Prima BioMed Receives Positive Scientific Advice From the European Medicines Agency for Its Lead Product, IMP321

SYDNEY, AUSTRALIA--(Marketwired - Jul 7, 2015) - Prima BioMed Ltd (ASX: PRR) (NASDAQ: PBMD) ("Prima" or the "Company"), a leading immuno-oncology company, is pleased to announce that it has received positive Scientific Advice from the European Medicines Agency ("EMA" or the "Agency") on the development path for its lead product, IMP321 in metastatic breast cancer.

The EMA, located in London, is the agency responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union. After dialogue between Prima and the EMA, the Agency has now confirmed in writing its endorsement of the development program of IMP321 in metastatic breast cancer.

Encouragingly, the planned Phase IIb study, to be called AIPAC (Active Immunotherapy PAClitaxel) is considered well designed by the Agency. AIPAC is now expected to initiate in Europe during the 4th quarter of 2015. While the EMA never endorses any statement on the likelihood of future regulatory decisions, the Agency's communication has suggested that the achievement of certain clinical endpoints may lead to Marketing Authorization in the EU based on this one pivotal study.

After a smaller safety run-in phase that will extend into 2016 and will yield valuable safety, pharmacokinetic and pharmacodynamic data, AIPAC will proceed to recruit around 200 patients with HER-2 negative metastatic breast cancer, randomising them 1:1 to either standard-of-care paclitaxel plus placebo or paclitaxel plus IMP321.The trial will have Progression-Free Survival as its Primary Endpoint, with response rates according to the RECIST criteria and Overall Survival among the secondary endpoints. The study has been powered to show a four-month PFS advantage for the treatment group¹. Allowing time for patient recruitment and follow-up, AIPAC's expected duration is around three years.

Prima's Chief Scientific and Medical Officer, Professor Frédéric Triebel, stated, "The EMA's Scientific Advice represents a significant step forward in terms of IMP321 clinical development in Europe. We now have the opportunity to introduce active immunotherapy to metastatic breast cancer patients, a promising novel strategy that we believe has the potential to fulfil an unmet medical need," Dr. Triebel added, "We wish to thank the EMA's Scientific Advice Working Party for their input and guidance."