cardiology of Phase I/II Data for LX2006 in Friedreich Ataxia. Retrieved June 18, 2026, from https://www.globenewswire.com/news-release/2026/06/17/3313795/0/en/lexeo-therapeutics-announces-publication-in-jama-cardiology-of-phase-i-ii-data-for-lx2006-in-friedreich-ataxia.html

[14] uniQure Announces Preliminary Data on the First Cohort in the Phase I/IIa Clinical Trial of AMT-260 in Refractory Mesial Temporal Lobe Epilepsy. Retrieved June 18, 2026, from https://www.globenewswire.com/news-release/2026/06/19/3314701/0/en/uniqure-announces-preliminary-data-on-the-first-cohort-in-the-phase-i-iia-clinical-trial-of-amt-260-in-refractory-mesial-temporal-lobe-epilepsy.html

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