IGC 2024 (the 8th Immuno-Gene and Cell Therapy Conference) was grandly opened on September 6-7 at the Beijing International Convention Center. During the period from 9:00 a.m. to 12:35 p.m. on September 6, 2024, Hillgene carefully prepared a satellite conference session themed with “Diving Deeper - A New Track and Platform for Immune Cell Therapy”, bringing together experts from various cutting-edge fields such as CAR-γδT, CAR-NK, CAR-T, TCR-T and TIL as invited speakers. They brought the latest research results and insights in their respective fields, and jointly discussed the latest progress, technological innovation, and commercialization prospects in the field of immune cell therapy.

Academician Zhang Dan, Co-founder & Co-chairman of Hillgene, served as the moderator of this satellite conference. The conference was rich in content and presented a splendid academic feast for the participants.

- Opening Remarks and Opening Speech -

The satellite conference kicked off with the excellent introduction of Academician Zhang Dan. As the Co-founder and Co-chairman of Hillgene, Academician Zhang Dan presented his high hopes for the current status and future of immune cell therapy, and set the tone for in-depth exploration of this satellite conference.

Academician Zhang Dan

Jiangsu Hillgene Biopharma (“Hillgene”)

Co-founder & Co-chairman

Academician Zhang Dan mentioned in his opening remarks that cell therapy has such typical characteristics as forward-looking, exploratory, disruptive, and pioneering in the future industry. With continuous breakthroughs in the foundation and application of cutting-edge fields, cell therapy is providing innovative solutions for the treatment of tumors, systemic, degenerative and other diseases, meeting people’s growing health needs, fundamentally improving human quality of life, and leading human society into the era of bioeconomy. The development in the field of cell therapy in China is flourishing, showing a trend of catching up with the international community, especially in the field of ATMP clinical trials where China is leading the world. Faced with the challenge of solid tumor treatment, we need to make continuous efforts in innovation and break through the limitations of CAR-T, so as to bring new hope to patients and jointly open a new chapter for life health with the help of cell therapy drugs.

“Application Prospects and Regulatory Requirements of Novel Enveloped Lentiviruses”, revealed to the attendees the key role of lentiviral vectors in gene therapy and corresponding regulatory challenges, laying a theoretical foundation for subsequent discussions.

Zhao Yuan

Jiangsu Hillgene Biopharma (“Hillgene”)

Chief Technology Officer (CTO)

Professor Zhao Yuan elaborated on the challenges of cell gene therapy, the development of novel enveloped lentiviruses, safety considerations concerning new vectors, and regulatory requirements in his speech. Professor Zhao stated that in the field of cell and gene therapy (CGT), despite of a growing number of researchers making constant efforts in pursuing innovation, there is still no vector that can perfectly meet all the needs of gene delivery. Especially the novel enveloped lentiviruses, after 30 years of continuous development and optimization, have become an important tool in this field. However, the application of lentivirus products also comes with critical safety risks, such as unpredictable consequences caused by gene insertion mutations and the generation of replication competent lentivirus (RCL) due to homologous recombination, which pose potential threats to patient safety. Therefore, regulatory authorities have established strict safety and quality control requirements for lentivirus products to ensure their clinical safety and efficacy.

Hillgene has developed different novel enveloped lentivirus platforms and transfection systems for T cells, TIL, γδT, NK, NKT, and HSC, which can efficiently and compliantly establish suitable transduction systems for different cell drugs and accelerate the completion of product proof-of-concept.

- Keynote Speech -

Unicet Biotech

Dr. Ma Weiwei, Co-founder and CTO of Unicet Biotech, gave a keynote speech titled “Preclinical Development and Research Progress of Innovative CAR-γδT Cell Drugs”:

Ma Weiwei

Unicet Biotech

Co-founder & CTO

Dr. Ma Weiwei first introduced in his speech the γδ T cells, which have the natural advantage of allogeneic transplant and great potential in the treatment of solid tumors. Next, he introduced a series of platforms established by Unicet Biotech, including GDex γδ T cell preparation platform, GDcyroγδ T cell cryopreservation technology platform, GDit γδ T cell gene editing platform, and GDance cell enhancement technology platform, which can provide support for the clinical development of γδ T cell drugs. Finally, Dr. Ma also introduced the latest clinical trial results of the self-developed allogeneic universal B7H3-targeting CAR-γδ T cell drug QH104. His sharing sparked strong interest among the participants in γδ T cell therapy and its future applications. This achievement not only validates the efficacy of QH104 in tumor treatment, but also demonstrates the innovative strength and forward-looking vision of Unicet Biotech in the field of cell therapy. We look forward to and wish this product an early entry into the commercialization stage.

TCRx Therapeutics

Dr. Jiao Shiping, Founder, Chairman and CEO of TCRx Therapeutics, shared with us a keynote speech titled “TCR-T Cell Therapy in Solid Tumors: Sequence Screening and Clinical Applications”:

Jiao Shiping

TCRx Therapeutics

Founder, Chairman & CEO

In his speech, Dr. Jiao Shiping elaborated on the development history of T cells, the mechanism of T cell recognition of tumors, personalized TCR-T cell drugs and clinical operation pathways, the research and development of new immunotherapy, and the latest data from clinical trials. He mentioned that TCR-T therapy of TCRx Therapeutics can leverage the combined advantages of innovative artificial intelligence platforms and comprehensive databases of tumor-reactive TCR sequences and tumor omics data to focus on developing and manufacturing personalized and targeted TCR-T products specifically for the treatment of solid tumors. In March 2023, the US FDA officially granted an orphan drug designation to KSH01 TCR-T cell product developed by TCRx Therapeutics for the treatment of solid tumors. Later in April this year, this product obtained the clinical trial implied permission from NMPA, marking it is the first TCR-T cell drug for most common cancers of the digestive and urinary systems in China. Equally noteworthy and anticipated is the KSX01-TCRT personalized TCR T drug pipeline developed by TCRx Therapeutics, which has non fixed targets and no HLA typing restrictions. It has also obtained human safety and efficacy data from the Phase I research-oriented clinical trials. As the world’s most cutting-edge genetically engineered T cell therapy for solid tumors, it has huge clinical demand and broad market prospects, and is a new variety of cell drugs expected globally.

Sino-Cell Biomed

Dr. Zhang Xinhua, Vice President of Quality Department of Sino-Cell Biomed, gave a keynote speech titled “Commercialization Prospects and Feasibility of TIL Cell Therapy Products in China”:

Zhang Xinhua

Sino-Cell Biomed

Vice President of Quality Department

In her speech, Dr. Zhang Xinhua deeply analyzed the challenges faced by the commercialization of TIL therapy products, and highly praised the unremitting efforts and innovative breakthroughs made by Chinese enterprises in this field. She specifically introduced the characteristics of the TIL therapy product independently developed by Sino-Cell Biomed, such as reducing the amount of tumor tissue used, shortening the culture time, reshaping the tumor microenvironment, and developing multiple cancer processes. These characteristics not only demonstrate the excellent safety and efficacy potential of TIL therapy, but also accelerate the promotion of TIL therapy in larger varieties of solid tumor types. The first domestic self-developed TIL therapy drug, HS-IT101 injection, obtained clinical trial implied permission from NMPA in November last year and is currently undergoing Phase I clinical trials. This product has excellent technological advantages in the international market, and has activity and efficacy not inferior to Amtagvi products even at dosage as low as IL-2. HS-IT201 is a genetically modified TIL product independently developed by Sino-Cell Biomed, which has also entered the IIT clinical trial stage. This product can significantly reduce tumor immune escape through genetic modification, effectively controlling the recurrence and metastasis of solid tumors.

Dahua Kaite

Professor Tang Dongqi, CSO of Dahua Kaite, shared with us a keynote speech titled “CAR-X Entering the Fast Lane”:

Wang Ting

NK CellTech

R&D Director

Dr. Wang focused on two aspects in his speech: the rise of NK cell therapy and the initial IIT practice by NK CellTech. He elaborated on three strategies for differentiated development of NK cell therapy drugs, namely, allogeneic NK cells are the key to promoting the large-scale application of cell drugs; adopt the drug targeting pattern of NK cell receptor (NKR) replacing CAR/TCR cells; and develop the synthetic immunology technologies to achieve precision, multifunctionality, intelligence, and controllability, which will determine the ultimate winners in the competition of immune cell therapy field. In addition, Dr. Wang also shared the practical experience of the NK010 IIT clinical trial, especially the in-depth analysis of NK cells over the human lifespan and its important implications for treatment safety, providing valuable insights and reflections for the attendees. The NK010 injection and NK042 injection independently developed by NK CellTech obtained clinical trial (IND) approvals from FDA and NMPA in January and May of this year, respectively. NK010 injection is a non-genetically modified allogeneic NK cell from peripheral blood that has great potential in tumor treatment. It also has application value in non-cancer diseases and in combination with other therapies such as monoclonal antibodies and chemotherapy.

Dahua Kaite

Professor Tang Dongqi, CSO of Dahua Kaite, shared with us a keynote speech titled “CAR-X Entering the Fast Lane”:

Tang Dongqi

Dahua Kaite

CSO

Professor Tang Dongqi analyzed in his sharing the cutting-edge trends of CAR-X cell therapy technology in a clear and concise manner, revealing the remarkable latest breakthroughs and thriving development momentum in this field. He emphasized that immune gene and cell therapy technologies have not only shown unprecedented potential in cancer treatment, providing patients with new treatment options and hope, but also have broad application prospects in the fight against genetic and autoimmune diseases. In his speech, Professor Tang not only comprehensively reviewed the current scientific research progress in this field in detail, but also deeply analyzed the current situation of industry development from a unique perspective, presented the challenges faced by us, and keenly pointed out the valuable opportunities as well.

- Roundtable Discussion: Gathering Wisdom for a Brighter Future -

The climax of the conference was undoubtedly the roundtable discussion session, where under the guidance of the moderator Academician Zhang Dan, experts from different fields were gathered together to have in-depth exchanges on the theme of “International Development Strategies for Cell Therapy from an International Perspective”. The guests, based on their own experience and industry insights, expressed unique views on international cooperation, adaption to regulatory requirements, technological innovation, and other related aspects of cell therapy, providing valuable ideas and suggestions for the future development of the industry.

As for the topic on the high cost of cell therapy, guests also freely expressed their opinions. The flexibility of domestic approval policies ensures quality and safety while accelerating the launch of innovative drugs. Meanwhile, they emphasized that strengthening science popularization and education to enhance public awareness is the only way to expand market demand. Moreover, optimizing the international layout and promoting cross-border cooperation and experience sharing can not only introduce world-leading technologies and management experience and integrate global wisdom, but also reduce costs to some extent, thus ultimately making cell therapy products more accessible and benefiting patients worldwide.

Roundtable Discussion

- Summary and Prospect -

This satellite conference not only showcased the latest research achievements and technological progress in the field of immune cell therapy, but also promoted exchanges and cooperation within the industry. With the continuous breakthroughs in cell therapy technologies and the gradual expansion of clinical applications, we firmly believe that this field will usher in more brilliant development prospects in the future. Looking forward to the next gathering and making joint efforts to write a new chapter for life health with the help of cell therapy drugs!

All guests of the satellite conference took a group photo to mark the occasion