Avid Bioservices Inc (CDMO)

[BioBS2012]

PPHM statements on Breast Cancer IST Data over the past ~ 1-year

Steven King October 2013 - Annual Shareholders Meeting

In addition, we had very promising data for bavituximab plus paclitaxel in breast cancer, which certainly seems to support advancing that combination. Again, this is a combination we've had a lot of good success with in both preclinical studies and relative clinic and that the data was an 85% tumor response rate, a really nice number of complete remissions, really, I think support advancing this from our current ongoing study.

Joe Shan in December 2013 - Q2 Fiscal-2014 Earnings Call

Lastly, as you've heard from Steve, we are continuing to explore the potential of bavituximab in treating breast cancer. Interim data from an ISP with paclitaxel and bavituximab in patients with HER2-negative metastatic breast cancer presented at this year's ASCO meeting, demonstrated an encouraging 85% response rate in 11 of 13 evaluable patients with 2 of those 11 responders achieving a complete response. These results in our prior clinical experience in breast cancer makes this a high-priority development area. We're actively evaluating opportunities to move this program forward, as resources permit and will provide an update in the future.

March 2014 Q&A - Q3 Fiscal-2014 Earnings Call

George B. Zavoico - University of Virginia

And that segues into my next question, because, clearly, as a cost-saving measure, it's very efficient to use investigator-sponsored trials. And right now, you're moving into Phase III, really, with a single company-sponsored trial. You just mentioned some exciting results. Are you -- and obviously, company-sponsored trials add the greatest value to you in terms of being able to keep as much of the upside as possible, getting data before you partner it. Are you leaving some room in your budget to -- as you say, if you get some exciting breast cancer results, to actually start another late Phase II or pivotal Phase III trial in another cancer indication?

Steven W. King

Yes, I think we're going to leave that open. I mean, I think obviously, it's resource availability that will determine our ability to start those new studies. But absolutely, I mean, there's actually a lot of excitement about the breast cancer data that was presented at ASCO last year, in which we saw 85% tumor response rates in HER2-negative breast cancer patients, and about half those patients were actually triple negative, and that's a huge area of opportunity from a development standpoint, and also, I think an area that would be very attractive from a market perspective. So absolutely. I think we want to let the science and the clinical results guide us into what those next investments should be. But that's just an example of one that we have right now. And obviously, with this ongoing studies in liver cancer and the new study in melanoma, new things may pop up here. So yes, I mean I think our goal is to build the franchise here, and again, this is where partnering discussions come in as well, because that clearly would be a primary focus there of getting a partner with a mindset that they want to run a broad program, which could include multiple Phase IIIs even, potentially, and that's really level of interest there. If not, we can execute the Phase III and do some other things ourself. But we do want to make sure we get the most out of bavituximab and get it in as many hands as possible.

Joe Shan - Q4 Fiscal-2014 Earnings Call

Starting with breast cancer, we’ve now generated data from three separate clinical trials combining bavituximab with taxane chemotherapy. The most recent is from an investigator sponsored trial or IST by Dr. Alison Stopeck of the University of Arizona Cancer Center, in Tucson in which she previously reported an 85% response rate including a 15% complete response rate in patients with HER2-negative metastatic breast cancer.

Given these results in which approximately half of the patients were triple negative and extremely difficult to treat disease and the immune-stimulatory synergies that exist between bavituximab and taxane, breast cancer is high on our list of next indications. We look forward to the publication of final data in a manuscript form from this trial from Doctor Stopeck in the near future.