MC1963 Folate Receptor Alpha Dendritic Cells (FRαDCs) or Placebo for Patients With Advanced Stage Ovarian Cancer: A Phase II Double-Blind Randomized Clinical Trial (FAROUT)

This phase II trial compares the effect of folate receptor alpha dendritic cells (FRαDCs) to placebo in treating patients with stage III or IV ovarian, fallopian tube or primary peritoneal cancer. FRαDCs, a dendritic cell vaccine, is made from a person's white blood cells. The white blood cells are treated in the laboratory to make dendritic cells (a type of immune cell) mixed with folate receptor alpha (FRalpha), a protein found in high levels on ovarian tumor cells. FRαDCs work by boosting the immune system to recognize and destroy the tumor cells by targeting the FRalpha protein on the tumor cell. Placebo is an inactive substance that looks the same as, and is given the same way as, the active drug or treatment being tested. The effects of the active drug are compared to the effects of the placebo. Giving FRαDCs may work better in preventing or delaying recurrence compared to placebo in patients with stage III or IV ovarian, fallopian tube, or primary peritoneal cancer.

开始日期2024-11-12

申办/合作机构

Mayo Clinic

NCT02978222

/ Terminated临床2期

A Randomized Multicenter Phase II Trial to Evaluate the Safety, Efficacy and Immunogenicity of Vaccination With Folate Receptor Alpha Peptides With GM-CSF Versus GM-CSF Alone in Patients With Platinum Sensitive Ovarian Cancer and a Response or Stable Disease to Platinum Therapy

This is a double-blind, randomized, parallel groups Phase II trial. Patients with platinum-sensitive advanced ovarian cancer, defined as a lack of progression by RECIST v1.1 criteria following completion of standard-of-care chemotherapy, including a minimum of 4 cycles of a platinum-containing regimen. Patients will be randomized to either the vaccine regimen with GM-CSF adjuvant or GM-CSF adjuvant alone as a control group. Treatment will be administered as a consolidation therapy within one year of the last administration of platinum, targeting the first remission.

开始日期2017-07-20

申办/合作机构

Marker Therapeutics, Inc.

NCT02764333

/ Completed临床2期IIT

A Phase II Trial of TPIV200/huFR-1 (A Multi-Epitope Anti-Folate Receptor Vaccine) Plus Anti-PD-L1 MEDI4736 (Durvalumab) in Patients With Platinum Resistant Ovarian Cancer

This is a Phase 2 clinical trial, which tests two investigational drugs: TPIV200/huFR-1 (also called TPIV200), which is a vaccine consisting of proteins from the folate receptor alpha mixed with GM-CSF, and durvalumab (MEDI4736) , which is an antibody drug that help un-block parts of the immune system. The aim of this study is to find out whether these drugs, when given together are safe, and whether they are effective in treating cancer.

开始日期2016-05-06

申办/合作机构

Memorial Sloan Kettering Cancer Center

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100 项与 Folate receptor alpha vaccine(Mayo Clinic) 相关的临床结果

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100 项与 Folate receptor alpha vaccine(Mayo Clinic) 相关的转化医学

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100 项与 Folate receptor alpha vaccine(Mayo Clinic) 相关的专利（医药）

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项与 Folate receptor alpha vaccine(Mayo Clinic) 相关的文献（医药）

2026-01-06·CLINICAL CANCER RESEARCH

A Phase II Trial to Evaluate the Safety and Immunogenicity of Two Doses of a Folate Receptor Alpha Vaccine in Patients with Triple-Negative Breast Cancer

Article

作者: Graff, Stephanie L. ; Sparano, Joseph A. ; Cogen, Davitte ; Erskine, Courtney L. ; Hamilton, Erika P. ; Block, Matthew S. ; Norton, Nadine ; Tiersten, Amy ; Assad, Hadeel ; Knutson, Keith L. ; Wilson, Glynn ; McIntyre, Kristi J. ; Abu-Fares, Hala ; Han, Hyo S. ; Nassar, Aziza ; Garrett, Gerald ; Tkaczuk, Katherine H. ; Kenney, Richard T. ; Keating, Patricia ; Sharma, Priyanka ; Ward, Patrick J.

Abstract:

Purpose::

CD4 T-cell immunity is associated with improved survival in patients with breast cancer. We previously reported a phase I trial evaluating a folate receptor alpha (FRα) vaccine administered with cyclophosphamide (CP), demonstrating excellent safety and immunogenicity. To simplify the vaccine strategy for ease of use, we report here the results of a randomized phase II trial evaluating a lower vaccine dose alongside the original dose, administered with or without CP pretreatment.

Patients and Methods::

Patients with triple-negative breast cancer who completed all systemic and local therapies were assigned to receive either low-dose (825 μg) or high-dose (2.5 mg) vaccine peptides plus GM-CSF in six 4-week cycles, with or without CP prior to vaccination. Safety was monitored, and immunogenicity was evaluated before and after vaccination.

Results::

A total of 80 patients were dosed with vaccine, and 58 patients were evaluable for immunogenicity. Vaccination was well tolerated and elicited immunity in 83% of patients. Levels of FRα-specific T cells were high, persistent, and comparable with T-cell levels against tetanus toxoid. No differences in immunity were observed between the two doses. CP pretreatment also did not affect the immune responses. Recurrences occurred in eight evaluable patients and were unrelated to the treatment arm. No patients died during the study because of their disease.

Conclusions::

The reduced-dose FRα vaccine is as effective as the original dose and does not require CP to generate maximal immunity. These findings may inform the design of trials testing efficacy in triple-negative breast cancer or other cancers.

2024-10-01·GYNECOLOGIC ONCOLOGY

Vaccination with folate receptor-alpha peptides in patients with ovarian cancer following response to platinum-based therapy: A randomized, multicenter clinical trial

Article

作者: Potts, James ; Knutson, Keith L ; Kenney, Richard T ; Wenham, Robert M ; O'Cearbhaill, Roisin E ; Block, Matthew S ; Garrett, Gerald ; Hamilton, Erika ; Gupta, Aditi ; Konner, Jason A

OBJECTIVE:

Folate receptor alpha (FRα) is overexpressed on >90% of high-grade epithelial ovarian cancers (EOC). Targeting FRα with antibody-drug conjugates has proven utility in the platinum-resistant setting. It is also a potential therapeutic target for immuno-oncologic agents, such as peptide vaccines that work primarily via adaptive and humoral immunity. We tested the hypothesis that FRα peptide immunization could improve outcomes in patients with EOC following response to platinum-based therapy.

METHODS:

We conducted a randomized, double-blind, multicenter, phase II study to evaluate the safety and efficacy of TPIV200 (a multi-epitope FRα peptide vaccine admixed with GM-CSF) versus GM-CSF alone in 120 women who did not have disease progression after at least 4 cycles of first-line platinum-based therapy. Patients were vaccinated intradermally once every 4 weeks up to 6 times, followed by a boosting period of 6 vaccinations at 12-week intervals. Primary endpoints included safety, tolerability, and progression free survival (PFS).

RESULTS:

At study termination with a median follow-up of 15.2 months (range 1.2-28.4 months), 68 of 119 intention-to-treat patients had disease progression (55% in TPIV200 + GM-CSF arm and 59% in GM-CSF alone arm). The median PFS was 11.1 months (95% CI 8.3-16.6 months) with no significant difference between the treatment groups (10.9 months with TPIV200 + GM-CSF versus 11.1 months with GM-CSF, HR, 0.85; upper 90% CI 1.17]. No patient experienced a ≥ grade 3 drug-related adverse event.

CONCLUSION:

TPIV200 was well tolerated but was not associated with improved PFS. Additional studies are required to uncover potential synergies using multiepitope vaccines targeting FRα. Trial Registration NLM/NCBI Registry, NCT02978222, https://clinicaltrials.gov/search?term=NCT02978222.

2020-06-01·Journal for immunotherapy of cancer2区 · 医学

Safety, immunogenicity, and clinical efficacy of durvalumab in combination with folate receptor alpha vaccine TPIV200 in patients with advanced ovarian cancer: a phase II trial

2区 · 医学

ArticleOA

作者: Torrisi, Jean M ; Zamarin, Dmitriy ; Holland, Aliya ; Erskine, Courtney L ; O’Cearbhaill, Roisin E ; Aghajanian, Carol ; Li, Yanyun ; Mcdonnell, Autumn S ; Konner, Jason A ; Knutson, Keith L ; Hollmann, Travis J ; Grisham, Rachel N ; Chesebrough, Lewis F ; Gallagher, Jacqueline M ; Block, Mathew S ; Walderich, Sven ; Merghoub, Taha ; Iasonos, Alexia E ; Zhou, Qin

Background:

Immune checkpoint inhibitors (ICIs) to date have demonstrated limited activity in advanced ovarian cancer (OC). Folate receptor alpha (FRα) is overexpressed in the majority of OCs and presents an attractive target for a combination immunotherapy to potentially overcome resistance to ICI in OCs. The current study sought to examine clinical and immunologic responses to TPIV200, a multiepitope FRα vaccine administered with programmed death ligand 1 (PD-L1) inhibitor durvalumab in patients with advanced platinum-resistant OC.

Methods:

Following Simon two-stage phase II trial design, 27 patients were enrolled. Treatment was administered in 28-day cycles (intradermal TPIV200 and granulocyte-macrophage colony-stimulating factor (GM-CSF) for 6 cycles and intravenous durvalumab for 12 cycles). Primary endpoints included overall response rate and progression-free survival at 24 weeks. Translational parameters focused on tumor microenvironment, PD-L1 and FRα expression, and peripheral vaccine-specific immune responses.

Results:

Treatment was well tolerated, with related grade 3 toxicity rate of 18.5%. Increased T cell responses to the majority of peptides were observed in all patients at 6 weeks (p<0.0001). There was one unconfirmed partial response (3.7%) and nine patients had stable disease (33.3%). Clinical benefit was not associated with baseline FRα or PD-L1 expression. One patient with prolonged clinical benefit demonstrated loss of FRα expression and upregulation of PD-L1 in a progressing lesion. Despite the low overall response rate, the median overall survival was 21 months (13.5–∞), with evidence of benefit from postimmunotherapy regimens.

Conclusions:

Combination of TPIV200 and durvalumab was safe and elicited robust FRα-specific T cell responses in all patients. Unexpectedly durable survival in this heavily pretreated population highlights the need to investigate the impact of FRα vaccination on the OC biology post-treatment.

项与 Folate receptor alpha vaccine(Mayo Clinic) 相关的新闻（医药）

2026-03-02

·康圣真源

叶酸受体α（FRα）：实体瘤精准治疗的下一个“黄金靶点”

在精准医疗的时代浪潮中，医学界始终致力于寻找能够精准识别肿瘤细胞、同时最大限度保护正常组织的理想靶点。叶酸受体α（FRα）正是近年来在卵巢癌、肺癌、乳腺癌等实体瘤治疗领域备受瞩目的新兴靶点。近日，国家药品监督管理局（NMPA）正式批准全球首个靶向FRα的抗体药物偶联物——索米妥昔单抗注射液在中国上市，用于治疗既往接受过1-3线系统性治疗的FRα阳性铂类耐药卵巢癌患者。随着该药物落地临床，通过免疫组化方法检测FRα蛋白表达水平，已成为精准筛选获益人群、指导靶向治疗决策的关键步骤。 FRα靶点简介 FRα是一种由FOLR1基因编码的分子量约为38-40 kDa的细胞表面糖蛋白，通过糖基磷脂酰肌醇（GPI）锚定于细胞膜上。它最早于1991年被克隆鉴定为一种肿瘤相关抗原，其核心生理功能是作为高亲和力的叶酸结合蛋白，介导细胞对叶酸（维生素B9）的摄取。 FRα属于高亲和力叶酸受体家族成员之一，该家族还包括FRβ、FRγ和FRδ，分别由FOLR2、FOLR3和FOLR4基因编码。在功能上，FRα犹如一把精准的“分子钥匙”，负责协助细胞高效摄取叶酸——这是合成DNA与RNA所不可或缺的营养素。由于肿瘤细胞增殖异常活跃，其对叶酸的需求远高于正常组织，因而会大量表达FRα，形成其细胞膜上显著的“营养通道”。与此形成鲜明对比的是，绝大多数正常组织中FRα的表达水平极低。这种“肿瘤高表达、正常低表达”的分布特征，使FRα成为开发抗体药物偶联物等靶向治疗的理想靶点，为实现精准杀伤肿瘤细胞奠定了分子基础【1】【2】。 FRα实体瘤中的表达情况 FRα在正常组织中表达有限，却在多种上皮性恶性肿瘤中呈现显著高表达，这一特征使其成为理想的抗肿瘤治疗靶点。有研究显示，在卵巢癌中，76–89%的上皮性卵巢癌呈现高表达，且与高级别及晚期肿瘤密切相关；在非小细胞肺癌中，14–74%的病例显示FRα过表达；在乳腺癌中，三阴性乳腺癌的 FRα 表达率为35–68%，而正常乳腺组织几乎不表达【1】。一项针对6000余例泛癌样本的真实世界研究显示，整体FRα阳性率达43.5%，其中卵巢癌样本阳性率为39.6%。研究还发现，切除术样本的FRα阳性率较活检样本高74%，浆液性亚型的阳性率较非浆液性亚型高121%【3】。与正常组织（如正常卵巢组织表达率0-25%）相比，FRα在肿瘤组织中的特异性高表达为靶向治疗提供了理想窗口，使其能够精准杀伤肿瘤细胞的同时最大限度保护正常组织。在癌症和非恶性组织中FRα过表达情况 FRα药物研发进展靶向FOLR1的抗肿瘤药物研发已形成多元化格局，其中抗体药物偶联物（ADC）的临床进展最为显著。索米妥昔单抗（Elahere）作为全球首个靶向FRα的ADC药物，已在中国、美国及欧盟获批用于FRα阳性铂耐药复发性卵巢癌的治疗。关键III期MIRASOL研究显示，该药较化疗显著延长患者总生存期，死亡风险降低33%，且安全性更优，并于2025年11月在中国转为常规批准。此外，多款在研药物也取得积极进展：STRO-002（luveltamab tazevibulin）已进入II/III期临床，在铂耐药卵巢癌中客观缓解率超过30%；CBP-1008作为首款靶向FRα/TRPV6的双配体药物获FDA快速通道资格，目前处于II期研究阶段【4】。同时，针对FRα的双抗及CAR-T等创新疗法也处于不同临床研发阶段，为肿瘤治疗提供了新的可能性。靶向FOLR1的药物研发进展（来源：药研网） FRα检测在卵巢癌中指南和共识推荐精准检测是精准治疗的基础。针对FRα的检测，国内外权威指南与专家共识已形成明确推荐，使其成为卵巢癌精准诊疗路径中不可或缺的关键环节。《2025 NCCN卵巢癌指南》明确建议对所有复发性卵巢癌患者进行FRα检测，对于FRα表达≥75%的铂耐药复发卵巢癌患者，指南推荐索米妥昔单抗单药作为首选单药治疗方案【5】。 2025年10月，《卵巢癌中叶酸受体α免疫组织化学检测及临床应用专家共识》【6】在《中华病理学杂志》发布。共识指出：推荐意见1：基于国内外临床研究及索米妥昔单抗在国内的获批现状，推荐在既往接受过1～3线系统性治疗的铂耐药及铂敏感复发的卵巢癌、输卵管癌或原发性腹膜癌患者中开展FRα蛋白免疫组织化学检测，以协助临床根据检测结果选用适当的治疗方案（证据质量：高；推荐强度：强）。推荐意见2：基于国内外多项临床研究数据，建议对于卵巢、输卵管及腹膜的高级别浆液性癌进行FRα蛋白常规检测（证据质量：高；推荐强度：强）。对其他组织病理类型（如卵巢子宫内膜样癌、透明细胞癌、黏液性癌、低级别浆液性癌等）尚无确凿依据具有临床治疗价值，不推荐作为常规检测。有条件的单位，可进行探索性检测，以便积累相关数据（证据质量：中；推荐强度：强）。推荐意见3：卵巢癌一经病理确诊，即可进行FRα检测。若术后复发/转移，可获得组织样本（二次手术或穿刺）的情况下，推荐用复发/转移灶进行检测（证据质量：高；推荐强度：强）。 FRα在乳腺癌与肺癌中的应用叶酸受体α（FRα）在乳腺癌（尤其是三阴性亚型）及肺癌（非小细胞肺癌）中呈现显著高表达，使其成为继卵巢癌之后极具潜力的实体瘤治疗靶点。目前，针对FRα的靶向治疗正从卵巢癌向肺癌、乳腺癌领域快速拓展。除已上市用于卵巢癌的索米妥昔单抗（Elahere）外，多款在研FRα ADC药物正积极布局乳腺癌和肺癌适应症，部分已进入临床II期【7】【8】【9】。此外，针对FRα的疫苗（如TPIV200）在TNBC的II期临床中已证实可诱导强效持久的免疫应答，安全性良好【10】。 FRα是多种实体瘤的潜在治疗靶点。在乳腺癌（特别是三阴性乳腺癌，TNBC）和非小细胞肺癌（NSCLC）中，检测FRα表达水平是筛选患者使用FRα靶向ADC药物（如索米妥昔单抗、Luveltamab Tazevibulin等）的关键依据。通过检测，可将患者分为“高表达/阳性”与“低表达/阴性”，实现精准用药。总结叶酸受体α（FRα）作为经过临床验证的实体瘤治疗新靶点，其相关药物与检测方案的成熟，标志着精准医疗在卵巢癌等领域迈出了坚实一步。未来，随着研究向肺癌、乳腺癌等更广癌种拓展，有望为更多患者带来新的治疗希望。参考文献： [1]Scaranti M, Cojocaru E, Banerjee S, Banerji U. Exploiting the folate receptor α in oncology. Nat Rev Clin Oncol. 2020 Jun;17(6):349-359. [2]杨诗婷, 刘雪, 罗文新. 以叶酸受体α为靶点的抗体偶联药物在肿瘤治疗中的临床应用[J]. 中国生物化学与分子生物学报, 2025, 41(11): 1633-1644. [3]Krivak T C, Puentes R, Gannon T, et al. Real-world analysis of folate receptor alpha (FRα; FOLR1) expression in pan-tumor samples from over 6000 patients in the US[J]. 2025. [4]Lee J Y, Oaknin A, Lorusso D, et al. Efficacy and safety of luveltamab tazevibulin in patients with recurrent platinum-resistant ovarian cancer: results from the dose-optimization stage of the REFRαME-O1 (GOG-3086, ENGOT-79OV, and APGOT-OV9) phase 2/3 study[C]//2025 Society of Gynecologic Oncology Annual Meeting on Women’s Cancer. Seattle, WA, 2025: 922978. [5]NCCN临床实践指南：卵巢癌包括输卵管癌和原发性腹膜癌（2025.V3） [6]中华医学会病理学分会, 中国抗癌协会卵巢癌专业委员会, 国家病理质控中心. 卵巢癌中叶酸受体α免疫组织化学检测及临床应用专家共识（2025版）[J]. 中华病理学杂志, 2025, 54(11): 1136-1143. [7]Xie B, Chen C, Cai H, Wang L, Chen M, Liu J, Wu F, Huang W. Application and Progress of Antibody-Drug Conjugates (ADCs) in the Treatment of Metastatic Triple-Negative Breast Cancer. Oncol Ther. 2025 Sep 15. [8]Babbar R, Vanya, Bassi A, Arora R, Aggarwal A, Wal P, et al.Understanding the promising role of antibody drug conjugates in breast and ovarian cancer. Heliyon. 2023 Oct 30;9(11):e21425. [9]Yuan R, McGeehan A, Zhou S, et al. The anti-FRα antibody-drug conjugate luveltamab tazevibulin demonstrates efficacy in non-small cell lung cancer preclinical models and induces immunogenic cell death. Mol Cancer Ther. 2025;24(9):1428-1441. [10]Knutson KL, Abu-Fares H, Keating P, et al. A phase II trial to evaluate the safety and immunogenicity of two doses of a folate receptor alpha vaccine in patients with triple-negative breast cancer. Clin Cancer Res. 2025;32(1):106-117. ✦ 往期推荐国际天使综合征日 | 解锁“天使”密码，守护每一份微笑科普频道丨从“药神父亲”的故事，读懂铜代谢紊乱的另一面—一种更常见的“铜过剩”遗传病喜报！康圣真源顺利通过病原微生物tNGS室间质评！

2026-01-08

·格隆汇

肽癌疫苗市场占有率报告：主要企业及行业数据分析排名

根据QYResearch报告出版商调研统计，2025年全球肽癌疫苗市场销售额达到了亿元，预计2032年将达到亿元，年复合增长率（CAGR）为19.8%（2026-2032）。中国市场在过去几年变化较快，2025年市场规模为亿元，约占全球的 %，预计2032年将达到亿元，届时全球占比将达到 %。全球癌症患者数量持续增长，推动对高效、安全及个性化治疗方案的强烈需求。企业年报显示，多家领先生物制药企业加大肽癌疫苗研发投入，推动技术革新和临床试验进展，增强市场竞争力。各国政府通过出台支持创新医疗技术的政策和资金，促进肽癌疫苗的研发与商业化应用。肽癌疫苗具有针对性强和组合治疗潜力，满足不同癌种和患者的多样化需求，特别是在难治性和复发性肿瘤中的应用价值突出。精准医疗理念普及及生物信息学辅助设计的提升，进一步加速了肽癌疫苗的研发效率和市场推广。肽癌疫苗市场面临技术复杂性高、研发周期长和临床验证要求严苛的挑战。不同国家和地区的监管政策和审批流程差异，增加了国际市场拓展的难度和成本。市场竞争日趋激烈，传统疗法与多种新兴免疫疗法并存，企业需要持续创新以保持领先地位。高昂的研发投入和生产成本也限制了部分中小企业的参与和产品价格的普及。疗效和安全性的不确定性要求企业加强临床数据支持和风险管理，保障产品的市场接受度和长期竞争力。未来肽癌疫苗的下游需求将表现出个性化、多样化和融合化的特点。大型综合医疗机构和肿瘤专科中心作为主要市场，注重产品疗效、安全性及与现有治疗方案的协同效果。患者对精准治疗和副作用低的创新疗法需求旺盛，推动个性化肽疫苗定制及组合治疗的快速发展。随着辅助诊断和生物标志物技术进步，肽癌疫苗将更加精准地匹配患者特征，实现疗效最大化。供应商需不断提升研发能力和服务水平，以适应复杂多变的临床需求和监管环境。QYResearch调研团队最新发布的【2026年全球肽癌疫苗行业总体规模、主要企业国内外市场占有率及排名】，本文侧重研究全球肽癌疫苗总体规模及主要厂商占有率和排名，主要统计指标包括肽癌疫苗产能、销量、销售收入、价格、市场份额及排名等，企业数据主要侧重近三年行业内主要厂商的市场销售情况。地区层面，主要分析过去五年和未来五年行业内主要生产地区和主要消费地区的规模及趋势。如您需要查看完整版（目录+图表）或申请报告样本可点击链接：https://www.qyresearch.com.cn/reports/6438451/peptide-cancer-vaccine肽癌疫苗报告主要研究企业名单如下，也可根据客户要求增加目标企业：Boston Biomedical、 Ultimovacs、 BrightPath Biotherapeutics、 TapImmune、 Immatics、 Sellas、 Imugene、 VAXON Biotech、 Generex Biotechnology、 ISA Pharmaceuticals、 OncoTherapy Science肽癌疫苗报告主要研究产品类型包括：ITK-1、 GRN-1201、 TPIV200、 TPIV110、 UV1、 Galinpepimut-S、 TARP 27-35、 HER-Vaxx、 Vx-001、其他肽癌疫苗报告主要研究应用领域，主要包括：乳腺癌、肺癌、黑色素瘤、前列腺癌、其他领域肽癌疫苗报告主要研究内容以下几点：第1章：肽癌疫苗报告统计范围、所属行业、产品细分及主要的下游市场，行业现状及进入壁垒等第2章：国内外主要企业市场占有率及排名第3章：全球肽癌疫苗总体规模（产能、产量、销量、需求量、销售收入等数据，2021-2032年）第4章：全球肽癌疫苗主要地区分析，包括销量、销售收入等第5章：全球肽癌疫苗主要厂商基本情况介绍，包括公司简介、肽癌疫苗产品型号、销量、收入、价格及最新动态等第6章：全球不同产品类型肽癌疫苗销量、收入、价格及份额等第7章：全球不同应用肽癌疫苗销量、收入、价格及份额等第8章：行业发展趋势、驱动因素、行业政策等第9章：产业链、上下游分析、生产模式、销售模式及销售渠道分析等第10章：报告结论第11章：研究方法与数据来源肽癌疫苗报告目录主要内容展示：1 统计范围及所属行业1.1 产品定义1.2 所属行业1.3 全球市场肽癌疫苗市场总体规模1.4 中国市场肽癌疫苗市场总体规模1.5 行业发展现状分析1.5.1 肽癌疫苗行业发展总体概况1.5.2 肽癌疫苗行业发展主要特点1.5.3 肽癌疫苗行业发展影响因素1.5.3.1 肽癌疫苗有利因素1.5.3.2 肽癌疫苗不利因素1.5.4 进入行业壁垒2 国内外市场占有率及排名2.1 全球市场，近三年肽癌疫苗主要企业占有率及排名（按收入）2.1.1 近三年肽癌疫苗主要企业在国际市场占有率（按收入，2023-2026）2.1.2 2025年肽癌疫苗主要企业在国际市场排名（按收入）2.1.3 近三年全球市场主要企业肽癌疫苗销售收入（2023-2026）2.2 中国市场，近三年肽癌疫苗主要企业占有率及排名（按收入）2.2.1 近三年肽癌疫苗主要企业在中国市场占有率（按收入，2023-2026）2.2.2 2025年肽癌疫苗主要企业在中国市场排名（按收入）2.2.3 近三年中国市场主要企业肽癌疫苗销售收入（2023-2026）2.3 全球主要厂商肽癌疫苗总部及产地分布2.4 全球主要厂商成立时间及肽癌疫苗商业化日期2.5 全球主要厂商肽癌疫苗产品类型及应用2.6 肽癌疫苗行业集中度、竞争程度分析2.6.1 肽癌疫苗行业集中度分析：2025年全球Top 5厂商市场份额2.6.2 全球肽癌疫苗第一梯队、第二梯队和第三梯队厂商（品牌）及市场份额2.7 新增投资及市场并购活动3 全球肽癌疫苗主要地区分析3.1 全球主要地区肽癌疫苗市场规模分析：2021 VS 2025 VS 20323.1.1 全球主要地区肽癌疫苗销售额及份额（2021-2026）3.1.2 全球主要地区肽癌疫苗销售额及份额预测（2027-2032）3.2 北美肽癌疫苗销售额及预测（2021-2032）3.3 欧洲肽癌疫苗销售额及预测（2021-2032）3.4 中国肽癌疫苗销售额及预测（2021-2032）3.5 日本肽癌疫苗销售额及预测（2021-2032）3.6 东南亚肽癌疫苗销售额及预测（2021-2032）3.7 印度肽癌疫苗销售额及预测（2021-2032）3.8 南美肽癌疫苗销售额及预测（2021-2032）3.9 中东肽癌疫苗销售额及预测（2021-2032）4 产品分类，按传递途径4.1 产品分类，按传递途径4.1.1 ITK-14.1.2 GRN-12014.1.3 TPIV2004.1.4 TPIV1104.1.5 UV14.1.6 Galinpepimut-S4.1.7 TARP 27-354.1.8 HER-Vaxx4.1.9 Vx-0014.1.10 按传递途径细分，全球肽癌疫苗销售额对比（2021 VS 2025 VS 2032）4.1.11 按传递途径细分，全球肽癌疫苗销售额及预测（2021-2032）4.1.11.1 按传递途径细分，全球肽癌疫苗销售额及市场份额（2021-2026）4.1.11.2 按传递途径细分，全球肽癌疫苗销售额预测（2027-2032）4.1.12 按传递途径细分，中国肽癌疫苗销售额及预测（2021-2032）4.1.12.1 按传递途径细分，中国肽癌疫苗销售额及市场份额（2021-2026）4.1.12.2 按传递途径细分，中国肽癌疫苗销售额预测（2027-2032）5 产品分类，按应用5.1 产品分类，按应用5.1.1 乳腺癌5.1.2 肺癌5.1.3 黑色素瘤5.1.4 前列腺癌5.1.5 其他领域5.2 按应用细分，全球肽癌疫苗销售额对比（2021 VS 2025 VS 2032）5.3 按应用细分，全球肽癌疫苗销售额及预测（2021-2032）5.3.1 按应用细分，全球肽癌疫苗销售额及市场份额（2021-2026）5.3.2 按应用细分，全球肽癌疫苗销售额预测（2027-2032）5.4 中国不同应用肽癌疫苗销售额及预测（2021-2032）5.4.1 中国不同应用肽癌疫苗销售额及市场份额（2021-2026）5.4.2 中国不同应用肽癌疫苗销售额预测（2027-2032）6 主要企业简介6.1 Boston Biomedical6.1.1 Boston Biomedical公司信息、总部、肽癌疫苗市场地位以及主要的竞争对手6.1.2 Boston Biomedical 肽癌疫苗产品及服务介绍6.1.3 Boston Biomedical 肽癌疫苗收入及毛利率（2021-2026）&（万元）6.1.4 Boston Biomedical公司简介及主要业务6.1.5 Boston Biomedical企业最新动态6.2 Ultimovacs6.2.1 Ultimovacs公司信息、总部、肽癌疫苗市场地位以及主要的竞争对手6.2.2 Ultimovacs 肽癌疫苗产品及服务介绍6.2.3 Ultimovacs 肽癌疫苗收入及毛利率（2021-2026）&（万元）6.2.4 Ultimovacs公司简介及主要业务6.2.5 Ultimovacs企业最新动态6.3 BrightPath Biotherapeutics6.3.1 BrightPath Biotherapeutics公司信息、总部、肽癌疫苗市场地位以及主要的竞争对手6.3.2 BrightPath Biotherapeutics 肽癌疫苗产品及服务介绍6.3.3 BrightPath Biotherapeutics 肽癌疫苗收入及毛利率（2021-2026）&（万元）6.3.4 BrightPath Biotherapeutics公司简介及主要业务6.3.5 BrightPath Biotherapeutics企业最新动态6.4 TapImmune6.4.1 TapImmune公司信息、总部、肽癌疫苗市场地位以及主要的竞争对手6.4.2 TapImmune 肽癌疫苗产品及服务介绍6.4.3 TapImmune 肽癌疫苗收入及毛利率（2021-2026）&（万元）6.4.4 TapImmune公司简介及主要业务6.5 Immatics6.5.1 Immatics公司信息、总部、肽癌疫苗市场地位以及主要的竞争对手6.5.2 Immatics 肽癌疫苗产品及服务介绍6.5.3 Immatics 肽癌疫苗收入及毛利率（2021-2026）&（万元）6.5.4 Immatics公司简介及主要业务6.5.5 Immatics企业最新动态6.6 Sellas6.6.1 Sellas公司信息、总部、肽癌疫苗市场地位以及主要的竞争对手6.6.2 Sellas 肽癌疫苗产品及服务介绍6.6.3 Sellas 肽癌疫苗收入及毛利率（2021-2026）&（万元）6.6.4 Sellas公司简介及主要业务6.6.5 Sellas企业最新动态6.7 Imugene6.7.1 Imugene公司信息、总部、肽癌疫苗市场地位以及主要的竞争对手6.7.2 Imugene 肽癌疫苗产品及服务介绍6.7.3 Imugene 肽癌疫苗收入及毛利率（2021-2026）&（万元）6.7.4 Imugene公司简介及主要业务6.7.5 Imugene企业最新动态6.8 VAXON Biotech6.8.1 VAXON Biotech公司信息、总部、肽癌疫苗市场地位以及主要的竞争对手6.8.2 VAXON Biotech 肽癌疫苗产品及服务介绍6.8.3 VAXON Biotech 肽癌疫苗收入及毛利率（2021-2026）&（万元）6.8.4 VAXON Biotech公司简介及主要业务6.8.5 VAXON Biotech企业最新动态6.9 Generex Biotechnology6.9.1 Generex Biotechnology公司信息、总部、肽癌疫苗市场地位以及主要的竞争对手6.9.2 Generex Biotechnology 肽癌疫苗产品及服务介绍6.9.3 Generex Biotechnology 肽癌疫苗收入及毛利率（2021-2026）&（万元）6.9.4 Generex Biotechnology公司简介及主要业务6.9.5 Generex Biotechnology企业最新动态6.10 ISA Pharmaceuticals6.10.1 ISA Pharmaceuticals公司信息、总部、肽癌疫苗市场地位以及主要的竞争对手6.10.2 ISA Pharmaceuticals 肽癌疫苗产品及服务介绍6.10.3 ISA Pharmaceuticals 肽癌疫苗收入及毛利率（2021-2026）&（万元）6.10.4 ISA Pharmaceuticals公司简介及主要业务6.10.5 ISA Pharmaceuticals企业最新动态6.11 OncoTherapy Science6.11.1 OncoTherapy Science公司信息、总部、肽癌疫苗市场地位以及主要的竞争对手6.11.2 OncoTherapy Science 肽癌疫苗产品及服务介绍6.11.3 OncoTherapy Science 肽癌疫苗收入及毛利率（2021-2026）&（万元）6.11.4 OncoTherapy Science公司简介及主要业务6.11.5 OncoTherapy Science企业最新动态7 行业发展环境分析7.1 肽癌疫苗行业发展趋势7.2 肽癌疫苗行业主要驱动因素7.3 肽癌疫苗中国企业SWOT分析7.4 中国肽癌疫苗行业政策环境分析7.4.1 行业主管部门及监管体制7.4.2 行业相关政策动向7.4.3 行业相关规划8 行业供应链分析8.1 肽癌疫苗行业产业链简介8.1.1 肽癌疫苗行业供应链分析8.1.2 肽癌疫苗主要原料及供应情况8.1.3 肽癌疫苗行业主要下游客户8.2 肽癌疫苗行业采购模式8.3 肽癌疫苗行业生产模式8.4 肽癌疫苗行业销售模式及销售渠道9 研究结果10 研究方法与数据来源10.1 研究方法10.2 数据来源10.2.1 二手信息来源10.2.2 一手信息来源10.3 数据交互验证10.4 免责声明 2026-2032全球及中国肽癌疫苗行业研究及十五五规划分析报告2026-2032中国肽癌疫苗市场现状研究分析与发展前景预测报告2026-2032全球与中国肽癌疫苗市场现状及未来发展趋势【数据来源】80%数据来自一手渠道，20%数据来自二手渠道。本公司利用大量的一手及二手资料来源核实所收集的数据或资料。【一手资料】来源于研究团队对行业内重点企业访谈获取的一手信息数据，主要采访对象有公司CEO、营销/销售总监、高层管理人员、行业专家、技术负责人、下游客户、分销商、代理商、经销商以及上游原料供应商等。【二手资料】来源主要包括全球范围相关行业新闻、公司年报、非盈利性组织、行业协会、政府机构、海关数据及第三方数据库等。本文应用了收集到的二手信息有来自新闻网站及第三方数据库如彭博新闻社、Market Watch、Hoovers、statista、TradingEconomics、Federal Reserve Economic Data、BIS Statistics、ICIS、CAS (American Chemical Society)、Investor Presentations、SEC文件、公司年报、Emerging Markets Information Service (EMIS)、Osiris、Zephyr、Uncomtrade、万得资讯、国研网、中国资讯行数据库、csmar数据库、皮书数据库及中经专网等。官网网址：https://www.qyresearch.com.cn/咨询热线：4006068865、邮箱：market@qyresearch.com商务微信号：176- 7575 -2412 ; 150 -1303- 8387 ; 18127421474 ; 130-0513-4463；130-4429-5150关注微信公众号：QYResearch，每日分享行业最新资讯。欢迎咨询QYResearch市场调研机构。报告编码：6438451

疫苗免疫疗法

2025-10-31

·FiercePharma

Pediatrician group declines to back leucovorin for routine use against autism

The American Academy of Pediatrics acknowledged that small studies have pointed to “potential benefit in carefully selected cases,” but said large clinical trials are needed to determine leucovorin’s efficacy and safety profile for the broader autism population. The American Academy of Pediatrics (AAP) on Friday said it does not recommend the routine use of leucovorin for children with autism.Calls for the professional association of pediatricians to provide guidance on leucovorin for autism emerged in September after U.S. health officials positioned the decades-old drug as a treatment for cerebral folate deficiency (CFD), which is present in some children with autism spectrum disorder (ASD).As the FDA works with GSK to allow the British pharma’s previously discontinued leucovorin product Wellcovorin to treat CFD, the Department of Health and Human Services said in a Sept. 22 release that the move will “authorize treatment for children with ASD,” and that state Medicaid programs will be able to cover the drug for the indication of autism. But in an “interim guidance” posted Friday, the AAP said “the current evidence base remains too limited to support” recommendations for the drug, suggesting that large clinical trials are needed to determine leucovorin’s efficacy and safety profile for the broader autism population. In its Sept. 22 release, the HHS said the National Institutes of Health will launch confirmatory trials and new research into the effects of leucovorin.“The AAP does not have prescribing guidelines for leucovorin for the indication of autism,” the organization said.In some children with autism, folate receptor alpha (FRα) autoantibodies block the transport of folate—a B vitamin—into the brain, leading to CFD. Leucovorin, or folinic acid, bypasses the defective folate transport system and delivers folate directly to the brain, according to an HHS fact sheet. To back its decision on Wellcovorin, the FDA cited a “systematic analysis of literature published between 2009-2024, including published case reports with patient-level information, as well as mechanistic data.”In a double-blind, placebo-controlled trial among 80 patients, researchers in India recorded better changes in Childhood Autism Rating Scale scores, as well as better changes in behavioral problems measured by the Child Behavior Checklist, for those who took leucovorin versus placebo. In the leucovorin group, improvement was more pronounced in children with higher levels of folate receptor autoantibodies.The study was clearly too small, based on a recent Centers for Disease Control and Prevention estimate that in 2022, 1 in 31 children were diagnosed with autism by age 8 in the U.S.The APP acknowledged that small studies have pointed to “potential benefit in carefully selected cases,” and that these “preliminary results are promising and have laid the groundwork for further investigation.”The organization also said guidance needs “to be grounded in both scientific rigor and respect for neurodiversity.”The doctors’ association previously blasted the Trump administration for linking autism to childhood vaccines and to the use of the pain reliever acetaminophen during pregnancy without evidence. It also criticized the administration for aggressively promoting leucovorin as an autism treatment.Following a Sept. 22 White House press conference on autism, AAP President Susan Kressly, M.D., said in a statement that the event was “filled with dangerous claims and misleading information that sends a confusing message to parents and expecting parents and does a disservice to autistic individuals.”“Don’t take Tylenol,” President Donald Trump repeatedly said during the Sept. 22 press conference, referring to the original Kenvue drug by its brand name. But during an Oct. 29 event, U.S. Health Secretary Robert R. Kennedy Jr. said there’s no sufficient evidence to definitely link Tylenol to autism.“The causative association… between Tylenol given in pregnancy and the perinatal periods is not sufficient to say it definitely causes autism. But it is very suggestive,” Kennedy said, as cited by Reuters.“There should be a cautious approach to it,” he added.Kenvue has pushed back against the claim by the Trump administration, having urged the FDA not to change the label of the popular pain medication over the uncorroborated link between its pregnancy use and autism.Meanwhile, Texas Attorney General Ken Paxton has filed a new lawsuit against the Johnson & Johnson consumer health spinoff, alleging the company “deceptively” marketed Tylenol to pregnant women despite knowing exposure to the drug can cause a “significantly increased risk of autism and other disorders.”

100 项与 Folate receptor alpha vaccine(Mayo Clinic) 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
子宫内膜样癌	临床2期	美国	Mayo Clinic	2024-11-12
卵巢子宫内膜样癌	临床2期	美国	Mayo Clinic	2024-11-12
输卵管透明细胞腺癌	临床2期	美国	Mayo Clinic	2024-11-12
高级别输卵管浆液性腺癌	临床2期	美国	Mayo Clinic	2024-11-12
卵巢高级别浆液性腺癌	临床2期	美国	Mayo Clinic	2024-11-12
卵巢腺癌	临床2期	美国	Mayo Clinic	2024-11-12
卵巢癌肉瘤	临床2期	美国	Mayo Clinic	2024-11-12
原发性腹膜透明细胞癌	临床2期	美国	Mayo Clinic	2024-11-12
原发性腹膜子宫内膜样腺癌	临床2期	美国	Mayo Clinic	2024-11-12
原发性腹膜高级别浆液性腺癌	临床2期	美国	Mayo Clinic	2024-11-12

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临床结果

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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


NCT02978222 (Pubmed) 人工标引	临床2期	卵巢癌	120	TPIV200receptor-alpha peptides (TPIV200 + GM-CSF)	積鹽獵餘蓋衊製襯積膚(醖顧積齋選廠鏇膚繭製) = 鑰餘糧餘鑰膚網醖獵遞淵鬱襯簾遞鹽鏇壓夢襯 (觸網壓遞鏇艱壓積膚糧 )	不佳	2024-10-01
				GM-CSF alone	積鹽獵餘蓋衊製襯積膚(醖顧積齋選廠鏇膚繭製) = 範蓋衊餘憲壓鏇醖淵選淵鬱襯簾遞鹽鏇壓夢襯 (觸網壓遞鏇艱壓積膚糧 )
NCT02978222 (NCT02978222 \| ###DELETE, CTgov)	临床2期	铂敏感性卵巢癌	120	FRα peptide plus Adjuvant (GM-CSF) (FRα Peptide Plus Adjuvant (GM-CSF))	衊鹹壓膚醖餘鏇遞淵壓(壓獵壓憲繭鏇製蓋齋膚) = 膚築襯願簾餘繭選窪選願糧顧鏇鬱淵鑰網衊繭 (齋餘衊壓築壓顧齋遞繭, 壓鑰鹹製憲鬱淵觸簾鹽 ~ 選鑰壓壓淵鑰齋網網製) 更多	-	2022-12-15
				GM-CSF (Adjuvant (GM-CSF) Alone)	衊鹹壓膚醖餘鏇遞淵壓(壓獵壓憲繭鏇製蓋齋膚) = 餘窪簾憲憲願積顧艱窪願糧顧鏇鬱淵鑰網衊繭 (齋餘衊壓築壓顧齋遞繭, 襯顧膚憲艱淵構醖遞選 ~ 鑰憲艱獵遞蓋襯廠鑰糧) 更多
NCT02764333 (CTgov)	临床2期	铂耐药性卵巢癌	29	TPIV200+Durvalumab	憲膚簾醖憲繭觸糧襯鑰 = 窪艱鹹鹹夢簾鑰製繭鑰鑰積廠餘製蓋顧鏇窪鹹 (製齋願壓蓋壓選觸糧衊, 醖膚衊蓋衊襯衊鹽憲遞 ~ 糧襯築夢積網鹽鏇遞簾) 更多	-	2021-11-30
NCT02764333 (Pubmed \| J Immunother Cancer) 人工标引	临床2期	卵巢癌	27	durvalumab+TPIV200	鹽衊願鏇醖廠艱築糧積(醖鏇構齋繭築鬱鹹獵糧) = 糧蓋襯簾觸淵夢觸選衊鑰獵餘鏇鬱網鏇窪鹹繭 (範鬱齋網夢餘觸衊積構 ) 更多	积极	2020-06-01
NCT02978222 (ASCO 12020 \| ASCO 22020) 人工标引	临床2期	卵巢癌	120	FRα peptides+GM-CSF	鏇糧遞醖鏇觸築顧簾鹹(構顧夢鏇鹹糧選齋齋蓋) = 淵繭願顧淵窪醖製窪餘選齋夢餘網鏇餘鏇獵製 (膚鬱選鏇壓餘製遞窪壓 ) 更多	不佳	2020-05-25
				GM-CSF	鏇糧遞醖鏇觸築顧簾鹹(構顧夢鏇鹹糧選齋齋蓋) = 鏇網鹽鹽壓鹽鹽廠鹽窪選齋夢餘網鏇餘鏇獵製 (膚鬱選鏇壓餘製遞窪壓 ) 更多