TB511 / Twinpig Biolab - LARVOL DELTA

Clinical Trial of TB511 in Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=12 | Not yet recruiting | Sponsor: Twinpig Biolab, Inc. | Trial completion date: May 2027 ➔ Mar 2028 | Trial primary completion date: May 2026 ➔ Mar 2027

IO biomarker • Monotherapy • Trial completion date • Trial primary completion date • Colorectal Cancer • Genito-urinary Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Solid Tumor

Combination therapy with TB511 and anti-nectin-4 antibody drug conjugate in a human pancreatic cancer mouse model (AACR 2025) - "As a result, TB511, PADCEV, and their combination significantly reduced tumor growth and Ki67 expression. No significant off-target effects were observed in the spleen, liver, lung, or brain. In conclusion, combination therapy with TB511 and ADC effectively suppresses pancreatic tumor growth and reprograms the immune microenvironment by decreasing M2 macrophages and enhancing cytotoxic T and NK cell responses, offering a promising strategy for pancreatic cancer treatment."

Combination therapy • IO biomarker • Preclinical • Oncology • Pancreatic Cancer • Solid Tumor • CD163 • CD8 • CDH1 • FOXP3 • GZMB • IFNG • ITGAM • ITGB2 • LAG3 • VIM

Clinical Trial of TB511 in Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=12 | Not yet recruiting | Sponsor: Twinpig Biolab, Inc. | Trial completion date: Oct 2025 ➔ May 2027 | Trial primary completion date: Mar 2025 ➔ May 2026

IO biomarker • Monotherapy • Trial completion date • Trial primary completion date • Colorectal Cancer • Genito-urinary Cancer • Hepatocellular Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Solid Tumor

Experimental cancer drug targets immune cells to shrink hard-to-treat tumors in mice: study (Korea Biomedical Review) - "The National Research Foundation of Korea announced the development Monday, following the publication of the findings Sunday in the Journal for ImmunoTherapy of Cancer....The drug, called TB511, is a peptide-drug conjugate-a type of molecule that links a tumor-targeting peptide to a cytotoxic payload for selective delivery....In mouse models of colon, lung, and pancreatic cancer, TB511 significantly slowed tumor growth and increased infiltration of CD8+ T cells, a key marker of anti-tumor immune activation. The drug’s effect was eliminated in models where CD18 was blocked or genetically removed, confirming CD18 as a critical driver of its mechanism, according to the study. TB511 received approval from the Ministry of Food and Drug Safety in 2024 to begin a phase 1/2a clinical trial. Human trials are set to begin later this year."

New P1/2 trial • Preclinical • Colorectal Cancer • Non Small Cell Lung Cancer • Pancreatic Cancer

Conformation-sensitive targeting of CD18 depletes M2-like tumor-associated macrophages resulting in inhibition of solid tumor progression. (PubMed, J Immunother Cancer) - "Collectively, our findings suggest that activated CD18 holds promise as a novel target protein for cancer therapy, and TB511 shows potential as a therapeutic agent for tumor treatment."

IO biomarker • Journal • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CD8 • ITGB2

Clinical Trial of TB511 in Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=12 | Not yet recruiting | Sponsor: Twinpig Biolab, Inc.

Combination therapy • IO biomarker • Metastases • Monotherapy • New P1/2 trial • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Hepatocellular Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Solid Tumor • CD163 • CD8 • GZMB • IFNG • IL10 • IL2 • IL2RA • ITGB2 • NCAM1 • PTPRC • TNFA

The apoptotic peptide TB511 targets activated CD18 and suppresses solid tumor progression (AACR 2024) - "Removal of M2-TAMs by TB511 significantly increased the infiltration of tumor-killing cells, such as granzyme B-positive CD8+ T cells and natural killer cells, in the TME. Collectively, our findings suggest that targeting CD18 in M2-TAMs using peptide drugs is a potential strategy for immunotherapy in various tumors, including non-small cell lung cancer, colorectal cancer, hepatocellular carcinoma, renal cell carcinoma, and prostate cancer."

IO biomarker • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor • CD8 • GZMB • ITGB2