SBIR Phase II: Anti-Tumor Immune Redirectors (AIRs) for cancer treatment

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to develop a new class of oncology therapeutics termed “Anti-tumor Immune Redirectors (AIR)”. AIRs redirect the body’s pre-existing immune response obtained through previous childhood vaccination or past infections to target tumor cells for cancer eradication. Globally, cancer continues to be one of the top five leading causes of death, resulting in a high unmet need for novel therapies and treatments. Blockade of immune checkpoint inhibitor drugs have emerged as a potent solution with demonstrated clinical benefits. However, such treatments are expensive and toxic. Furthermore, many patients are ineligible, do not respond, or acquired resistance to such drugs due to the absence of an anti-tumor response. In contrast, our strategy tailors the patient’s tumor to become susceptible toward pre-existing anti-pathogenic or childhood vaccine immunity. Our approach will change or extend treatment opportunities for many cancer patients. This also circumvents the risky and costly R&D challenges in identifying and/or producing potent immune responses against cancer. This Small Business Innovation Research (SBIR) Phase II project advances the development of a lead AIR that could redirect different viral immune memory responses toward tumors in vitro, and in vivo with mouse tumor models. Phase II will advance the development: (1) Advanced optimization coupled with characterization studies will be performed on our current product and purification methods to further define a consistent process compatible with scaled manufacturing; (2) we will initiate more in-depth non-clinical safety and toxicology studies to ensure the AIR solution achieves the required safety attributes; and (3) we will perform additional in vivo studies in animal tumor models more aligned with the initial target application. The proposed approach potentially serves as an “off the shelf” immunotherapy based on the patient’s individual health/vaccine history, thereby extending additional treatment opportunities to a broader cancer patient population. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.