On April 20, Zhongshan Hengsai Biotechnology Co., Ltd. ("Hengsai Bio" for short) announced that it has completed the Pre-A round of financing of tens of millions of RMB. The funding is led by Fuho Capital, with the participation of Hengyue Investment, and MedBio Capital assuming the responsibility of the exclusive financial advisor.
Founded in 2018, Hengsai Bio is a high-tech enterprise focusing on tumor immunotherapy. It is mainly engaged in the R&D and industrialization of a new generation of individualized dendritic cell tumor treatment vaccine (DC vaccine).
What is the DC vaccine? What fields can it be applied to? Which stage of research progress does it hold currently? How huge the potential market is?
Dendritic cells (DC) are the most powerful antigen-presenting cells (APC) found at present. Their antigen-presenting function is much stronger than other antigen-presenting cells, such as macrophages and B cells. They have a sharp capacity to activate CD8+ and CD4+ T cells and can secrete a variety of cytokines to participate in immune regulation and response.
DCs were identified in 1973 by Professors Zanvil Cohn and Ralph Steinman. Professor Ralph Steinman treated himself with the DC vaccine for pancreatic cancer, which substantially extended his survival time. Hence, in 2011 Professor Ralph Steinman was awarded the Nobel Prize in Medicine for his pioneering work in identifying DCs. Substantial breakthrough in the DC vaccine has been obtained in the clinical research of tumor immunotherapy at home and abroad, and now, the DC vaccine has grown to be a fascinating research area in the field of tumor immunotherapy.
The theory of the DC vaccine preparation is very simple. DC precursor cells of patients are separated and cultured in vitro. Loading with tumor antigen, they are transferred to patients. Then, DCs stimulate specific anti-tumor T cells to make the anti-tumor effect come into play. Besides, DCs can establish a persistent anti-tumor-specific immune response, holding a critical position in anti-tumor immunity.
Since the anti-tumor properties of DCs remain consistent with the vaccine theory, DC therapy is mostly called DC vaccine clinically.
Research Progress of DC Vaccine
The first anti-cancer vaccine approved by FDA in 2010, Provenge (sipuleucel-T), was the DC vaccine. It is applied for the treatment of metastatic prostate cancer. Currently, various DC vaccines have been approved for marketing in the world, including CreaVaxRCC, Hybricell, DCVax-Brain, Provenge, and APCEDEN. The indications involve prostate cancer, malignant melanoma, renal cell carcinoma, non-Hodgkin's lymphoma, glioma, lung cancer, liver cancer, colorectal cancer, breast cancer, and nasopharyngeal carcinoma.
It deserves to be mentioned that Dendreo, which once developed Provenge, has a troubling sales condition in the later period on account of great production cost, complex operation, and marketing. In November 2014, the company declared bankruptcy because of heavy liabilities. Later, after rounds of twists and turns, SanPower Group, a private Chinese enterprise, finally acquired Provenge with US$ 819 million.
Till now, when the keyword "DC vaccine" is inputted in ClinincalTrials.gov for retrieval, a total of 256 trials on the DC vaccine can be reported. Both the ongoing clinical research and the marketing-approved DC vaccine have proved the possibility of it being innovative and effective immunotherapy for treating tumors.
Clinical Progress of DC Vaccine in Solid Tumors
Renal cell carcinoma
At the 2020 ASCO SITC Clinical Immuno-oncology Symposium, Immunicum released the latest data of Phase II clinical research MERECA of its DC vaccine, ilixadencel, on metastatic renal cell carcinoma (mRCC). The data showed that: as of December 2019, the survival rate of the ilixadencel treatment group was 54%, while that of the control group was 37%. The objective response rate (ORR) of the ilixadencel treatment group was 42% and that of the control group was 24%.
Glioblastoma
In April 2020, AIVITA analyzed the Phase II clinical trials (NCT03400917) of its candidate DC vaccine, AV-GBM-1, against glioblastoma (GBM). The resul...
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