Candel Therapeutics Inc (NASDAQ:CADL) announced that its experimental immunotherapy, CAN-2409, met its main goal in a Phase 3 trial, significantly improving disease-free survival in patients with localized prostate cancer.
The trial showed a 14.5% improvement in disease-free survival (DFS) at 54 months for the CAN-2409 group compared to the control arm and significantly reduced recurrence risk while improving prostate cancer-free survival.
In addition, the treatment group demonstrated a statistically significant improvement in DFS in the intent-to-treat population. The study also revealed a significant increase in the proportion of patients achieving a prostate-specific antigen (PSA) nadir of less than 0.2 ng/ml, with 67.1% of patients in the CAN-2409 group achieving this compared to 58.6% in the placebo group.
Moreover, 80.4% of patients in the CAN-2409 treatment arm achieved pathological complete responses at two years, significantly higher than the 63.6% observed in the control arm.
Shares surged on the news, gaining over 150% to trade at $11.60 at the open Wednesday.
“We have not seen significant advances in this indication in decades,” said Dr. Glen Gejerman, Co-Director of Urologic Oncology at Hackensack Meridian Health and a principal investigator in the study.
“CAN-2409 has demonstrated the potential to significantly improve long-term outcomes without adding substantial toxicity to standard of care radiation. 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.”
The multicenter, double-blind study enrolled 745 randomized patients to receive either CAN-2409 plus prodrug valacyclovir with standard external beam radiation therapy or radiation therapy alone.
Patients were grouped based on their use of short-term androgen deprivation therapy (ADT).
The therapy uses a replication-defective adenovirus to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to tumor cells, triggering immunogenic cell death and activating a tumor-specific immune response. The safety profile was consistent with earlier trials, with the most common side effects being mild flu-like symptoms.
“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,” Candel CEO Paul Peter Tak told investors.
Tak also noted the study was conducted under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA), adding the data could support a regulatory submission for CAN-2409.
Prostate cancer remains the second leading cause of cancer death among men in the United States, with more than 100,000 cases diagnosed annually in its localized form.
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