BioVaxys: "Back to the Future"

BioVaxys, a clinical-stage biopharma group, are excelling in the development of antiviral and anticancer immunotherapeutics. Their speciality? A haptenized antigen vaccine platform. Haptenization stimulates a robust immune response, as it "teaches" the patient's immune system to recognise the target viral or tumor antigens as foreign. But how does it achieve this? The process of haptenization involves the modification of tumor cells, it's viral proteins, with a 'hapten' molecule. A hapten is a small chemical that is capable of tightly binding to tumor antigens or viral surface proteins, thus eliciting a targeted immune response to the unmodified antigens that would otherwise not be 'visible' to the immune system. Haptenization induces a very robust T-cell response, which is crucial in developing long term immunity. 

One of BioVaxys' leading clinical programs is their tumor cell vaccine, BVX-0918A, which is being developed for Stage III and Stage IV ovarian cancer. The vaccine takes advantage of haptenization to induce a targeted T-cell response to both the modified ovarian cancer cells from the vaccine, as well as against the patient's unmodified cancer cells. A differentiating feature of this vaccine is that it is created using the patient's own cancer cells and so each vaccine is specific to the patient, therefore ensuring that all of the tumor antigens are haptenized and therefore made 'recognizable' to the immune system. A significant roadblock in the development of new cancer therapeutics has been the identification of the responsible tumor antigens in different types of cancer that trigger the correct immune response. Haptenization essentially targets all of the tumor antigens already expressed on the patient's own tumor cell, therefore eliminating this roadblock. 

BioVaxys' established and well-studied immunotherapeutic approach to cancer treatment has been clinically evaluated in both regional and disseminated metastatic tumors in Phase I and II clinical trials with a first generation haptenized tumor vaccine, also invented by BioVaxys founder David Berd, MD. BioVaxys has enhanced the first generation vaccine to utilize two hapten molecules, believing it to induce a stronger immune response and hence yield superior results. 

BioVaxys strategy is to develop its advanced bihaptenized vaccine together with a checkpoint inhibitor, which is a type of drug that blocks proteins called checkpoints that are made by some types of immune system cells, such as T cells, and some cancer cells. These checkpoints help keep immune responses from being too strong and sometimes can keep T cells from killing cancer cells. When these checkpoints are blocked, T cells can more effectively kill cancer cells. BioVaxys' rationale is that there is (1) a persistent unmet clinical need because the majority of ovarian cancer patients do not benefit from anti-checkpoint monotherapy; (2) evidence that not all patients make immune responses to their tumors; (3) evidence that immune responses to autologous tumor antigens can be induced by patient-specific vaccines; and (4) clinical evidence from the pre-checkpoint era that suggests survival can be positively impacted by such patient-specific vaccines. 

Another very relevant program at BioVaxys, is their IND-stage SARS-CoV-2 vaccine candidate, BVX-0320. This haptenized vaccination has an emerging profile that appears superior to many currently in development against SARS-Cov-2, as haptenized SARS-CoV-2 proteins are shown to induce a more potent T-cell response, which is vital for achieving long term immunity against this infection. The critical role of T-cells is supported by analysis of patients that are recovering from the disease which have shown a spike in helper T-cells that recognized the SARS-CoV-2 S-spike protein, with virus-specific T-cells were detected in over 70% of those assessed. This goes to show the importance of T-cell response in immunity, with haptenized vaccination development enhancing this greatly.