Scancell Holdings Plc, (AIM: SCLP), the developer of novel immunotherapies for the treatment of cancer, is pleased to announce that the United States Food and Drug Administration (‘FDA’) has granted orphan drug designation to its SCIB1 ImmunoBody® (‘SCIB1’) for the treatment of metastatic melanoma.
Orphan drug status in the United States qualifies the development of SCIB1 for a 50% tax credit for clinical trials, a waiver of the prescription drug user fee for the drug approval procedure and a period of seven years of market exclusivity following drug approval by the FDA. During the orphan market exclusivity period, the FDA cannot approve a NDA (new drug application) or a generic drug application for the same product including the principal molecular structure features of the drug and for the same rare disease indication.
The 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 U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug.1
Richard Goodfellow, Joint CEO of Scancell, said: “The grant of orphan drug status gives SCIB1 further protection in our key US market in addition to our patent portfolio. We also welcome the financial incentives afforded by such a designation. Following encouraging data from Part 2 of our SCIB1 Phase I/II trial announced in December, development work continues apace and we look forward to disclosing data from additional patients receiving the 8mg dose in due course. ”
For Further Information:
Dr Richard Goodfellow, Joint CEOProfessor Lindy Durrant, Joint CEO
Scancell Holdings Plc
Scancell Holdings Plc
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Scancell is developing novel immunotherapies for the treatment of cancer based on its ImmunoBody® and Moditope® technology platforms. Scancell’s first ImmunoBody®, SCIB1 is being developed for the treatment of melanoma and is being evaluated in a Phase 1/2 clinical trial. Data from the trial demonstrate that SCIB1 produced a melanoma-specific immune response and promising survival trend
Scancell’s ImmunoBody® vaccines target dendritic cells and stimulate both parts of the cellular immune system; the helper cell system where inflammation is stimulated at the tumour site; and the cytotoxic T-lymphocyte or CTL response where immune system cells are primed to recognise and kill specific cells.
Scancell has also identified and patented a series of modified epitopes that stimulate the production of killer CD4 that destroy tumours without toxicity. The Directors believe that the Moditope® platform could play a major role in the development of safe and effective cancer immunotherapies in the future.
Holloway says generating clinical data's a big focus for them in the near-term.
''Over the next two years we expect to see clinical readouts from two of our programmes - SCIB1 and Modi-1''.
''We'll be extending our pipeline particularly around Moditope with the Modi-3 programme, if we're successful with the grand challenge''.
''Then it's around looking at technical partnerships that will allow us to de-risk our developments''.
Thu, 15 Feb 2018 12:38:00
Dutch group ISA Pharmaceutical will incorporate its Amplivant technology into Modi-1, the first cancer treatment candidate being developed on the platform
Thu, 15 Feb 2018 15:00:00
Immuno-therapy SCIB1, which is expected to progress into Phase II clinical trials in the second-half of the year, was the focus of a peer-reviewed paper in OncoImmunology
Mon, 12 Feb 2018 11:50:00