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Candel Therapeutics to Present Phase 3 Results of CAN-2409 in Localized Prostate Cancer at ASTRO 2025

Key Takeaway: Candel Therapeutics, Inc. announced that an abstract detailing Phase 3 results of its CAN-2409 treatment for localized prostate cancer has been accepted for presentation at the 2025 ASTRO Annual Meeting. The presentation will highlight a clinical trial which achieved its primary endpoint and includes findings from the company's research in other cancer types as well. Further, CAN-2409 has received significant FDA designations, showcasing its potential impact on patients with prostate cancer.

Market Sentiment Analysis

POSITIVE FACTORS

  • Candel Therapeutics is set to present promising Phase 3 trial results at ASTRO 2025.
  • The company achieved the primary endpoint in its pivotal trial of CAN-2409.
  • CAN-2409 has received multiple FDA designations, including Regenerative Medicine Advanced Therapy and Fast Track Designations.

Full Press Release Details

NEEDHAM, Mass., Sept. 17, 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 an abstract was accepted for an oral presentation at the 2025 American Society for Radiation Oncology (ASTRO) Annual Meeting, taking place from September 27 to October 1, 2025, in San Francisco, CA. The oral presentation will feature data from the Company’s phase 3 clinical trial of CAN-2409 in patients with intermediate-to-high-risk localized prostate cancer.
Details are as follows:
CAN-2409 – Localized Prostate Cancer
Abstract Title: Phase 3, Randomized, Placebo Controlled Clinical Trial of CAN-2409+Prodrug in Combination with Standard of Care External Beam Radiation (EBRT) for Newly Diagnosed Localized Prostate Cancer
Presenter: Glen Gejerman, MD, MBA, Hackensack University Medical Center, Hackensack, NJ
Session Title: SS 03 - GU 1: Advances in Localized Prostate Cancer
Session Date/Time: Sunday, September 28, 2025; 2:30 PM - 2:40 PM PT
Location: Room 24, Moscone Center, San Francisco, CA
The abstract has also been selected for inclusion in ASTRO’s Science Highlights - Genitourinary Cancer session on Sunday, September 28 at 8:00 a.m. PT in Room 24, which will provide a high-level overview of top-rated research in the field.
About Candel Therapeutics
Candel is a clinical-stage biopharmaceutical company focused on developing off-the-shelf, multimodal viral 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 herpes simplex virus (HSV) gene constructs, respectively. CAN-2409 is the lead product candidate from the adenovirus platform.
The Company recently completed a pivotal, placebo-controlled, phase 3 clinical trial of CAN-2409 in localized prostate cancer, conducted under a Special Protocol Assessment agreed with the U.S. Food and Drug Administration (FDA), which achieved the primary endpoint supported by secondary endpoints. The Company also reported successful phase 2a clinical trials of CAN-2409 in non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC). The FDA also granted Regenerative Medicine Advanced Therapy Designation to CAN-2409 for the treatment of newly diagnosed localized prostate cancer in patients with intermediate-to-high-risk disease. The FDA had previously granted Fast Track Designation to CAN-2409 in NSCLC and prostate cancer, and Fast Track Designation and Orphan Drug Designation to CAN-2409 in PDAC.
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. Initial results were published in Nature and CAN-3110 received Fast Track Designation and Orphan Drug Designation from the FDA. 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 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; and expectations regarding the potential benefits conferred by regulatory designations. 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 June 30, 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.
Vice President, Investor Relations and Business Development
Candel Therapeutics, Inc.

Frequently Asked Questions

What is Candel Therapeutics known for?

Candel Therapeutics focuses on developing multimodal biological immunotherapies for cancer.

What presentation will Candel give at ASTRO 2025?

Candel will present data from a phase 3 trial of CAN-2409 for localized prostate cancer.

Who will present the CAN-2409 data?

Dr. Glen Gejerman from Hackensack University Medical Center will present the data.

What regulatory designations has CAN-2409 received?

CAN-2409 has received Fast Track and Regenerative Medicine Advanced Therapy Designation.

What platforms does Candel use for their therapies?

Candel employs adenovirus and herpes simplex virus platforms for their immunotherapies.

Last updated: Sep 17, 2025