Full Press Release Details
An APC activator (IMP321 or LAG-3Ig) combined
with anti-PD-1 blockade
Fr d ric Triebel, M.D., PhD. , Prima Biomed Ltd
Society for Immunotherapy of Cancer
Three groups of patients responding to anti-PD-1 (IFN-y signature)
A- Inflamed responders respond to anti-PD-1
B- Inflamed non-responders (some
infiltrates in the tumor margins but no response)
C- Non inflamed. Cold tumor with no response
Optimal checkpoint combos will target groups B and C and help them:
Promote cross presentation
Induce T cell recruitment into tumor microenvironment
ADVANCING CANCER IMMUNOTHERAPY WORLDWIDE
Society for Immunotherapy of Cancer
IMP321 induces a better Tc1 differentiation than sCD40L or
Human blood lymphocytes are analyzed in a 16 hr ex vivo assay
Intracellular staining of CD8 T cells
Only IMP321 induces IFN+ CD8 T cell
TLR agonists but not IMP321 induce IL-10 production which suppresses Tc1 differentiation
2.50 2.00 1.50 1.00 0.50 0.00
IMP321 TLR1-2 TLR3 TLR4 TLR5 TLR6 TLR7-8 TLR9
medium IMP321 L243 I3 sCD40L
TLR1-2 TLR3 TLR4 TLR5 TLR6 TLR7-8 TLR9
IL-2+IFN+TNF+ IL-2+IFN+ IL-2+TNF+ IFN+TNF+ IL-2+ TNF+ IFN+
Donor 1 Door 2 ADVANCING CANCER
IMMUNOTHERAPY WORLDWIDE
Society for Immunotherapy of Cancer
In vitro and in vivo preclinical data supporting the
CMV-stimulated PBMCs from 10 healthy donors after 48hrs
| 7 | ||||||||
| 6 | ||||||||
| IFN-y secretion (fold increase) | 5 | |||||||
| 4 | ||||||||
| 3 | ||||||||
| 2 | ||||||||
| 1 | ||||||||
| 0 | ||||||||
| IMP321 (ng/ml) | 0 | 30 | 30 | 0 | ||||
| Anti-PD-1 (ng/ml) | 30 | 0 | 30 | 1000 |
Anti-PD-1 (10 mg/kg) + mLAG-3Ig (1 mg/kg) In a subcutaneous CT26wt colon cancer model Vehicle PD-1 mab Mlag-3lg
Combo Mean of tumor volume (mm3)
2000 1800 1600 1400 1200 1000 800 600 400 200 0 0 5 10 15 20
Days after tumor cell implantation ADVANCING CANCER IMMUNOTHERAPY WORLDWIDE
Society for Immunotherapy of Cancer
TACTI-mel: Two ACTive Immunotherapeutics in melanoma
immuno-immuno combination in unresectable or metastatic melanoma in Australia
up to 24 patients, 3 cohorts, max. 8 patients each
IMP321 + anti-PD-1 (Keytruda)
Multicenter, open label, dose escalation
Safety and tolerability
First patient in May 2016
Phase I, multi-centre, open-label, dose escalation
Safety, tolerability and recommended dose finding for phase II with
pembrolizumab + IMP321 in unresectable or metastic melanoma
Pharmakokinetic and pharmakodynamic of IMP321, objective response rate, time to next treatment, progress-free survival
Patients with asymptomatic or suboptimal response after three cycles of
3 cohorts: 1/6/30 mg IMP321; s.c. q2w + pembrolizumab;
starting with the 5th cycle of
6 clinical sites are approved and all are
Dose escalation decision of the interim data of the first cohort is expected at the end of this year
ADVANCING CANCER IMMUNOTHERAPY WORLDWIDE