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LAG-3Ig (IMP321) Demonstrates Positive Safety and Efficacy Qualities in Breast Cancer Clinical Trial
Prima BioMed Ltd (ASX:PRR) (NASDAQ:PBMD) (“Prima” or the “Company”) has announced positive safety and efficacy data from the safety run-in stage of its clinical trial for IMP321 (LAG-3Ig) in metastatic breast cancer (MBC) at the American Society of Clinical Oncology (ASCO) 53rd annual meeting in Chicago, Illinois AIPAC (Active Immunotherapy PAClitaxel) is Prima’s multicentre, Phase IIb, randomised, double-blind, placebo-controlled study in hormone receptor-positive MBC patients receiving IMP321 or placebo as adjunctive to first-line weekly chemotherapy, paclitaxel. The safety run-in phase trialled the safety, immune-monitoring and activity of 15 patients. At both the 6mg and 30mg dose levels, IMP321 was shown to be safe and well tolerated. The higher 30mg dose demonstrated a stronger immune response, and was determined to be the recommended phase two dose (RPTD) for the ongoing randomised phase of 226 patients. In addition, the safety run-in phase demonstrated that IMP321:
The increase of APC numbers in the blood and their activation, which stimulate the body’s immune response to fight cancer cells, has not previously been seen with other immune checkpoint inhibitors as IMP321 has a broader mode of activation, not restricted to T cells. Furthermore, the increased numbers of CD8 T cells and natural killer cells, and corresponding baseline Th1 status is a very positive indicator of the potential efficacy of IMP321 as these are known to be related to anti-tumour efficacy in patients.” The poster presentation, titled “Combination of paclitaxel and LAG-3Ig (IMP321), a novel MHC class II agonist, as a first-line chemoimmunotherapy in patients with metastatic breast carcinoma (MBC): Interim results from the run-in phase of a placebo controlled randomized phase II” was delivered by lead author, Dr Francois P. Duhoux from Université Catholique de Louvain, Cliniques universitaires Saint-Luc, Brussels, Belgium on Sunday, 4th June. The full poster presentation can be found on the Prima BioMed website at http://primabiomed.com.au/media/2017-05-30_AIPAC_PosterASCO_V4final.pdf. Details of the AIPC study are posted on www.clinicaltrials.gov (clinicaltrials.gov identifier NCT 02614833). About Prima BioMed Prima BioMed is listed on the Australian Securities Exchange and on the NASDAQ in the US. For further information please visit www.primabiomed.com.au.
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