Billion-Dollar mRNA Cancer Vaccine Market Attracts Global Pharma Rush Amid New IPO Filings

　　【Pharmaceutical Network Industry Dynamics】Compared with antibodies and cell therapies, mRNA can achieve intracellular drug delivery for treatment. In the prevention and treatment of tumors, the industry believes that mRNA has significant advantages in terms of both safety and efficacy. Additionally, it offers the benefit of rapid production speed, making it applicable for the preparation of personalized tumor vaccines, showing great potential.
 

Relevant data shows that by 2035, the global market size for mRNA preventive cancer vaccines is expected to reach $12 billion to $15 billion, while the market size for mRNA personalized cancer vaccines will be approximately $7 billion to $10 billion, corresponding to a total market potential of around $23 billion to $30 billion for mRNA vaccines in cancer treatment and prevention.
 

In recent years, the mRNA tumor vaccine field has attracted fierce competition among pharmaceutical companies. On January 24, 2024, Grand Pharmaceutical Group Limited announced that the IND (Investigational New Drug) application for its subsidiary Nanjing Orol Bio's therapeutic tumor vaccine ARC01 (A002), targeting human papillomavirus type 16 (HPV-16) positive advanced unresectable or recurrent/metastatic solid tumors, was approved by the National Medical Products Administration.
 

According to reports, ARC01 is China's first mRNA therapeutic tumor vaccine approved for clinical trials, classified as a Category 1 biological product for therapeutic use.
 

HPV is a non-enveloped, double-stranded circular DNA virus that targets epithelial tissues and can cause proliferative lesions in human skin and mucous membranes.
 

The clinical study approved for ARC01 this time aims to evaluate the safety, tolerability, immunogenicity, pharmacokinetic characteristics, and efficacy of the drug in Chinese subjects with HPV-16 positive advanced unresectable or recurrent/metastatic solid tumors.
 

In addition to Grand Pharmaceutical Group Limited, many pharmaceutical companies in China, such as Abogen and Stemirna Therapeutics, have also placed bets on the mRNA tumor vaccine track.
 

In June 2023, Stemirna announced that its IL-12 non-replicating mRNA injection, SW0715, received implied permission for clinical trial application (IND) for the treatment of recurrent/metastatic advanced malignant solid tumors.
 

In March 2023, the clinical trial application for ABO2011 injection, an mRNA drug under research by Abogen in the field of cancer treatment, was approved by the National Medical Products Administration (NMPA) for the treatment of advanced solid tumors that have progressed or metastasized after systemic standard therapy.
 

In March 2023, the Investigational New Drug (IND) application for XH101 Injection, an mRNA tumor neoantigen vaccine submitted by NeoBio, was accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration. It is reported that XH101 Injection is NeoBio's First-in-Class therapeutic mRNA tumor vaccine targeting public neoantigens in gastric cancer.
 

Meanwhile, a look at multinational pharmaceutical companies shows that many overseas firms, including BioNTech, Moderna, and CureVac, are actively positioning themselves in the mRNA tumor vaccine field.
 

On February 22, 2023, Moderna announced that its tumor neoantigen mRNA vaccine mRNA-4157/V940, used in combination with Merck's anti-PD-1 therapy Keytruda as an adjuvant treatment for high-risk melanoma, received Breakthrough Therapy Designation from the U.S. FDA. On December 14, 2023, local time in the U.S., Moderna and Merck announced that within three years, the use of the mRNA vaccine mRNA-4157 (V940) combined with the PD-1 therapy Keytruda (pembrolizumab) reduced the risk of recurrence by nearly half in patients with skin cancer melanoma. Following this news, Moderna’s stock opened with a surge of 20%.
 

Industry data shows that, as of March 2023, there are already dozens of clinical trials worldwide related to mRNA tumor vaccines. With active participation from pharmaceutical companies both in and outside China, the industry believes this will benefit the continuous advancement of neoantigen-based tumor vaccine research. Meanwhile, under increasingly fierce competition, the future price of tumor vaccines may continue to decrease.
 

Disclaimer: Under no circumstances shall the information or opinions expressed in this article constitute investment advice to any person.