Candel Therapeutics Gains EMA Orphan Designation for CAN-2409

Candel Therapeutics Celebrates EMA Orphan Designation for CAN-2409

In a significant development for cancer treatment, Candel Therapeutics, Inc. (Nasdaq: CADL), a clinical-stage biopharmaceutical company specializing in innovative immunotherapy solutions, has received Orphan Designation from the European Medicines Agency (EMA) for its investigational drug, CAN-2409, specifically targeting pancreatic cancer.

Understanding Orphan Designation

The EMA grants Orphan Designation to therapies developed for rare and life-threatening diseases affecting fewer than five in 10,000 individuals in the EU. This designation provides considerable advantages to pharmaceutical companies including reduced regulatory fees, guidance on clinical protocols, research grants, and a potential market exclusivity of up to 10 years upon approval.

Innovative Mechanism Behind CAN-2409

CAN-2409, also known as aglatimagene besadenovec, is a groundbreaking, off-the-shelf adenoviral-based therapy designed to enhance anti-tumor immune responses in patients. The drug works by delivering the herpes simplex virus thymidine kinase (HSV-tk) gene into tumor cells. When paired with prodrugs like valacyclovir, it effectively converts these compounds into nucleotide analogs that lead to immunogenic cell death in cancer cells and promote a robust immune response, which is crucial for fighting tumors resistant to multiple therapies.

Clinical Trial Successes

Candel previously shared promising results from a phase 2 clinical trial demonstrating the efficacy of CAN-2409 combined with valacyclovir in patients with borderline resectable pancreatic ductal adenocarcinoma (PDAC). The trial showed an impressive median overall survival of 31.4 months in the treatment group, compared to just 12.5 months in the control group. Remarkably, three patients in the trial continued to thrive, with survival rates of 66.0, 63.6, and 35.8 months, respectively.

Expert Insights

According to Dr. Garrett Nichols, Chief Medical Officer at Candel, the transformation observed in the tumor microenvironment from 'cold' to 'hot' is particularly noteworthy. This shift allows for enhanced immune infiltration, which is pivotal in extending patient survival rates for those battling this formidable cancer.

Future Prospects for CAN-2409

Earning the EMA’s Orphan Designation for CAN-2409 marks a significant milestone for Candel, especially as it complements the existing FDA Orphan Drug and Fast Track Designation statuses that the drug has garnered for PDAC treatment. Paul Peter Tak, President and CEO of Candel, emphasized the therapy's promise and the company's ongoing commitment to providing innovative solutions for patients with limited options.

Expanding Regulatory Recognitions

In addition to its recent achievement, CAN-2409 has also received FDA Fast Track Designation for other conditions such as non-small cell lung cancer (NSCLC) and localized prostate cancer, showcasing its broad applicability across various solid tumor indications. Furthermore, it has been granted FDA Regenerative Medicine Advanced Therapy (RMAT) designation, reflecting its potential to address the needs of patients with intermediate-to-high-risk localized prostate cancer.

Candel Therapeutics' Innovative Approach

Candel is committed to developing multimodal biological immunotherapies that not only offer individualized treatment but also bolster the broader immune response against cancer. The company's dual-platform based on genetically modified adenoviruses and herpes simplex viruses presents a promising avenue for addressing solid tumors comprehensively.

Looking Ahead

With ongoing clinical trials in progress, including pivotal studies for CAN-2409 in localized prostate cancer, Candel Therapeutics is positioned to revolutionize the treatment landscape for challenging malignancies. The company is dedicated to advancing its research and regulatory strategies across global markets to make these innovative therapies accessible to those who need them most.

Frequently Asked Questions

What is the significance of EMA Orphan Designation for CAN-2409?

The EMA Orphan Designation provides regulatory benefits for CAN-2409, facilitating its development and potential market exclusivity for treating pancreatic cancer.

How does CAN-2409 function in treating cancer?

CAN-2409 utilizes an engineered adenovirus to deliver the HSV-tk gene to tumor cells, converting certain prodrugs into compounds that induce cell death, triggering an immune response.

What were the results of the clinical trials for CAN-2409?

In clinical trials, CAN-2409 showed significantly improved overall survival for patients with pancreatic cancer, with some patients achieving longer than expected survival times.

Is CAN-2409 safe for use in patients?

Clinical trials so far indicate that CAN-2409 has a favorable tolerability profile, with more than 1,000 patients dosed, supporting its combination with standard treatments.

What are Candel Therapeutics’ future plans for CAN-2409?

Candel plans to continue development of CAN-2409, pursuing regulatory approvals and conducting further clinical studies to maximize its therapeutic potential in various types of cancers.

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