Prima says IMP321 trial progressing well

Prima BioMed has announced that the company’s clinical studies of IMP321 are progressing well.

The company’s Australian melanoma trial TACTI-mel (Two ACTive Immunotherapeutics in melanoma) has completed recruitment of the first two cohorts of six patients and has now commenced recruitment of the third cohort. No dose limiting toxicity has been observed in any patient. Patients with unresectable or metastatic melanoma will be dosed with IMP321 in combination with an approved checkpoint inhibitor (anti-PD-1 antibody) after the patient did not optimally respond to the checkpoint inhibitor alone.

As previously disclosed, data from the first cohort was presented in March at the ICI conference in Boston. This included one patient with complete remission after progress on anti-PD-1 therapy alone. This patient remains in complete remission, while other patients from the first cohort have shown a partial remission and stabilisations of disease.

Data from all three cohorts is expected in H1 2018.

AIPAC (Active Immunotherapy PAClitaxel) started the recruitment of the randomised part of the study in January 2017. In addition to centres in Belgium and the Netherlands, patient recruitment has also now commenced in Poland and Hungary, with the United Kingdom to follow in due course. In total, 19 clinical sites have been activated and more activations will follow in the coming months. The study is expected to be fully recruited in H1 2018.

As announced earlier in June, data from the open-label safety run-in cohort of 15 patients, who received 6 and 30 mg doses of IMP321 in combination with paclitaxel, were presented at ASCO in Chicago. Final results of the 15 patients from the safety run-in phase of AIPAC are expected in the fourth quarter of 2017.

Prima’s Chinese partner for IMP321, EOC Pharma, an oncology focused affiliate of Eddingpharm, applied in first quarter of 2017 for an Investigational New Drug (IND) in China, as a preparation to start clinical trials. Recent positive changes in the Chinese regulatory environment provide the possibility to speed up the development of IMP321 in China. Prima and EOC Pharma will work together to advance this promising drug to meet unmet medical need in China.