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Prima BioMed Collaborates in Investigator Sponsored New Clinical

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harmsen   Tuesday, 07/12/16 07:46:08 AM
Re: DavenCT post# 1280
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Prima BioMed Collaborates in Investigator Sponsored New Clinical Trial for IMP321 in Solid Tumors.


SYDNEY, AUSTRALIA--(Marketwired - Jul 12, 2016) - Prima BioMed Ltd (ASX: PRR) (NASDAQ: PBMD) today announced a new collaborative study investigating the intra-tumoural injection of IMP321. The investigator sponsored study will be conducted by the Institute of Clinical Cancer Research, Krankenhaus Nordwest GmbH in Frankfurt Germany ("IKF"; Institute for clinical oncology research at the Northwest University Hospital in Frankfurt). The new study will explore the potential for IMP321 as an activator of dendritic cells found within solid cancer tumours.

The new clinical trial is called "INSIGHT: An explorative, single centre, open-label, phase I study to evaluate the feasibility and safety of intra-tumoural, intra-peritoneal, and subcutaneous injections with IMP321 (LAG-3Ig fusion protein) for advanced stage solid tumour entities."

The Lead Investigator of this up-to-40-patients trial is Professor Doctor Salah-Eddin Al-Batran, the Medical Director of the IKF. The study will commence subject to receiving the necessary approvals from the competent regulatory authority and ethics committee.

Dr Al-Batran commented: "The promising results from previous studies and favourable safety profile of IMP321 have led us to conduct a phase I trial investigating a potential enhancement of the immune-activating effects of IMP321 by new routes of administration. Furthermore, we will explore the possibility to extend the positive results obtained by subcutaneous injections of IMP321 in metastatic renal cell and breast carcinomas to further solid tumour entities."

Marc Voigt, Chief Executive of Prima, said: "This is potentially an exciting new therapeutic application for IMP321 and is the result of the extensive research carried out by Dr Frédéric Triebel and the Prima team in our Paris laboratory. It is the first ever investigation into whether direct injection of IMP321 into a solid tumour can activate the antigen presenting cells located inside the tumour to boost the body's immune response. As this trial is investigator initiated, it will also not require any significant near-term resource commitment from Prima."

Clinical Trial Synopsis

Title of Study INSIGHT: An explorative, single centre, open-label, phase I study to evaluate the feasibility and safety of intra-tumoural, intra-peritoneal, and subcutaneous injections with IMP321 (LAG-3Ig fusion protein) for advanced stage solid tumour entities
Objectives Feasibility, safety and toxicity
Immune response in whole blood and tumour tissue
Identification of biomarkers that correlate with clinical response / clinical outcome
Study design Monocentre, open-label, phase I study

Planned Sample size Up to 40 patients
Clinical trial identifier: To be determined


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