Late clinical stage biopharmaceutical company Candel Therapeutics (CADL) developes novel oncolytic viral immunotherapies, they announced that it has completed patient enrollment for its pivotal phase 3 study of CAN-2409 immunotherapy in patients with intermediate-high risk localized prostate cancer.
This placebo-controlled, randomized clinical trial is evaluating CAN-2409 treatment in combination with valacyclovir added to upfront standard of care external beam radiation therapy for patients with localized prostate cancer compared to standard of care radiation therapy alone.
The primary endpoint of the study is disease-free survival. Secondary endpoints include prostate cancer specific survival, overall survival, freedom from biochemical failure, patient reported health-related quality of life, and safety.
CADL reports earnings
This has been a transformational year for Candel Therapeutics as we continue to execute on our corporate strategy by advancing the development of our lead product candidate from our adenovirus platform, CAN-2409, and our lead product candidate from our HSV platform, CAN-3110, both in areas of significant unmet need, with the completion of our IPO in August and multiple data readouts across our broad pipeline over the next 12 months, we are in a strong position to advance our strategy and well-capitalized to support achievement of important milestones toward bringing novel immunotherapies to patients with cancer.
Paul Peter Tak, M.D., Ph.D., FMedSci, President and Chief Executive Officer of Candel Therapeutics.
Second Quarter 2023 & Recent Highlights
- On April 13, the Company announced formation of its new Research Advisory Board that included 2018 Nobel Laureate, James Allison, Ph.D. (MD Anderson Cancer Center), Henry Brem, M.D. (Johns Hopkins University), Roy S. Herbst, M.D., Ph.D. (Yale Cancer Center), Elizabeth Jaffee, M.D. (Johns Hopkins University), Philip Kantoff, M.D. (formerly Memorial Sloan Kettering Cancer Center), and Padmanee Sharma, M.D., Ph.D. (MD Anderson Cancer Center).
- On April 22, the Company announced it completed enrollment in a phase 1 clinical trial in patients with newly diagnosed high-grade glioma to evaluate the safety and efficacy of CAN-2409 in combination with Opdivo® (nivolumab) and standard of care radiation therapy, as well as temozolomide for patients who have a methylated MGMT promoter.
- On June 4, the Company reported data from an ongoing phase 1 clinical trial of its oncolytic virus, CAN-3110, in patients with high-grade glioma that has recurred after initial treatment. The data presented at the 2023 American Society of Clinical Oncology (ASCO) demonstrated a favorable safety and tolerability profile and durable responses in a number of patients.
- On June 22, the U.S. Food and Drug Administration granted Fast Track designation for CAN-2409 in combination with standard-of-care surgery and chemoradiation to improve survival in adults with newly diagnosed high-grade glioma.
- On July 15, the Company announced the appointment of Diem Nguyen, Ph.D., M.B.A. to its Board of Directors.
- On August 17, the Company announced the completion of its Initial Public Offering, raising gross proceeds of $79.1 million, before deducting underwriting discounts and commissions and offering expenses, to support ongoing research and development efforts.
- On September 7, the Company announced it completed enrollment in its phase 3 clinical trial of CAN-2409 in combination with valacyclovir for the treatment of intermediate- to high-risk localized prostate cancer.
Key Upcoming Milestones
- Initial efficacy and safety data from a phase 1 clinical trial of CAN-2409 in combination with Opdivo® (nivolumab) in patients with high-grade glioma are expected to be presented in the fourth quarter of 2023.
- Blinded safety data from a phase 2 clinical trial of CAN-2409 in patients undergoing active surveillance for prostate cancer are expected to be presented in the third quarter of 2023.
- Biomarker results from a phase 1 clinical trial of CAN-3110 in patients with recurrent high-grade glioma are expected to be presented in the fourth quarter of 2023.
