IMD303 / Affinity Biopharma - LARVOL DELTA

A novel chemical conjugated anti-CTLA-4 antibody with tumor microenvironment activation (AACR 2025) - "In animal models, IMD-303 demonstrated strong anti-tumor activities as single agent in multiple syngeneic murine tumor models, and it displayed significant synergistic effects when combined with IMD101 (a TMEA-Cytokine releasing IL-2) in EMT6 tumor model, in which IMD-303 can eliminate the number of Treg cells in tumors that are slightly up-regulated by IMD101. Preclinical toxicology studies showed that the favorable safety profile of IMD-303 allows for continued treatment with repeated dosing, and it's well-tolerated with a weekly repeated regimen of 200mg/kg in cynomolgus monkeys. All these findings indicate that IMD-303, with its preferential activation within tumors, exhibits superior efficacy and safety performances and has the potential to successfully transform the cold tumor microenvironment which lacks T-cell infiltration and immune responses."

Biomarker • IO biomarker • Tumor microenvironment • Oncology • Solid Tumor • CD8 • CD80 • CD86 • FCGR2A • FCGR3A • IL2 • LGMN

A Phase Ib/II Study to Evaluate the Safety, Tolerability and Efficacy of IMD303 in Participants With Advanced Malignant Solid Tumors (ANZCTR) - P1/2 | N=52 | Not yet recruiting | Sponsor: Catalysis Therapeutics Pty Ltd/Affinity (Chengdu) Pharmaceutical Co., Ltd

New P1/2 trial • Hepatocellular Cancer • Melanoma • Oncology • Renal Cell Carcinoma • Solid Tumor

A Study to Evaluate the Safety, Tolerability and Efficacy of IMD303 in Participants With Advanced Malignant Solid Tumors (ANZCTR) - P1 | N=30 | Recruiting | Sponsor: Catalysis Therapeutics Pty Ltd/Affinity (Chengdu) Pharmaceutical Co., Ltd

New P1 trial • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor