UK-based immunotherapy company Scancell (AIM: SCLP) has been granted orphan drug designation for its SCIB1 ImmunoBody for the treatment of metastatic melanoma by the US Food and Drug Administration.
The news sent Scancell’s shares up 2.0% at 35.95 pence to a two-month high last week. Broker Cenkos said: “We believe that the award of ODD will increase the commercial attractiveness to a pharmaceutical partner for SCIB1 alongside what it exciting clinical data, thus far generated in the Phase I/II clinical trial.”
The FDA’s Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the USA, or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug.
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