Candel Therapeutics (NASDAQ: CADL) Reports Positive Data From Phase 2 Trial Of CAN-2409 In Borderline Resectable Pancreatic Cancer

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By Jeremy Golden, Benzinga

Clinical-stage biopharmaceutical company Candel Therapeutics, Inc. (NASDAQ: CADL) reported updated survival data from its randomized phase 2 clinical trial of CAN-2409 in borderline resectable pancreatic cancer. Pancreatic cancer is the fourth leading cause of cancer-related death in the U.S. The disease accounts for approximately 3% of all cancers, with an estimated 64,050 patients diagnosed in 2023.

The randomized, controlled clinical trial is specifically looking into the safety and efficacy of CAN-2409 plus valacyclovir (prodrug), together with standard of care (SoC) chemoradiation, followed by resection if possible in borderline resectable pancreatic ductal adenocarcinoma (PDAC).

Very encouraging results were recently reported by the Needham, Massachusetts-based company.

Patients reached an estimated median overall survival of 28.8 months after experimental treatment with CAN-2409 versus only 12.5 months in the control group in PDAC. At 24 months, the survival rate was 71.4% in CAN-2409 treated patients compared to only 16.7% in the control group after chemoradiation. Thus, prolonged and sustained survival was observed after experimental treatment with CAN-2409 in patients with borderline resectable PDAC. Importantly, 4 out of 7 patients who received CAN-2409 were still alive at the time of data cut-off, with 2 patients surviving more than 50.0 months from enrollment. Only 1 out of 6 patients in the randomized control SoC chemotherapy group remained alive at the data cut-off (50.6 months).

No new safety signals were observed, providing further support that multiple injections of CAN-2409 are generally well tolerated. Additionally, there were no dose-limiting toxicities or cases of pancreatitis reported.

Previous analysis of resected tumors showed dense aggregates of immune cells including CD8+, cytotoxic tumor-infiltrating lymphocytes and dendritic cells in PDAC tissue after CAN-2409 administration. This reinforces the potential of CAN-2409 to activate a robust antitumoral immune response in patients with cancer also in cold, immunosuppressive tumors like PDAC.

Given the frequent recurrence and short survival with SoC chemotherapy for non-metastatic PDAC, effective new treatment options are urgently needed, said Garrett Nichols, MD, MS, Chief Medical Officer of Candel. We are very encouraged by the improved survival associated with CAN-2409, which has been shown to be durable after prolonged follow-up based on the updated data in this randomized clinical trial. CAN-2409 was generally well tolerated without significant additional local or systemic toxicity when added to SoC chemoradiation.

Candels most advanced viral immunotherapy candidate, CAN-2409, is an investigational off-the-shelf, replication-defective adenovirus designed to induce an individualized, systemic immune response against the tumor. Because of its versatility, CAN-2409 has the potential to treat a broad range of solid tumors. More than 1,000 patients have been dosed with CAN-2409 to date, with a favorable reported tolerability profile and proof of concept in each indication that the company is currently pursuing.

CAN-2409 is injected directly into the tumor or target tissue using a localized injection method that is akin to the standard approach for in situ vaccination to elicit an immune response against the injected tumor and uninjected metastases.

Long-term survival data in PDAC was recently updated with eight months of further follow-up since the first analysis was presented at the 2023 Society for Immunotherapy (SITC) Annual Meeting. Based on the data presented at SITC, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to Candel Therapeutics for CAN-2409 in combination with valacyclovir for the treatment of patients with PDAC in December 2023. More recently, the FDA also granted Orphan Drug Designation.

The failure of conventional immunotherapy to improve outcomes in pancreatic cancer is attributed to the highly immunosuppressive tumor microenvironment, which is largely devoid of immune cells, said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel. The immunological changes induced by CAN-2409, evident in the pancreatic tissue and the peripheral blood after administration, suggest that CAN-2409 is able to change the balance between the tumor and the patients anti-tumor immune response, which can convert progressive cancer into a chronic disease associated with improved survival.

Featured photo by National Cancer Institute on Unsplash.

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. CAN-2409 is the lead product candidate from the adenovirus platform and is currently in ongoing clinical trials in non-small cell lung cancer (NSCLC) (phase 2), borderline resectable pancreatic cancer (phase 2), and localized, non-metastatic prostate cancer (phase 2 and phase 3). CAN-3110 is the lead product candidate from the HSV platform and is currently in an ongoing investigator-sponsored phase 1 clinical trial in recurrent high-grade glioma (HGG). Finally, Candels 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.

This article 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 development programs, including the timing and availability of additional data, key data readout milestones, including CAN-3110 in HGG; expectations regarding the potential benefits conferred by Fast Track Designation; expectations regarding the therapeutic benefit of its programs, including the potential for its programs to extend patient survival; and expectations regarding cash runway and expenditures. 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 managements 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 Companys programs; that final data from our pre-clinical studies and completed clinical trials may differ materially from reported interim data from ongoing studies and trials; the Companys ability to efficiently discover and develop product candidates; the Companys ability to obtain and maintain regulatory approval of product candidates; the Companys ability to maintain its intellectual property; the implementation of the Companys business model, and strategic plans for the Companys business and product candidates, and other risks identified in the Companys SEC filings, including the Companys most recent Quarterly Report on Form 10-Q filed with the SEC, and 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 Companys views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

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