Immunicum AB has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for the Company’s lead candidate, ilixadencel, a cell-based, off-the-shelf immune primer, for the treatment of the orphan indication, Gastrointestinal Stromal Tumors (GIST).
The FDA’s decision is based on results from the Phase I/II clinical trial in GIST, a rare and difficult-to treat cancer indication belonging to the group of cancers referred to as soft tissue sarcomas (STS), said Immunicum. Fast Track Designation facilitates frequent communication with the FDA, related guidance on clinical trial design and can result in expedited review timelines to ensure novel therapies are available sooner for patients with serious illnesses, the company said.
“Having achieved Proof of Concept and RMAT designation for ilixadencel in Renal Cell Carcinoma, our next objective as a company is to move our lead program through clinical development and toward the market as rapidly as possible. As described in our clinical development strategy, GIST has been identified as one of the opportunities for pursuing commercialization of ilixadencel independently,” said Sven Rohmann, CEO of Immunicum.
He said that the Fast Track Designation serves as a strong external validation of ilixadencel and will further accelerate company’s development timelines. “We are eager to continue our preparations for the next clinical trial in this indication.”
As defined by the FDA, Fast Track Designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions, thereby meeting an unmet medical need. As a novel therapy with a favorable safety profile and positive signs of therapeutic value in this indication, ilixadencel has already demonstrated potential benefits when combined with standard tyrosine kinase inhibitors (TKIs). As Immunicum advances ilixadencel into the next phase of clinical development in GIST with Fast Track Designation, the company said it will be able to engage more frequently with the FDA to optimally align its development plan.