Lupin Limited announced it will present Phase 1a clinical trial data for its experimental cancer drug LNP7457 at the American Society of Clinical Oncology (ASCO) Annual Meeting 2025. The presentation, scheduled for June 2, 2025, will showcase results from a dose escalation study of the PRMT5 inhibitor in patients with advanced or metastatic solid tumors.
Clinical Trial Results
The Phase 1a study demonstrated that LNP7457 was generally safe and well-tolerated across the patient population. The drug exhibited a favorable pharmacokinetic and pharmacodynamic (PK/PD) profile, with investigators noting no food-related effects on pharmacokinetics—a finding that could simplify dosing protocols in future development phases.
Researchers successfully identified the maximum tolerated dose during the dose escalation study, providing crucial data to inform the recommended Phase 2 dosage. This determination was based on comprehensive analysis of safety parameters, preliminary efficacy signals, and existing preclinical data.
Mechanism and Differentiation
LNP7457 represents a novel approach to cancer treatment as a SAM-competitive PRMT5 inhibitor. PRMT5 (protein arginine methyltransferase 5) is an epigenetic enzyme that plays a critical role in cancer cell survival and proliferation. The drug's unique mechanism of action positions it as a potentially differentiated therapeutic option within the emerging class of PRMT5 inhibitors.
"We are delighted to share the initial results from Phase I study of our PRMT5 Inhibitor, a novel epigenetic onco-therapeutic targeted for monotherapy," said Vinita Gupta, CEO of Lupin. "We are committed to innovation and advancing cutting-edge science to offer meaningful therapeutic options for patients with difficult-to-treat cancers."
Development Strategy
Lupin plans to advance LNP7457 into Phase 1b trials in India, focusing on cancers with significant unmet medical needs. The company's strategy emphasizes targeting difficult-to-treat malignancies where current therapeutic options remain limited.
The ongoing development program reflects Lupin's broader commitment to oncology innovation, particularly in the epigenetic therapeutics space. The PRMT5 pathway has emerged as an attractive target for cancer therapy due to its role in multiple cellular processes essential for tumor growth and survival.
ASCO Presentation Details
The presentation, titled "A phase 1 dose escalation study of LNP7457 (PRMT5 inhibitor) in patients with advanced or metastatic solid tumors," will be featured during the Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology session. The poster presentation is scheduled for Poster Board #422 on June 2, 2025, from 1:30 PM to 4:30 PM CDT.
The trial is registered under CTRI/2023/07/054753, and the presentation will be accessible online through ASCO's platform, allowing global access to the clinical findings.
