Pipeline

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.

We have two ongoing clinical trials to evaluate our lead molecule, HCW9218, in chemo-refractory/chemo-resistant solid tumor cancer indications, including one of the most difficult-to-treat cancers, advanced pancreatic cancer. The Company selected solid tumors for its first clinical indications because solid tumor cancers are characterized by a dense fibrotic stroma or desmoplasia that allows a tumor to shield itself from standard-of-care treatment such as chemotherapy and immune-checkpoint inhibitors. TGF-β plays a major role in the formation of desmoplasia and promoting metastasis. HCW9218 is an injectable, bifunctional fusion protein complex that innovatively combines a TGF-β receptor to neutralize a highly immunosuppressive cytokine secreted by tumors, and IL-15, a potent cytokine, to stimulate the natural killer and CD8+T cell cytotoxicity. As a result, we believe this bifunctional immunotherapeutic has the potential to drive significant anti-tumor activity.

The Masonic Cancer Center (MCC), University of Minnesota initiated a first-in-human Phase 1 clinical trial to evaluate HCW9218 in patients with chemo-refractory/chemo-resistant, advanced solid tumors with progressive disease after prior chemotherapies. Preliminary clinical results from this trial were presented in a poster at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC 2022) by Dr. Melissa Geller, Principal Investigator. The SITC 2022 poster is available on the Company’s investor website. See, “HCW9218 in Select Advanced Solid Tumors,” at ClinicalTrials.gov Identifier: NCT05322408.

The Company has also initiated a multi-center, Company-sponsored Phase 1b/2 clinical trial to evaluate HCW9218 in patients with chemo-refractory/chemo-resistant advanced pancreatic cancer. We expect to have two to four clinical sites at NCI-designated Comprehensive Cancer Centers participating in this trial. See, “HCW9218 for Advanced Pancreatic Cancer,” at ClinicalTrials.gov Identifier: NCT05304936.

Our lead molecule, HCW9302, which activates and expands regulatory T cells, is in the process of completing IND-enabling activities. We expect to submit an IND to the FDA in the first half of 2023 for a Phase 1b/2 clinical trial to evaluate HCW9302 in an autoimmune indication.

Once the safe dose level and regimen of HCW9218 and HCW9302 are defined in the initial clinical trials, the Company plans to 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 proinflammatory autoimmune and metabolic diseases (e.g., alopecia areata, type 2 diabetes and coronary artery disease).

Part of the Company’s strategy is to license marketing rights and other rights that are outside of our core focus. We entered our first license in 2020 which was a license for limited rights to develop cell-based therapies for cancer based on our clinical-stage molecule, HCW9201, and a preclinical-stage molecule, HCW9206. We retained rights for injectable applications for these molecules as well as manufacturing rights. 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. They are also conducting IND-enabling activities to prepare for a clinical trial to evaluate HCW9206 in the same indication.