Following the ASCO Round table discussion held on 31 May, 2015, PPHM released the following updates:
Sunrise Phase III Trial
Completion of enrollment is anticipated by calendar year-end 2015.There will be two planned interim efficacy analyses which will be reviewed by the trial's Independent Data Monitoring Committee (IDMC). The first interim analysis, which will be conducted when 33% of the targeted overall survival events reached, is for futility and the second interim analysis, for futility or superiority, will be conducted at 50% of events. As these analyses are event driven, the exact timing of each is unknown, however the company plans to provide updates as these events are reached.
What can we know from this? The Sunrise Phase III trial has been ongoing for 18 months now. It lends credence that the patients are surviving longer, surpassing the 33% target for futility. This means that there is a likelihood that the first look-in if it happens could be a deciding factor to end the trial and grant approval. Just my opinion of course.
Exploring Checkpoint Inhibitor Combinations For Lung Cancer
PPHM plans to initiate an open -label multi-centre, randomised PHase II Trial of the anti-PD-1 monoclonal antibody nivolumab (Opdivo) vs nivolumab + Bavituximab in patients with previously treated locally advanced metastatic NSCLC. Enrollment will iclude patients with squamous and non-squamos NSCLC who have not received a prior PD-L1 or PD-! inhibitor.The primary endpoint of this trial will be overall response rate (ORR) with secondary endpoints including tumour response and duration, progression free survival, overall survival (OS) and safety.The trial is in the final stages of design and the details of which will be made available once details are completed. Trial initiation is anticipated in H2 2015.
My opinion. Nivolumab is a drug marketed by Bristol Myers Squibb (BMY). Previously PPHM conducted a trial combining Yervoy + Bavituximab for advanced melanoma (a type of deadly Skin Cancer). Yervoy is also a BMY drug. The involvement of BMY drugs may give hint of a potential partnership perhaps? Just my opinion but it is an interesting prospect to consider.
Leveraging Positive data In Breast Cancer
PPHM plans to initiate a Phase II/III open-label trial of either docetaxel or paclitaxel with or without Bavituximab in patients with locally advanced or metastatic HER2 negative breast cancer. The primary endpoint for the for the Phase II trial will be ORR. Results from this trial are expected to inform decisions on future studies in breast cancer and add value to the overall programme. The initiation of this trial is anticipated in H2 2015.
Fiscal Year End Cash Position
As at 30 April 2015, PPHM has cash and equivalents of US$68 million.
Avid Bioservices' Expansion On Track And Strongly Positioned To Meet Demand
The new facility is anticipated to be ready for cGMP production of biotechnology prodcuts in July 2015.
My disclosure: I am long PPHM
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