Biosyngen Secures Global First IND Approvals for BST02, a Breakthrough TIL Therapy Targeting All Liver Cancer Types

Jan 25, 2024 08:51 CST Updated 08:51

Biosyngen

Developer of Innovative Immune Cell Technology Products

January 25, 2024

eMedClub News

Recently, the CDE official website showed that Baiji Bio's fourthGlobally Exclusive and OriginalBST02 Injection IND Application Approved in China for TreatmentAll types of liver cancer (including hepatocellular carcinoma and cholangiocarcinoma), which belongs to adoptive immunotherapy technology.

Previously, on October 26, 2023, the Phase I/II clinical trial application for BST02 was approved by the U.S. FDA, becomingThe world's first TIL cell therapy drug for liver cancer to enter the clinical stage. This approval not only represents another milestone for BioGene, completing its eighth clinical approval, but also marks the third pillar of its TIL therapy, following CAR-T and TCR-T, once again receiving dual certification from China and the US. With each initiative being a first of its kind, BioGene has once again embarked on a journey to lead globally.

Primary liver cancer is a common malignant tumor and a leading cause of cancer-related deaths in China, mainly including three different pathological types: hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma (ICC), and mixed HCC-ICC. Among these, HCC accounts for 85%-90%. Globally, it is estimated that 905,700 people are diagnosed with liver cancer annually, and 830,200 people die from the disease each year.More than half of the estimated cases and deaths of liver cancer worldwide occur in East Asia.(54.3% and 54.1%, respectively), of which China accounts for 45.3% of the world's liver cancer cases and 47.1% of liver cancer deaths. In terms of market size, in 2022 alone, the global lung cancer market reached 29.8 billion US dollars, with growth accelerating further. Liver cancer is known as the "king of cancers" because it is often discovered at an advanced stage when traditional drugs are unlikely to be effective.Leaving a huge空白 market for biotech innovation drugs. In this vast untapped market, the first indication for BioGCT's TIL therapy BST02 "takes an unconventional path" directly targeting liver cancer, undoubtedly alreadySeize the Opportunity。

The news that the world's first TIL therapy is about to be launched not only ushers in a new era of commercialization for this 35-year-old technology but also sets the stage forConquer Solid TumorsThe bugle has sounded. Currently, TIL has achieved impressive data in the research of melanoma, lung cancer, cervical cancer, breast cancer and other fields, but successful research in liver cancer is still rare. The reason is that the environment of liver tumors is more complex, and few other cell therapies have ventured into it. This also provides greater room for TIL therapy to play its advantages such as high diversity, excellent ability to infiltrate tumor sites, and low toxicity.

Biotheus is not only focused on a single trackDifferentiated layout in terms of indications, and has also made full preparations in core technologies to achieve "overtaking on a curve." TIL, this highly customized therapy, is still in the early stages of development and faces challenges in terms of effectiveness and accessibility, such as heavy reliance on IL-2 and limitations due to immunosuppression in the tumor microenvironment. BioGendics possesses four major technological platforms, with BST02’s final product cells exhibitingHigh memory T-cell, low regulatory T-cell ratio phenotype, with more potent tumor-killing ability both in vivo and in vitro.Persistence, and giveLow-dose interleukin-2 adjuvant therapy can significantly activate anti-tumor efficacy., balancing effectiveness and safety. Meanwhile, BST02 isFreezable Products, overcoming the geographical limitations between production and clinical centers, laying a solid foundation for pharmaceutical supply and drug accessibility, and is expected to become an important force in the new generation of TIL therapies.

▲Four Major Technology Platforms of BioG Biotech (Source: Official Website)

Currently, the world's first TIL therapy has not yet been launched on the market,A new generation of TIL therapy that is safer and more effective is ready to be launched., and in terms of progress, companies within and outside China are advancing side by side. BioGend focuses on the solid tumor field, simultaneously advancing the three key areas of CAR-T, TCR-T, and TIL.The First-of-Its-Kind: 4 Pipelines and 8 IND Approvals, is an innovative pharmaceutical company with international competitiveness. Strategically, Bio-Gene is based in Asia and oriented towards the global market. It owns the largest private GMP cell production and R&D bases in South China and Singapore, located in Guangzhou and Singapore respectively, forming an integrated industrial chain layout encompassing R&D, production, and sales.

▲BioGerm pipeline (Source: official website)

Professor Jean Paul Thiery, Chief Scientist and Chairman of the Scientific Committee of Biotheus, Academician of the French Academy of Sciences, and Academician of the European Academy of Sciences, stated: "The approval of BST02 NMPA IND is another significant milestone in Biotheus' IND submission journey."Marks Biotheus’ four world-first pipelines, covering the three cutting-edge T-cell therapies of CAR-T, TCR-T, and TIL, all of which have gained recognition from the pharmaceutical regulatory authorities in both China and the United States., and has officially entered the clinical stage. More excitingly, two of the product pipelines are about to enter Phase II clinical trials, with the potential to fill market gaps and meet unmet clinical needs."

References: CDE and corporate official websites

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