(NewsDirect)
By Jeremy Golden,Benzinga
Clinical-stage biopharmaceutical company CandelTherapeutics, Inc. (NASDAQ: CADL) reported updated survival datafrom its randomized phase 2 clinical trial of CAN-2409 in borderlineresectable pancreatic cancer. Pancreatic cancer is the fourth leadingcause of cancer-related death in the U.S. The disease accounts for approximately3% of all cancers, with an estimated 64,050 patients diagnosedin 2023.
Therandomized, controlled clinical trial is specifically looking into thesafety and efficacy of CAN-2409 plus valacyclovir (prodrug), togetherwith standard of care (SoC) chemoradiation, followed by resection –if possible – in borderline resectable pancreatic ductaladenocarcinoma (PDAC).
Very encouraging results were recently reported by the Needham,Massachusetts-based company.
Patients reached an estimated median overallsurvival of 28.8 months after experimental treatment with CAN-2409versus 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 toonly 16.7% in the control group after chemoradiation. Thus, prolongedand sustained survival was observed after experimental treatment withCAN-2409 in patients with borderline resectable PDAC. Importantly, 4out of 7 patients who received CAN-2409 were still alive at the timeof data cut-off, with 2 patients surviving more than 50.0 months fromenrollment. Only 1 out of 6 patients in the randomized control SoCchemotherapy group remained alive at the data cut-off (50.6months).
No newsafety signals were observed, providing further support that multipleinjections of CAN-2409 are generally well tolerated. Additionally,there were no dose-limiting toxicities or cases of pancreatitisreported.
Previous analysis of resected tumors showed dense aggregates ofimmune cells – including CD8+, cytotoxic tumor-infiltratinglymphocytes and dendritic cells – in PDAC tissue after CAN-2409administration. This reinforces the potential of CAN-2409 to activatea robust antitumoral immune response in patients with cancer also in‘cold’, immunosuppressive tumors like PDAC.
“Given the frequentrecurrence and short survival with SoC chemotherapy for non-metastaticPDAC, effective new treatment options are urgently needed,” saidGarrett Nichols, MD, MS, Chief Medical Officer of Candel. “We arevery encouraged by the improved survival associated with CAN-2409,which has been shown to be durable after prolonged follow-up based onthe updated data in this randomized clinical trial. CAN-2409 wasgenerally well tolerated without significant additional local orsystemic toxicity when added to SoC chemoradiation.”
Candel’s most advancedviral immunotherapy candidate, CAN-2409, is an investigationaloff-the-shelf, replication-defective adenovirus designed to induce anindividualized, systemic immune response against the tumor. Because ofits versatility, CAN-2409 has the potential to treat a broad range ofsolid tumors. More than 1,000 patients have been dosed with CAN-2409to date, with a favorable reported tolerability profile and proof ofconcept in each indication that the company is currentlypursuing.
CAN-2409 is injecteddirectly into the tumor or target tissue using a localized injectionmethod that is akin to the standard approach for in situ vaccinationto elicit an immune response against the injected tumor and uninjectedmetastases.
Long-term survival data in PDAC was recently updated with eightmonths of further follow-up since the first analysis was presented atthe 2023 Society for Immunotherapy (SITC) Annual Meeting. Based on thedata presented at SITC, the U.S. Food and Drug Administration (FDA)granted Fast Track Designation to Candel Therapeutics for CAN-2409 incombination with valacyclovir for the treatment of patients with PDACin December 2023. More recently, the FDA also granted Orphan DrugDesignation.
“The failure of conventional immunotherapy to improveoutcomes in pancreatic cancer is attributed to the highlyimmunosuppressive tumor microenvironment, which is largely devoid ofimmune cells,” said Paul Peter Tak, MD, PhD, FMedSci, President andChief Executive Officer of Candel. “The immunological changesinduced by CAN-2409, evident in the pancreatic tissue and theperipheral blood after administration, suggest that CAN-2409 is ableto change the balance between the tumor and the patient’s anti-tumorimmune response, which can convert progressive cancer into a chronicdisease associated with improved survival.”
Featured photo by NationalCancer Institute on Unsplash .
Candelis a clinical stage biopharmaceutical company focused on developingoff-the-shelf multimodal biological immunotherapies that elicit anindividualized, systemic anti-tumor immune response to help patientsfight cancer. Candel has established two clinical stage multimodalbiological immunotherapy platforms based on novel, geneticallymodified adenovirus and herpes simplex virus (HSV) gene constructs,respectively. CAN-2409 is the lead product candidate from theadenovirus platform and is currently in ongoing clinical trials innon-small cell lung cancer (NSCLC) (phase 2), borderline resectablepancreatic cancer (phase 2), and localized, non-metastatic prostatecancer (phase 2 and phase 3). CAN-3110 is the lead product candidatefrom the HSV platform and is currently in an ongoinginvestigator-sponsored phase 1 clinical trial in recurrent high-gradeglioma (HGG). Finally, Candel’s enLIGHTEN™ Discovery Platform is asystematic, iterative HSV-based discovery platform leveraging humanbiology and advanced analytics to create new viral immunotherapies forsolid tumors.
This article includes certain disclosures thatcontain “forward-looking statements” within the meaning of thePrivate Securities Litigation Reform Act of 1995, as amended,including, without limitation, express or implied statements regardingthe timing and advancement of development programs, including thetiming and availability of additional data, key data readoutmilestones, including CAN-3110 in HGG; expectations regarding thepotential benefits conferred by Fast Track Designation; expectationsregarding the therapeutic benefit of its programs, including thepotential for its programs to extend patient survival; andexpectations 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 expressionsare intended to identify forward-looking statements, although not allforward-looking statements contain these identifying words. Anyforward-looking statements in this press release are based onmanagement’s current expectations and beliefs and are subject to anumber of risks, uncertainties and important factors that may causeactual events or results to differ materially from those expressed orimplied by any forward-looking statements contained in this pressrelease, including, without limitation, those risks and uncertaintiesrelated to the timing and advancement of development programs;expectations regarding the therapeutic benefit of the Company’sprograms; that final data from our pre-clinical studies and completedclinical trials may differ materially from reported interim data fromongoing studies and trials; the Company’s ability to efficientlydiscover and develop product candidates; the Company’s ability toobtain and maintain regulatory approval of product candidates; theCompany’s ability to maintain its intellectual property; theimplementation of the Company’s business model, and strategic plansfor the Company’s business and product candidates, and other risksidentified in the Company’s SEC filings, including the Company’smost recent Quarterly Report on Form 10-Q filed with the SEC, andsubsequent filings with the SEC. The Company cautions you not to placeundue reliance on any forward-looking statements, which speak only asof the date they are made. The Company disclaims any obligation topublicly update or revise any such statements to reflect any change inexpectations or in events, conditions or circumstances on which anysuch statements may be based, or that may affect the likelihood thatactual results will differ from those set forth in the forward-lookingstatements. Any forward-looking statements contained in this pressrelease represent the Company’s views only as of the date hereof andshould not be relied upon as representing its views as of anysubsequent date.
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