Global biotechnology firm Prima BioMed has begun dosing patients in a Phase IIb clinical trial of its antigen presenting cell (APC) activator, IMP321, for the treatment of metastatic breast cancer.
During the Active Immunotherapy PAClitaxel (AIPAC) trial, half of the 226 patients enrolled for the trial will receive paclitaxel along with a placebo, while the remaining half will receive paclitaxel in conjunction with IMP321.
Once approved by the Dose Escalation Committee, the study will be followed by the use of 30mg dosage level for IMP321.
Prima BioMed chief medical officer Dr Frédéric Triebel said: “We are pleased to have dosed the first patient in the randomised and double-blind Phase of the AIPAC trial.
“Following positive interim data released in December and the 30mg dosage approval, we are now focused on the screening and enrolment of the enlarged patient cohort across our European centres.”
The company also noted that its IMP321 activator is based on the immune checkpoint target LAG-3 immune control mechanism that plays an important role in the regulation of the T-cell immune response.
IMP321 also 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.
Additionally, the drug improves the network of dendritic cells in the body that can respond to tumour antigens for a better anti-tumour CD8 T-cell response.