Candel Therapeutics (NASDAQ:CADL) has announced results from its multicenter Phase 3 trial evaluating CAN-2409 viral immunotherapy in patients with localized prostate cancer. The study achieved its primary endpoint, demonstrating a significant improvement in disease-free survival for patients treated with CAN-2409 plus prodrug (valacyclovir), in combination with standard of care (SOC) radiation therapy, compared to SOC alone.
According to Candel, the safety profile of CAN-2409 was generally consistent with previous studies, with no new safety signals identified.
“The improvement observed in disease-free survival in this phase 3 clinical trial is clinically meaningful. We have not seen significant advances in this indication in decades. CAN-2409 has demonstrated the potential to significantly improve long-term outcomes without adding substantial toxicity to standard of care radiation,” said Glen Gejerman, M.D., MBA, co-director of Urologic Oncology at Hackensack Meridian Health, and one of the principal investigators of the study.
“If approved, this approach has the potential to transform the treatment paradigm in prostate cancer, offering patients with localized disease an effective treatment option that may reduce the risk of disease recurrence,” Dr. Gejerman added.
Paul Peter Tak, M.D., Ph.D., FMedSci, president and CEO of Candel, commented, “We are thrilled to report the phase 3 results for CAN-2409 in intermediate-to-high risk, localized prostate cancer. This study validates previous observations of CAN-2409 activity seen in difficult-to-treat solid tumors, often resistant to immunotherapy, and confirms our previous observation of synergies with radiation therapy in models of prostate cancer.”
“Importantly, this study was conducted under a Special Protocol Assessment (SPA) agreed with the U.S. Food and Drug Administration (FDA), on key aspects of study design, meaning that safety and efficacy data generated from the study could be sufficient for the Company to seek regulatory approval for CAN-2409 in this indication. We look forward to working with the FDA, as a next step, to seek approval to bring CAN-2409 to patients in the U.S., and advance our broad viral immunotherapy pipeline across other large oncology indications of high unmet need,” Dr. Tak concluded.
