DKN-01, what is the likelihood that the drug will be approved?

DKN-01 is under clinical development by Leap Therapeutics and currently in the Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect DKN-01’s likelihood of approval (LoA) and phase transition for Adenocarcinoma Of The Gastroesophageal Junction took place on 27 Nov 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

In addition, the same event on 27 Nov 2022 decreased DKN-01’s LoA and PTSR for Bile Duct Cancer (Cholangiocarcinoma), decreased LoA and PTSR for Colorectal Cancer, decreased LoA and PTSR for Endometrial Cancer, decreased LoA and PTSR for Epithelial Ovarian Cancer, decreased PTSR for Metastatic Biliary Tract Cancer, decreased LoA and PTSR for Metastatic Hormone Refractory (Castration Resistant, Androgen-Independent) Prostate Cancer, decreased LoA and PTSR for Peritoneal Cancer, decreased LoA and PTSR for Uterine Cancer, decreased LoA and PTSR for Esophageal Cancer, decreased PTSR for Extrahepatic Bile Duct Cancer, decreased LoA and PTSR for Fallopian Tube Cancer, decreased LoA and PTSR for Gallbladder Cancer, decreased LoA and PTSR for Gastric Cancer, and decreased LoA and PTSR for Hepatocellular Carcinoma.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their DKN-01 LoA and PTSR Report.

DKN-01 overview

DKN-01 (LY-2812176) is under development for the treatment of bile duct cancer, esophageal cancer, fallopian tube cancer, adenocarcinoma of the gastroesophageal junction, epithelial ovarian cancer, peritoneal cancer, endometrial cancer, carcinosarcoma (uterine cancer), gallbladder cancer, metastatic castration-resistant prostate cancer, colorectal cancer, advanced gynecological cancers and extrahepatic bile duct cancer. The drug candidate is administered intravenously. It is a monoclonal antibody targeting dickkopf homolog 1 (Dkk-1). The drug candidate was also under development for the treatment of relapsed or refractory multiple myeloma and non-small cell lung cancer.

Leap Therapeutics overview

Leap Therapeutics is a clinical-stage biopharmaceutical company that develops novel therapeutics to treat patients with different types of cancer. The company’s pipeline products include DKN-01. DKN-1 is a monoclonal antibody that targets the Dickkopf-1 (DKK-1) protein, intended for the treatment of gastroesophageal cancer, prostate cancer and gynecologic cancer. The company has an agreement with BeiGene Ltd for development rights and commercialization of DKN-01 in Australia, Asia (excluding Japan) and New Zealand. Leap Therapeutics is headquartered in Cambridge, Massachusetts, the US.

Quick View DKN-01 LOA Data