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.
- There is an ongoing Company-sponsored Phase 1b/2 clinical trial to evaluate HCW9218 in patients with advanced chemo-refractory/chemo-resistant pancreatic cancer.
- There is an ongoing Investigator-sponsored Phase 1 clinical trial to evaluate HCW9218 in patients with chemo-refractory/chemo-resistant solid tumors, including ovarian, prostate, breast and colorectal cancers.
- Wugen’s lead clinical program, WU-NK-101, is based on HCWB licensed molecules. Wugen holds an exclusive worldwide license for two of our molecules, HCW9201 and HCW9206. The Wugen License conveys limited rights to develop cell-based therapy treatments for cancer using the licensed molecules. HCW Biologics has retained all other rights to HCW9201 and HCW9206, including, but not limited to, manufacturing rights and injectable rights.
Our lead molecule, 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 (“NK”) cells and CD8+ T cell cytotoxicity. As a result, we believe this bifunctional immunotherapeutic agent has the potential to drive significant anti-tumor activity. 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.
We have two ongoing clinical trials to evaluate HCW9218 in chemo-refractory/chemo-resistant solid tumor cancer indications, including the most difficult-to-treat cancers.
- 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, entitled “A Phase I Study of HCW9218, a Bifunctional TGF-β Antagonist/IL-15 Protein Complex, in Advanced Solid Tumors,” at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (“SITC 2022”) by Dr. Melissa Geller, Principal Investigator. 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. There are currently four clinical sites participating in this trial, including the NCI Center for Cancer Research, Medical University of South Carolina (an NCI-designated Comprehensive Cancer Center), Washington University in St. Louis (an NCI-designated Comprehensive Cancer Center), and HonorHealth Research Institute. See, “HCW9218 for Advanced Pancreatic Cancer,” at ClinicalTrials.gov Identifier: NCT05304936.
Our lead molecule, HCW9302, is an injectable single-chain, IL-2-based fusion protein. Preclinical studies in mouse models have demonstrated the ability of HCW9302 to activate Treg cells and reduce inflammation-related diseases, supporting the potential of HCW9302 to treat a wide variety of autoimmune and age-related diseases. The Company is in the process of completing IND-enabling activities required for an Investigational New Drug application (“IND”). We expect to submit an IND to the FDA in the second 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, expanded indications include fibrotic diseases, such as Nonalcoholic Fatty Liver Diseases and liver cancer, and neurodegenerative diseases, such as Parkinson’s Disease. For HCW9302, expanded indications include autoimmune disease and pro-inflammatory metabolic disorders, such as atherosclerosis.
Part of the Company’s strategy is to license marketing rights and other rights that are outside of our core focus. We signed our first out-license in 2020 with Wugen Inc. for a worldwide exclusive license for limited rights for HCW9201 and HCW9206 to develop cell-based therapies for cancer treatments. We retained all other rights, including injectable rights and manufacturing rights for these products.