Runsheng Cytomed Advances Personalized Cancer Immunotherapy with Dual-Immunity Tvac® Platform

In the race against cancer, human ingenuity has sparked unprecedented innovation. The journey from initial helplessness to surgical tumor resection, and then to systemic treatments such as chemotherapy and radiotherapy, has been long and arduous. Yet cancer remains aggressive and has now become the second leading cause of death worldwide.

The advent of CAR-T therapy has marked the full entry of humanity’s fight against cancer into the era of immunotherapy, drawing significant attention from both academia and industry. However, existing immunotherapies remain unsatisfactory, as a large number of cancer patients still lack access to effective treatment. One of the reasons for the difficulty in developing broad-spectrum cancer therapies is the pathological heterogeneity among cancer patients.

Dr. Ruan Runsheng, Founder of RUNSHENG CYTOMED

Dr. Ruan Runsheng, the founder of GZ RUNSHENG CYTOMED TECHNOLOGY CO. LTD., previously conducted research in the Department of Medicine at the University of Zurich, Switzerland, focusing on cellular and genetic diagnostics and therapeutics for tumor immunology and age-related diseases. He also brings many years of clinical medical experience. Dr. Ruan candidly stated that the unmet anti-cancer needs of clinical oncology patients were the primary driving force behind his entrepreneurial venture into innovative oncology drug development. “Currently, many cancer patients still do not receive effective treatment. The global medical community is searching for an anti-cancer therapy capable of inhibiting tumor cell growth and extending patient survival without causing any side effects.”

From an immunotherapy perspective, Dr. Ruan Runsheng is disappointed with the efficacy of existing targeted drugs designed to block specific tumor pathways. “Ten years ago, targeted therapies were highly regarded; however, over time, some patients have developed drug resistance. Moreover, by blocking physiological pathways involved in cell growth, these agents have inevitably led to certain adverse effects,” he stated. “Currently, only well-established cell-based therapies can eliminate treatment-related side effects. The key question, therefore, is how to leverage technological advancements in cell therapy to achieve optimal anti-cancer outcomes. This is the focus of our discussion.”

In 2018, a paper titled “Rational combinations of in vivo cancer antigen priming and adoptive T-cell therapy mobilize immune and clinical responses in terminal cancers” was published in the renowned oncology journal Cancer Immunology, Immunotherapy. The study preliminarily described the researchers’ approach of screening tumor mutation genes to identify neoantigens, preparing therapeutic vaccines, administering them to patients, isolating antigen-specific T cells from the patients, expanding and culturing these cells ex vivo, and then reinfusing them for adoptive cell therapy. The trial results were highly promising.

Behind this paper lies Dr. Ruan Runsheng’s team, which has given rise to Tvac, the core technology of Runsheng Cell.^®Therapy (Personalized Precision Combination Immunotherapy).

GZ RUNSHENG CYTOMED TECHNOLOGY CO. LTD., a biotechnology company dedicated to the research and development of cell-based therapeutics and their clinical translation, has a core team composed of experts and professors in bioinformatics, tumor molecular biology, and tumor immunology from prestigious institutions such as the National University of Singapore, Stanford University School of Medicine, and Harvard Medical School.

To understand RUNSHENG CYTOMED’s “Tvac^®(Personalized Precision Combination Immunotherapy)”—its name intuitively highlights the key features of this therapy: “personalized,” “precision,” and “combination.” Dr. Ruan Runsheng introduced this innovative therapy to reporters:

Runsheng Cell first analyzes the DNA of tumor patients to identify their specific cell mutation genes. Due to the diversity of genetic mutations, each patient’s profile of mutated genes is unique. Therefore, Runsheng Cell conducts DNA analysis for every individual patient, which embodies the principle of “personalization.”

Identifying Mutated Genes in Cancer Patients Is Only the Tip of the Iceberg for Tvac^®In the first step, Runsheng Cell compares the patient’s tumor cells with normal cells to determine which mutations are transcribed and translated into proteins and which are not expressed. The products encoded by these mutated genes are what are commonly known as “neoantigens.” This approach of identifying each individual tumor patient’s “neoantigens” through gene-level screening is precisely Tvac^®The Core of “Precision” in Therapy.

However, not all identified neoantigens (proteins) elicit an immune response. Runsheng Cell utilizes proprietary technology to precisely identify proteins capable of activating the body’s immune response, referring to them as “tumor neo-peptides.” The primary purpose of identifying these neo-peptides is to prepare “therapeutic vaccines.” Based on the patient’s “tumor neo-peptides,” Runsheng Cell selects several to more than ten of them to formulate a mixed therapeutic vaccine, which is then administered via subcutaneous injection to activate the patient’s immune system. After the immune system generates specific T cells, Runsheng Cell isolates these specific T cells, performs extensive ex vivo culture and expansion, and finally infuses the expanded specific T cells back into the patient, thereby achieving “combination” therapy.

Dr. Ruan Runsheng calls Tvac^®The therapy is an innovative approach combining "active immunization" and "passive immunization." Active immunization refers to the administration of therapeutic vaccines to patients to actively stimulate their immune response, while passive immunization primarily involves the infusion of specific T cells back into the patient’s body to mediate a passive immune response.

Currently, Runsheng Cell has applied for TVac.^®the trademarks and patents, the company plans to apply for Tvac within the next three years^®NDA, officially applied in the clinical treatment of tumors. This therapy is an innovative tumor treatment developed after years of research and experiments by the team, which began exploration when Dr. Ruan Runsheng was engaged in cancer immunology-related research at the University of Zurich in Switzerland. Previously, Dr. Ruan Runsheng's team applied this therapy for five to six years in scientific research, conducting trials on 300 late-stage cancer patients who could not be cured by existing treatments, significantly improving their three-year survival rate.

It is worth mentioning that, due to GZ RUNSHENG CYTOMED's Tvac^®The therapy is entirely personalized, with clinical trials involving patients with a wide variety of advanced-stage cancers, rather than being limited to any single cancer type. It was the success of these trials that gave Dr. Ruan Runsheng the confidence to translate this therapy into clinical practice.

A major challenge in cancer treatment lies in tumor recurrence. After undergoing malignant transformation, cancer cells can disseminate throughout the body; therefore, therapies targeting specific sites are often unable to achieve a radical cure, leading to tumor regrowth.

If a vaccine could be administered as a single dose to cancer patients shortly after their recovery from major illness, thereby preventing recurrence of the same cancer, its value would be self-evident. This is Runsheng Cell’s Tvac.^®A Major Application Scenario for the Therapy.

“For some patients in the early stages of cancer, after their tumor tissue is resected, we can analyze their fresh tumor tissue and then use Tvac”^®“The therapy involves customizing tumor vaccines based on underlying principles to prevent recurrence of the same type of cancer in patients,” explained Dr. Ruan Runsheng. Due to the high variability of tumor genes, Runsheng Cell emphasizes that fresh tumor tissue must be obtained from patients immediately during vaccine preparation to prevent further mutations induced by external stimuli or tumor metastasis.

Against the clock, GZ RUNSHENG CYTOMED TECHNOLOGY CO. LTD. ensures that customized tumor vaccines for patients can be prepared and completed within approximately six weeks. The research team is also optimizing the manufacturing process to further reduce vaccine production time.

Although theoretically, Tvac^®The therapy holds curative potential for all cancer types; however, Runsheng Cell has initiated clinical pipeline development with liver cancer, as its shorter disease course can accelerate the company’s clinical trial progress. Dr. Ruan Runsheng also stated that the company will sequentially launch clinical trials for other tumors in the future.

It is reported that Runsheng Cell raised RMB 9 million in seed funding in the second half of 2019. The company is planning to launch a new round of financing, with an initial target of approximately RMB 30 million, in exchange for around 10% equity. The proceeds will be primarily used for clinical trial research, recruitment of team talent, and laboratory establishment.