Pharma Valley Rising Star | Binnovate Bio: Advancing CGT for Solid Tumors Toward the 'Lantern-Lit Horizon'

On the wall of Dr. Guo Xiaoning's office, co-founder and CEO of BioE Pharm, hangs a piece of calligraphy with the words "Dao follows nature." Over 20 years of global new drug research and clinical development experience have made Guo Xiaoning increasingly respectful of life and more inclined to follow the laws of nature.

In Guo Xiaoning's view, all things in the universe follow the law of "naturalness." "The human body also has its own 'way.' When we catch a cold, we may get better within a few days without taking medicine. This is because our bodies have a large number of immune cells, such as T-cells, B-cells, NK cells, and macrophages, which are responsible for identifying and eliminating external threats like viruses."

But as we age, the immune capacity of the human body gradually declines. "This requires us to provide supplementation or even assistance — the simple logic of 'replenishing what is lacking.'" Guo Xiaoning frankly admitted. Cell and gene therapy (CGT) works by infusing and replenishing fresh immune cells, reversing the exhausted state of T cells, and even enhancing T cells and NK cells by equipping them with "weapons" — CAR (which means "car"), increasing their lethality ("power") to defeat stronger "enemies" — tumor cells.

In recent years, cell therapies represented by chimeric antigen receptor T-cell immunotherapy (CAR-T) have achieved significant breakthroughs in the field of hematological tumor treatment. However, in the field of solid tumors, CAR-T therapy still faces certain challenges.

"Based on an in-depth understanding of the tumor microenvironment and precise manipulation of immune cells, TIL therapy shows great potential in the field of solid tumor treatment," introduced Guo Xiaoning. TIL cells are derived from lymphocytes in tumor tissues, including T cells and NK cells in the tumor stroma. Since TIL cells infiltrate into the interior of tumor tissues, most of them already possess the ability to recognize tumor antigens and kill tumor cells. In addition, the diversity of TIL cells enables them to cover tumor targets more comprehensively, effectively killing tumor cells.

On February 16, 2024, the U.S. Food and Drug Administration (FDA) announced the approval of Iovance Biotherapeutics' TIL therapy Amtagvi (lifileucel) for advanced melanoma that has progressed after PD-1/PD-L1 treatment. This is also the world's first approved and marketed TIL cell therapy.

"The approval of Amtagvi has also dispelled some doubts about TIL therapy, leading to higher expectations for it. An increasing number of industry insiders are intensifying their efforts to research how to enhance the accessibility of TIL therapy," said Guo Xiaoning. "Biocytogen is also continuing to deepen its expertise in the TIL field and accelerating innovation."

Now, relying on the team's years of accumulation in basic research, product development, and process optimization,Biological BinuojiDeveloped two core technology platforms: nu-TECH and nu-GENE.

Supported by an innovative platform, BioNex Biotech has advanced two pipelines into the clinical development stage, one of which is an enhanced TIL product, and the other is a next-generation gene-edited TIL product.“In addition, we also actively carry out industry-university-research cooperation. For example, we signed strategic cooperation agreements with Shanghai Jiao Tong University and Renji Hospital to jointly build a joint laboratory and promote collaboration.TILIndustrial Development of Therapies.”

Beyond the TIL field, BioVenn Biotech has also made strategic deployments.Treg TherapyTreg, as a key T-cell subset in maintaining immune tolerance and homeostasis in the body, can suppress overactivated immune responses in autoimmune diseases. In recent years, Treg cell therapy has demonstrated therapeutic potential in a variety of diseases.

"But currently, Treg therapy is still in its early stages, with the most advanced companies globally just entering Phase I clinical trials. The product pipeline of Biokino Bio is in the clinical validation stage, and it is expected to enter clinical trials this year," Guo Xiaoning introduced.

This also means that there is no path to follow in the development of Treg therapy. "However, this is also the charm of developing innovative drugs——You never know what's going to happen next. What matters is innovation, resilience, and patience."We hope to leverage our innovative capabilities to develop Treg therapies that restore immune homeostasis in patients with autoimmune diseases, helping them regain their health. This is also the driving force behind our journey into the unknown."