6 May 2020 - Immunicum announced today that it has received regenerative medicine advanced therapy designation from the U.S. FDA for the Company’s lead candidate, ilixadencel, a cell-based, off-the-shelf immune primer for the treatment of metastatic renal cell carcinoma.
The FDA’s decision was made based on the previously communicated results from the Phase II MERECA clinical trial that evaluated the safety and efficacy of ilixadencel in combination with Sutent (sunitinib) in patients with newly diagnosed metastatic renal cell carcinoma.