Benzinga | Aug 24, 2021 07:47AM EDT

HCW Biologics Highlights Publication Of Paper In Molecular Therapy Titled 'Bifunctional TGF- trap/IL-15 Protein Complex Elicits Potent NK Cell and CD8+ T Cell Immunity Against Solid Tumors'

ead Drug Candidate Engineered Using Tissue FactOr-Based FusIon (TOBI(tm)) Platform



Preclinical Data Demonstrated HCW9218 Antitumor Activity as Single-Agent Monotherapy and as an Adjunct to Enhance Potency of Therapeutic Antibodies

Investigational New Drug Application ("IND") for Chemotherapy-Refractory Pancreatic Cancer Expected to be Filed by Year-End 2021

MIRAMAR. Fla., Aug. 24, 2021 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the "Company") (NASDAQ:HCWB), an innovative, biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between chronic, low-grade inflammation and age-related diseases, today announced the publication of a scientific paper, authored by the Company's scientific research team in the peer-reviewed journal, Molecular Therapy. Entitled, "Bifunctional TGF-? trap/IL-15 Protein Complex Elicits Potent NK Cell and CD8+ T Cell Immunity Against Solid Tumors," the paper highlights preclinical data from in vivo studies demonstrating the potential of the Company's lead investigational candidate, HCW9218, as a novel immunostimulant with the ability to simultaneously lessen immunosuppression in patients with cancer.

This novel immunotherapeutic, HCW9218 is a heterodimeric, bifunctional fusion protein complex comprising extracellular domains of the human transforming growth factor-? (TGF-?) receptor II, as TGF-? trap for TGF-? neutralization, and a human interleukin (IL)-15/IL-15 receptor ? complex for immune-cell stimulation. HCW9218 was engineered using the TOBI(tm) platform technology developed internally by HCW Biologics with Company-owned technology. The unique combination of a TGF-? receptor that neutralizes a highly immunosuppressive cytokine secreted by tumors, combined with IL-15, a potent cytokine that stimulates the NK- and CD8+- cell cytotoxicity, creates an immunotherapeutic with the potential to drive significant bifunctional antitumor activity.

As detailed in the paper, preclinical data demonstrated that HCW9218, administered as a monotherapy, was well tolerated and showed potent anti-cancer activity in animal models of melanoma. The data showed limited side effects, with none of the bleeding episodes often associated with high doses of other antibody-based TGF-? neutralizers. HCW9218 showed an ability to promote proliferation and metabolic activity of immune cells as well as enhance the cells' cytotoxicity with tumor targets. Importantly, we presented data from mouse animal models in melanoma which demonstrated that HCW9218 slowed tumor growth and prolonged survival in mice treated with HCW9218 as a monotherapy. This antitumor activity was mediated by immune cells and correlated with increased immune cell infiltration into tumors. HCW9218 demonstrated a 10-fold stronger TGF-?1 neutralizing activity than a molecule containing two TGF-? receptor II dimers with the Fc scaffold; a high level of potency that could be driven by the unusual property of HCW9218 to bind the latency-associated protein/TGF-? complexes.

HCW9218 was also observed to enhance the antibody dependent cell mediated toxicity of rituximab against human lymphoma cells. Antibody therapies are commonly used in cancer treatment.

"The HCW team is excited by the publication of its latest scientific paper in Molecular Therapy, which marks yet another important milestone for our team. This paper validates the potential clinical utilities of our lead molecule, HCW9218, created with our TOBI(tm) discovery platform. With this technology, we intend to develop additional next-generation cancer immunotherapeutics," stated Hing Wong, Ph.D., Founder and CEO of HCW Biologics and the paper's corresponding author. "Advances in immunostimulatory and anti-immunosuppressive treatments have revolutionized cancer treatment, but few of these therapies are able to do both. We believe we may have created such an immunotherapeutic with our bifunctional molecule, HCW9218. These encouraging preclinical results support our decision to advance clinical development of HCW9218 for chemotherapy-refractory pancreatic cancer and other solid tumors."

HCW Biologics expects to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for a Phase 1b/2 clinical trial to evaluate HCW9218 in chemotherapy-refractory pancreatic cancer by year-end 2021. The Company is in the final stages of IND-enabling activities.