HCW11-018 / HCW Biologics - LARVOL DELTA

HCW Biologics Delivers a Major Update for its T-Cell Engager Program Revealing Mechanism of Action and Validating Tissue Factor as Target for Treatment of Solid Tumors (GlobeNewswire) - "Poster presented at the American Association of Cancer Research Annual Meeting 2026....The Company’s preclinical data showed HCW11-018b could significantly shrink well-established tumors and prevent cancer metastasis in xenograft animal models with broad coverage for human solid tumor indications....The data showed that HCW11-018b is only activated within the tumor microenvironment, which is expected to increase the efficacy and tolerability of this tetra-valent T Cell Engager against human tumor cells....IND application expected to be filed in first half of 2027 to seek authorization for clinical study in patients with pancreatic cancer."

IND • Preclinical • Pancreatic Cancer

An innovative approach to improve bispecific T-cell engagers for solid tumor therapy (AACR 2026) - "HCW11-018b is currently in IND-enabling studies for clinical development against solid tumors. In summary, we demonstrate that the addition of TGFβ-trap and IL-15 components onto BiTE using our novel TRBC platform can overcome the deficiencies of BiTE for solid tumor therapy."

Bispecific • IO biomarker • Hematological Malignancies • Oncology • Pancreatic Cancer • Solid Tumor • BCL2 • CCR5 • CD69 • CD8 • GZMB • IFNG • IL15 • IL2RA • NKG2D • STAT5 • TGFB1

HCW Biologics Presents Preclinical Data for TRBC-Based T-Cell Engager Program at the Society for Immunotherapy of Cancer’s (SITC) 40th Annual Meeting (GlobeNewswire) - "HCW Biologics debuted the results from its preclinical study of HCW11-018b, the Company’s lead T-cell engager product candidate....Broad coverage for human solid tumor indications by targeting tissue factor, with high potency and precision, shown in xenograft models including the Patient-Derived Xenograft (PDX) tumor model. Tetra-valent construct to address immunosuppressive tumor microenvironment. Activates tumor-infiltrated exhausted T cells."

Preclinical • Solid Tumor

A novel multi-functional bispecific T-cell engager molecule for cancer therapy (SITC 2025) - "Additionally, HCW11-018b was well tolerated in tested mouse models (absence of lethargy, hunching) and its tolerability is being further evaluated in non-human primates. HCW11-018b is currently in an IND-enabling process for future clinical development against PC.Conclusions Altogether, these data demonstrate that (1) our TCE can induce potent anti-tumor activity against 'difficult-to-treat' pancreatic tumors and (2) the versatility of the TRBC platform can be used to create next-generation multi-specific T-cell engagers against solid tumors.Ethics Approval HCW Biologics IACUC committee ID#VG2025-009SPNew"

IO biomarker • Oncology • Pancreatic Cancer • Solid Tumor • CD69 • CD8 • GZMB • IL15 • IL2RA • NKG2D • TGFB1

HCW Biologics to Showcase Important Updates on IND-Enabling Studies and Preclinical Success of Its Novel Multi-Specific T-Cell Engagers Against Solid Tumors - "HCW Biologics Inc...announced today that its scientists have successfully developed second-generation, multi-specific T-cell engagers against solid tumors, particularly for pancreatic cancer, using its novel proprietary TRBC product discovery and development platform technology...The Company’s two lead T-cell engagers target tissue factor and mesothelin, which are proven solid tumor antigens. These product candidates exhibit potent and antigen-specific anti-pancreatic cancer activities both in vitro and in humanized mouse models at dose levels that are well tolerated...In our preclinical studies, after treatment with our TRBC-based T-cell engagers, there was 100% survival among tumor-bearing mice in the test group, whereas none of the untreated mice survived. We believe our approach could expand the number of indications that can be treated with T-cell engagers, including enhancing health span for patients suffering with solid tumors..."

Preclinical • Glioblastoma • Pancreatic Cancer • Solid Tumor