Candel Secures $100M to Fast-Track Groundbreaking Cancer Drug Before FDA Review

Candel Therapeutics has secured a $100 million funding deal with RTW Investments to support its lead cancer treatment. The agreement centres on aglatimagene besadenovec, a drug from the company's adenovirus platform, which is nearing FDA submission. This funding will help prepare for a potential U.S. launch and expand commercial efforts.

The company also continues trials for another treatment, linoserpaturev, targeting recurrent high-grade glioma.

Candel's lead product, aglatimagene besadenovec, has already completed phase 2a trials in non-small cell lung cancer and pancreatic ductal adenocarcinoma. The FDA previously granted it Fast Track and Regenerative Medicine Advanced Therapy designations for localized prostate cancer in high-risk patients. A phase 3 trial under a Special Protocol Assessment has also been finalised.

Under the new deal, RTW will receive a tiered, single-digit percentage of U.S. net sales of aglatimagene, capped at a set amount, once the drug gains FDA approval. Candel plans to submit its Biologics License Application (BLA) for the treatment in the fourth quarter of this year.

Meanwhile, the company's second key candidate, linoserpaturev, remains in an ongoing phase 1b trial for recurrent high-grade glioma. This drug is part of Candel's HSV platform, separate from the adenovirus-based aglatimagene.

The $100 million injection will primarily fund the U.S. rollout of aglatimagene, should it receive regulatory clearance. It will also support broader commercial development, including manufacturing and market preparation.

The funding agreement with RTW hinges on FDA approval of aglatimagene in prostate cancer. If successful, the deal will provide Candel with the resources to launch its treatment and scale up operations. The company's next milestone is the planned BLA submission later this year. Meanwhile, trials for linoserpaturev continue, expanding Candel's pipeline in oncology.