1. Who is Bioven?
    1. Bioven is a drug development company founded in Malaysia in 2002 and since 2008 it has focused on projects in cancer research and development;
    2. Bioven is a privately owned company whose shareholders include Malaysia’s innovation agency, Agenci Inovasia Malaysia
  2. What is Bioven’s lead programme?
    1. Bioven’s lead programme is EGF Pathway Targetted Immunisation (EGF PTI), currently in an ongoing Phase III trial in inoperable late-stage non-small cell lung cancer
    2. EGF PTI is a novel cancer immunotherapy initially developed in Cuba at the Centre of Molecular Immonology
    3. Bioven in-licensed EGF PTI and currently holds licensing rights in multiple territories.
  3. What is EGF PTI?
    1. EGF PTI is a biological compound, which comprises a recombinant human EGF conjugated with meningococcal P64k protein. This conjugate is mixed with the adjuvant Montanide to create a stable water-in-oil suspension
  4. What is EGF PTI’s mode of action?
    1. EGF PTI targets the epithelial growth factor receptor / epithelial growth factor (EGFR/EGF) pathway
    2. EGF PTI induces the generation of anti-EGF antibodies, which bind with EGF circulating in the blood to prevent the EGF binding with the EGFR receptor, hence blocking the EGFR/EGF pathway and uncontrolled cell division
  5. What is the status of the Bioven Phase III trial of EGF PTI?
    1. Bioven commenced a pivotal Phase III study in 6 continents and 71 centers internationally including the UK, Germany, Poland, Czech Republic, Malaysia and Philippines
    2. Ongoing applications exist in USA, Spain and Thailand
    3. The trial is targeting enrolment of 419 patients in inoperable, late stage non-small cell lung cancer
  6. What are the primary and second endpoints and when will it report out?
    1. The primary endpoint is the assessment of overall survival compared with control
    2. Secondary endpoints include survival rates and progression-free survival
    3. KRAS and ALK mutations will also be assessed
    4. The study is an open label study and forecast interim analysis is expected end of Q1 2017
  7. What biomarker is being used in patient recruitment?
    1. EGF concentration in the blood is being used as a biomarker to identify patients where the EGFR/EGF pathway is implicated in disease progression
    2. 50-60% of patients with late-stage non-small cell lung cancer are estimated to have over-expression of EGF
  8. Who is the Principal Investigator of the Phase III trial?
    1. The Principal Investigator (PI) of the Phase III global trial is Dr. Marianne Nicolson of the Aberdeen Royal Infirmary, Aberdeen;
    2. Dr. Nicolson is a past Chair of the National Cancer Research Network (NCRN) Lung Clinical Studies Group. The NCRN Clinical Studies Groups represent a central component of the new framework for cancer research in the UK, providing the primary route through which new ideas for clinical trials are developed
    3. The Bioven study is a NCRN accredited study
  9. Where is the study taking place in the UK?
    1. The sites include Aberdeen, Edinburgh, Nottingham, Stockton-on-Tees and Southampton
  10. Is the Phase III study taking place in the US?
    1. An IND has been submitted in the US and is currently being reviewed
  11. Where is EGF PTI clinical trial stock manufactured?
    1. The product for the current Phase III study is manufactured under good manufacturing practice (GMP) in Havana, Cuba, and is Quality Controlled and Approved by an accredited European Quality Person;
    2. Stock is held in the UK and shipped globally for the trial;
    3. The adjuvant, the second component of the therapy, is manufactured in France. The adjuvant Montanide is used widely in human clinical trials and the Drug Master File is available at US FDA
  12. Tell me about Cuba and what is the status of the Cuban trials today?
    1. EGF PTI was initially developed in Cuba at the Centre for Molecular Immunology
    2. Phase I, Phase II and Phase III trials have been conducted in Cuba.
    3. These Cuban studies were conducted without biomarker enrichment. They have however consistently shown a doubling in overall survival in studies involving more than 700 patients.
  13. How can I find out further information about the study and enrollment?
    1. For further information and any questions on the study please contact us.