HCW Biologics is a clinical-stage company advancing a pipeline of potentially transformative immunotherapy product candidates for the treatment of inflammaging and age-related diseases. Our initial clinical trials are in the oncology arena, an age-related disease with a high unmet need. The Masonic Cancer Center, University of Minnesota, initiated a first-in-human Phase 1 clinical trial to evaluate our lead drug candidate, HCW9218, in patients with advanced solid tumors with progressive disease after prior chemotherapies. HCW Biologics has also been cleared by the U.S. Food and Drug Administration to proceed to evaluate HCW9218 in a first-in-human Phase 1b clinical trial in patients with advanced pancreatic cancer, which we expect to initiate in mid-2022. We have out-licensed limited rights to our clinical-stage molecule, HCW9201, to develop cell-based therapy treatments. Our licensee is now conducting a pair of Phase 2 clinical trials using HCW9201 for a cell-based therapy treatment for acute myeloid leukemia (AML) with Washington University as the sponsor. Our other lead product candidate, HCW9302, is currently undergoing IND-enabling studies for an autoimmune indication, which we expect to complete in 2022.
Once the safe dose level and regimen of the lead product candidates are defined in the initial clinical trials, HCW will expand into clinical trials for treatments of other age-related pathologies. For HCW9218, these include fibrotic diseases (e.g., Nonalcoholic Fatty Liver Diseases (NAFLDs) and liver cancer); and for HCW9302, these include autoimmune and metabolic diseases (e.g., alopecia areata, type 2 diabetes and coronary artery disease).