FAQ on Candel Therapeutics' European Orphan Status for Pancreatic Cancer Drug CAN-2409

What is CAN-2409?

CAN-2409 is an investigational, off-the-shelf, replication-defective adenovirus engineered to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to tumor cells, designed to induce an individualized, systemic immune response against multiple therapy-resistant solid tumors.

Why is the Orphan Designation for CAN-2409 significant?

The Orphan Designation by the European Medicines Agency underscores the significant unmet medical need in treating pancreatic cancer and provides Candel Therapeutics with benefits like reduced regulatory fees and up to 10 years of market exclusivity in the EU, if approved.

How does CAN-2409 work?

When administered with a prodrug, the HSV-tk enzyme in CAN-2409 converts the prodrug into DNA-incorporating nucleotide analogs, causing immunogenic cell death and the release of tumor antigens within the tumor microenvironment, potentially inducing a systemic immune response.

What are the survival benefits observed with CAN-2409?

In a phase 2a clinical trial, CAN-2409 plus standard of care showed an estimated median overall survival of 31.4 months versus 12.5 months in the control arm, with some patients surviving up to 66 months after enrollment.

Who is involved in the development of CAN-2409?

Candel Therapeutics, Inc., a clinical-stage biopharmaceutical company, is developing CAN-2409, with key figures like Garrett Nichols, MD, MS, Chief Medical Officer, and Paul Peter Tak, MD, PhD, FMedSci, President and CEO, leading the efforts.

When was CAN-2409 granted Orphan Designation by the EMA?

The article does not specify the exact date of the EMA Orphan Designation, but it mentions the designation complements FDA Orphan Drug and Fast Track Designations awarded in April 2024 and December 2023, respectively.

Where is CAN-2409 applicable?

CAN-2409 is intended for the treatment of pancreatic ductal adenocarcinoma (PDAC) and has potential applications in other therapy-resistant solid tumors like prostate cancer and non-small cell lung cancer (NSCLC).

What are the implications of CAN-2409’s development?

The development of CAN-2409 represents a promising advance in cancer immunotherapy, offering a novel approach to transform the tumor microenvironment and extend survival in patients with limited therapeutic options.

How can I get more information about CAN-2409?

For more information, you can visit Candel Therapeutics’ website at https://candeltx.com/ or contact the company directly through the provided LinkedIn profiles of key personnel like Garrett Nichols and Paul Peter Tak.