BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) (“BioVaxys”) and Sona Nanotech Inc. (CSE: SONA) (OTC: SNANF) (“Sona”) announce today that they have entered into a Research Agreement (“Agreement”) to collaborate on the development of new cancer therapeutics based on BioVaxys’ DPX™ Immune Educating Platform (“DPX”) in combination with Sona’s Targeted Hyperthermia Therapy™ (“THT”), a photothermal cancer therapy that uses highly targeted infrared light to treat solid tumors. The heat for THT is delivered to tumors using infrared light that is absorbed by Sona’s proprietary biocompatible Gold Nanorod (“GNR”) technology which elicits a strong immune response.

Carman Giacomantonio, MD, Chief Medical Officer (“CMO”) for Sona Nanotech Inc., commented, “Looking beyond our approaching first-in-human Early Feasibility Study clinical trial for our THT cancer therapy, Sona continues to conduct research to build our pipeline of programs to fully exploit the potential of our GNR technology platform. To that end, we’re pleased to enter this research collaboration with BioVaxys whose DPX technology provides a unique delivery system that better presents antigens to the immune system. We believe that DPX, with its immune stimulating properties and antigen presentation capabilities, could be an ideal carrier for the neo-antigens that Sona’s THT enables, thereby accelerating THT’s efficacy and so we look forward to working with the BioVaxys team to quickly assess the potential for technology synergies.”  

We are very pleased to have the opportunity to evaluate synergies between our DPX platform and Sona’s THT and GNR technologies, as our collaboration is ideal for advancing the highly promising applications of our respective technologies,” says Kenneth Kovan, President and Chief Operating Officer at BioVaxys. “With Sona’s exciting study data and the clinical trial data we have with DPX it’s conceivable that our collaboration could lead to a new and even better treatment for immunotherapy-resistant solid tumors.” 

The collaboration between BioVaxys and Sona will evaluate the immune stimulatory properties of DPX (without an antigen cargo) administered together with THT, as a characteristic of DPX is that it helps prime the innate immune system which in turn can activate and strengthen the adaptive immune response. The collaboration will also evaluate the combination use of THT together with a DPX formulation as a carrier for novel neoantigens expressed on the surface of tumor cells following immunotherapy, such as with THT. Neoantigens are unique proteins that are not present in healthy tissues that arise from changes in cancer cells and play a crucial role in stimulating anti-tumor immune response. Immunotherapy such as THT can trigger these tumor cell changes and the expression of neoantigens, so packaging a tumor neoantigen in DPX for presentation to the immune system is anticipated to accelerate THT’s efficacy. 

The research studies based on the BioVaxys and Sona technologies will be conducted at Dalhousie University, Halifax, Nova Scotia, under the direction of Sona’s CMO, Carman Giacomantonio, MD MSc FRCSC, Division of General and Gastrointestinal Surgery, Department of Pathology, Dalhousie University, and Barry Kennedy, PhD, of the Giacomantonio Immuno-Oncology Research Group at Dalhousie University (the “Principal Investigators”).

Each company will contribute their respective technologies for the study with the research costs covered by the Giacomantonio Immuno-Oncology Research Group. Any novel candidate therapeutic developed in this program will be co-owned and co-prosecuted by BioVaxys and Sona, with the parties planning to enter into a commercialization agreement for a vaccine clinical candidate prior to the initiation of any Phase 1 study. 

Sona’s current focus for advanced biomedical applications using its biocompatible GNR platform technology with its THT therapy aims to shrink cancerous tumors for certain solid cancers and in so doing trigger a systematic immune response to eliminate both treated and distant, untreated metastases. Sona’s GNRs are uniquely manufactured without the use of CTAB (cetyltrimethylammonium bromide), eliminating the toxicity risks associated with the use of other GNR technologies in medical applications.

In a preclinical study presented at the 19th International Canadian Melanoma Conference in Vancouver this past February, Sona’s research team confirmed that its GNR-based THT causes cancer-specific cell death that activates a strong immune response by the body’s immune system. Of critical importance is evidence that the immunity generated by Sona’s THT is observed in cancers that are known to be resistant to modern immunotherapies. Using an industry standard, immunotherapy resistant, CT-26 colon cancer model, Sona’s THT -activated systemic immunity that, when followed by previously ineffective PD-1 inhibition, demonstrated a 100% response rate in these previously resistant tumors. These findings were published in Frontiers in Immunology and repeated in industry standard preclinical breast cancer and melanoma models.

BioVaxys’ DPX™ technology is a patented delivery platform that can incorporate a range of bioactive molecules, such as mRNA/polynucleotides, peptides/proteins, virus-like particles, and small molecules, to produce targeted, long-lasting immune responses enabled by various formulated components. The DPX platform, which is non-aqueous and non-systemic, facilitates antigen delivery to regional lymph nodes and has been demonstrated to induce robust and durable T cell and B cell responses in pre-clinical and clinical studies for both cancer and infectious disease. The DPX platform has been proven in multiple Phase 1 and Phase 2 clinical studies across a range of different antigens in oncology and infectious disease applications, and has demonstrated excellent safety and tolerability.

A study conducted by Hakimeh Ebrahimi-Nik, DVM, PhD, of The Ohio State University Comprehensive Cancer Center and Pelotonia Institute for Immuno-Oncology, and presented December by BioVaxys at the Personalized Cancer Vaccine Summit in Boston, compared the immune-stimulating properties of the most commonly used vaccine adjuvants that are frequently given together with cancer immunotherapies to boost their efficacy, against DPX antigen formulations as well as DPX administered just on its own. The DPX formulations were shown to be more effective than any of the popular adjuvants, as effective as the gold standard—bone marrow-derived dendritic cells—and DPX on its own appeared to have meaningful immune stimulating properties.