全球mRNA癌症疫苗的臨床試驗趨勢:各適應症市場趨勢，開發優先順序，市場機會(2025年)

Global mRNA Cancer Vaccines Clinical Trials, Market Trends By Indication, Development Priority Status & Market Opportunity Insight 2025

出版日期: 2025年05月01日 | 出版商:

KuicK Research | 英文 150 Pages | 商品交期: 最快1-2個工作天內

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簡介目錄圖表

全球mRNA癌症疫苗臨床試驗趨勢報告重點：按適應症、開發重點和市場機會劃分的市場趨勢（2025年）

mRNA癌症疫苗臨床試驗洞察：60多種mRNA癌症疫苗
mRNA癌症疫苗臨床試驗洞察：按公司、國家、適應症和分期劃分
主要疫苗臨床試驗開始和完成年份洞察
持續的市場合作、交易與投資情景
mRNA癌症疫苗開發的專有技術和研究方法
按地區和適應症劃分的市場發展趨勢
競爭格局

mRNA癌症疫苗領域已成為現代製藥業發展最快的領域之一。受mRNA技術在新冠疫情期間取得成功的推動，製藥業和研發機構正利用這項平台開發高度個人化的抗癌療法。與不精準且易產生全身毒性的傳統療法不同，mRNA癌症疫苗提供針對每個腫瘤中特定基因突變的標靶免疫療法。這種特異性有可能重新定義腫瘤學的治療標準。

在臨床方面，目前有60多種mRNA癌症疫苗候選藥物處於不同的研發階段。其中大多數處於初步研究或臨床前開發階段，但也有一些已進入中後期臨床試驗階段。與傳統疫苗不同，mRNA癌症疫苗可以根據個別患者的腫瘤模式進行客製化。

目前正在研發的最先進的mRNA癌症疫苗之一是Moderna和Merck聯合研發的Intismeran Autogene (mRNA-4157/V940)，該疫苗目前正處於治療黑色素瘤和非小細胞肺癌(NSCLC)的III期臨床試驗階段。該疫苗與免疫檢查點抑制劑帕博利珠單抗合併使用，以最大限度地提高免疫識別和殺死癌細胞的能力。這種聯合療法旨在優化免疫活化並破壞抗藥性機制。如果成功，兩家公司計劃在2027年第二季將Intismeran Autogene商業化。

BioNTech與紀念斯隆凱特琳癌症中心合作研發的Autogene sevumeran (BNT122)最近也在胰臟癌的I期臨床試驗中顯示出良好的療效。 2025年初的數據顯示，疫苗誘發的免疫細胞在某些患者體內持續存在了近四年。對疫苗有反應的患者有較長的無復發期，這表明可以產生持久的腫瘤特異性T細胞反應。

商業界對mRNA癌症疫苗的興趣也日益增長。大型生物科技公司和大型製藥公司正在投入數十億美元用於研發。此外，新一代生物科技新創公司正在啟動臨床試驗，探索新的抗原標靶方法、遞送策略和疫苗生產方法。 CK Life Sciences開發的針對TROP2（一種與三陰性乳癌等惡性腫瘤相關的蛋白質）的環狀mRNA疫苗是一項前景光明的研發成果。動物模型的臨床前試驗表明，該疫苗幾乎完全抑制了腫瘤。

儘管前景一片光明，但必須指出的是，目前尚無任何mRNA癌症疫苗獲得監管部門的批准。儘管如此，疫苗研發進程很快，監管機構也相應地進行調整。美國食品藥物管理局（FDA）、歐洲藥品管理局（EMA）和英國藥品和保健產品監管局（MHRA）等機構正在積極制定指南，以適應個人化免疫療法。 NHS 癌症疫苗啟動平台就是此類發展的一個例子，它在英格蘭各地招募患者進行個人化疫苗試驗。

全球有超過 60 種 mRNA 癌症疫苗候選藥物正在開發中，其中一些已進入後期臨床試驗階段，這些療法具有巨大的潛力，有望徹底改變腫瘤學。特別是那些面臨監管審批和量產挑戰的療法，生物技術、基因組學和免疫療法的協同作用，或許很快就會讓癌症疫苗個性化，惠及最受益的個體。

本報告提供全球mRNA癌症疫苗的臨床試驗市場相關調查，市場概要，以及藥物趨勢，臨床試驗趨勢，各地區趨勢，及的加入此市場的主要企業的競爭情形等。

Insight On mRNA Cancer Vaccines In Clinical Trials: > 60 mRNA Cancer Vaccines
mRNA Cancer Vaccine Clinical Trials Insight By Company, Country, Indication & Phase
Key Vaccines Initiation & Completion Year Insight
Ongoing Market Collaborations, Deals & Investments Scenario
Proprietary Technologies & Methodologies For mRNA Cancer Vaccine Development
Market Development Trends By Region & Indications
Competitive Landscape

mRNA cancer vaccine space has become one of the most rapidly evolving domains in modern pharmaceutical sciences. Encouraged by the success with mRNA technology during the COVID-19 pandemic, the pharmaceutical industry and research institutions are currently leveraging this platform to develop highly individualized anticancer therapies. Unlike conventional therapies, which tend to be imprecise and cause systemic toxicity, mRNA cancer vaccines provide targeted immunotherapy depending on the specific genetic mutations present in an individual tumor. Such specificity has the potential to redefine oncology standards of care.

On the clinical front, over 60 mRNA cancer vaccine candidates are under development at different stages. Though most of them are in preliminary research and preclinical development, a few are already in mid- and late stage clinical trials. These vaccines function by teaching the body to generate tumor-specific antigens, eliciting an immune response against cancer cells. mRNA cancer vaccines differ from conventional vaccines in that they can be customized to each individual patient's tumor pattern, a tactic which has already yielded encouraging results in enhancing long-term immune surveillance.

One of the most advanced mRNA cancer vaccine in the pipeline is Moderna and Merck's Intismeran Autogene (mRNA-4157/V940), currently in Phase 3 for melanoma and non-small cell lung cancer (NSCLC). The vaccine is given in combination with Pembrolizumab, an immune checkpoint inhibitor, to maximize immune recognition and killing of cancer cells. This combination approach is meant to optimize immune activation with breakage of resistance mechanisms. Upon a successful outcome, the firms seek to commercialize Intismeran Autogene by the second quarter of 2027.

Another top contender, Autogene cevumeran (BNT122), from BioNTech in partnership with Memorial Sloan Kettering Cancer Center, is also showed promising Phase 1 trial results in pancreatic cancer recently. Early 2025 data showed the vaccine-induced immune cells lasted in some patients for almost four years. Patients who responded to the vaccine had longer relapse-free periods, which suggested the development of long-lasting, tumor-specific T-cell responses.

Commercial interest in mRNA cancer vaccines is also heating up. Billions are being invested in R&D by large biotech companies and big pharma alike. On top of this, a new generation of biotech startups is going into clinical trials with new antigen targeting modalities, delivery strategies, and vaccine production methods. CK Life Sciences' circular mRNA-based vaccine for TROP2, a protein associated with aggressive tumors such as triple-negative breast cancer, is a promising development. Preclinical outcomes in animal models produced almost complete tumor suppression.

Although the enthusiasm is evident, it must be mentioned that none of the mRNA cancer vaccines have been approved by regulatory authorities yet. That said, the journey is rapid, and regulatory agencies are also adapting themselves in tune. Organizations like the FDA, EMA, and the MHRA of the UK are keenly defining guidelines to accommodate individualized immunotherapies. The NHS's Cancer Vaccine Launch Pad is a real-life example of such development, recruiting patients for individualized vaccine trials throughout England.

With more than 60 mRNA cancer vaccine candidates in development worldwide and some at late stages of clinical trials, the possibility of these treatments revolutionizing oncology is vast. Despite challenges, especially in approval by regulators and mass production, bioengineering, genomics, and immunotherapy synergy could soon bring cancer vaccines personalized to individuals who would benefit the most from them.

1. mRNA Vaccines As Next Generation Cancer Immunotherapy

1.1 mRNA Vaccines Overview
1.2 mRNA Vaccines v/s Other Cancer Therapeutic Approaches
1.3 mRNA Vaccines v/s Other Vaccines

2. Global mRNA Cancer Vaccines Market Overview

2.1 Current Market Trends
2.2 Future Market Commercialization & Clinical Opportunities

3. Global mRNA Cancer Vaccine Clinical Trials Insight By Company, Country, Indication & Phase

3.1 Research
3.2 Preclinical
3.3 Phase I
3.4 Phase I/II
3.5 Phase II
3.6 Phase II/III
3.7 Phase III

4. Global Cancer mRNA Vaccines Clinical Pipeline Overview

4.1 By Company
4.2 By Country
4.3 By Indication
4.4 By Patient Segment
4.5 By Phase
4.6 By Priority Status

5. Global mRNA Cancer Vaccines Clinical Landscape By Indication

5.1 Breast Cancer
5.2 Brain Cancer
5.3 Melanoma
5.4 Head & Neck Cancers
5.5 Lung Cancer
5.6 Cervical Cancer
5.7 Gastrointestinal Cancers

6. Global mRNA Cancer Vaccines Market Trends By Country

6.1 US
6.2 China
6.3 Australia
6.4 Europe
6.5 Canada
6.6 UK

7. Global mRNA Cancer Vaccines Market Collaborations, Deals & Investments

8. Proprietary Technologies & Methodologies For mRNA Cancer Vaccine Development

9. Competitive Landscape

9.1 BioNTech
9.2 Combined Therapeutics
9.3 CureVac
9.4 EpiVax
9.5 HDT Bio
9.6 Immorna
9.7 Immune Design
9.8 MDimune
9.9 Moderna Therapeutics
9.10 NeoCura
9.11 pHion Therapeutics
9.12 Providence Therapeutics
9.13 RinuaGene
9.14 RNAimmune
9.15 TransCode Therapeutics

簡介目錄圖表

List of Figures

Figure 4-1: Global - mRNA Cancer Vaccines Clinical Pipeline by Company (Numbers), 2025
Figure 4-2: Global - Number Of mRNA Cancer Vaccines Trials by Country (Numbers), 2025
Figure 4-3: Global - mRNA Cancer Vaccines Clinical Trials by Indication (Numbers), 2025
Figure 4-4: Global - mRNA Cancer Vaccines Clinical Pipeline by Patient Segment (Numbers), 2025
Figure 4-5: Global - mRNA Cancer Vaccines Clinical Pipeline by Phase (Numbers), 2025
Figure 4-6: Global - mRNA Cancer Vaccines Clinical Pipeline by Priority Status (Numbers), 2025
Figure 5-1: KEYNOTE-603 Phase I (NCT03313778) Study - Initiation & Completion Year
Figure 5-2: Autogene Cevumeran Phase I (NCT03289962) Study - Initiation & Completion Year
Figure 5-3: CVGBM Phase I (NCT05938387) Study - Initiation & Completion Year
Figure 5-4: Autogene Cevumeran Phase I (NCT03289962) Study - Initiation & Completion Year
Figure 5-5: BNT111 Phase I (NCT04526899) Study - Initiation & Completion Year
Figure 5-6: mRNA-4157 Phase II (NCT03897881) Study - Initiation & Completion Year
Figure 5-7: mRNA-4157 Phase III (NCT05933577) Study - Initiation & Completion Year
Figure 5-8: BNT113 Phase II (NCT04534205) Study - Initiation & Completion Year
Figure 5-9: mRNA-4157 Phase I (NCT03313778) Study - Initiation & Completion Year
Figure 5-10: V940 Phase III (NCT06077760) Study - Initiation & Completion Year
Figure 5-11: LuCa-MERIT-1 Phase I (NCT05142189) Study - Initiation & Completion Year
Figure 5-12: EMPOWERVAX Lung 1 Phase I (NCT05557591) Study - Initiation & Completion Year
Figure 5-13: Autogene Cevumeran Phase I (NCT04161755) Study - Initiation & Completion Year
Figure 5-14: Autogene cevumeran Phase II (NCT05968326) Study - Initiation & Completion Year
Figure 5-15: BNT122 Phase II (NCT04486378) Study - Initiation & Completion Year
Figure 8-1: BioNTech - uRNA products
Figure 8-2: BioNTech - iNeST technology
Figure 8-3: CureVac - CureVac Method for Generation of mRNA Therapeutics
Figure 8-4: Moderna - mRNA Technology
Figure 8-5: NeoCura - NeoCura Ag Platform
Figure 8-6: Providence Therapeutic - mRNA Medicines Platform Benefits

List of Tables

Table 1-1: mRNA Vaccines v/s Other Cancer Therapeutic Approaches
Table 1-2: mRNA-Based Cancer Vaccines vs. Other Cancer Vaccines
Table 2-1: Regulatory Designations Granted to Investigational mRNA Cancer Vaccines
Table 5-1: Breast Cancer - Some mRNA Vaccines in Clinical Trials
Table 5-2: Brain Cancer - Some mRNA Vaccines in Clinical Trials
Table 5-3: Melanoma - Some mRNA Vaccines in Clinical Trials
Table 5-4: Head & Neck Cancer - mRNA Vaccines in Clinical Trials
Table 5-5: Lung Cancer - Some mRNA Vaccines in Clinical Trials
Table 5-6: Cervical Cancer - Some mRNA Vaccines in Clinical Trials
Table 5-7: Gastrointestinal Cancers - Some mRNA Vaccines in Clinical Trials

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