LAG-3Ig (IMP321) Demonstrates Positive Safety and Efficacy Qualities in Breast Cancer Clinical Trial
June 04 2017 - 8:36PM
- Breast cancer clinical trial demonstrates LAG-3Ig
(IMP321) is safe and well tolerated
- Data shows IMP321 in combination with chemotherapy
leads to a sustainable increase in antigen presenting cells (APC),
CD8 T cells and an improved pre-dose Th1 status
- Encouraging activity with a disease control rate of
87%
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:
- in combination with paclitaxel shows an encouraging disease
control rate (DCR) of 87%;
- leads to a sustainable (more than 6 month) increase and
activation of antigen presenting cells (APCs), the primary
PharmacoDynamic (PD) marker; and
- leads to a sustainable (more than 6 month) increase in CD8
T-cell and natural killer (NK) cell numbers, together with an
improved pre-dose Th1 status, the secondary PD marker.
Prima’s Chief Medical Officer, Dr Frédéric Triebel, said: “This
very positive data is a major milestone for our AIPAC trial. It
further supports previous clinical data in metastatic breast
cancer, which led to Prima designing and starting AIPAC along with
Scientific Advice from the European Medicines Agency (EMA). The
similar disease-free rate to that 30 patient trial, and stronger
immune response from the higher 30mg dose further underpins the
randomised phase for AIPAC currently underway.
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.
For further information please contact:
U.S. Investors:
Matthew Beck, The Trout Group LLC
+1 (646) 378-2933; mbeck@troutgroup.com
Australian Investors/Media:
Matthew Gregorowski, Citadel-MAGNUS
+61 2 8234 0105; mgregorowski@citadelmagnus.com
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