Prima BioMed Receives Approval for Third Cohort of Phase I Melanoma Trial
April 18 2017 - 9:45PM
Prima BioMed Ltd (ASX:PRR) (NASDAQ:PBMD) (“Prima” or the “Company”)
today announced that approval has been granted for the third cohort
of its Phase I clinical trial for IMP321 in combination with
KEYTRUDA® being conducted in Australia. The third cohort will
recruit six patients with unresectable or metastatic melanoma.
Interim data results from the first patient cohort
released in December 2016 indicate IMP321 at the 1mg dose level is
safe and well tolerated. Out of the six patients in the first
cohort (all with suboptimal response to KEYTRUDA® monotherapy) two
patients had a partial or complete radiological tumour response
according to immune related response criteria (irRC).
The positive safety profile was also confirmed in
the second cohort dosed with 6 mg of IMP321. None of the 6 patients
treated with KEYTRUDA® plus IMP321 at this higher dose level
experienced any serious adverse reaction nor dose limiting
toxicity. As a result, the independent Drug Safety Monitoring Board
(DSMB) has granted approval for the third cohort, at the 30mg dose
level, to commence with the first patient to be dosed in due
course.
TACTI-mel (Two ACTive Immunotherapeutics in
melanoma) is a multicentre, open label, Phase I study in which
patients with unresectable or metastatic melanoma will be dosed
with IMP321 in combination with the PD-1 checkpoint inhibitor
pembrolizumab (KEYTRUDA®). The study will evaluate safety as the
primary endpoint and anti-tumour activity and the immune response
to the combination as secondary endpoints.
About IMP321
IMP321, a first-in-class Antigen Presenting Cell (APC) activator
based on the immune checkpoint LAG-3, represents one of the first
proposed active immunotherapy drugs in which the patient’s own
immune system is harnessed to respond to tumour antigenic debris
created by chemotherapy. As an APC activator IMP321 boosts the
network of dendritic cells in the body that can respond to tumour
antigens for a better anti-tumour CD8 T cell response.
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:
Mr Matthew Gregorowski, Citadel-MAGNUS
+61 2 8234 0105; mgregorowski@citadelmagnus.com
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