EVERSANA, a purpose-built, partner-led commercial organization, positions Candel for potential U.S. commercial launch following planned BLA submission in Q4 2026
NEEDHAM, Mass., April 29, 2026 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal immunotherapies to help patients with cancer, today announced that it entered into a product commercialization agreement (the "Agreement") with EVERSANA, a leading provider of global commercialization services to the life sciences industry, to support the potential U.S. commercial launch of aglatimagene besadenovec (aglatimagene or CAN-2409) for the treatment of intermediate- to high-risk, localized prostate cancer.
Under the terms of the agreement, EVERSANA will provide Candel with a broad suite of integrated commercialization services including data and analytics, medical affairs, market access and field operations. EVERSANA joins IDEA Pharma, a division of SAI MedPartners (IDEA), which has been providing path-to-market strategies and strategic positioning for aglatimagene. Candel has worked in close collaboration with both EVERSANA and IDEA on key pre-commercial workstreams as previously announced during Candel's virtual Research and Development Day in December 2025.
This collaboration reflects Candel's deliberate approach to building a world class commercial organization with global reach, designed from the ground up and leveraging a team of highly experienced professionals poised to support the potential commercial launch of aglatimagene for the treatment of intermediate- to high-risk, localized prostate cancer, subject to regulatory approval. This operating model gives Candel access to leading commercial capabilities while maintaining financial flexibility, capital efficiency, and scientific focus that has driven Candel's progress to date.
"From the beginning, we designed Candel's commercial strategy around a partner-led model that allows us to stay focused on advancing the science and navigating the regulatory pathway, while having access to world-class commercial capabilities on demand," said Paul Peter Tak, M.D., Ph.D., FMedSci, President and Chief Executive Officer of Candel. "With the addition of EVERSANA, that model is fully in place, and with the progress we've already made across our pre-commercialization workstreams, we have confidence in our readiness for the potential commercial launch of aglatimagene for the treatment of intermediate- to high-risk, localized prostate cancer. We look forward to working with EVERSANA and IDEA Pharma in providing a novel and potentially invaluable therapeutic for localized prostate cancer patients."
"We are proud to support Candel as it advances what could be a new and potentially transformative treatment option for patients with localized prostate cancer," said Gregory Skalicky, President of EVERSANA. "Candel's unique approach to commercialization, building a dedicated and flexible platform with specialized partners, rather than a fixed pharmaceutical infrastructure, is exactly the type of model EVERSANA was designed to support. We have already integrated our resources alongside the Candel team, with key commercial workstreams actively underway, and we look forward to helping ensure that aglatimagene reaches patients efficiently and effectively upon potential approval."
About EVERSANA
EVERSANA is a leading independent provider of global services to the life sciences industry. Eversana's integrated solutions are rooted in the patient experience and span all stages of the product life cycle to deliver long-term, sustainable value for patients, prescribers, channel partners and payers. Eversana serves more than 650 organizations, including innovative start-ups and established pharmaceutical companies, to advance life sciences solutions for a healthier world. To learn more about EVERSANA, visit eversana.com or connect through LinkedIn and X.
About aglatimagene besadenovec
Aglatimagene, 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 tumor. After intratumoral administration, HSV-tk enzyme activity results in conversion of prodrug (valacyclovir) into deoxyribonucleic acid (DNA)-incorporating nucleotide analogs, leading to immunogenic cell death in cells exhibiting DNA damage and proliferating cells, with subsequent release of a variety of tumor (neo)antigens in the tumor microenvironment. At the same time, the adenoviral serotype 5 capsid proteins promote inflammation through the induction of expression of pro-inflammatory cytokines, chemokines, and adhesion molecules. 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. Aglatimagene 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 aglatimagene in clinical trials with a favorable tolerability profile to date, supporting the potential for combination with standard of care, when indicated. Aglatimagene is currently not approved by the U.S. Food and Drug Administration (FDA).
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 herpes simplex virus (HSV) gene constructs, respectively. Aglatimagene is the lead product candidate from the adenovirus platform. The Company recently completed successful phase 2a clinical trials of aglatimagene in non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC), and a pivotal, placebo-controlled, phase 3 clinical trial of aglatimagene in localized prostate cancer, conducted under a Special Protocol Assessment agreed with the FDA. The FDA also granted Fast Track Designation and Regenerative Medicine Advanced Therapy Designation to aglatimagene for the treatment of newly diagnosed localized prostate cancer in patients with intermediate-to high-risk disease, Fast Track Designation in NSCLC, and both Fast Track Designation and Orphan Drug Designation to aglatimagene for the treatment of PDAC.
Linoserpaturev (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, evaluating the effects of repeat linoserpaturev injections. Initial results were published in Nature and Science Translational Medicine, and linoserpaturev 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 submission of the BLA for aglatimagene in intermediate- to high-risk localized prostate cancer; expectations regarding the Company's ability to prepare and implement commercialization plans for aglatimagene in partnership with EVERSANA and IDEA and the potential benefits and duration of such partnerships; expectations regarding early biological readouts as predictor of clinical response; expectations regarding the therapeutic benefit of the Company's programs, including the ability of aglatimagene to treat a broad range of solid tumors and improve disease-free survival, overall survival, and post-progression survival; 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 pre-clinical 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; the Company's ability to successfully prepare and implement commercialization plans for aglatimagene with its strategic partners, the impact of the Company's existing and any future indebtedness on its ability to operate its business; the Company's ability to access any future tranches under its debt facility and to comply with all of its obligations thereunder 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 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
EVERSANA Contact:
Matt Braun
Vice President, Corporate Communications
matt.braun@eversana.com
