Precigen Reports EC’s Orphan Drug Designation to PRGN-2012 to Treat Recurrent Respiratory Papillomatosis (RRP)
Shots:
- The company’s PRGN-2012 has received ODD from the EC for treating recurrent respiratory papillomatosis (RRP). It has previously received ODD from the US FDA
- The P-I/II study is evaluating PRGN-2012 for its safety and efficacy for the treatment of adult patients with RRP across the US. P-II data presentation is expected in Q2’24, with a planned BLA submission for accelerated approval to the FDA in H2’24. Commercial readiness preparations are in progress for the US launch in 2025
- PRGN-2012 is a therapeutic vaccine, utilizing gorilla adenovector technology in Precigen's AdenoVerse platform, designed to generate immune responses against cells infected with HPV 6 or HPV 11
Ref: Precigen | Image: Precigen
Related News:- Precigen Receives the US FDA’s IND Clearance of PRGN-2009 + Pembrolizumab for the Treatment of Recurrent or Metastatic Cervical Cancer
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Shivani is a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
