EP-2101

iStock, valiantsin suprunovich Recent approvals for Corcept Therapeutics and Merck have injected momentum into the space, where GSK, Allarity Therapeutics, OSE Immunotherapies and others are advancing their own candidates. The market for drugs designed to treat the deadliest gynecological malignancy—ovarian cancer—is gaining steam, thanks to two recent approvals and a crop of novel candidates in earlier-stage trials. In February, Merck secured an FDA approval for Keytruda and subcutaneous injection Keytruda Qlex with paclitaxel for patients with platinum-resistant ovarian cancers (PROC). The addition of the blockbuster immunotherapy led to a 24% reduction in the risk of death, according to Phase 3 trial data. The agency then approved Corcept Therapeutics’ glucocorticoid blocker Lifyorli in PROC in March, with recent data showing a 35% reduction in the risk of death in combination with nab-paclitaxel compared to chemotherapy alone. Both approvals were huge wins, particularly for platinum-resistant ovarian cancer, where treatment options are limited, said Premal Thaker, the WashU Medicine director of gynecological oncology clinical research at Siteman Cancer Center . Thaker is the principal investigator on the Phase 3 OVATION-3 trial, which is evaluating a gene therapy from Imunon called IMNN-001 that is designed to boost levels of IL-12 and change the tumor microenvironment, alongside chemotherapy. Phase 2 data reported in March showed a 14.7-month increase in overall survival compared to standard of care chemotherapy. IMNN-001 is one of several candidates bringing new interest to a stubborn disease with a relative 5-year survival rate of 52% and limited treatment options. “A lot of drugs have gone into trials for many, many decades, and we just haven’t had the same success that we’re seeing right now,” Thaker told BioSpace . “It’s smarter drugs and medications.” Here are four candidates, each with a different mechanism of action, that the field is watching. Make way for GSK’s Mo-Rez and the ADCs The biggest frontrunners poised to make a dent in ovarian cancer are antibody-drug conjugates (ADCs), where AbbVie’s folate receptor antagonist Elahere is first-in-class . Another candidate with recent data is GSK’s mocertatug rezetecan, or Mo-Rez, a novel ADC that targets an antigen called B7-H4 and carries a topoisomerase inhibitor payload. In its Phase 1 dose-escalation trial, BEHOLD-1, Mo-Rez had a confirmed objective response rate (cORR) of 62% in patients with PROC and 67% in those with endometrial cancer, according to data presented at the Society for Gynecological Oncology’s annual meeting in April. “We were pretty happy with that,” Eric Richards, senior vice president and head of medicine development leaders for oncology at GSK, told BioSpace . “What we’re seeing is not only a high level of clinical activity but initial signs of pretty good durability.” Richards added that the immune checkpoint protein B7-H4 is overexpressed in the vast majority of ovarian cancer cells, making it an attractive target. GSK is launching five Phase 3 trials evaluating Mo-Rez this year across ovarian and endometrial cancers, including BEHOLD-Ovarian01 in PROC and BEHOLD-Ovarian02 in platinum-sensitive ovarian cancer. Elsewhere, German biotech Tubulis, recently acquired by Gilead, also recently reported positive results from a Phase 1 trial evaluating its ADC, TUB-040, in PROC. And Daiichi Sankyo and Merck are progressing their candidate raludotatug deruxtecan (R-Dxd) in a Phase 2/3 trial. It’s too early to say which candidates look most promising, Thaker said, adding that many of them carry the same topoisomerase payload. Their side effects will likely be a differentiating factor, she said. “It’s a little bit of a scientific conundrum right now—how are we going to sequence these? Because they all look very exciting.” Cancer ASCO: A battle of bispecifics, Eli Lilly’s big win and more Practice-changing data in lung cancer, prostate cancer and more were on display over the weekend at the American Society of Clinical Oncology annual meeting in Chicago. Plus, early readouts on assets that could reshape the cancer landscape. June 1, 2026 · 4 min read · Brianna Abbott Read more Zentalis chases a new target in WEE1 Zentalis Pharmaceuticals, meanwhile, is enrolling a Phase 3 global trial evaluating its novel inhibitor azenosertib in patients with cyclin E1–positive PROC against standard single-agent chemotherapy, according to a May press release . Azenosertib is designed to inhibit the protein kinase WEE1, a master regulator of cell cycle checkpoints. At the 2026 American Society of Clinical Oncology annual meeting, data from the Phase 1b MUIR trial showed that azenosertib plus paclitaxel resulted in an ORR of 39% and a median progression-free survival (PFS) of 7.3 months in an all-comer PROC population. Both the cyclin E1-positive and negative groups had similar responses, the trial found. The FDA granted Fast Track designation to the drug in January 2025 for patients who are positive for the cyclin E1 protein, which is overexpressed in around half of PROC patients. Ovarian cancer tumors positive for cyclin E1 are often especially hard to treat, Thaker noted. “It’s nice that we’re developing a medication that can help overcome that,” Thaker—who is also involved in the research—said. Plus, she added, the azenosertib pill might be easier to take than some of the ADCs, which are delivered via infusions. OSE’s proof-of-concept for cancer vaccines More positive ovarian cancer data at ASCO 2026 came from OSE Immunotherapeutics, which reported Phase 2 results for its off-the-shelf vaccine Tedopi (OSE2101), designed to stimulate a patient’s T cells and target five different tumor-linked antigens. In the TEDOVA trial, some 185 patients with platinum-sensitive recurrent ovarian cancer (PSOC) were randomized to Tedopi, Tedopi plus pembrolizumab or best supportive care as maintenance treatment after chemo. Patients in the trial were also required to be HLA-A2 positive, which shrinks the number of potentially eligible patients, Thaker said. “We have to be mindful when we look at some of these targets, we have to cut the pie a little bit more.” With a median follow-up of 22 months, patients on Tedopi and pembrolizumab experienced a median PFS of 4.1 months, compared to 2.8 months for those getting the best supportive care. The addition of pembrolizumab to Tedopi led to a 28% reduction in the risk of progression or death, compared to Tedopi alone, the trial found, though that result missed the mark for statistical significance. The results are the first proof of concept for a therapeutic vaccine in ovarian cancer and the first positive trial for PSOC in years, Alexandra Leary, deputy head of the department of medical oncology at Gustave Roussy in France and lead investigator on the trial, said in a press release . Allarity’s next generation PARP inhibitor Allarity Therapeutics’ stenoparib is another candidate with FDA Fast Track designation. The drug is a dual-target inhibitor that homes in on PARP 1/2 and tankyrase 1/2, differentiating it from earlier PARP inhibitors such as AstraZeneca and Merck’s Lynparza and GSK’s Zejula. Inhibiting tankyrase can disrupt signaling in the WNT pathway, which has been implicated in multiple cancers, Jeremy R. Graff, president and chief developmental officer at Allarity, told BioSpace . “It really seems to be particularly highly activated in really advanced, chemo- and radio-resistant cancers.” Allarity licensed stenoparib in 2017 from Eisai based on the drug’s Phase 1 data. In Phase 2 data reported in September 2025, the median overall survival had not been reached at 25 months for patients with platinum-resistant and refractory ovarian cancer. The drug appeared to benefit patients regardless of their BRCA status, Graff added. The company is expanding its Phase 2 trial for patients with PROC and has amended its trial protocol to focus on advanced, recurrent, platinum-resistant or platinum-ineligible ovarian cancer. Like with Zentalis’s azenosertib, the pill will likely be easier to take with milder toxicities than the ADCs, Graff said, which could be particularly helpful for older women. Ovarian cancer hasn’t historically garnered as much attention as cancers with the biggest patient pools, including breast or prostate cancer, Graff said. But the hard-to-treat disease is now capturing more interest. “It’s a huge unmet medical need,” Graff said. “We’d love to, with the era of targeted therapies, go beyond just poisoning people with chemotherapy.” .responsive-container { display: flex; flex-wrap: wrap; border: 1px solid #ededed; font-family: Helvetica, Arial, Sans-Serif; padding: 20px 20px 10px 20px; } .column-left { flex: 1; max-width: 45%; padding: 20px 20px 10px 20px; } .column-right { flex: 2; padding: 20px 20px 10px 20px; } @media (max-width: 768px) { .column-left, .column-right { max-width: 100%; flex: 100%; padding: 10px 0; } } Subscribe to ClinicaSpace! Clinical trial results, research news, the latest in cancer, cell and gene therapy hbspt.forms.create({ region: "na1", portalId: "4413123", formId: "674f4dc0-7371-4190-86cc-e1afd00b08ea", onFormSubmitted: function($form, data) { window.dataLayer = window.dataLayer || []; window.dataLayer.push({ 'event': 'GTMevent', 'event_name': 'newsletter_sign_up' }); } });

2021年，62岁的Kim Garland被诊断为4级胶质母细胞瘤（这是一种最具侵袭性的脑瘤），她可能没有想到，她参与的GNOS-PV01疫苗试验会让她在近五年后依然健康地活着，肿瘤没有复发，她本人更是成为了长期生存的典范。 对于绝大多数人来说，“疫苗”这个词总是和“预防”绑定在一起，我们从小接种疫苗，是为了在病原体入侵之前建立起免疫防线。但近两年，一个全新的概念正在颠覆这种认知：疫苗，也可以用来治疗已经发生的癌症。 关于癌症疫苗 癌症疫苗是抗击癌症的一种开创性方法，为预防和治疗某些恶性肿瘤带来了希望。它们通过利用人体免疫系统识别并清除癌细胞来发挥作用。最显著的成功之一是针对人乳头瘤病毒（HPV）的疫苗研发。这些疫苗在预防宫颈癌方面显示出卓越的疗效。自HPV疫苗问世以来，HPV感染和癌前宫颈病变显著减少。一些国家报告称，在接种疫苗的人群中，HPV流行率降低了高达90%。但癌症疫苗的潜力不仅限于癌症预防。旨在治疗现有癌症的治疗性癌症疫苗也展现出希望。 与传统疫苗利用病毒的部分成分来预防疾病类似，癌症疫苗使用来自癌细胞表面的无害蛋白质，这些蛋白质被称为抗原。 当这些抗原被引入人体后，它们应能刺激免疫系统产生针对这些抗原的抗体，从而使免疫系统具备杀死癌细胞的能力。 但这并非易事。每个患者的肿瘤都不同，它们所携带的抗原也各不相同。因此，不可能有一种通用的癌症疫苗-需要针对不同的肿瘤类型研发不同的疫苗。 这还不是唯一的问题。癌细胞产生的许多抗原可能与体内的其他抗原相似。如果在疫苗中使用这些抗原，可能会导致免疫系统攻击健康细胞，从而产生危险的副作用。 幸运的是，研究人员已经识别出了一系列肿瘤特异性抗原（这些抗原不存在于健康细胞上）以及肿瘤相关抗原（这些抗原仅存在于部分正常细胞上）。这些抗原是有用的标记物，能够帮助免疫系统靶向癌细胞，同时不攻击身体的健康部位。 如果您希望了解更多关于癌症疫苗（包括mRNA疫苗、DC疫苗等）的最新进展、适应症，或咨询自身情况是否适合参与相关临床试验、评估博鳌乐城用药可能性，请联系康和源免疫之家（400-880-3716）。 癌症疫苗的类型 蛋白质或多肽疫苗：这类疫苗由癌细胞中的特殊蛋白质或蛋白质小片段（多肽）制成。它们旨在刺激免疫系统攻击癌症。科学家已经破译了许多癌细胞蛋白质的遗传密码，因此可以在实验室中大量制造它们。安达生物开发的个性化多肽肿瘤新抗原疫苗PCNAT-01临床数据显示，接种疫苗的胰腺癌患者取得了良好的生存结局，3年无复发生存率为56%，3年总生存率为74%。 DNA和RNA疫苗：使用通常在癌细胞中发现的遗传物质片段（DNA或RNA）。这些DNA或RNA被注射到体内，将信息传递给人体细胞，并指示它们制造蛋白质，从而启动免疫反应。 Moderna的mRNA-4157（V940）与帕博利珠单抗联用，用于高风险黑色素瘤术后辅助治疗的IIb期研究长期随访数据显示，持续将复发或死亡风险降低49%。这为mRNA疫苗在辅助治疗领域的价值提供了坚实证据。 全细胞疫苗：这类疫苗由完整的癌细胞制成，而不仅仅是特定的细胞抗原。癌细胞被提取出来，在实验室中进行改造，然后注射到体内。在体内，它们帮助免疫系统了解如何找到其他癌细胞。科学家可以利用患者自身的癌细胞、他人的癌细胞或在实验室中培养的癌细胞来制造这些疫苗。 树突状细胞疫苗：树突状细胞帮助免疫系统识别并攻击异常细胞。科学家可以通过将癌细胞抗原装载到树突状细胞中来制造疫苗-树突状细胞会像佩戴徽章一样将这些抗原展示在自身表面。疫苗利用这个“徽章”来刺激免疫系统攻击癌症。 如Provenge(Sipuleucel-T)：美国FDA批准的首个治疗性癌症疫苗，用于无症状或症状轻微的转移性去势抵抗性前列腺癌（mCRPC）。 病毒载体疫苗：科学家还可以改造病毒，将癌症抗原递送到体内。这些病毒载体不会引起严重疾病，但它们能够激发免疫反应，从而帮助免疫系统识别癌症抗原并对其作出反应。 卵巢癌突破：Tedopi联合疗法将疾病进展或死亡风险降低47% Tedopi（OSE2101）是一种新型基于T细胞表位的癌症疫苗。近日，OSE Immunotherapeutics公布其研发的多表位癌症疫苗Tedopi®（OSE2101）联合帕博利珠单抗，在针对铂敏感复发性卵巢癌（PSOC）的II期临床试验（TEDOVA）中的疗效。与最佳支持治疗相比，联合治疗将疾病进展或死亡风险降低了47%。 该研究在卵巢癌中验证了疫苗策略的概念，这也是多年来在铂敏感卵巢癌领域首个取得阳性结果的试验。 脑瘤惊艳数据：GNOS-PV01靶向新抗原，患者无病生存超4年 Kim Garland接受的GNOS-PV01，其靶点是所谓的新抗原——即患者癌细胞所特有的、能够被其免疫细胞识别的蛋白质。GNOS-PV01的I期试验结果发表于《自然·癌症》，带来了颠覆性数据：所有患者的6个月无进展生存率和12个月总生存率均为66.7%，中位总生存期达16.3个月，24个月生存率为33%。尤为引人注目的是，一名患者（8号）在数据截止时已无病生存超过4年。 WGc-043 mRNA疫苗落地海南 中国在癌症疫苗领域的研发正展现出强大的创新活力与临床转化能力。近日，中国成都威斯津生物自主研发的全球首款中美双报获批的EB病毒（EBV）阳性肿瘤mRNA治疗性疫苗WGc-043注射液，正式在海南博鳌乐城国际医疗旅游先行区落地应用，为鼻咽癌、NK/T细胞淋巴瘤等患者提供了全新的精准免疫治疗选择。其早期临床数据显示，在EBV阳性复发/难治性NK/T细胞淋巴瘤患者中，客观缓解率（ORR）达42.86%，疾病控制率（DCR）为57.14%。 这些接踵而至的突破性进展，清晰地勾勒出一个正在加速到来的现实：癌症疫苗，正从实验室的蓝图，稳步走向临床治疗的舞台中央，成为继手术、放疗、化疗、靶向治疗和免疫检查点抑制剂之后，肿瘤综合治疗的重要支柱。 目前，国内有临床试验正在招募患者，符合条件的患者可入组接受治疗。如果您或家人正面临晚期实体瘤的治疗困境，希望深入了解癌症疫苗（包括新抗原疫苗、肿瘤相关抗原疫苗等）的最新全球研究进展、适用条件、国内外临床试验机会，或需要对您的病理及基因检测报告进行专业解读以评估潜在获益，请联系康和源免疫之家（400-880-3716）。 癌症患者关心的四个现实问题 针对患者最关心的几个现实问题，我们提供以下客观分析： 癌症疫苗会取代传统治疗吗？ 不会。在可预见的未来，癌症疫苗的角色更可能是“联合部队”中的“精锐特种兵”。其主要应用场景是辅助治疗或与现有疗法（如免疫检查点抑制剂）联合，用于清除微小残留病灶、巩固疗效、降低复发风险，而非替代手术、化疗等根治性手段。 癌症疫苗上市了吗？如何获取？ 目前，绝大多数治疗性癌症疫苗（包括文中提及的大部分）仍处于临床试验阶段。患者接触前沿疗法的主要途径是参与临床试验。此外，通过海南博鳌乐城等“先行先试”区，可以合法使用国内尚未正式上市但已在国外或国内完成早期临床验证的创新产品（如WGc-043、LK101）。 费用高昂吗？ 完全个体化定制的疫苗目前成本确实极高。但随着技术进步、生产工艺优化、市场竞争加剧以及更多产品上市，价格有望逐步下降。参与临床试验通常是免费接受治疗的方式。 我适合接受癌症疫苗治疗吗？ 这需要严格的医学评估。评估因素包括：肿瘤类型、基因突变特征（是否有足够的新抗原）、既往治疗史、身体状况、免疫状态等。通常需要患者提供详细的病理报告、基因检测报告和完整病史，由专业的肿瘤免疫团队进行综合判断。 结语 从Tedopi®在卵巢癌的破冰，到WGc-043在中国落地，再到GNOS-PV01在脑瘤中创造的生存奇迹，我们正站在癌症治疗一个新时代的门口。癌症疫苗不再仅仅是科幻小说的构想，它已成为肿瘤免疫治疗武器库中一件日益锋利的武器。这并不意味着癌症疫苗会在一夜之间成为“灵丹妙药”。但它的发展方向已经清晰可见：更精准、更个性、更持久、更联合。对于每一位正在与癌症作战的患者和家庭来说，这些进展传递的最重要信息或许是：治疗癌症的武器库里，正在增加一个全新的品类-不是杀死细胞的毒药，而是唤醒免疫的“教官”。 参考资料 1.https://www.geneostx.com/personalized-vaccine-shows-promise-against-aggressive-brain-cancer/ 2.https://www.ose-immuno.com/wp-content/uploads/2026/05/EN_260522_OSE-Immunotherapeutics-2026-ASCO-TEDOVA-Results-vdef.pdf 3.https://news.cancerresearchuk.org/shorthand_story/cancer-vaccines-where-are-we/ 4.https://www.aicr.org/resources/blog/cancer-vaccines-a-new-frontier-in-cancer-prevention-and-treatment/ 5.https://www.cancernetwork.com/view/immunizing-cancer-patients-which-patients-which-vaccines-when-give 6.https://www.nature.com/articles/s41590-025-02308-2 7.https://www.nature.com/articles/s41392-023-01674-3 如果您在阅读本文后仍有困惑，或需要帮助，可通过康和源免疫之家医学部（400-880-3716）获取专业指导。您可以通过添加以下微信方式联系我们。 赵老师微信：15810815293 曹老师微信：17801183037 康和源免疫之家-癌症患者的生命希望桥梁 康和源免疫之家作为肿瘤诊疗服务平台，始终秉持“以患者为中心”的理念。在肿瘤治疗领域，患者面临着巨大的身心压力和复杂的治疗选择，康和源免疫之家深知患者的需求和困境，致力于为患者提供全方位、个性化的服务。 为了实现这一目标，该平台整合了中国、美国、欧洲、日本、韩国等全球顶尖肿瘤专家资源。这些专家拥有丰富的临床经验和先进的治疗理念，能够为患者提供专业的诊断和治疗建议。同时，平台还与知名药企、创新药物研发机构建立了深度合作关系，这使得患者能够及时了解到前沿的抗癌药物和治疗技术，为治疗提供更多的选择。 国际专家会诊服务 肿瘤治疗具有复杂性和个体差异性，不同患者的病情和身体状况各不相同，因此需要个性化的治疗方案。康和源免疫之家通过国际专家会诊服务，可协调中美欧日韩等多国权威肿瘤专家，针对癌症开展跨国联合诊疗。 对于那些需要第二诊疗意见的患者来说，国际专家会诊可以提供不同的视角和建议，帮助患者更全面地了解自己的病情和治疗方案。而对于寻求海外先进治疗方案的患者，平台的专业团队能够帮助他们获取国际前沿治疗指南，为患者制定更加科学、合理的治疗计划。 临床试验 作为连接患者与创新疗法的纽带，康和源免疫之家与全球领先药企及研发机构保持战略合作，持续提供涉及PD-1/L1抑制剂、CAR-T细胞治疗、ADC药物等领域的临床试验项目。这些临床试验项目代表了当前癌症治疗的前沿进展和研究方向，为患者提供了接触新型抗癌药物和治疗技术的机会。 康和源免疫之家团队会根据患者的病情阶段、基因检测结果和治疗史，精准匹配适合的临床试验机会。这不仅提高了患者参与临床试验的成功率，也确保了患者能够接受更加适合自己的治疗。在康和源免疫之家，每个生命都被视为值得更好的医疗选择，无论是寻求国际顶尖专家的诊疗建议，还是尝试突破性的临床试验，平台都将竭诚为患者提供专业、可靠的全方位支持。让我们携手，在抗击肿瘤的征程上走得更远。 END 如果您或您身边的人正在遭受癌症的困扰，不妨拨打咨询电话400-880-3716，登录官网 https://www.myimm.net/或关注微信公众号“康和源免疫之家”（头条、知乎、百度、搜狐等自媒体同名），了解更多关于临床试验和肿瘤诊疗服务的信息。 🌿抗癌，不仅是力量的抗争，更是精准的博弈。🌿 当亲人面对癌症，我们常问：“什么治疗方案更有效？会不会产生耐药？这种病会遗传给家人吗？”这些关乎生存与未来的关键问题，答案可能就藏在每个人的基因里。 🧬基因检测：为患者点亮精准治疗的“导航”，为家属揭开遗传风险的“谜底”。🧬 精准打击肿瘤，避免无效治疗肿瘤千差万别，用药也需“量体裁衣”。我们的基因检测能明确揭示肿瘤的基因突变靶点，就像为导弹装上“精确制导系统”，快速匹配更可能有效的靶向药物，避免在无效的化疗中消耗宝贵的生命与希望。 评估遗传风险，为家人构筑健康防线部分癌症与遗传密切相关。通过基因检测，可以评估患者是否携带明确的遗传易感基因突变。这不仅解释了病因，更能为您的子女、兄弟姐妹等近亲提供至关重要的预警，让他们能及早干预，主动守护健康。 🔬康和源免疫之家，用基因图谱，守护您与家人的生命延续。🔬 我们提供的不仅是冰冷的报告，更是一份贯穿诊断、治疗与康复的“科学行动指南”。我们的医学专家将为您深度解读基因信息，在复杂的治疗选择中提供决策支持，并为整个家庭的健康风险管理提供专业建议。 📞一人检测，可能惠及全家。立即拨打400-880-3716，康和源免疫之家医学部，为您与家人的未来，提供一份科学的答案。 让科学指引方向，让选择更有力量。 扫描下方二维码，或者直接电话咨询康和源免疫之家医学部（400-880-3716），持续为您关注并分享癌症前沿消息。 免责声明:文本参考来源于网络，版权归原作者所有。 该文章仅供分享，如涉嫌侵犯您的著作权请联系我们删除，谢谢！