G1 Therapeutics and Pepper Bio Announce Global Lerociclib License Agreement (Excl. Asia-Pac)

G1 Therapeutics, a company specializing in oncology treatments, along with Pepper Bio, renowned for its transomics drug discovery capabilities, have announced a strategic global licensing agreement for the cancer drug lerociclib. This agreement, which excludes the Asia-Pacific region, grants Pepper Bio the rights to develop, manufacture, and commercialize lerociclib for all indications except specific radioprotectant uses.

Lerociclib, a powerful and selective inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6), has shown notable efficacy in clinical trials, particularly in HR+/HER2- metastatic breast cancer. This drug is set to become Pepper Bio’s first in-licensed therapeutic, marking a significant milestone for the company. Leveraging its transomics platform, COMPASS, Pepper Bio identified CDK4 and CDK6 as critical targets for treating hepatocellular carcinoma (HCC), the most common type of liver cancer and a leading cause of cancer-related deaths.

The COMPASS platform integrates multiple layers of biological data, including genomics, transcriptomics, proteomics, and phosphoproteomics, offering a comprehensive view of disease impact on biology. This holistic approach distinguishes Pepper Bio from other drug discovery platforms by providing real-time functional insights into proteins within a biological system, rather than merely measuring their presence and quantity. This capability allows for a deeper understanding of protein functions and their implications for drug development.

Pepper Bio's CEO and co-founder, Jon Hu, emphasized the significance of adding lerociclib to their oncology portfolio, expressing hope that this drug could become a cornerstone in their efforts to develop treatments for challenging diseases. The exclusive licensing deal is set to propel lerociclib into Phase 2 clinical trials, supported by promising preclinical results that demonstrated superior efficacy compared to current standard treatments.

The licensing agreement stipulates that G1 Therapeutics will receive initial payments in the mid-single-digit millions within the first year. Additionally, G1 could earn up to $135 million upon achieving specific development and commercial milestones for up to three different indications. Furthermore, Pepper Bio has agreed to pay G1 a double-digit royalty based on the annual net sales of lerociclib.

Jack Bailey, CEO of G1 Therapeutics, highlighted Pepper Bio's innovative approach as a key factor in choosing them to advance lerociclib through subsequent clinical development stages. This collaboration aligns with G1's strategy of forming partnerships that expand global access to their cancer therapies. Bailey expressed optimism that Pepper Bio's expertise would help unlock lerociclib's full therapeutic potential across new oncology indications.

Pepper Bio's recent oversubscribed seed funding round, backed by notable investors including NFX, Silverton Partners, and Merck Digital Sciences Studio, positions the company well to commence clinical development programs for lerociclib. The ultimate goal is to secure regulatory approvals and deliver the drug to patients in need as swiftly as possible.

In summary, the agreement between G1 Therapeutics and Pepper Bio marks a pivotal step in advancing the development and commercialization of lerociclib. With Pepper Bio's transomics platform and innovative approach, there is strong potential for significant advancements in cancer treatment, offering hope to many patients battling this devastating disease.