IMD101 / Affinity Biopharma - LARVOL DELTA

Novel tumor microenvironment (TME) activated interleukin-2 (IL-2) fused to anti-PD-1 or anti-PD-1/VEGF-A antibodies for enhanced anti-tumor immunity (AACR 2026) - "Preclinical toxicology studies in cynomolgus monkeys indicated that IMD2035 was well tolerated following repeated doses of 12 mg/kg, exceeding the clinical exposure levels of anti-PD1-VEGF antibodies. Collectively, these findings support the favorable safety profile and therapeutic efficacy of IMD-101, IMD-2032, and IMD-2035, highlighting their potential as next-generation immunotherapeutic candidates for clinical development."

Biomarker • Tumor microenvironment • Oncology • FCGR3A • IL2 • LGMN • PD-L1

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

Dual-payload TME-activated ADC platform (AACR 2025) - "Such advantageous characteristics of TMEA linkers could be supported by a TMEA-SMDC drug Legubicin in clinical trial that releases payload Doxorubicin...In various PBMCs-CDX models, dual-payload TMEA-ADCs such as IMD526 (HER2-ADC), IMD2126 (PD-L1-ADC) and IMD2113 (EGFR&TROP2-ADC) have displayed significant dose-dependent antitumor activities and induced complete tumor regressions with no observable toxicities. Compared to mono- or combo treatments with single-payload ADCs, IMD526 validated its superiority in the in-vivo CT26-HER+ syngeneic mouse model, and long-term elimination of detectable tumors was achieved with IMD526 both alone and combined with IMD101 (a TMEA-Cytokine releasing IL-2)...And different from the tumor cell endocytosis activation by GGFG-DXd ADCs, the bio-distribution of TMEA-ADCs resulted in faster and higher levels of payload accumulation in the tumor local tissues. In summary, by integrating antibody targeting, TME activation, cytotoxic therapy,..."

IO biomarker • Oncology • Solid Tumor • CTSS • EGFR • HER-2 • IL2 • LGMN • PD-L1 • PRKDC