Candel Therapeutics Inc (NASDAQ:CADL) announced positive final overall survival data from its Phase 2 clinical trial of CAN-2409, an investigational immunotherapy for pancreatic ductal adenocarcinoma (PDAC), showing a significant survival benefit for patients with borderline resectable disease.
The trial demonstrated an estimated median overall survival of 31.4 months for patients receiving CAN-2409 in combination with valacyclovir and standard-of-care chemoradiation, compared to just 12.5 months in the control group.
Among the seven patients treated with CAN-2409, three remained alive after more than five years, with survival durations of 66.0, 63.6, and 35.8 months, respectively.
Candel said in a statement that the data suggest a potential long-term survival benefit beyond what is typically expected with standard therapies.
“Pancreatic cancer remains one of the most difficult to treat diseases,” said Candel’s chief medical officer, Dr W Garrett Nichols.
“CAN-2409 is a first-in-class multimodal immunotherapy candidate designed for in situ vaccination against the patient’s tumor, which offers the potential to control this disease and to prolong survival, thus improving outcomes following this dismal prognosis.”
Candel CEO Dr Paul Peter Tak noted that the results further support the broader potential of CAN-2409 in solid tumors.
“The data presented today support the potential of CAN-2409 across various solid tumors, by showing its potential to alter the balance between the pancreatic tumor and the anti-tumor immune response, even in patients with residual tumor, improving long-term survival in a subset of the patients,” Tak said, adding that the company is now preparing for a larger, late-stage randomized controlled trial.
CAN-2409 has previously received Fast Track and Orphan Drug designations from the US Food and Drug Administration (FDA) for the treatment of PDAC.