HCW Biologics (HCWB) announced that its scientists have developed second-generation, pembrolizumab-based immunotherapeutics against solid tumors, particularly for pancreatic and ovarian cancer, using its novel proprietary TRBC product discovery and development platform technology. Since their introduction to the treatment of cancer in 2011, immune checkpoint inhibitors have been hailed as a breakthrough cancer therapy. Immune checkpoint proteins are expressed on the surface of T cells as the acting regulators for inhibiting the over-activation of T cells. By using ICIs, the immune response of T cells can be largely activated to re-establish the immune effects of anti-tumor exhausted T cells. However, there is vast evidence in preclinical and clinical studies suggesting that the lack of immune-cell costimulatory activities on ICIs diminishes their anti-tumor efficacy. Hing Wong, CEO stated, “Immune checkpoint inhibitors revolutionized the immunotherapeutic approach against cancer. Unfortunately, it has been reported they only induce an overall response in less than 20% of cancer patients within their FDA-approved indications, and most responses are not durable. However, immune checkpoint inhibitors still commanded over $40B in annual worldwide sales in 2024. HCWB believes the efficacy of immune checkpoint inhibitors can be improved by equipping them with other moieties which could neutralize the immunosuppressive cytokine, Transforming Growth Factor beta, and activate effector immune cell responses.” HCWB’s TRBC technology enables its scientists to construct pembrolizumab-based fusion molecules that not only have the potential to release the tumor immune surveillance blockade of immune cells by cancer cells and neutralize the most immunosuppressive cytokine, TGF-beta, in the tumor microenvironment, but also simultaneously activate immune cells and promote their infiltration into solid tumors. The Company’s pembrolizumab-based fusion molecule has been selected as leading clinical product candidate because in preclinical studies it exhibits potent anti-pancreatic cancer activities and outperform pembrolizumab as monotherapy for cancer both in vitro and in humanized mouse models at dose levels that are well tolerated. This novel fusion immunotherapeutic is designed to block the checkpoint receptors and engages the costimulatory receptors, analogous to taking the foot off the brake and simultaneously hitting the gas, thus, representing a breakthrough second-generation ICI which revives anti-tumor function of T cells. Dr. Wong will present the details of IND-enabling studies as an invited speaker for the College of Pharmacy Seminar Series, hosted by Nova Southeastern University, located in Fort Lauderdale, Florida, on September 12, 2025.
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