Patients with gastric or gastroesophageal junction cancers have a reason to build on their hope for better treatment. Thanks to positive initial data from the DisTinGuish study, a Phase 2a clinical trial evaluates Leap’s anti-Dickkopf-1 (DKK1) antibody, DKN-01. The data presented by Leap Therapeutics, Inc. (NASDAQ: LPTX) at the ESMO Congress demonstrated tolerated and exciting activity. In addition, there were also notable robust objective clinical responses resulting from the combination of tislelizumab, BeiGene Ltd.’s anti-PD-1 antibody, and chemotherapy.
“Initial data from this trial… show evidence that not only is DKK1 a critical biomarker in predicting response to DKN-01 and tislelizumab therapy, but also that the combination can induce deep responses regardless of the patient’s PD-L1 status…,” Samuel Klempner, Member of Harvard Medical School outlined.
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Since its inception, Leap Therapeutics has filed several patents in the US. In addition, it has entered into significant collaborations through the years, among them with Merck to evaluate DKN-01 and Pfizer/Merck KGaA to evaluate TRX518. However, the announcement of Orphan Drug Designation of DKN-01 for the Treatment of Gastric/Gastroesophageal Junction Cancer in 2020 was the greatest of all milestones that year.
There are two parts of DKN-01’s study currently underway; in the United States and the Republic of Korea. Part A has 25 first-line HER2- G/GEJ, cancer patients. Part B will enroll up to 48 patients with second-line, DKK1-high G/GEJ cancer. This explains LPTX’s commitment to change the practice of cancer medicine by bringing forward promising cancer drugs. The company supports the ongoing campaign to offer patients early access to Investigational Medicinal Products (IMP)
From recent publications, DKK1 is purported to have the ability to maintain an environment around a tumor that suppresses the immune system’s capability. In addition, it activates the suppressive effects of myeloid-derived suppressor cells (MDSCs). All these and other activities surrounding DKK1 have proven the need to evaluate it further. Meanwhile, Leap has an exclusive agreement with BeiGene to develop DKN-01 in Asia (excluding Japan), Australia, and New Zealand.