NEEDHAM, Mass., May 27, 2025 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today announced that Candel management will host a webcast and conference call on Tuesday, June 3, 2025, at 1:00PM ET. The call will discuss the Company’s positive phase 3 clinical results for CAN-2409 in localized, intermediate-to-high risk prostate cancer, which demonstrated a statistically significant 30% reduction in disease recurrence compared with placebo when combined with standard-of-care radiation therapy. The discussion will follow Dr. Theodore DeWeese’s* oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.
The call will also feature insights from leading prostate cancer specialists, John E. Sylvester, M.D., Atlantic Urology Clinics, Myrtle Beach, South Carolina, and Ronald F. Tutrone, Jr., M.D., FACS, CPI, National Medical Director of Clinical Research, United Urology Group, Towson, Maryland. Both physicians were principal investigators on the phase 3 clinical trial.
Dr. Sylvester is a renowned prostate cancer specialist with over two decades of experience in radiation oncology. He is widely recognized for his expertise in prostate brachytherapy and advanced radiation treatment techniques. Dr. Sylvester has played a pivotal role in pioneering innovative approaches to prostate cancer care and has authored numerous peer-reviewed publications in the field. He has trained physicians globally and continues to contribute to advancing clinical best practices. His leadership and dedication have earned him a reputation as a trusted authority in prostate cancer treatment and a passionate advocate for improving patient outcomes.
Dr. Tutrone is a leading urologist specializing in the diagnosis and treatment of prostate cancer. With over 25 years of clinical experience, he serves as Medical Director of Chesapeake Urology Research Associates and has been principal investigator in numerous clinical trials focused on urologic oncology. Dr. Tutrone is recognized for his commitment to advancing prostate cancer care through research, innovation, and patient-centered treatment. He has published extensively in peer-reviewed journals and is frequently invited to speak at national and international conferences. His work has significantly contributed to improving outcomes for men with prostate cancer.
Conference Call and Webcast
Candel will host a webcast and conference call on Tuesday, June 3, 2025, at 1:00PM ET. The webcast can be accessed here and on the Candel website at https://candeltx.com/, under News & Events, in the IR section of the website.
Participants may register for the conference call here to receive dial-in numbers and unique PIN to access the call. Joining 10 minutes prior to the start of the event is recommended, although you may register and dial in at any time during the call. An archived webcast will be available on Candel’s website for 30 days following the presentation.
* Dr. DeWeese has no relationship with Candel, other than serving as the national principal investigator for Candel’s phase 3 clinical trial of CAN-2409 in patients with intermediate-to-high-risk localized prostate cancer. He has never received reimbursements, consulting fees, or any other fees from Candel, and he has no shares of common stock, options to purchase common stock or any other affiliation with Candel.
About CAN-2409
CAN-2409 (aglatimagene besadenovec), Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s specific tumor and induce an individualized, systemic immune response against the tumor. HSV-tk is an enzyme that locally converts orally administered valacyclovir into a toxic metabolite that kills nearby cancer cells. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ immunization against a variety of tumor antigens. Because of its versatility, CAN-2409 has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. More than 1,000 patients have been dosed with CAN-2409 with a favorable tolerability profile to date, supporting the potential for combination with other therapeutic strategies.
Currently, Candel is evaluating CAN-2409 in non-small cell lung cancer (NSCLC) and borderline resectable pancreatic adenocarcinoma (PDAC) and has recently completed a successful phase 3 clinical trial in localized prostate cancer. CAN-2409 plus prodrug (valacyclovir) has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of PDAC, for the treatment of stage III/IV NSCLC in patients who are resistant to first line PD-(L)1 inhibitor therapy and who do not have activating molecular driver mutations or have progressed on directed molecular therapy, and for the treatment of localized primary prostate cancer. Candel’s pivotal phase 3 clinical trial in prostate cancer was conducted under a Special Protocol Assessment (SPA) agreed with the FDA. The FDA has also granted Orphan Drug Designation to CAN-2409 for the treatment of PDAC.
About Candel Therapeutics
Candel is a clinical stage biopharmaceutical company focused on developing off-the-shelf multimodal biological immunotherapies that elicit an individualized, systemic anti-tumor immune response to help patients fight cancer. Candel has established two clinical stage multimodal biological immunotherapy platforms based on novel, genetically modified adenovirus and HSV gene constructs, respectively. CAN-2409 is the lead product candidate from the adenovirus platform and recently completed successful phase 2a clinical trials in NSCLC and PDAC, and a pivotal phase 3 clinical trial in localized prostate cancer. CAN-3110 is the lead product candidate from the HSV platform and is currently in an ongoing phase 1b clinical trial in recurrent high-grade glioma. Finally, Candel’s enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new viral immunotherapies for solid tumors.
For more information about Candel, visit: www.candeltx.com
Forward-Looking Statements
This press release includes certain disclosures that contain “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the timing and advancement of current and future development programs, expectations regarding the submission of the BLA for CAN-2409 in intermediate-to-high-risk localized prostate cancer and expectations regarding early biological readouts as predictor of clinical response; expectations regarding the therapeutic benefit of the Company’s platforms, including the ability of its platforms to improve overall survival and/or disease-free survival of patients living with difficult to treat, solid tumors. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of development programs; expectations regarding the therapeutic benefit of the Company’s programs; that final data from the Company’s preclinical studies and completed clinical trials may differ materially from reported interim data from ongoing studies and trials; the Company’s ability to efficiently discover and develop product candidates; the Company’s ability to obtain and maintain regulatory approval of product candidates; the Company’s ability to maintain its intellectual property; the implementation of the Company’s business model, including strategic plans for the Company’s business and product candidates; and other risks identified in the Company’s filings with the U.S. Securities and Exchange Commission (SEC), including the Company’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, each as filed with the SEC and any subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.
Investor Contact:
Theodore Jenkins
VP, Investor Relations and Business Development
Candel Therapeutics, Inc.
tjenkins@candeltx.com
Media Contact:
Ben Shannon
ICR Healthcare
CandelPR@icrhealthcare.com
