Candel Therapeutics Inc (NASDAQ:CADL) CEO talked with Proactive earlier this week about the company’s recent achievements in oncology drug development, with a strong focus on its gene therapy programs.
CEP Dr Paul Peter Tak said Candel has had “another very successful quarter”, highlighting that its lead program CAN-2409 achieved its primary endpoint in early localized, newly diagnosed prostate cancer.
The company is aiming for curative outcomes and received oral presentation acceptance at ASCO. This was described as “a big thing” and was presented by Johns Hopkins’ CEO and Dean, Ted DeWeese.
He confirmed that based on the strength of this data, the company secured an RMAT (Regenerative Medicine Advanced Therapy) designation from the FDA — an important validation for CAN-2409 as a gene therapy candidate.
In addition to progress in prostate cancer, Candel is expanding into non-small cell lung cancer and pancreatic cancer. It recently received orphan designation from the EMA for pancreatic cancer.
Dr Tak also discussed progress toward BLA submission, supported by a manufacturing partnership with one of the largest adenovirus producers, which is “going very well”.
Looking ahead, the company anticipates a pivotal 2026. With protocols in development for late-stage studies and regulatory engagement continuing, Candel remains focused on delivering value.
Its second program, CAN-3110 for glioblastoma, has shown a doubling in expected median survival following a single injection. Fast track and orphan designations have been granted by the FDA, and the company is exploring multiple-dose effects, with a paper under review by a high-impact journal.
“All of this is within the current runway”, Dr. Tak added, confirming that funding is secured through Q1 2027.