Latest news with #CandelTherapeutics
Globe and Mail
16-07-2025
- Business
- Globe and Mail
Oncolytic Virus Cancer Therapy Pipeline Appears Robust With 120+ Key Pharma Companies Actively Working in the Therapeutics Segment
DelveInsight's, 'Oncolytic Virus Cancer Therapy Pipeline Insight, 2025,' report provides comprehensive insights about 120+ companies and 125+ pipeline drugs in Oncolytic Virus Cancer Therapy pipeline landscape. It covers the Oncolytic Virus Cancer Therapy pipeline drug profiles, including clinical and non-clinical stage products. It also covers the Oncolytic Virus Cancer Therapy pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Explore our latest breakthroughs in Oncolytic Virus Cancer Therapy Research. Learn more about our innovative pipeline today! @ Oncolytic Virus Cancer Therapy Pipeline Outlook Key Takeaways from the Oncolytic Virus Cancer Therapy Pipeline Report In June 2025, Replimune Inc. conducted a study is to evaluate whether treatment with RP2 can provide efficacy as 2L treatment combined with atezolizumab plus bevacizumab in patients with locally advanced unresectable, recurrent, and/or metastatic HCC. DelveInsight's Oncolytic Virus Cancer Therapy pipeline report depicts a robust space with 120+ active players working to develop 125+ pipeline therapies for Oncolytic Virus Cancer Therapy treatment. The leading Oncolytic Virus Cancer Therapy Companies such as Genelux Corporation, Candel Therapeutics, CG Oncolgy, DNAtrix, SillaJen Biotherapeutics, Oncolytics Biotech, Wuhan Binhui Biotechnology, Oryx GmbH, Jiangsu Sinorda Biomedicine Co., Ltd, Elicera Therapeutics, Orgenesis, Replimune, Immvira Pharma, ViroCure, GeneMedicine, PsiOxus Therapeutics, Vyriad, VCN Biosciences, Beijing Syngentech, Oncolys BioPharma, Turnstone Biologics and others. Promising Oncolytic Virus Cancer Therapy Pipeline Therapies such as Gemcitabine, Valacyclovir, CG0070, Keytruda, atezolizumab, Ipilimumab, TBI-1401(HF10), Bevacizumab, Sorafenib, Pembrolizumab, Talimogene Laherparepvec and others. Stay informed about the cutting-edge advancements in Oncolytic Virus Cancer Therapy treatments. Download for updates and be a part of the revolution in Oncology Care @ Oncolytic Virus Cancer Therapy Clinical Trials Assessment Oncolytic Virus Cancer Therapy Emerging Drugs Profile Olvi-Vec: Genelux Corporation Olvi-Vec is a proprietary, non-pathogenic oncolytic vaccinia virus, modified to increase its safety, tumor selectivity and anti-tumor activity. Virus-mediated oncolysis results in immunogenic cell death and triggers immune activation and memory for long-term immunotherapy against cancer. Clinical results in more than 150 subjects have shown Olvi-Vec is well tolerated with documented clinical benefits. Currently the product is in Phase III stage of development for the treatment of Platinum-Resistant/Refractory Ovarian Cancer CAN-2409: Candel Therapeutics CAN-2409 (aglatimagene besadenovec) is an adenovirus-based replication deficient engineered gene construct encoding the thymidine kinase gene derived from the herpes simplex virus. It is injected directly into the tumor or target tissue The prodrug-derived cytotoxic nucleotide analogs are designed to inhibit DNA replication and repair, leading to the death of multiplying tumor cells, and in particular of cells undergoing repair from radiation or chemotherapy damage. Currently the product is in Phase III stage of development for the treatment of Prostrate Cancer. CG0070: CG Oncology CG0070 is an investigational oncolytic immunotherapy based on a modified common cold adenovirus backbone that contains a cancer-specific promoter and a GM-CSF transgene. CG0070, first replicates inside the tumor's cells causing tumor cell lysis and immunogenic cell death. Then, the rupture of the cancer cells can release tumor-derived antigens, along with GM-CSF, that can stimulate a systemic anti-tumor immune response that involves the body's own white blood cells. CG0070 is in development for a variety of solid tumor types to be used alone or in combination with immune checkpoint modulators. The therapy is in clinical development for the treatment of Bladder cancer and preclinical studies for solid tumors. In advanced clinical studies, CG0070 has been shown to be a safe and efficacious agent in NMIBC following BCG failure. Currently the product is in Phase III stage of development for the treatment of Non Muscular Invasive Bladder Cancer. Pelareorep: Oncolytics Biotech Pelareorep, is an investigational drug being developed by Oncolytics Biotech. It is an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved oncology treatments. Currently the drug is being investigated in Phase III stage of Clinical trial evaluation for the treatment of Metastatic Breast Cancer. ParvOryx: Oryx GmbH ParvOryx is an oncolytic parvovirus H1 (H-1PV), a wild type rat virus that infects and lyses tumor cells from a wide variety of cancers. These tumor types include glioblastoma multiforme, pancreatic cancer, breast cancer, lung cancer, melanoma, lymphoma, pediatric tumors such as neuroblastoma and medulloblastoma, prostate cancer and renal cancer, as well as tumor stem cells. H-1PV acts at relatively low multiplicities of infection. The virus exerts both cytotoxic and oncolytic (replication) effects. The cytotoxic effect is predominantly mediated by the non-structural protein (NS1), resulting in cell transcription dysregulation, cell cycle arrest, cell replication shut off, and activation of cellular stress response and induction of cell death. In addition, viral oncolysis induces a strong tumor-specific immune response leading to the recognition and elimination of minimal residual disease (bystander effect). ParvOryx is the smallest of all oncolytic viruses and is able to cross the blood brain barrier. Unlike other natural or modified oncolytic viruses currently under investigation, ParvOryx does not affect normal cells and is not pathogenic to humans. Currently the product is in Phase II stage of development for the treatment of pancreatic cancer. SND005: Jiangsu Sinorda Biomedicine SND005 Oncolytic virus is a type of virus that preferentially infects and kills tumor cells. Initially, some tumor cells were specifically infected and destroyed by oncolytic viruses. Subsequently, the oncolytic virus replicates and proliferates in tumor cells, releasing new infectious virus particles to infect and destroy other tumor cells. Oncolytic viruses exert their oncolytic effects by directly lysing tumor cells or stimulating the host to produce an anti-tumor immune response. Among the new oncolytic virus drugs currently underway, SND005 is the only wild-type virus without genetic modification. It has a 14 - year history of clinical use. In a trial of 540 patients with melanoma, more than 44% of the patients benefited. In the safety and tolerability study of 190 patients, no serious adverse events were found, and the most common adverse event was low-grade fever. The clinical data and observations after the overseas market show that the survival rate of patients is increased by 4- 5 times, and it has excellent performance in stage II melanoma patients. VCN-01: VCN Biosciences VCN-01 is an innovativeconditionally replicative oncolytic adenovirus expressing PH20 hyaluronidase. Expression of hyaluronidase from VCN-01 facilitates virus penetration and decreases intratumorfluid pressure, enhancing antibodyup-take. In addition, VCN-01 capsid has been modified to allow the virus to partially evade liver tropism and target selectively the tumor after intravenous administration. Currently the product is in Phase I stage of development for the treatment of Pancreatic, Serous Epithelial Ovarian Cancer and Squamous Cell of Head and Neck. The Oncolytic Virus Cancer Therapy Pipeline Report provides insights into The report provides detailed insights about companies that are developing therapies for the treatment of Oncolytic Virus Cancer Therapy with aggregate therapies developed by each company for the same. It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Oncolytic Virus Cancer Therapy Treatment. Oncolytic Virus Cancer Therapy Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects. Oncolytic Virus Cancer Therapy Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type. Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Oncolytic Virus Cancer Therapy market. Learn more about Oncolytic Virus Cancer Therapy Drugs opportunities in our groundbreaking Oncolytic Virus Cancer Therapy research and development projects @ Oncolytic Virus Cancer Therapy Unmet Needs Oncolytic Virus Cancer Therapy Companies Genelux Corporation, Candel Therapeutics, CG Oncolgy, DNAtrix, SillaJen Biotherapeutics, Oncolytics Biotech, Wuhan Binhui Biotechnology, Oryx GmbH, Jiangsu Sinorda Biomedicine Co., Ltd, Elicera Therapeutics, Orgenesis, Replimune, Immvira Pharma, ViroCure, GeneMedicine, PsiOxus Therapeutics, Vyriad, VCN Biosciences, Beijing Syngentech, Oncolys BioPharma, Turnstone Biologics and others. Oncolytic Virus Cancer Therapy pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Intranasal Intravenous Oral Oral/Intravenous Parenteral Subcutaneous Subcutaneous/Intramuscular Oncolytic Virus Cancer Therapy Products have been categorized under various Molecule types such as Oncolytic Virus Discover the latest advancements in Oncolytic Virus Cancer Therapy treatment by visiting our website. Stay informed about how we're transforming the future of Oncology @ Oncolytic Virus Cancer Therapy Market Drivers and Barriers, and Future Perspectives Scope of the Oncolytic Virus Cancer Therapy Pipeline Report Coverage- Global Oncolytic Virus Cancer Therapy Companies- Genelux Corporation, Candel Therapeutics, CG Oncolgy, DNAtrix, SillaJen Biotherapeutics, Oncolytics Biotech, Wuhan Binhui Biotechnology, Oryx GmbH, Jiangsu Sinorda Biomedicine Co., Ltd, Elicera Therapeutics, Orgenesis, Replimune, Immvira Pharma, ViroCure, GeneMedicine, PsiOxus Therapeutics, Vyriad, VCN Biosciences, Beijing Syngentech, Oncolys BioPharma, Turnstone Biologics and others. Oncolytic Virus Cancer Therapy Pipeline Therapies- Gemcitabine, Valacyclovir, CG0070, Keytruda, atezolizumab, Ipilimumab, TBI-1401(HF10), Bevacizumab, Sorafenib, Pembrolizumab, Talimogene Laherparepvec and others. Oncolytic Virus Cancer Therapy Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination Oncolytic Virus Cancer Therapy Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III For a detailed overview of our latest research findings and future plans, read the full details of Oncolytic Virus Cancer Therapy Pipeline on our website @ Oncolytic Virus Cancer Therapy Emerging Drugs and Companies Table of Contents Introduction Executive Summary Oncolytic Virus Cancer Therapy: Overview Pipeline Therapeutics Therapeutic Assessment Oncolytic Virus Cancer Therapy– DelveInsight's Analytical Perspective Late Stage Products (Phase III) Olvi-Vec: Genelux Corporation Mid Stage Products (Phase II) SND005: Jiangsu Sinorda Biomedicine Early Stage Products (Phase I/II) AloCelyvir: Orgenesis Early Stage Products (Phase I) VCN-01: VCN Biosciences Preclinical and Discovery Stage Products SynOV 1.3: Beijing Syngentech Inactive Products Oncolytic Virus Cancer Therapy Key Companies Oncolytic Virus Cancer Therapy Key Products Oncolytic Virus Cancer Therapy- Unmet Needs Oncolytic Virus Cancer Therapy- Market Drivers and Barriers Oncolytic Virus Cancer Therapy- Future Perspectives and Conclusion Oncolytic Virus Cancer Therapy Analyst Views Oncolytic Virus Cancer Therapy Key Companies Appendix About Us DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve. Media Contact Company Name: DelveInsight Business Research LLP Contact Person: Yash Bhardwaj Email: Send Email Phone: 09650213330 Address: 304 S. Jones Blvd #2432 City: Las Vegas State: NV Country: United States Website:
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.
Globe and Mail
23-06-2025
- Business
- Globe and Mail
Candel Therapeutics Appoints Charles Schoch as Chief Financial Officer
NEEDHAM, Mass., June 23, 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 Charles Schoch as Chief Financial Officer (CFO). Mr. Schoch, who has served as interim CFO of Candel since January 2024, will transition to the CFO role permanently, effective immediately. 'Charles has demonstrated exceptional financial and organizational leadership during his tenure as interim CFO,' said Paul Peter Tak, M.D., Ph.D., FMedSci, President and Chief Executive Officer of Candel. 'He has effectively supported our strategic priorities in a complex market environment while maintaining disciplined capital management. His deep understanding of our business will continue to be instrumental as we advance our clinical pipeline, prepare for our Biologics License Application submission for CAN-2409 in localized prostate cancer, and execute on our near- and long-term corporate goals.' Since joining Candel in November 2021, Mr. Schoch has served in various financial reporting and accounting positions of increasing responsibility, most recently as VP of Finance and Corporate Controller, before being named interim CFO in January 2024. In his interim CFO role, Mr. Schoch developed significant investment banking relationships and has led the company through engagements with top-tier institutional investors, culminating in a previously-announced capital raise with net proceeds of approximately $86 million following the disclosure of positive results in the phase 3 clinical trial of CAN-2409 in localized prostate cancer in December 2024. In January 2025, he was promoted to Senior VP. During his time at Candel, Mr. Schoch has built a high-performing finance function that oversees Candel's financial close process, internal controls, SEC reporting, financial planning, procurement, payroll, and treasury operations. Mr. Schoch has also worked closely with Candel's executive leadership team on investor relations, business development, and financing initiatives. Prior to joining Candel, Mr. Schoch served as Corporate Controller at Corbus Pharmaceuticals from 2019 to 2021. Before Corbus, he spent seven years in PwC's Health Industry assurance practice where he served a diverse group of audit clients, ranging from pre-IPO to multinational public companies within the life sciences sector. Earlier in his career, Mr. Schoch worked for several Third Rock Venture portfolio companies as a financial and operational consultant. Mr. Schoch holds an M.B.A. and M.S.A. from Northeastern University and a B.S. in business administration with a concentration in finance from Elon University. 'I am honored to continue serving in this role and excited about the opportunities that lie ahead for Candel,' commented Mr. Schoch. 'Our strong financial foundation and disciplined approach to capital allocation and value creation position us well for sustainable growth. As we advance our promising clinical pipeline and prepare for key milestones, my focus remains on maintaining financial stability while strategically investing in our future. I look forward to working with our talented team on our goals of driving value for our stakeholders and ultimately helping to deliver clinically meaningful solutions to cancer patients in need.' 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 most recently 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 BLA for CAN-2409 in intermediate-to-high-risk localized prostate cancer; and 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@
Associated Press
06-06-2025
- Business
- Associated Press
Candel Therapeutics Appoints Maha Radhakrishnan, M.D., to its Board of Directors
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 Jenkins VP, Investor Relations and Business Development Candel Therapeutics, Inc. [email protected] Media Contact: Ben Shannon ICR Healthcare [email protected]
Yahoo
31-05-2025
- 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.
