Neoantigen-Based Personalized Cancer Therapeutic Vaccines - Competitive Landscape and Market Forecast to 2035

Executive Summary

Neoantigen-based Personalized Cancer therapeutic Vaccines Overview

Cancer vaccines use weakened or killed viruses, bacteria, or other infection-causing agents to initiate an immune response in the body. These vaccines are designed to work similarly, wherein the immune system will recognize, attack, and destroy cancer cells. They identify cancer cells as foreign, and therefore, prepare the immune system to attack the cancer cells. Cancer vaccines are one way to utilize the body's immune system to fight cancer.

Neoantigens that arise from cancer-specific mutations represent another class of attractive antigens for therapeutic cancer vaccines. Vaccination against the tumor-specific neoantigens minimizes the potential induction of central and peripheral tolerance as well as the risk of autoimmunity. Neoantigen-based cancer vaccines have recently showed marked therapeutic potential in both preclinical and early-phase clinical studies.

Tumor-specific antigens, also termed as neoantigens, are derived from random somatic mutations in tumor cells and not present in normal cells. Compared to those non-mutated self-antigens, neoantigens could be recognized as non-self by the host immune system and are thus attractive targets for immunotherapies with potentially increased specificity, efficacy, and safety.

Tumor vaccines that target neoantigens mainly include nucleic acid, dendritic cell (DC)-based, tumor cell, and synthetic-long peptide (SLP) vaccines. The combination with immune checkpoint inhibition therapy or radiotherapy and chemotherapy might achieve better therapeutic effects. Currently, several clinical trials have demonstrated the safety and efficacy of these vaccines. Neoantigen-related immunotherapy is a truly personalized therapy because most neoantigens are derived from unique mutations in each tumor genome. Therefore, identification of patient-specific immunogenic neoantigens is the first step in developing such personalized vaccines.

Key Findings

The total Market size of Neoantigen-based Personalized Cancer therapeutic Vaccines for Non-small Cell Lung Cancer, Pancreatic Ductal Adenocarcinoma, Colorectal Cancer, Urothelial Carcinoma, Cutaneous Melanoma, Renal Cell Carcinoma along with few other indications were determined for calculating the market size of several vaccines in the 7MM countries by 2035.

Neoantigen-based Personalized Cancer therapeutic Vaccines Emerging Therapies Chapters

This segment of the Neoantigen-based Personalized Cancer therapeutic Vaccines report encloses its detailed analysis of various vaccines in different stages of clinical development, including phase III, I/II, and I. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included vaccine, and the latest news and press releases.

Neoantigen-based Personalized Cancer therapeutic Emerging Vaccines

Tedopi (OSE2101): OSE Immunotherapeutics

OSE Immunotherapeutics' lead clinical immune-oncology asset is Tedopi, which is neoantigen-based immunotherapy in development for the treatment of HLA-A2+ NSCLC. It contains a combination of 10 optimized neo-epitopes, which are parts of proteins that structurally alter cancer cells and trigger strong immune responses against them. The epitopes present in Tedopi are optimized from five tumorous antigens. The epitopes express a minimum of one of the tumor antigens and generate a specific response from cytotoxic (aka killer) T-cells against cancer cells. Tedopi works by stimulating killer T-cells, enabling them to spot and eliminate cancerous cells, which is a key process in the treatment of disease. Currently, the vaccine is in phase III stage of clinical development for Non-small Cell Lung Cancer.

GRANITE (GRT-C901) + SLATE (GRT-R902): Gritstone Oncology

Gritstone Oncology is developing a combination vaccine product; wherein, GRANITE is personalized neoantigen-based immunotherapy. It is engineered to elicit a significant T-cell response (particularly CD8+ cytotoxic T-cells) against mutation-derived tumor-specific neoantigens, or TSNA, identified for each patient through the company's proprietary EDGE machine learning-based platform. It consists of two components, first an adenoviral priming vector followed by monthly boosting with an RNA vector, each containing the same 20 patient-specific TSNA. On the other hand, SLATE will utilize the same antigen delivery system as GRANITE but includes a fixed set of neoantigens that are shared across a subset of cancer patients rather than neoantigens unique to an individual patient, providing with an off-the-shelf alternative to GRANITE. Currently, the vaccine combination is in phase I/II stage of clinical development for multiple cancer indications such as Colorectal Cancer, Urothelial Carcinoma, and others.

GEN-009 Adjuvanted Vaccine: Genocea Biosciences

GEN-009 is a personalized cancer vaccine that uses Genocea's proprietary ATLAS platform to optimize target selection so that the vaccine has the best chance of targeting the right tumor mutations in each person. It is an adjuvanted neoantigen peptide vaccine candidate designed to direct a patient's immune system to attack their tumor. Currently, the vaccine is in phase I/II stage of clinical development for multiple cancer indications, such as Cutaneous Melanoma, Non-small Cell Lung Cancer, Squamous Cell Carcinoma of the Head and Neck, Urothelial Carcinoma, and Renal Cell Carcinoma.

TG01 Vaccine: Targovax

TG01 is a Neoantigen-specific peptide vaccine targeting RAS mutations - that result in uncontrolled cell divisions - in solid tumors being developed by Targovax. It has developed a unique vaccine against mutant RAS. Upon intradermal administration, TG01 peptides are taken up by activated dendritic cells that migrate to lymph nodes where DCs present the peptides to T cells. Subsets of T cells learn to recognize (CD4+ T helper cells directly and CD8+ Cytotoxic T cells by cross-presentation) the RAS mutations and enter the circulation of the body. When encountering cancer cells with RAS mutations, the T cells are re-activated to generate and trigger immunological killing of the cancer cells. Currently, the vaccine has completed phase I/II stage of clinical development for Pancreatic Cancer.

iNeo-Vac-P01: Hangzhou Neoantigen Therapeutics

iNeo-Vac-P01 by Hangzhou Neoantigen Therapeutics is a peptide-based, personalized cancer vaccine consisting of patient-specific mutated long peptides, which are immunogenic and unique to the patient's tumor, with potential immunomodulating and antineoplastic activities. Upon vaccination with the personalized neoantigen peptide vaccine iNeo-Vac-P01, the peptides stimulate the host immune system to mount a specific and potent cytotoxic T-lymphocyte (CTL) response against tumor cells expressing the neoantigens, which results in tumor cell lysis. Currently, the vaccine is in phase I stage of clinical development for advanced malignant solid tumor such as Pancreatic Carcinoma.

NEO-PV-01: Neon Therapeutics

NEO-PV-01 is a fully personalized cancer vaccine targeting neoantigens that are custom-designed and manufactured for each individual patient based upon the tumor's unique mutational fingerprint. The neoantigen-targeting peptides in NEO-PV-01 are intended to generate an antitumor immune response that directs patients' T-cells to target and kill their cancer cells. NEO-PV-01 is being studied in multiple ongoing phase I clinical trials for Urinary Bladder Cancer, Non-small Cell Lung Cancer, and Metastatic Melanoma.

Further product details are provided in the report.

Neoantigen-based Personalized Cancer therapeutic Vaccines Therapeutic Assessment

This segment of the report provides insights about the different emerging vaccines segregated based on following parameters that define the scope of the report, such as:

• Major Key Players
• Phases
• Route of Administration
• Target Indications of various Vaccines

Neoantigen-based Personalized Cancer therapeutic Vaccines: Market Outlook

The Neoantigen-based Personalized Cancer therapeutic Vaccines market outlook of the report helps in building the detailed understanding of the forecasted Cancer therapeutic Vaccines market by analyzing the therapeutic vaccines based on its promising safety and efficacy results, extent of T-cell responses, tolerability, extent of tumor reduction, extent of recurrence reduction, improvement in median overall survival rate, improvement in progression free survival rate, degree of overcoming unmet needs, market drivers and barriers along with promising novel technologies.

This segment gives a thorough understanding of Neoantigen-based personalized cancer therapeutic vaccines market trend of each pipeline emerging vaccine by evaluating their impact based on the annual cost of therapy, inclusion and exclusion criteria's, mechanism of action, compliance rate, growing need of the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market and view of the key opinion leaders. The calculated market data is presented with relevant tables and graphs to give a clear view of the market at first sight.

According to the publisher, Neoantigen-based Personalized Cancer Therapeutic Vaccines market in 7MM is expected to change in the study period by 2035.

Key Findings

This section includes a glimpse of the Neoantigen-based Personalized Cancer Therapeutic Vaccines market in 7MM.

The United States Market Outlook

This section provides the total Neoantigen-based Personalized Cancer Therapeutic Vaccines market size along with market size by therapies in the United States.

EU-5 Countries: Market Outlook

The total Neoantigen-based Personalized Cancer Therapeutic Vaccines market size along with market size by therapies in EU5 Countries is provided in this section.

Japan Market Outlook

The total Neoantigen-based Personalized Cancer Therapeutic Vaccines market size along with market size by therapies in Japan is provided.

Neoantigen-based Personalized Cancer Therapeutic Vaccines Uptake
This section focusses on the emerging vaccines of the Neoantigen-based Personalized Cancer Therapeutics, which will get launched in the market during the study period by 2035. The analysis covers Neoantigen-based Personalized Cancer Therapeutic Vaccines market, patient uptake by therapies, and sales of each vaccine.

This helps in understanding the vaccines with the most rapid uptake, reasons behind the maximal use of new vaccines, and allows the comparison of the vaccines on the basis of market share and size, which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

Neoantigen-based Personalized Cancer therapeutic Vaccines Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, and Phase I/II stage. It also analyses Neoantigen-based Personalized Cancer Therapeutic Vaccines key players involved in developing targeted therapeutics.

Pipeline Development Activities

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

KOL - Views

To keep up with current market trends, we take KOLs and SME's opinion working in Neoantigen-based Personalized Cancer therapeutic Vaccines domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps understand and validate current and emerging therapies treatment patterns or market trend. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.

Competitive Intelligence Analysis

The publisher performs competitive and market intelligence analysis of the Neoantigen-based Personalized Cancer Therapeutic Vaccines Market by using various tools that include SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.

• OSE Immunotherapeutics
• Gritstone Oncology
• Genocea Biosciences
• Targovax
• Hangzhou Neoantigen Therapeutics
• Neon Therapeutics