RaCRx-101 causes multiple changes to the immune system that significantly enhance its ability to destroy cancer cells.
Single Agent
RaCRx-101 has been tested as a single agent in a FIH trial and found to be safe and showed efficacy against B-Cell lymphoma and multiple myeloma. The human immune system exhibited beneficial changes similar to those observed in animal studies.
Combination Therapy
In preclinical studies, RaCRx-101 acts synergistically in combination with anti PD-1 drugs against melanoma, bladder and colorectal cancer. Combination therapy is more effective than either RaCRx-101 or anti PD-1 drugs alone, yielding larger tumor volume reductions and a significant number of complete responses (CR) whereas monotherapy yielded none.
Anti PD-1 drugs are extremely effective in defeating one of cancer's main defenses to the immune system, which allows the immune system to destroy cancer cells. But this effect is temporary. Preclinical trials show that RaCR-101 enhances the lethality of the immune system allowing greater tumor volume reduction and, in some animals, all cancer cells to be destroyed before the anti PD-1 drug stops working, resulting in CR.
Improving Outcomes
In human trials as a single agent, RaCR-101 shows safety, tumor shrinkage, restoration of the immune system (delayed type hypersensitivity), and measurably increased lethality to cancer.
Synergistic Effect
In animal trials as a combination therapy with anti PD-1 drugs, RaCR-101 has been proven effective against multiple cancers including bladder, colon, and melanoma, yielding greater tumor volume reduction and more CRs than either drug alone. We believe this will be true for most cancers treatable with anti PD-1 drugs.
Favorable Risk vs. Benefit
Little apparent downside risk to RaCR-101/anti PD-1 combination therapy and significant upside potential for better outcomes, including cures, make combination therapy a standard of care candidate.
