BioVaxys Technology Corp. (CSE:BIOV, OTCQB:BVAXF) has said it plans to advance an Investigator-Sponsored Clinical Trial Application(CTA) for BVX-0922, its autologous haptenized tumor vaccine for colorectal cancer (CRC), with the European Medicines Agency (EMEA) this year.
An Investigator Sponsored CTA is submitted to regulatory authorities by a clinical investigator, who both initiates and conducts an initial clinical study of a new drug or procedure, and under whose immediate direction the investigational drug is administered.
CRC is the third most common malignancy and the second most deadly cancer worldwide, with an estimated 1.9 million new CRC cases diagnosed and 0.9 million deaths globally in 2020. The incidence of CRC is higher in highly developed countries, with global new CRC cases predicted to reach 3.2 million in 2040.
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“A major benefit of the company's autologous haptenized tumor vaccine technology platform is the rapid scalability into a range of tumor types, especially those where the standard of care for these cancer patients typically involves surgical excision of tumor tissue,” the biotechnology company said.
The BioVaxys vaccine platform is based on the established immunological concept that modifying surface proteins, whether they are viral or tumor, with haptens, makes them more visible to the immune system. This process of haptenization "teaches" a patient's immune system to recognize and make target proteins more "visible" as foreign, thereby stimulating a T-cell mediated immune response.
BioVaxys' cancer vaccines are created by extracting a patient's own cancer cells, chemically linking with a hapten, and re-injecting them into the patient to induce an immune response to proteins that are otherwise not immunogenic.
Based in Vancouver, BioVaxys has a significant advantage over many other companies looking at cancer therapies in that it already has extensive promising clinical data for its cancer vaccines.
Contact the author at jon.hopkins@proactiveinvestors.com