MNPR-101 is not expected to replace existing therapies, but rather to complement them. Based upon the non-overlapping toxicity and distinct mechanism of action, we plan to develop MNPR-101 in combination with existing cancer therapies to potentially improve treatment outcomes, rather than merely competing with current therapies in the market. The selective expression of uPAR in tumors underpins the expectation that MNPR-101 will be well-tolerated and amenable to a variety of treatment approaches, including combinations with existing treatments, radiopharmaceutical, and antibody-drug conjugate approaches. Published preclinical data have shown the ability of MNPR-101 to enhance the anti-tumor activity of chemotherapies such as paclitaxel and gemcitabine. Our current strategy is to advance MNPR-101 into a Phase 1a/1b trial in indications where uPAR expression is highly prevalent and explore novel combinations, such as with checkpoint Inhibitors or as a radiotherapeutic, in the Phase 1b portion.
The ubiquitous expression of uPAR on activated immune cells, and its central importance in chemotaxis, invasion and recognition, makes uPAR a very attractive drug target in a wide variety of inflammatory indications, including bacterial and viral infection. MNPR-101, as a first-in-class anti-uPAR humanized monoclonal antibody, represents a selective means for delivery of cytotoxic agents to hyperactive immune cells. Conjugation of MNPR-101 to a radionuclide would produce a potent and selective cytotoxic agent, with applicability to a wide range of inflammatory indications.
One such indication is severe COVID-19. By targeting aberrantly activated immune cells in severe COVID-19 patients, the risk of a lethal cytokine storm could be significantly reduced. Such a radio-immuno-therapeutic (RIT) would constitute a powerful new therapeutic tool, with the potential to drastically reduce the burden of disease and mortality incidence of COVID-19. Monopar, in collaboration with NorthStar Medical Radioisotopes, an industry-leading producer of medical radionuclides, is pursuing accelerated development of such an RIT, based on MNPR-101.