HCW Biologics reports promising results for new cancer immunotherapy

MIRAMAR, Fla. - HCW Biologics Inc. (NASDAQ:HCWB), a small-cap biotech company with a market capitalization of $8.8 million, announced Monday that it has developed a second-generation pembrolizumab-based immunotherapy showing improved effectiveness against solid tumors in preclinical studies, particularly for pancreatic and ovarian cancers. The company’s stock has faced significant headwinds, declining over 80% in the past year.

The biopharmaceutical company’s new therapy, created using its proprietary TRBC platform technology, is designed to overcome limitations of current immune checkpoint inhibitors (ICIs), which according to the company show response rates below 20% in approved indications. According to InvestingPro data, while the company shows promising technological developments, it faces financial challenges with a weak overall financial health score and rapidly depleting cash reserves.

HCW’s pembrolizumab-based fusion molecule aims to both neutralize TGF-β, an immunosuppressive cytokine in the tumor microenvironment, and simultaneously activate immune cells to infiltrate solid tumors.

"In our preclinical studies, our second-generation checkpoint inhibitor outperformed pembrolizumab in immune-cell activation and expansion, enhancement of immune cell infiltration into the tumors, and immune cell cytotoxicity against cancer cells," said Dr. Hing C. Wong, Founder and CEO of HCW Biologics.

The company indicated that its novel approach works by both "taking the foot off the brake and simultaneously hitting the gas" on immune response against cancer cells.

Dr. Wong will present details from the IND-enabling studies at Nova Southeastern University in Fort Lauderdale, Florida, on September 12, 2025. With the company’s next earnings report due on November 13, 2025, InvestingPro subscribers can access 10+ additional exclusive insights about HCWB’s financial health and market position.

Pembrolizumab, marketed as KEYTRUDA by Merck, is currently the leading FDA-approved immune checkpoint inhibitor, with the company noting that ICIs generated over $40 billion in worldwide sales in 2024.

HCW Biologics is also exploring potential applications of its technology for treating age-related diseases by removing senescent cells. Despite reporting revenue of $830,000 in the last twelve months and maintaining a gross profit margin of 20%, the company faces significant financial challenges with negative EBITDA of -$12 million and a concerning current ratio of 0.11.

The information in this article is based on a company press release statement.

In other recent news, HCW Biologics Inc. has announced that it has regained compliance with all Nasdaq Capital Market listing requirements, having satisfied the minimum stockholders’ equity requirement. This development comes after the company received a delisting notice earlier, indicating non-compliance with Nasdaq Listing Rule 5550(b)(1). Furthermore, HCW Biologics reported that Armistice Capital Master Fund Ltd. has fully exercised its pre-funded warrants, completing the purchase of 513,140 shares of the company’s common stock. In addition, HCW Biologics has developed second-generation, multi-specific T-cell engagers targeting solid tumors, particularly pancreatic cancer, using its proprietary TRBC platform technology. These candidates have shown activity against pancreatic cancer in laboratory and humanized mouse models. The company has also partnered with WY Biotech Co., Ltd. for the technology transfer of a novel immunotherapy molecule, HCW11-006, with HCW Biologics receiving a $7.0 million upfront license fee. The licensing agreement allows for further development milestone payments and royalties, with HCW Biologics retaining certain rights to the molecule in the Americas.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.