With the release of encouraging primary endpoint findings from its phase 3 clinical study assessing CAN-2409 viral immunotherapy in localized prostate cancer, Candel Therapeutics, Inc. (NASDAQ: CADL) has reached a noteworthy milestone. The shares of CADL jumped 144.61% after this statement, trading at $11.28 as of the latest market check.
A landmark Results of the Phase 3 Trial
In this phase 3 trial, which was randomized, double-blind, and placebo-controlled, 745 individuals with intermediate-to-high-risk, localized prostate cancer were included. When CAN-2409 was used in conjunction with valacyclovir and usual treatment, the experiment showed a statistically significant increase in disease-free survival (DFS).
This combination outperformed standard care alone. To further assess the safety and efficacy of short-term androgen deprivation therapy (ADT), the patients were stratified. A significant breakthrough in localized prostate cancer treatment, the study’s main goal highlights CAN-2409’s potential to improve patient outcomes without causing significant harm.
A Novel Viral Immunotherapy, CAN-2409
The herpes simplex virus thymidine kinase (HSV-tk) gene is delivered directly to tumor cells by the replication-defective, experimental adenovirus CAN-2409. When used in conjunction with valacyclovir, this treatment destroys immunogenic cells and stimulates the tumor microenvironment, which results in a customized CD8+ T cell-mediated defense against tumor antigens.
This novel method targets a wide range of tumor antigens and functions as an in situ vaccination. Evidence from preclinical and clinical studies suggests that CAN-2409 synergizes effectively with localized radiotherapy, further validating its role in the trial’s success.
Treatment Implications for Prostate Cancer
In the US, more than 100,000 men are affected by localized prostate cancer each year, and more than 50,000 of them need radiation treatment. In the United States alone, the addressable market for CAN-2409 is estimated to be worth over $10 billion.
Candel plans to talk with the FDA about regulatory options in light of the encouraging study findings. CADL plans to present comprehensive data at forthcoming medical conferences. If approved, CAN-2409 could revolutionize prostate cancer treatment, providing patients with an effective option to reduce recurrence risk and improve long-term outcomes.
