Pepper Bio’s drug-hunting efforts have turned up its first clinical-stage drug candidate, but not by discovering a novel molecule in its labs. Instead, the startup’s proprietary technology found another company’s shelved breast and lung cancer drug also shows promise for treating cancer of the liver.
Boston-based Pepper is acquiring rights to the G1 Therapeutics drug, lerociclib, under an agreement announced Wednesday. The deal covers all indications, except for the radioprotective applications that are a focus of Research Triangle Park, North Carolina-based G1.
Lerociclib is a small molecule designed to block the cancer-driving proteins CDK and CD6. G1 has already commercialized a CDK4/6 inhibitor, Cosela. Blocking these proteins has the effect of shielding bone marrow, protecting it from adverse effects that limit the use of chemotherapy. In 2021, the FDA approved Cosela, which is administered intravenously prior to chemotherapy in the treatment of extensive-stage small cell lung cancer.
A Personalized Approach to Medication Nonadherence
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
Lerociclib is an oral CDK4/6 inhibitor that G1 designed to offer potential dosing and safety advantages over currently approved CDK4/6 inhibitors, such as Pfizer’s Ibrance and Novartis’s Kisqali. Under G1, lerociclib generated positive Phase 1/2 clinical data in ER positive, HER2 negative breast cancer. But the company decided against pursuing further development of the molecule and instead looked for a partner to take it on.
In 2020, China-based Genor Biopharma acquired rights to lerociclib in Australia and certain Asian countries. The agreement covers the development of the drug for all indications in those regions. According to G1 regulatory filings, Genor paid G1 $6 million up front. Soon after, G1 reached a separate agreement with EQRx, which paid the company $20 million up front for lerociclib’s rights in most of the rest of the world. But after EQRx was acquired by Revolution Medicines in an all-stock deal last year, EQRx gave G1 notice it would terminate the license agreement.
Pepper Bio has described its platform technology as “a Google maps for drug discovery.” The platform takes in a variety of “-omics” data—genomics, proteomics, phosphoproteomics, and transcriptomics. These “trans-omics” data create a full and comprehensive picture of the biology of disease, which in turn guides the company’s efforts to find drugs to treat it. Pepper Bio said its technology identified CDK4/6 as potentially important targets for treating hepatocellular carcinoma, the most common type of liver cancer. The company said it then tested lerociclib in animals, yielding results that showed superior efficacy over standard liver cancer treatments during and after dosing.
Pepper Bio’s deal with G1 gives the startup all rights to lerociclib, excluding the regions already licensed to Genor. G1 and Pepper Bio said the upfront payments are in the single-digit millions, which is less than EQRx had paid. Pepper Bio’s agreement makes it responsible for a maximum $135 million in milestone payments, depending on the drug’s progress in up to three indications. If Pepper Bio can commercialize the drug, it would owe G1 royalties from sales.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
The Pepper Bio pipeline already has a liver cancer drug candidate. PEP001 is in preclinical development for hepatocellular carcinoma driven by the Myc oncogene. Two additional programs are in development for diffuse large B-cell lymphoma. A fourth program is in preclinical development for solid tumors.
“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,” Pepper Bio co-founder and CEO Jon Hu said in a prepared statement.
Pepper Bio launched in 2021. Last November, the company announced a $6.5 million seed financing that was led by NFX.
Image by Flickr user Ed Uthman via a Crreative Commons license
