Oral namodenoson for pancreatic cancer to advance in clinical testing
Upcoming Phase 2b trial aims to test drug in combo with immunotherapy
Written by |
Following “encouraging findings” from an early study, Can-Fite Biopharma is planning a clinical trial to test its oral therapy candidate namodenoson — now as a combination treatment with immunotherapy — in people with advanced pancreatic cancer.
That’s according to a company press release announcing that the Israel-based developer will advance its experimental therapy into a Phase 2b trial based on positive data from the small Phase 2a study.
“We are encouraged by the emerging data from our ongoing pancreatic cancer study and believe the advancement into a combination Phase 2b trial represents an important next step in the development of Namodenoson for this devastating disease,” said Salomon Stemmer, MD, leader of the ongoing Phase 2a study and a professor at the Davidoff Institute of Oncology of the Rabin Medical Center in Israel.
Namodenoson is a small molecule designed to activate a protein called the A3 adenosine receptor (A3AR). In pancreatic cancer cells, activation of this protein receptor can trigger programmed cell death, known as apoptosis. Can-Fite is now running clinical trials testing the therapy for potential use in pancreatic cancer, as well as certain liver diseases, namely liver cancer and MASH (metabolic dysfunction-associated steatohepatitis), which is marked by liver inflammation and scarring due to an abnormal buildup of liver fat.
The ongoing Phase 2a clinical trial (NCT06387342) enrolled 20 people with advanced pancreatic cancer that had progressed following at least one prior line of treatment. All participants in the study were started on namodenoson at a dose of 25 mg twice daily.
The study’s main goals are to evaluate namodenoson’s safety and its effect on the Eastern Cooperative Oncology Group Performance Status scale. That assessment measures how well patients are able to function in day-to-day life, on a scale from zero, indicating normal activity, to five, or death.
Early data show namodenoson kept cancer from getting worse
Less than a month ago, Can-Fite announced interim data from the Phase 2a study. The company said namodenoson has so far shown a favorable safety profile, and more than 30% of patients had stable disease, basically meaning the cancer did not get worse. Some patients were on namodenoson treatment for more than a year, and 35% are still being treated and undergoing follow-up, according to the company.
“Pancreatic cancer remains one of the deadliest malignancies with very limited therapeutic options, particularly in advanced disease. We believe Namodenoson’s favorable safety profile together with its potential additive effect with chemotherapy support continued clinical advancement of the program,” Stemmer said.
The upcoming Phase 2b trial will test namodenoson in combination with immunotherapy, evaluating the effect on endpoints including overall survival, disease stabilization, and time without disease progression. Immunotherapy broadly refers to treatments that activate the immune system to attack and kill tumor cells. Can-Fite said it’s in discussions with other oncology companies regarding partnerships for the namodenoson program.
