June 26th 2017
SYDNEY, Australia, June 26, 2017 (GLOBE NEWSWIRE) -- Prima BioMed Ltd (ASX:PRR) (NASDAQ:PBMD), has provided an update on the Company’s two active clinical trials in IMP321. Prima is pleased to advise that clinical studies of IMP321 are progressing well.
TACTI-mel (Two ACTive Immunotherapeutics in melanoma), the Company’s Australian melanoma trial, 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 stabilizations of disease. The company expects to present a data set from the first two cohorts at the following conferences:
- World Immunotherapy Congress, Basel, Switzerland on October 31st, 2017; and
- SITC, Society for Immunotherapy of Cancer, National Harbor, MD, USA, November 08-12, 2017
Data from all three cohorts is expected in H1 2018.
AIPAC (Active Immunotherapy PAClitaxel), started the recruitment of the randomized 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.
IMP321 Partnering Update
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.
CYTLIMIC, the Japanese NEC spin off with which Prima has a collaboration agreement, presented a poster at ASCO (http://abstracts.asco.org/199/AbstView_199_183394.html) which showed the results of their T-cell based therapeutic cancer vaccine with IMP321 as an adjuvant to the vaccine.
About Prima BioMed
Prima BioMed is listed on the Australian Stock Exchange, and on the NASDAQ in the US. For further information please visit www.primabiomed.com.au