Latest news with #CAN-2409
Business Insider
10-07-2025
- Business
- Business Insider
Candel Therapeutics initiated with a Buy at Brookline
Brookline analyst Kemp Dolliver initiated coverage of Candel Therapeutics (CADL) with a Buy rating and $25 price target Candel is a clinical stage biopharmaceutical company focused on developing off-the-shelf viral immunotherapies, the analyst tells investors in a research note. The firm says the company's lead candidate CAN-2409 met the primary endpoint in a Phase 3 trial in newly-diagnosed localized prostate cancer in intermediate- or high-risk patients, setting the stage for an application filing in Q4 of 2026. Don't Miss TipRanks' Half-Year Sale Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. Make smarter investment decisions with TipRanks' Smart Investor Picks, delivered to your inbox every week.
Yahoo
06-06-2025
- Business
- Yahoo
Candel Therapeutics Appoints Maha Radhakrishnan, M.D., to its Board of Directors
Appointment of seasoned strategic industry executive strengthens the Board of Directors as Candel advances toward Biologics License Application submission and commercial development NEEDHAM, Mass., June 06, 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 the appointment of Maha Radhakrishnan, M.D., to the Company's Board of Directors (Board) effective June 4, 2025. 'We are delighted to welcome Maha as a new member of Candel's Board,' said Paul Peter Tak, M.D., Ph.D., FMedSci, President and Chief Executive Officer of Candel. 'Her extensive industry experience will be extremely valuable as Candel advances its late-stage oncology programs toward potential approval and commercial development, with the aim of providing benefit to patients with significant unmet need.' Dr. Radhakrishnan brings significant experience in product development and commercialization that will be particularly valuable as Candel prepares for its Biologics License Application (BLA) submission for CAN-2409 in intermediate-to-high-risk prostate cancer, anticipated in Q4 2026. "I am honored to join the Board at this pivotal moment as Candel advances its innovative immunotherapy candidates across multiple cancer indications," said Dr. Radhakrishnan. 'Candel's multimodal approach has the potential to address significant unmet needs in cancers that have historically been difficult to treat with conventional immunotherapies.' Dr. Radhakrishnan has over 20 years of experience advancing large strategic portfolios across various therapeutic areas through product development and commercialization within major biotechnology and pharmaceutical companies. Since August 2024, Dr. Radhakrishnan has served as an Executive Partner at Sofinnova Investments, a venture capital firm focused on life sciences, where she leads diligence across clinical-ready assets in multiple therapeutic areas and provides expertise to portfolio companies in product development and commercialization. Previously, Dr. Radhakrishnan served as Group Senior Vice President and Chief Medical Officer at Biogen Inc. Earlier in her career, she was Senior Vice President and Global Head of Medical, Primary Care Business Unit at Sanofi S.A. Dr. Radhakrishnan has also held leadership roles at Bioverativ, Inc., Bristol-Myers Squibb Company, UnitedHealth Group, Inc., and Cephalon, Inc. She received her M.D. with honors from the People's Friendship University in Moscow, Russia. 'Maha's expertise will be invaluable as we look forward to her contributions while we prepare to submit our Biologics License Application for CAN-2409 in intermediate-to-high-risk prostate cancer, anticipated in Q4 2026,' said Paul B. Manning, Chairman of Candel's Board. 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. CAN-2409 is the lead product candidate from the adenovirus platform. The Company recently completed successful phase 2a clinical trials of CAN-2409 in non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC), and a pivotal phase 3 clinical trial of CAN-2409 in localized prostate cancer, conducted under a Special Protocol Assessment (SPA) agreed with the U.S. Food and Drug Administration (FDA). CAN-2409 plus prodrug (valacyclovir) has been granted Fast Track Designation by the FDA for the treatment of PDAC, stage III/IV NSCLC in patients who are resistant to first line PD-(L)1 inhibitor therapy and who do not have activating molecular driver mutations or have progressed on directed molecular therapy and localized primary prostate cancer. The FDA also granted Regenerative Medicine Advanced Therapy (RMAT) Designation to CAN-2409 for the treatment of newly diagnosed localized prostate cancer in patients with intermediate-to-high-risk disease and Orphan Drug Designation to CAN-2409 for the treatment of 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 (rHGG). 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 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 Biologics License Application for CAN-2409 in intermediate-to-high-risk localized prostate cancer; and expectations regarding the therapeutic benefit of the Company's platforms. 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 March 31, 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. Investor Contact:Theodore JenkinsVP, Investor Relations and Business DevelopmentCandel Therapeutics, Media Contact:Ben ShannonICR HealthcareCandelPR@
Yahoo
30-05-2025
- Business
- Yahoo
Candel Therapeutics, Inc. (CADL)'s CAN-2409 Advances with FDA RMAT Status for Localized Prostate Cancer
Candel Therapeutics, Inc. (NASDAQ:CADL) has secured FDA Regenerative Medicine Advanced Therapy (RMAT) designation for its lead immunotherapy candidate, CAN-2409 (aglatimagene besadenovec), targeting newly diagnosed, localized prostate cancer in intermediate-to-high-risk patients. The designation, based on positive phase III trial results, aims to expedite the development and review of regenerative medicine therapies that address serious or life-threatening conditions with unmet medical needs. CAN-2409, an off-the-shelf adenovirus delivering the HSV-tk gene, is administered with the prodrug valacyclovir alongside standard radiation therapy. The phase III study met its primary endpoint, showing a significant improvement in disease-free survival compared to standard care alone, with a favorable safety profile. A technician in a lab coat adjusting a MRI Radiation Therapy system in a hospital clinic. The RMAT status provides Candel Therapeutics, Inc. (NASDAQ:CADL) with enhanced FDA guidance and the possibility of accelerated or priority review for its future Biologics License Application, which the company plans to submit by the end of 2026. CAN-2409 had previously received Fast Track designation for the same indication. Following the announcement, Candel Therapeutics, Inc. (NASDAQ:CADL)'s shares rose by over 6%. The company's CEO, Dr. Paul Peter Tak, highlighted the designation as validation of CAN-2409's potential to transform prostate cancer treatment. While we acknowledge the potential of CADL to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than CADL and that has 100x upside potential, check out our report about this READ NEXT: and Disclosure: None. Sign in to access your portfolio
Yahoo
27-05-2025
- Business
- Yahoo
Candel Therapeutics to Host Investor Conference Call Featuring Expert Clinical Perspectives on CAN-2409 Phase 3 Prostate Cancer Data Following 2025 ASCO Presentation
NEEDHAM, Mass., May 27, 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 Candel management will host a webcast and conference call on Tuesday, June 3, 2025, at 1:00PM ET. The call will discuss the Company's positive phase 3 clinical results for CAN-2409 in localized, intermediate-to-high risk prostate cancer, which demonstrated a statistically significant 30% reduction in disease recurrence compared with placebo when combined with standard-of-care radiation therapy. The discussion will follow Dr. Theodore DeWeese's* oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The call will also feature insights from leading prostate cancer specialists, John E. Sylvester, M.D., Atlantic Urology Clinics, Myrtle Beach, South Carolina, and Ronald F. Tutrone, Jr., M.D., FACS, CPI, National Medical Director of Clinical Research, United Urology Group, Towson, Maryland. Both physicians were principal investigators on the phase 3 clinical trial. Dr. Sylvester is a renowned prostate cancer specialist with over two decades of experience in radiation oncology. He is widely recognized for his expertise in prostate brachytherapy and advanced radiation treatment techniques. Dr. Sylvester has played a pivotal role in pioneering innovative approaches to prostate cancer care and has authored numerous peer-reviewed publications in the field. He has trained physicians globally and continues to contribute to advancing clinical best practices. His leadership and dedication have earned him a reputation as a trusted authority in prostate cancer treatment and a passionate advocate for improving patient outcomes. Dr. Tutrone is a leading urologist specializing in the diagnosis and treatment of prostate cancer. With over 25 years of clinical experience, he serves as Medical Director of Chesapeake Urology Research Associates and has been principal investigator in numerous clinical trials focused on urologic oncology. Dr. Tutrone is recognized for his commitment to advancing prostate cancer care through research, innovation, and patient-centered treatment. He has published extensively in peer-reviewed journals and is frequently invited to speak at national and international conferences. His work has significantly contributed to improving outcomes for men with prostate cancer. Conference Call and Webcast Candel will host a webcast and conference call on Tuesday, June 3, 2025, at 1:00PM ET. The webcast can be accessed here and on the Candel website at under News & Events, in the IR section of the website. Participants may register for the conference call here to receive dial-in numbers and unique PIN to access the call. Joining 10 minutes prior to the start of the event is recommended, although you may register and dial in at any time during the call. An archived webcast will be available on Candel's website for 30 days following the presentation. * Dr. DeWeese has no relationship with Candel, other than serving as the national principal investigator for Candel's phase 3 clinical trial of CAN-2409 in patients with intermediate-to-high-risk localized prostate cancer. He has never received reimbursements, consulting fees, or any other fees from Candel, and he has no shares of common stock, options to purchase common stock or any other affiliation with Candel. About CAN-2409 CAN-2409 (aglatimagene besadenovec), 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 specific tumor and induce an individualized, systemic immune response against the tumor. HSV-tk is an enzyme that locally converts orally administered valacyclovir into a toxic metabolite that kills nearby cancer cells. 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. Because of its versatility, CAN-2409 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 CAN-2409 with a favorable tolerability profile to date, supporting the potential for combination with other therapeutic strategies. Currently, Candel is evaluating CAN-2409 in non-small cell lung cancer (NSCLC) and borderline resectable pancreatic adenocarcinoma (PDAC) and has recently completed a successful phase 3 clinical trial in localized prostate cancer. CAN-2409 plus prodrug (valacyclovir) has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of PDAC, for the treatment of stage III/IV NSCLC in patients who are resistant to first line PD-(L)1 inhibitor therapy and who do not have activating molecular driver mutations or have progressed on directed molecular therapy, and for the treatment of localized primary prostate cancer. Candel's pivotal phase 3 clinical trial in prostate cancer was conducted under a Special Protocol Assessment (SPA) agreed with the FDA. The FDA has also granted Orphan Drug Designation to CAN-2409 for the treatment of PDAC. 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 HSV gene constructs, respectively. CAN-2409 is the lead product candidate from the adenovirus platform and recently completed successful phase 2a clinical trials in NSCLC and PDAC, and a pivotal phase 3 clinical trial in localized prostate cancer. 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. 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: 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 CAN-2409 in intermediate-to-high-risk localized prostate cancer and expectations regarding early biological readouts as predictor of clinical response; 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. 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 March 31, 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. Investor Contact:Theodore Jenkins VP, Investor Relations and Business Development Candel Therapeutics, Inc. tjenkins@ Media Contact:Ben ShannonICR Healthcare CandelPR@ in to access your portfolio
Yahoo
23-05-2025
- Business
- Yahoo
Candel Therapeutics, Inc. (CADL) to Present Positive Phase 3 Prostate Cancer Data at ASCO 2025
Candel Therapeutics, Inc. (NASDAQ:CADL) has announced a major breakthrough in prostate cancer treatment, revealing that its Phase 3 trial of CAN-2409, an innovative immunotherapy, achieved both its primary and secondary endpoints in patients with intermediate-to-high-risk localized prostate cancer. The trial, to be presented at the 2025 ASCO Annual Meeting, demonstrated a statistically significant 30% reduction in the risk of cancer recurrence or death (hazard ratio 0.7, p=0.0155) for patients receiving CAN-2409 with valacyclovir and standard radiation therapy, compared to placebo. Notably, the study reported an 80.4% pathological complete response rate versus 63.6% in the control group, and a significant increase in the proportion of patients reaching very low PSA levels, all while maintaining a favorable safety profile with minimal treatment-related adverse events. This marks the first time in over 20 years that a multicenter, randomized Phase 3 trial in localized prostate cancer has met such rigorous efficacy benchmarks, potentially redefining curative treatment standards for this patient population. Candel Therapeutics, Inc. (NASDAQ:CADL) plans to submit a Biologics License Application for CAN-2409 in late 2026, aiming to provide a new, less toxic option for patients seeking to avoid recurrence and long-term disease progression. While we acknowledge the potential of CADL to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than CADL and that has 100x upside potential, check out our report about this READ NEXT: and Disclosure: None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
