Swedish immuno-oncology company Immunicum AB (STO:IMMU) said on Tuesday that it has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its lead candidate, ilixadencel, as a treatment for Soft Tissue Sarcoma (STS).

Ilixadencel is an off-the-shelf, cell-based cancer immunotherapy developed for the treatment of solid tumours.

The FDA's decision is based on the positive data from a Phase I/II clinical trial in Gastrointestinal Stromal Tumors (GIST), a rare and difficult-to-treat cancer indication belonging to the group of cancers referred to as Soft Tissue Sarcoma.

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. In December 2020 the company received Fast Track Designation from the FDA for ilixadencel in GIST.

ODD may allow Immunicum to be eligible for a seven-year period of US marketing exclusivity upon approval of ilixadencel and a waiver of the Prescription Drug User Fee Act filing fees, subject to certain conditions.