EMEA-003370-PIP01-22 - paediatric investigation plan

Palmitoyl-KSS-MHGDTPTLHEYMLDLQPETT (HPV-16 E7 1-20)

Palmitoyl-KSS-YMLDLQPETT (HPV-16 E7 11-20)

Palmitoyl-KSS-GQAEPDRAHYNIVTF (HPV-16 E7 43-57)

Palmitoyl-KSSKKLLMGTLGIVCPICSQKP (HPV-16 E7 82-98)

Palmitoyl-KSS-LLMGTLGIV (HPV-16 E7 82-90)

Palmitoyl-KSS-ELQTTIHDIILECVYCKQQLL (HPV-16 E6 25-45) + [(2R)-2,3-bis[[(Z)-octadec-9- enoyl]oxy]propyl]-trimethylazanium chloride (R-DOTAP chloride)

Key facts

• Active Substance:
  • Palmitoyl-KSS-MHGDTPTLHEYMLDLQPETT (HPV-16 E7 1-20)
  • Palmitoyl-KSS-YMLDLQPETT (HPV-16 E7 11-20)
  • Palmitoyl-KSS-GQAEPDRAHYNIVTF (HPV-16 E7 43-57)
  • Palmitoyl-KSSKKLLMGTLGIVCPICSQKP (HPV-16 E7 82-98)
  • Palmitoyl-KSS-LLMGTLGIV (HPV-16 E7 82-90)
  • Palmitoyl-KSS-ELQTTIHDIILECVYCKQQLL (HPV-16 E6 25-45) + [(2R)-2,3-bis[[(Z)-octadec-9- enoyl]oxy]propyl]-trimethylazanium chloride (R-DOTAP chloride)
• Therapeutic area:
  Oncology
• Decision number:
  P/0169/2023
• PIP number:
  EMEA-003370-PIP01-22
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of human papilloma virus (HPV) type 16 positive malignancies
• Route(s) of administration:
  All routes of administration
• Contact for public enquiries:

  PDS Biotechnology Corp.; E-mail: [e-mail] ; Tel: [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  15/05/2023

Decision

P/0169/2023 : EMA decision of 15 May 2023 on the granting of a product specific waiver for palmitoyl-KSS-MHGDTPTLHEYMLDLQPETT (HPV-16 E7 1-20) / Palmitoyl-KSS-YMLDLQPETT (HPV-16 E7 11-20) / Palmitoyl-KSS-GQAEPDRAHYNIVTF.....(EMEA-003370-PIP01-22)

AdoptedReference Number: EMA/160482/2023