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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) has announced positive final survival data from its Phase 2 clinical trial of CAN-2409 in non-metastatic pancreatic cancer. The randomized controlled study showed a remarkable improvement in estimated median overall survival - 31.4 months in the CAN-2409 treatment group versus only 12.5 months in the control group for patients with borderline resectable pancreatic ductal adenocarcinoma (PDAC).
Notably, three of seven patients treated with CAN-2409 were still alive at 66.0, 63.6, and 35.8 months after enrollment, with survival from diagnosis reaching 73.5, 68.8, and 41.3 months respectively. This survival duration significantly exceeds expectations for standard pancreatic cancer treatment.
CAN-2409, a first-in-class multimodal immunotherapy designed for in situ vaccination against the patient's tumor, demonstrated a favorable safety profile and has previously received both Fast Track Designation and Orphan Drug Designation from the FDA for PDAC treatment. Based on these promising results, Candel plans to prepare for a larger, late-stage randomized controlled clinical trial of CAN-2409 in PDAC.
Candel Therapeutics (NASDAQ: CADL) provided a corporate update highlighting pipeline progress and 2025 milestones. The company reported positive phase 3 data for CAN-2409 in prostate cancer, showing a 30% reduction in cancer recurrence risk and 80.4% pathological complete responses. Updated survival data for CAN-2409 in pancreatic cancer showed median overall survival of 28.8 months versus 12.5 months in the control group.
Key upcoming milestones include updated overall survival data for CAN-2409 in pancreatic cancer and non-small cell lung cancer (Q1 2025), overall survival data for CAN-3110 in recurrent high-grade glioma (Q4 2025), and BLA submission for CAN-2409 in prostate cancer (Q4 2026). The company's cash position of $102.9M as of December 31, 2024, is expected to fund operations into Q1 2027.
Candel Therapeutics (NASDAQ: CADL) has successfully closed its public offering, selling 12,000,001 shares of common stock at $6.00 per share and 3,333,333 pre-funded warrants at $5.99 per warrant. The offering includes 2,000,000 additional shares from the full exercise of the underwriters' option. The company raised approximately $92 million in gross proceeds before deducting expenses.
The funds will be used to advance product development, including the preparation of a Biologics License Application for CAN-2409 in prostate cancer, and for general corporate purposes. The offering was managed by Citigroup, BofA Securities, and Canaccord Genuity as joint bookrunners, with H.C. Wainwright & Co. as lead manager.
Candel Therapeutics (CADL) has announced the pricing of a public offering, consisting of 10,000,001 shares of common stock at $6.00 per share and pre-funded warrants to purchase 3,333,333 shares at $5.99 per warrant. The offering is expected to generate approximately $80 million in gross proceeds and close around December 16, 2024. The company has granted underwriters a 30-day option to purchase up to 2,000,000 additional shares. Proceeds will fund product development, including preparation for a Biologics License Application for CAN-2409 in prostate cancer, and general corporate purposes. The offering is led by joint bookrunning managers Citigroup, BofA Securities, and Canaccord Genuity.
Candel Therapeutics (NASDAQ: CADL) has announced an underwritten public offering of $80 million of its common stock and pre-funded warrants. The company will grant underwriters a 30-day option to purchase up to an additional $12 million of common stock. The proceeds will be used to continue product development, including preparing a Biologics License Application for CAN-2409 in prostate cancer, and for general corporate purposes. Citigroup, BofA Securities, and Canaccord Genuity are acting as joint bookrunning managers, with H.C. Wainwright & Co. as lead manager. The offering will be made through a shelf registration statement previously filed with the SEC.
Candel Therapeutics (CADL) announced positive Phase 3 clinical trial results for CAN-2409 viral immunotherapy in localized prostate cancer patients. The trial met its primary endpoint, demonstrating statistically significant improvement in disease-free survival when combined with radiation therapy. Key results include:
- 14.5% relative improvement in disease-free survival at 54 months
- Highly significant effect on prostate cancer-free survival (p=0.0046)
- 80.4% pathological complete responses vs 63.6% in control group
- Safety profile consistent with previous studies
The trial enrolled 745 patients and was conducted under FDA Special Protocol Assessment. The addressable market for CAN-2409 in localized prostate cancer is estimated at over $10 billion in the U.S. alone. The company plans to initiate FDA discussions regarding regulatory approval.
Candel Therapeutics (CADL) reported Q3 2024 financial results with a net loss of $10.6 million compared to $8.4 million in Q3 2023. Research and development expenses decreased to $5.4 million from $5.8 million year-over-year, while general and administrative expenses increased to $3.3 million from $3.0 million. The company's cash position stands at $16.6 million, expected to fund operations through Q1 2025.
The company remains on track for two key clinical trial readouts in Q4 2024: topline disease-free survival data from the phase 3 trial of CAN-2409 in intermediate/high-risk prostate cancer and topline progression-free survival data from the phase 2b trial in low/intermediate risk prostate cancer. Additionally, promising clinical data was reported for CAN-3110 in recurrent high-grade glioma, with 3 out of 6 patients surviving over one year.
Candel Therapeutics (Nasdaq: CADL), a clinical stage biopharmaceutical company developing biological immunotherapies for cancer treatment, has announced its participation in the Jefferies London Healthcare Conference 2024.
The company's President and CEO, Paul Peter Tak, will deliver a presentation on Wednesday, November 20, 2024, from 9:30-9:55AM GMT / 4:30-4:55AM EST. The presentation will be accessible via webcast, with a replay available for up to 90 days on the company's website under the Investors section.
Candel Therapeutics announced preclinical results for CAN-3110 in melanoma models, showing potential expansion beyond high-grade glioma treatment. CAN-3110, a first-in-class HSV-1 oncolytic viral immunotherapy, demonstrated potent antitumor activity in both in vitro human cell lines and in vivo murine melanoma models. The therapy's effectiveness is linked to Nestin expression in cancer cells and specific genetic alterations. The data showed tumor-specific cytotoxicity with dose-dependent inhibition of tumor growth and regression in some cases. The treatment was well-tolerated and associated with systemic immune activation, similar to effects observed in high-grade glioma patients.
Candel Therapeutics presented three key developments at the 16th Annual International Oncolytic Virotherapy Conference. The highlights include promising data from the CAN-3110 phase 1b trial in recurrent high-grade glioma, showing 3 out of 6 patients surviving over one year after treatment. The trial demonstrated improved survival compared to historical controls, with survival times of 12.2, 13.0, and 18.7 months.
The company also showcased a new multimodal immunotherapy candidate featuring IL-12 and IL-15, which showed significant tumor growth inhibition. Additionally, biopsy analysis revealed dense lymphocyte infiltrates and minimal tumor cells post-treatment, suggesting effective immune system activation.
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