G1 Therapeutics, Inc. has inked a global licensing agreement (excluding the Asia-Pacific region) with Pepper Bio 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.

Using Pepper Bio’s transomics platform, COMPASS, the company was able to identify CDK4 and CDK6 as potentially important targets in treating HCC. Pepper Bio then tested lerociclib in preclinical models, which showed superior efficacy over standard of care during and after dosing. With this in-licensing deal, lerociclib will be Pepper Bio’s first therapeutic on its way to Phase 2 clinical trials.

Pepper Bio’s platform, COMPASS, translates layers of biological maps, including genomics (genes), transcriptomics (RNA), proteomics (proteins), and phosphoproteomics (function of proteins), to offer researchers a complete picture of how diseases impact biology.

Setting Pepper Bio apart from other drug discovery platforms is its unprecedented ability to look at the real-time function of proteins in a biological system, as opposed to the current methods of only measuring the presence, type, and quantity of proteins. COMPASS unveils the intricate functions of these proteins, which significantly impact how drugs are built and developed. 

"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," Hu commented.

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.

This news follows Pepper Bio's oversubscribed seed funding round, led by NFX, Silverton Partners, Merck Digital Sciences Studio, and others. Pepper Bio is now poised to initiate clinical development programs for lerociclib, with the ultimate goal of obtaining regulatory approvals and making lerociclib available to patients as quickly as possible.

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 USD 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," Bailey added.