Neoantigen Biologics Announces Significant Preclinical Efficacy of Its Personalized Cancer Peptide Vaccine and Imminent IND Submission

The capital industry’s assessment of technological prospects, to a certain extent, determines the future development of China’s technology market. Professor Chen Shuqing, as one of the earliest pioneers in China to propose the application of neoantigens for tumor therapy, has dedicated nearly two decades of research to the fields of personalized medicine and precision oncology.

However, as of now, no personalized therapy products based on tumor neoantigens have been approved for market launch either domestically or internationally. Consequently, domestic capital has adopted a cautious and wait-and-see stance toward companies engaged in such R&D. In China, the investment logic of most institutional investors in pharmaceutical companies hinges on identifying U.S. counterparts; if a new therapy gains regulatory approval in the United States, Chinese investors will actively seek out comparable domestic enterprises to deploy capital in related projects within that field.

Although this investment logic appears prudent, it prevents China’s medical technology innovations from surpassing those of the United States, relegating them to a perpetual position of catching up. CAR-T therapy serves as one such example. From another perspective, this investment approach supports entrepreneurship rather than true innovation; consequently, it fails to capture the substantial profits generated by innovation, forcing companies to compete solely through price wars and cost reduction. Therefore, the ability of the capital sector to assess the prospects of medical technologies will become critically important. It is essential to forecast the competitive advantages and future market potential of tumor neoantigen vaccines among various anti-cancer therapies. Will this therapeutic approach become the next breakthrough in conquering cancer?

Professor Chen Shuqing is a scientist in the pharmaceutical field. The primary mission of scientists is to address unresolved societal challenges, with cancer being the most significant threat to human health. Consequently, it has become a key disease target that scientists strive to conquer through relentless, round-the-clock research.

Professor Chen Shuqing, Founder of Newanjin Biotechnology

In the early 1990s, Professor Chen Shuqing’s research focus was on genetic polymorphism, exploring how genetic differences among individuals lead to variations in drug dosage and other aspects. “At that time, I raised a question:Are the genes in different cells of one's own body completely identical?“Professor Chen Shuqing recalled that it was this ordinary moment of reflection that marked the beginning of his gradual unveiling of the ‘tumor neoantigen vaccine.’”

At that time, most people believed that an individual’s human genes remained constant throughout their lifetime. However, some scientists conducting cutting-edge research discovered genetic alterations in human tumor cells. “If genes in tumor cells can mutate, then genes in other cells may also mutate.” This insight became a new research direction for Professor Chen Shuqing at the time.

What is the utility of identifying intrinsic genetic variations within the human body? Professor Chen Shuqing began with theoretical research to explore its practical significance.

From an immunological perspective, human health is maintained through the dynamic equilibrium of the immune system—lesion cells emerge and are cleared by the immune system, a process that occurs daily. “The development of tumors represents a disruption of this balance.” When a single cancerous cell evades immune clearance, a mass forms. Professor Chen Shuqing vividly described this as ““The bad guys” (tumors) are too cunning, while the “police” (immune system) are too incompetent."Hangzhou Newanjin Biotechnology approaches cancer research from this perspective."

Hangzhou Newanjin Biotechnology Co., Ltd. is a high-tech innovative enterprise founded by Professor Chen Shuqing in 2016, specializing in the research and development of personalized cancer immunotherapy. The company is dedicated to developing various personalized immunotherapeutic products based on neoantigens. Newanjin Biotechnology aims to “file named reports” against “culprits” with the “police,” enabling the immune system to precisely locate and selectively eliminate cancerous cells.

Among these, the “credentials” that enable immune cells to precisely identify cancerous cells are tumor neoantigens—cell surface markers present only on tumor cells and absent on normal cells.

As the cost of gene sequencing decreases, it has become feasible to detect mutated genes corresponding to neoantigens in tumor cells. Hangzhou Newanjin Biotechnology Co., Ltd.’s artificial intelligence analysis platform leverages this capability to predict neoantigens and design tumor vaccines. After these personalized vaccines are custom-manufactured and injected subcutaneously into patients, dendritic cells uptake them and present the signals to T cells. The T cells, acting as “police,” then receive this “verified tip-off” and selectively eliminate cancerous cells.

Following the discovery of this fundamental mechanism underlying immunotherapy, scientists were greatly enthused. As the cost of gene sequencing declined, related academic papers began to appear one after another. Professor Chen Shuqing received support from the National Natural Science Foundation of China and other funding bodies, and conducted in-depth research for several years on tumor neoantigen vaccines.

However, Professor Chen Shuqing also pointed out that merely staying at the research stage is far from enough to industrialize tumor neoantigen vaccines and truly benefit the people; clinical trials are essential. With this in mind, Professor Chen Shuqing believes that leveraging social capital is necessary to accelerate the industrialization of personalized neoantigen vaccines. Thus, Hangzhou Newanjin Biotechnology Co., Ltd. was established, with Dr. Mo Fan, the company's general manager, serving as a co-founder and a key figure in the company.

Dr. Mo Fan earned his degree in bioinformatics through the joint program between Zhejiang University and the University of Washington. Prior to returning to China, he served as a Senior Research Fellow at the University of British Columbia and the Vancouver Prostate Centre in Canada. He specializes in developing bioinformatics and big data analytics algorithms, leveraging artificial intelligence and other computational methods to construct tumor biomarker models, identify targets for targeted cancer therapies, and design neoantigen vaccines, thereby advancing the development of personalized precision diagnosis and treatment strategies.

The collaboration between Professor Chen Shuqing and Dr. Mo Fan has strengthened the company’s resolve to translate its research achievements in tumor neoantigen vaccines into clinical applications. The company’s team comprises top-tier talents from Zhejiang University, the University of British Columbia (UBC) in Canada, Cornell University, and The Ohio State University in the United States, focusing on the development of novel tumor immunotherapy products based on neoantigens.

Genetic mutations in tumor cells occur randomly, with a very small proportion of mutations shared among patients; consequently, the number of shared neoantigens is also limited. Nevertheless, this represents one of the strategic directions in the R&D pipeline of Hangzhou Newanjin Biotechnology Co., Ltd.

Neoantigens derived from driver gene mutations are shared among the tumors of a certain proportion of patients; therefore, these patients can be treated with pre-manufactured peptide vaccines without waiting for customization, thereby avoiding delays in optimal treatment timing. Hangzhou Newanjin Biotechnology Co., Ltd. has developed a pipeline of off-the-shelf tumor neoantigen peptide vaccine products, which are currently in the preclinical research stage.

However, the company’s most advanced product remains iNeo-Vac-P01, an individualized tumor neoantigen peptide vaccine. Leveraging the iNeo AI-powered vaccine design platform and a personalized peptide drug manufacturing and quality control system, this product enables the customization of individualized peptide vaccines for each patient. Since late 2017, multiple non-registration clinical trials have been conducted at several Grade A tertiary hospitals, enrolling a total of more than 50 patients with advanced-stage pan-cancer solid tumors who had failed second-line or subsequent therapies.

Notably, the results of a clinical trial conducted at Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, were recently published in the prestigious international journal Clinical Cancer Research. The findings indicate that90.9% of subjects experienced no serious adverse reactions，38.1% of subjects exhibited tumor shrinkage during monotherapy with the neoantigen peptide vaccine. Following monotherapy with iNeo-Vac-P01,The disease control rate in patients was 71.4%.，Median progression-free survival was 4.6 months，The 12-month overall survival rate was 55.1%., demonstrating the safety and efficacy of personalized vaccines. Furthermore,80% of peptide vaccines elicited antigen-specific immune responses, potential biomarkers predictive of therapeutic efficacy were also identified through TCR sequencing, T-cell subset analysis, and cytokine profiling.

Hangzhou Newanjin Biotechnology Co., Ltd. will submit an Investigational New Drug (IND) application for its personalized tumor peptide vaccine (iNeo-Vac-P01) in the near future.

Furthermore, to address the high tumor burden and compromised immune systems in patients with advanced-stage cancer, Hangzhou Newanjin Biotechnology Co., Ltd. has established a third pipeline for tumor immunotherapy products: individualized neoantigen-specific autologous immune cell therapy (iNeo-Vac-T01). This product involves collecting the patient’s own immune cells, which are then activated and expanded ex vivo to generate a large population of immune cells capable of recognizing tumor neoantigens. These cells are subsequently infused back into the patient intravenously to achieve targeted killing of tumor cells.

Currently, Hangzhou Newanjin Biotechnology Co., Ltd. possesses globally leading AI-based identification and optimization systems for neoantigens, personalized vaccine production and quality control systems, and platforms for monitoring immune responses and tumor cells. With a complete industrial chain, well-equipped talent pool, and abundant clinical and industrial resources, it is the first neoantigen new drug R&D company in China to independently build core technology platforms and achieve a closed-loop full industry chain. The company aims to become a leader in the era of customized precision immunotherapy 2.0.

It is reported that Hangzhou Newanjin Biotechnology Co., Ltd. completed an angel financing round worth tens of millions of yuan in 2016. The company has now launched a Pre-A financing round, with plans to use the raised funds for subsequent regulatory filings and clinical trials of iNeo-Vac-P01 and iNeo-Vac-T01.