RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill cancer cells. Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop cancer cells from growing. Giving vaccine therapy together with GM-CSF may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects of vaccine therapy and GM-CSF in treating patients with acute myeloid leukemia, myelodysplastic syndromes, non-small cell lung cancer, or mesothelioma.

开始日期2006-10-01

申办/合作机构

Memorial Sloan Kettering Cancer Center

[+2]

100 项与 WT-1 analog peptide vaccine(NCI) 相关的临床结果

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100 项与 WT-1 analog peptide vaccine(NCI) 相关的转化医学

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100 项与 WT-1 analog peptide vaccine(NCI) 相关的专利（医药）

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项与 WT-1 analog peptide vaccine(NCI) 相关的文献（医药）

2020-06-01·Pediatrics international : official journal of the Japan Pediatric Society

¹³¹I‐MIBG therapy with WT‐1 peptide for refractory neuroblastoma

Article

作者: Seigo, Kinuya ; Iguchi, Akihiro ; Hosoya, Yosuke ; Manabe, Atsushi ; Sugiyama, Minako

This article describes about the ¹³¹I-MIBG therapy with WT-1 peptide for refractory neuroblastoma.After a chemotherapy course of vincristine, irinotecan, and cyclophosphamide and two chemotherapy courses of etoposide, cyclophosphamide, and topotecan, peripheral blood stem cell harvest (PBSCH) was performed.Subsequently, chemotherapy courses were administered after resecting the right adrenal tumor.

2010-10-01·Cancer immunology, immunotherapy : CII2区 · 医学

WT1 peptide vaccinations induce CD4 and CD8 T cell immune responses in patients with mesothelioma and non-small cell lung cancer

2区 · 医学

Article

作者: Andrew B. Brown ; Lee M. Krug ; Hao Li ; Tatyana Korontsvit ; Peter Maslak ; Victoria Zakhaleva ; Sara Bekele ; David A. Scheinberg ; Tao Dao ; William Travis ; Leslie Tyson ; Jianda Yuan ; Jedd Wolchok

BACKGROUND:

The transcription factor, WT1, is highly overexpressed in malignant pleural mesothelioma (MPM) and immunohistochemical stains for WT1 are used routinely to aid in its diagnosis. Using computer prediction analysis we designed analog peptides derived from WT1 sequences by substituting amino acids at key HLA-A0201 binding positions. We tested the safety and immunogenicity of a WT1 vaccine comprised of four class I and class II peptides in patients with thoracic neoplasms expressing WT1.

METHODS:

Therapy consisted of six subcutaneous vaccinations administered with Montanide adjuvant on weeks 0, 4, 6, 8, 10, and 12, with 6 additional monthly injections for responding patients. Injection sites were pre-stimulated with GM-CSF (70 mcg). Immune responses were evaluated by DTH, CD4 T-cell proliferation, CD8 T-cell interferon gamma release, intracellular cytokine staining, WT1 peptide MHC-tetramer staining, and cytotoxicity against WT1 positive tumor cells.

RESULTS:

Nine patients with MPM and 3 with NSCLC were vaccinated, with 8 patients receiving at least 6 vaccinations; in total, 10 patients were evaluable for immune response. Six out of nine patients tested demonstrated CD4 T-cell proliferation to WT1 specific peptides, and five of the six HLA-A0201 patients tested mounted a CD8 T-cell response. Stimulated T cells were capable of cytotoxicity against WT-1 positive cells. Vaccination also induced polyfunctional CD8 T cell responses.

CONCLUSIONS:

This multivalent WT1 peptide analog vaccine induces immune responses in a high proportion of patients with thoracic malignancies with minimal toxicity. A randomized trial testing this vaccine as adjuvant therapy in MPM is planned.

项与 WT-1 analog peptide vaccine(NCI) 相关的新闻（医药）

2022-08-10

·药明康德

过去一周，这16款创新疗法获得新临床进展

▎药明康德内容团队编辑近期，又有多种创新药物取得了早期进展，其中包括噬菌体疗法、溶瘤病毒疗法、六抗原靶向T细胞疗法等多种新颖的疗法类型，值得关注。在今天这篇文章里，药明康德内容团队将结合公开资料，与读者分享过去一周中部分创新疗法的早期临床进展。MT-601：通过IND申请开发机构：Marker Therapeutics疗法类型：六抗原靶向T细胞疗法适应症：复发/难治性非霍奇金淋巴瘤Marker Therapeutics是一家致力于开发用于治疗血液系统恶性肿瘤和实体肿瘤的下一代基于T细胞的免疫疗法的临床阶段的免疫肿瘤公司。MT-601是该公司开发的一种针对六种抗原的多肿瘤相关抗原（multiTAA）特异性T细胞产品，用于治疗复发/难治性非霍奇金患者。这些患者受抗CD19 CAR-T细胞治疗后疾病进展，或是不适合这种疗法。Marker Therapeutics的细胞治疗技术基于非工程化的肿瘤特异性T细胞的选择性扩增，这些T细胞能够识别肿瘤相关抗原，并杀死表达这些靶标的肿瘤细胞。这种T细胞组合在输注到患者体内后可以攻击多个肿瘤靶点，并激活患者的免疫系统以产生广谱抗肿瘤活性。Marker Therapeutics表示，由于这些T细胞没有进行基因工程改造，因此制造起来更容易、成本更低，毒性也更低。这项新的临床试验将建立在此前的五抗原靶向T细胞疗法的1/2期研究（TACTAL）中观察到的结果之上。在TACTAL研究中，multiTAA特异性T细胞产品具有出色的反应持久性，同时没有出现其他过继性细胞疗法中时常会发生的严重毒性（例如细胞因子释放综合征或神经毒性）。基于这些结果，FDA在IND中批准将WT-1作为第六种肿瘤相关抗原添加到MT-601中。ALRN-6924：修改1b期临床试验策略开发机构：Aileron Therapeutics疗法类型：MDM2/MDMX双重抑制剂适应症：p53突变乳腺癌Aileron Therapeutics致力于使化疗更安全，从而更有效地挽救更多患者的生命。ALRN-6924是Aileron Therapeutics开发的MDM2/MDMX双重抑制剂，旨在通过激活p53，进而上调p21（一种已知的细胞复制周期抑制剂）来治疗p53突变癌症患者。此次对方案的改进旨在加强ALRN-6924对p53突变乳腺癌患者免受化疗引起的严重中性粒细胞减少、脱发和潜在其他毒性的保护作用的证据。AGEN1571：完成首例患者给药开发机构：Agenus疗法类型：抗ILT2抗体适应症：晚期实体瘤Agenus是一家专注于发现和开发利用人体免疫系统对抗癌症和感染的疗法的临床阶段免疫肿瘤公司。AGEN1571是Agenus开发的一种旨在调节肿瘤相关巨噬细胞、T细胞、NK细胞和NKT细胞的新型抗ILT2抗体。ILT2是抗肿瘤免疫反应的主要抑制因子，也是导致患者对PD-1靶向疗法产生耐药性的原因之一。在临床前实验中，AGEN1571能够将巨噬细胞分化为促炎表型，并增强激活肿瘤微环境中的CD8阳性T细胞、NK和NKT细胞，以克服肿瘤对免疫检查点阻滞的耐药性。在这项1期临床试验中，受试者将接受AGEN1571作为单一药物或与botensilimab（Fc增强型抗CTLA-4抗体）和/或balstilimab（抗PD-1抗体）联合治疗。UCART20x22：通过IND申请开发机构：Cellectis疗法类型：同种异体双靶点CAR-T疗法适应症：B细胞恶性肿瘤Cellectis是一家利用基因编辑平台开发细胞和基因疗法的临床阶段的生物技术公司。UCART20x22是Cellectis开发的第一个同时靶向CD20和CD22的同种异体双靶点CAR-T疗法，用于复发或难治性非霍奇金淋巴瘤（r/r NHL）患者。CD20和CD22是经过验证的B细胞恶性肿瘤靶标，有潜力增强对肿瘤细胞的杀伤力并增加抗原靶向的广度。UCART20x22还使用TALEN基因编辑技术干扰TRAC基因（已被证明可降低移植物抗宿主病风险）和CD52基因（能够允许在患者的预处理方案中使用CD52定向单克隆抗体，并增强CAR-T细胞的植入、扩展和持久性）表达。该1/2a期临床试验（NatHaLi-01）将在今年下半年开始招募患者。AP-SA02：通过IND申请开发机构：Armata Pharmaceuticals疗法类型：噬菌体适应症：假体关节感染（PJI）Armata Pharmaceuticals是一家专注于开发抗生素病原体特异性噬菌体疗法来治疗耐药和难以治疗的细菌感染的生物技术公司。AP-SA02是该公司开发的一种靶向金黄色葡萄球菌的天然裂解噬菌体，具有强大的治疗特性，能对约95%的金黄色葡萄球菌临床分离株（包括耐甲氧西林和耐万古霉素的菌株）产生强大的抗菌活性，可与标准抗生素治疗产生协同作用，性质稳定。该1b/2a期试验将探索AP-SA02作为假体关节感染受试者标准抗生素治疗的辅助手段在静脉内和关节内剂量的安全性、耐受性和药代动力学。IMC-F106C：1期临床数据即将公布开发机构：Immunocore疗法类型：T细胞受体（TCR）双特异性免疫疗法适应症：实体肿瘤Immunocore是一家商业阶段的生物技术公司，其开发的新型TCR双特异性免疫疗法IMC-F106C将在今年ESMO大会上公布其在多个实体肿瘤中的1期临床数据。IMC-F106C是一种抗癌免疫动员单克隆TCR（ImmTAC）分子，被设计用于以超高亲和力识别细胞内的癌抗原，并通过与CD3受体结合，激活效应T细胞选择性地杀死这些癌细胞。根据Immunocore的新闻稿，ImmTAC的作用机制具有治疗血液肿瘤和实体肿瘤的潜力，包括免疫“冷”肿瘤及低突变率的肿瘤。BI-1607：完成首例患者给药开发机构：BioInvent International疗法类型：抗FcyRIIB抗体适应症：HER2阳性实体瘤BioInvent International是一家专注于发现和开发用于癌症免疫治疗的新型免疫调节抗体的生物技术公司。BI-1607是该公司开发的第二款抗FcγRIIB（一种抑制性Fc受体，是抗肿瘤免疫中的T细胞检查点）抗体，旨在提高现有癌症治疗（如曲妥珠单抗）的疗效并克服肿瘤的耐药性。近日，BI-1607联合曲妥珠单抗治疗HER2+实体瘤的1/2a期试验完成了首例患者给药。HER2是大约20%的乳腺癌（全球女性中最常见的癌症）以及胃和胃食管结合部腺癌中肿瘤形成和生长的驱动因素。临床前数据表明，使用BI-1607治疗可增强当前抗HER2方案（如曲妥珠单抗）的疗效。KB407：通过IND申请开发机构：Krystal Biotech疗法类型：基因治疗适应症：囊性纤维化（CF）Krystal Biotech是一家专注于开发可重复给药基因疗法的公司，其开发的KB407是一种吸入性、可重复给药的基因治疗产品，通过一种修饰的HSV-1载体携带囊性纤维化跨膜电导调节器（CFTR）基因的两种拷贝到肺呼吸细胞。通过诱导肺中全长正常CFTR蛋白的表达，KB407治疗有可能恢复肺细胞的离子和水的出入平衡，以纠正患者的肺部表现，且无论其潜在的基因突变如何。临床前研究显示，KB407能够在体外2D和3D类器官系统及啮齿类动物模型中成功应用。NVG-291：介绍1/2期研究设计开发机构：NervGen Pharma疗法类型：模拟肽适应症：阿尔茨海默病NervGen Pharma是一家致力于开发“first-in-class”神经修复药物以治疗神经系统损伤的临床阶段的生物技术公司。NVG-291是该公司开发的一种模拟受体蛋白酪氨酸磷酸酶σ（PTPσ）的细胞内结构域的治疗性多肽。PTPσ是一种可以与硫酸软骨素蛋白聚糖（CSPG）相互作用的细胞表面受体，这两者均已被证明可抑制神经系统损伤后的神经修复机制。NVG-291-R是NVG-291的啮齿动物形式，已被证明可通过增强可塑性、轴突再生和再髓鞘化在一系列动物模型中促进功能恢复和神经系统修复，包括脊髓损伤、周围神经损伤、多发性硬化和中风模型。NeuroNova：通过IND申请开发机构：Calidi Biotherapeutics疗法类型：溶瘤病毒适应症：复发性高级别胶质瘤Calidi Biotherapeutics是一家致力于开创基于同种异体细胞平台以彻底改变溶瘤病毒疗法的临床阶段的生物技术公司。NeuroNova（NSC-CRAd-S-pk7）是一种由装载了工程化溶瘤腺病毒的永生化神经干细胞（NSC）系组成的同种异体“现货型”疗法。在手术切除肿瘤后，将选择性递送溶瘤腺病毒的嗜肿瘤神经干细胞NeuroNova注射到切除腔的壁中可以导致病毒感染并摧毁剩余的肿瘤细胞。NeuroNova此前曾作为放射治疗和替莫唑胺治疗的辅助治疗开展过针对新诊断的神经胶质瘤患者的1 期剂量递增临床试验。结果显示，NeuroNova的耐受性良好，并显示出有希望的初步疗效。此次获批的临床试验旨在探索在复发性组织学证实的高级别胶质瘤（WHO III或IV级）成人患者中给予连续剂量NeuroNova的安全性和耐受性。CLBS201：完成1b期临试验最后一例患者给药开发机构：Caladrius Biosciences疗法类型：CD34+细胞疗法适应症：糖尿病肾病（DKD）Caladrius Biosciences是一家旨在开发治疗或逆转疾病疗法的临床阶段的生物医药公司。CLBS201是该公司开发的一种在研的用于肾内动脉给药的CD34+再生细胞治疗产品，用于治疗糖尿病肾病。Caladrius Biosciences于近日宣布完成了CLBS201的1b期临试验最后一例患者给药，预计将在2023年公布数据。人体中的所有组织都需要通过更换细胞来维持其功能，同时，还必须能够在受伤后生成新的血管。CD34+细胞是一种具有刺激新血管形成能力的干细胞，具有治疗由潜在缺血性损伤引起的包括糖尿病肾病在内的多种疾病的潜力。STP0404：1期临床数据公布开发机构：ST Pharm疗法类型：变构HIV-1整合酶抑制剂（ALLINI）适应症：艾滋病ST Pharm是一家致力于开发基于RNA的药物的创新公司。STP0404是该公司开发的新型强效HIV-1变构整合酶抑制剂，是一种通过阻断HIV再激活的新机制治疗艾滋病的候选疗法。ST Pharm在其新闻稿中表示，STP0404不仅对HIV野生型菌株具有抗病毒效果，对临床分离株和已产生耐药性的再激活病毒也表现出了优异的抗病毒活性。尽管利用ALLINI机制开发的针对HIV的疗法存在毒性问题，但在1期临床试验中，STP0404药物暴露随剂量增加的比例较小，并且尚未观察到严重的不良事件（AE）。基于此，ST Pharm将在今年启动STP0404的2a期研究。NX-13：1b期临床研究数据发布开发机构：Landos Biopharma疗法类型：NLRX1激动剂适应症：溃疡性结肠炎（UC）Landos Biopharma是一家专注于为自身免疫性疾病患者开发新型口服药物的临床阶段的生物制药公司。NX-13是该公司开发的一种新型口服小分子NLRX1激动剂，用于治疗溃疡性结肠炎（UC）。NLRX1是一种具有调节免疫反应能力的线粒体相关受体。NX-13可以通过激活NLRX1通路增加免疫细胞中的氧化磷酸化，减少效应CD4+ T细胞的分化，并减少胃肠道中炎性细胞因子的产生。NX-13的1b期临床试验结果显示，与安慰剂相比，NX-13用药四周后的耐受性良好。公司基于这些数据计划启动2期临床试验，以评估NX-13在UC患者中的安全性、有效性和最佳剂量。REGN5678：1/2期临床试验数据公布开发机构：Regeneron Pharmaceuticals疗法类型：PSMAxCD28共刺激性双特异性抗体适应症：转移性去势抵抗性前列腺癌（mCRPC）Regeneron Pharmaceuticals于近日宣布，其开发的PSMAxCD28共刺激性双特异性抗体REGN5678与PD-1抑制剂cemiplimab联用治疗前列腺癌的1/2期临床试验的初步数据令人鼓舞——当与标准剂量cemiplimab联合使用时，研究性REGN5678具有剂量依赖性的抗肿瘤活性，表明其具有克服mCRPC对PD-1抑制的耐药性的潜力。REGN5678是一种靶向CD28的共刺激双特异性抗体。基于对T细胞杀伤癌症能力的理解，Regeneron认为T细胞必须接受至少两种不同的刺激信号才能被完全激活以杀灭肿瘤细胞。该双抗一端与癌细胞表面的PSMA抗原结合，另一端与T细胞表面的CD28受体结合，通过选择性激活肿瘤部位T细胞的CD28通路，协同增强PD-1抑制剂和/或CD3双特异性分子的抗肿瘤活性。AVB-001：通过IND申请开发机构：Avenge Bio疗法类型：细胞疗法适应症：腹膜恶性肿瘤（卵巢癌）Avenge Bio是一家通过LOCOcyte免疫治疗平台开发用于治疗难治性实体瘤的转化细胞免疫治疗产品的生物技术公司。LOCOcyte平台可以利用递送到局部肿瘤环境的专有工程细胞，在肿瘤附近产生高浓度的免疫效应分子。这可以引起强大、局部和持久的全身性免疫反应，同时又避免了与全身性免疫疗法相关的毒性。基于该平台开发的AVB-001是一种把经工程设计可以分泌天然IL-2的细胞封装在可以激活免疫的藻蛋白酸盐胶囊中的疗法。该公司于近日宣布，FDA批准了AVB-001在腹膜恶性肿瘤中的IND申请。CRN04894：即将公布1期临床数据开发机构：Crinetics Pharmaceuticals疗法类型：促肾上腺皮质激素（ACTH）拮抗剂适应症：库欣病、先天性肾上腺皮质增生症（CAH）和其他ACTH过量的疾病Crinetics Pharmaceuticals是一家专注于发现、开发和商业化用于罕见内分泌疾病和内分泌相关肿瘤的新型疗法的临床阶段的医药公司。CRN04894是一种口服给药的非肽类小分子ACTH拮抗剂，用于治疗库欣病、先天性肾上腺皮质增生症（CAH）和其他ACTH过量的疾病。该公司宣布将于近期公布其1期临床试验结果，包括单剂量递增和多剂量爬坡研究的安全性、药代动力学和药效学。CAH是由基因突变引起的疾病，可导致皮质醇合成障碍。皮质醇的缺乏导致反馈机制的丧失，并引发持续高水平的ACTH，进而引起肾上腺皮质的过度刺激。由此引起的肾上腺增生和其他类固醇（尤其是雄激素）和类固醇前体的过度分泌，可导致性腺发育不良，严重者可因盐皮质激素失调危及生命。药明康德为全球生物医药行业提供一体化、端到端的新药研发和生产服务，服务范围涵盖化学药研发和生产、生物学研究、临床前测试和临床试验研发、细胞及基因疗法研发、测试和生产等领域。如您有相关业务需求，欢迎点击下方图片填写具体信息。▲如您有任何业务需求，请长按扫描上方二维码，或点击文末“阅读原文/Read more”，即可访问业务对接平台，填写业务需求信息参考资料：[1] Aileron Therapeutics Is Pleased to Outline Strategy to Strengthen Phase 1b Clinical Trial of ALRN-6924 in Patients with p53-Mutated Breast Cancer. Retrieved August 1, 2022, from https://investors.aileronrx.com/news-releases/news-release-details/aileron-therapeutics-pleased-outline-strategy-strengthen-phase[2] Study will evaluate safety and tolerability of AGEN1571 as a single agent and in combination with botensilimab and balstilimab. Retrieved August 1, 2022, from https://investor.agenusbio.com/news-releases/news-release-details/agenus-announces-first-patient-dosed-phase-1-study-agen1571-anti[3] Cellectis Receives IND clearance for UCART20x22, its First in-house Manufactured Product Candidate for the Treatment of B-cell Malignancies. Retrieved August 1, 2022, from https://cellectis.com/en/press/cellectis-receives-ind-clearance-for-ucart20x22-its-first-in-house-manufactured-product-candidate-for-the-treatment-of-b-cell-malignancies/[4] Armata Pharmaceuticals Announces Clearance of IND for Prosthetic Joint Infections. Retrieved August 1, 2022, from https://investor.armatapharma.com/2022-08-01-Armata-Pharmaceuticals-Announces-Clearance-of-IND-for-Prosthetic-Joint-Infections[5] Immunocore announces upcoming oral presentation of initial Phase 1 data of ImmTAC® candidate IMC-F106C targeting PRAME at European Society for Medical Oncology （ESMO） Congress 2022. Retrieved August 1, 2022, from https://ir.immunocore.com/news-releases/news-release-details/immunocore-announces-upcoming-oral-presentation-initial-phase-1[6] BioInvent enrolls first patient in Phase 1/2a trial of BI-1607 in HER2 positive solid tumors. Retrieved August 1, 2022, from https://bioinvent.com/media/press-releases/mfnsingle/?slug=bioinvent-enrolls-first-patient-in-phase-1-2a-trial-of-bi-1607-in-her2-positive-solid-tumors[7] Krystal Biotech Announces FDA Acceptance of KB407 IND Application for Cystic Fibrosis Clinical Trial. Retrieved August 1, 2022, from https://ir.krystalbio.com/news-releases/news-release-details/krystal-biotech-announces-fda-acceptance-kb407-ind-application[8] NervGen Presenting Study Design For Upcoming Phase 1b/2a In Alzheimer’s Disease At The 2022 Alzheimer’s Association International Conference. Retrieved August 2, 2022, from https://nervgen.com/nervgen-presenting-study-design-for-upcoming-phase-1b-2a-in-alzheimers-disease-at-the-2022-alzheimers-association-international-conference/[9] Calidi Biotherapeutics Announces FDA Authorization of IND for a Phase 1 Clinical Trial of NeuroNova in Patients with Recurrent High-Grade Glioma. Retrieved August 2, 2022, from https://calidibio.com/2022/08/02/calidi-biotherapeutics-announces-fda-authorization-of-ind-for-a-phase-1-clinical-trial-of-neuronova-in-patients-with-recurrent-high-grade-glioma/[10] Caladrius Biosciences Completes Enrollment in Phase 1b Study of CLBS201 for the Treatment of Diabetic Kidney Disease. Retrieved August 2, 2022, from https://ir.caladrius.com/news-releases/news-release-details/caladrius-biosciences-completes-enrollment-phase-1b-study[11] ST PHARM Present Phase 1 Clinical Trial Results of HIV Treatment Candidate at AIDS 2022. Retrieved August 4, 2022, from https://www.stpharm.co.kr/en/pr/all/st-pharm-present-phase-1-clinical-trial-results-of-hiv-treatment-candidate-at-aids-2022[12] LANDOS BIOPHARMA REPORTS POSITIVE TOP-LINE RESULTS FROM NX-13 PHASE 1B TRIAL. Retrieved August 3, 2022, from https://ir.landosbiopharma.com/news-releases/news-release-details/landos-biopharma-reports-positive-top-line-results-nx-13-phase[13] NOVEL COSTIMULATORY BISPECIFIC ANTIBODY SHOWS ENCOURAGING ANTI-TUMOR ACTIVITY WHEN COMBINED WITH PD-1 INHIBITOR LIBTAYO® （CEMIPLIMAB） IN ADVANCED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER （MCRPC）. Retrieved August 3, 2022, from https://investor.regeneron.com/news-releases/news-release-details/novel-costimulatory-bispecific-antibody-shows-encouraging-anti[14] Avenge Bio Announces FDA Clearance of the AVB-001 IND for the Treatment of Ovarian Cancer, a Novel Cellular Therapy Leveraging the LOCOcyteTM Immunotherapy Platform. Retrieved August 3, 2022, from https://avengebio.com/wp-content/uploads/2022/08/AvengeBio_IND-Clearance-PR_v3AUG_Final-1.pdf[15] MARKER THERAPEUTICS ANNOUNCES FDA CLEARANCE OF IND FOR MT-601, THE SIX-ANTIGEN TARGETED T CELL THERAPY FOR THE TREATMENT OF RELAPSED/REFRACTORY NON-HODGKIN LYMPHOMA. Retrieved August 4, 2022, from https://ir.markertherapeutics.com/news-releases/news-release-details/marker-therapeutics-announces-fda-clearance-ind-mt-601-six[16] ADDITIONAL ANALYSES OF CRN04894 PRECLINICAL AND PHASE 1 RESULTS TO BE PRESENTED AT THE 10TH INTERNATIONAL CONGRESS OF NEUROENDOCRINOLOGY. Retrieved August 3, 2022, from https://crinetics.com/crinetics-pharmaceuticals-presenting-crn04894-preclinical-and-phase-1-at-icn2022/免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

免疫疗法细胞疗法抗体基因疗法小分子药物

2022-08-04

·BioSpace

Marker Therapeutics Announces FDA Clearance of IND for MT-601, the six-antigen targeted T Cell Therapy for the treatment of relapsed/refractory Non-Hodgkin Lymphoma

HOUSTON, Aug. 04, 2022 (GLOBE NEWSWIRE) -- Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for MT-601, a multi-tumor-associated antigen (multiTAA)-specific T cell product targeting six antigens, for the treatment of patients with relapsed/refractory non-Hodgkin lymphoma who have failed or are ineligible to receive anti-CD19 CAR T cell treatment. “This new clinical trial will build upon results that were observed in the Phase I/II TACTAL study conducted by BCM, which assessed the safety and efficacy of five-antigen-directed multiTAA-specific T cell product,” stated Dr. Mythili Koneru, Marker’s Chief Medical Officer. “In the TACTAL study, BCM observed long-term CR rates that were comparable to recently approved CD19 CAR-T therapies, even at very low cell doses. Unlike CD19 CAR-T cell therapies, patients receiving multiTAA-specific T cell product had superior durability of response, without the severe toxicities that commonly occur with other adoptive cell therapies, such as cytokine release syndrome or neurotoxicity. Based on these results, we believe that multiTAA-specific T cell products can be easily administered in an outpatient setting without hospitalization.” In the TACTAL study, patients were treated with five-antigen-directed multiTAA-T cell product. Based upon the safety pro with multiTAA-specific T cell therapies containing WT-1 in multiple cancer indications, the FDA cleared in the IND the addition of WT-1 as the sixth tumor-associated antigen to the MT-601 product that will be used to treat patients in the Marker sponsored study. In addition, the FDA has cleared Marker to initiate its study at a dose level of 200 million cells per infusion, versus the dose range of 10-40 million cells per infusion used in the TACTAL study. This increase in the cell dose will be possible due to Marker’s development and adoption of a 9-day manufacturing process, which also accelerates the time to treatment. Dr. Koneru continued: “We believe that the most important finding of the TACTAL study was that the administration of multiTAA therapy consistently drove an enhanced immunological response from the patient’s own immune system, which we believe was due to the lack of lymphodepletion which allowed the patient’s own immune system to play a part. We believe that this phenomenon, known as epitope spreading, was critical in driving more durable responses than have been observed with other cell therapies like TCRs and CAR-Ts. It is notable that none of the patients who developed a CR in the TACTAL study relapsed during the follow up period, and several patients have been in CR for over five years at their last follow-up. This contrasts strongly with the experience of CD-19 CAR-Ts, where up to 40% of patients are expected to relapse within 12 months of developing a complete response.” Marker’s MT-601 Phase 1 trial will focus on r/r NHL patients who have failed CD19 CAR-T therapy, or those who are ineligible for treatment with those therapies. MT-601 targets a series of tumor antigens other than CD19, offering patients a therapeutic alternative even if their tumor has escaped by downregulating the expression of CD19. For patients who cannot access CD19 therapies, MT-601 has the potential to generate objective responses, with tolerability and potentially longer duration of response. “FDA clearance of our IND for MT-601 is a significant milestone as we advance our pipeline in a number of Company-sponsored trials,” said Peter L. Hoang, Marker’s President and Chief Executive Officer. “We believe that MT-601, which targets six tumor-associated antigens highly expressed in lymphoma, has the potential to build upon results of the TACTAL study. We look forward to initiating our Company-sponsored Phase 1 study next year.” About Marker Therapeutics, Inc. Marker Therapeutics, Inc. is a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications. Marker’s cell therapy technology is based on the selective expansion of non-engineered, tumor-specific T cells that recognize tumor associated antigens (i.e. tumor targets) and kill tumor cells expressing those targets. This population of T cells is designed to attack multiple tumor targets following infusion into patients and to activate the patient’s immune system to produce broad spectrum anti-tumor activity. Because Marker does not genetically engineer its T cell therapies, we believe that our product candidates will be easier and less expensive to manufacture, with reduced toxicities, compared to current engineered CAR-T and TCR-based approaches, and may provide patients with meaningful clinical benefit. As a result, Marker believes its portfolio of T cell therapies has a compelling product profile, as compared to current gene-modified CAR-T and TCR-based therapies. To receive future press releases via email, please visit: . Forward-Looking Statements This release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the Company’s expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are “forward-looking statements.” Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our research, development and regulatory activities and expectations relating to our non-engineered multi-tumor antigen specific T cell therapies, including MT-601; the effectiveness of these programs or the possible range of application and potential curative effects and safety in the treatment of diseases; and the timing, conduct and success of our clinical trials, including the Phase 1 trial of MT-601. Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could cause actual results to differ materially from those stated in such statements. Such risks, uncertainties and factors include, but are not limited to the risks set forth in the Company’s most recent Form 10-K, 10-Q and other SEC filings which are available through EDGAR at Such risks and uncertainties may be amplified by the COVID-19 pandemic and its impact on our business and the global economy. The Company assumes no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. Investors and Media Contacts Marker Therapeutics: Neda Safarzadeh Vice President/Head of Investor Relations, PR & Marketing (713) 400-6451 Investor.Relations@markertherapeutics.com Solebury Trout: Media Amy Bonanno Abonanno@soleburytrout.com

合作细胞疗法

100 项与 WT-1 analog peptide vaccine(NCI) 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
肾母细胞瘤	临床1期	美国	Innovive Pharmaceuticals, Inc.	2006-10-31
急性髓性白血病	临床1期	美国	National Cancer Institute	2006-10-01
急性髓性白血病	临床1期	美国	Innovive Pharmaceuticals, Inc.	2006-10-01
恶性间皮瘤	临床1期	美国	Innovive Pharmaceuticals, Inc.	2006-10-01
恶性间皮瘤	临床1期	美国	National Cancer Institute	2006-10-01
骨髓增生异常综合征	临床1期	美国	National Cancer Institute	2006-10-01
骨髓增生异常综合征	临床1期	美国	Innovive Pharmaceuticals, Inc.	2006-10-01
非小细胞肺癌	临床1期	美国	Innovive Pharmaceuticals, Inc.	2006-10-01
非小细胞肺癌	临床1期	美国	National Cancer Institute	2006-10-01
腹膜癌	临床1期	美国	Innovive Pharmaceuticals, Inc.	2006-10-01

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分期

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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


NCT00398138 (CTgov)	临床1期	急性髓性白血病 \| 恶性间皮瘤 \| 非小细胞肺癌 ... 更多	22	immunoenzyme technique+WT-1 analog peptide vaccine+sargramostim	鬱廠製鹹鬱製顧窪繭觸(艱網廠衊鬱夢選鬱襯糧) = 壓範醖鑰齋鏇願鑰遞選築鏇顧鏇鑰艱蓋鏇繭憲 (糧繭膚餘襯艱鏇壓網顧, 遞糧積遞鹽簾襯築膚觸 ~ 餘築積壓蓋膚鬱簾觸獵) 更多	-	2016-03-02