FCF is pleased to announce that it has entered into a partnership agreement with Dracen Pharmaceuticals, Inc. to supply a glutamine antagonist pro-drug, DRP-104 (sirpiglenastat), for a planned clinical trial in fibrolamellar patients. Under the agreement, Dracen will provide the product, as well as regulatory and operational support for the trial.
In fibrolamellar carcinoma, recent research indicates that the DNAJB1-PKACA fusion that drives the cancer shifts the cancer’s metabolism away from the aerobic (oxygen-utilizing) breakdown of sugar, and towards using large amounts of the amino acid glutamine. Cancers like FLC that are “addicted” to glutamine metabolism also display increased resistance to killing by immune cells. Researchers believe that FLC tumor cells may deplete glutamine from their vicinity, and thereby cripple T cells, which could otherwise kill cancer cells.
A drug called DON (6-Diazo-5-oxo-l-norleucine) is an analog of glutamine and an irreversible inhibitor of all glutamine-metabolizing enzymes. Past preclinical and clinical studies have shown that DON can have a strong anti-tumor effect on glutamine-addicted cancers. Unfortunately, broad-acting inhibitors like DON also are highly toxic to healthy tissues that require glutamine.
Dracen Pharmaceuticals, Inc. is a private clinical-stage biotech company developing DRP-104, a special “prodrug” version of DON. DRP-104 is an inactive compound that is converted into DON by metabolic processes. DRP-104 is activated within tumors and mostly remains inactivated in other tissues; as a result, DRP-104 delivers DON into tumors while sparing healthy tissues. A recently completed phase I single agent study of DRP-104 in patients with advanced solid tumors (who progressed after failing all other therapies) confirmed that DRP-104 preferentially converts to DON in tumors and demonstrated the anti-tumor activity of the drug.
FCF is very excited about establishing this collaborative relationship and exploring DRP-104’s applicability to FLC treatment. Click here to learn more about DRP-104.
More information on the planned clinical trial to come!