Processa Pharmaceuticals Inc. has entered into a contingent precedent exclusive licensing agreement with Elion Oncology Inc. to develop, manufacture and commercialize eniluracil (PCS6422) globally.

What is PCS6422?

PCS6422 is an oral drug to be administered with fluoropyrimidine cancer drugs (e.g., capecitabine, 5-FU) to decrease the breakdown of the cancer drug to inactive metabolites or metabolites that are known to cause unwanted side effects and to interfere with the anticancer activity.

Fluoropyrimidines are still the cornerstone of treatment for many different types of cancers, either as monotherapy or in combination with other chemotherapy agents. Capecitabine, an oral prodrug of 5-FU, is approved as first-line therapy for metastatic colorectal and breast cancer. However, its use is limited by adverse effects that usually requires dose interruptions/adjustments and even therapy discontinuation resulting in suboptimal tumor effects.

PCS6422 is an oral, potent, selective and irreversible inhibitor of dihydropyrimidine dehydrogenase (DPD), the enzyme that rapidly metabolizes 5-FU to inactive metabolites, such as α-fluoro-β-alanine (F-Bal). F-Bal is thought to cause the neurotoxicity and Hand–Foot Syndrome associated with 5-FU while greater formation of F-Bal has been associated with a decrease in the antitumor activity of 5-FU. Inhibition of DPD by PCS6422 is expected to significantly increase the cancer exposure to the 5-FU cytotoxic metabolites, potentially improving tumor response while reducing side effects.

“Having worked on 5-FU and other cancer agents in the past, adding PCS6422 to our pipeline and expanding our involvement in oncology was an easy decision given the significant impact that PCS6422 may have on improving the efficacy and safety of capecitabine or other fluoropyrimidines,” said Dr. David Young, CEO of Processa.

The grant of license is conditioned on the closing of an equity offering by Processa with at least $15 million in gross proceeds and the successful up-listing to Nasdaq by October 30, 2020. Following the satisfaction of the conditions, Processa must pay Elion $100,000 and issue Elion shares of common stock. As additional consideration, Processa will pay Elion development, regulatory, and commercial milestone payments up to a maximum of $88 million in cash and additional shares of common stock. Royalties on net sales will also be paid to Elion.