Monday, March 23, 2009 12:23:56 PM
Peregrine’s Public Statements on the Duke/Gates/NIH HIV Collab. (10/2005–3/2009). Updated with CFO Paul Lytle’s 3-18-09 comments at the Cowen Healthcare Conf. in Boston. (for linking into iBox).
= = = = = = = ALL PUBLIC COMMENTS ON THE DUKE-HIV COLLAB: = = = = = = = (Chronological)
10-24-05 ANNUAL SHM: http://tinyurl.com/c9bnq
SK: “Tulane & Duke are working on Bavituximab for the treatment of HIV” [The first mention of Duke & Bavituximab]
12-15-05 CFO P.LYTLE, N.Y. SEC. ANALYSTS BIODEFENSE CONF.: http://tinyurl.com/raxu5
PL: ”Regarding HIV, we know that we have positive binding to both HIV1 & HIV2. There are plans underway for important collaborations in HIV, and we expect announcements during 1H-2006.”
2-15-06 CEO S.KING, BIO-CEO INVESTORS CONF., NYC: http://tinyurl.com/a7842
SK: “We’re also studying the potential for HIV. We know we have pos. binding for HIV1, HIV2, SIV, and SHIV. We have active collab’s at Duke and Tulane…”
9-11-06 QTLY. CONF. CALL (KING/LYTLE): http://tinyurl.com/k7uo6
SK: “BAVI HIV INITIATIVE: HIV is currently our primary area of interest for potential new AV indications... We have already generated positive data supporting the fact that Bavi recognizes both HIV virus and HIV infected cells. In order to fully evaluate the potential of Bavi in HIV therapy, we have expanded our collaborations in the HIV area. Our curr. collaborators include investigators at Tulane National Primate Res. Center, Duke Univ., as well as contract research labs. Some of our collaborators at Duke recently received funding from The Gates Foundation for studies related to their HIV Vaccine Initiative. As part of these studies, we will be working with these researchers to assess phospholipids as a potential target for combating HIV. Because the program is being conducted by the researchers at Duke, we are not able to discuss the details at this time, but needless to say, we are very pleased to be involved in this collaboration, in increasing recognition that phospholipids may be an attractive target in HIV infection. We will provide an update on these studies as mutually agreed upon with our collaborators or at appropriate times for data generated internally, or at contract research institutions. It is important to remember that Univ. collaborators can be a very valuable asset to Peregrine, bringing us world-class expertise, access to cutting-edge researchers and facilities, and the potential for eventual support from key opinion leaders. At the same time, these researchers operate on their own timetables, and we have limited control concerning when the study results are completed and when they can be made public. These studies are proceeding and we will report on the results in due course.”
10-24-06 ANNUAL SHM, incl. Thorpe presentation on Bavi AC/AV: http://tinyurl.com/vmasl
SK: “On the pre-clinical front, we are continuing our collab’s for AV applications, with the primary focus on HIV. Approx. 40% of HCV patients are HIV-positive as well, obviously representing a large part of the market. Those studies are ongoing at Tulane & Duke, as well as at contract labs.”
3-12-07 QTLY. CONF. CALL (KING/LYTLE): http://tinyurl.com/2dtmca
SK: “Expanding the patient population we are treating to potentially include HCV/HIV co-infected individuals is a 3rd focus area… Our interest in this patient population has been further stimulated by solid evidence, thru our collab’s at Duke, that Bavi binds to HIV virus, binds to HIV-infected cells, and may have potent neutralizing effects on the virus. We plan to lay out our plans for each of these studies over the upcoming weeks as protocols are finalized and initiated.”
Q&A, R.Siracusa (Merrill Lynch): Earlier you had mentioned the progress that Duke University had made with regard to HIV. It was quite impressive, and I know that they have received Gates Foundation money for HIV trials. Do you anticipate that they would conduct clinical trials, or you, or both?
SK: ”One thing to keep in mind is the goal of the group at Duke is to develop vaccines for HIV. Our drug, again, one of the areas of focus they have is, they believe these phospholipids, phosphatidylserine [PS] in particular, may be a very promising target for vaccine development. So the funding that's coming out of there is actually funding a lot of studies that are being done with bavituximab as a model for them to develop later on - vaccines, which would clearly take quite a long time. So whether or not they would support clinical trials is somewhat questionable. Those would probably be trials we would run, and clearly, as we're able to initiate this coinfected patient population we'll start to get some glimpses of at least how our drug interacts with the HIV infection, in an HCV setting. And so, I think from our standpoint, we're just viewing this as a real net-positive. They've given us access to data that we otherwise would not have been able to generate. We clearly, and I know that everyone would love to see the data from the Duke collaboration out there, we're obviously as anxious as anyone. The collaboration is going extremely well, the data we're generating is really helping us in the way we think about our development of bavituximab for HCV & HIV, so it's been a real successful collaboration, and we do look forward to hopefully a little bit later this year getting that data out there and really showing the progress, but in the meantime they're a very conservative group. We're more than happy to comply with their wishes as far as data release, although we certainly do take every opportunity to prod along the release of data when we get a chance.”
7-11-07 QTLY. CONF. CALL (KING/LYTLE): http://tinyurl.com/2c9kwr
SK: “We have also been collaborating with researchers at Duke and other institutions to better understand the potential of Bavi in an HIV setting. Significant findings of these studies include data supporting Bavi binding to mult. strains of HIV and binding to HIV-infected cells… Our collab. with the researchers at Duke remains strong and continues to provide new insights into the potential of Bavi as well as other Anti-Phospholipid antibodies in HIV. We look fwd to reporting on the results of these studies at an appropriate time in the future.”
8-18-07: DR. ROLF BREKKEN (PPHM SRB), 27-PG PDF “BAVITUXIMAB: PRE-CLINICAL STUDIES”
...Collaborators include Duke’s Barton Haynes (CHAVI/CAVD) and Tony Moody (Dir., Bcell Immunology Lab)
http://tinyurl.com/2hc8zl
9-10-07 QTLY. CONF. CALL (KING/LYTLE): http://tinyurl.com/38lky9
SK: “Our collab. with HIV researchers at Duke remains strong and is making good progress. The collab. is providing exciting, new insights into the potential of Bavi, and other Anti-PS antibodies, in HIV – data which otherwise would be extremely difficult, if not impossible, to generate. We look fwd to reporting on these results at a time our collab’s feel appropriate.”
Q&A, M.Mundo (Ladenberg): At what point are you going to take over and start updating Wall Street and the shareholders to what's going on at Duke?
SK: ”The collaboration with Duke, as I mentioned, is a good collaboration, but I think you have to understand the nature of the collaboration. We are working with them. Our role in the studies is primarily to provide materials that are then being tested as part of their overall pgm to look at the potential of anti-PS antibodies, really for the dev. of vaccines for HIV. They are responsible for running all the studies, and aside from the cost of producing the materials, they cover all the costs of the ongoing animal studies as well as the other testing that is going on. So, while we are happy with the collaboration and are getting a lot of data from the studies they are doing, we do not necessarily have direct access to the day to day data that's being generated. It is really up to them to decide the appropriate point for updating the public. Clearly, they have an interest in this and they do have a certain amount of pressure on them as well to get the data out there. But, they're also aware that they have to be very cautious as they go out promising data in the HIV area. So, it's our intention to continue supporting the collaboration. We do believe the data will be coming out there. I wish we had a little more control over the outlay of that data, but at this point we are happy with the collaboration and I think we have to continue to support it.””
Q&A, R.Adams: 2 questions related to the CHAVI research pgm. 1st, is the work that Dr. Norm Letvin has been doing with Bavi in primates has completed and have you had a chance to become generally excited about that data or do you have any comments you could share with us about those results? And 2nd, could you tell us about some of the Powerpoint slides that doctors in the CHAVI pgm have published on the Internet? They show an Anti-PS antibody that’s had activity on microparticles and other aspects of their work. As far as you know, is it likely they are talking about Bavi in those slides?
SK: ”Yes, it is likely they are talking about Bavi in those slides. We are working with a group at Duke. In particular, we participated in a pgm that has been funded through the Gates Foundation [CAVD]. The CHAVI pgm is actually a separate pgm. They are both studying phospholipids as potential targets for the dev. of vaccines. So, in order to pursue that, they’ve been testing Bavi as well as a number of other Anti-PS antibodies that have the potential to model, if you will, model what you might be able to generate through a vaccination pgm. So as part of that, there are ongoing studies, non-human primate studies. There are add’l studies being planned. It’s a very large pgm that’s being run, again, simultaneously through these 2 different pgms – the CHAVI and then the Gates pgm [CAVD]. We are as anxious as anyone else to be able to get some of this info. out there. I know the guys at Duke will want to get it out there at the appropriate time. We are getting a lot of insight into, not just Bavi, but other antibodies that we have generated through our various collaborations. Over the long run, that’s going to be some extremely valuable info. that is only going to strengthen our overall antiviral pgm.”
12-10-07 QTLY. CONF. CALL (KING/LYTLE): http://tinyurl.com/393mau
SK: DUKE – “In addition to the clinical study, we are continuing a significant amount of preclinical work in the antiviral area. Our leading collaboration is with researchers at Duke University [Barton Haynes: http://tinyurl.com/5xwjk4] and a number of other institutions, including Harvard. This collaboration is progressing very nicely and we are highly encouraged by the results we have seen. As a reminder, we are exploring the potential of Bavituximab in several other anti-PS antibodies for their potential in the treatment and prevention of HIV infections. This collaboration is particularly important because without the collaboration we would not be able to conduct this informative research into the potential of our anti-PS platform for the treatment of HIV. Both we and our collaborators believe we are getting close to being able to share results of these studies either through publications or presentations in the upcoming months.”
2-12-08: CFO P.LYTLE, BIO-CEO CONF. (NYC) - Replay w/slides: http://tinyurl.com/387mqp
SLIDE4: SNAPSHOT OF ANTICIPATED NEAR TERM VALUE DRIVERS
• PRE-CLINICAL PUBLICATIONS
. . . Duke Univ. (anti-viral)
. . . UTSW-MC/Dallas (oncology & anti-viral)
PL(1:15): “…we have a number of anticipated upcoming publications covering our Anti-PS technology. For instance, at Duke University, we are working with top researchers in HIV to study our Anti-PS technology in the area of HIV, and we’re working with leading researchers in the HIV community. This research is partially being funded by The Gates Foundation, and I can tell you that these researchers are very excited about the progress they’ve seen to date.”
PL(24:20): “…On the Bavi AV front, we’re looking at a number of potential publications here, kind of outlining the whole Bavi pgm, the moa, and these should be coming from Duke University and UTSW. So, potentially some ground-breaking news on these two fronts.”
3-11-08 QTLY. CONF. CALL (KING/LYTLE): http://tinyurl.com/3zj74d
SK: “…we have also continued supporting HIV, influenza, and biodefense research pgms at Duke University, UTSW, and other supporting institutions. These research collaborations have expanded and are extremely active. We look forward to presenting data through peer-reviewed journal articles in the near future, that highlight the potential of our Anti-PS technology in these difficult to treat diseases. A real positive for these preclinical programs is that they have significant support from outside grants.”
PL (Q&A): “At BIO-CEO (2-12-08), I spoke about an AV publication coming from the Duke University Group and also from UTSW. So, we have number of those pubs. that we believe are upcoming, and they are moving thru the process and we’re optimistic that they will be issued. …it’s hard to determine the exact timing when those will be accepted, and how long it takes to get those journals & publications reviewed. We’re still optimistic that those publications will issue. It’s just the timing is a little uncertain right now, but they are forthcoming.”
7-14-08 QTLY. CONF. CALL (KING/LYTLE): http://tinyurl.com/6jnovb
SK: “In addition to initiating the DTRA contract, we have also continued our pre-clinical collaborations with Researchers at Duke and other institutions evolved in evaluating our Anti-PS platform for use in the possible prevention and treatment of HIV infections. While we had hoped to have data related to the collaboration publicly available by now, the delay has been caused by an expansion of the collaboration and the generation of addl. data that only makes the story potentially more interesting. There are currently more than 40 scientists and 9 institutions involved in the collaboration. While I cannot share more at this time, I look forward to being able to update you on these activities in the not so distant future.”
Question re: Duke/’addl. data’ timing…
SK: “I know the work is ongoing. Essentially, the work needed for the initial publication & presentations has pretty much been completed. There’s still a little bit of polish up work going, but again these delays are overall a real positive for the program because what we’re finding, I think, is even more exciting than what we originally had hoped going into the studies. And, in fact, our effort here internally has probably tripled over the course of the collaboration and the number of outside investigators working with us on the studies is also greatly increased. So, there is a lot of excitement around what we are doing here, what we are finding, and the potential applications of that knowledge base that we are gathering right now.”
…Followup: “Yes, some of [the addl. data] has [been gathered]. It’s obviously an ongoing process, so the more we learn, the more we get to do research, but as far as the initial publications and what have you, the data is essentially available now. There are publications that are in process and others that have been submitted, and so things are moving along very nicely.”
9-9-08 QTLY. CONF. CALL (KING/LYTLE): http://tinyurl.com/3p3s33
SK: “In particular, our collaboration with researchers at Duke and other institutions, testing our anti-PS antibodies, continues to yield valuable insights into the potential of this technology platform in HIV. And, I am happy to report that data from this collaboration will be highlighted this fall at the prestigious AIDS Vaccine 2008 Conference to be held in Cape Town, South Africa from Oct. 13-16. This will mark the first time that data from our collaboration has been presented and we are very pleased with the opportunity to share the information with the broader scientific community. These collaborations have allowed us to make considerable progress in understanding the potential of our anti-PS technology platform for the treatment and possible prevention of serious virus infections, and have only served to heighten our excitement over the antiviral potential of this platform.”
- - - - -
Q&A, R.Siracusa (Merrill Lynch): …the AIDS conference in Africa, is that going to be a comprehensive presentation of everything that Duke has being doing?
SK: “Ahhh - good question… It’s probably not a comprehensive, but it will be certainly laying out an awful lot of the story of what we’ve learned with the anti-PS platform technology. And, it’s what we think is great promise as potentially playing a role in treating or developing an AIDS vaccine. So, it’s going to be a lot of data. The bottom line is we’ve generated more data than we could possibly present in one simple presentation.”
RS: Who will be presenting it?
SK: “That will be presented by Bart Haynes. He is the head of the group there and obviously very well known in the HIV research area. So, there will be a lot of data presented there. But there’s a lot more coming. So, I would see really this being sort of the kick off, if you will, of a number of potential presentations & publications in this area for the program and our collaboration with Duke and the other institutions involved.”
RS: Okay. Could a scientific publication precede this conference?
SK: “It possibly could. And again, that’s – it’s a litter harder to predict. Once things are submitted, the review process, sometimes they sail through and sometimes they want you to make some adjustments to the manuscripts. But yes, I think there is a lot of – we’ve generated so much data, we probably have enough for quite a few future activities around it.”
[ Dr. Barton Haynes & Dr. Tony Moody, AIDSVaccine’08 (CapeTown),10-14-08: HATNES: ”The Search for New Broadly Neutralizing Antibodies & Methods of their Induction: Finding a Path to Successful HIV-1 Vaccine Dev.”, MOODY: “Anti-lipid Human Mabs Inhibit HIV-1 Infection of PBMC by Binding to Host Cells” http://tinyurl.com/47ltv9 ]
PR 10-13-08: PPHM’S ANTI-PS AT AIDS-VACCINE’08 (CAPETOWN): http://tinyurl.com/47ltv9
SK: "We are pleased that our anti-PS approaches are being discussed at this leading scientific meeting of AIDS vaccine researchers. We and our collaborators have been preparing and submitting publications to key scientific journals highlighting the role of phosphatidylserine as a potential target for viral disease prophylaxis and therapy in general, as well as the potential of our anti-PS antibodies in specific virus infections. We look forward to reporting on the results of these studies in more detail as the research articles are published."
10-30-08: CEO S.KING, BIO-INV. FORUM (SANFRAN) - Replay w/slides: http://tinyurl.com/5olr6q
SK: “We are looking at the evaluation of Anti-PS antibodies for the treatment of HIV, primarily thru work funded thru the Gates & NIH Foundations. This is a large collaboration in which the target, phosphotidylserine, or amino-phospholipids in general, are being looked at as a potential for the dev. of a vaccine, eventually. The key collaborator here is [Duke’s] Bart Haynes – he’s the head of the group; he’s a very well-known HIV researcher, and he is really the one who’s spearheading the potential of PS as a target, not only for the dev. of a vaccine, but also over the shorter term, for the dev. of therapeutics or preventatives that could be developed from existing agents, such as our antibodies. We recently presented the 1st data from our collaboration at the AIDS VACCINE 2008 meeting in Capetown a couple of weeks ago [ 10-14-08 http://tinyurl.com/47ltv9 ]. The key findings there, which I think are quite exciting from the entire HIV community standpoint, is the finding that certain classes of Anti-Phospholipid antibodies broadly neutralize HIV infection. And, in fact, the most potent antibodies were those that were provided by Peregrine. This is a very important finding, because it’s believed, in order to be effective against HIV, certainly at least from the prevention standpoint or the early truncation of infection, that virus neutralization is a key component of that, and obviously our antibodies have that potential. Commercial applications we will be pursuing include post-exposure prophylaxis, as well as the dev. of topical microbicides, which again could both be ideal companions for our technologies.”
Slide19 10-30-08: “Collaborators – Gates Grant / NIH”
==> [10-2008: Short profiles of ~40 Gates/NIH HIV collaborators: http://tinyurl.com/57tanp ]
Slide20 10-30-08: “Anti-PS Antibodies in HIV Infection – Consortium Recent Findings”
11-11-08: CEO S.KING, R&R HEALTHCARE CONF./NYC - Replay w/slides: http://tinyurl.com/5ahzwy
SK: “This [Gates/NIH Anti-PS vs. HIV] is a very large collab. The primary participants are at Duke Univ., under Bart Haynes, who heads up the group there, and who has really, I think, identified Phosphotidylserine as the potential lynchpin for the way in which HIV #1) actually evades the immune system early on in the course of the infection process, but also #2) as a potential target that could have some therapeutic, and even preventative applications. We recently presented data for the 1st time on this pgm. about 3 weeks ago at AIDS-Vaccine’08/Capetown [ 10-14-08 http://tinyurl.com/47ltv9 ]. The key findings from those studies were that certain classes of Anti-PS mabs broadly neutralize HIV infection – and this was across many different viral strains of HIV as well as thru infection of many different patient samples. And, in fact, the most potent antibodies to date have been provided by Peregrine as part of its Anti-PS pgm. We’re currently pursuing this with the idea that commercial applications could include post-exposure prophylaxis as well as a topical microbicide. And, of course, from our clinical trial in HCV-HIV co-infected patients, we’ll actually be able to look at the effects in a chronic HIV setting. So, we’re really excited about this – I know the group at Duke is excited. This was selected as one of the highlights of the conference at which it was presented.”
11-23-08 PR: DR.THORPE PUBLISHES BAVI-AV IN DEC.’08 NATURE-MED:
“Dr. Barton Haynes, director of Duke Univ.'s Human Vaccine Institute [DHVI] and the Center for HIV/AIDS Vaccine Immunology (CHAVI) is currently investigating PS as a potential target for preventing HIV infection. He [Haynes] commented, ‘Targeting a host cell lipid such as PS as an anti-viral strategy is an intriguing concept that may have relevance for new therapeutic and possibly prophylactic innovations in a number of virus infections.’”
12-10-08 QTLY. CONF. CALL (KING/LYTLE): http://tinyurl.com/5h26hx
SK: “In October, Duke Univ. researchers, presented, for the first time, data from our collaboration at the AIDS Vaccine’08 Conference [ http://tinyurl.com/47ltv9 ]. As a reminder, the collaboration is primarily funded by the NIH and The Gates Foundation to evaluate the potential of Anti-PS antibodies in preventing or controlling HIV infection. The data presented at the conference highlighted the potential of Anti-PS antibodies to broadly neutralize HIV infection, with antibodies provided by Peregrine being the most active in the testing. This data opens the door to a number of potential commercial applications including post-exposure prophylaxis and topical microbicides… Combined with the data we are generating from the ongoing clinical study of Bavituximab in patients chronically co-infected with HCV+HIV, we have considerable opportunities to learn more about the Anti-PS technology platform and the prevention & treatment of HIV. We look forward to updating you over the next few months on addl. advancements in these studies, and as we move forward we do anticipate the potential for a number of high profile publications coming out of this research.”
3-18-09: CFO PAUL LYTLE, COWEN & CO. HEALTHCARE CONF., BOSTON
http://www.corporate-ir.net/ireye/confLobby.zhtml?ticker=PPHM&item_id=2111135
PL: “Also, we have significant outside research funding in the area of HIV, under multi-mm$ university grants thru the Gates Foundation and the NIH, and these groups are focused on our anti-phospholipid antibodies… We are working with the top leaders in HIV research right now. And these researchers are well-funded, under both the BMGF & NIH. In fact, Dr. Barton Haynes is the P.I. on the CHAVI grant, which is a $300mm grant over 7 years. These researchers are highly focused on anti-phospholipid antibodies, and exactly the antibodies that we have provided them. Recent findings from this consortium were presented at the AIDS-VACCINE’08 Conf. late last year [ 10-14-08: http://tinyurl.com/7dnmpe ]. There’s been a whole shift after the Merck vaccine failure, and now they’re focusing on neutralizing antibodies as the new way to develop a vaccine. They also presented that certain classes of phospholipid antibodies broadly neutralize HIV virus infection in potentially multiple HIV strains. In addition, the most potent mabs presented at this meeting were provided by Peregrine. Our presentation was actually one of the highlights of the entire conference last year. We also have learned that there are nearer-term commercial applications that could include post-exposure treatment and topical microbicides. We are expecting a high-profile publication, which is currently in process thru Duke Univ., to be presented within the 1st half of 2009.”
Slide30:
Slide31:
= = = = = = = = = =
The War on HIV…
GLOBAL HIV VACCINE ENTERPRISE http://www.hivvaccineenterprise.org
Comprised of 2 “implementation projects”:
1. CHAVI - Center for HIV/AIDS Vaccine Immunology http://www.chavi.org
. . . . . . $300mm over 7 years from NIAID to CHAVI (Dir=B.Haynes).
2. CAVD - Collaboration for AIDS Vaccine Discovery http://www.cavd.org
. . . . . . $287mm over 5 years from BMGF to CAVD ($15mm to B.Haynes).
Dr. Barton Haynes, Immunologist
Duke Univ., Dept. of Medicine
Director, CHAVI http://www.chavi.org
Director, Duke Human Vaccine Institute (DHVI) http://humanvaccine.duke.edu
Interests: Human immunity, Tcell function, HIV/AIDS vaccines
Profile: http://humanvaccine.duke.edu/modules/haynes/index.php?id=1
HAYNES VDC MISSION & GOALS WEBPAGE:
http://humanvaccine.duke.edu/modules/haynes_vdc/index.php?id=2
= = = = = = = = = =
THE DUKE/HAYNES/CAVD/GATES/NIH HIV COLLABORATION:
Duke's B.Haynes DHVI website & CAVD-Reports outline Thorpe’s Role in the CAVD-Gates HIV-Vaccine Initiative: http://tinyurl.com/5xwjk4
…”Philip Thorpe is determining the role of lipid binding of anti-HIV antibodies and anti-phosphatidylserine (PS) autoantibodies to protection from HIV infection.”
…2005-May2009: All Peregrine Public Statements on the Duke HIV Collab: http://tinyurl.com/c4fv9v
…10-2008: Short profiles of ~40 Gates/NIH HIV collaborators: http://tinyurl.com/57tanp
...3-18-09: CFO Paul Lytle on the Duke-HIV Collab. at the Cowen Healthcare Conf: http://tinyurl.com/cal9br
...“We are expecting a high-profile publication, which is currently in process thru Duke Univ., to be presented within the 1st half of 2009.”
...3-17-09 CAVD 2006-2008 Recap Report – (57-pg PDF): http://tinyurl.com/d2jpm9
...““researchers in the Haynes VDC have discovered that anti-lipid antibodies in fact may play a role in HIV-1 protection. They found that anti-lipid antibodies produced in autoimmune disease have the capacity to broadly inhibit the infection of peripheral blood mononuclear cells by virtually all CCR5-dependent HIV-1 primary isolates. They are working now to translate this finding into a novel strategy of HIV-1 vaccine development.”
...10-30-08: CEO S.KING, BIO-INV. Forum (SanFran) - replay w/slides: http://tinyurl.com/664mgd
...SK on Duke/Gates/NIH HIV collab: “At AIDS-VACCINE’08, a key finding was that certain classes of Anti-Phospholipid antibodies broadly neutralize HIV infection. And, in fact, the most potent antibodies were those that were provided by Peregrine. This is a very important finding…”
...10-14-08: “The AIDS Vaccine 2008 Conference”, CapeTown, So.Africa http://tinyurl.com/7dnmpe
......Duke’s B.Haynes & T.Moody present Anti-PS data for 1st time publicly: “The most potent mAb, PGN632 [11.31], inhibited 7/7 B & C clade HIV-1 isolates & SHIV SP162P3... Studies showed the mAbs acted at host cell surfaces to inhibit HIV-1 infection."
…..Dr. Ralph Pantophlet’s summary of T.Moody’s Talk, incl. two PGN632=11.31 test data graphs: http://tinyurl.com/7w4udz.
......SK: "This data opens the door to a # of potential commercial app's incl. post-exposure prophylaxis & topical microbicides” http://tinyurl.com/cxv2st
.....1-24-09: Mojo’s Comparison Graphs of Bavi vs. 11.31(PGN632) against HIV (in-vitro): http://tinyurl.com/dkmrdp
......1-6-09: NIAID reviews CapeTown AIDS’08, commenting on the Tony Moody Anti-Lipids/PGN632 talk: http://tinyurl.com/7dnmpe
......1-15-09: JBM’s 'AIDS-Vaccine’08/Capetown Wrapup' (Anti-PS Blog): http://tinyurl.com/8cmmcs
......2-23-09 Duke article about 2F5, a ‘Rare, Potent Antibody to HIV-1’ – comp. vs. PGN632: http://tinyurl.com/aozpd2
…9-22-08: Haynes CAVD Update: ”The team has recently found that non-pathogenic anti-lipid antibodies that do not require B2GPI for lipid binding do prevent HIV-1 & SHIV-SF162P3 (and all R5 HIVs tested) from infecting PBMC in vitro..." http://tinyurl.com/3g6vbm
…2-12-08: CFO P.Lytle, BIO-CEO/INV.CONF(NYC), Replay w/slides: http://tinyurl.com/2xpzth
......PL: “On the Bavi/AV front, we’re looking at a # of potential pubs here… these s/b coming from Duke Univ. & UTSW - potentially some ground-breaking news on these 2 fronts.”
…12-2007: UCLA’s Dr. Pojen Chen (active in CHAVI/Duke HIV studies) joins PPHM’s SRB: http://tinyurl.com/2nxcm2
...7-2007: PPHM licenses "certain Anti-PS Antibodies" from UCLA - the Dr. Pojen Chen connection? http://tinyurl.com/5t8jvm
…4-24-07: GATES-FOUND. rep's lecture at U-WASH lists P.Thorpe on CAVD grants map: http://tinyurl.com/3t67gj
...3-2007: Duke’s D.Montefiori Europrise-HIV Assay paper refs. “BAVITUX” & “3G4RHD” http://tinyurl.com/448d8k
…1-27-07: Dr. Haynes (Chavi Dir.) report - pg.31 shows slide “Labeling of Microparticles by Anti-PS Antibodies”: http://tinyurl.com/289a5g
......JBM’s interesting & educational blog on Anti-PS science, esp. HIV: http://anti-ps.blogspot.com
...Haynes-BF pubs: http://tinyurl.com/3nspyw ...Moody-MA pubs: http://tinyurl.com/5yeh2e
...Duke Health News: http://www.dukehealth.org/HealthLibrary/News ...CAVD(Gates) Annual repts: http://tinyurl.com/47uhtu
= = = = = = = ALL PUBLIC COMMENTS ON THE DUKE-HIV COLLAB: = = = = = = = (Chronological)
10-24-05 ANNUAL SHM: http://tinyurl.com/c9bnq
SK: “Tulane & Duke are working on Bavituximab for the treatment of HIV” [The first mention of Duke & Bavituximab]
12-15-05 CFO P.LYTLE, N.Y. SEC. ANALYSTS BIODEFENSE CONF.: http://tinyurl.com/raxu5
PL: ”Regarding HIV, we know that we have positive binding to both HIV1 & HIV2. There are plans underway for important collaborations in HIV, and we expect announcements during 1H-2006.”
2-15-06 CEO S.KING, BIO-CEO INVESTORS CONF., NYC: http://tinyurl.com/a7842
SK: “We’re also studying the potential for HIV. We know we have pos. binding for HIV1, HIV2, SIV, and SHIV. We have active collab’s at Duke and Tulane…”
9-11-06 QTLY. CONF. CALL (KING/LYTLE): http://tinyurl.com/k7uo6
SK: “BAVI HIV INITIATIVE: HIV is currently our primary area of interest for potential new AV indications... We have already generated positive data supporting the fact that Bavi recognizes both HIV virus and HIV infected cells. In order to fully evaluate the potential of Bavi in HIV therapy, we have expanded our collaborations in the HIV area. Our curr. collaborators include investigators at Tulane National Primate Res. Center, Duke Univ., as well as contract research labs. Some of our collaborators at Duke recently received funding from The Gates Foundation for studies related to their HIV Vaccine Initiative. As part of these studies, we will be working with these researchers to assess phospholipids as a potential target for combating HIV. Because the program is being conducted by the researchers at Duke, we are not able to discuss the details at this time, but needless to say, we are very pleased to be involved in this collaboration, in increasing recognition that phospholipids may be an attractive target in HIV infection. We will provide an update on these studies as mutually agreed upon with our collaborators or at appropriate times for data generated internally, or at contract research institutions. It is important to remember that Univ. collaborators can be a very valuable asset to Peregrine, bringing us world-class expertise, access to cutting-edge researchers and facilities, and the potential for eventual support from key opinion leaders. At the same time, these researchers operate on their own timetables, and we have limited control concerning when the study results are completed and when they can be made public. These studies are proceeding and we will report on the results in due course.”
10-24-06 ANNUAL SHM, incl. Thorpe presentation on Bavi AC/AV: http://tinyurl.com/vmasl
SK: “On the pre-clinical front, we are continuing our collab’s for AV applications, with the primary focus on HIV. Approx. 40% of HCV patients are HIV-positive as well, obviously representing a large part of the market. Those studies are ongoing at Tulane & Duke, as well as at contract labs.”
3-12-07 QTLY. CONF. CALL (KING/LYTLE): http://tinyurl.com/2dtmca
SK: “Expanding the patient population we are treating to potentially include HCV/HIV co-infected individuals is a 3rd focus area… Our interest in this patient population has been further stimulated by solid evidence, thru our collab’s at Duke, that Bavi binds to HIV virus, binds to HIV-infected cells, and may have potent neutralizing effects on the virus. We plan to lay out our plans for each of these studies over the upcoming weeks as protocols are finalized and initiated.”
Q&A, R.Siracusa (Merrill Lynch): Earlier you had mentioned the progress that Duke University had made with regard to HIV. It was quite impressive, and I know that they have received Gates Foundation money for HIV trials. Do you anticipate that they would conduct clinical trials, or you, or both?
SK: ”One thing to keep in mind is the goal of the group at Duke is to develop vaccines for HIV. Our drug, again, one of the areas of focus they have is, they believe these phospholipids, phosphatidylserine [PS] in particular, may be a very promising target for vaccine development. So the funding that's coming out of there is actually funding a lot of studies that are being done with bavituximab as a model for them to develop later on - vaccines, which would clearly take quite a long time. So whether or not they would support clinical trials is somewhat questionable. Those would probably be trials we would run, and clearly, as we're able to initiate this coinfected patient population we'll start to get some glimpses of at least how our drug interacts with the HIV infection, in an HCV setting. And so, I think from our standpoint, we're just viewing this as a real net-positive. They've given us access to data that we otherwise would not have been able to generate. We clearly, and I know that everyone would love to see the data from the Duke collaboration out there, we're obviously as anxious as anyone. The collaboration is going extremely well, the data we're generating is really helping us in the way we think about our development of bavituximab for HCV & HIV, so it's been a real successful collaboration, and we do look forward to hopefully a little bit later this year getting that data out there and really showing the progress, but in the meantime they're a very conservative group. We're more than happy to comply with their wishes as far as data release, although we certainly do take every opportunity to prod along the release of data when we get a chance.”
7-11-07 QTLY. CONF. CALL (KING/LYTLE): http://tinyurl.com/2c9kwr
SK: “We have also been collaborating with researchers at Duke and other institutions to better understand the potential of Bavi in an HIV setting. Significant findings of these studies include data supporting Bavi binding to mult. strains of HIV and binding to HIV-infected cells… Our collab. with the researchers at Duke remains strong and continues to provide new insights into the potential of Bavi as well as other Anti-Phospholipid antibodies in HIV. We look fwd to reporting on the results of these studies at an appropriate time in the future.”
8-18-07: DR. ROLF BREKKEN (PPHM SRB), 27-PG PDF “BAVITUXIMAB: PRE-CLINICAL STUDIES”
...Collaborators include Duke’s Barton Haynes (CHAVI/CAVD) and Tony Moody (Dir., Bcell Immunology Lab)
http://tinyurl.com/2hc8zl
9-10-07 QTLY. CONF. CALL (KING/LYTLE): http://tinyurl.com/38lky9
SK: “Our collab. with HIV researchers at Duke remains strong and is making good progress. The collab. is providing exciting, new insights into the potential of Bavi, and other Anti-PS antibodies, in HIV – data which otherwise would be extremely difficult, if not impossible, to generate. We look fwd to reporting on these results at a time our collab’s feel appropriate.”
Q&A, M.Mundo (Ladenberg): At what point are you going to take over and start updating Wall Street and the shareholders to what's going on at Duke?
SK: ”The collaboration with Duke, as I mentioned, is a good collaboration, but I think you have to understand the nature of the collaboration. We are working with them. Our role in the studies is primarily to provide materials that are then being tested as part of their overall pgm to look at the potential of anti-PS antibodies, really for the dev. of vaccines for HIV. They are responsible for running all the studies, and aside from the cost of producing the materials, they cover all the costs of the ongoing animal studies as well as the other testing that is going on. So, while we are happy with the collaboration and are getting a lot of data from the studies they are doing, we do not necessarily have direct access to the day to day data that's being generated. It is really up to them to decide the appropriate point for updating the public. Clearly, they have an interest in this and they do have a certain amount of pressure on them as well to get the data out there. But, they're also aware that they have to be very cautious as they go out promising data in the HIV area. So, it's our intention to continue supporting the collaboration. We do believe the data will be coming out there. I wish we had a little more control over the outlay of that data, but at this point we are happy with the collaboration and I think we have to continue to support it.””
Q&A, R.Adams: 2 questions related to the CHAVI research pgm. 1st, is the work that Dr. Norm Letvin has been doing with Bavi in primates has completed and have you had a chance to become generally excited about that data or do you have any comments you could share with us about those results? And 2nd, could you tell us about some of the Powerpoint slides that doctors in the CHAVI pgm have published on the Internet? They show an Anti-PS antibody that’s had activity on microparticles and other aspects of their work. As far as you know, is it likely they are talking about Bavi in those slides?
SK: ”Yes, it is likely they are talking about Bavi in those slides. We are working with a group at Duke. In particular, we participated in a pgm that has been funded through the Gates Foundation [CAVD]. The CHAVI pgm is actually a separate pgm. They are both studying phospholipids as potential targets for the dev. of vaccines. So, in order to pursue that, they’ve been testing Bavi as well as a number of other Anti-PS antibodies that have the potential to model, if you will, model what you might be able to generate through a vaccination pgm. So as part of that, there are ongoing studies, non-human primate studies. There are add’l studies being planned. It’s a very large pgm that’s being run, again, simultaneously through these 2 different pgms – the CHAVI and then the Gates pgm [CAVD]. We are as anxious as anyone else to be able to get some of this info. out there. I know the guys at Duke will want to get it out there at the appropriate time. We are getting a lot of insight into, not just Bavi, but other antibodies that we have generated through our various collaborations. Over the long run, that’s going to be some extremely valuable info. that is only going to strengthen our overall antiviral pgm.”
12-10-07 QTLY. CONF. CALL (KING/LYTLE): http://tinyurl.com/393mau
SK: DUKE – “In addition to the clinical study, we are continuing a significant amount of preclinical work in the antiviral area. Our leading collaboration is with researchers at Duke University [Barton Haynes: http://tinyurl.com/5xwjk4] and a number of other institutions, including Harvard. This collaboration is progressing very nicely and we are highly encouraged by the results we have seen. As a reminder, we are exploring the potential of Bavituximab in several other anti-PS antibodies for their potential in the treatment and prevention of HIV infections. This collaboration is particularly important because without the collaboration we would not be able to conduct this informative research into the potential of our anti-PS platform for the treatment of HIV. Both we and our collaborators believe we are getting close to being able to share results of these studies either through publications or presentations in the upcoming months.”
2-12-08: CFO P.LYTLE, BIO-CEO CONF. (NYC) - Replay w/slides: http://tinyurl.com/387mqp
SLIDE4: SNAPSHOT OF ANTICIPATED NEAR TERM VALUE DRIVERS
• PRE-CLINICAL PUBLICATIONS
. . . Duke Univ. (anti-viral)
. . . UTSW-MC/Dallas (oncology & anti-viral)
PL(1:15): “…we have a number of anticipated upcoming publications covering our Anti-PS technology. For instance, at Duke University, we are working with top researchers in HIV to study our Anti-PS technology in the area of HIV, and we’re working with leading researchers in the HIV community. This research is partially being funded by The Gates Foundation, and I can tell you that these researchers are very excited about the progress they’ve seen to date.”
PL(24:20): “…On the Bavi AV front, we’re looking at a number of potential publications here, kind of outlining the whole Bavi pgm, the moa, and these should be coming from Duke University and UTSW. So, potentially some ground-breaking news on these two fronts.”
3-11-08 QTLY. CONF. CALL (KING/LYTLE): http://tinyurl.com/3zj74d
SK: “…we have also continued supporting HIV, influenza, and biodefense research pgms at Duke University, UTSW, and other supporting institutions. These research collaborations have expanded and are extremely active. We look forward to presenting data through peer-reviewed journal articles in the near future, that highlight the potential of our Anti-PS technology in these difficult to treat diseases. A real positive for these preclinical programs is that they have significant support from outside grants.”
PL (Q&A): “At BIO-CEO (2-12-08), I spoke about an AV publication coming from the Duke University Group and also from UTSW. So, we have number of those pubs. that we believe are upcoming, and they are moving thru the process and we’re optimistic that they will be issued. …it’s hard to determine the exact timing when those will be accepted, and how long it takes to get those journals & publications reviewed. We’re still optimistic that those publications will issue. It’s just the timing is a little uncertain right now, but they are forthcoming.”
7-14-08 QTLY. CONF. CALL (KING/LYTLE): http://tinyurl.com/6jnovb
SK: “In addition to initiating the DTRA contract, we have also continued our pre-clinical collaborations with Researchers at Duke and other institutions evolved in evaluating our Anti-PS platform for use in the possible prevention and treatment of HIV infections. While we had hoped to have data related to the collaboration publicly available by now, the delay has been caused by an expansion of the collaboration and the generation of addl. data that only makes the story potentially more interesting. There are currently more than 40 scientists and 9 institutions involved in the collaboration. While I cannot share more at this time, I look forward to being able to update you on these activities in the not so distant future.”
Question re: Duke/’addl. data’ timing…
SK: “I know the work is ongoing. Essentially, the work needed for the initial publication & presentations has pretty much been completed. There’s still a little bit of polish up work going, but again these delays are overall a real positive for the program because what we’re finding, I think, is even more exciting than what we originally had hoped going into the studies. And, in fact, our effort here internally has probably tripled over the course of the collaboration and the number of outside investigators working with us on the studies is also greatly increased. So, there is a lot of excitement around what we are doing here, what we are finding, and the potential applications of that knowledge base that we are gathering right now.”
…Followup: “Yes, some of [the addl. data] has [been gathered]. It’s obviously an ongoing process, so the more we learn, the more we get to do research, but as far as the initial publications and what have you, the data is essentially available now. There are publications that are in process and others that have been submitted, and so things are moving along very nicely.”
9-9-08 QTLY. CONF. CALL (KING/LYTLE): http://tinyurl.com/3p3s33
SK: “In particular, our collaboration with researchers at Duke and other institutions, testing our anti-PS antibodies, continues to yield valuable insights into the potential of this technology platform in HIV. And, I am happy to report that data from this collaboration will be highlighted this fall at the prestigious AIDS Vaccine 2008 Conference to be held in Cape Town, South Africa from Oct. 13-16. This will mark the first time that data from our collaboration has been presented and we are very pleased with the opportunity to share the information with the broader scientific community. These collaborations have allowed us to make considerable progress in understanding the potential of our anti-PS technology platform for the treatment and possible prevention of serious virus infections, and have only served to heighten our excitement over the antiviral potential of this platform.”
- - - - -
Q&A, R.Siracusa (Merrill Lynch): …the AIDS conference in Africa, is that going to be a comprehensive presentation of everything that Duke has being doing?
SK: “Ahhh - good question… It’s probably not a comprehensive, but it will be certainly laying out an awful lot of the story of what we’ve learned with the anti-PS platform technology. And, it’s what we think is great promise as potentially playing a role in treating or developing an AIDS vaccine. So, it’s going to be a lot of data. The bottom line is we’ve generated more data than we could possibly present in one simple presentation.”
RS: Who will be presenting it?
SK: “That will be presented by Bart Haynes. He is the head of the group there and obviously very well known in the HIV research area. So, there will be a lot of data presented there. But there’s a lot more coming. So, I would see really this being sort of the kick off, if you will, of a number of potential presentations & publications in this area for the program and our collaboration with Duke and the other institutions involved.”
RS: Okay. Could a scientific publication precede this conference?
SK: “It possibly could. And again, that’s – it’s a litter harder to predict. Once things are submitted, the review process, sometimes they sail through and sometimes they want you to make some adjustments to the manuscripts. But yes, I think there is a lot of – we’ve generated so much data, we probably have enough for quite a few future activities around it.”
[ Dr. Barton Haynes & Dr. Tony Moody, AIDSVaccine’08 (CapeTown),10-14-08: HATNES: ”The Search for New Broadly Neutralizing Antibodies & Methods of their Induction: Finding a Path to Successful HIV-1 Vaccine Dev.”, MOODY: “Anti-lipid Human Mabs Inhibit HIV-1 Infection of PBMC by Binding to Host Cells” http://tinyurl.com/47ltv9 ]
PR 10-13-08: PPHM’S ANTI-PS AT AIDS-VACCINE’08 (CAPETOWN): http://tinyurl.com/47ltv9
SK: "We are pleased that our anti-PS approaches are being discussed at this leading scientific meeting of AIDS vaccine researchers. We and our collaborators have been preparing and submitting publications to key scientific journals highlighting the role of phosphatidylserine as a potential target for viral disease prophylaxis and therapy in general, as well as the potential of our anti-PS antibodies in specific virus infections. We look forward to reporting on the results of these studies in more detail as the research articles are published."
10-30-08: CEO S.KING, BIO-INV. FORUM (SANFRAN) - Replay w/slides: http://tinyurl.com/5olr6q
SK: “We are looking at the evaluation of Anti-PS antibodies for the treatment of HIV, primarily thru work funded thru the Gates & NIH Foundations. This is a large collaboration in which the target, phosphotidylserine, or amino-phospholipids in general, are being looked at as a potential for the dev. of a vaccine, eventually. The key collaborator here is [Duke’s] Bart Haynes – he’s the head of the group; he’s a very well-known HIV researcher, and he is really the one who’s spearheading the potential of PS as a target, not only for the dev. of a vaccine, but also over the shorter term, for the dev. of therapeutics or preventatives that could be developed from existing agents, such as our antibodies. We recently presented the 1st data from our collaboration at the AIDS VACCINE 2008 meeting in Capetown a couple of weeks ago [ 10-14-08 http://tinyurl.com/47ltv9 ]. The key findings there, which I think are quite exciting from the entire HIV community standpoint, is the finding that certain classes of Anti-Phospholipid antibodies broadly neutralize HIV infection. And, in fact, the most potent antibodies were those that were provided by Peregrine. This is a very important finding, because it’s believed, in order to be effective against HIV, certainly at least from the prevention standpoint or the early truncation of infection, that virus neutralization is a key component of that, and obviously our antibodies have that potential. Commercial applications we will be pursuing include post-exposure prophylaxis, as well as the dev. of topical microbicides, which again could both be ideal companions for our technologies.”
Slide19 10-30-08: “Collaborators – Gates Grant / NIH”
==> [10-2008: Short profiles of ~40 Gates/NIH HIV collaborators: http://tinyurl.com/57tanp ]
Slide20 10-30-08: “Anti-PS Antibodies in HIV Infection – Consortium Recent Findings”
11-11-08: CEO S.KING, R&R HEALTHCARE CONF./NYC - Replay w/slides: http://tinyurl.com/5ahzwy
SK: “This [Gates/NIH Anti-PS vs. HIV] is a very large collab. The primary participants are at Duke Univ., under Bart Haynes, who heads up the group there, and who has really, I think, identified Phosphotidylserine as the potential lynchpin for the way in which HIV #1) actually evades the immune system early on in the course of the infection process, but also #2) as a potential target that could have some therapeutic, and even preventative applications. We recently presented data for the 1st time on this pgm. about 3 weeks ago at AIDS-Vaccine’08/Capetown [ 10-14-08 http://tinyurl.com/47ltv9 ]. The key findings from those studies were that certain classes of Anti-PS mabs broadly neutralize HIV infection – and this was across many different viral strains of HIV as well as thru infection of many different patient samples. And, in fact, the most potent antibodies to date have been provided by Peregrine as part of its Anti-PS pgm. We’re currently pursuing this with the idea that commercial applications could include post-exposure prophylaxis as well as a topical microbicide. And, of course, from our clinical trial in HCV-HIV co-infected patients, we’ll actually be able to look at the effects in a chronic HIV setting. So, we’re really excited about this – I know the group at Duke is excited. This was selected as one of the highlights of the conference at which it was presented.”
11-23-08 PR: DR.THORPE PUBLISHES BAVI-AV IN DEC.’08 NATURE-MED:
“Dr. Barton Haynes, director of Duke Univ.'s Human Vaccine Institute [DHVI] and the Center for HIV/AIDS Vaccine Immunology (CHAVI) is currently investigating PS as a potential target for preventing HIV infection. He [Haynes] commented, ‘Targeting a host cell lipid such as PS as an anti-viral strategy is an intriguing concept that may have relevance for new therapeutic and possibly prophylactic innovations in a number of virus infections.’”
12-10-08 QTLY. CONF. CALL (KING/LYTLE): http://tinyurl.com/5h26hx
SK: “In October, Duke Univ. researchers, presented, for the first time, data from our collaboration at the AIDS Vaccine’08 Conference [ http://tinyurl.com/47ltv9 ]. As a reminder, the collaboration is primarily funded by the NIH and The Gates Foundation to evaluate the potential of Anti-PS antibodies in preventing or controlling HIV infection. The data presented at the conference highlighted the potential of Anti-PS antibodies to broadly neutralize HIV infection, with antibodies provided by Peregrine being the most active in the testing. This data opens the door to a number of potential commercial applications including post-exposure prophylaxis and topical microbicides… Combined with the data we are generating from the ongoing clinical study of Bavituximab in patients chronically co-infected with HCV+HIV, we have considerable opportunities to learn more about the Anti-PS technology platform and the prevention & treatment of HIV. We look forward to updating you over the next few months on addl. advancements in these studies, and as we move forward we do anticipate the potential for a number of high profile publications coming out of this research.”
3-18-09: CFO PAUL LYTLE, COWEN & CO. HEALTHCARE CONF., BOSTON
http://www.corporate-ir.net/ireye/confLobby.zhtml?ticker=PPHM&item_id=2111135
PL: “Also, we have significant outside research funding in the area of HIV, under multi-mm$ university grants thru the Gates Foundation and the NIH, and these groups are focused on our anti-phospholipid antibodies… We are working with the top leaders in HIV research right now. And these researchers are well-funded, under both the BMGF & NIH. In fact, Dr. Barton Haynes is the P.I. on the CHAVI grant, which is a $300mm grant over 7 years. These researchers are highly focused on anti-phospholipid antibodies, and exactly the antibodies that we have provided them. Recent findings from this consortium were presented at the AIDS-VACCINE’08 Conf. late last year [ 10-14-08: http://tinyurl.com/7dnmpe ]. There’s been a whole shift after the Merck vaccine failure, and now they’re focusing on neutralizing antibodies as the new way to develop a vaccine. They also presented that certain classes of phospholipid antibodies broadly neutralize HIV virus infection in potentially multiple HIV strains. In addition, the most potent mabs presented at this meeting were provided by Peregrine. Our presentation was actually one of the highlights of the entire conference last year. We also have learned that there are nearer-term commercial applications that could include post-exposure treatment and topical microbicides. We are expecting a high-profile publication, which is currently in process thru Duke Univ., to be presented within the 1st half of 2009.”
Slide30:
Slide31:
= = = = = = = = = =
The War on HIV…
GLOBAL HIV VACCINE ENTERPRISE http://www.hivvaccineenterprise.org
Comprised of 2 “implementation projects”:
1. CHAVI - Center for HIV/AIDS Vaccine Immunology http://www.chavi.org
. . . . . . $300mm over 7 years from NIAID to CHAVI (Dir=B.Haynes).
2. CAVD - Collaboration for AIDS Vaccine Discovery http://www.cavd.org
. . . . . . $287mm over 5 years from BMGF to CAVD ($15mm to B.Haynes).
Dr. Barton Haynes, Immunologist
Duke Univ., Dept. of Medicine
Director, CHAVI http://www.chavi.org
Director, Duke Human Vaccine Institute (DHVI) http://humanvaccine.duke.edu
Interests: Human immunity, Tcell function, HIV/AIDS vaccines
Profile: http://humanvaccine.duke.edu/modules/haynes/index.php?id=1
HAYNES VDC MISSION & GOALS WEBPAGE:
http://humanvaccine.duke.edu/modules/haynes_vdc/index.php?id=2
= = = = = = = = = =
THE DUKE/HAYNES/CAVD/GATES/NIH HIV COLLABORATION:
Duke's B.Haynes DHVI website & CAVD-Reports outline Thorpe’s Role in the CAVD-Gates HIV-Vaccine Initiative: http://tinyurl.com/5xwjk4
…”Philip Thorpe is determining the role of lipid binding of anti-HIV antibodies and anti-phosphatidylserine (PS) autoantibodies to protection from HIV infection.”
…2005-May2009: All Peregrine Public Statements on the Duke HIV Collab: http://tinyurl.com/c4fv9v
…10-2008: Short profiles of ~40 Gates/NIH HIV collaborators: http://tinyurl.com/57tanp
...3-18-09: CFO Paul Lytle on the Duke-HIV Collab. at the Cowen Healthcare Conf: http://tinyurl.com/cal9br
...“We are expecting a high-profile publication, which is currently in process thru Duke Univ., to be presented within the 1st half of 2009.”
...3-17-09 CAVD 2006-2008 Recap Report – (57-pg PDF): http://tinyurl.com/d2jpm9
...““researchers in the Haynes VDC have discovered that anti-lipid antibodies in fact may play a role in HIV-1 protection. They found that anti-lipid antibodies produced in autoimmune disease have the capacity to broadly inhibit the infection of peripheral blood mononuclear cells by virtually all CCR5-dependent HIV-1 primary isolates. They are working now to translate this finding into a novel strategy of HIV-1 vaccine development.”
...10-30-08: CEO S.KING, BIO-INV. Forum (SanFran) - replay w/slides: http://tinyurl.com/664mgd
...SK on Duke/Gates/NIH HIV collab: “At AIDS-VACCINE’08, a key finding was that certain classes of Anti-Phospholipid antibodies broadly neutralize HIV infection. And, in fact, the most potent antibodies were those that were provided by Peregrine. This is a very important finding…”
...10-14-08: “The AIDS Vaccine 2008 Conference”, CapeTown, So.Africa http://tinyurl.com/7dnmpe
......Duke’s B.Haynes & T.Moody present Anti-PS data for 1st time publicly: “The most potent mAb, PGN632 [11.31], inhibited 7/7 B & C clade HIV-1 isolates & SHIV SP162P3... Studies showed the mAbs acted at host cell surfaces to inhibit HIV-1 infection."
…..Dr. Ralph Pantophlet’s summary of T.Moody’s Talk, incl. two PGN632=11.31 test data graphs: http://tinyurl.com/7w4udz.
......SK: "This data opens the door to a # of potential commercial app's incl. post-exposure prophylaxis & topical microbicides” http://tinyurl.com/cxv2st
.....1-24-09: Mojo’s Comparison Graphs of Bavi vs. 11.31(PGN632) against HIV (in-vitro): http://tinyurl.com/dkmrdp
......1-6-09: NIAID reviews CapeTown AIDS’08, commenting on the Tony Moody Anti-Lipids/PGN632 talk: http://tinyurl.com/7dnmpe
......1-15-09: JBM’s 'AIDS-Vaccine’08/Capetown Wrapup' (Anti-PS Blog): http://tinyurl.com/8cmmcs
......2-23-09 Duke article about 2F5, a ‘Rare, Potent Antibody to HIV-1’ – comp. vs. PGN632: http://tinyurl.com/aozpd2
…9-22-08: Haynes CAVD Update: ”The team has recently found that non-pathogenic anti-lipid antibodies that do not require B2GPI for lipid binding do prevent HIV-1 & SHIV-SF162P3 (and all R5 HIVs tested) from infecting PBMC in vitro..." http://tinyurl.com/3g6vbm
…2-12-08: CFO P.Lytle, BIO-CEO/INV.CONF(NYC), Replay w/slides: http://tinyurl.com/2xpzth
......PL: “On the Bavi/AV front, we’re looking at a # of potential pubs here… these s/b coming from Duke Univ. & UTSW - potentially some ground-breaking news on these 2 fronts.”
…12-2007: UCLA’s Dr. Pojen Chen (active in CHAVI/Duke HIV studies) joins PPHM’s SRB: http://tinyurl.com/2nxcm2
...7-2007: PPHM licenses "certain Anti-PS Antibodies" from UCLA - the Dr. Pojen Chen connection? http://tinyurl.com/5t8jvm
…4-24-07: GATES-FOUND. rep's lecture at U-WASH lists P.Thorpe on CAVD grants map: http://tinyurl.com/3t67gj
...3-2007: Duke’s D.Montefiori Europrise-HIV Assay paper refs. “BAVITUX” & “3G4RHD” http://tinyurl.com/448d8k
…1-27-07: Dr. Haynes (Chavi Dir.) report - pg.31 shows slide “Labeling of Microparticles by Anti-PS Antibodies”: http://tinyurl.com/289a5g
......JBM’s interesting & educational blog on Anti-PS science, esp. HIV: http://anti-ps.blogspot.com
...Haynes-BF pubs: http://tinyurl.com/3nspyw ...Moody-MA pubs: http://tinyurl.com/5yeh2e
...Duke Health News: http://www.dukehealth.org/HealthLibrary/News ...CAVD(Gates) Annual repts: http://tinyurl.com/47uhtu
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