What You Should Know:
– G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, and Pepper Bio, the world’s first transomics drug discovery and development company, announced a global licensing agreement (excluding the Asia-Pacific region) for lerociclib for all indications outside acute radiation syndrome (ARS).
– As Pepper Bio’s first in-licensed therapeutic, lerociclib is a potent and selective inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6). The therapeutic has previously demonstrated impressive efficacy in clinical studies across various cancer types, including two completed Phase 3 clinical trials in HR+/Her2- metastatic breast cancer.
Pepper Bio Advances Liver Cancer Treatment with Lerociclib: A Breakthrough in Precision Medicine
Pepper Bio’s revolutionary transomics platform, COMPASS, is reshaping the landscape of drug discovery by offering a comprehensive view of disease biology. By translating biological maps encompassing genomics, transcriptomics, proteomics, and phosphoproteomics, COMPASS provides researchers with unprecedented insights into the real-time function of proteins, revolutionizing drug development methodologies. Leveraging COMPASS, Pepper Bio identified CDK4 and CDK6 as promising targets in hepatocellular carcinoma (HCC), the most prevalent form of liver cancer and the third leading cause of cancer-related deaths.
In a significant milestone, Pepper Bio conducted preclinical testing of lerociclib, a potential therapeutic for HCC, demonstrating superior efficacy compared to standard care both during and after dosing. This success led to an in-licensing agreement, marking lerociclib as Pepper Bio’s inaugural therapeutic slated for Phase 2 clinical trials.
Under this partnership, Pepper Bio gains exclusive rights to develop, manufacture, and commercialize lerociclib for non-ARS indications across major global markets, excluding the Asia-Pacific region licensed to Genor Biopharma. Collaborating closely with G1 Therapeutics, Pepper Bio aims to seamlessly transition lerociclib through clinical trials and regulatory approval processes.
This development follows Pepper Bio’s oversubscribed seed funding round, supported by notable investors such as NFX, Silverton Partners, and Merck Digital Sciences Studio. With these resources, Pepper Bio is poised to initiate clinical development programs for lerociclib, with the overarching objective of expediting regulatory approvals and bringing this innovative therapy to patients worldwide.
The agreement outlines upfront payments to G1 totaling mid-single-digit millions, with potential milestone payments reaching up to $135M across three indications, alongside double-digit royalties on lerociclib’s annual net sales. This collaboration underscores the commitment of both parties to advancing precision medicine and addressing unmet medical needs in liver cancer treatment.
“Liver cancer is a real and devastating diagnosis for hundreds of thousands of patients each year. Adding lerociclib into our pipeline is a significant step forward in our mission to find treatments for untreatable diseases,” said Jon Hu, Chief Executive Officer and co-founder of Pepper Bio. “Lerociclib holds tremendous promise as a cornerstone of our oncology portfolio, and we are excited to leverage its potential to bring life-saving treatments to those in need.”
