Eftilagimod Alpha (LAG-3Ig Or IMP321) Pre-IND Meeting With the FDA

19:00 EST 14 Nov 2017 | Globe Newswire

SYDNEY, Australia, Nov. 15, 2017 (GLOBE NEWSWIRE) -- Prima BioMed Ltd (ASX:PRR) (NASDAQ:PBMD) (“Prima”) is pleased to announce that it held a Pre-Investigational New Drug Application (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) in November to discuss the regulatory pathway for the development of Eftilagimod Alpha (LAG-3Ig or IMP 321) in the United States.

The FDA addressed Prima's questions related to preclinical, nonclinical, and clinical data and design of clinical trials of Eftilagimod Alpha in a chemo-immunotherapy setting and in an immuno-oncology combination trial. Prima intends to file an investigational new drug application (IND) in the first half of calendar year 2018. After having successfully started clinical development of Eftilagimod Alpha in Australia and Europe, an IND would provide Prima with the opportunity to commence clinical studies and regulatory interactions in the United States.

"The U.S. is the largest pharmaceutical market in the world, so the pre-IND meeting regarding Eftilagimod Alpha was an important milestone. Our meeting with the FDA was very productive and their guidance will be most valuable in assessing the appropriate U.S.  clinical and regulatory strategies for Eftilagimod Alpha," said Marc Voigt, Prima's Chief Executive Officer.

Prima BioMed

Prima BioMed is listed on the Australian Securities Exchange (PRR) and on the NASDAQ (PBMD) in the US. For further information please visit

For further information please contact:

U.S. Investors:
Jay Campbell, Vice President of Business Development and Investor Relations, Prima Biomed
+1 (917) 860-9404;

Matthew Beck, The Trout Group LLC
+1 (646) 378-2933;

Australian Investors/Media:
Matthew Gregorowski, Citadel-MAGNUS
+61 2 8234 0105;


More From BioPortfolio on "Eftilagimod Alpha (LAG-3Ig Or IMP321) Pre-IND Meeting With the FDA"

Quick Search


Relevant Topics

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...

Drug Approvals
In order to become availible to pateints, drugs need to undergo a number of phases of clinical trials to test their efficacy and safty and to then be authorised by the drug approval organistion in each respective country. This is the FDA in the USA and N...