更新于：2024-07-01
CUE-101
更新于：2024-07-01
概要
基本信息
药物类型 融合蛋白 |
别名 CUE 101 |
靶点 |
作用机制 E7抑制剂(人乳头瘤病毒E7蛋白抑制剂) |
在研适应症 |
非在研适应症 |
非在研机构- |
最高研发阶段临床2期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评快速通道 (美国) |
关联
2
项与 CUE-101 相关的临床试验Non-Randomized Phase 2 Trial of Three Schedules of CUE-101 Administered Before Surgery or Definitive Chemoradiation Therapy in HLA-A*0201 Positive Patients With Locally Advanced, HPV16-Positive Oropharyngeal Squamous-Cell Carcinoma
This is a phase 2 trial to assess the safety and tolerability of three schedules of CUE-101 administered in the neoadjuvant phase before standard of care (SOC) therapy to treatment naïve, HLA-A*0201 positive patients with newly diagnosed, locally advanced HPV16+ oropharyngeal squamous-cell carcinoma (OPSCC). This is an exploratory trial of a limited sample size to confirm safety and to assess for pharmacodynamic signals of efficacy in each of three schedules of CUE-101. Safety assessments will be performed at baseline and after CUE-101 administration. To assess for efficacy, peripheral blood and tumor samples will be collected at baseline and after CUE-101 administration. Following CUE-101, patients will proceed with SOC therapy, as prescribed by the treating physician.
开始日期2021-12-06 |
申办/合作机构 |
A Phase1, First-in-Human, Open-Label, Dose Escalation and Expansion Study of CUE-101 Monotherapy in Second Line or CUE-101 Combination Therapy With Pembrolizumab in First Line Patients With HPV16+ Recurrent/Metastatic HNSCC
This is a multi-center, open-label, phase 1 dose escalation and expansion study evaluating the safety, anti-tumor effect, and immunogenicity of CUE-101 as monotherapy treatment in second line or CUE-101 Combination Therapy with Pembrolizumab in first line patients with HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
开始日期2019-07-30 |
申办/合作机构  Cue Biopharma, Inc. [+1] |
100 项与 CUE-101 相关的临床结果
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100 项与 CUE-101 相关的转化医学
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100 项与 CUE-101 相关的专利（医药）
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1
项与 CUE-101 相关的文献（医药）2020-04-15·Clinical cancer research : an official journal of the American Association for Cancer Research1区 · 医学
CUE-101, a Novel E7-pHLA-IL2-Fc Fusion Protein, Enhances Tumor Antigen-Specific T-Cell Activation for the Treatment of HPV16-Driven Malignancies
1区 · 医学
Article
作者: Seidel, Ronald ; Witt, Luke ; Quayle, Steven N. ; Girgis, Natasha ; Haydock, Mark ; Pienta, Kenneth J. ; Almo, Steven ; Cemerski, Saso ; Histed, Alex ; Chaparro, Rodolfo ; Spaulding, Emily ; Kemp, Melissa M. ; Zhao, Fan ; Thapa, Dharma R. ; Merazga, Zohra ; Beal, Dominic R. ; Hulot, Sandrine ; Simcox, Mary Ellen ; Suri, Anish ; Ruthardt, Paige ; Soriano, Jonathan ; Moreta, Miguel ; Ross, John F. ; Kiener, Peter A. ; Ryabin, Jessica ; Kraemer, Lauren D. ; Nelson, Alyssa
Abstract:
Purpose::
To assess the potential for CUE-101, a novel therapeutic fusion protein, to selectively activate and expand HPV16 E711-20-specific CD8+ T cells as an off-the shelf therapy for the treatment of HPV16-driven tumors, including head and neck squamous cell carcinoma (HNSCC), cervical, and anal cancers.
Experimental Design::
CUE-101 is an Fc fusion protein composed of a human leukocyte antigen (HLA) complex, an HPV16 E7 peptide epitope, reduced affinity human IL2 molecules, and an effector attenuated human IgG1 Fc domain. Human E7-specific T cells and human peripheral blood mononuclear cells (PBMC) were tested to demonstrate cellular activity and specificity of CUE-101, whereas in vivo activity of CUE-101 was assessed in HLA-A2 transgenic mice. Antitumor efficacy with a murine surrogate (mCUE-101) was tested in the TC-1 syngeneic tumor model.
Results::
CUE-101 demonstrates selective binding, activation, and expansion of HPV16 E711-20-specific CD8+ T cells from PBMCs relative to nontarget cells. Intravenous administration of CUE-101 induced selective expansion of HPV16 E711-20-specific CD8+ T cells in HLA-A2 (AAD) transgenic mice, and anticancer efficacy and immunologic memory was demonstrated in TC-1 tumor-bearing mice treated with mCUE-101. Combination therapy with anti-PD-1 checkpoint blockade further enhanced the observed efficacy.
Conclusions::
Consistent with its design, CUE-101 demonstrates selective expansion of an HPV16 E711-20-specific population of cytotoxic CD8+ T cells, a favorable safety profile, and in vitro and in vivo evidence supporting its potential for clinical efficacy in an ongoing phase I trial (NCT03978689).
77
项与 CUE-101 相关的新闻（医药）2024-06-09
·药明康德
▎药明康德内容团队编辑
本期看点
1. 新型口服双重抑制剂TU2218联用PD-1抑制剂pembrolizumab治疗晚期实体瘤患者，在一项1b期临床试验中的疾病控制率（DCR）达100%。
2. 用于治疗遗传性血管水肿（HAE）的在研体内CRISPR基因编辑疗法NTLA-2002早期临床数据亮眼，单次给药后使患者的月度发作率平均下降了98%。
3. 现货型基因疗法PRGN-2012治疗复发性呼吸乳头状瘤病（RRP）患者的1/2期临床试验达到主要终点，有望成为首个获得FDA批准的用于治疗RRP的疗法。
4. 男性无激素避孕药YCT-529完成了1a期临床试验，在临床前研究中，该候选疗法预防小鼠妊娠的有效率为99%，且100%可逆。
药明康德内容团队整理
TU2218：公布1b期临床试验的中期数据
TiumBio公司公布了新型口服双重抑制剂TU2218联用PD-1抑制剂pembrolizumab治疗晚期实体瘤患者1b期临床试验的中期结果。TU2218靶向转化生长因子β受体1（TGFR1）和血管内皮生长因子受体2（VEGFR2）。肿瘤微环境中的TGF-ß和VEGF通路会干扰免疫检查点抑制剂的抗肿瘤活性，因此TU2218有望通过抑制这两种通路最大限度地提高免疫疗法的疗效。
此次公布的结果显示，5名接受2期推荐剂量（RP2D）TU2218联用pembrolizumab治疗的患者的DCR为100%，其中两名患者达到了部分缓解（PR），3名患者达到了疾病稳定（SD）。所有剂量组中，12名接受联合治疗的患者中有2人达到了PR，6人达到了SD。在这项研究中，TU2218联用pembrolizumab的耐受性良好，没有观察到剂量限制性毒性（DLT），这与之前的单药治疗试验一致。
NTLA-2002：公布1期临床试验的长期数据
Intellia Therapeutics公司宣布其用于治疗遗传性血管水肿的在研疗法NTLA-2002的1期临床试验的长期数据。NTLA-2002是一种体内CRISPR基因编辑候选疗法，通过脂质纳米颗粒（LNP）以mRNA形式递送CRISPR-Cas9基因编辑系统，靶向敲除血浆前激肽释放酶（KLKB1）基因，以永久性降低血浆中激肽释放酶活性，从而防止遗传性血管水肿的发作。
此次公布的结果显示，中位随访时间为20.1个月时，单次NTLA-2002治疗让患者的月均疾病发作率平均减少了98%，中度至重度发作平均减少了99%。在测试的每个剂量水平上，HAE发作率均显著减少。单次输注后，患者最长的无发作期超过26个月，并且仍在持续。此外，100%接受NTLA-2002治疗的患者在停止其他预防性治疗后无需再进行预防性治疗。
PRGN-2012：公布1/2期临床试验的新数据
Precigen公司公布了其现货型基因疗法PRGN-2012治疗复发性呼吸乳头状瘤病患者的1/2期临床试验数据。PRGN-2012旨在激发对抗受HPV6或HPV11感染细胞的免疫反应，以治疗RRP。此前，PRGN-2012已获得FDA和欧盟委员会授予的孤儿药资格，还获得了FDA授予的突破性疗法认定。
此次公布的结果显示，该1/2期临床试验达到了主要的安全性和疗效终点。中位随访时间为20个月时，51%（18/35）接受PRGN-2012治疗的患者达到了完全缓解（CR），且不再需要进行手术治疗，CR持续时间超过12个月。86%的患者在接受PRGN-2012治疗后的一年内需要进行的手术次数较治疗前一年减少，从治疗前一年的中位次数4次减少到接受治疗后的0次。此外，PRGN-2012显著改善了达到CR患者的Derkay评分（一种用于测量RRP生长程度的量表）和生活质量评分。安全性方面，PRGN-2012的耐受性良好，无DLT，也没有＞2级的治疗相关不良事件。
▲PRGN-2012的1/2期临床试验结果（图片来源：参考资料[9]）
该公司计划在2024年下半年通过加速批准途径提交PRGN-2012的滚动生物制品许可申请（BLA）。新闻稿指出，如果获得批准，PRGN-2012有可能成为首个获得FDA批准用于治疗RRP的疗法。
YCT-529：公布1a期临床试验数据
YourChoice Therapeutics公司公布其男性无激素避孕药YCT-529的1a期临床试验结果。YCT-529是一种视黄酸受体-α（RAR-a）抑制剂，通过阻断RAR-α来阻止睾丸中精子的产生和释放。临床前研究表明，YCT-529在预防小鼠妊娠方面有99%的有效性，且100%可逆。该研究的结果表明，YCT-529是安全的。
C-CAR031：公布1期临床试验的初步数据
阿斯利康（AstraZeneca）公布其GPC3靶向CAR-T疗法C-CAR031的最新临床试验结果。GPC3是一种在肝癌中过表达的表面抗原，该蛋白在健康组织中几乎不存在。C-CAR031是一种GPC3靶向的自体CAR-T疗法，这款CAR-T疗法还同时“装备”了TGFβ以抵抗免疫抑制微环境，以增强其效力。
此次公布的结果显示，中位随访时间为5.82个月时，22例可评估疗效的GPC3阳性晚期肝细胞癌（HCC）患者的DCR为90.9%，客观缓解率为50.0%，且该疗法的安全性可控。阿斯利康的早期肿瘤学开发负责人Matt Hellmann博士在接受行业媒体STAT采访时表示：“这是首个在肝癌治疗上显示具疗效的CAR-T疗法。这也是GPC3靶点的首次临床验证。”
▲C-CAR031的疗效结果摘要（图片来源：参考资料[1]）
CB-010：公布1期临床试验数据
Caribou Biosciences公司公布了其同种异体CAR-T细胞疗法CB-010治疗复发/难治性B细胞非霍奇金淋巴瘤患者的新数据。CB-010利用基因编辑技术生成，除了表达靶向CD19的嵌合抗原受体，还利用基因编辑技术敲除了免疫检查点蛋白PD-1的表达，旨在提高抗肿瘤活性的持久性。
截至2024年4月1日的数据，CB-010的疗效和安全性可与已获批的自体CAR-T细胞疗法相媲美。13名部分人类白细胞抗原（HLA）匹配（≥4个等位基因）患者的总缓解率达92%，CR率为46%，中位无进展生存期（PFS）获得改善，为14.4个月。
▲接受CB-010治疗患者的无进展生存曲线（图片来源：参考资料[4]）
▲接受CB-010治疗患者的疗效结果（图片来源：参考资料[4]）
INB-200：公布1期临床试验的新数据
IN8bio公司公布其耐化疗的转基因自体γδ T细胞疗法INB-200用于治疗新确诊的多形性胶质母细胞瘤的积极早期数据。INB-200是一种强大的协同治疗方法，能在患者接受化疗时持续存在，并保持其识别、参与和杀死癌细胞的自然能力。
截至2024年5月30日的数据，中位随访时间为11.7个月，92%接受INB-200治疗的可评估患者的中位PFS超过了7个月（即接受标准治疗方案的患者的中位PFS）。一名患有IDH突变神经胶质瘤的患者在接受治疗后的34.9+个月时仍然存活，且疾病没有进展。近期发表的一项IDH抑制剂治疗IDH突变脑胶质瘤患者的临床试验中，对照组患者的中位PFS为11.1个月，试验组患者的中位PFS为28.5个月。安全性方面，在任何队列中均未报告与治疗相关的严重不良事件、DLT、细胞因子释放综合征、输注反应或免疫效应细胞相关神经毒性综合征。
IFx-2.0：公布1b期临床试验数据
TuHURA Biosciences公司公布了其个体化的候选癌症疫苗IFx-2.0治疗对免疫检查点抑制剂（ICI）耐药的晚期Merkel细胞癌（MCC）和皮肤鳞状细胞癌（cSCC）患者的1b期试验的初步结果。该候选疗法旨在克服患者对ICI的原发性耐药。
此次公布的结果显示，连续三周每周给药一次IFx-2.0的耐受性良好。5名此前接受ICI治疗后在3.8个月内疾病就发生进展的晚期MCC患者中，有4人在接受IFx-2.0治疗后重新对ICI治疗产生了持久的应答，包括1例CR、1例病理完全缓解（pCR）和两例PR。患者的平均缓解时间为25个月，其中两名患者已分别持续缓解19个月和23个月，并且仍在持续缓解中。
MDNA11：公布1/2期临床试验的新数据
Medicenna Therapeutics公司公布了其下一代长效IL-2超级激动剂MDNA11治疗晚期实体瘤的新临床结果。MDNA11具有优秀的CD122（IL-2受体β）结合作用，而没有CD25（IL-2受体α）亲和力，从而能优先刺激癌症杀伤效应T细胞和NK细胞。
此次公布的结果显示，MDNA11的耐受性良好，没有报告DLT和血管渗漏综合征。MDNA11在胰腺癌患者中表现出持久的缓解，1例转移性胰腺导管腺癌患者在基线时存在的所有病灶均完全消退，已维持超过104周，在停止治疗4个月后仍然保持着缓解。一例双检查点抑制剂治疗后进展的黑色素瘤患者的靶病灶在第28周时完全消退，在第44周的扫描时靶病灶仍保持完全消退。目前，该患者仍在接受MDNA11的治疗，非靶病灶也在继续消退。
WTX-124：公布1/1b期临床试验数据
Werewolf Therapeutics公司公布了其条件激活的白介素-2（IL-2）候选疗法WTX-124治疗接受过ICI治疗的局部晚期或转移性实体瘤患者的1/1b期临床试验数据。结果显示，WTX-124在此类患者中具有临床活性，且耐受性良好。截至2024年5月1日的数据，接受WTX-124单药治疗的患者中有1人获得了持久并经过确认的CR，2人达到了PR。获得缓解的患者在治疗的前两个治疗周期内就出现了缓解，并且靶病灶实现了100%的消退。此外，没有发现WTX-124联用pembrolizumab出现新的安全信号。
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参考资料（可上下滑动查看）
[1] Phase I study of C-CAR031, a GPC3-specific TGFβRIIDN armored autologous CAR-T, in patients with advanced hepatocellular carcinoma (HCC). Retrieved June 4, 2024 from https://meetings.asco.org/abstracts-presentations/234377
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[10] YourChoice Therapeutics Completes Phase 1a Clinical Study for First Hormone-Free Male Birth Control Pill. Retrieved June 7, 2024, from https://www.businesswire.com/news/home/20240603886060/en/
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[16] Vivet Therapeutics Presents Interim Data from its Phase 1/2 GATEWAY Trial for the Treatment of Wilson Disease at EASL Congress 2024. Retrieved June 7, 2024, from https://www.prnewswire.com/news-releases/vivet-therapeutics-presents-interim-data-from-its-phase-12-gateway-trial-for-the-treatment-of-wilson-disease-at-easl-congress-2024-302164666.html
[17] Altimmune Presents Data at EASL International Liver Congress™ 2024 Supporting the Disease Modifying Potential and Differentiated Therapeutic Profile of Pemvidutide in Metabolic Dysfunction-Associated Steatohepatitis (MASH). Retrieved June 7, 2024, from https://www.globenewswire.com/news-release/2024/6/5/2893731/0/en/Altimmune-Presents-Data-at-EASL-International-Liver-Congress-2024-Supporting-the-Disease-Modifying-Potential-and-Differentiated-Therapeutic-Profile-of-Pemvidutide-in-Metabolic-Dysf.html
[18] Quell Therapeutics Advances QEL-001, its Multi-modular Engineered CAR-Treg Cell Therapy, into Efficacy Cohort of LIBERATE Phase 1/2 Trial in Liver Transplant Patients. Retrieved June 7, 2024, from https://www.globenewswire.com/news-release/2024/06/04/2893353/0/en/Quell-Therapeutics-Advances-QEL-001-its-Multi-modular-Engineered-CAR-Treg-Cell-Therapy-into-Efficacy-Cohort-of-LIBERATE-Phase-1-2-Trial-in-Liver-Transplant-Patients.html
[19] Surrozen Initiates Dosing of First Patient in Phase 1b Clinical Trial of SZN-043 for Severe Alcohol-Associated Hepatitis. Retrieved June 7, 2024, from https://www.globenewswire.com/news-release/2024/06/04/2893050/0/en/Surrozen-Initiates-Dosing-of-First-Patient-in-Phase-1b-Clinical-Trial-of-SZN-043-for-Severe-Alcohol-Associated-Hepatitis.html
[20] Cue Biopharma Presents Updated Data from Phase 1 Trial of CUE-101 in Recurrent/Metastatic HPV+ Head and Neck Cancer at the 2024 ASCO Annual Meeting. Retrieved June 7, 2024, from https://www.globenewswire.com/news-release/2024/06/04/2892974/0/en/Cue-Biopharma-Presents-Updated-Data-from-Phase-1-Trial-of-CUE-101-in-Recurrent-Metastatic-HPV-Head-and-Neck-Cancer-at-the-2024-ASCO-Annual-Meeting.html
[21] Merus Presents Interim Data on MCLA-145 Monotherapy and in Combination with Pembrolizumab at the 2024 ASCO® Annual Meeting. Retrieved June 7, 2024, from https://ir.merus.nl/news-releases/news-release-details/merus-presents-interim-data-mcla-145-monotherapy-and-combination
[22] BlueSphere Bio Announces IND Clearance of its First in Human Candidate and New Cell Therapy Portfolio for High-Risk Leukemia Patients. Retrieved June 7, 2024, from https://www.globenewswire.com/news-release/2024/06/03/2892552/0/en/BlueSphere-Bio-Announces-IND-Clearance-of-its-First-in-Human-Candidate-and-New-Cell-Therapy-Portfolio-for-High-Risk-Leukemia-Patients.html
[23] Grey Wolf Therapeutics Presents First Clinical Data for GRWD5769, a First-in-Class ERAP1 Inhibitor, at the 2024 American Society for Clinical Oncology (ASCO) Annual Meeting. Retrieved June 7, 2024, from https://www.prnewswire.com/news-releases/grey-wolf-therapeutics-presents-first-clinical-data-for-grwd5769-a-first-in-class-erap1-inhibitor-at-the-2024-american-society-for-clinical-oncology-asco-annual-meeting-302161297.html
[24] Puma Biotechnology Announces Presentation of Findings from a Phase I/Ib Study of Alisertib in Advanced EGFR-Mutated Lung Cancer. Retrieved June 7, 2024, from https://www.businesswire.com/news/home/20240603691086/en
[25] Cyclacel Pharmaceuticals Reports New Clinical Data at 2024 ASCO Annual Meeting Highlighting Oral Fadraciclib’s Potential as a Precision Medicine for Cancer. Retrieved June 7, 2024, from https://investor.cyclacel.com/news-releases/news-release-details/cyclacel-pharmaceuticals-reports-new-clinical-data-2024-asco
[26] Obsidian Therapeutics Announces Additional OBX-115 Safety and Efficacy Data in Oral Presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Retrieved June 7, 2024, from https://www.businesswire.com/news/home/20240603008329/en
[27] Replimune Presents RP1 Data from the IGNYTE anti-PD1 Failed Melanoma Cohort and RP2 Data in Uveal Melanoma at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. Retrieved June 7, 2024, from https://ir.replimune.com/news-releases/news-release-details/replimune-presents-rp1-data-ignyte-anti-pd1-failed-melanoma
[28] RS Oncology Announces Positive Data from a Phase 1 Clinical Trial of RSO-021, a First-in-Class Therapeutic for Malignant Pleural Mesothelioma. Retrieved June 7, 2024, from https://www.businesswire.com/news/home/20240603559175/en
[29] Ascendis Pharma Presents New Data and Updated Results from Phase 1/2 IL-Believe Trial at ASCO 2024. Retrieved June 7, 2024, from https://www.globenewswire.com/news-release/2024/06/03/2892565/0/en/Ascendis-Pharma-Presents-New-Data-and-Updated-Results-from-Phase-1-2-IL-Believe-Trial-at-ASCO-2024.html
[30] Scholar Rock Presents New Data from SRK-181 Phase 1 DRAGON Trial at ASCO 2024 Annual Meeting. Retrieved June 7, 2024, from https://www.businesswire.com/news/home/20240603004778/en
[31] invoX Pharma Presents Positive Clinical Data from Phase 1 Study of FS222 in Patients with Advanced Solid Tumours at the 2024 American Society of Clinical Oncology Annual Meeting. Retrieved June 7, 2024, from https://www.businesswire.com/news/home/20240603068133/en
[32] Eledon Presents Updated Data from Ongoing Phase 1b Trial Evaluating Tegoprubart for Prevention of Rejection in Kidney Transplantation. Retrieved June 7, 2024, from https://www.globenewswire.com/news-release/2024/06/03/2892558/0/en/Eledon-Presents-Updated-Data-from-Ongoing-Phase-1b-Trial-Evaluating-Tegoprubart-for-Prevention-of-Rejection-in-Kidney-Transplantation.html
[33] ImmuneOncia Announces Biomarker Results from Phase 1 Clinical Trial of CD47 Antibody at ASCO. Retrieved June 7, 2024, from https://www.businesswire.com/news/home/20240603017832/en
[34] Entera Bio Reports Phase 1 Clinical Data of First-in-Class, Oral PTH(1-34) Peptide Candidate (EB612) for Patients with Hypoparathyroidism at ENDO 2024. Retrieved June 7, 2024, from https://www.globenewswire.com/news-release/2024/06/03/2892199/0/en/Entera-Bio-Reports-Phase-1-Clinical-Data-of-First-in-Class-Oral-PTH-1-34-Peptide-Candidate-EB612-for-Patients-with-Hypoparathyroidism-at-ENDO-2024.html
[35] Enlivex Receives Regulatory Authorization for the Initiation of a Placebo-Controlled Phase I/II Trial Evaluating Allocetra in Up To 46 Patients with Thumb Osteoarthritis. Retrieved June 7, 2024, from https://www.globenewswire.com/news-release/2024/06/03/2892206/0/en/Enlivex-Receives-Regulatory-Authorization-for-the-Initiation-of-a-Placebo-Controlled-Phase-I-II-Trial-Evaluating-Allocetra-in-Up-To-46-Patients-with-Thumb-Osteoarthritis.html
[36] Indaptus Therapeutics Announces New Positive Data from Ongoing Phase 1 Trial of Decoy20. Retrieved June 7, 2024, from https://www.globenewswire.com/news-release/2024/06/03/2892212/0/en/Indaptus-Therapeutics-Announces-New-Positive-Data-from-Ongoing-Phase-1-Trial-of-Decoy20.html
[37] Alkermes Presents Data From Phase 1b Study of ALKS 2680 Demonstrating Improved Wakefulness in Patients With Narcolepsy Type 1 at SLEEP 2024. Retrieved June 7, 2024, from https://www.prnewswire.com/news-releases/alkermes-presents-data-from-phase-1b-study-of-alks-2680-demonstrating-improved-wakefulness-in-patients-with-narcolepsy-type-1-at-sleep-2024-302161336.html
[38] IDRx Reports Updated Preliminary Phase 1 Data from Ongoing Phase 1/1b StrateGIST 1 Trial Supporting Best-in-Class Potential for IDRX-42 in Patients with GIST. Retrieved June 7, 2024, from https://www.businesswire.com/news/home/20240531639390/en
[39] Century Therapeutics Presents Interim Results from Phase 1 ELiPSE-1 Study at ASCO 2024 Annual Meeting. Retrieved June 7, 2024, from https://www.globenewswire.com/news-release/2024/06/03/2892097/0/en/Century-Therapeutics-Presents-Interim-Results-from-Phase-1-ELiPSE-1-Study-at-ASCO-2024-Annual-Meeting.html
[40] MediciNova Announces Data from Phase 1b/2a Clinical Trial of MN-166 (ibudilast) in Glioblastoma Patients at the American Society of Clinical Oncology (ASCO) Annual Meeting 2024. Retrieved June 7, 2024, from https://www.globenewswire.com/news-release/2024/06/03/2892064/7767/en/MediciNova-Announces-Data-from-Phase-1b-2a-Clinical-Trial-of-MN-166-ibudilast-in-Glioblastoma-Patients-at-the-American-Society-of-Clinical-Oncology-ASCO-Annual-Meeting-2024.html
[41] FibroGen Announces FDA Clearance of Investigational New Drug Application for FG-3165, a Galectin-9 Targeting Monoclonal Antibody, for the Treatment of Patients with Solid Tumors. Retrieved June 7, 2024, from https://www.globenewswire.com/news-release/2024/06/03/2892568/0/en/FibroGen-Announces-FDA-Clearance-of-Investigational-New-Drug-Application-for-FG-3165-a-Galectin-9-Targeting-Monoclonal-Antibody-for-the-Treatment-of-Patients-with-Solid-Tumors.html
[42] STORM Therapeutics Presented Interim Phase 1 Clinical Data on its METTL3 RNA Methyltransferase Inhibitor STC-15 at ASCO 2024. Retrieved June 7, 2024, from https://www.prnewswire.com/news-releases/storm-therapeutics-presented-interim-phase-1-clinical-data-on-its-mettl3-rna-methyltransferase-inhibitor-stc-15-at-asco-2024-302160864.html
[43] Black Diamond Therapeutics Presents Promising BDTX-1535 Clinical Data in Patients with Recurrent Glioblastoma at 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Retrieved June 7, 2024, from https://investors.blackdiamondtherapeutics.com/news-releases/news-release-details/black-diamond-therapeutics-presents-promising-bdtx-1535-clinical
[44] Immunocore reports updated Phase 1 data of brenetafusp (IMC-F106C), an ImmTAC bispecific targeting PRAME, in immune checkpoint pre-treated cutaneous melanoma patients at ASCO 2024. Retrieved June 7, 2024, from https://www.globenewswire.com/news-release/2024/05/31/2891735/0/en/Immunocore-reports-updated-Phase-1-data-of-brenetafusp-IMC-F106C-an-ImmTAC-bispecific-targeting-PRAME-in-immune-checkpoint-pre-treated-cutaneous-melanoma-patients-at-ASCO-2024.html
[45] Kymera Therapeutics Presents New Clinical Data from Ongoing Phase 1 Trial of MDM2 Degrader KT-253 at ASCO Annual Meeting. Retrieved June 7, 2024, from https://www.globenewswire.com/news-release/2024/06/01/2891812/0/en/Kymera-Therapeutics-Presents-New-Clinical-Data-from-Ongoing-Phase-1-Trial-of-MDM2-Degrader-KT-253-at-ASCO-Annual-Meeting.html
[46] Accutar Biotechnology Presents Phase 1 Data of AC699 Monotherapy in Patients with ER+ / HER2- Breast Cancer at ASCO 2024. Retrieved June 7, 2024, from https://www.businesswire.com/news/home/20240601126229/en
[47] Molecular Partners Presents Positive Data From Completed Phase 1 Trial Of MP0317 (FAP X CD40 DARPin) Monotherapy In Patients With Advanced Solid Tumors At ASCO 2024. Retrieved June 7, 2024, from https://www.globenewswire.com/news-release/2024/06/01/2891809/0/en/Molecular-Partners-Presents-Positive-Data-From-Completed-Phase-1-Trial-Of-MP0317-FAP-X-CD40-DARPin-Monotherapy-In-Patients-With-Advanced-Solid-Tumors-At-ASCO-2024.html
[48] Updated Data from the Phase 1/2 Study of Olomorasib in KRAS G12C-Mutant Advanced Solid Tumors Presented at the 2024 ASCO® Annual Meeting. Retrieved June 7, 2024, from https://www.prnewswire.com/news-releases/updated-data-from-the-phase-12-study-of-olomorasib-in-kras-g12c-mutant-advanced-solid-tumors-presented-at-the-2024-asco-annual-meeting-302160829.html
[49] ALX Oncology Presents First Evorpacept Combination Data with an Antibody-Drug Conjugate from Phase 1 ASPEN-07 Clinical Trial in Patients with Advanced Bladder Cancer. Retrieved June 7, 2024, from https://www.globenewswire.com/news-release/2024/06/02/2891851/0/en/ALX-Oncology-Presents-First-Evorpacept-Combination-Data-with-an-Antibody-Drug-Conjugate-from-Phase-1-ASPEN-07-Clinical-Trial-in-Patients-with-Advanced-Bladder-Cancer.html
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临床结果基因疗法免疫疗法临床2期
2024-06-04
Overall response rate (ORR) of 46% and 12-month overall survival (OS) of 96% in first line (1L) recurrent/metastatic (R/M) HPV+ head and neck squamous cell carcinoma (HNSCC) treated with CUE-101 and KEYTRUDA® (pembrolizumab)
Median overall survival (mOS) of 20.8 months in second line (2L) and beyond HPV+ HNSCC patients treated with CUE-101 monotherapy compared with historical mOS of 7.5 and 8.4 months for third-party checkpoint inhibitor trials in 2L R/M HNSCC: CheckMate 141 and KEYNOTE-040
CUE-101 data will be presented in an oral presentation at ASCO today
BOSTON, June 04, 2024 (GLOBE NEWSWIRE) --Cue Biopharma Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells, today announced updated data from its ongoing Phase 1 trial evaluating its lead oncology asset from the CUE-100 series of biologics, CUE-101. The data will be presented in an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting today June 4, 2024, in Chicago, IL.
Oral Presentation Details:
Abstract Number: 6004
Session Type and Title: Oral Abstract Session; Head and Neck Cancer
Session Date and Time: June 4, 2024, 9:45 AM-12:45 PM CDT
Title: A phase 1 dose-escalation and expansion study of CUE-101, given as monotherapy and in combination with pembrolizumab in patients with recurrent/metastatic HPV16+ head and neck squamous cell cancer (R/M HNSCC).
Presenter: Douglas R. Adkins, M.D., Professor of Medicine, Washington University School of Medicine
In addition, on Saturday, June 1, 2024, the Company presented a poster on its second clinical asset from the CUE-100 series, CUE-102, in which data-to-date has demonstrated expansion of Wilms’ Tumor 1 (WT1)-specific T cells, anti-tumor activity and favorable tolerability.
“The objective response rate observed with CUE-101 and pembrolizumab is very encouraging. The combination was well-tolerated, and responses appeared to be durable,” said Douglas R. Adkins, M.D., Professor, Division of Oncology at the Washington University School of Medicine in St. Louis, and a principal investigator participating in the CUE-101 clinical trial. “These results appear to support the continued development of CUE-101 with the potential of CUE-101 providing an improved treatment alternative for this patient population.”
Key data highlights to date from the expansion portion of the trial evaluating CUE-101 at the recommended Phase 2 dose (RP2D) of 4mg/kg in combination with pembrolizumab with 24 evaluable 1L patients (data cutoff of May 1, 2024):
ORR of 46% and Disease Control Rate (DCR) of 79% in patients with combined positive score (CPS) ≥1, compared to an ORR of 19% observed with pembrolizumab alone in the historical third-party KEYNOTE-048 trial. This includes one complete response (CR) and 10 partial responses (PR), in addition to eight durable stable diseases (DSD) of >12 weeks.
12-month overall survival (OS) of 96%.
Median progression free survival (PFS) of 5.8 months compared to 3.2 months with pembrolizumab alone in the third-party KEYNOTE-048 trial.
Key data highlights from the CUE-101 expansion portion of the Phase 1b trial evaluating CUE-101 at the RP2D as monotherapy with 20 evaluable 2L+ patients (majority 3L+):
mOS of 20.8 months, notably longer than the historical mOS of 7.5 and 8.4 months reported in third-party 2L R/M HNSCC trials: CheckMate 141 and KEYNOTE-040, respectively.
No unanticipated, significant safety concerns have emerged in either the combination or monotherapy trials, and adverse events have been readily managed with appropriate medical care.
Matteo Levisetti, M.D., chief medical officer of Cue Biopharma added, "We are pleased with the clinical activity observed in patients treated with CUE-101 in combination with pembrolizumab. We believe that the data provide a strong foundation for further development, supporting our goal of bringing a new treatment option to this patient population.”
Key data highlights to date from the fully enrolled CUE-102 dose escalation part of the Phase 1 clinical trial (data cutoff of May 1, 2024) include:
DCR of 43.5%
Two patients at the 2mg/kg dose, one with gastric cancer and one with ovarian cancer have demonstrated reductions in tumor burden.
Selective expansion of WT1-specific T cells in multiple patients.
No dose-limiting toxicities or drug-related serious adverse events have been reported to date in patients treated during the dose escalation phase at doses ranging between 1-8mg/kg of CUE-102.
Expansion at CUE-102 4mg/kg is ongoing.
The CUE-101 oral presentation and CUE-102 poster presentation will be available in the Investors & Media section of the Company’s website at under Scientific Publications and Presentations, following ASCO.
About the CUE-100 Series
The CUE-100 series consists of Fc-fusion biologics that present two signals to T cells. Signal #1 is a tumor-specific peptide linked to a major histocompatibility complex (pMHC) to enable selectivity and specificity. Signal #2 is a rationally engineered interleukin 2 (IL-2) molecule to trigger T cell activation. These singular biologics are anticipated to selectively target, activate and expand a robust repertoire of tumor-specific T cells directly in the patient’s body. The binding affinity of IL-2 for its receptor has been deliberately attenuated to achieve preferential selective activation of tumor-specific effector T cells while reducing the potential for effects on regulatory T cells (Tregs) or broad systemic activation, potentially mitigating the dose-limiting toxicities associated with current IL-2-based therapies.
About CUE-101 and the Phase 1 trial
CUE-101 is Cue Biopharma’s lead clinical drug candidate from the CUE-100 series of interleukin 2 (IL-2)-based biologics. It is designed to activate and expand HPV16 tumor-specific T cells by presenting the HPV E7 protein to the HPV-specific T cell receptor. CUE-101 is currently being evaluated in a fully enrolled Phase 1 open-label, dose escalation and expansion study, for the treatment of HPV16+ driven recurrent/metastatic head and neck squamous cell carcinoma in second line (2L) and beyond patients as a monotherapy, and as a first line (1L) therapy in combination with pembrolizumab (KEYTRUDA®).
About CUE-102 and the Phase 1 trial
CUE-102 is Cue Biopharma’s second lead clinical drug candidate from the CUE-100 series of interleukin 2 (IL-2)-based biologics. It is designed to activate and expand Wilms’ Tumor 1 (WT1)-specific T cells by presenting the WT1 peptide to the WT1- specific T cell receptor. WT1 is a well-recognized onco-fetal protein known to be over-expressed in a number of cancers, including solid tumors and hematologic malignancies. CUE-102 is being evaluated in a Phase 1 open label, two-part dose escalation and expansion study, for patients with late-stage colorectal, gastric/gastroesophageal junction, pancreatic and ovarian cancers that express WT1.
About Cue Biopharma
Cue Biopharma, a clinical-stage biopharmaceutical company, is developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient’s body. The company’s proprietary platform, Immuno-STAT™ (Selective Targeting and Alteration of T cells) and biologics are designed to harness the curative potential of the body’s intrinsic immune system through the selective modulation of disease-specific T cells without the adverse effects of broad systemic immune modulation.
Headquartered in Boston, Massachusetts, we are led by an experienced management team and independent Board of Directors with deep expertise in immunology and immuno-oncology as well as the design and clinical development of protein biologics.
For more information please visit and follow us on X and LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, those regarding: the company’s belief that the Immuno-STAT platform stimulates targeted immune modulation through the selective engagement of disease-relevant T cells and the applicability of the company’s platform across many cancers and autoimmune diseases; the company’s business strategies, plans and prospects, including potential clinical paths for CUE-101; and the Company’s expectations regarding the potential benefits of, and prospects for, its drug candidates, including CUE-101 and CUE-102. Forward-looking statements, which are based on certain assumptions and describe the company’s future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “would,” “could,” “seek,” “intend,” “plan,” “goal,” “project,” “estimate,” “anticipate,” “strategy,” “future,” “likely” or other comparable terms, although not all forward-looking statements contain these identifying words. All statements other than statements of historical facts included in this press release regarding the company’s strategies, prospects, financial condition, operations, costs, plans and objectives are forward-looking statements. Important factors that could cause the company’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the company’s limited operating history, limited cash and a history of losses; the company’s ability to achieve profitability; potential setbacks in the company’s research and development efforts including negative or inconclusive results from its preclinical studies or clinical trials or the company’s ability to replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates; serious and unexpected drug-related side effects or other safety issues experienced by participants in clinical trials; its ability to secure required U.S. Food and Drug Administration (“FDA”) or other governmental approvals for its product candidates and the breadth of any approved indication; adverse effects caused by public health pandemics, including possible effects on the company’s operations and clinical trials; delays and changes in regulatory requirements, policy and guidelines including potential delays in submitting required regulatory applications to the FDA; the company’s reliance on licensors, collaborators, contract research organizations, suppliers and other business partners; the company’s ability to obtain adequate financing to fund its business operations in the future and ability to continue as a going concern; the company’s ability to maintain and enforce necessary patent and other intellectual property protection; competitive factors; general economic and market conditions and the other risks and uncertainties described in the Risk Factors and Management's Discussion and Analysis of Financial Condition and Results of Operations sections of the company’s most recently filed Annual Report on Form 10-K and any subsequently filed Quarterly Report(s) on Form 10-Q. Any forward-looking statement made by the company in this press release is based only on information currently available to the company and speaks only as of the date on which it is made. The company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Investor Contact
Marie Campinell
Senior Director, Corporate Communications
Cue Biopharma, Inc.
mcampinell@cuebio.com
Media Contact
Jonathan Pappas
LifeSci Communications
jpappas@lifescicomms.com
临床1期临床结果ASCO会议免疫疗法临床2期
2024-05-09
BOSTON, May 09, 2024 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells, today provided a business and financial update for the first quarter 2024. Recent Business Highlights CUE-101 abstract accepted for an oral presentation and poster presentation at the upcoming 2024 American Society of Clinical Oncology (ASCO) Annual Meeting scheduled for May 31-June 4, 2024.CUE-102 abstract accepted for a poster presentation at the upcoming 2024 American Society of Clinical Oncology (ASCO) Annual Meeting scheduled for May 31-June 4, 2024.Advanced preclinical CUE-401 program, in collaboration with Ono Pharmaceutical, with potential for broad application across multiple autoimmune and inflammatory diseases.Expanded pipeline to include the preclinical CUE-500 series for the treatment of autoimmune and inflammatory diseases via T cell-mediated B cell depletion.Immuno-STAT™ platform posters for oncology and autoimmune diseases accepted for presentation at PEGS Boston Summit 2024 to be held May 13-14. “We have made significant progress during the first quarter on several fronts, including further advancement of our CUE-101 clinical trial and a meeting with the FDA to define a registrational path forward for the program, as well as continued advancement of the Phase 1 clinical trial for CUE-102,” said Daniel Passeri, chief executive officer of Cue Biopharma. “Additionally, important progress has been made advancing our autoimmune program CUE-401, in collaboration with Ono Pharmaceutical, and expanding our autoimmune pipeline with the bispecific Immuno-STAT CUE-500 series designed to redirect virus-specific T cells to deplete B cells in autoimmune and inflammatory diseases. We believe our strategy of demonstrating the transformative breakthrough potential of our platform to address a broad spectrum of indications from cancer and autoimmune disease positions us well to potentially deliver value creation for our shareholders.” First Quarter 2024 Financial Results The Company reported collaboration revenue of $1.7 million and $0.2 million for the three months ended March 31, 2024 and 2023, respectively. The increase was due to revenue earned from our Collaboration and Option Agreement with Ono Pharmaceutical, which was executed in February 2023. Research and development expenses were $10.2 million and $9.4 million for the three months ended March 31, 2024 and 2023, respectively. The increase was primarily due to an increase in clinical trial expenses. General and administrative expenses were $4.2 million for both the three months ended March 31, 2024 and 2023. As of March 31, 2024, the Company had $41.0 million in cash and cash equivalents. We expect our current cash and cash equivalents to fund operations into the first quarter of 2025. Cue Biopharma, Inc.Condensed Consolidated Statements of Operations and Comprehensive Loss(Unaudited, In thousands, except share and per share amounts)
Three Months EndedMarch 31, 2024 2023Collaboration revenue$1,717 $187 Operating expenses: General and administrative 4,186 4,176 Research and development 10,199 9,391 Total operating expenses 14,385 13,567 Loss from operations (12,668) (13,380)Other income (expense): Interest income 562 641 Interest expense (241) (370)Total other income (expense) 321 271 Net loss$(12,347)$(13,109)Unrealized gain from available-for-sale securities - 57 Comprehensive loss$(12,347)$(13,052)Net loss per common share – basic and diluted$(0.25)$(0.29)Weighted average common shares outstanding – basic and diluted 49,466,711 44,652,353
Cue Biopharma, Inc.Condensed Consolidated Balance Sheets(Unaudited, In thousands)
March 31, 2024 December 31, 2023 Assets
Cash and cash equivalents$41,029 $48,514 Other assets 12,922 13,016 Total assets$53,951 $61,530 Liabilities and stockholders’ equity
Liabilities$23,913 $24,445 Stockholders' equity 30,038 37,085 Total Liabilities and stockholders’ equity$53,951 $61,530
About Cue BiopharmaCue Biopharma, a clinical-stage biopharmaceutical company, is developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient’s body. The company’s proprietary platform, Immuno-STAT™ (Selective Targeting and Alteration of T cells) and biologics are designed to harness the curative potential of the body’s intrinsic immune system through the selective modulation of disease-specific T cells without the adverse effects of broad systemic immune modulation. Headquartered in Boston, Massachusetts, we are led by an experienced management team and independent Board of Directors with deep expertise in immunology and immuno-oncology as well as the design and clinical development of protein biologics. For more information please visit www.cuebiopharma.com and follow us on X and LinkedIn. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, those regarding: the company’s belief that the Immuno-STAT platform stimulates targeted immune modulation through the selective engagement of disease-relevant T cells and the applicability of the company’s platform across many cancers and autoimmune diseases; the company’s business strategies, plans and prospects, including potential clinical paths for CUE-101; the company’s collaboration with Ono Pharmaceutical; the company’s beliefs regarding its competitive positioning to deliver value creation for shareholders; and the cash runway of the company and the sufficiency of the company’s cash and cash equivalents to fund its operations. Forward-looking statements, which are based on certain assumptions and describe the company’s future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “would,” “could,” “seek,” “intend,” “plan,” “goal,” “project,” “estimate,” “anticipate,” “strategy,” “future,” “likely” or other comparable terms, although not all forward-looking statements contain these identifying words. All statements other than statements of historical facts included in this press release regarding the company’s strategies, prospects, financial condition, operations, costs, plans and objectives are forward-looking statements. Important factors that could cause the company’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the company’s limited operating history, limited cash and a history of losses; the company’s ability to achieve profitability; potential setbacks in the company’s research and development efforts including negative or inconclusive results from its preclinical studies or clinical trials or the company’s ability to replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates; serious and unexpected drug-related side effects or other safety issues experienced by participants in clinical trials; its ability to secure required U.S. Food and Drug Administration (“FDA”) or other governmental approvals for its product candidates and the breadth of any approved indication; adverse effects caused by public health pandemics, including possible effects on the company’s operations and clinical trials; delays and changes in regulatory requirements, policy and guidelines including potential delays in submitting required regulatory applications to the FDA; the company’s reliance on licensors, collaborators, contract research organizations, suppliers and other business partners; the company’s ability to obtain adequate financing to fund its business operations in the future and ability to continue as a going concern; the company’s ability to maintain and enforce necessary patent and other intellectual property protection; competitive factors; general economic and market conditions and the other risks and uncertainties described in the Risk Factors and Management's Discussion and Analysis of Financial Condition and Results of Operations sections of the company’s most recently filed Annual Report on Form 10-K and any subsequently filed Quarterly Report(s) on Form 10-Q. Any forward-looking statement made by the company in this press release is based only on information currently available to the company and speaks only as of the date on which it is made. The company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Investor Contact Marie Campinell Senior Director, Corporate CommunicationsCue Biopharma, Inc.mcampinell@cuebio.com Media ContactJonathan PappasLifeSci Communicationsjpappas@lifescicomms.com
财报临床1期免疫疗法ASCO会议
100 项与 CUE-101 相关的药物交易
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| HPV阳性的口咽鳞状细胞癌 | 临床2期 | 美国 | 2021-12-06 | |
| 复发性头颈部鳞状细胞癌 | 临床1期 | 美国 | 2019-07-30 | |
| 转移性头颈部鳞状细胞癌 | 临床1期 | 美国 | 2019-07-30 |
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| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
临床1期 | 80 | 艱觸壓齋膚廠觸鬱鏇鬱(廠築廠築廠簾構製壓鹹) = 6.3% 糧襯顧壓繭鬱壓鬱蓋選 (觸蓋膚鹽艱夢繭範觸積 ) 更多 | 积极 | 2024-05-24 | |||
临床1期 | 76 | (second line (2L) and beyond) | 夢繭遞願網夢壓膚遞衊(衊網鹽積鏇廠餘範夢製) = 獵蓋願積鹹構築鬱艱築 醖襯鏇壓構壓糧醖簾齋 (繭鏇壓夢蓋襯網醖遞壓 ) 更多 | 积极 | 2024-02-29 | ||
(first line) | 夢繭遞願網夢壓膚遞衊(衊網鹽積鏇廠餘範夢製) = 衊鬱夢鹹鏇顧壓願窪鏇 醖襯鏇壓構壓糧醖簾齋 (繭鏇壓夢蓋襯網醖遞壓 ) 更多 | ||||||
临床1期 | 67 | 廠繭廠構餘窪衊網鏇構(窪廠積衊築築醖築網築) = Frequent adverse events include fatigue (45%), anemia (34%), chills (27%), infusion related reactions (25%), constipation (22%), lymphopenia (22%) and nausea (22%). 觸鹹獵願網顧鹽窪淵窪 (鑰艱鬱鏇鬱繭淵襯襯築 ) 更多 | 积极 | 2023-05-26 | |||
临床1期 | 53 | 鏇觸壓鑰餘鹽鹹憲選鏇(構壓鏇襯鏇夢夢糧遞觸) = 鹹範餘廠遞鑰鑰築醖憲 鹹齋網顧鹹衊顧壓顧遞 (衊淵繭醖簾夢積積顧鬱 ) 更多 | 积极 | 2022-06-02 | |||
鏇觸壓鑰餘鹽鹹憲選鏇(構壓鏇襯鏇夢夢糧遞觸) = 構糧醖遞遞廠鏇範鬱鹹 鹹齋網顧鹹衊顧壓顧遞 (衊淵繭醖簾夢積積顧鬱 ) 更多 |
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