I-Mab Shares Positive Uliledlimab Pharmacokinetics Data at 2024 Lung Cancer Conference

ROCKVILLE, Md., Sept. 10, 2024 -- I-Mab, a U.S.-based global biotech company dedicated to developing advanced immunotherapies for cancer treatment, announced a significant poster presentation of pharmacokinetic/pharmacodynamic (PK/PD) modeling data for uliledlimab at the 2024 World Conference on Lung Cancer (WCLC) organized by the International Association for the Study of Lung Disease (IASLD) in San Diego, CA.

Uliledlimab, also known as TJ004309, is an antibody aimed at inhibiting CD73, a crucial enzyme that fosters adenosine-driven immunosuppression within the tumor environment. By targeting and blocking CD73, uliledlimab enables the immune system to combat tumors without the interference of adenosine-induced suppression. The data presented at WCLC 2024 included analyses from three Phase 1 studies involving patients with metastatic non-small cell lung cancer (mNSCLC).

Phillip Dennis, MD, PhD, Chief Medical Officer of I-Mab, emphasized the significance of these findings, stating, "The PK/PD analysis highlights uliledlimab's potential as a leading CD73 inhibitor. The data underpin our dose selection process and support the upcoming combination studies, with a trial involving uliledlimab, pembrolizumab, and chemotherapy slated to commence in the first half of 2025."

The WCLC presentation underscored several key findings from the three Phase 1 studies. The studies, conducted in China, tested uliledlimab both as a monotherapy and in combination with checkpoint inhibitors toripalimab or atezolizumab on patients with advanced cancers, including mNSCLC.

Among the critical findings presented:

1. Target Achievement: Approximately 95% of the simulated patient population reached the target threshold with a dose of 30 mg/kg of uliledlimab.
2. Positive Correlation: The integrated PK/PD modeling and pharmacometric analyses revealed a positive correlation between the probability of overall response and uliledlimab trough concentration in NSCLC patients.
3. Receptor Occupancy: CD73 receptor occupancy in peripheral B cells was observed to be 90% or higher and remained at these levels until the end of treatment.
4. Dose Efficacy: The 30 mg/kg dose, combined with a booster dose on Cycle 1, Day 8 (C1D8), achieved and maintained the target concentration of 80 μg/mL after the first dose.
5. Clinical Significance: The Ctrough target threshold of 80 μg/mL, associated with progression-free survival (PFS) benefit, is achievable with the proposed dosing regimen.

Additionally, the exposure-response (E-R) analysis demonstrated a positive relationship between uliledlimab concentration and the overall response rate (ORR) in mNSCLC patients, reinforcing the potential clinical benefits of uliledlimab.

The poster, titled "Integrated PK/PD Modeling for Uliledlimab, an Anti-CD73 Monoclonal Antibody, in Non-Small Cell Lung Cancer Patients" (Poster #2979), is available on the I-Mab website.

I-Mab, headquartered in Rockville, Maryland, continues to focus on advancing its pipeline of differentiated immunotherapies. The company anticipates that the combination study of uliledlimab with pembrolizumab and chemotherapy will further elucidate uliledlimab's potential to significantly enhance patient outcomes in mNSCLC.

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