On September 10, 2024 I-Mab (NASDAQ: IMAB) (the "Company"), a U.S.-based, global biotech company exclusively focused on the development of highly differentiated immunotherapies for the treatment of cancer, reported a poster presentation of PK/PD modeling data for uliledlimab at the International Association for the Study of Lung Disease (IASLD)’s 2024 World Conference on Lung Cancer (WCLC 2024) held September 7-10, 2024 in San Diego, CA (Press release, I-Mab Biopharma, SEP 10, 2024, View Source [SID1234646482]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Uliledlimab (TJ004309) is an antibody designed to target CD73, the rate-limiting enzyme critical for adenosine-driven immunosuppression in the tumor microenvironment. Blocking CD73 allows anti-tumor immunity to proceed without the presence of an adenosine-induced "immunological fog". The WCLC 2024 presentation includes data from uliledlimab PK/PD analyses from three Phase 1 studies including patients with treatment naïve metastatic non-small cell lung cancer (mNSCLC).
"The PK/PD analysis presented at WCLC underscores our view that uliledlimab has the potential to be a differentiated, best-in-class, CD73 inhibitor. The data support our dose selection work and upcoming combination studies, with a study of uliledlimab plus pembrolizumab plus chemotherapy expected to begin in the first half of 2025," said Phillip Dennis, MD, PhD, Chief Medical Officer of I-Mab. "We are particularly encouraged by the E-R analysis, which showed a positive relationship between uliledlimab exposure and the probability of an overall response in patients with NSCLC, as well as positive target engagement data and dose proportional PK results. These data, plus a previously presented favorable safety profile and clinical efficacy, fortify our view that uliledlimab has the potential to meaningfully improve the care of patients with mNSCLC."
Poster Title: Integrated PK/PD Modeling for Uliledlimab, an Anti-CD73 Monoclonal
Antibody, in Non-Small Cell Lung Cancer Patients (Poster #2979)
Data are based on analysis of three Phase 1 studies conducted in China evaluating uliledlimab, as a monotherapy and in combination studies with the checkpoint inhibitors, toripalimab or atezolizumab, in patients with advanced cancers, including mNSCLC.
Key Findings Include:
Most of the simulated population (95%) could achieve the target threshold with 30 mg/kg of uliledlimab
Integrated PK/PD modeling and pharmacometrics analyses indicate there is a positive relationship between the probability of overall response and uliledlimab trough concentration in NSCLC patients
CD73 receptor occupancy (RO) in peripheral B cells achieved 90% or above and maintained at high levels until the end of treatment
The 30 mg/kg dose with a single boost dose on C1D8 provided uliledlimab concentrations that achieved the target concentration of 80 μg/mL immediately after the first dose and maintained this threshold afterward
A Ctrough target threshold of 80 μg/mL may be clinically meaningful, associated with PFS benefit and is achievable by a 30 mg/kg initial dose followed by a booster dose on Cycle 1, Day 8 (C1D8)
A full copy of the poster is available on the I-Mab website, on the "Innovation, Publications & Presentations" tab.