2A Pharma Initiates Phase 1 Clinical Trial of HPV Vaccine Candidate

Press Release

Malmö, Sweden – 13 March 2019
2A Pharma, the Swedish/Danish vaccine company today announced that, approximately 27 months after the company was founded, its novel, broad coverage, HPV L2 vaccine candidate formulated without adjuvant, has progressed into a phase 1 clinical trial and dosing of the sentinel group is completed.

The first-in-human, phase 1, randomised, placebo-controlled, double-blind study is designed to assess the safety and tolerability, and to explore immunological effects of intramuscularly administered 2AP01 vaccine in healthy adult male and female volunteers between the ages of 18 and 45. Recruitment is continuing and is expected to be completed by the end of March 2019. The trial is being conducted by Celerion in Belfast, Northern Ireland and is being conducted under a Clinical Trial Authorisation issued by the UK Medicines and Healthcare products Regulatory Agency (MHRA).

“We are extremely proud to reach this important milestone for both our HPV vaccine and the company as a whole. We believe that, compared to existing vaccines, our novel approach of targeting the HPV L2 protein will substantially improve protection against HPV infections associated with a range of cancers and genital warts in both women and men”, said Preben Bruun-Nyzell, CEO of 2A Pharma.

“It has been two exciting and exhilarating years for 2A Pharma due to good team work and excellent collaboration with external partners, including our CROs Citoxlab and Celerion, and CMO Vigene Biosciences. The team is very excited for the future of the HPV project as well as other vaccine candidates in the pipeline”, added Jeanette Prangsgaard, MSc, Project Manager.

About 2A Pharma’s HPV vaccine candidate (2AP01)
2AP01 is a human papillomavirus (HPV) vaccine based on 2A Pharma’s proprietary adeno-associated virus-like particle (AAVLP) platform and targets the HPV L2 protein.

The HPV genome is packaged inside a capsid consisting of the L1 major protein and the L2 minor protein. All existing approved vaccines target the L1 protein which varies significantly between HPV types. In existing HPV L1 vaccines, different particles must be produced for each HPV type and then mixed in the final product, increasing production complexity and cost.

The L2 capsid protein, targeted by 2A Pharma’s HPV vaccine, is well conserved across HPV types which means our vaccine candidate provides protection for a wide range of HPV types with just one AAVLP particle type. The result is a potentially superior product with broader protection and lower production cost.

About 2A Pharma
2A Pharma is a clinical stage Swedish/Danish biopharmaceutical company focused on discovering, developing and commercialising novel, cost effective prophylactic and therapeutic vaccines based on our proprietary AAVLP technology. The pipeline consists of seven vaccine candidates that are being developed in-house or in collaboration with partners.

For further information please contact:
Preben Bruun-Nyzell, CEO
Tel: +46 760 58 01 08
Email: pbn@2apharma.com