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Biovest Seeking Marketing Approval in the EU for BiovaxID® Personalized Lymphoma Cancer Vaccine

Biovest International, Inc. is an emerging leader in the field of active personalized immunotherapies. In collaboration with the National Cancer Institute, Biovest has developed a patient-specific, cancer vaccine, BiovaxID®, with three clinical trials completed, including a Phase III study, demonstrating evidence of safety and efficacy for the treatment of indolent follicular non-Hodgkin’s lymphoma. Headquartered in Tampa, Florida with its bio-manufacturing facility based in Minneapolis, Minnesota, Biovest is publicly-traded on the OTCQB Market with the stock-ticker symbol “BVTI”.  OneMedRadio interviewed CEO, Sam Duffy, and Senior Vice President of Product Development and Regulatory Affairs, Carlos Santos. Click below to hear full audio interview and see transcript that follows. Brett Johnson:  Welcome, this is Brett Johnson with OneMed Radio in New York. Today, I am with Samuel Duffy who’s the president and CEO and Carlos Santos, PhD, who’s the senior VP of product development and regulatory affairs for Tampa-based Biovest International. The symbol is BVTI. They’re traded on the bulletin board. Thanks for joining us today, gentlemen. Click below to peruse the company's most relevant slideshow.
 
  Samuel Duffy:       You bet. My pleasure. BJ:   So we interviewed you guys about a month ago with regard to some of the regulatory things you had going on in Canada and Europe. You’re seeking approval for the BiovaxID, your personalized cancer medicine for the treatment of non-Hodgkin’s lymphoma. Since then you’ve been active in Europe so can you tell us what’s happening over there? SD:  Yeah, thanks for asking. You’re absolutely correct. In the interview that we did before, we discussed the regulatory strategy that we have, which started us out with a prefiling meeting in Canada and at that time we discussed the fact that we were planning similar regulatory prefiling meetings in Europe. So this announcement is to the effect that we’ve completed those meetings with the national medical agencies and as was the case in Canada, we’re moving forward now with the commitment to seek marketing approval with the EU. This is really important in terms of a milestone for Biovest because it’s a second assurance that our regulatory strategy is happening right on schedule and as per its intended outcome. BJ:   So what is the sense then in when you would get some regulatory approval in Europe? SD:   Well, the target that we have similar to Canada is to file our application seeking marketing approval around the end of the year. And also similar to Canada, the EU is slightly less than a year long process as they do their rigorous and comprehensive review of the marketing application. BJ:        So what is the significant economic point of view in terms of the EU market? I mean how big a market is that for you? SD:     Well, it’s really significant in two ways. In one sense, and as your question inquires, the EU in its own is a slightly larger market for us compared to the US. When you compare the EU with Canada, it really is a substantial marketplace for us. That doesn’t diminish our desire to also be marketing our drug in the US, but the EU is really exciting for us. It represents about 23,000 new patients diagnosed with follicular lymphoma each year. That number is growing so unfortunately the disease is continuing to expand and it’s a large market for us. Secondarily, the importance of the EU, as I indicated earlier, is that our regulatory strategy marches on and we couldn’t be more excited that our carefully conceived strategy is advancing nicely for us. BJ:        So I know in your press release, you had indicated that you’re going to start pushing down deal with the FDA. Can you tell us a little bit about what you see happening with the FDA? SD:  Absolutely. With our regulatory strategy, we continue to be on task and as we have said before, we expect to complete our prefiling meetings with the FDA before the end of the summer. We are really excited about meeting with the FDA and discussing with them our regulatory developments that we have. We started the development, the clinical development of BiovaxID almost 18 years ago and this has been a very significant and, I think, positive public-private partnership between Biovest and the US National Cancer Institute. We’re convinced that without the vision and the resources and the dedication of the NCI, a really forward-looking, perhaps paradigm-shifting therapy like this cancer vaccine for follicular lymphoma just wouldn’t have been possible. So we are really excited about sharing our clinical data, which we believe is comprehensive and in depth with the FDA and we look forward to their input and their thoughts and suggestions on the best way for Biovest to move toward marketing approval in the US. BJ:      So what makes BiovaxID unique from other cancer vaccines? Carlos Santos: I think I can take that. Brett, I think that’s a wonderful question. You know, as you know, cancer vaccines really have to be tailored towards treating cancer and cancer is ultimately a personalized individual disease. It arises from a single cell and as it develops, any cell in the body can become a cancerous cell and eventually patients develop disease right now, which becomes resistant. When you use one-size-fits-all therapy, you select for cancer cells that can escape and so the push towards personalizing medicine has really been a push towards doing just that, treating cancer one patient at a time, treating their specific disease. BiovaxID is a cancer vaccine that uses a unique protein on the cell surface of the cancer. This is a survival protein that’s necessary for the cancer cells, in this case lymphoma cells, to survive and importantly, it distinguishes those cells from other healthy cells in the body. So the marker is unique to each lymphoma patient, as unique as a fingerprint and really when we get a biopsy from a treating physician that has shipped us a tumor sample, we then can grow the patient’s own tumor cells in a bioreactor that we’ve designed, the AutovaxID cell culture instrument, and then using those tumor cells, we’ll manufacture this patient’s own tumor protein to become the antigen in the vaccine. That vaccine is then applied to patients after they finish chemotherapy. Importantly, this isn’t a vaccine that is a live cell preparation being shipped back to the patient. So it’s actually a protein. It requires really a substantially less complicated management from the side of the physicians when they receive the vaccine since it’s not a live cell population. For logistic purposes, it should really be a much more streamlined process than some of the other live cell vaccines that we’ve seen. Importantly, one of the features that distinguishes this from other cancer’s vaccine is the amount of clinical data that we’ve got in support of this. We’ve done now two phase II clinical trials with the National Cancer Institute and one phase III clinical trial that the National Cancer Institute also initiated and then we collaborated with them in accreta. In those phase II clinical trials, we’ve measured the reaction of the immune system to the vaccine and we reported T cell responses that are able to recognize and kill the cancer cells in treated patients and that now over a decade later in follow-up, we’ve got the two trials that have really presented very promising data. We presented some data that shows that these responses to the vaccine correlate to improved survival. That was presented at the ASH meeting last December and then we’re looking forward to presenting additional exciting new data at the ASCO meeting coming up in June. Then, the big distinguishing feature for us is that we’ve got a phase III clinical trial that was randomized and controlled and it showed that the vaccine could extend the duration of remission in treated patients. So these are patients treated after chemotherapy in first complete remission and the vaccine provided over a year improvement in that remission duration. So in terms of both the protein product we’re delivering and in terms of really the wealth and the duration of the clinical data, it’s really a unique product and really be applicable and it’s extremely safe in treated patients. BJ:      It sounds very promising. I know you also had talked about you engaged the Fhergana Group to help look for and help you explore some of your partnering type arrangements, can you tell us a little bit about that? SD:    Absolutely. As we continue to progress in our development program, we now view ourselves as a late stage biotech company as we have moved from the clinic now into the regulatory approval process. It’s appropriate for us to be positioned to receive the best advice and input on partnering in other matters such as that and we believe that Fhergana Group is best in class. We’re really delighted to have them on side with us at this juncture. Beyond that, it’s not appropriate for me to discuss Fhergana other than just to acknowledge that the purpose of the press release was to indicate that they are our prime advisor in this regard. BJ:    Yeah, that’s terrific. Well it sounds like some exciting things happening at Biovest and congratulations on your great progress. SD:      Well thank you. CS:  Well thank you. BJ: So that is Samuel Duffy who is president and Carlos who’s the senior VP of regulatory affairs who’ve been talking about some of developments at Biovest with their BiovaxID. Brett Johnson in New York City signing off for OneMedRadio. Good day.      
Statements in this presentation/interview that are not strictly historical in nature constitute "forward-looking statements.“  Such statements include, but are not limited to, statements about Biovest and its product candidate, BiovaxID® and any other statements relating to products, product candidates, product development programs, the FDA or clinical study process including the commencement, process, or completion of clinical trials or the regulatory process.  Such statements may include, without limitation, statements with respect to the Company's plans, objectives, expectations and intentions, and other statements identified by words such as "may," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," or similar expressions. In particular (and without limitation), statements regarding the timing of anticipated filing of a New Drug Submission for BiovaxID with Health Canada, pre-filing meetings with the FDA, Europe or other jurisdictions an/or commercial plans reflect current expectations but are subject to inherent risks of delay in compilation and finalization of all components of the licensing application. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause the actual results of Biovest to be materially different from historical results or from any results expressed or implied by such forward-looking statements.  These factors include, but are not limited to, risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval for product candidates; competition from other pharmaceutical or biotechnology companies; and the additional risks discussed in filings with the Securities and Exchange Commission.  All forward-looking statements are qualified in their entirety by this cautionary statement, and Biovest undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof.  The product names used in this statement are for identification purposes only.  All trademarks and registered trademarks are the property of their respective owners.

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