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Candel Therapeutics, Inc. (NASDAQ: CADL) is a clinical-stage biopharmaceutical company at the forefront of developing innovative viral-based immunotherapies to combat cancer. Headquartered in Massachusetts, the company leverages its proprietary multimodal platforms to deliver off-the-shelf therapies that elicit a robust and individualized systemic anti-tumor immune response. Operating within the competitive and rapidly evolving immuno-oncology space, Candel Therapeutics addresses significant unmet medical needs by targeting solid tumors with precision and innovation.
Core Technologies and Platforms
Candel Therapeutics has established two proprietary viral-based immunotherapy platforms designed to revolutionize cancer treatment:
- Gene Mediated Cytotoxic Immunotherapy (GMCI™) Platform: This platform utilizes genetically modified adenoviruses to deliver a localized, tumor-targeted immune response. As an "off-the-shelf" solution, GMCI™ activates the patient’s immune system to generate a personalized and precise response against cancer cells without requiring extensive customization.
- enLIGHTEN™ Discovery Platform: A systematic, iterative platform leveraging herpes simplex virus (HSV) constructs and advanced analytics to create novel viral immunotherapies. This platform is designed to accelerate the discovery and development of therapies for solid tumors, utilizing human biology insights to optimize therapeutic outcomes.
Pipeline and Key Product Candidates
Candel’s product pipeline is anchored by two lead candidates:
- CAN-2409: Developed from the adenovirus platform, this candidate is undergoing clinical trials for multiple indications, including non-small cell lung cancer (NSCLC), borderline resectable pancreatic ductal adenocarcinoma (PDAC), and localized prostate cancer. CAN-2409 aims to address patients who are non-responsive to traditional immune checkpoint inhibitors, providing a novel therapeutic option.
- CAN-3110: Originating from the HSV platform, this candidate is being evaluated in phase 1b trials for recurrent high-grade glioma (rHGG). Designed to treat difficult-to-treat cancers, CAN-3110 demonstrates the potential of HSV-based therapies in addressing aggressive tumor types.
Market Position and Competitive Landscape
Operating within the immuno-oncology sector, Candel Therapeutics competes against established biopharmaceutical giants and emerging innovators. The company differentiates itself through its multimodal approach, combining the benefits of viral-based platforms with advanced analytics and human biology insights. This unique positioning allows Candel to address complex cancers with tailored, systemic solutions that complement existing therapies.
Significance and Industry Impact
Candel Therapeutics’ commitment to developing off-the-shelf, multimodal immunotherapies positions it as a key player in the fight against cancer. By focusing on systemic, individualized immune responses, the company addresses critical gaps in current treatment paradigms. Its innovative platforms and promising clinical results underscore its potential to transform cancer care, making it a noteworthy entity in the biopharmaceutical industry.
Candel Therapeutics (Nasdaq: CADL) presented promising data from its oncology pipeline, highlighting CAN-2409's 77% disease control rate in advanced non-small cell lung cancer patients and CAN-3110's median overall survival of 11.6 months in recurrent high-grade glioma. The company plans to prioritize CAN-3110 for further development and will not pursue phase 3 trials for CAN-2409 in glioma. Additionally, Candel announced a partnership with the University of Pennsylvania to enhance CAR-T cell therapies using its enLIGHTEN™ Discovery Platform. Cash reserves were reported at $77.2M, ensuring operations into Q1 2024.
Candel Therapeutics (Nasdaq: CADL) will host its first virtual R&D Day on December 6, 2022, presenting new clinical data from its phase 2 trial of CAN-2409 in late-stage non-small cell lung cancer (NSCLC) and CAN-3110 in high-grade glioma. The event will showcase insights from leading experts in immunology and oncology, discussing therapeutic combination opportunities and the scientific rationale behind Candel's collaboration with the University of Pennsylvania using the enLIGHTEN™ discovery platform. An interactive Q&A session will follow the presentations.
Candel Therapeutics presented updated results from its phase 1 trial of CAN-3110 for recurrent high-grade glioma (rHGG) at the SNO Annual Meeting. The trial involved 41 patients, with no dose-limiting toxicities observed. The median overall survival was reported at 11.6 months post-administration, with one patient achieving a complete response lasting over a year. The treatment showed positive effects on T cell activation and diversity, suggesting a shift in the tumor microenvironment. Future studies will explore the impact of multiple CAN-3110 injections on survival.
Candel Therapeutics, Inc. (Nasdaq: CADL) presented late-breaking data from a phase 1 trial of its lead viral immunotherapy, CAN-2409, combined with nivolumab for high-grade glioma patients. The combination showed promising results, being well tolerated with no significant added toxicity. It induced systemic immune activation and improved median overall survival (mOS) for patients with methylated MGMT promoter to 30.6 months after gross total resection. The trial supports the potential therapeutic synergy between CAN-2409 and immune checkpoint inhibitors.
Candel Therapeutics (Nasdaq: CADL) reported Q3 2022 results, achieving significant developments, including a partnership with the University of Pennsylvania's Center for Cellular Immunotherapies to explore viral immunotherapy and CAR-T cell combinations. The Company secured orphan drug designation for CAN-2409 in glioma and added new leadership. Financially, Q3 net loss decreased to $8.7 million from $16.2 million YoY. Cash position stood at $77.2 million, sufficient to sustain operations through Q1 2024.
Candel Therapeutics (Nasdaq: CADL) announced new clinical data to be presented at the 37th Annual Meeting of the Society for Immunotherapy of Cancer and the 27th Annual Meeting of the Society for Neuro-Oncology, scheduled for November 11 and 18, 2022, respectively. Key highlights include presentations on CAN-2409's efficacy in high-grade glioma and its impact on tumor microenvironments. These findings could significantly advance understanding of viral immunotherapy in treating cancer.
On November 1, 2022, Candel Therapeutics, Inc. (Nasdaq: CADL) announced that its CEO, Paul Peter Tak, will participate in several investor conferences this month. The events include the Credit Suisse 31st Annual Healthcare Conference on November 8 at 8:35 am PT, the BMO Biopharma Spotlight Series: Oncology Day on November 9 at 10:00 am ET, and the Jefferies London Healthcare Conference on November 16 at 7:25 am GMT. For webcast recordings, visit Candel's website. Candel focuses on developing viral immunotherapies for cancer using genetically modified viruses to enhance anti-tumor responses.
Candel Therapeutics (Nasdaq: CADL) announced a collaboration with the University of Pennsylvania to explore novel viral immunotherapies aimed at enhancing CAR-T cell therapies for solid tumors. Utilizing Candel’s enLIGHTEN Discovery Platform, the research will focus on herpes simplex virus vectors to improve T-cell efficacy. Both organizations will maintain rights to their respective programs and the ability to advance these therapies into clinical trials. This partnership aims to address significant barriers in the solid tumor microenvironment to improve treatment outcomes.
Candel Therapeutics (Nasdaq: CADL) announced on September 15, 2022, that the European Medicines Agency (EMA) COMP issued a positive opinion for orphan drug designation of CAN-2409 to treat glioma. This follows the fast track designation from the FDA in June 2021. CAN-2409, a genetically modified adenovirus, is in phase 2 and 3 trials for various cancers. The orphan drug designation provides potential benefits such as a 10-year marketing exclusivity in the EU and reduced fees during development.
Candel Therapeutics (Nasdaq: CADL) announces the appointment of Jason A. Amello as Chief Financial Officer and Garrett Nichols, MD, MS as Chief Medical Officer, effective September 21, 2022. Mr. Amello replaces John Canepa, who is moving on for personal reasons. Both new leaders bring extensive experience in biopharmaceuticals, with Amello's previous roles including CFO at Saniona AB and Akebia Therapeutics, and Nichols having served as CMO at Istari Oncology. Their leadership is expected to enhance Candel's efforts in developing oncolytic viral immunotherapies for cancer treatment.
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