UK approves Prima BioMed to initiate Phase II b trial of IMP321 to treat metastatic breast cancer


Australian biotechnology firm Prima BioMed has secured approval from the UK’s Competent Authority and Ethics Committee to begin a Phase II b, active immunotherapy paclitaxel (AIPAC) trial of its IMP321 drug to treat metastatic breast cancer.

A re-phased safety run of the trial is expected to be completed later this month, while the larger, randomised phase of the study is scheduled to begin by January next year.

The newly approved trial is also subject to a dose escalation committee meeting and screening in the UK.

Prima BioMed noted that IMP321, which is a soluble LAG-3Ig fusion protein, is currently under a Phase II clinical trial as a chemo-immunotherapy for metastatic breast cancer, termed AIPAC.

The drug is also in a Phase I combination therapy trial in metastatic melanoma, termed TACTI-mel.

"The newly approved trial is also subject to a dose escalation committee meeting and screening in the UK."

Conducted as a multi-national, randomised, double-blind, placebo-controlled study, AIPAC involves the evaluation of IMP321-plus-paclitaxel to treat metastatic breast cancer.

Prima BioMed is currently conducting the safety run-in phase of the first cohort of 15 patients of the trial across 11 clinical sites in Belgium, the Netherlands and Hungary.

The first safety and pharmacokinetic data from this first cohort of patients is expected later this month.

Recruitment of patients for the second cohort of AIPAC study has also been completed.

Prima BioMed further noted that interim data from the first cohort of patients in its Phase I, TACTI-mel clinical trial of IMP321, together with KEYTRUDA for treating metastatic melanoma patients, is also expected later this month.