Neoantigen-Based Personalized Cancer Therapeutic Vaccines - Pipeline Insight, 2025

This “Neoantigen-Based Personalized Cancer Therapeutic Vaccines - Pipeline Insight, 2025” report provides comprehensive insights about 8+ companies and 10+ pipeline drugs in Neoantigen-Based Personalized Cancer Therapeutic Vaccines pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Neoantigen-Based Personalized Cancer Therapeutic Vaccines: Understanding

Neoantigen-Based Personalized Cancer Therapeutic Vaccines: Overview

Neoantigen-based personalized cancer therapeutic vaccines target unique Tumor-Specific Antigens (TSAs) that arise from somatic mutations or viral infections, offering a more precise and effective treatment compared to traditional Tumor-Associated Antigen (TAA) vaccines. Unlike TAAs, which are also present in normal tissues and may trigger immune tolerance, neoantigens are exclusive to tumor cells, reducing the risk of autoimmune toxicity. The development of these vaccines involves complex processes, including genomic sequencing of tumor and normal tissues, bioinformatic analysis to identify optimal neoantigens, and personalized vaccine production. Despite challenges in predicting neoantigens, these vaccines offer a promising, tailored approach to cancer treatment.

Compared to traditional vaccines, neoantigen vaccines offer several significant advantages. They effectively stimulate, enhance, and diversify anti-tumor T cell responses, maximizing therapeutic specificity and overcoming immune tolerance; Their strong affinity for major histocompatibility complex (MHC) molecules ensures precise targeting of tumor cells, preventing immune cells from attacking normal cells and ensuring treatment safety; and They are highly feasible, generally safe, and easier to manufacture. Additionally, because neoantigens are unique to each patient’s tumor, these vaccines can be personalized to target the specific mutations in an individual's cancer, further improving efficacy. The ability to tailor the treatment to individual patients enhances their therapeutic potential while minimizing side effects, making them a promising option in cancer immunotherapy.

Neoantigen-based personalized cancer vaccines are an innovative approach to immunotherapy that targets unique tumor-specific antigens (neoantigens) generated by somatic mutations or viral infections in cancer cells. Unlike traditional vaccines targeting tumor-associated antigens (TAAs), which may be present in normal tissues and cause immune tolerance, neoantigens are exclusively found on tumor cells, ensuring more precise targeting and reducing the risk of autoimmune reactions. These vaccines are highly personalized, as they are tailored to the specific mutations present in an individual’s tumor, enhancing the immune system’s ability to recognize and eliminate cancer cells. Neoantigen vaccines are also easier to manufacture, generally safe, and can effectively stimulate anti-tumor T cell responses. Despite challenges in predicting and identifying neoantigens, this approach holds great promise for improving the specificity, safety, and effectiveness of cancer treatments.

Neoantigen-based personalized cancer vaccines have shown significant potential across various cancer types, including melanoma, non-small cell lung cancer, and colorectal cancer. By targeting unique mutations specific to a patient's tumor, these vaccines stimulate a highly personalized immune response, enhancing the body's ability to recognize and destroy cancer cells. Clinical trials have demonstrated promising results, particularly when neoantigen vaccines are combined with immune checkpoint inhibitors, which further boost immune activity. In addition to improving patient outcomes by reducing tumor recurrence and progression, these vaccines offer the potential for long-term protection through the induction of memory T cells. As the technology advances, neoantigen vaccines could become a vital component of personalized cancer therapy, especially when tailored to individual tumor profiles and used in combination with other treatment modalities.

'Neoantigen-Based Personalized Cancer Therapeutic Vaccines- Pipeline Insight, 2025' report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Neoantigen-Based Personalized Cancer Therapeutic Vaccines pipeline landscape is provided which includes the disease overview and Neoantigen-Based Personalized Cancer Therapeutic Vaccines treatment guidelines. The assessment part of the report embraces, in depth Neoantigen-Based Personalized Cancer Therapeutic Vaccines commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Neoantigen-Based Personalized Cancer Therapeutic Vaccines collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence Neoantigen-Based Personalized Cancer Therapeutic Vaccines R&D. The therapies under development are focused on novel approaches to treat/improve Neoantigen-Based Personalized Cancer Therapeutic Vaccines.

Neoantigen-Based Personalized Cancer Therapeutic Vaccines Emerging Drugs Chapters

This segment of the Neoantigen-Based Personalized Cancer Therapeutic Vaccines report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase III, II, I, Preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Neoantigen-Based Personalized Cancer Therapeutic Vaccines Emerging Drugs

mRNA-4157: Moderna, Inc.

mRNA-4157 (V940) is a novel investigational messenger RNA (mRNA)-based individualized neoantigen therapy (INT) consisting of a synthetic mRNA coding for up to 34 neoantigens that is designed and produced based on the unique mutational signature of the DNA sequence of the patient's tumor. Upon administration into the body, the algorithmically derived and RNA-encoded neoantigen sequences are endogenously translated and undergo natural cellular antigen processing and presentation, a key step in adaptive immunity. Individualized neoantigen therapies are designed to train and activate an antitumor immune response by generating specific T-cell responses based on the unique mutational signature of a patient's tumor. The U.S. Food and Drug Administration and European Medicines Agency granted Breakthrough Therapy Designation and the Priority Medicines (PRIME) scheme, respectively, for mRNA-4157 (V940) in combination with KEYTRUDA for the adjuvant treatment of patients with high-risk melanoma. Currently, the drug is in Phase III stage of its development for the treatment of Resected High-Risk (Stage IIB-IV) Melanoma.

TG4050: NEC Corporation

TG4050 is an individualized immunotherapy being developed for solid tumors that is based on Transgene's myvac® technology and powered by NEC's longstanding Artificial Intelligence (AI) and Machine Learning (ML) expertise. This virus-based therapeutic vaccine encodes neoantigens (patient-specific mutations) identified and selected by NEC's Neoantigen Prediction System. The prediction system is based on more than two decades of expertise in AI and has been trained on proprietary data allowing it to accurately prioritize and select the most immunogenic sequences. TG4050 is designed to stimulate the immune system of patients in order to induce a T-cell response that is able to recognize and destroy tumor cells based on their own neoantigens. This individualized immunotherapy is developed and produced for each patient. Currently, the drug is in Phase I/II stage of its clinical trial for the treatment of Squamous Cell Carcinoma of Head and Neck.

VB10.NEO: Nykode Therapeutics

VB10.NEO is a proprietary individualized neoantigen vaccine in development for the treatment of locally advanced or metastatic solid tumors. The vaccine is designed to be produced on-demand according to the neoantigen profile of an individual patient. Neoantigens are proteins generated by tumor-specific mutations not present in normal tissues and are thus an attractive target for cancer immunotherapy as they may be recognized as foreign by the immune system. It has been shown to be generally well tolerated and with an ability to generate uniquely broad patient- and tumor-specific long-lasting immune responses. Currently, the drug is in Phase I/II stage of its clinical trial for the treatment of Solid Tumors.

Neoantigen-Based Personalized Cancer Therapeutic Vaccines: Therapeutic Assessment

This segment of the report provides insights about the different Neoantigen-Based Personalized Cancer Therapeutic Vaccines drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Neoantigen-Based Personalized Cancer Therapeutic Vaccines

• There are approx. 8+ key companies which are developing the therapies for Neoantigen-Based Personalized Cancer Therapeutic Vaccines. The companies which have their Neoantigen-Based Personalized Cancer Therapeutic Vaccines drug candidates in the most advanced stage, i.e. Phase III include, Moderna, Inc.

Phases

The report covers around 10+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

Route of Administration

Neoantigen-Based Personalized Cancer Therapeutic Vaccines pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Neoantigen-Based Personalized Cancer Therapeutic Vaccines: Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, II, I, preclinical and discovery stage. It also analyses Neoantigen-Based Personalized Cancer Therapeutic Vaccines therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Neoantigen-Based Personalized Cancer Therapeutic Vaccines drugs.

Neoantigen-Based Personalized Cancer Therapeutic Vaccines Report Insights

• Neoantigen-Based Personalized Cancer Therapeutic Vaccines Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Neoantigen-Based Personalized Cancer Therapeutic Vaccines Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Neoantigen-Based Personalized Cancer Therapeutic Vaccines drugs?
• How many Neoantigen-Based Personalized Cancer Therapeutic Vaccines drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Neoantigen-Based Personalized Cancer Therapeutic Vaccines?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Neoantigen-Based Personalized Cancer Therapeutic Vaccines therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Neoantigen-Based Personalized Cancer Therapeutic Vaccines and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Moderna, Inc.

NEC Corporation

• Nykode Therapeutics
• EVAXION BIOTECH A/S
• Nouscom
• Geneos Therapeutics

Key Products

• mRNA-4157
• TG4050
• VB10.NEO
• EVX-02
• NOUS-PEV
• GNOS-PV02

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