NSCLC is just the beginning
"Our preclinical results study show that the combination treatment with an anti-PD-1 antibody yield superior growth inhibition in a large percentage of subjects, while also exhibiting multiple immunostimulatory changes associated with an anti-immune response as compared to anti-PD-1 alone. Taken together, these results...provide a rationale for the clinical evaluation of bavituximab with PD-1 or PDL-1 targeting drugs in lung cancer and other indications." -- Jeffrey Hutchins, VP of Preclinical Research
While bavituximab as a second-line therapy for NSCLC has the potential to validate bavituximab as a viable therapy and demonstrate the value of Peregrine's drug development platform, NSCLC isn't the end of the line for Peregrine -- it's just the beginning.
Peregrine has presented a number of preclinical studies in recent months that demonstrate bavituximab's PS-blocking activity (binding with PS receptors blocks the immunosuppressant quality of cancer cells) may actually heighten the effect of anti-PD-1 and anti-PD-L1 cancer immunotherapies, which are all the rage among oncology researchers. The PD-1 and PD-L1 drug market is being described on Wall Street as a "tens of billions of dollars" opportunity in the coming decade, and if bavituximab can latch on with these immunotherapies as a combination therapy that improves response rates and survival, it could be a big positive.
You want a catalyst timetable? You got one!
"We plan IDMC interim analysis [for SUNRISE] at 33% and 50% of targeted overall survival events as those are reached, with estimated unblinding of the trial to occur approximately near the calendar year end of 2016. Regarding our planned Phase II second-line non-small cell lung cancer, bavituximab plus nivo [Opdivo], and our planned Phase II, III HER2-negative breast cancer trial, evaluating docetaxel or paclitaxel with bavituximab, we estimate trial initiation for both of those studies during the second half of 2015. And in these open-label studies, we will have the potential for interim data from both studies as early as 2016." -- Steven King
When it comes to clinical-stage biopharmaceutical companies, nothing wets the whistle of investors more than clinical-stage data. Given the success Peregrine has witnessed with its PS-targeting vaccine in preclinical studies, it's moving into a number of midstage and late-stage trials with bavituximab as a combination therapy. These include a second-line NSCLC trial involving Bristol-Myers Squibb 's checkpoint inhibitor Opdivo and a phase 2/3 breast cancer study with either docetaxel or paclitaxel.
While it's impossible to predict the timetable when data might be available, CEO Steven King did his best to offer a tentative timeline for investors during the conference call. An independent data monitoring committee interim analysis for SUNRISE will be conducted for futility at 33% of targeted events, while a second interim analysis will be conducted at 50% of events to examine predictive success or futility. These events are likely to happen before the end of calendar year 2016.
Additionally, interim data for second-line NSCLC with Opdivo and phase 2/3 in breast cancer could be out in early 2016.
Source: Peregrine Pharmaceuticals.
Source: Bristol-Myers Squibb.
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