I-Mab Unveils Promising Uliledlimab Data in Lung Cancer Study

I-Mab Showcases Positive Pharmacokinetics Findings for Uliledlimab

Pharmacokinetic and pharmacodynamic (PK/PD) modeling data from three Phase 1 studies were presented by I-Mab, highlighting critical dosing information for future clinical trials. The data revealed a significant correlation between uliledlimab concentration and overall response rate (ORR) probability in patients with metastatic non-small cell lung cancer (mNSCLC). Furthermore, the company is gearing up for a randomized Phase 2 study involving uliledlimab combined with pembrolizumab and chemotherapy anticipated to kick off in the first half of 2025.

Study Insights from WCLC 2024

The presentation occurred during the International Association for the Study of Lung Disease's 2024 World Conference on Lung Cancer (WCLC 2024), which gathered experts and innovators in lung cancer treatments. I-Mab, a global biotech entity focused on pioneering immunotherapy solutions, showcased research conducted on uliledlimab (TJ004309). This monoclonal antibody is designed to inhibit CD73, an enzyme that plays a pivotal role in fostering an immunosuppressive environment within tumors.

Understanding Uliledlimab

By blocking CD73, uliledlimab seeks to restore the body's natural anti-tumor immunity, allowing for enhanced immunological responses and improved therapeutic outcomes. The data shared at the conference, based on comprehensive PK/PD analyses from three Phase 1 studies, suggest that patients exhibiting treatment-naïve mNSCLC can particularly benefit from this innovative approach.

Key Findings of the Study

Dr. Phillip Dennis, Chief Medical Officer of I-Mab, pointed out the favorable findings of their study. "The presented PK/PD analysis reinforces our belief that uliledlimab stands out as a potential best-in-class CD73 inhibitor. The encouraging exposure-response analysis indicates a promising relationship between uliledlimab levels and patient responses in NSCLC, accompanied by robust safety and target engagement findings," he stated.

Poster Overview and Statistical Highlights

The poster presented at the conference was titled: Integrated PK/PD Modeling for Uliledlimab, an Anti-CD73 Monoclonal Antibody, in Non-Small Cell Lung Cancer Patients (Poster #2979). The insights derived from the studies highlighted several key points:

• Approximately 95% of the modeled population achieved the targeted therapeutic threshold with a 30 mg/kg dose of uliledlimab.
• Integrated analyses indicated a significant positive correlation between uliledlimab's trough concentration and the likelihood of overall response in NSCLC cases.
• CD73 receptor occupancy reached and sustained over 90% in peripheral B cells throughout the treatment period.
• The specified dosing regimen of 30 mg/kg followed by a boost on Cycle 1, Day 8 successfully maintained drug levels above the effective threshold of 80 ?g/mL.
• The achievable trough concentration correlates with considerable clinical benefits, potentially linking to progression-free survival advantages.

About I-Mab and Their Research Initiatives

I-Mab (NASDAQ: IMAB) is on a mission to innovate cancer treatments through sophisticated immunotherapy approaches. The company has established its operational base in Rockville, Maryland, focusing on leveraging scientific advancements to benefit patients facing formidable cancer challenges. With uliledlimab and other leading-edge candidates in their pipeline, I-Mab is continuously progressing toward optimizing cancer care.

Frequently Asked Questions

What is uliledlimab designed to target?

Uliledlimab is designed to target CD73, an enzyme crucial for creating an immunosuppressive environment in tumors.

What were the major findings from the Phase 1 studies?

The findings highlighted a positive correlation between uliledlimab concentrations and overall response rates in patients with metastatic non-small cell lung cancer.

When is the Phase 2 study of uliledlimab expected to begin?

The randomized Phase 2 study combining uliledlimab with pembrolizumab and chemotherapy is expected to start in the first half of 2025.

How does uliledlimab work in treating cancer?

By inhibiting CD73, uliledlimab allows anti-tumor immunity to thrive, potentially reversing the immunosuppressive effects of adenosine in tumors.

What is I-Mab's goal in the oncology sector?

I-Mab aims to develop differentiated immunotherapy solutions to improve outcomes for cancer patients worldwide, continually pushing the boundaries of existing treatments.

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