NK CellTech: Zhangjiang Is the Ideal Ecosystem for CGT Innovation and Commercialization

In addition,NK Cell Therapy Expected to Become More "Affordable".As a new type of precision targeted therapy tailored to the specific conditions of cancer patients, CAR-T therapy is also called a "custom-made product," and its cost has been one of the major challenges the industry has focused on in recent years.

"The production and preparation process of CAR-T drugs is complex and繁琐, with a high degree of personalization. The quality control环节 involved has very high requirements, making the accessibility of these drugs for patients and healthcare systems a significant challenge. This limits their clinical application推广, and reducing costs while improving efficiency has become an urgent priority in the development of such drugs," analyzed Fang Fang.

NK Cells Naturally Possess the Characteristic of Being Usable in Allogeneic Applications. More than 30 years ago, Academician Tian Zhigang, a member of the Chinese Academy of Engineering and founder of Enka Therapeutics, along with his team, validated the feasibility of clinical applications of allogeneic NK cells in both animal models and clinical studies. "NK cell products have the inherent potential to achieve 'universal' and 'off-the-shelf' supply. From a production standpoint, they can be manufactured in batches, reducing production costs and making them more affordable. If they could further enter the medical insurance system, the accessibility of NK cell therapy products would be significantly improved."

Currently, there are two main approaches in NK cell therapy: one is the use of unmodified NK cells for treatment, and the other is the use of genetically modified engineering to enhance the function of NK cells for therapeutic purposes.

On these two pathways, Enkaicell has made arrangements: NK010 isThe first non-gene-edited allogeneic peripheral blood NK cell drug in China to receive FDA approval; NK042 is a universal gene-modified NK cell drug derived from allogeneic peripheral blood.

NK010 and NK042 have successively obtained clinical approvals from the pharmaceutical regulatory authorities in China and the United States, markingEnkaisai Medicine has overcome two core technical challenges: in vitro expansion and cultivation of NK cells and gene modification, reaching industrial production standards.。

A Corner of Encyte Lab

In the challenges of NK cell drug development, Enka Therapeutics has carried out technological innovation at an early stage. "At present, we have overcome these two major technical problems. The non-feeder cell expansion system can achieve a single-batch expansion of thousands of times; meanwhile, the newly modified virus system can stably achieve high transfection efficiency of NK cells," said Fang Fang.

It is worth noting that although Enkaisai Pharmaceutical has overcome the key core technology of NK cell virus infection, the high cost of virus production and potential clinical application risks are common problems currently faced in the CGT field.

On August 1 last year, Enkaicell andRongcan BioAnnounce the signing of a strategic cooperation agreement, under which the two parties will establish a long-term strategic partnership in the field of LNP delivery systems. The aim is to explore more safe and effective gene transduction pathways that reduce the production costs of genetically modified NK cells, achieve cost reduction and efficiency improvement of products, enhance clinical accessibility, and benefit a wide range of patients.

"Rongcan Bio is also a Zhangjiang enterprise."It can be said that Zhangjiang is currently the best and most suitable place for the development of the CGT industry.Here, we can not only gain cooperation across the upstream and downstream of the industry chain, but also receive strong support from Zhangjiang in terms of policies, funding, and more. In terms of policy, Zhangjiang keeps its promises and delivers on commitments, and won’t make false claims if they can’t deliver. In terms of funding,Zhangjiang Group's Investment, Loan, Incubation, and Education Platform: Zhangjiang Kaitou (Herun Fund)"Participated in our early financing." Fangfang introduced.

“Established for more than two years, Zhangjiang has accompanied NKMed's growth and development all the way, and we have also witnessed its rapid changes., including the establishment of universities and research institutions, an increasing number of innovative companies are gathering here. In the park, you can feel a strong atmosphere of innovation, which also keeps us sober and determined to move towards our goals." Fang Fang sighed.

Now,Enkaicell has achieved the transformation from laboratory to industrialization, as well as the leap from preclinical to clinical stages.。"This is a huge breakthrough for Enkaice Pharmaceuticals. Because for innovative R&D companies, most creative ideas come from basic research and are produced in laboratories. How to overcome technical bottlenecks, achieve technology transfer, and pass market validation is undoubtedly a significant challenge."

Inside Enkaicell Laboratory

Although, compared with large molecule drugs, cell therapy products, as living drugs, are expected to achieveMultipotent, Precise, Intelligent, Controllable, but it still has many technical bottlenecks, such as those involving the logical relationships of multi-gene functions.

"Relying on decades of accumulation in the field of gene and cell therapy, our team has built three platforms to achieve multi-functional, intelligent, and controllable gene editing of NK cells," said Fang Fang.

Among them,SynNK^TMSynthetic Immune Technology PlatformBy integrating multidisciplinary fields such as the immunological principles of cross-fusion cell anti-tumor activity, logic-gated engineering principles, computer science principles, and synthetic biology technologies, a groundbreaking technological bottleneck in the interdisciplinary field of synthetic immunology has been innovatively overcome. This has led to the development of a series of innovative, proprietary key common technologies in synthetic immunology. More importantly, based on this technological platform, by remodeling, correcting, and reconstructing the body's immune system, it enables the scalable and industrialized production of "living," manipulable, and intelligent synthetic NK cell therapies, which can be applied to immunotherapy for major diseases.

NKR-NK Target PlatformThe natural NK cell receptor-ligand repository can be utilized to equip genetically modified NK cells with novel, biologically principled target recognition systems, effectively giving NK cells "eyes" to more precisely target and kill tumor cells.

ABCDE-NK^®Industrial Production PlatformWe can leverage the unique advantages of NK cells' natural anti-tumor properties to develop a series of innovative, clinical "off-the-shelf" NK cell products, which utilize allogeneic blood as raw material and can be "customized" based on donor/recipient and disease characteristics, meeting pharmaceutical testing and clinical standards for large-scale production. This approach maximizes the therapeutic potential of NK cells, providing optimal NK cell treatment options for patients with advanced cancer.

R&D Staff at Enka Therapeutics Working Scene

"On the basis of the three major platforms mentioned above, Enkaipharmon is also advancing several product pipelines."We hope that through the pioneering development of next-generation immune cell therapy technologies, we can continuously provide a steady stream of proprietary source products, systematically addressing the challenge of the lack of original cell-based drugs in China, and bringing more novel therapies to patients worldwide."Fang Fang said.