On August 18, 2016 Prima BioMed Ltd (ASX: PRR; NASDAQ: PBMD), reported an update on the Company’s cash position and the recruitment progress in its two active clinical trials in IMP321 (Press release, Prima Biomed, AUG 18, 2016, View Source [SID:1234514637]).
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Financial Position
As a result of careful financial management, Prima remains in a solid financial position, with approximately A$20M cash as of 30 June 2016. Based on the Company’s forecasts, the current operational cash reach has been extended well into the fourth quarter of 2017.
Clinical Trial Updates: IMP321
The IMP321 clinical samples were the first biologic manufactured in China to receive regulatory approval for administration in clinical trials in Europe. Prima is pleased to advise that both IMP 321 clinical programs are progressing well.
TACTI-mel (Two ACTive Immunotherapeutics in melanoma), the Company’s Australian melanoma trial, now has six clinical centres approved, all of which have been activated. Three patients have been recruited in the first cohort and no dose limiting toxicity has been reached. The open label, Phase I study will recruit up to 24 patients, with the first data expected in the fourth quarter of 2016. Patients with unresectable or metastatic melanoma will be dosed with IMP321 in combination with an approved checkpoint inhibitor.
AIPAC (Active Immunotherapy PAClitaxel), has recruited three out of the nine patients expected to be enrolled in the second cohort of the trial’s safety run-in phase. As announced in June, data from the initial open-label run-in cohort of six patients, who received 6 mg doses of IMP321 in combination with paclitaxel, confirmed the safety, pharmacokinetics and pharmacodynamics of IMP321.
The results of all 15 patients from the safety run-in phase of AIPAC are expected in the fourth quarter of 2016.