Candel Therapeutics готовит подачу заявки на регистрацию терапии против рака простаты к концу 2026 года

Candel Therapeutics (NASDAQ:CADL) is advancing two off-the-shelf viral immunotherapy candidates designed for local administration intended to generate systemic immune responses against tumors, Chief Scientific Officer Francesca Barone said at the Canaccord Genuity Growth Conference in Boston. The company’s lead program, aglatimagene besadenovec, also known as aglatimagene or CAN-2409, is a replication-defective adenovirus that delivers the thymidine kinase gene and is administered with a prodrug. Candel is developing the therapy primarily for localized prostate cancer, while also advancing it in non-small cell lung cancer. Prostate cancer filing preparations The Phase III program was conducted under a Special Protocol Assessment with the U.S. Food and Drug Administration. Aglatimagene has received Fast Track and Regenerative Medicine Advanced Therapy, or RMAT, designations. Barone said Candel plans to submit a biologics license application, or BLA, for the therapy by the end of 2026. The company has focused heavily on manufacturing work ahead of the planned filing, including scaling commercial production to 200 liters and completing process performance qualification activities. Barone said Candel was about three-quarters through its PPQ campaign and had aligned with the FDA on a comparability protocol for product manufactured under the clinical and commercial processes. “We are generating this data, and we’re putting together the Module 3, all gearing up at the moment for the timeline of submission by the end of the year,” Barone said. At the American Society for Radiation Oncology, or ASTRO, meeting in September 2026, Candel expects to present an AI-enabled digital pathology analysis of paired prostate biopsies collected at baseline and two years after radiation. The analysis is intended to evaluate changes in the tumor microenvironment, including immune-cell aggregates, their distribution and proximity to cancer cells. Barone noted that Candel had previously reported pathological complete response rates, defined as absence of tumor in the two-year biopsy, of 80% for aglatimagene-treated patients and 63% in the control arm. The upcoming presentation will provide additional detail on biological engagement in samples from the Phase III study, she said. Barone said physician feedback on the prostate data has been encouraging, particularly given that patients whose disease recurs after radiation or surgery may subsequently receive androgen deprivation therapy, or ADT. She said physicians and patients have concerns about ADT’s effects on quality of life, including effects on musculature, bone loss and cardiovascular risk. Candel also presented longer-term exploratory clinical outcomes at the American Urological Association meeting, according to Barone. She said those findings indicated that disease-free survival improvement was associated with longer time to metastasis, biochemical failure and new anticancer treatment. Localized prostate market opportunity Barone said approximately 65,000 patients per year diagnosed with localized prostate cancer undergo radiation therapy, representing about 40% of the intermediate- and high-risk localized prostate cancer population. Candel estimates the commercial opportunity among radiation-treated patients at between $10 billion and $16 billion. Some physicians have characterized the treatment decision as a choice between radical prostatectomy and radiation combined with aglatimagene, rather than between surgery, radiation alone or radiation plus aglatimagene, Barone said. She added that a potential shift toward radiation treatment is not included in the company’s current forecast. Phase III lung cancer study underway Candel recently began recruitment for AURORA, a potentially registrational Phase III study of aglatimagene in stage IV, non-squamous non-small cell lung cancer patients who did not respond to first-line checkpoint inhibitor therapy. The study follows what Barone described as a positive end-of-Phase II meeting with the FDA. AURORA is designed to enroll 500 patients in a one-to-one randomization against docetaxel, with median overall survival as the primary endpoint. Barone said the company observed median overall survival of 24.5 months in a non-squamous subgroup in its Phase II study, while the intent-to-treat non-squamous population had median overall survival of 17 months. She said docetaxel’s median overall survival has been approximately 12 months across prior Phase II and Phase III studies. In lung cancer, aglatimagene is administered in two injections, either into the same lesion or two separate lesions. Barone said Phase II biomarker data showed activation of T-cell and B-cell responses, while non-injected lesions regressed in approximately 60% to 70% of patients depending on the response threshold used by the company. Glioblastoma program Candel’s second clinical asset, linoserpaturev, previously called CAN-3110, is an oncolytic virus being developed for recurrent high-grade glioma. The virus has been modified so that a gene responsible for replication is controlled by the nestin promoter, which Barone said is intended to enable selective replication in tumor cells. The treatment is injected directly into tumors through burr holes. Barone said the company has observed a median overall survival of 12 months following a single injection in its program and plans to disclose data from a multiple-injection cohort, along with additional follow-up for long-surviving patients, at the end of 2026. She said some Phase I participants had survived more than 49 to 50 months. About Candel Therapeutics (NASDAQ:CADL) Candel Therapeutics (NASDAQ:CADL) is a clinical-stage immuno-oncology company focused on the development of next-generation oncolytic viral therapies designed to treat solid tumors. The company’s lead candidate, CAN-2409, is a locally administered, gene-delivered viral therapy engineered to selectively replicate in cancer cells and induce immunogenic cell death. Candel leverages proprietary virus engineering platforms to enhance tumor-specific replication and stimulate anti-tumor immune responses, aiming to improve outcomes for patients with high unmet medical needs. In addition to its lead program, Candel’s pipeline includes CAN-3110, an oncolytic herpes simplex virus targeting recurrent high-grade glioma, and other novel viral constructs being explored for a variety of solid tumor indications.