Immunicum has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for the company’s lead candidate, ilixadencel.
Ilixadencel is 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). 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.
“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,” says Sven Rohmann, CEO of Immunicum. “The Fast Track Designation serves as a strong external validation of ilixadencel and will further accelerate our development timelines. We are eager to continue our preparations for the next clinical trial in this indication.”
Fast Track Designation
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 will be able to engage more frequently with the FDA to optimally align its development plan.
Positive trial results
Immunicum announced positive results from the Phase I/II open-label, single arm clinical trial evaluating ilixadencel in combination with different TKIs in patients with GIST in June 2019. The latest results of the final data analysis from the clinical study were published in June 2020 in the journal, Cancer Immunology, Immunotherapy. The trial met the primary endpoint of safety showing that ilixadencel in combination with TKIs maintained a favorable safety profile with no treatment-related serious adverse events. In addition, analysis of the secondary clinical trial endpoints provided initial signals of clinical benefit in two out of six patients who experienced tumor shrinkage after adding ilixadencel treatment to TKI treatment despite previous tumor progression on the same TKI.
In May 2020, Immunicum received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for ilixadencel to be used for treatment of patients with metastatic Renal Cell Carcinoma.
Photo (right): Sven Rohmann: Immunicum