Bavi's_Goal: More anti-PD-1/L1 Responders AND Prolong The Attack. Bavi's effect (hopefully to be proven in human trials), when combined with an anti-PD-1 inhibitor like AZN's durvalumab(MEDI4736SK), is more than just to increase the # of patients who respond to PD-L1, but also to cause the responses to be more prolonged & robust. SK 10-15-15/ASM, “Get it started, and keep it going.”
10-15-15 PR(PPHM/AZN Collab. Expanded): “Preclinical data have demonstrated that combining the enhanced T-cell mediated anti-tumor activity of bavituximab with checkpoint inhibitors, like PD-L1 antibodies, prolong the ability of tumor-specific T-cells to continue attacking the tumor.”http://tinyurl.com/q79bkam
10-15-15/CEO S.King(ASM) 1:50: “Some of the most exciting data that we've seen to date is that, when you look at the immunotherapy revolution in the way cancer is being treated, what's really becoming clear is that the PD-1/PL-L1 inhibitors are very potent in patients who have an active immune response. So, what happens is, when you have an immune response, these markers, PD1/PD-L1, become expressed and basically shutdown the immune response. So, what those drugs are doing is basically stopping this inhibition that's caused by the PD-1/PD-L1 interaction. So, very simple – block the checkpoint and then now the immune system can keep mounting that immune response. But actually the majority of patients don't have that immune response going, and we really believe it's because they have this exposed PS which is knocking down that immune response from ever getting started. So what we see as a potential beautiful fit for bavituximab is, now we're able to block that PS signal, now the immune system gets started, and now we can keep it going with these PD-1/PD-L1 inhibitors. So, “get it started, and keep it going”, and now we believe, and we'll show this in data, that we can help more patients respond. Patients who are already responding are doing great, but it's the minority of patients, and now it's getting more & more patients to respond, and that's the whole goal of this combination therapy paradigm, which is really highlighted by today's announcement with AstraZeneca [10-15-15: http://tinyurl.com/q79bkam ] that we're expanding our collaboration into new areas to be able to look at those combinations.” 9:40: ”Now, immuno-oncology agents, as I mentioned earlier, are showing even by themselves very nice survival tails in a minority of patients, and this is typically 20-30% of patients who get such long-term benefits. So, the question is here, how do we make more & more patients able to enjoy that benefit of long-term survival, which means your body is really fighting the disease and helping the therapy, and when you look at our pre-clinical data, and obviously our goal next is to generate similar clinical data - when you at what happens when you're treating with an anti-PD-1 checkpoint inhibitor, you see some animals responding very well, but then you see these animals that just basically don't respond at all, or they have a very minimal response which then gives out over time. And this is exactly what you're seeing in patients, right? - the minority of patients are getting a long-term benefit, but most patients actually escaping treatment and relapsing. When you combine an anti-PD-1 with a bavituximab-equivalent for pre-clinical studies, what you see now is this wide variety of responses really beg ins to tighten up, so that most of these animals are now enjoying the benefit of a more-robust, combined anti-tumor effect caused by the immune system. Our goal thru our collaborations and with our clinical studies is to demonstrate this same effect in patients, so we're getting more & more patients with these long-term effects.” **10-15-15/ASM Webcast Replay: http://edge.media-server.com/m/p/jghjvabo
= = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = Opdivo works in only ~20-35% of NSCLC Patients, those that express PD-L1 > 10%. In BMY’s Checkmate-057 NSCLC trial, Opdivo DID NOT increase survival vs. DOCE in the 64% of All Pts that didn’t express PD-L1 > 10% (see BMY’s K-M Charts below). Thus, the window of opportunity for Bavi is essentially 2/3+ of the NSCLC market. Of course, the other 1/3 of the patients where Opdivo works well might live even longer if Bavi were added to the mix, or possibly Bavi will allow Opdivo at reduced dosages to cut back on its considerable side-effects… - - - - - - - - - PD-1/PD-L1 blockade therapies like Opdivo+Keytruda benefit 20-25% of patients. Peregrine’s objective with Bavi is to “increase the extent & amplitude” of such therapies… “Although PD-1/PD-L1 blockade therapy [ex: Opdivo, Keytruda ] provides clinical benefits to approx. 20% of patients with advanced NSCLC, about 80% of patients still remain refractory to this treatment. Therefore, new molecules & combinations are urgently needed to address primary & secondary resistance to these new agents.” From 3-2015 ClinCancerRes. article, “Immune Checkpoint Modulation for Non–Small Cell Lung Cancer”: http://clincancerres.aacrjournals.org/content/21/10/2256.abstract http://www.ncbi.nlm.nih.gov/pubmed/25979932 => Bavi’s goal is to Extend The Range of patients that would benefit from the anti-PD1 mabs, in addition to helping the 20% that do benefit get Better Results.
10-15-15: AstraZeneca and Peregrine Pharmaceuticals Expand Ongoing Immuno-Oncology Collaboration to Include Phase II Lung Cancer Combination Clinical Trial Global, Randomized Phase II Trial to Evaluate Immunotherapy Combination of Peregrine's PS-Targeting Bavituximab and AstraZeneca's PD-L1 Inhibitor Durvalumab (MEDI4736) in Previously Treated NSCLC http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=936766
By: djohn 10-15-15 6:49pm iHub #239179 http://investorshub.advfn.com/boards/read_msg.aspx?message_id=117754746 I attended the ASM this morning. My impression is very good. I am now very comfortable with my investment in PPHM. These are real good people doing a real difficult job to move Bavi forward. I don't have much time because I have to get to JW for a flight to SFO then the redeye to ORD. Sorry I did not get on earlier, but had business to attend to in OC. I will give more details tomorrow when I have time. I don't have my notes but the 175mm share increase was approved - rough numbers: For/106.5mm, Against/44.5mm, Abstained/2mm (so, 40 some million didn't vote. Interesting!) I voted all my shares for. Everything else passed. I talked to everyone... CJ is a very nice guy, southern guy went to Auburn. I felt he has the best interests for PPHM and shareholders. I have no problem with him being COB now. If and when we get in the big leagues I will maybe re-look. I liked him, real guy not a fake! ES Good guy, genuinely concerned about pps and long time shareholders. Remember he holds a big stake of real shares not just options. DP was there. Talked briefly. Came crossed as a good board member. Didn't talk very long. My take away is these guys are doing a good job and ARE concerned about the shareholders. I am good with them being the independent directors. Talked to SK,JH,JS briefly and others (don't have my notes) Gerber's presentation was great. Got to go. I said I was going to the ASM to see if I would continue my investment, buy more or bale. At this point I will carefully buy more! -dj FU/239180: Oh forgot: Garnick was there talked to him briefly. I like him, he likes big bullets. Maybe someday soon PPHM will be a big bullet. FU/239327: EB, after talking to everyone it kind of all came together. These guys Have an excellent plan and are executing it well. When we were talking about the 175mm share increase and someone asked the question how they came up with the 175mm figure. PL kind of dropped the ball and SK came up and started talking, when he said, “we want to be able to react and respond to success”. First of all, at that point I thought SK displayed leadership and really looked like a CEO. It was funny, because when SK was talking on the webcast, he sounded like a scientist giving a canned presentation. But when the webcast was over and talking to him personally, he sounded like a CEO. We asked these guys to get Bavi FDA approved. They developed a plan and are exciting it. But I think there is a big bold plan if and when Bavi is approved. This is where shareholder value maximizes, IMO. If and when Bavi is approved, we won't be sitting around and waiting for a BP to come around and offer us a deal. We will be ready to go on our own (at least in the US), Not having to share revenues other than with the UTSW regents. Cash Cow comes to mind. FU/239340[re: bringing Bavi to mkt]: It will not be worldwide just in US. We will partner in Europe & Asia. Sorry [carboat], but it will highly increase shareholder upside. Don't underestimate this mgt. team until you have talked to them. FU/239343: N40, Dr Gerber's talk was more on Lung Cancer, the different types, and how PS-targeting & Bavi fit into the different types. Nothing earth-shattering at I can recall. FU/239689[re: ”You were lied to.”]: It's funny, I had some of the same concerns you have before I talked to each Board Member and most of the Top Mgt. people at the Peregrine ASM. They all answered all my questions without hesitation and IMO truthfully. I suggest you attend next year's meeting, talk and ask all you want before you jump to your opinion. I did that and my opinion changed. I would value your opinion so much more should you do this. FU/239694[re: 1) 3 other Penny Stocks BOD involved with; 2) PPS down over 80% yet why don't they don't buy on open-mkt?]: I did not hear anyone ask your 1st question. I think the people there asked questions related to their own concerns, and that did not concern me. Each and every person I talked to at the ASM was confident in their plan to get Bavi approved, and when approved move Bavi to commercialization. If Bavi is approved by the FDA, that plan will move quickly and shareholders will be rewarded. I formed that opinion from my conversations. IMO there is an excellent plan in place and once the first domino falls, things will move quickly.
By: eb0783 10-15-15 11:43pm iHub #239200 http://investorshub.advfn.com/boards/read_msg.aspx?message_id=117759249 Actually the sign at the door today specifically said no recordings, no photos, no videos. Sorry you couldn't make it this year Green. It was refreshing as always. Looked to be slightly less than 50 attendees with about 20 -25 being shareholders. FU/239201: Avid will not be operational/FDA-certified for another 4-5 weeks minimum. It is running test/pilot batches but (imo) like any new mfg. complex, it needs to be run through (and wrung out) to perfection. FU/239203[re: possible Avid Expansion beyond the current expansion]: You did not misunderstand. They are thinking about it only. No plans yet. Besides the need to control the mabufacturing & delivery of their own drugs, they are under increasing demand from new and growing customers. They are the latest in new, high-tech, and leading-edge biologic manufacturing. They are in demand. FU/239204: I fell quite vindicated. Eom [at voting Yes for Auth-Shares increase] FU/239204: Proposal #2: For/144.5, Against/6.4, Abstain/2.2 Proposal #3: 106.5, 44.5, 2 Proposal #4: 43, 18, 0.8 Proposal #5: 35.5, 25.5, 1 Finally, I totally agree with djohn, and I'm glad he finally got to look into their eyes to find they are good people doing a pretty good job in shark infested waters. Good report djohn. FU/239324[re: new ANZ Bavi+durvalumab NSCLC/Ph2=global/enrolls faster]: Keep in mind that although PPHM will “conduct” the trial, AZN will be involved and they have contacts, doctors that are familiar with them, and other ”networked” people/orgs especially in Europe. They will help. King said they have been very good to work with. King also said that he expects the new trial to be started/using the same locations and doctors (as SUNRISE), so there will be less relationship/training/process issues. Hence, faster, cheaper. AVID: Agree with what is said here. My take also is that Avid II is not as simple as an extension of an existing facility. It is absolutely the latest technology and most leading edge design out there today. Although they tried to duplicate the Avid existing equipment as such, even to using the same vendors & models, it is a few years later than the first Avid and some insignificant code and technical upgrades may have been made (like a different connector), and not made clear in specs, which has to be noted & documented or changed as they turn them up and make their trial runs. They do want their runs to be perfect and data perfectly “replicate-able.” VOTE: I’m not sure how much of the Q&A on the addl. shares that you heard on the webcast, but shareholders asked a number of questions and got decent, straight-forward answers. One answer (to a question that created days of wasted discussion & fud ammunition) was by CJ: The board was unanimous in proposal #3 [Auth.Addl.Shares]. FU/239328[re: were BOD vote results reported?]: I was ready with pen-in-hand and they did not. They just said that all 4 got the most votes and are hereby elected. FU/239336: That reminds me of one point that Gerber made, I think during the Q&A. He was asked if there were any difference between PD-L drugs (which one is better). He said that as of now, Oct. 2015, he could not tell the difference about if one was better than another. I'm not sure if that was in his presentation, like if patients ask him that, or if it was later in discussion of the difference, if any, between Opdivo and the AZN drug [durvalumab=MEDI4736]. FU/239345[re: Sunrise enrollment completion timing]: Hayward, this is not a real answer to your question, but it might make others feel better about this full enrollment concern. King was asked if we were “on target for end of year” (or some term like that). He smiled and said, we are right where we have been saying. And he was asked then, or soon thereafter, if he thought it was important for us (or maybe it was additionally termed “for investors”) to PR when we hit the end. He said it was real important so that people would see Peregrine as a company that could complete trials and not just start them.
By: Holotawoopas 10-16-15 11:42am iHub #239275 http://investorshub.advfn.com/boards/read_msg.aspx?message_id=117770870 Good morning everyone. The ASM was a pleasant experience for me this time as I got a better opinion of where my investment stands. Being invested in PPHM for 15 years and having attended many ASM's, I walked away feeling that the business side of PPHM outside of AVID is in progress and that the timeline for it to reflect in the share price did not make me concerned about the 175mm newly approved shares (which I voted no). I talked to SK, ES, and Dr. Garnick to get a better understanding of where we are, and I was satisfied with their answers/opinions. With all the generalization I just wrote, I am now in the camp that the first reflection of the value of bavi in the share price should be after the announcement of the completion of enrollment in the Sunrise trial.
By: Copper888 10-16-15 12:56pm iHub #239300 http://investorshub.advfn.com/boards/manage_msg.asp?message_id=117773742 Sorry for the delay, but I am snaking my way back up the coast to my home in Paso Robles, CA today. Have some good notes on my thoughts of the ASM for those interested. Great input from Dr.J and Eb. Did anyone mention that Dr. Gerber said that he is publishing an article this month about how Bavi is the only molecule they have worked with that binds directly to the tumor? He had a slide that showed a tumor "lit up" after Bavi exposure. FU/239310[re: Dr.Gerber/Bavi-or-PGN650?]: I am 80% sure that it was Bavi, as he never talked about PGN650. He was going pretty fast and said it in the context that it was a bit of a surprise...thus the article to be published. I am not sure about the tumor being human or not. FU/239316: Also, it was pretty clear to me that they are actively seeking to further expand to a 3rd Avid facility. This came up a few times subtly weaved into their answers on a range of topics. PL said they use an industry metric of 2-4 times sales for valuation. He had a slide deck with his presentation. I am in my car with an iPad and have no idea whether the company plans on posting it or not. However I can tell you that the Bavi relevant info was contained on the last 2 slides. They were chock full of info and he sped through them in about 30 seconds. FU/239322[re: Dr.Gerber's pres.]: He had a slide deck with his presentation. I am in my car with an iPad and have no idea whether the company plans on posting it or not. However, I can tell you that the Bavi relevant info was contained on the last 2 slides. They were chock full of info and he sped through them in about 30secs. I turned to my wife and said "did he just say that he is publishing an article later this month"? She said yes. By: Copper888 10-17-15 3:44pm iHub #239501 http://investorshub.advfn.com/boards/read_msg.aspx?message_id=117793495 Observations from the ASM: I apologize in advance for what may be redundant or deemed unimportant by some, but these are my observations, information and impressions from the ASM. Since I do not know what was cut off from the webcast, there might be some overlap. * Attendance - Stockholders. there were definitely less than last year. Someone posted that they thought attendance was around 20 25 people…I think that is pretty close. * During the pre-meeting chat session, I overheard CJ tell an attendee that "yes, but Cotara works, I was there when a doctor administered Cotara directly into a patients brain, and 3 days later that guy was out mowing his lawn." * CJ - During the introduction by CJ when he was introducing PL, he commented that those attendees that are upset at the use of the ATM should "throw their darts" at him. But then praised him for a job well done. This led to an offhand comment by someone from PPPH (I couldn't see who) that CJ reads the "Chat Rooms" and that's where he gets the impression that people are pissed at the ATM usage. CJ said that in fact he does not read the Chat rooms, but some people do print certain posts for him to read which he sometimes reluctantly does. * When talking about the new Avid Facilities, CJ thought that we would have the opportunity after the meeting to go and tour the facilities…this was quickly poopoo'd by the mgmt team, saying that there was too much activity going on there to have a tour that day. * CJ also commented about the growth of the company and number of employees over the years. He said that there is no more room in the company parking lot and that employees are now forced to park in the streets which is not looked on favorably by the Tustin PD. * As a strange side note, during CJ's preamble, PL was at times laughing so hard he was red in the face, lots of innuendo and inside jokes being tossed about between the 2…and PL was laughing so often and loud that my wife said it was "borderline unprofessional". IMO as I was sitting and having lost well over 100K on paper, I wasn't in as good a mood as they seemed to be.* During the lead up to the votes, and in an unscheduled way, 2 of our stockholders (who should be commended by the way) wanted to know more about the 175M share increase and a discussion took place. PL did a decent job of explaining how they basically have calculated the cash needs over the short & long hauls and that they need to plan on a variety of scenarios to make sure they have everything they need. IMO he gave the company line, stock answer and did it well. However, he was asked then why can't you ask for 50M now and 50M later or some other smaller amt. than what we are now faced with. It was then that SK stepped up and took control of the meeting, he first said that he understood the concern, and said that we all want the same thing, BUT they now have to start planning for success - that there is a possibility that the trial is stopped early during the 2nd look-in (he mentioned this a few times during the meeting) and that they have to be prepared for commercialization, which is a very expensive process. IMO, having listened and seen SK over the last few years, he has come a LOOONG way…he was very professional, and spoke frankly & confidently. He sounded like a CEO! * Dr. Jeff Hutchins - Always a good speaker IMO but no new INFO to speak of. * Dr. Gerber - I have posted on him prior. 100% on the intricacies of Lung Cancer, look for an article to be published on BAVI attaching directly to the tumor. Last 2 Slides were the BAVI focused slides. Blazed through them. (North - are you trying to get your hands on these?) Q&A Period (the things that stood out to me; I have to paraphrase throughout this - but the other attendees PLEASE help me with any inaccuracies or if you heard things differently... 1. MSK Collaboration - Preclinical or Clinical? Answer: the collaboration will contain both preclinical & Clinical aspects on an on-going basis. 2. Are there cancers that don't respond well to I/O, how do they determine what studies to pursue? Answer: they are looking to start trials that why think will offer them the biggest differential between control and with BAVI arms. As an example, SK said that in Breast cancer patients/tumors with the highest mutations respond best (sorry for the non-scientific interpretation). 3. Addl. study readouts prior to Sunrise Unblinding…why is this important? Answer: they are trying to have as much data available as they can prior to Sunrise unblinding. SK said that they view this data as being "supportive from a regulatory standpoint" This played into the decision to go with AZ vs. Opdivo. He said that not only did the save substantial money with AZ, but the DATA gathering would be much faster. Shan confirmed this by saying that "time is money". 4. Is the IDMC able to ask for a look-in or can they view the data PRIOR to the scheduled look-ins for efficacy? Answer: No the only thing that they can do is stop the trial for a safety problem. they do not have access to data other than that is it may cause "operational bias". SK gave the impression that there was little to no chance that the trial would be stopped at 1st look-in as it is for futility only. (he did say offhandedly that maybe if ALL the BAVI patients were alive and therefore all of the events were the control arm that they might suggest stopping, but that is not going to happen). He stated again that the chance for an early stop could be the 2nd look-in, and at that time they would determine what to do. They have the option to keep going with the trial to garner further data and complete the study. IMO it sounded like that is what they are leaning towards…no stop even if they can. (my interpretation based on Shan, who was sitting right next to Garnick). 5. Why don't we seek a BTD on Breast? Don't you guys realize how that would effect the stock price?…we could sell our ATM shares at $2 or $3 vs. $1 today. Answer: Garnick stood up and said that in his opinion, BTD is meaningless. It was designed to ease the pressure off of the FDA, and that our Fast Track designation gives us everything that we want and could get from a BTD. The questioner then pushed that from a perception and PPS standpoint, a BTD could be huge. SK agreed that "who doesn't like the sound of a BTD?" and they are not ruling anything out, and if the opportunity would arise that would fit applying for one, that they would consider it. 6. The poison Pill is expiring this Spring, what are you going to do? Answer: we are aware and are meeting on the topic as we speak, we are determining what to do. 7. Why are the PR's written so vaguely? They are written in Scientific Jargon and the average investor does not get it and/or does not get excited about the company? Answer: SK - this is great feedback and we will look into writing our PR's in a more accessible way. IMO, here again, SK said that we all want the same thing here (PPS to go up). 8. I have to ask about getting a partnership to boost the PPS, is this a unicorn or is it a real possibility? Will the Full Enrollment PR be a big deal or is it meaningless? Throw us a bone please! Answer: SK thinks that the enrollment is a big deal, because not only does it prove that we can get the job done, BUT it starts a timer ticking. As each month goes by the pressure of 1st look-in, then 2nd look-in, is looming. This is the only time that Worsley spoke…he said that he is seeing the interest ramping up, and that as we get closer that he expects the pressure to make deals from potential suitors to pick up substantially. FWIW - I came to the meeting a bit pissed but hopeful. I walked out feeling that they have it handled and they have a plan. No i was not drinking the Kool-Aid, it was Passion Tea…seriously. I apologize for the long rambling post but I wanted to get everything in - for those that attended, PLEASE Feel free to add, change or edit as you see fit. I truly hope this in some ways will help! FU/239536[re: confidence level of mgt team?]: I would say they seemed very confident. SK really took control of the meeting this year...he was the clear leader. Last year CJ took more of the leader role presiding over the meeting. The room is Much better served with SK IMO.
By: JJ1223 10-16-15 4:37pm iHub #239382 http://investorshub.advfn.com/boards/read_msg.aspx?message_id=117782249 [re: results for BOD voting]: Paul Lytle went through every proposal and gave the total votes for/against and the number abstaining. After each proposal presented, he declared it approved by shareholders. Not sure how anyone could have heard anything else. FU239386[re: SK's remarks on Sunrise enrollment]: He said in today’s environment, it was normal for companies to not finish a trial on time...for many reasons. I spoke with him directly and he remains confident on Bavi completing enrollment by EOY. He also mentioned it would be important to the share price because it would signal that the clinical data would be forth coming within a defined period of time. All the people I spoke with had glowing comments about the working relationship with AstraZeneca. I had many good & positive conversations, but the most excited guy in the room seemed to be Steve Worsley. FU/239569[re: BTD option]: Garnick spoke only about BTD as it relates to speed-to-market, saying fast track gives Bavi the same advantages in terms of FDA meetings & priority review. SK did comment that if the opportunity presented, the company would make the application. FU/239746: The company continues to make great strides in the IO space. The collaborations, MSK in particular, will pay great dividends in the not to distant future. IMO, the company has navigated some rough waters successfully and has put shareholders in a solid position to win. Not perfect, but the BOD deserves credit here. The next several months will be interesting. I was told (in a sidebar at the ASM meeting) that the company compared Bavi data against 67 other IO agents currently approved or in test...none had reported data results as strong or with a response as positive as those reported with Bavituximab. I am sure those comparisons are documented and being shared with many BP's and other interested companies. FU/239791[re: maybe they said “6-to-7”?]: Very clearly 67, and the enthusiasm was very evident. FU/239951: At the ASM, I was told that Peregrine has 2 full time employees working on Ebola. I have no other details.
= = = = = = = = = = = = = = = = = = = = 10-15-15 PR(PPHM/AZN Collab. Expanded): “Preclinical data have demonstrated that combining the enhanced T-cell mediated anti-tumor activity of bavituximab with checkpoint inhibitors, like PD-L1 antibodies, prolong the ability of tumor-specific T-cells to continue attacking the tumor.”http://tinyurl.com/q79bkam
10-15-15/CEO S.King(ASM) 1:50: “Some of the most exciting data that we've seen to date is that, when you look at the immunotherapy revolution in the way cancer is being treated, what's really becoming clear is that the PD-1/PL-L1 inhibitors are very potent in patients who have an active immune response. So, what happens is, when you have an immune response, these markers, PD1/PD-L1, become expressed and basically shutdown the immune response. So, what those drugs are doing is basically stopping this inhibition that's caused by the PD-1/PD-L1 interaction. So, very simple – block the checkpoint and then now the immune system can keep mounting that immune response. But actually the majority of patients don't have that immune response going, and we really believe it's because they have this exposed PS which is knocking down that immune response from ever getting started. So what we see as a potential beautiful fit for bavituximab is, now we're able to block that PS signal, now the immune system gets started, and now we can keep it going with these PD-1/PD-L1 inhibitors. So, “get it started, and keep it going”, and now we believe, and we'll show this in data, that we can help more patients respond. Patients who are already responding are doing great, but it's the minority of patients, and now it's getting more & more patients to respond, and that's the whole goal of this combination therapy paradigm, which is really highlighted by today's announcement with AstraZeneca [10-15-15: http://tinyurl.com/q79bkam ] that we're expanding our collaboration into new areas to be able to look at those combinations.” 9:40: ”Now, immuno-oncology agents, as I mentioned earlier, are showing even by themselves very nice survival tails in a minority of patients, and this is typically 20-30% of patients who get such long-term benefits. So, the question is here, how do we make more & more patients able to enjoy that benefit of long-term survival, which means your body is really fighting the disease and helping the therapy, and when you look at our pre-clinical data, and obviously our goal next is to generate similar clinical data - when you at what happens when you're treating with an anti-PD-1 checkpoint inhibitor, you see some animals responding very well, but then you see these animals that just basically don't respond at all, or they have a very minimal response which then gives out over time. And this is exactly what you're seeing in patients, right? - the minority of patients are getting a long-term benefit, but most patients actually escaping treatment and relapsing. When you combine an anti-PD-1 with a bavituximab-equivalent for pre-clinical studies, what you see now is this wide variety of responses really begins to tighten up, so that most of these animals are now enjoying the benefit of a more-robust, combined anti-tumor effect caused by the immune system. Our goal thru our collaborations and with our clinical studies is to demonstrate this same effect in patients, so we're getting more & more patients with these long-term effects.” **10-15-15/ASM Webcast Replay: http://edge.media-server.com/m/p/jghjvabo
ATTENDEE Reports from 10-15-2015 ASM (updated*/will delete+repost as more added - thanks for sharing, contributors!)… *HorseLover45/Djohn/Eb0783/followups
By: djohn 10-15-15 6:49pm iHub #239179 http://investorshub.advfn.com/boards/read_msg.aspx?message_id=117754746 I attended the ASM this morning. My impression is very good. I am now very comfortable with my investment in PPHM. These are real good people doing a real difficult job to move Bavi forward. I don't have much time because I have to get to JW for a flight to SFO then the redeye to ORD. Sorry I did not get on earlier, but had business to attend to in OC. I will give more details tomorrow when I have time. I don't have my notes but the 175mm share increase was approved - rough numbers: For/106.5mm, Against/44.5mm, Abstained/2mm (so, 40 some million didn't vote. Interesting!) I voted all my shares for. Everything else passed. I talked to everyone... CJ is a very nice guy, southern guy went to Auburn. I felt he has the best interests for PPHM and shareholders. I have no problem with him being COB now. If and when we get in the big leagues I will maybe re-look. I liked him, real guy not a fake! ES Good guy, genuinely concerned about pps and long time shareholders. Remember he holds a big stake of real shares not just options. DP was there. Talked briefly. Came crossed as a good board member. Didn't talk very long. My take away is these guys are doing a good job and ARE concerned about the shareholders. I am good with them being the independent directors. Talked to SK,JH,JS briefly and others (don't have my notes) Gerber's presentation was great. Got to go. I said I was going to the ASM to see if I would continue my investment, buy more or bale. At this point I will carefully buy more! -dj FU/239180: Oh forgot: Garnick was there talked to him briefly. I like him, he likes big bullets. Maybe someday soon PPHM will be a big bullet. FU/239327: EB, after talking to everyone it kind of all came together. These guys Have an excellent plan and are executing it well. When we were talking about the 175mm share increase and someone asked the question how they came up with the 175mm figure. PL kind of dropped the ball and SK came up and started talking, when he said, “we want to be able to react and respond to success”. First of all, at that point I thought SK displayed leadership and really looked like a CEO. It was funny, because when SK was talking on the webcast, he sounded like a scientist giving a canned presentation. But when the webcast was over and talking to him personally, he sounded like a CEO. We asked these guys to get Bavi FDA approved. They developed a plan and are exciting it. But I think there is a big bold plan if and when Bavi is approved. This is where shareholder value maximizes, IMO. If and when Bavi is approved, we won't be sitting around and waiting for a BP to come around and offer us a deal. We will be ready to go on our own (at least in the US), Not having to share revenues other than with the UTSW regents. Cash Cow comes to mind. FU/239340[re: bringing Bavi to mkt]: It will not be worldwide just in US. We will partner in Europe & Asia. Sorry [carboat], but it will highly increase shareholder upside. Don't underestimate this mgt. team until you have talked to them. FU/239343: N40, Dr Gerber's talk was more on Lung Cancer, the different types, and how PS-targeting & Bavi fit into the different types. Nothing earth-shattering at I can recall. FU/239689[re: ”You were lied to.”]: It's funny, I had some of the same concerns you have before I talked to each Board Member and most of the Top Mgt. people at the Peregrine ASM. They all answered all my questions without hesitation and IMO truthfully. I suggest you attend next year's meeting, talk and ask all you want before you jump to your opinion. I did that and my opinion changed. I would value your opinion so much more should you do this. FU/239694[re: 1) 3 other Penny Stocks BOD involved with; 2) PPS down over 80% yet why don't they don't buy on open-mkt?]: I did not hear anyone ask your 1st question. I think the people there asked questions related to their own concerns, and that did not concern me. Each and every person I talked to at the ASM was confident in their plan to get Bavi approved, and when approved move Bavi to commercialization. If Bavi is approved by the FDA, that plan will move quickly and shareholders will be rewarded. I formed that opinion from my conversations. IMO there is an excellent plan in place and once the first domino falls, things will move quickly. FU/241327[re: carboat's ”Garnick is just a part-time consultant.”]: Try talking to Dr. Garnick face to face and ask the right questions and you will soon realize his the real deal! Have you ever had a face to face discussion with him???? It's easy speculate on a person's worth not knowing anything, but when you gather all the facts from the person, Well, that's the real deal!!!
By: eb0783 10-15-15 11:43pm iHub #239200 http://investorshub.advfn.com/boards/read_msg.aspx?message_id=117759249 Actually the sign at the door today specifically said no recordings, no photos, no videos. Sorry you couldn't make it this year Green. It was refreshing as always. Looked to be slightly less than 50 attendees with about 20 -25 being shareholders. FU/239201: Avid will not be operational/FDA-certified for another 4-5 weeks minimum. It is running test/pilot batches but (imo) like any new mfg. complex, it needs to be run through (and wrung out) to perfection. FU/239203[re: possible Avid Expansion beyond the current expansion]: You did not misunderstand. They are thinking about it only. No plans yet. Besides the need to control the mabufacturing & delivery of their own drugs, they are under increasing demand from new and growing customers. They are the latest in new, high-tech, and leading-edge biologic manufacturing. They are in demand. FU/239204: I fell quite vindicated. Eom [at voting Yes for Auth-Shares increase] FU/239204: Proposal #2: For/144.5, Against/6.4, Abstain/2.2 Proposal #3: 106.5, 44.5, 2 Proposal #4: 43, 18, 0.8 Proposal #5: 35.5, 25.5, 1 Finally, I totally agree with djohn, and I'm glad he finally got to look into their eyes to find they are good people doing a pretty good job in shark infested waters. Good report djohn. FU/239324[re: new ANZ Bavi+durvalumab NSCLC/Ph2=global/enrolls faster]: Keep in mind that although PPHM will “conduct” the trial, AZN will be involved and they have contacts, doctors that are familiar with them, and other ”networked” people/orgs especially in Europe. They will help. King said they have been very good to work with. King also said that he expects the new trial to be started/using the same locations and doctors (as SUNRISE), so there will be less relationship/training/process issues. Hence, faster, cheaper. AVID: Agree with what is said here. My take also is that Avid II is not as simple as an extension of an existing facility. It is absolutely the latest technology and most leading edge design out there today. Although they tried to duplicate the Avid existing equipment as such, even to using the same vendors & models, it is a few years later than the first Avid and some insignificant code and technical upgrades may have been made (like a different connector), and not made clear in specs, which has to be noted & documented or changed as they turn them up and make their trial runs. They do want their runs to be perfect and data perfectly “replicate-able.” VOTE: I’m not sure how much of the Q&A on the addl. shares that you heard on the webcast, but shareholders asked a number of questions and got decent, straight-forward answers. One answer (to a question that created days of wasted discussion & fud ammunition) was by CJ: The board was unanimous in proposal #3 [Auth.Addl.Shares]. FU/239328[re: were BOD vote results reported?]: I was ready with pen-in-hand and they did not. They just said that all 4 got the most votes and are hereby elected. FU/239336: That reminds me of one point that Gerber made, I think during the Q&A. He was asked if there were any difference between PD-L drugs (which one is better). He said that as of now, Oct. 2015, he could not tell the difference about if one was better than another. I'm not sure if that was in his presentation, like if patients ask him that, or if it was later in discussion of the difference, if any, between Opdivo and the AZN drug [durvalumab=MEDI4736]. FU/239345[re: Sunrise enrollment completion timing]: Hayward, this is not a real answer to your question, but it might make others feel better about this full enrollment concern. King was asked if we were “on target for end of year” (or some term like that). He smiled and said, we are right where we have been saying. And he was asked then, or soon thereafter, if he thought it was important for us (or maybe it was additionally termed “for investors”) to PR when we hit the end. He said it was real important so that people would see Peregrine as a company that could complete trials and not just start them. FU/241337[re: HorseLover's comments about Rob Garnick]: I was standing right beside you Horselover45, and that was part of a good conversation with Garnick. You are right, hearing him say it (and other things) was more confirmation of what we have here in Bavi! [Astronomical value]
By: Holotawoopas 10-16-15 11:42am iHub #239275 http://investorshub.advfn.com/boards/read_msg.aspx?message_id=117770870 Good morning everyone. The ASM was a pleasant experience for me this time as I got a better opinion of where my investment stands. Being invested in PPHM for 15 years and having attended many ASM's, I walked away feeling that the business side of PPHM outside of AVID is in progress and that the timeline for it to reflect in the share price did not make me concerned about the 175mm newly approved shares (which I voted no). I talked to SK, ES, and Dr. Garnick to get a better understanding of where we are, and I was satisfied with their answers/opinions. With all the generalization I just wrote, I am now in the camp that the first reflection of the value of bavi in the share price should be after the announcement of the completion of enrollment in the Sunrise trial.
By: Copper888 10-16-15 12:56pm iHub #239300 http://investorshub.advfn.com/boards/manage_msg.asp?message_id=117773742 Sorry for the delay, but I am snaking my way back up the coast to my home in Paso Robles, CA today. Have some good notes on my thoughts of the ASM for those interested. Great input from Dr.J and Eb. Did anyone mention that Dr. Gerber said that he is publishing an article this month about how Bavi is the only molecule they have worked with that binds directly to the tumor? He had a slide that showed a tumor "lit up" after Bavi exposure. FU/239310[re: Dr.Gerber/Bavi-or-PGN650?]: I am 80% sure that it was Bavi, as he never talked about PGN650. He was going pretty fast and said it in the context that it was a bit of a surprise...thus the article to be published. I am not sure about the tumor being human or not. FU/239316: Also, it was pretty clear to me that they are actively seeking to further expand to a 3rd Avid facility. This came up a few times subtly weaved into their answers on a range of topics. PL said they use an industry metric of 2-4 times sales for valuation. He had a slide deck with his presentation. I am in my car with an iPad and have no idea whether the company plans on posting it or not. However I can tell you that the Bavi relevant info was contained on the last 2 slides. They were chock full of info and he sped through them in about 30 seconds. FU/239322[re: Dr.Gerber's pres.]: He had a slide deck with his presentation. I am in my car with an iPad and have no idea whether the company plans on posting it or not. However, I can tell you that the Bavi relevant info was contained on the last 2 slides. They were chock full of info and he sped through them in about 30secs. I turned to my wife and said "did he just say that he is publishing an article later this month"? She said yes. By: Copper888 10-17-15 3:44pm iHub #239501 http://investorshub.advfn.com/boards/read_msg.aspx?message_id=117793495 Observations from the ASM: I apologize in advance for what may be redundant or deemed unimportant by some, but these are my observations, information and impressions from the ASM. Since I do not know what was cut off from the webcast, there might be some overlap. * Attendance - Stockholders. there were definitely less than last year. Someone posted that they thought attendance was around 20 25 people…I think that is pretty close. * During the pre-meeting chat session, I overheard CJ tell an attendee that "yes, but Cotara works, I was there when a doctor administered Cotara directly into a patients brain, and 3 days later that guy was out mowing his lawn." * CJ - During the introduction by CJ when he was introducing PL, he commented that those attendees that are upset at the use of the ATM should "throw their darts" at him. But then praised him for a job well done. This led to an offhand comment by someone from PPPH (I couldn't see who) that CJ reads the "Chat Rooms" and that's where he gets the impression that people are pissed at the ATM usage. CJ said that in fact he does not read the Chat rooms, but some people do print certain posts for him to read which he sometimes reluctantly does. * When talking about the new Avid Facilities, CJ thought that we would have the opportunity after the meeting to go and tour the facilities…this was quickly poopoo'd by the mgmt team, saying that there was too much activity going on there to have a tour that day. * CJ also commented about the growth of the company and number of employees over the years. He said that there is no more room in the company parking lot and that employees are now forced to park in the streets which is not looked on favorably by the Tustin PD. * As a strange side note, during CJ's preamble, PL was at times laughing so hard he was red in the face, lots of innuendo and inside jokes being tossed about between the 2…and PL was laughing so often and loud that my wife said it was "borderline unprofessional". IMO as I was sitting and having lost well over 100K on paper, I wasn't in as good a mood as they seemed to be.* During the lead up to the votes, and in an unscheduled way, 2 of our stockholders (who should be commended by the way) wanted to know more about the 175M share increase and a discussion took place. PL did a decent job of explaining how they basically have calculated the cash needs over the short & long hauls and that they need to plan on a variety of scenarios to make sure they have everything they need. IMO he gave the company line, stock answer and did it well. However, he was asked then why can't you ask for 50M now and 50M later or some other smaller amt. than what we are now faced with. It was then that SK stepped up and took control of the meeting, he first said that he understood the concern, and said that we all want the same thing, BUT they now have to start planning for success - that there is a possibility that the trial is stopped early during the 2nd look-in (he mentioned this a few times during the meeting) and that they have to be prepared for commercialization, which is a very expensive process. IMO, having listened and seen SK over the last few years, he has come a LOOONG way…he was very professional, and spoke frankly & confidently. He sounded like a CEO! * Dr. Jeff Hutchins - Always a good speaker IMO but no new INFO to speak of. * Dr. Gerber - I have posted on him prior. 100% on the intricacies of Lung Cancer, look for an article to be published on BAVI attaching directly to the tumor. Last 2 Slides were the BAVI focused slides. Blazed through them. (North - are you trying to get your hands on these?) Q&A Period (the things that stood out to me; I have to paraphrase throughout this - but the other attendees PLEASE help me with any inaccuracies or if you heard things differently... 1. MSK Collaboration - Preclinical or Clinical? Answer: the collaboration will contain both preclinical & Clinical aspects on an on-going basis. 2. Are there cancers that don't respond well to I/O, how do they determine what studies to pursue? Answer: they are looking to start trials that why think will offer them the biggest differential between control and with BAVI arms. As an example, SK said that in Breast cancer patients/tumors with the highest mutations respond best (sorry for the non-scientific interpretation). 3. Addl. study readouts prior to Sunrise Unblinding…why is this important? Answer: they are trying to have as much data available as they can prior to Sunrise unblinding. SK said that they view this data as being "supportive from a regulatory standpoint" This played into the decision to go with AZ vs. Opdivo. He said that not only did the save substantial money with AZ, but the DATA gathering would be much faster. Shan confirmed this by saying that "time is money". 4. Is the IDMC able to ask for a look-in or can they view the data PRIOR to the scheduled look-ins for efficacy? Answer: No the only thing that they can do is stop the trial for a safety problem. they do not have access to data other than that is it may cause "operational bias". SK gave the impression that there was little to no chance that the trial would be stopped at 1st look-in as it is for futility only. (he did say offhandedly that maybe if ALL the BAVI patients were alive and therefore all of the events were the control arm that they might suggest stopping, but that is not going to happen). He stated again that the chance for an early stop could be the 2nd look-in, and at that time they would determine what to do. They have the option to keep going with the trial to garner further data and complete the study. IMO it sounded like that is what they are leaning towards…no stop even if they can. (my interpretation based on Shan, who was sitting right next to Garnick). 5. Why don't we seek a BTD on Breast? Don't you guys realize how that would effect the stock price?…we could sell our ATM shares at $2 or $3 vs. $1 today. Answer: Garnick stood up and said that in his opinion, BTD is meaningless. It was designed to ease the pressure off of the FDA, and that our Fast Track designation gives us everything that we want and could get from a BTD. The questioner then pushed that from a perception and PPS standpoint, a BTD could be huge. SK agreed that "who doesn't like the sound of a BTD?" and they are not ruling anything out, and if the opportunity would arise that would fit applying for one, that they would consider it. 6. The poison Pill is expiring this Spring, what are you going to do? Answer: we are aware and are meeting on the topic as we speak, we are determining what to do. 7. Why are the PR's written so vaguely? They are written in Scientific Jargon and the average investor does not get it and/or does not get excited about the company? Answer: SK - this is great feedback and we will look into writing our PR's in a more accessible way. IMO, here again, SK said that we all want the same thing here (PPS to go up). 8. I have to ask about getting a partnership to boost the PPS, is this a unicorn or is it a real possibility? Will the Full Enrollment PR be a big deal or is it meaningless? Throw us a bone please! Answer: SK thinks that the enrollment is a big deal, because not only does it prove that we can get the job done, BUT it starts a timer ticking. As each month goes by the pressure of 1st look-in, then 2nd look-in, is looming. This is the only time that Worsley spoke…he said that he is seeing the interest ramping up, and that as we get closer that he expects the pressure to make deals from potential suitors to pick up substantially. FWIW - I came to the meeting a bit pissed but hopeful. I walked out feeling that they have it handled and they have a plan. No i was not drinking the Kool-Aid, it was Passion Tea…seriously. I apologize for the long rambling post but I wanted to get everything in - for those that attended, PLEASE Feel free to add, change or edit as you see fit. I truly hope this in some ways will help! FU/239536[re: confidence level of mgt team?]: I would say they seemed very confident. SK really took control of the meeting this year...he was the clear leader. Last year CJ took more of the leader role presiding over the meeting. The room is Much better served with SK IMO.
By: JJ1223 10-16-15 4:37pm iHub #239382 http://investorshub.advfn.com/boards/read_msg.aspx?message_id=117782249 [re: results for BOD voting]: Paul Lytle went through every proposal and gave the total votes for/against and the number abstaining. After each proposal presented, he declared it approved by shareholders. Not sure how anyone could have heard anything else. FU239386[re: SK's remarks on Sunrise enrollment]: He said in today’s environment, it was normal for companies to not finish a trial on time...for many reasons. I spoke with him directly and he remains confident on Bavi completing enrollment by EOY. He also mentioned it would be important to the share price because it would signal that the clinical data would be forth coming within a defined period of time. All the people I spoke with had glowing comments about the working relationship with AstraZeneca. I had many good & positive conversations, but the most excited guy in the room seemed to be Steve Worsley. FU/239569[re: BTD option]: Garnick spoke only about BTD as it relates to speed-to-market, saying fast track gives Bavi the same advantages in terms of FDA meetings & priority review. SK did comment that if the opportunity presented, the company would make the application. FU/239746: The company continues to make great strides in the IO space. The collaborations, MSK in particular, will pay great dividends in the not to distant future. IMO, the company has navigated some rough waters successfully and has put shareholders in a solid position to win. Not perfect, but the BOD deserves credit here. The next several months will be interesting. I was told (in a sidebar at the ASM meeting) that the company compared Bavi data against 67 other IO agents currently approved or in test...none had reported data results as strong or with a response as positive as those reported with Bavituximab. I am sure those comparisons are documented and being shared with many BP's and other interested companies. FU/239791[re: maybe they said “6-to-7”?]: Very clearly 67, and the enthusiasm was very evident. FU/239951: At the ASM, I was told that Peregrine has 2 full time employees working on Ebola. I have no other details.
By: HorseLover45 11-3-15 7:56am iHub #241312 http://investorshub.advfn.com/boards/read_msg.aspx?message_id=118195423 Spoke to him [Rob Garnick] on Oct 15th at the meeting. Very positive about Bavi. Exact statement that he made to me was I am not here for the money have way more then I can ever spend. Of course, most of us know that but it was nice to personally hear it from him.
= = = = = = = = = = = = = = = = = = = = 10-15-15 PR(PPHM/AZN Collab. Expanded): “Preclinical data have demonstrated that combining the enhanced T-cell mediated anti-tumor activity of bavituximab with checkpoint inhibitors, like PD-L1 antibodies, prolong the ability of tumor-specific T-cells to continue attacking the tumor.”http://tinyurl.com/q79bkam
10-15-15/CEO S.King(ASM) 1:50: “Some of the most exciting data that we've seen to date is that, when you look at the immunotherapy revolution in the way cancer is being treated, what's really becoming clear is that the PD-1/PL-L1 inhibitors are very potent in patients who have an active immune response. So, what happens is, when you have an immune response, these markers, PD1/PD-L1, become expressed and basically shutdown the immune response. So, what those drugs are doing is basically stopping this inhibition that's caused by the PD-1/PD-L1 interaction. So, very simple – block the checkpoint and then now the immune system can keep mounting that immune response. But actually the majority of patients don't have that immune response going, and we really believe it's because they have this exposed PS which is knocking down that immune response from ever getting started. So what we see as a potential beautiful fit for bavituximab is, now we're able to block that PS signal, now the immune system gets started, and now we can keep it going with these PD-1/PD-L1 inhibitors. So, “get it started, and keep it going”, and now we believe, and we'll show this in data, that we can help more patients respond. Patients who are already responding are doing great, but it's the minority of patients, and now it's getting more & more patients to respond, and that's the whole goal of this combination therapy paradigm, which is really highlighted by today's announcement with AstraZeneca [10-15-15: http://tinyurl.com/q79bkam ] that we're expanding our collaboration into new areas to be able to look at those combinations.” 9:40: ”Now, immuno-oncology agents, as I mentioned earlier, are showing even by themselves very nice survival tails in a minority of patients, and this is typically 20-30% of patients who get such long-term benefits. So, the question is here, how do we make more & more patients able to enjoy that benefit of long-term survival, which means your body is really fighting the disease and helping the therapy, and when you look at our pre-clinical data, and obviously our goal next is to generate similar clinical data - when you at what happens when you're treating with an anti-PD-1 checkpoint inhibitor, you see some animals responding very well, but then you see these animals that just basically don't respond at all, or they have a very minimal response which then gives out over time. And this is exactly what you're seeing in patients, right? - the minority of patients are getting a long-term benefit, but most patients actually escaping treatment and relapsing. When you combine an anti-PD-1 with a bavituximab-equivalent for pre-clinical studies, what you see now is this wide variety of responses really begins to tighten up, so that most of these animals are now enjoying the benefit of a more-robust, combined anti-tumor effect caused by the immune system. Our goal thru our collaborations and with our clinical studies is to demonstrate this same effect in patients, so we're getting more & more patients with these long-term effects.” **10-15-15/ASM Webcast Replay: http://edge.media-server.com/m/p/jghjvabo
PPHM's Jeff Hutchins(VP/PreClinRes) speaking 1-25-16 at Immunotherapy World Conf. (WashDC). “750 deal-makers will gather to discuss the direction, future and value of cell, gene and immunotherapy portfolios.”
Jan25-27 2016: “Phacilitate's Immunotherapy World Conf.”, WashDC http://www.immunotherapyforum.com/Content/Conference “After years of posting impressive clinical results and pushing analyst projections to greater and greater heights, immuno-oncology has solidified its status as the most exciting development in cancer treatment for a long time. Now that checkpoint inhibitors have uncloaked cancer cells, drug developers are investigating dozens of immune drug cocktails (everything from CAR-T to antibodies, vaccines and other cellular therapies) to find well-tolerated treatments which could become the first-in-line to fight cancer in patients. We have all heard of the stunning breakthroughs at ASCO'15. BMS’ Opdivo + Yervoy study which lead to a 58% shrinkage of tumors and a PFS superiority of 8.6mos. against monotherapies in patients with melanoma. AstraZeneca’s own PD-L1 (MEDI4736/durvalumab)[see 10-15-15 AZN/PPHM Collab. Expansion: http://tinyurl.com/q79bkam ] and CTLA-4 (Tremelimumab) inhibitor combination, which demonstrated an ORR of 27% in the treatment of NSCLC… On Jan25-27 2016, 750 deal-makers will gather in the Grand Hyatt Hotel to discuss the direction, future and value of cell, gene and immunotherapy portfolios.” --------- Jan25(Day1): Focus Session1, “Cellular Cancer Immunotherapy: Optimizing Combination Therapy Development Strategy” 2:40-2:55pm: Chair's intro, David Lebwohl, NOVARTIS 2:55-3:10pm: Michael Hanna, VACCINOGEN, “The Provocative Issues of Tumor Heterogeneity on Active Specific Immunotherapy...” 3:10-3:25pm: Laura Benjamin, ELI LILLY, “Challenges/Opportunities for Translational Science to Guide Angiogenesis/Combos w/Immunotherapy” 3:25-3:40pm: Taylor Schreiber, HEAT BIOLOGICS, “Dual-Acting Immunotherapy with ComPACT - Vaccination & Co-Stimulation...” ------- 1-25-16 3:40-3:55pm: Jeff T. Hutchins (PEREGRINE'S VP/PreClinRes), “Combination Immunotherapies - Opening the Gate: Increasing Tumor Infiltrating Activated T-cells to Optimize and Expand the Benefits of Immune Checkpoint Therapies” * Analyzing complimentary mechanisms in therapeutics and building solid partnerships * Utilizing scientifically-driven data to build a product value story * Demonstrating how a product fits within a treatment in combination(s) and against competitive therapies ------- 3:55-4:20pm: Robert Preti, PCT(CALADRIUS), “What Does Commercialization Look Like?”
1-6-16: Peregrine enters Research Collab. with Natl-Comprehensive-Cancer-Network (NCCN), via a $2mm research grant to NCCN's Oncology Research Program (ORP). Will “significantly expand our clinical evaluation of bavituximab and augment Peregrine's internal IST program” at “26 of the world's leading cancer centers”.
1-6-16: Peregrine Pharmaceuticals and National Comprehensive Cancer Network (NCCN) Form Clinical Collaboration to Evaluate Novel Cancer Treatment Combinations With Bavituximab • NCCN Alliance Includes 26 Leading Cancer Centers and World-Class Thought Leaders on Innovative Cancer Combination Therapies http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=949024
TUSTIN, Jan. 6, 2016: Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) (NASDAQ:PPHMP), a biopharmaceutical company focused on developing therapeutics to stimulate the body's immune system to fight cancer, today announced a new research collaboration with the National Comprehensive Cancer Network (NCCN)[ http://www.nccn.org ] to expand the company's ongoing clinical research and development of bavituximab for the treatment of a range of tumors. NCCN, a not-for-profit alliance of 26 of the world's leading cancer centers devoted to patient care, research, and education, is dedicated to improving the quality, effectiveness, and efficiency of cancer care so that patients can live better lives. Peregrine will fund multiple investigator-initiated clinical and correlative studies with bavituximab in multiple cancers at NCCN Member Institutions and their affiliate community hospitals through a $2 million research grant to NCCN's Oncology Research Program (ORP). NCCN will be responsible for oversight and monitoring of the clinical studies through the research grant.
Bavituximab is an investigational immunotherapy designed to assist the body's immune system by targeting and modulating the activity of phosphatidylserine (PS), a highly immune-suppressive signaling molecule expressed broadly on the surface of cells in the tumor microenvironment. Peregrine's PS targeted inhibitor, bavituximab, is thought to reverse the immunosuppressive environment that many tumors establish in order to proliferate and spread, while also fighting cancer by activating immune cells that target and fight cancer. According to Peregrine, a broad set of preclinical and translational data has been assembled that supports the ability of bavituximab to improve the therapeutic activity of a range of cancer treatments, from traditional approaches, such as chemotherapy and radiation, to novel immuno-oncology agents such as checkpoint inhibitors.
"This collaboration with NCCN will allow us to significantly expand our clinical evaluation of bavituximab and augment Peregrine's internal investigator sponsored trial (IST) program," said Steven W. King, President and CEO of Peregrine. "Importantly, NCCN shares our strong research interest in evaluating unique bavituximab combination therapies for the treatment of cancer, and the group's oversight of the program will allow for the conducting of many more studies than would have been otherwise possible."
"NCCN is very pleased to collaborate with Peregrine Pharmaceuticals on their first-in-class novel targeted monoclonal antibody, bavituximab," said Robert C. Young, MD, Interim Vice President, ORP, NCCN. "We look forward to a productive interaction in both clinical and pre-clinical studies undertaken at the NCCN Member Institutions."
Peregrine expects results from this collaboration to further support the ongoing development of bavituximab as a key component of various combination cancer treatments. Bavituximab is currently being evaluated in combination with docetaxel (chemotherapy) for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) in the ongoing Phase III SUNRISE trial. In addition, as part of its recently formed collaboration with AstraZeneca, Peregrine expects to initiate a global Phase II study of bavituximab in combination with AstraZeneca's investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736), in patients with previously treated squamous or non-squamous NSCLC. The company will also be evaluating bavituximab with chemotherapy combinations in HER2-negative breast cancer.
About Bavituximab: A Targeted Investigational Immunotherapy Bavituximab is an investigational chimeric monoclonal antibody that targets phosphatidylserine (PS). Signals from PS inhibit the ability of immune cells to recognize and fight tumors. Bavituximab blocks PS, which is believed to remove this immunosuppressive signal and send an alternate immune activating signal. PS targeting antibodies have been shown to shift the functions of immune cells in tumors, resulting in robust anti-tumor immune responses.
About Peregrine Pharmaceuticals, Inc. Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a pipeline of novel drug candidates in clinical trials focused on the treatment of cancer. The company's lead immunotherapy candidate, bavituximab, is in Phase III development for the treatment of previously treated non-small cell lung cancer (the "SUNRISE trial") along with several ongoing and planned company-sponsored trials evaluating other treatment combinations and additional oncology indications. Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. ( http://www.avidbio.com ), which provides development and biomanufacturing services for both Peregrine and third-party customers. For more information, please visit http://www.peregrineinc.com .
About the National Comprehensive Cancer Network[ http://www.nccn.org ] The National Comprehensive Cancer Network (NCCN), a not-for-profit alliance of 26 of the nation's leading cancer centers devoted to patient care, research, and education, is dedicated to improving the quality, effectiveness, and efficiency of cancer care so that patients can live better lives. Through the leadership and expertise of clinical professionals at NCCN Member Institutions, NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. As the arbiter of high-quality cancer care, NCCN promotes the importance of continuous quality improvement and recognizes the significance of creating clinical practice guidelines appropriate for use by patients, clinicians, and other health care decision-makers.
The NCCN Member Institutions are: Fred & Pamela Buffett Cancer Center, Omaha, NE; Case Comprehensive Cancer Center/University Hospitals Seidman Cancer Center and Cleveland Clinic Taussig Cancer Institute, Cleveland, OH; City of Hope Comprehensive Cancer Center, Los Angeles, CA; Dana-Farber/Brigham and Women's Cancer Center | Massachusetts General Hospital Cancer Center, Boston, MA; Duke Cancer Institute, Durham, NC; Fox Chase Cancer Center, Philadelphia, PA; Huntsman Cancer Institute at the University of Utah, Salt Lake City, UT; Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance, Seattle, WA; The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL; Mayo Clinic Cancer Center, Phoenix/Scottsdale, AZ, Jacksonville, FL, and Rochester, MN; Memorial Sloan Kettering Cancer Center, New York, NY; Moffitt Cancer Center, Tampa, FL; The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute, Columbus, OH; Roswell Park Cancer Institute, Buffalo, NY; Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine, St. Louis, MO; St. Jude Children's Research Hospital/The University of Tennessee Health Science Center, Memphis, TN; Stanford Cancer Institute, Stanford, CA; University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, AL; UC San Diego Moores Cancer Center, La Jolla, CA; UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA; University of Colorado Cancer Center, Aurora, CO; University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; The University of Texas MD Anderson Cancer Center, Houston, TX; Vanderbilt-Ingram Cancer Center, Nashville, TN; and Yale Cancer Center/Smilow Cancer Hospital, New Haven, CT.
Clinicians, visit http://NCCN.org . Patients and caregivers, visit http://NCCN.org/patients . Safe Harbor *snip* • Jay Carlson Peregrine Pharmaceuticals, Inc. 800-987-8256 info@peregrineinc.com • Stephanie Diaz (Investors) Vida Strategic Partners 415-675-7401 sdiaz@vidasp.com • Tim Brons (Media) Vida Strategic Partners 415-675-7402 tbrons@vidasp.com
= = = = = = = = =NCCN's 1-6-16 PR: 1-6-16: NCCN Awarded $2 Million in Research Funding from Peregrine Pharmaceuticals to Study Bavituximab in Various Cancers • The NCCN Oncology Research Program (ORP) was awarded a $2-million grant from Peregrine Pharmaceuticals, Inc. to facilitate studies of bavituximab in various cancers. http://www.nccn.org/about/news/newsinfo.aspx?NewsID=565
FORT WASHINGTON, PA —The National Comprehensive Cancer Network (NCCN) Oncology Research Program (ORP) has been awarded a $2-million grant from Peregrine Pharmaceuticals, Inc. to study bavituximab, a first-in-class treatment approach for various cancers.
“NCCN is very pleased to collaborate with Peregrine Pharmaceuticals on their first-in-class novel targeted monoclonal antibody, bavituximab,” said Robert C. Young, MD, Interim Vice President, ORP, NCCN. “We look forward to a productive interaction in both clinical and pre-clinical studies undertaken at the NCCN Member Institutions.”
“This collaboration with NCCN will allow us to significantly expand our clinical evaluation of bavituximab and augment Peregrine’s internal investigator sponsored trial (IST) program,” said Steven W. King, President and CEO, Peregrine. “Importantly, NCCN shares our strong research interest in evaluating unique bavituximab combination therapies for the treatment of cancer, and the group’s oversight of the program will allow for the conducting of many more studies than would have been otherwise possible.”
Bavituximab is an investigational immunotherapy designed to assist the body's immune system by targeting and modulating the activity of phosphatidylserine (PS), a highly immune-suppressive signaling molecule expressed broadly on the surface of cells in the tumor microenvironment. Peregrine’s PS targeted inhibitor, bavituximab, is thought to reverse the immunosuppressive environment that many tumors establish in order to proliferate and spread, while also fighting cancer by activating immune cells that target and fight canceri. According to Peregrine, a broad set of pre-clinical and translational data has been assembled that supports the ability of bavituximab to improve the therapeutic activity of a range of cancer treatments, from traditional approaches, such as chemotherapy and radiation, to novel immuno-oncology agents such as checkpoint inhibitors.
The first phase of the program will involve the establishment of an NCCN Bavituximab Request for Proposals Development Team to evaluate existing data and to discuss and define the data and type of studies necessary to further characterize the safety and clinical effectiveness of bavituximab.
The NCCN ORP draws on the expertise of the investigators of the NCCN Member Institutions and NCCN Affiliate Research Consortium (ARC) to facilitate all phases of clinical research. This research is made possible by collaborations with pharmaceutical and biotechnology companies in order to advance therapeutic options for patients with cancer.
The NCCN ORP will utilize the grant from Peregrine Pharmaceuticals to support investigator-initiated clinical and correlative studies at NCCN Member Institutions and their affiliate community hospitals for bavituximab. To date, this successful research model has received approximately $58 million in research grants and supported more than 132 studies that have produced a number of publications in peer-reviewed journals.
To learn more about the NCCN ORP and ongoing clinical trials, visit http://NCCN.org/ORP . *end*
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