NI-3201 / LightChain Bioscience - LARVOL DELTA

Preclinical development of NI-3201, a PD-L1xCD28 bispecific antibody mediating CD28 costimulation upon PD-L1 blockade (AACR 2024) - "The favorable profile seen in NHP was supported by data generated in vitro further de-risking the cytokine release syndrome (CRS) potential. Quantitative systems pharmacology (QSP) modelling integrating both in vitro and NHP data predicted a drug concentration required for optimal NI-3201 activity in the TME, and preliminary data suggests optimal patient activity at Q2W-Q3W dosing schedule.The anti-tumor activity as a single agent or as universal combination partner for TCEs, shown in vitro and in vivo, together with the favorable safety profile of NI-3201, support its clinical development planned to start in Q1 2025."

Bispecific • Preclinical • Colon Adenocarcinoma • Colon Cancer • Colorectal Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • CRP • IL6

NI-3201 Is a Bispecific Antibody Mediating PD-L1-Dependent CD28 Co-stimulation on T Cells for Enhanced Tumor Control. (PubMed, Cancer Immunol Res) - "Quantitative systems pharmacology modeling predicted that NI-3201 exposure results in antitumor activity in patients, but this remains to be investigated. Overall, this study suggests that by combining PD-L1 blockade with safe and effective CD28 co-stimulation, NI-3201 has the potential to improve cancer immunotherapy outcomes, and the clinical development of NI-3201 for PD-L1+ solid tumors is planned."

Journal • Cytomegalovirus Infection • Oncology • Solid Tumor • PD-L1

NI-3201,a PD-L1xCD28 bispecific antibody for immune checkpoint-dependent CD28 co-stimulation (AACR 2023) - "In immunocompetent huCD28-transgenic mice engrafted with huPD-L1-expressing murine colon adenocarcinoma MC38 cells, NI-3201 displayed superior single-agent activity as compared to the anti-PD-L1 antibody Atezolizumab, with tumor regression being observed in all treated mice. The mechanism of action of NI-3201 and the data presented herein support the use of this molecule as a universal combination partner for CD3-bispecifics. Pre-clinical development of NI-3201 is ongoing, with pharmacokinetic and tolerability studies in non-human primates planned for early 2023."

Colon Cancer • Colorectal Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • CD4 • CD8