Candel Therapeutics Lands $100M FDA-Contingent Deal for Prostate Cancer Drug

Candel Therapeutics has secured a $100 million funding deal with RTW Investments for its cancer treatment, aglatimagene besadenovec. The agreement hinges on FDA approval of the drug for intermediate- to high-risk, localized prostate cancer. This comes after the company completed a key phase 3 trial under an FDA-agreed protocol.

The drug, also known as CAN-2409, is Candel's lead immunotherapy candidate. It recently received Fast Track and Regenerative Medicine Advanced Therapy designations from the FDA for newly diagnosed prostate cancer patients. A phase 3 trial in this area has already wrapped up under a Special Protocol Assessment with the regulator.

Earlier, aglatimagene showed promise in phase 2a trials for non-small cell lung cancer and pancreatic ductal adenocarcinoma. The new funding will support its U.S. launch if approved, as well as broader commercial efforts. RTW Investments' Roderick Wong highlighted confidence in the treatment's market potential.

No active clinical trials for aglatimagene are currently listed with the FDA or other global agencies. The royalty financing will only activate once the FDA grants formal approval and other standard conditions are met.

Candel's CEO, Paul Peter Tak, confirmed the funds will back the drug's U.S. rollout and further commercial development. The company specialises in off-the-shelf immunotherapies for cancer. The deal marks a significant step toward bringing aglatimagene to patients, pending regulatory clearance.