In the past decade, use of monoclonal antibodies and adoptive cellular therapy have make significant advance in the treatment of cancer by modulating the immune response and arousing the immune system., Recent clinical trials have shown great promise for immunotherapy in cancer treatment. However, treatment of solid tumor and the ability of tumor cells to evade the immune system remains a major challenge. Notably, viruses have been suggested to be useful as anti-cancer agents since the early 20th century, and groups of scientist began to explore the use of engineered viruses.
By taking advantage of tumor-specific mutation, oncolytic viruses are allowed to preferentially replicate in target cells, and thus to be useful in the therapy of various type of cancers. More importantly, the viral replication cycle allows dramatically local amplification of the input virus, and the oncolytic process continues as long as target cells exist.
With years of research in immunotherapy, Creative Biolabs has accumulated an increasing experience in oncology, and has built up a systemic R&D mode in oncotherapy. In the field of virotherapy, by integrating the technologies of viral biology, immunology and genetic engineering, our scientists have successfully developed the OncoVirapy™ platform. Upon the platform, Creative Biolabs is able to provide comprehensive service for developing engineered oncolytic virus, including oncolytic virus construction, oncolytic virus engineering, in vitro assay for proof-of-concept study, in vivo assay for proof-of-concept study, and oncolytic virus manufacture.
The background and related researches about the targeted tumor will be fully reviewed. Following identification of tumor-specific pathways and antigens, the virus species will be selected in the first place for further engineering. For a better utilization of the dual mechanism of action of oncolytic virus, including direct killing of target tumor cell and priming anticancer immunity, elements such as tropism, tumor-specific promoter, capsid protein, delivery of therapeutic gene and combination therapy potential will all be taken into consideration.
Both in vitro and in vivo study are included to achieve an overall understanding of the therapeutic efficacy and further developability of designed oncolytic virotherapy. For in vitro study, identity assay, transgene expression assay, transgene functional assay and tumor lytic assay etc. will be comprehensively integrated to study the virus cytotoxcity, and for in vivo study, after construction of xenograft animal models, the immunogenicity, biodistribution/PK and efficacy and toxicity will be tested.
Based on our extensive experience on GMP-certified oncolytic virus manufacture, Creative Biolabs has developed robust manufacturing processes to produce various types of oncolytic virus for clinical studies. Five major steps have been included as follows, a. removing cellular debris, b. nuclease treatment, c. chromatography for purification, d. concentration and buffer exchange and e. final sterile filtration.
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