G1 Therapeutics Inc., a commercial-stage oncology company, and Pepper Bio, a transomics drug discovery and development company, have announced a global licensing agreement (excluding the Asia-Pacific region) for lerociclib for all indications except for certain radioprotectant uses.
 
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.
 
“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.”

Terms of the Agreement

Pepper Bio will gain exclusive rights to develop, manufacture, and commercialize lerociclib for all indications except for certain radioprotectant uses in the US, Europe, Japan, and all other global markets, excluding the Asia-Pacific region, which G1 has already licensed to Genor Biopharma. G1 Therapeutics and Pepper Bio will collaborate closely to ensure a seamless transition and advance the development of lerociclib through clinical trials and regulatory approval processes.
 
Under the terms of the agreement, G1 is expected to receive upfront payments totaling mid-single-digit millions within 12 months and is eligible to receive a maximum of $135M upon achievement of development and commercial milestones in up to three indications. In addition, Pepper Bio will pay G1 a double-digit royalty on aggregate annual net sales of lerociclib.
 
“Pepper Bio’s commitment to innovation makes them the right partner for advancing lerociclib through the next stages of clinical development,” said Jack Bailey, Chief Executive Officer of G1 Therapeutics. “This agreement is consistent with our corporate strategy to form partnerships that enable global access to our promising oncology therapies; with Pepper Bio, we look forward to the opportunity to realize the full therapeutic potential of lerociclib across new oncology indications.”