Cancer prevalence is increasing yearly with the American Cancer Society predicting more than 1.8 million new cases to be diagnosed and over 600,000 deaths by the end of 2020 in the United States. A new therapeutic approach has never been more imperative (Siegel, Miller, and Jemal 2020). BioVaxys Technology Corp. ("BioVaxys") has discovered that modification of human cancer cells with a 'hapten', or small chemical that tightly binds to a tumor antigen to elicit an immune response, significantly increases the ability of the immune system to recognize and react to those tumor antigens which identify specific tumors as 'cancerous.'
Haptenization is known to encourage the body to induce an immune response to tumor surface antigens that would otherwise not be visible to the immune system, therefore targeting the cancer cells directly. The manufacturing process of this haptenized vaccine is surprisingly cost efficient and straightforward. It uses excised cancerous tissue from individual patients, where the tumor cells are extracted, irradiated and then linked with the hapten. As tumor cells are highly patient-specific, using the patient's own tumor material for the vaccine ensures that the vaccine administered is patient-specific, increasing its overall efficacy. The vaccine can be shipped to clinical sites when required and is injected intradermally into the patient.
Previous Phase I and Phase II clinical studies with an early generation of the haptenized vaccine approach showed great promise. Overall, 447 patients with varying tumour types were tested. Of those with metastatic stage IV melanoma (83 patients), 13% demonstrated anti-tumor responses, with 2% showing a complete reduction. Furthermore, patients with lymph node metastases (214 patients) showed a significant increase in survival rate, with the 5-year overall survival rate being 46% - roughly double the percentage expected through standard treatment routes alone. Results were also evaluated in women with advanced stage ovarian cancer, who had not responded to conventional chemotherapy. Of the 24 patients treated, 8 patients survived for more than 2 years, which would likely not have been possible without treatment with the haptenized vaccine.
Following the clinical results, two modifications to a next-generation vaccine have been realized. Adding a second hapten, such as sulfanilic acid, further modifies the vaccine cells, rendering the vaccine more effective. Once vaccinated, patients will also be given a drug called a 'checkpoint inhibitor' - a class of drugs that together with a vaccine is believed will increase the magnitude of an anti-cancer immune response significantly. BioVaxy is beginning the preparatory work for a planned Phase I trial for its ovarian cancer vaccine in the European Union.
Siegel, R. L., K. D. Miller, and A. Jemal. 2020. 'Cancer statistics, 2020', CA Cancer J Clin, 70: 7-30.
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