The European Commission (EC) has granted orphan drug designation (ODD) for Precigen‘s investigational therapeutic vaccine, PRGN-2012, aimed at treating recurrent respiratory papillomatosis (RRP).

The development comes after the medicine’s receipt of ODD and breakthrough therapy designations from the US Food and Drug Administration (FDA).

A neoplastic disease of the upper and lower respiratory tracts, RRP is caused by human papillomavirus type 6 (HPV 6) or HPV type 11 (HPV 11).

Using the gorilla adenovector technology of the company’s AdenoVerse platform, PRGN-2012 can induce immune responses against HPV 6 or HPV 11-infected cells.

Gorilla adenovectors of the medicine offer benefits such as the potential for repeated dosing, non-replication in vivo and the delivery of increased genetic payload.

The ODD is based on the positive opinion of the European Medicines Agency Committee for Orphan Medicinal Products.

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This designation is reserved for therapies treating serious ailments affecting fewer than five in 10,000 people within the European Union.

It provides regulatory, financial and commercial incentives for the development of drugs for rare diseases lacking successful treatment options.

The vaccine is being studied in a Phase I/II single-arm clinical trial involving adult RRP patients in the US.

The Phase II data readout is expected in the second quarter of 2024.

A biologics licence application submission to the FDA under an accelerated approval pathway is then planned for the second half of the year.

Precigen president and CEO Helen Sabzevari stated: “The ongoing Phase I/II study for PRGN-2012 in the United States has shown the immense potential for this therapy.

“Results from the Phase I study showed significant clinical benefit with 50% of patients remaining surgery-free after more than two years following treatment.

“Additionally, PRGN-2012’s favourable safety profile and ease of administration are potentially paradigm-shifting for both patients and their treating physicians.”