Peregrine Pharmaceuticals, Inc. (PPHM), Tustin CA. http://www.peregrineinc.com is committed to improving the lives of patients by delivering high quality pharmaceutical products through its contract development & mfg. organization (CDMO) services and through advancing and licensing its investigational immunotherapy and related products. Peregrine's in-house CDMO services, including cGMP mfg. & dev. capabilities, are provided through its wholly-owned subsidiary Avid Bioservices, Inc. ( http://www.avidbio.com ), which provides development & biomfg. services for both Peregrine & 3rd-party customers. The company is also working to evaluate its lead immunotherapy candidate, BAVITUXIMAB, in combination with immune stimulating therapies for the treatment of various cancers, and developing its PROPRIETARY EXOSOME TECHNOLOGY for the detection & monitoring of cancer using assays that are able to detect small amts of PS+ Exosomes in a patient's blood sample.
Bavituximab, a phosphatidylserine(PS)-targeting antibody, represents a new approach to treating cancer (3:34 video).
...Bavituximab was invented by UTSW's Dr. Philip Thorpe (1951-2013), and research continues in Dr. Rolf Brekken's UTSW lab.
• BAVI MOA: By blocking the immunosuppressive signal of exposed PS, Bavi mediates multiple immunostimulatory changes in the tumor environment, including a reduction of tumor-promoting immune cells and an increase in tumor fighting (M1) macrophages, dendritic cells, and cytotoxic T-cells (CD8+ CD45+ CD3+) that fight solid tumors. (see: AACR'15 & ASCO'15 & ImVacS’15 & SITC'15 & S.King/1-18-16 & AACR'16 & AACR'17 & ASCO'17)
• COLLABS: In addition to the ongoing UTSW/Brekken/Schroit research collab., Peregrine began working w/Mem-Sloan-Kettering(Jedd Wolchok Lab) in Jul'15(2 known studies a/o 4-2017: #1/Bavi+PD1+Rad, #2/Bavi+”ACT”) to investigate “Novel PS-Targeting Immunotherapy Combos”, then w/AstraZeneca in Aug'15(see PR) to run human trials evaluating Bavi+Durvalumab(Imfinzi) in "mult-solid-tumor-types", and w/The Natl. Comprehensive Cancer Network (NCCN) in Jan'16 via a $2M res. grant to NCCN which will “significantly expand Peregrine's clinical evaluation of bavituximab” at “27 of the world's leading cancer centers” (9-16-16: NCCN selects 3 Bavi Trials to in 2017 at Moffitt/MassGen/JohnsHopkins). Also, w/Duke Univ. (See Dr. Herbert K. Lyerly: AACR-IO/10-22-16), MD Anderson (See Dr. Jason Fleming), Rutgers Univ. (See Dr. Raymond Birge), and ImmunoVaccine Inc. (AACR'17 4-4-17 #3657). MORE on PreClin. Collabs: http://tinyurl.com/heg9t3v
• AVID: Peregrine also operates Avid Bioservices, a wholly owned cGMP CMO subsidiary, which provides contract mfg. services on a fee-for-service basis (revs. May'06-Jul17=$258.3mm), as well as support of Peregrine's own product pipeline. 5-2017: Avid II(Myford) expands; total Avid mfg. capacity now > 11,000L - see http://tinyurl.com/ky7bmu4
...??Cancer Moonshot 2020 http://www.cancermoonshot2020.org – see S.King's 1-14-16 EP-Vantage comments: http://tinyurl.com/z59pc6a
...??4-13-16: Sean Parker Donates $250mm to Launch Cancer Immunotherapy Inst. (6 key centers: MSKCC Stanford UCLA UCSF MDA UPenn). Dr. Jedd Wolchok says, "This new institute is paradigm shifting." http://tinyurl.com/gqmmsud
4-2-13: Peregrine Mourns Loss of Dr. Philip E. Thorpe (1951-2013) http://tinyurl.com/l9gqmt5
"Phil will be sorely missed as a colleague and friend. At Peregrine, each of us is pursuing Phil's dream of bringing important drugs to patients who need them based on his basic research. We are more motivated than ever to see this dream through."
…Dr. Thorpe’s successor at UTSW: long-time colleague, co-inventor of 2C3, Dr. Rolf A. Brekken, PhD - http://www.utsouthwestern.edu/labs/brekken
8-2014: UK colleagues from Chester Beatty Labs(ICR/Univ-London), ICRF(IsraelCancerRes), & UTSW create memorial for Dr.Thorpe in London’s Chelsea Physic Garden: http://tinyurl.com/lon73l7
Yahoo Quote & Profile for PPHM: Yahoo.com/PPHM ...Nasdaq Quote: http://www.nasdaq.com/symbol/pphm ...PPHM Tweets: http://stocktwits.com/symbol/PPHM
• IR: firstname.lastname@example.org: Stephanie Diaz (Investors) Vida Strategic Partners 415-675-7401 email@example.com, Tim Brons (Media) 415-675-7402 firstname.lastname@example.org
• PPHM's 7-13-17 Ronin PR had: MEDIA CONTACTS - John Christiansen / Matt Reid, Sard Verbinnen & Co., 415-618-8750 / 310-201-2040 http://www.sardverb.com
UPCOMING EVENTS: http://ir.peregrineinc.com/events.cfm
Sep11/AfterHrs: FY'18Q1 (qe 7-31-17) Financials & Conf. Call - http://ir.peregrineinc.com/events.cfm =>Transcript: http://tinyurl.com/y9y8qdac
Sep8-12/ESMO’17(Madrid), PPHM Booth #257: Final SUNRISE Ph3 Data http://tinyurl.com/yb9kjutp
...Sep9 1:15pm Poster #1364P: “Final Clinical Results from SUNRISE: A Ph3 Trial of Bavi+Doce/Prev. Treated IIIb/IV NSCLC”. In an exploratory analysis of OS for pts who received subsequent ICI, mOS was not reached.
Sep25-28/Avid Booth #918: Informa’s BPI’17: BioProcess Intl. Conf. & Exhibition, Boston https://lifesciences.knect365.com/bioprocessinternational
Oct2/NCI Scientist Gregoire Altan-Bonnet(MSKCC ties), AACR’s Tumor Immunotherapy Conf., Boston http://tinyurl.com/y74v76go
...“Long-Lived Disruption of Inflammation Stems from the Catch-and-Release of Cytokines Mediated by Surface Phosphatidylserine in Tumors”
Oct6/Avid(booth): LakePharma Protein Eng. Symposium, So.SanFran http://tinyurl.com/ya6yvetk
~Oct12(??IF same as 2016): Peregrine's Annual Shareholder’s Meeting (8-28-17: Amended 10K/orig. was 7-14-17 http://tinyurl.com/yb5jq7vc )
Nov8-12: 32th Annual SITC’17, Natl-Harbor MD http://tinyurl.com/ybfm75wj
...1. PPHM-PrecisionMed: “Results of Epigenetic-Based Quantitative PCR Assisted Immune Cell Counting Analysis in Bavi SUNRISE Trial Subgroup”
...2. MSKCC-PPHM: “PS-Targeting In Combo w/Rad+Immune Checkpoint Blockade Promotes Anti-Tumor Activity in Mouse B16 Melanoma”
Dec11-15/Avid Booth #311: KNect365’s Antibody Eng. & Therapeutics Conf., SanDiego https://lifesciences.knect365.com/antibody-engineering-therapeutics
~Dec11: FY'18Q2 (qe 10-31-17) Financials & Conf. Call - http://ir.peregrineinc.com/events.cfm
Jan18-22 2018: Phacilitate’s Immunotherapy World Forum, Miami http://www.immunotherapyforum.com
...Jan18 12:30-12:45, Joe Shan(VP/Reg+Clin): “Turning up the Heat: PS-Targeting Antibodies Modulate the Tumor Microenvironment & Enhance Checkpoint Blockade”
SCIENCE: "Evolution has favored pathogenesis that resembles apoptosis."
Dr. Judah Folkman: ”This [Thorpe’s VTA research] is very promising and very elegant work... The whole goal is really 2-part, reducing the harsh side effects of cancer treatment, and reducing the chance that some cancer cells will evade treatment. That would be a big step in the next decade, and anti-vascular therapy will play a major role." (’97 & ’02 http://tinyurl.com/k5qe96g & http://tinyurl.com/n6vh9hp )
Peregrine's Bavituximab Clinical Trials website: http://PeregrineTrials.com
Bavituximab MOA & Clinical Data: http://www.peregrineinc.com/pipeline/bavituximab-oncology.html
...Bavi Publications: http://www.peregrineinc.com/publications/publications.html
...Bavi Posters & Presentations: http://www.peregrineinc.com/publications/posters-and-presentations.html
Bavi MOA: Video (3:34) added ~3-2014 http://vimeo.com/87116642 "Bavituximab: A Novel Immunotherapy Candidate Targeting an Upstream Immune Checkpoint to Fight Cancer"
Bavi MOA: Video (1:33) on Bavi’s Immunotherapeutic MOA added to Youtube on 3-27-14 https://www.youtube.com/watch?v=Esewl35JD8s
BAVI MOA 4-3-17 AACR'17: Joint Memorial Sloan Kettering (Wolchok Lab) & PPHM poster: “PS Targeting+Adoptive TCell Transfer (ACT) Eliminates Adv. Tumors w/o Off-Target Toxicities, Melanoma” http://tinyurl.com/lxlltd6
BAVI MOA 1-30-17 Mol.Cancer article: MDA/J.Fleming, UTSW/Brekken, “PreClin. Eval of DNAtrix's DNX2401+BAVI for Pancreatic Cancer” http://tinyurl.com/hb6m3yj
...Combo DNAtrix's DNX-2401(Oncolytic Virus) + BAVI “significantly inhibited tumor growth; further enhanced its anticancer activity; warrants further clinical evaluation...”
BAVI MOA 11-14-16 SITC’16: Joint Memorial Sloan Kettering (Wolchok Lab) & PPHM poster on Triple Combo Rad+Bavi+aPD1 vs. Melanoma http://tinyurl.com/js3fca4
...Dr. Jedd Wolchok states, “Based on these study results, we believe that the targeting of PS is having meaningful activity within the tumor microenvironment in the B16 melanoma model. It appears that this activity creates a more immune active environment in which other treatments, including radiation, are able to have a greater anti-tumor impact." => AACR'17 Update 4-2-17 (#574) http://tinyurl.com/m7868sx
BAVI MOA 10-22-16: Duke’s Herbert K. Lyerly (w/PPHM) poster on AntiPS/TNBC data at AACR’s Tumor Immunotherapy Conf./Boston http://tinyurl.com/zzryfok
...”Modulating The Tumor Microenvironment to Enhance Cancer Immunotherapy by Inducing Phosphatidylserine Expression on the Tumor Surface”
BAVI MOA 9-27-16 AACR-CRI/Dr. Michael Gray: Preclin. Triple-Combo Bavi+PD1+LAG3 TNBC data in TNBC (80% Compl. Regression, Stat-Sig. Incr. in Key Tumor Fighting Immune Cells) http://tinyurl.com/zy9yv78
BAVI MOA 7-27-16 Shaul/Brekken/Thorpe/etal PLOS ONE article: Fhu/Bavi vs. APS-related Pregnancy Complications & Thrombosis http://tinyurl.com/jlhrdg2
...”The potential clinical impact of 1N11 (Fhu Bavi) in patients with APS is substantial. Spring-boarding from the present discovery of 1N11 as a highly-effective, mechanism-based treatment for APS in a comprehensive series of mouse models of APS-related disorders, clinical studies of 1N11 now warrant consideration.”
BAVI MOA 5-11-16 Breast Cancer Res. article, B.Freimark/M.Gray/CW.Hughes-et-al, “PS-Targeting/Bavi Combo w/Anti-PD1/PDL1 in Triple.Neg-MBC” http://tinyurl.com/zxu882y
...”our observations demonstrate that including PS-targeting antibodies such as bavituximab can enhance the anti-tumor activity of anti-PD-1/PD-L1 treatments, not only by increasing TIL responses but also by inhibiting cytokines stimulated by single-agent anti-PD-1 therapy that serve to suppress the immune response & promote tumor progression.”
BAVI MOA 4-20-16/AACR'16 & 4-4-16/Cancer-Immunology-Res.(AACR) article - preclin. data: Bavi combo w/anti-PD-1/anti-CTLA-4 “induces a shift in tumor microenvironment from immunosuppressive to immune active” http://tinyurl.com/jyox458
BAVI MOA 1-18-16: CEO Steve King explains PPHM's direct PS-Targeting advantage vs. the “individual-receptors” PS-binding approach of others like: Axl Mer TIM-3 RAGE Tyro3 GAS6 CD300a BAI1 MFG-E8 etc. http://tinyurl.com/h2h87mc
2-2016: Rutgers' Dr. Raymond Birge's relationship with Peregrine & UTSW's Dr. Rolf Brekken and his 2-26-16 article, “Phosphatidylserine is a Global Immunosuppressive Signal in Efferocytosis, Infectious Disease, and Cancer” http://tinyurl.com/z5d9qt9 and 9-26-16 AACR/CRI, “Characterization of a PS, TAM Receptor (Tyro3, Axl, Mertk), PDL1 Axis in Breast Cancer” http://tinyurl.com/ldlzka8
11-9-15 SITC'15: New Bavi+Checkpoint Inhibitors preclin. data (DUKE's Herbert K. Lyerly + PPHM + UTSW) http://tinyurl.com/pbof95w
...Also, collab. with Dr. Bernard Fox (Immunotherapist/Earle A. Chiles Res.Inst.) on new Immuno-Profiling Clinical Test (Opal 6-plex quantitative IF Assay), PPHM roundtable with Raymond Birge (Rutgers), Douglas Graham (Emory), Dmitry Gabrilovich (Wistar), Rolf Brekken (UTSW), Maria Karasarides (AstraZeneca) - ”Combining Bavi w/anti-PD-1 significantly enhanced O/S… significant incr. CD45+, CD8+ and CD3+ T-cells… led a prolonged anti-tumor immune response which protected the animals against a re-challenge w/same tumor.”
BAVI MOA 8-26-15: Jeff Hutchins(VP/PreClin-Res) ImVacS’15 Talk – 29pg. Slideshow http://tinyurl.com/qz64pzg
…“Expansion & Activation of T Cells via the Targeting of the Immunosuppressive Ligand PS: Combination Strategy with Conventional, Targeted, and Checkpoint Inhibitor Therapy”
5-31-15: ASCO’15 Roundtable (webcast), “Raising the Immuno-Oncology Bar” - 7 panel members, incl. 3 Sloan Kettering researchers http://tinyurl.com/qxu4w2x
BAVI MOA 3-25-15: PPHM/VP Dr. Jeff Hutchins’ presentation at "Immune Checkpoint Inhibitors Conf.", Boston - PDF(34 Slides): http://tinyurl.com/ooxkhq7
BAVI MOA 2-9-15: PPHM's Dr. Bruce Freimark’s presentation at KEYSTONE "Tumor Immunology Meeting", Banff/CN – PR & Slides: http://tinyurl.com/q6cx4w6
BAVI MOA 12-12-14 San Antomio Breast Cancer Symposium, Dr. Bruce Freimark, Bavi+anti-PD-1 vs. Breast Cancer http://tinyurl.com/p5ng6vs
BAVI MOA 11-2014 SITC’14: 3 posters on preclin. Bavi+aCTLA4/aPD1 combo data (Hutchins Freimark Brekken Huang etal) http://tinyurl.com/pchzr6h
BAVI MOA 8-28-14: Italy’s Dr. Federico Cappuzzo, Bavi/NSCLC profile article (DovePress OpenAccess, 7pgs) - http://tinyurl.com/n3oa7bc
BAVI MOA 8-11-14: PPHM/VP Dr. Jeff Hutchins’ presentation at ImVacS "Immunotherapies & Vaccine Summit", Boston - PR: http://tinyurl.com/lpjy3u7 ; PDF(31 Slides): http://tinyurl.com/oueldme
...MLV’s Dr. George Zavoico’s 8-27-14 report on Dr. Jeff Hutchins’ 8-11-14 ImVacS/Boston Bavi MOA presentation: http://tinyurl.com/l3tw63c
BAVI MOA 5-28-14: Dr. Rolf Brekken’s 47min CRI “Cancer Immunotherapy” webinar about Bavituximab as an Upstream/Global Immune Checkpoint Inhibitor – REPLAY: http://tinyurl.com/lxgftyx
. . .CRI=Cancer Research Institute (NYC – Supported by BMS): http://www.cancerresearch.org - Facebook: http://tinyurl.com/pbmhb2z , https://twitter.com/CancerResearch
. . .CRI launches “Answer to Cancer” (cancer immunotherapy) website http://www.theanswertocancer.org
. . .8-12-14: CRI adds Youtube links to the 5-28-14 CRI Immunotherapy webinar, incl. Dr. Brekken's talk "about Bavi and how it works against lung, liver, and other kinds of cancers" http://tinyurl.com/ps5h6h8
BAVI MOA 3-25-14: Dr. Rolf Brekken’s 40min talk at NYAS Lung Cancer Symposium http://tinyurl.com/lq9stnk (45 Slides)
. . .Dr.Brekken’s talk: “Antibody-mediated Inhibition of PS - A Novel Strategy for Immune Checkpoint Blockade” (the 5 speakers: Jessica Donington, Roy Herbst, Balazs Halmos, Suresh Ramalingam, Rolf Brekken)
12-10-13: With recent scientific insights highlighting bavi’s immunostimulatory moa, these additions to PPHM’s SAB: Dimitry Gabrilovich, Scott Antonia, David Carbone**, Hakan Mellstedt http://tinyurl.com/mw776mk
......**A/o 9-2015, Dr. David Carbone (PPHM SAB/KOL) is President of IASLC https://www.iaslc.org/about-us/board
BAVI MOA: 12-2013 Bavi’s Immunotherapeutic MOA overviewed by UTSW’s Brekken/Huang in Pan European Networks Jrnl. http://tinyurl.com/lnb46pq
BAVI MOA 11-9-13: Annual SITC (WashDC) – 2 posters about Bavi’s Immunostimulatory MOA http://tinyurl.com/mjaweu5
...“We are actively working towards initiating a clinical trial in the coming months to further investigate the potential synergistic effects of bavituximab and an approved [anti-CTLA-4] immunotherapy in patients with Melanoma."
10-28-13 IASLC/Sydney: “Immune Checkpoints in the Tumor Environment: Novel Targets & the Clinical Promise of Combined Immunotherapies” http://tinyurl.com/mjaweu5
…Symposium speakers: Scott J. Antonia/MD-PhD(H.Lee Moffitt CC), Dmitry I. Gabrilovich/MD-PhD(Wistar Inst), Rolf A. Brekken/PhD(UTSW), David E. Gerber/MD(UTSW)
BAVI MOA: 8-19-13 Data Supporting Bavituximab’s Immunotherapy MOA Published in “Cancer Immunology Research” (AACR) - http://tinyurl.com/mhjftka (PDF)
…“PS-Targeting Antibody Induces M1 Macrophage Polarization & Promotes Myeloid-Derived Suppressor Cell Differentiation” (Thorpe etal)
BAVI MOA: 8-13-13 PPHM/VP Dr. Jeff Hutchins’ Presentation on the Downstream Immunostimulatory Effects/Moa of PS-targeting antibodies (like Bavi) at CHI’s “Immunotherapies Congress”/Boston http://tinyurl.com/m6h2tvt
BAVI MOA: 10-12-12 NMB article on how Bavi "Induces Innate & Specific Anti-tumor Responses" http://tinyurl.com/cw9odb8
BAVI MOA: 5-1-12 Dr. Phil Thorpe's 46min talk at NYAS PS-Targeting Symposium http://tinyurl.com/9792gl5
. . .Symposium title: "Phosphatidylserine (PS) Asymmetry - Therapeutic Apps. in Cancer & Infectious Disease Symposium"
. . .Replays of 5 speakers: Alan Schroit, Chris Reutlingsperger, David Ucker, Ari Helenius, Philip Thorpe
BAVI MOA: 5-26-11 Dr.Thorpe's keynoter at Recombinant-Mabs/Barcelona http://tinyurl.com/3klpodc & http://tinyurl.com/3m33h33
BAVI MOA: 4-2010 Thrombosis Research article (Dr.Thorpe) http://tinyurl.com/9reso7s
BAVI MOA: See http://www.peregrineinc.com/technology/bavituximab-oncology/recent-data.html
Peregrine's SRB - Links to Profiles & Pubmeds: http://tinyurl.com/2cy3cv
Expert Quotes/Commentary On Bavituximab's Moa/Potential: http://tinyurl.com/nmdw4
Peregrine's Patent Estate - excl. licenses from UTSW MDA U-CALIF USC: http://tinyurl.com/58cn74
7-16-12 Form 10-K (fy/e 4-30-12): License Agreements between PPHM & UTSW/DNA/Avanir/Lonza (pg.10) http://tinyurl.com/agy6hn6
…Royalty %'s payable to UTSW/Dallas on sales of future-approved Anti-PS drugs will be in the "low single digits"
4-2006: Tarvacin (chimeric 3G4) will henceforth be referred to by its generic name, BAVITUXIMAB, to avoid confusion with OSI's anti-cancer drug Tarceva. http://tinyurl.com/2vawjv
- - - -Peregrine's Anti-PS Mabs:
• PGN635 (B2GPI-dep.) is Fully-Human Bavituximab=1N11=AT004 (B2GPI-depen.); Genentech studying 89Zr-PGN635 as a Tumor Imaging Agent, “indep. of cancer type”
• PGN632 (B2GPI-indep.) is the Duke-PPHM-HIV candidate=11.31=AT005; also being studied by PPHM+LSU vs. Ocular Herpes (Acute HSV-1 Keratitis), see http://tinyurl.com/cax9a4p
• PGN650 is a human F(ab’)2 fragment that targets PS expression (1st ref’d in AACR’12 #2452) – see http://tinyurl.com/76nqqkm . 124I-PGN650 is Peregrine’s PS-Imaging candidate (see http://tinyurl.com/7p7jovt )
• BETABODIES (Clipped/Nicked B2GPI - ex: KL15, “2nd-gen. PS-Targeting”) - bind to PS directly, are smaller in size (100 vs. 250KDa) and have a longer serum half-life (~5days) than natural antibodies (Bavi=~1day) – see http://tinyurl.com/khopa3d
...6-22-17: Nature(BJC): AntiPS Exosomes in Breast & Pancreatic, Alan Schroit/Rolf Brekken etal (UTSW/PPHM SAB) - Betabody KL15C being tested. http://tinyurl.com/ycrx9672
…2/17/15: UTSW/PPHM’s BetaBodies patent#8,956,616 Awarded(Granted) http://tinyurl.com/p75uyfu
Examples of anti-PD-1 drugs in development: (PD1=”Programmed Cell Death Protein 1”)
1. Merck’s Keytruda(pembrolizumab=MK-3475, formerly=labrolizumab) <=’14/Melanoma, ‘15/NSCLC, ‘16/Head&Neck
2. BMS’s Opdivo(nivolumab) <=’14/Melanoma, ’15/NSCLC & RenalCell
3. AZN/MedImmune’s MEDI0680 (formerly=AMP514)
4. GSK’s AMP-224 (collab. with Amplimmune)
Examples of anti-PD-L1 drugs in development: (PD-L1=”PD1 ligand”)
1. BMS’s BMS-936559 (MDX-1105)
2.. Roche/DNA’s Tecentriq(atezolizumab, aka MPDL3280A) <=2016/Bladder & 2L/NSCLC
3. AZN/MedImmune’s Imfinzi(durvalumab=MEDI4736)<=2015 PPHM+AZN collab. & expansion to run trials in Lung & "mult. tumor types"
4. Pfizer/Merck-KgaA’s Avelumab (formerly MSB0010718C)
7-14-14/CC: Steve Worsley (VP/BusDev) said that Peregrine is “seeking collaborators that build on other checkpoints of pathways such as PD-1, IDO, immune-stimulatory drugs, and even vaccines…” http://tinyurl.com/zor2vjs
...Interesting: PPHM KOL/SRB’r Dr. Scott Antonia’s (Moffitt-CC/Tampa) role in IDO dev: http://tinyurl.com/mol86st <=“1st to report in 2002 that IDO inhibitors delay growth of human lung cancer cells”
• Incyte’s immune checkpoint inhibitor INCB24360 is an oral inhibitor of IDO1 (indoleamine dioxygenase-1) – http://www.incyte.com
• NewLink Genetics’ immune checkpoint inhibitor indoximod is an oral inhibitor of IDO (indoleamine 2,3-dioxygenase) – http://newlinkgenetics.com
...“IDO pathway inhibitors are another class of immune check point inhibitors akin to the recently developed antibodies targeting CTLA-4 & PD-1 that represent potential breakthrough approaches to cancer therapy.”
"As of 4-30-17, we employed 319 full-time emps & 4 part-time emps." ('11=154/2, '12=172/2 '13=182/4 '14=180/4 '15=211/4 '16=281/3) http://tinyurl.com/yb4wulvu
8-9-17: PPHM commenced a restructuring plan… expected to be completed in Oct’17… reduced workforce by 60 emps (20%), reduced R&D from 22 to 11. http://tinyurl.com/ycrxq5tc
...On 3-18-09, CFO P.Lytle (Cowen/Boston) stated, "We have 135 emps, 85 under Avid Bioservices, and the remaining 50 emps reside at the Peregrine corp. level - 35 in R&D & 15 in G&A."
In 10-2009, Dr. Robert Garnick joined Peregrine as Head/Regulatory ( http://tinyurl.com/yga7z4x ). In his 24 years at Genentech (1984-2008; from Feb'01-Oct'08 as Senior V.P. of Regulatory, Quality & Compliance), he was responsible for 17 new product approvals, including most of DNA's top selling monoclonal antibody therapeutics such as Rituxan, Herceptin, Avastin, and Lucentis. He was responsible for all the regulated aspects of Genentech's business, including drug development, commercial production, and promotional & labeling compliance. As CEO Steve King said 6-29-11, "Rob is the ringmaster."
• See this 6-29-11 Minyanville article, "Peregrine Pharma's Secret Weapon" http://tinyurl.com/9jtnano
• Examples of Dr. Garnick's work at Genentech on Avastin (bevacizumab) approvals: http://tinyurl.com/yg7vtqa
• All of Dr. Robert Garnick's public comments (thru 3-7-2014) while at Peregrine: http://tinyurl.com/obvwyuh
Latest 10K 4-30-17 iss. 7-14-17 http://tinyurl.com/ycxu4l5n PR: http://tinyurl.com/yb4wulvu (Cash 4-30-17=$46.8mm); Amended 8-25-17: http://tinyurl.com/yb5jq7vc
Latest 10Q 7-31-17 iss. 9-11-17 http://tinyurl.com/ycbzp4zn PR: http://tinyurl.com/y9y8qdac (Cash 7-31-17=$37.3mm)
ALL SEC filings for PPHM: http://tinyurl.com/6d4jw8
PPHM's Corp. Bylaws (a/o 11-14-14): http://tinyurl.com/y8hsppea
Poison Pill adopted 3-16-06: http://tinyurl.com/yvypvh - 44-pg SEC filing: http://tinyurl.com/5m57ut BUNGLER explains in plain language: http://tinyurl.com/mft4nd6
5-15-17: Parties Settle 2013 Shareholder Derivative CA Lawsuit vs. BOD(re: Fiduciary Duties) http://tinyurl.com/y982h3rt
...7-27-17: Final Settlement Hearing - transcript excerpts, comments by Judge J. Travis Laster: http://tinyurl.com/y9m6ee59
10-13-16 ASM Voting Results: http://tinyurl.com/ycrrrb43
Shares O/S as of 9-6-17=45,096,081 - history since 4-2006: http://tinyurl.com/ybjgm425
...A/O 7-31-17: 39,040 warrants o/s with wgt.avg. exercise price of $17.29 -- 4,022,136 stock options outstanding at a wgt.avg. exercise price of $8.73. (pg.14 10Q)
7-7-17: PPHM shares to be 1:7 Reverse Split eff. 7-10-17 (315mm/$.606=>45mm/$.424) http://tinyurl.com/ycohqn6j
...4-12-17/8K: Nasdaq Delisting Notice($1 min.), 4-10-17 deadline missed; Peregrine to Appeal for Extension http://tinyurl.com/yagoqth5
...6-7-17/8K: Hearing Panel Grants Extension until 7-21-17 (must be over $1 by 7-7-17) http://tinyurl.com/yauwzhum
12-27-13: S-3 Registration, “up to $100,000,000”, Common & Preferred http://tinyurl.com/ky4ufth - S-3 cover: Michael A. Hedge (Leader, Life Sciences M&A team), K&L Gates LLP
...2-5-14: PPHM Announces Public Offering of 10.5% Series E Convertible Preferred Stock http://tinyurl.com/lkxsna6
...2-11-14: PPHM Raises net $16.2mm selling 700k Preferred Shares with 10.5% div. at $25/sh, convertible to common at $3/sh http://tinyurl.com/jwmsnsk (8-K)
...6/14/14-7/14/13: PPHM Raises net $9.5mm selling 400k Preferred Shares with 10.5% div. at $25/sh, convertible to common at $3/sh http://tinyurl.com/mhva3k3 (4-30-14 10-K pg. F-34; $20mm gross remaining)
...6-30-14: SABBY MGT. (led by Hal Mintz) holds 291600/PPHMP a/o 6-30-14 ($email@example.com/sh. common): http://tinyurl.com/kxezbsf
...4-13-14: PPHM Registers $30mm of 10.50% Series E Convertible Preferred Stock and $25mm ATM Common Stock in 2 424B5’s: http://tinyurl.com/lth28zj & http://tinyurl.com/kpjloar
...12-23-14: S-3 Registration, “up to $150,000,000”, Common & Preferred http://tinyurl.com/nhfr55a
A-T-M (At-The-Market) Sales 3/2009 - 7/14/17 ($272,500,000gr./34,869,747sh=$7.81/sh): http://tinyurl.com/yagmu2on
...12-29-10: ATM Agreement (up to $75mm) with MLV filed - 8K: http://tinyurl.com/2a6w76g
...3-9-12: PPHM files shelf to sell up to $150mm common stock, warrants, S3: http://tinyurl.com/7dl7pjm
...12-28-12: New ATM Agreement (up to $75mm) with MLV filed - 424B5: http://tinyurl.com/ayny2b3
…6-13-14: New ATM Agreement (up to $25mm) with MLV filed - 424B5: http://tinyurl.com/ycxje6pj
…8-7-15: New ATM Agreement (up to $20mm) with NOBLE filed - 424B5: http://tinyurl.com/q9zvw6n
…8-7-15: New ATM Agreement (up to $30mm) with MLV filed - 424B5: http://tinyurl.com/oc53ugn
...7-14-17: ALL Existing ATM's are fully exhausted - cannot do anymore until a new one is opened (and reported via 424B5), against the $67mm remaining on the orig. $150mm shelf filed 4-23-14/S-3.
INSIDER-Trans: http://tinyurl.com/ypkow8 & http://tinyurl.com/2yvlj4
Inst. Holdings (Nasdaq.com) - updated qtly, 45-days after each q/e cutoff: http://www.nasdaq.com/symbol/pphm/institutional-holdings
Short Interest, upd. twice a month: http://tinyurl.com/552p6n ...Updates 1 day earlier: http://tinyurl.com/292xyd
Nasdaq Last Sale (NLS) & Official Close for TODAY: http://tinyurl.com/kvplmj DETAIL: http://tinyurl.com/oc58jw
Currenty Halted Stocks: http://www.nasdaqtrader.com/Trader.aspx?id=Tradehalts
Director Eric Swartz's Jan-Feb'10 Buying Streak (100k @ 3.12/sh.): http://tinyurl.com/yegxpvu
10-17-17/13D: Group Ronin Trading/SWInvest (John Stafford III+Roger Farley+Stephen White) now owns 9.2% stake (4,135,462sh.) in PPHM http://tinyurl.com/ychgxr7x
...3,982,964 COMMON - 8.8% of 45,096,081 common O/S at 9-6-17 (total beneficial=4,135,462 if Pref. conv. x1.1905 to Common)
...128,099 PREFERRED – 7.8% of 1,647,760 preferred O/S at 7-31-17
......As a Group, ie, “people that share the furtherance of a common objective/concerted action”; 13D’s are reserved for ACTIVE INVESTORS who may be “interested in agitating for some kind of a change at the company”.
...10-10-17: RONIN/SW-Invest PR adding 4th BOD Nominee (James Egan) and ups stakes 8.8%=>8.9% http://tinyurl.com/ya8fgsr7
...8-29-17: RONIN/SW-Invest PRELIM. Proxy Statement (14A) http://tinyurl.com/yay55u3p - includes 35-pt. chronology of events (1-17-17 thru 8-14-17) & all Ronin/SW PPHM stock trans.
...8-14-17: Ronin/SW-Invest PR commenting on PPHM's 8-11-17 PR (laying off 20% employees) http://tinyurl.com/y7hjryog
...7-20-17: Ronin/SW-Invest Letter to Employees of Peregrine; PPHM Comments http://tinyurl.com/yb6ds27s
...7-13-17: Ronin/SW-Invest Letter to Stockholders; PPHM Comments http://tinyurl.com/ybr8ycbp - Ronin nominates Gregory Sargen, Brian Scanlan, Saiid Zarrabian for election to PPHM's board at next ASM ~10-12-17.
10-30-15: Kenneth Dart (Eastern Capital) acquires 9.6% stake (4,300,992sh.) in PPHM http://tinyurl.com/y95yskck
...3,777,183 COMMON - 8.4% of 45,096,081 common O/S at 9-6-17 (total beneficial=4,300,992 if Pref. conv. x1.19 to Common, 9.6%)
...440,000 PREFERRED - 26.7% of 1,647,760 preferred O/S at 1-31-17
...…...9-29-17/Form4: http://tinyurl.com/y9oadloa <=No chg. in Ownership; has had <10% stake for many months due to dilution. ??
Plus, INSTITUTIONS a/o 6-30-17 (+ 8-14-17 Tappan/13G): 7,476,857sh. = 16.6% (of $45mm) http://www.nasdaq.com/symbol/pphm/institutional-holdings
Tappan Street (Prasad Phatak) 1,656,252 +1,384,380 <=per 8-14-17/13G http://tinyurl.com/ybgqp9uq
Kennedy Capital Mgt. 1,394,066 +146,842
Vanguard Group 1,029,755 +146,791
Blackrock (Larry Fink) 806,022 -49,433
Renaissance Technologies 481,160 +41,487
Geode Capital Mgt. 225,679 +20,319
Bandera Partners 203,004 New
9-8-11: Roth arranges direct sale of 893,179sh.@$7.77 to 3 inst's, net=$6.5mm http://tinyurl.com/3otm3t5
10-19-09 PPHM executes 1:5 R/S to regain Nasdaq $1 min-bid compliance: http://tinyurl.com/ykuw588
8-6-10: Bavituximab listed #8 in EP-Vantage's 'Biggest Unpartnered Pipeline Assets' chart, with NPV=$1.022b: http://tinyurl.com/34lpt5j
5-22-13: Citigroup analyst Andrew S. Baum’s report, "Immunotherapy - The Beginning of the End for Cancer" http://tinyurl.com/pob7ktc
…”A new wave of medicines that tap the power of the immune system to fight cancer could become the biggest drug class in history… We believe this market will gen. sales of up to $35B/yr. over the next 10yrs and be used in some way in the mgt. of up to 60% of all cancers…”
Noble Financial/Kumaraguru Raja http://noblefcm.com/research (init. 7-16-15); 9-29-16: Buy/PT=$10.00 http://tinyurl.com/yd2tfz6s
FBR & Co./ThomasYip http://www.fbr.com 9-9-16: Outperform/PT=$1.00
Roth Capital /Joe Pantginis (init. 7-15-10), 7-15-16: Neutral/$.50 http://www.roth.com <="In Transition" a/o 12-2016
MLV/George B. Zavoico(Jones Trading?) - init. 2-8-10 Buy/PT=$10, CURR: Buy/$3.50 http://www.mlvco.com <=dropped 2015
Piper Jaffray/Charles Duncan - init. 3-5-13 http://www.piperjaffray.com/3col.aspx?id=103 <=Coverage dropped 12-2015
JMP Securities/Jason Butler - init. 8-30-2011 OutPerf/PT=$5, CURR: OutPerf/$6.50 http://www.jmpg.com <=7-2014: dropped from PeregrineInc.com
LifeTech-Cap/Steve Dunn - init. 4-14-10 Spec-Buy/PT=$8, CURR: Spec-Buy/$5 <=Dropped 4-2012
1-2011: PPHM has Exec. Info. Report (EIO) prepared by Crystal Research (Jeffery Kraws): http://tinyurl.com/2dja6uo
12-21-07/Terminated: Rodman&Ren. (Jaikaria/Benjamin) initiate: Mkt-Perform: http://tinyurl.com/624dmd
AVID BIOSERVICES, Inc. (Peregrine's Mfg. Subsidiary): http://www.avidbio.com
9-11-17: PPHM's Revs & Burns By Qtr Table, FY07/Q1 thru FY18/Q1 (q/e 7-31-17): http://tinyurl.com/y9y8qdac (since 5-2006: Avid=$258.3mm, Total=$284.9mm, incl.Govt)
......Avid FY18 (fye 4-30-18) revs guidance: $50-55mm; committed backlog=$33mm. Recently Leased +42,000sf in same bldg. as MYFORD for future expansion.
......7-14-17: PPHM’s 10K Notes re: Avid FY18 & Beyond (FY18 Guidance announced 7-14-17: $50-55mm), plus HALO’s comments about projected 2017/2018 Roche’s demand for bulk rHuPH20 in their 3-31-17 10-Q filed 5-9-17. http://tinyurl.com/y9vks8dz
9-11-17: Roger J. Lias (ex-Allergan) to become Avid’s President and join PPHM’s BOD eff. 9-25-17 http://tinyurl.com/yd3eh3uv
7-14-17: Avid Scientists develop “Antibody Discovery & Characterization Platform” http://tinyurl.com/ycr3erft
...S.King: “through which we can generate antibodies against virtually any target. These capabilities are state-of-the-art and meant for rapid screening for high affinity antibodies as drug candidates.”
5-2017: Avid II (Myford) adds 2 MilliporeSigma Mobius 2,000L single-use bioreactors; total mfg. capacity now ">11,000L". http://tinyurl.com/ky7bmu4
5-10-17: Halozyme comments on Avid II(Myford) expansion in their 3-31-17/10Q pub. 5-9-17: http://tinyurl.com/mrl34uk
..."validation of the new facility is scheduled to end in Q2/2017… Once this new facility is approved, it will become the primary source for Roche of bulk rHuPH20.”
2-28-17: Avid & Cook remain Halozyme's 2 CMO's (“working to scale-up/validate/qualify Avid II/Myford for Roche collab.”): http://tinyurl.com/h75teta
...9-19-2017: Catalent to acquire CDMO Cook Pharmica for $950M ($179M/sales x 5.3) http://tinyurl.com/yd46m8py
6-2-16: Corp.Update – Avid Expansion & Drug Development - http://tinyurl.com/zvmhqmr
5-23-16: Pete Gagnon (100pubs/presentations, 12+patents, 30 pending patents) Appointed VP/Process-Services of Avid http://tinyurl.com/hg6abdq – See Oct'15: https://www.youtube.com/watch?v=JqJIH33JY8g
3-7-16/Avid II: Formal Commissioning of Avid's New 40,000sq "Myford" Facility, “single-use/fully disposable” (potentially $40M addl revs) http://tinyurl.com/za2j9mt
12-10-15/Avid II: Avid Expansion into MYFORD Facility now GMP-run ready (potential +$40mm sales) - contemplating further expansion http://tinyurl.com/z35623w
6-17-15: Avid’s John Haney (ex-Genentech/Pfizer) speaking at BIO-INTL’5/Philly http://tinyurl.com/pnlquu3 & http://tinyurl.com/nl4vbgk
...”Designing & Implementing Avid’s New State-of-the-Art Single-Use Facility for Late Ph.3 & Commercial Prod.” - SK: "We've seen tremendous interest for production in the new facility, both from new & existing clients"
12-10-14: Avid to Double Mfg. Capacity (“expanding client roster; potential commercial launch of bavituximab”) http://tinyurl.com/mmc3qgy & http://tinyurl.com/kmdgq8t
3-24-15: Avid Receives CMO Leadership Awards for Its Commitment to Innovation & Reliability http://tinyurl.com/psep47f
3-12-13: Avid Q3'FY13 GP=$3.3mm; S.King 3-2012, "We have a profitable CMO, Avid Bioservices" http://tinyurl.com/l97rzm8
2-26-13: Avid Presents QbD/CPPs/CQAs at "BiopharmDev/Prod-Week" http://tinyurl.com/cjzfh73
4-2-12 AACR'12: Avid presents New Mab-Eng. Process (Fc/ADCC), Client Proj. http://tinyurl.com/7yrwqm7 (see #2510)
6-14-10: Avid adds 'Line #4 FILL-FINISH' capability, CMOLocator.com http://tinyurl.com/3xgu3ox
5-3-10: PPHM leases addl. 11,000sq adjacent space (Avid exp?): http://tinyurl.com/327dk2j
9-21-09: Avid becomes sole U.S. W.Coast CMO in Boehringer Ingelheim's Global Prod. Alliance Network http://tinyurl.com/l9nf4n
11-10-08: Avid expands capacity by adding 100L & 1000L Hyclone bioreactors: http://tinyurl.com/69qgl5
6-25-08: Avid Selected as 1st U.S. CMO for DSM/Crucell's PER.C6 Cell Line: http://tinyurl.com/4geqxw
7-14-08: Avid is CMO for Arius Research's lead drug, "AR001 Targeting CD44": http://tinyurl.com/6hrwrt - 7-23-08 Roche buys Arius for $190mm http://tinyurl.com/5fg6jd
PPHM's EXOSOME-BASED (PS Positive) CANCER DETECTION & MONITORING TECHNOLOGY ("Liquid Biopsy")
...Excellent Exosome (aka microparticles, microvesicles) info: http://www.exosome-rna.com
9-11-17/Status: "The company continues to make progress... The assay has been successfully optimized; we are evaluating options to license/partner/sell this technology." http://tinyurl.com/y9y8qdac
6-22-17: Nature/BJoC, Dr. Alan Schroit/UTSW etal: "Detection of PS+ Exosomes for the Diagnosis of Early-Stage Breast & Pancreatic [Betabody KL15C]" http://tinyurl.com/yd3n5kbk
2-9-17/PR: PS+ Exosomes Proof-of-Concept Data (N=44, Ovarian, Dr. Alan Schroit/UTSW etal) pub. 1-22-17 in OncoTarget http://tinyurl.com/jhv57ua
...Data (blinded plasma from 34 O.C. pts & 10 healthy subjects) supports the “high diagnostic power” of PS+ Exosomes in Ovarian Malignancies.
...Dr. Stephen Worsley (VP/BusDev): “...we believe this has potential app's in several solid tumors beyond ovarian cancer. With that in mind, we look forward to aligning with a partner to help explore the potential of this promising technology."
...PPHM’s PS Exosomes platform advantages outlined: UTSW/website and World Patent #WO/2016/201064: http://tinyurl.com/zbwr7cc
......U.S. Patent app. #20170146542 “DIAGNOSTIC TEST FOR EARLY STAGE CANCER” pub. 5-25-17 (A.Schroit, S.Ward, A.Gazdar) http://tinyurl.com/y7clom9w
7-14-16: Peregrine Licenses Exosome-based technology from UTSW (Inventors: Alan Schroit/Philip Thorpe) http://tinyurl.com/zszd4fj
...“relates to assays that are able to detect small amts of PS+ Exosomes in a patient's blood sample as a way to detect cancer at a very early stage of development.”
...Dr. Jeff Hutchins (VP/PreclinRES): "Once we have successfully validated this assay, we plan to establish proof-of-concept through an efficient preclinical & clinical testing pgm. We have no intention of conducting further development work beyond the proof-of-concept stage. Rather, we expect to initiate partnering discussions for commercialization of this pgm in 2017."
3 NCCN Bavituximab Trials Announced 9-6-16 ($2mm grant from PPHM) http://tinyurl.com/gutgwb5
#1: Ph1/HepC-Related Hepatocellular(Liver) (Bavi+RAD+Bayer’s Nexavar=Sorafenib), MOFFITT CC (N=18)
. . . . . . .PI: Jessica Frakes, MD https://clinicaltrials.gov/ct2/show/NCT02989870 <=Recruiting a/o 3-27-17
#2: Ph2/Newly Diag. Glioblastoma (Bavi+RAD+Merck’s Temodar), MASS-GEN. & DANA FARBER (N=36)
. . . . . . .PI: Elizabeth Gerstner, MD https://clinicaltrials.gov/ct2/show/NCT0313991 <=Recruiting/6-16-17; 1stDose/9-7-17
#3: Ph2/Progressive Squamous Head+Neck (Bavi+Merck’s Keytruda), JOHNS-HOPKINS(Sidney Kimmel CC)
. . . . . . .PI: Ranee Mehra, MD https://clinicaltrials.gov/ct2/show/XXXXXXXXX - See Dr. R.Mehra Jan'17/IFN-y Biomarker: http://tinyurl.com/h8gzkww
BAVITUXIMAB "SUNRISE" PHASE III TRIAL: http://www.SunriseTrial.com (Start=Dec'13 EstPrimComp=Dec’16)
A. Phase III Bavi+Doce vs. 2nd-Line NSCLC "SUNRISE" (randomized, double-blind, placebo-ctl'd, n=582)
USA Protocol: http://www.clinicaltrials.gov/ct2/show/NCT01999673 <=chgd. to "Active, Not Recruiting." 2-1-16
...2 ARMS: A=BAVI/3mg+DOCE(Weekly), B=Doce+Placebo(Weekly)
...ECOG's: Ph3SUNRISE/0-1, Ph2Bavi+Doce(n=120)/0-1-2, Ph2Bavi+Durva(AZN)/0-1, Ph3Herbst2010/0-1 (2L/NSCLC)
...161 sites a/o 7-9-15 (USA/39 Aus/9 Bel/7 Fr/9 Ger/15 Greece/10 Hungary/7 Italy/10 Korea/9 Rom/6 Rus/8 Spain/16 Taiwan/10 Ukraine/6) - Growth: http://tinyurl.com/qbemrr2
...Sunrise Biomarker studies - 4 announced thru ASCO'17, see http://tinyurl.com/ydhf6tfx
......#1 10-10-16/ESMO’16: B2GPI/200-240(30%pts) StatSig MOS 7.7=>13.2mos. http://tinyurl.com/hp73njt
......#2 12-7-16/WCLC’16(IASLC): “Complement & IL-10 Pathways: Pts Benefiting from Bavi+Doce” <=Presentation CANCELLED/”Anal.Not.Finished(IR)” http://tinyurl.com/z8cq8vx
......#3 4-3-17/AACR'17: "IFN-y Analysis In Blood & Tissue as a Potential Prognostic and/or Predictive Biomarker” See: http://tinyurl.com/ktzr782
......#4 6-3-17/ASCO'17: "Prelim. Correlative Analysis of PD-L1 Expression from the Sunrise Study” See ASCO'17: http://tinyurl.com/y93upatl
9-9-17/ESMO’17(Madrid): Final SUNRISE Ph3 Data to be presented (poster# 1364P) http://tinyurl.com/yb9kjutp
..."In an exploratory analysis of OS for pts who received subsequent immune checkpoint inhibitors (ICI), mOS was not reached.”
2-25-16: IDMC Halts SUNRISE at 1st Look-in. Bavi+Doce arm “OS performing as expected”; Doce arm “dramatically outperforming OS expectations” http://tinyurl.com/jbg48vs
...CC Replay: http://edge.media-server.com/m/p/xfa9fy5v 12:22/Q&A: RahulJasuja/Noble, “You said that the performance of the Doce/Ctl arm was higher than ever seen in such a trial?” - SK “Yes, we've never seen these #'s reported. It's quite perplexing… at this point, the performance of the Doce arm was just completely out in left field.”
2-1-16: SUNRISE Trial status updated: “Study ongoing, but not recruiting.” http://www.clinicaltrials.gov/ct2/show/NCT01999673
12-10-15: “Sunrise >90% enrolled; sufficient to allow the 2 planned interim looks (33%/50%) & final readout based on PrimEndPt=OS” http://tinyurl.com/jkp885g
5-31-14 ASCO’14: David Gerber/Joe Shan Poster on Ph3/SUNRISE Trial (#TPS8129) http://tinyurl.com/nv4jloo
3-7-14: PR & Conf-Call: "first patients enrolled and dosed." http://tinyurl.com/kh9cnrg
1-6-14: FDA grants FAST TRACK status to Bavi in 2ndLine NSCLC http://tinyurl.com/l799ukk
12-30-13: Pivotal Ph.3 ‘SUNRISE’ NSCLC Trial Initiated (n=~600, sites=100+) http://tinyurl.com/kdjb9qz
5-20-13: FDA Approves Bavituximab Ph.III Design for 2L/NSCLC; 600-pt trial to begin by y/e’13 http://tinyurl.com/n3dxtm6
...S.King: “We will now focus on starting the Ph.III trial while continuing ongoing partnering discussions.”
…R.Garnick: “This was a highly collaborative effort with the FDA; this trial, when combined with Bavi’s supporting data to date, could be sufficient to support a future BLA submission."
15 COMPLETED PH. I/II BAVITUXIMAB CANCER TRIALS (2005-2015):
These 2nd 10 (latest ones, 2010-2015) completed Ph.1/2 Bavi Trials archived to: http://tinyurl.com/ybjap4fb
O. 6th IST Trial: Bavi+Ipilimumab(Yervoy) vs. Adv.Melanoma (Ph1b, random, open-lab, 2arms, n=24)
N. 5th IST Trial (Bavi+Capecitabine+RAD) vs. Rectal Cancer (Ph1, open-lab, 1arm, n=18)
M. Tumor Imaging/Dosimetry trial of I124-PGN650 (FH-Bavi) in Adv. Solid Tumors (Ph0, open-lab, 1arm, n=12)
L. 4th IST Trial (Bavi+Cabazitaxel vs. PROSTATE, open-lab Ph.1B/IIA) CANCELLED/SOC-Chg.
K. 3rd IST Trial (Bavi+PemCarbo vs. Frontline NSCLC, open-lab Ph.1B, n=25)
J. 2nd IST Trial (Bavi+Paclitaxel(Taxol) vs. Her2- Met. Breast Cancer, open-lab Ph.1, n=14)
I. Ph.II Bavi+GEM vs. Front-Line Adv. PANCREATIC (randomized, unblinded, n=70)
H. 1st IST Ph.I/II Trial (Bavi+Sorafenib vs. Liver, open-lab, n=9+38=47)
G. Ph.IIb Bavi+PC vs. Front-Line NSCLC (randomized, unblinded, 'confirmatory', n=86)
F. LEAD IND: Phase IIb Bavi+Doce vs. 2nd-Line NSCLC (random/double-blind, n=120, 'registrational')
These 1st 5 (oldest ones, 2005-2009) completed Ph.1/2 Bavi Trials archived to: http://tinyurl.com/72dnkfg
1. Ph.1A Bavi/Mono vs. Solid Cancers (USA n=26, 6/2005-6/2009)
2. Ph.1B Bavi+Chemo vs. Solid Cancers (India n=12, 11/2006-5/2007)
3. Ph.2 Bavi+Doce/BREAST/Refractory (RepGA n=46, 1/2008-5/2009): ORR=61%(Her2+=86%), MOS=20.7mos
4. Ph.2 Bavi+PC/BREAST/Frontline (India n=46, 8/2008-9/2009): ORR=74%(Her2+=100%), MOS=23.2mos
5. Ph.2 Bavi+PC/NSCLC/Frontline (India n=49, 6/2008-10/2009): ORR=43%, PFS=6.1mos, MOS=12.4mos
COMPANY UPDATES & ARTICLES: [ PPHM News: http://finance.yahoo.com/q/h?s=PPHM ]
9-11-17 Qtly. Conf. Call (King/Lias/Lytle) Transcript http://tinyurl.com/y9y8qdac
...CEO SK: “For this reason, we have concluded that in order to best position Peregrine’s R&D assets for successful development, they should be advanced by a partner with the appropriate expertise and ample resources to invest in the necessary clinical trials. To that end, we have been working diligently towards the transformation of the overall business to becoming a pure-play CDMO, while assessing the best strategic options for the R&D assets that would allow stockholders to directly see the future value from their continued developments. By partnering & eliminating future R&D expenditures, we believe we are best positioning Avid for future growth. Through reinvestment & expansion, we believe we will attract new customers and extend current contracts that will help position Avid as a leading U.S. CDMO. We are moving forward expeditiously with strategic discussions as we recognize the need to move quickly both from the R&D & CDMO standpoints. We hope to bring this process to completion over the coming months and will update you on our progress.”
7-14-17 Qtly. Conf. Call (King/Shan/Lytle) Transcript http://tinyurl.com/yb4wulvu
...CEO SK: “We are seriously considering the possibility of separating our 2 distinct businesses, Avid and R&D/PS-Targeting.”
3-13-17 Qtly. Conf. Call (King/Shan/Worsley/Lytle) Transcript http://tinyurl.com/grhwjvy
...CEO SK: “We believe the recent improvement of stock price is a growing recognition of the value of Avid, and having the full value of the Avid business reflected in our stock price is a top priority.”
12-12-16 Qtly. Conf. Call (King/Shan/Hutchins/Lytle) Transcript http://tinyurl.com/hhn4gga
...CEO SK: “Our goal is to bring the overall company to profitability within the next 18mos. We believe just the value of Avid Bioservices is far greater than our current market cap and is only growing in value."
10-13-16 Peregrine's ASM: ATTENDEE Reports & Link to CEO Steve King's 35min/45slide webcast: http://tinyurl.com/jx7ouay
9-8-16 Qtly. Conf. Call (King/Shan/Garnick/Hutchins/Lytle) Transcript http://tinyurl.com/jydtkoy
...CEO SK: “Our ultimate goal remains to reach overall profitability within the next 21mos, and Avid will be an important driver for achieving that goal, in combination with making strategic investments in our R&D while pursuing partnerships to help advance our programs.”
7-14-16 Qtly. Conf. Call (King/Garnick/Hutchins/Shan/Lytle) Transcript http://tinyurl.com/h8eqtg5 (Avid revs guidance for FY17=$50-55mm, curr. committed B/L=$68mm)
...CEO SK: “The recent licensing of Novel PS Exosome Tech. for detection/monitoring of cancer from UTSW will allow the co. to continue its R&D activities with significant upside coming from partnering as we move towards profitability.”
6-2-16: Corp.Update – Avid Expansion & Drug Development - http://tinyurl.com/zvmhqmr
...Avid Revs for FY16(fye 4-30-16) will be $44mm; B/L=$56M; FY17/guidance=$50-55mm(3 curr. clients). Avid III being designed/already secured 25,000sf loc/expect complete=1H/2017. “Expect future sustainable profitability for the company in 24mos.”
3-9-16 Qtly. Conf. Call (King/Shan/Worsley/Lytle) Transcript http://tinyurl.com/gom7md5
...CEO SK: “Peregrine remains a strong company with a valuable clinical asset and a rapidly growing biomfg. business... We believe our relationships with AstraZeneca, Mem. Sloan Kettering, UTSW, & NCCN will be invaluable as we establish & execute our overall strategy for advancing the bavituximab I-O combination plans in a range of cancers.”
3-7-16: Formal Commissioning of Avid's New 40,000sq "Myford" Facility, “single-use/fully disposable” (potentially $40M addl revs) http://tinyurl.com/za2j9mt
2-25-16: IDMC Halts Ph.3/NSCLC SUNRISE Trial at 1st Look-in. Bavi+Doce arm “OS performing as expected”; Doce arm “dramatically outperforming OS expectations” http://tinyurl.com/jbg48vs
1-18-16: CEO Steve King's 1-18-16 presentation at Noble-Financial's Investor Conf. (21min replay, 31 slides) http://tinyurl.com/j9dkekm
1-11-16: Update on 4 New Bavi Clinical Trials (Lung/AZN, Breast/1Co./1MSKCC, Other Cancers/AZN). SUNRISE est's: Look1=Early'16, Look2=Mid'16, FinalUnblind=End'16 http://tinyurl.com/zhdy37a
1-6-16: Peregrine enters into Research Collab. with Natl-Comprehensive-Cancer-Network (NCCN) http://tinyurl.com/zmxtpsb
...$2mm res. grant to NCCN's Oncology Res. Pgm (ORP), will “significantly expand our clinical evaluation of Bavi and augment Peregrine's IST pgm at 26 of the world's leading cancer centers”.
12-10-15 Qtly. Conf. Call (King/Shan/Worsley/Garnick/Lytle) Transcript http://tinyurl.com/jkp885g
...CEO SK: “Although our SUNRISE enrollment milestone has been reached, we have no intention of slowing down, quite the opposite. We are aggressively moving to initiate new clinical trials [Lung, Breast, Mult-Types] that will allow us to build the most robust oncology business possible… With each of these studies our goal is the same - we are committed to identifying key indications, patient populations, and therapeutics that can benefit from combination treatment with bavituximab. From what we have seen to-date, the opportunity appears vast and we are hard at work converting the most promising prospects into true value.”
10-15-15 Peregrine's ASM: ATTENDEE Reports & Link to SK's 18min/16slide webcast: http://tinyurl.com/o6z4bm4
10-15-15: Peregrine & AstraZeneca Expand Collab. w/Ph2/2ndLine-NSCLC Trial, Bavi+Imfinzi(durvalumab), squamous or non-squamous. http://tinyurl.com/q79bkam
9-9-15 Qtly. Conf. Call (King/Shan/Worsley/Lytle) Transcript http://tinyurl.com/ph22vdn
...CEO S.King: “The Memorial Sloan Kettering & AstraZeneca collaborations are an important part of our announced plans to expand our bavituximab clinical pgm.”
8-24-15: AstraZeneca & Peregrine Collaborate on Bavi+Imfinzi(durvalumab) Ph1/1B Trial for “multiple solid tumors” http://tinyurl.com/owlxpsf
...Imfinzi=durvalumab=MEDI4736(anti-PD-L1 immune checkpoint inhibitor). AZN’s Head/I-O(Robert Iannone): “Our partnership with Peregrine provides the opportunity to explore an exciting, novel combination that could deliver important clinical benefit to patients across a range of cancers."
7-14-15 Qtly. Conf. Call (King/Shan/Hutchins/Lytle) Transcript http://tinyurl.com/nw2v5u6
...CEO S.King: “We recently entered into collaboration with investigators at Memorial Sloan Kettering Cancer Ctr to continue expanding on this important work, as well as to explore other potential applications of bavituximab and other agents that target PS-signaling pathway.”
5-29-15: Peregrine & Sloan Kettering Enter Collab. to “Investigate Novel PS-Targeting Immunotherapy Combos” http://tinyurl.com/o3k9ux8
3-12-15 Qtly. Conf. Call (King/Garnick/Shan/Hutchins/Lytle) Transcript http://tinyurl.com/q78oxvm
...CEO S.King: “Bavituximab represents the most clinically advanced agents that target the immunosuppressive PS signaling pathway, and we are driven to bring this product to the market and believe it has the potential to help change the way cancer patients are treated. Our Ph.3 SUNRISE NSCLC trial continues to make great progress & is on track to complete enrollment in the study by YrEnd’15.”
3-9-15: CEO Steve King’s 24min. talk at ROTH Conf. (DanaPT CA) - SLIDES http://tinyurl.com/p873grw
12-10-14 Qtly. Conf. Call (King/Shan/Hutchins/Lytle) Transcript http://tinyurl.com/kmdgq8t
...CEO S.King: “We believe Peregrine is in a unique position with an immune-oncology program already in Phase III, with what has been a positive safety profile and a target that is ideal for combining with other IO agents.”
10-16-14 Peregrine's ASM: Slides(42), Audio-Replay-Link, Attendee-Reports http://tinyurl.com/oyc3e5v
9-9-14 Qtly. Conf. Call (King/Hutchins/Shan/Lytle) Transcript http://tinyurl.com/ktrfswj
...CEO S.King: “In addition to our clinical trials, many of which have also have translational data points built in to tie together pre-clin. data with the clinic, we have also continued to build momentum in our pre-clin. collaborations which now number in the dozens. We are evaluating new combinations & dosing strategies combining bavituximab with chemotherapy, radiation, and immune-oncology approaches, including those targeting CTLA-4, PD-1, as well as other downstream immune checkpoints."
7-14-14 Qtly. Conf. Call (King/Shan/Hutchins/Worsley/Lytle) Transcript http://tinyurl.com/o2e4a4g
...CEO S.King: “Partnering remains a priority with the goal being to use partnerships to continue expanding the bavituximab program, while we continue to execute the SUNRISE Phase III trial.”
3-10-14: CEO Steve King’s 22min. talk at ROTH Conf. (DanaPT CA) - SLIDES http://tinyurl.com/n65myfk
3-7-14 Qtly. Conf. Call (King/Shan/Garnick/Lytle) Transcript http://tinyurl.com/kh9cnrg
...CEO S.King: “I don't want to overuse the word ‘excitement’, but these are truly exciting times that have positioned us for success on all fronts.”
12-10-13 Qtly. Conf. Call (King/Shan/Garnick/Hutchins/Worsley/Lytle) Transcript http://tinyurl.com/mw776mk
...With recent scientific insights highlighting bavi’s immunostimulatory moa, these additions to PPHM’s SAB: Dimitry Gabrilovich, Scott Antonia, David Carbone, Hakan Mellstedt
...CEO S.King: “We believe that Peregrine is uniquely positioned among the companies developing immunotherapies… and that because of our current valuation, we represent a unique investment opportunity.”
11-2013: Stephen Worsley joins Peregrine as VP of Bus.Dev. http://tinyurl.com/mmet4eb
11-12-13: CEO Steve King's 23min. talk at Credit-Suisse Conf. (Scottsdale) http://tinyurl.com/nu3vxgt
9-9-13 Qtly. Conf. Call (King/Hutchins/Shan/Lytle) Transcript http://tinyurl.com/q3zooj6
...CEO S.King: “In addition to the immunotherapy research, there has been significant interest in the results presented at ASCO showing an 84% tumor response rate in HER2- breast cancer patients.”
8-14-13: CEO Steve King's 26min. talk at Wedbush/NYC http://tinyurl.com/m22n9pl - SK. "We have very active partnering discussions [ongoing] around our 2 lead programs.”
7-11-13 Qtly. Conf. Call (King/Shan/Garnick/Lytle) Transcript http://tinyurl.com/khpokw6
...CEO S.King: “This [new bavi] moa insight has opened the door to completely new combinations not previously explored. Bavi acts on an upstream immune checkpoint, and thus, makes a potentially ideal combination with downstream-acting immune checkpoint inhibitors such as anti PD1 antibodies & CTLA-4 targeted approaches… Preclinical studies are well underway to explore these combinations, and we look forward to generating and reporting data later this year that could support moving these concepts into the clinic.”
6-27-13: Updates on Bavituximab Pgm. & Cash Position http://tinyurl.com/pmcgsgp
…“primary focus remains on the init. of the PhIII trial in 2nd-Line NSCLC by y/e; recent data supporting an immunotherapy moa for bavituximab opens many new development opportunities including new combinations not previously planned and has created a lot of excitement around the potential of bavituximab in combination with other immunotherapeutic agents…"
4-2-13: Peregrine Mourns Loss of Dr. Philip E. Thorpe (1951-2013) http://tinyurl.com/c5zhd4q
3-18-13: CEO Steve King's 27min. talk at Roth Conf.(DanaPT CA) - Excerpts & SLIDES http://tinyurl.com/cebtwen
…CEO S.King: "Our goal is to initiate the Phase III trial (2ndLine NSCLC) by the end of 2013."
3-12-13 Qtly. Conf. Call (King/Shan/Garnick/Lytle) Transcript http://tinyurl.com/c48osut
...Rob Garnick (Head/Reg.): "Re: 2nd-Line NSCLC: …the 3rd piece, which is important, is the efficacy piece, and as I point out to many people, there are very few and far between Phase II trials that ever show statistical significance in efficacy - that's an absolutely unbelievable hurdle for a Phase II product. And, what you're really looking for is an ability to describe that you do have clinical efficacy, and as Joe has said, showing 11.7 mos. for the 3mg arm and a difference in the pooled dataset for the product of 7.3 mos. when you combine the control & the placebo, definitely gives you the indication that in overall survival, we have a potentially highly efficacious product… we're going to discuss the entire situation of the investigation with the agency, as well as all the data I just described, and we feel pretty confident that we have enough data to move the product effectively into Phase III."
3-5-13: CEO Steve King's 24min. talk at Cowen HC Conf.(Boston) - Excepts & SLIDES http://tinyurl.com/bczyfb3
12-10-12 Qtly. Conf. Call (King/Garnick/Shan/Lytle) Transcript http://tinyurl.com/a954bmw
...CEO Steve King: "The goal of this (2nd-Line NSCLC ) review is to be able to generate a final data set that we believe could be used in discussions with the FDA to support advancing the program into a pivotal trial. Our partnering phase for Bavi has not changed. The partnering discussions are still ongoing, with potential partners remaining engaged, and like all of us, awaiting the outcome from this review…"
...Rob Garnick (Head/Reg.): "(Re: Cotara FDA-Approved Ph3 Design), we're pivoting right now and following the discussions with the FDA to discuss the same trial design plan with the Eur. agency and as well as potentially other global regulatory authorities. So, it's going to take a lot of effort and a lot of time, but we're very confident that we're going to be able to come up with one unified trial that will accomplish all of our goals."
10-17-12: Corp-Update ($14.3mm/ATM, Avid, Mult-Milestones, ASM Webcast Oct18) http://tinyurl.com/c7gax7y
…PDF of 10-18-12 ASM Presentation/S.King http://tinyurl.com/8e5p6m5 (19 slides), Attendee Reports: http://tinyurl.com/9b2xfzu
9-24-12: Peregrine sues CSM Over Bavi Ph.2B 2nd-Line NSCLC Clinical Trial Mix-Up http://tinyurl.com/8fpgngu
…CSM = Clinical Supplies Management Inc., Fargo ND http://www.csmondemand.com
9-25-12: Peregrine Pays Off $15mm Loan from Oxford, triggered by 3rd-party data error: http://tinyurl.com/9pucqn8
……"we will have sufficient capital to fund our operations into Q4'13 based on current projections."
...8-30-12: $30mm Loan ($15mm/immed, $15mm/option) from Oxford Fin. http://tinyurl.com/cm2lkgs 8K: http://tinyurl.com/9hedbaf
9-2012 PPHM's 2012 Annual Report: Theme => "Transformation" http://tinyurl.com/8myww6w
9-10-12 Qtly. Conf. Call (King/Shan/Garnick/Lytle) Transcript http://tinyurl.com/8nkwrml
...CEO Steve King: "These are truly remarkable results that are not only great for the pgm… but also great news for the NSCLC patients in the trial…"
...Rob Garnick (Head/Reg.): "The NSCLC data we announced 9-7-12 has far exceeded our expectations, and I hope that you're as excited as I am with bavituximab's potential. I feel strongly that Peregrine should be recognized for having the corporate courage to conduct the rigorous, randomized placebo-controlled Phase II trial that provided these robust data and that provide the basis for us to plan for a pivotal Phase III program.."
...CFO Paul Lytle: "As you can imagine, given the Bavi results that we shared with you on Friday [9-7-12 2nd-Line NSCLC], our partnering activities are continuing at a very active pace as we move closer towards the EOP2 meeting with the FDA. Our stated goal is to have a partner on board before we start the Phase III trial and, preferably, before the EOP2 meeting with the FDA, as we would like our future partner to be a part of that important meeting."
9-5-12: CEO Steve King's 26min. talk at Stifel-Nicolaus/Boston http://tinyurl.com/cr65pug
8-30-12: $30mm Term-Loan Secured ($15mm/immed, $15mm/option) + 273k 6yr firstname.lastname@example.org http://tinyurl.com/cm2lkgs 8K: http://tinyurl.com/9hedbaf
8-15-12: CEO Steve King's 29min. talk at Wedbush/NYC http://tinyurl.com/8mhrtld
…SK: "As we're sitting here today, we have still not reached MOS in either of the Bavi arms in the 2nd-Line NSCLC trial - and, in fact, we still have patients that are on treatments." Q&A: "it's going to be a very positive MOS result, it's just a matter now of magnitude. We've laid out our strategy for financing the company; we've not been raising money thru the capital markets in any way. We're not currently planning on going out for, nor have we been actively involved in any other fund-raising activities. Right now, our stated goal is to pursue a debt-arrangement - with an asset like Avid Bioservices, we can get very preferential rates on raising debt-type funding right now, which we feel is the least-dilutive for the company."
7-16-12 Qtly. Conf. Call (King/Shan/Garnick/Lytle) Transcript http://tinyurl.com/cs7spbz
...Steve King: "The strength of this 2nd-Line NSCLC data (esp. MOS trends) in this large area of high unmet medical need has also sparked a surge in partnering discussions that has included over 15 in-person partnering meetings since that time with major players in oncology, with all discussions ongoing and addl. parties showing interest. Our goal for the program is to position ourselves, along with a potential partner, to initiate Ph3 by mid-2013, which means an EOP2 meeting by yr-end'12. It would be ideal to have a partner on board to participate in the EOP2 meeting, and we have communicated this to interested parties and they agree."
...Robert Garnick: "We've been working very hard and very actively on the next steps in our Bavi 2nd-Line NSCLC pgm, given the favorable data that we've seen. As you can imagine, with data like this, there are many things that we need to consider. One consideration is that, should the data continue to trend the way it is, particularly in survival, this opens a door for potential discussions around a pathway for ACCELERATED APPROVAL. At this point, all options are being considered, with Peregrine working towards the most efficient path forward from a regulatory standpoint." Q&A: "…all in all, I think the data is extremely compelling and I think it makes a really good case. Certainly, I think, I've seen a lot of Ph2 & Ph3 data, and this is as compelling Ph2 data as I've ever seen. So, I'm very comfortable proposing a meeting with the FDA for Q4'12."
7-12-12: CEO Steve King's 26min. talk at JMP/NYC http://tinyurl.com/csdclwb
…SK: "Re: 2L/NSCLC trial, the most thrilling thing is the fact that, even though we had reached the MOS by the cutoff point at the end of April of less than 6mos. for the Doce ctl-arm, the majority of patients are still alive in both Bavi arms, and we expect that to continue for some period of time still."
6-20-12: PPHM hires Securities, Financing, and M&A Attorney Mark Ziebell as VP, General Counsel http://tinyurl.com/7ze229a
3-12-12: CEO Steve King's 24min. talk at ROTH-OC(DanaPT) http://tinyurl.com/7837qym
…SK: "I think the best-case result is, if we have just phenomenal results out of this study (2ndLine-NSCLC), that we would obviously talk to the FDA about Accelerated Approval; that was our intention to begin with."
3-9-12 Qtly. Conf. Call (King/Shan/Garnick/Lytle) Transcript http://tinyurl.com/7t2xsks
…Rob Garnick, "re: 1st-Line NSCLC, I personally don't read a lot into ORR data nor PFS and really go for the std. that really counts that's unequivocal & relatively straightforward to measure, which is MOS, and I think we have to wait for those results in order to make any judgment. And on top of that, I'd like to point out that our primary goal is in 2nd-line NSCLC, which is a disease with very low response rates in general (10% or 11%), and what we're expecting to show there is a real increase ultimately in survival. And, if we see that, that's what we'll take forward into a Phase III pivotal trial."
2-14-12: CEO Steve King's 24min. talk at BIO-CEO/2012 (NYC) - slides & excerpts http://tinyurl.com/86wque8
…SK: "Our pipeline is completely unencumbered, so as we look into 2012 & beyond, we think we can bring in significant monies thru partnering deals which will help us move the programs forward."
12-12-11 Qtly. Conf. Call (King/Shan/Lytle) Transcript http://tinyurl.com/75rfwrv
…SK, "Our goal is to secure regional partners for our Bavi oncology program, and we look forward to seeing addl. data points from our randomized trials as we advance these discussions. [re: Cotara/GBM Ph3], the FDA has agreed to provide specific feedback to us in writing on our proposed pivotal trial design that we submitted to them."
9-27-11: JMP Securities Healthcare Conf./NYC - SK's Slideshow Capture http://tinyurl.com/3qqslkb
9-9-11 Qtly. Conf. Call (King/Garnick/Shan/Lytle) Transcript http://tinyurl.com/3bx8eat
...Robert Garnick: "As we saw over the last couple of weeks, the most recently approved therapy for NSCLC drugs (Pfizer's crizotinib=Xalkori) can in fact receive Accelerated Approval based on ORR data gen'd from single-arm studies, and we're very eager to assess bavituximab's potential in our ongoing trials."
9-8-11: CEO Steve King presents at Stifel Nicolaus HC/Boston - a few slides, incl. milestones: http://tinyurl.com/3sk8rba
7-14-11 Qtly. Conf. Call (King/Shan/Garnick/Masten/Eso/Lytle) Transcript http://tinyurl.com/6k6y2as
...Robert Garnick: "It's really easier to approach regulatory agencies with promising survival data and a consistent safety profile, which is exactly what we have seen from both bavituximab & Cotara in our clinical trials to date."
6-29-11 Minyanville article, "Peregrine Pharma's Secret Weapon [Robert Garnick]" http://tinyurl.com/3lgoras
…CEO Steve King considers his company fortunate to have someone with Garnick's long history with the FDA. "Rob is the ringmaster," King says.
11-8-11: April Loui (ex-Genentech Sr.Mgr/QA) joins Peregrine as Director/QA http://tinyurl.com/6tzbfkt
5-31-11: Jeff Masten (ex-Genentech Sr.Dir. of Quality) joins Peregrine as VP/Quality http://tinyurl.com/3qxuvso
..."This is an exciting time to join Peregrine, as bavituximab advances through numerous Phase II clinical trials and Cotara's registrational path is being outlined. I look forward to working with CEO Steve King, head of regulatory affairs Rob Garnick, and the extended teams at Peregrine and Avid to drive industry-leading quality programs and facilitate regulatory agency inspections as we support Avid's third-party clients and prepare for potential launch of Peregrine's products."
5-26-11: Dr. Steven Chamow (ex-Genentech) joins Peregrine as Head of Process Science http://tinyurl.com/3bgglxj
5-19-11: Nuclear-Med. & Oncology Specialist Dr. Vladimir Evilevitch (ex-Parexel, ex-Novartis) joins PPHM as Med.Director http://tinyurl.com/3av4red
…"to execute Cotara Regulatory & Clinical strategy"
4-2011: Peregrine adds 2 more "Regulatory" people, Kathryn Hansen (ex-Amgen) & Soheila Dadgostari (ex-Valeant) http://tinyurl.com/3wy4sxm
3-14-11: S.King at Roth-OC/DanaPT - slides & excerpts: http://tinyurl.com/4d2voyy
...SK: "Cotara/GBM Ph.2/40pt enrollment completed in Dec'10; expect top-line by mid'11, We've already begun preparing for an FDA meeting in 2H'11, in which the goal is to get an SPA ("Special Protocol Assessment") approved; at that point, the drug is highly partnerable." [Per David Miller, "the idea is if you sign an SPA with the FDA and conduct the trial as agreed, good results from the trial will be sufficient for marketing approval."]
3-11-11 Qtly. Conf. Call (King/Shan/Thorpe/Lytle) Transcript http://tinyurl.com/4p4hqr5
3-9-11: Dr. Kerstin B. Menander (ex-Abbott) appointed Head of Medical Oncology http://tinyurl.com/4cjlbzn
3-4-11: Reuters' Deena Beasley Interviews Steve King http://tinyurl.com/4c9um52
...SK: "The study [ongoing Ph.2b Bavi+Doce/Refract-NSCLC] could provide the basis for seeking U.S. regulatory approval… This is easily a $1B+ potential drug in NSCLC alone."
12-9-10 Qtly. Conf. Call (King/Shan/Eso/Lytle) Transcript http://tinyurl.com/23kassc
…S.King: "our next planned virus therapy trial will evaluate Bavi+Ribavirin vs. HCV patients… we are planning to initiate addl. Co-sponsored trials & ISTs in the very near future."
11-2-10: Peregrine Awarded $977,917 Therapeutic Discovery Grant http://tinyurl.com/2funn26
10-21-10: Carlton Johnson appointed Chairman of BOD & SHM Results http://tinyurl.com/269zqn5
10-3-10/OCBJ: PPHM Repeats as #1 Growth Co. in OrangeCo. http://tinyurl.com/27cuv7o
...Last-12mos-Rev: $27.9mm, 3yr-Sales-Growth: +358.6%
9-13-10, CEO S.King, R&R/NYC: http://tinyurl.com/23fagxw
…S.King re:TMT: "We're at the point where we're getting into more advanced models of the disease, as well as starting to look at some combination-therapy potential of the drug. The plan now is to complete that evaluation, to firmly establish that pgm going forward - then at that point it'll be a contract modification, and from everything we hear, we s/b moving fwd with addl. animal studies."
9-9-10 Qtly. Conf. Call (King/Eso/Lytle) Transcript http://tinyurl.com/8megkre
…S.King: "[On the AV side], so far every type of virus we have looked at does induce PS exposure on infected cells. And that creates a vast number of opportunities, everything from immunocytokines, which we're currently evaluating as part of our UC Discovery grant work, all the way to targeting nanoparticles, in which you could basically take these nanoparticles, load them with different antivirals depending on the particular type of antiviral indication, and specifically deliver your drugs to the infected cells, reducing the toxicity of the agent and taking advantage of our technology platform. And, there's actually interest in all of those from both funding agencies as well as potential partners down the road. So, I think there's a lot of great utility of that technology platform and the group here is looking at a number of different areas that we really think have pretty dramatic potential from a market standpoint, but also just can build & build on what really is a platform that has so much utility."
9-7-10 PS Patents Granted: 7790860/Imaging 7790159/Antiviral http://tinyurl.com/27zlc8a
8-2010/IF LINKEDIN IS RIGHT: Dr. Shelley Suggett (ex-Genentech Sr.Product.Dir/Regulatory) joins PPHM as Director, Regulatory Affairs http://tinyurl.com/3lmw22s
7-14-10 Qtly. Conf. Call (King/Garnick/Shan/Eso/Lytle) Transcript http://tinyurl.com/3a4p66c
…Robert Garnick: "I like to end by again saying how optimistic I am about bavituximab's potential. The growing body of research points to bavituximab potentially providing a unique & valuable new approach for the treatment of cancer. The clinical results we have to date support moving forward with our regulatory strategy to advance this novel antibody."
6-14-10: PPHM set to join Russell 3000 - reconstitution occurs 6-28-10: http://tinyurl.com/2d87y3z
6-9-10 CFO Paul Lytle's 26min. talk at Needham HealthCare Conf./NYC http://tinyurl.com/2wt2gc7
...See slide5: considerable discussion of possible addl. Gov't Contracts & Grants, like new IRS "Therapeutic Discovery Proj. Pgm" (max=$5mm).
5-18-10: CEO Steve King's 20min. talk at R&R HealthcareConf/London http://tinyurl.com/23wqam9
…SK: "based on these [Bavi Ph.2] clinical data and our interactions with the FDA, we're in the process of operationalizing a Phase IIb Registrational Trial [Bavi+Doce 2nd-line NSCLC]. We're referring to this as a "registrational trial" because one potential is if we anywhere close to approximate the results we've seen in a prior study, this could be an opening for Accelerated Product Approval."
3-17-10: CEO Steve King's 23min. talk at ROTH Stock Conf. (DanaPT CA) http://tinyurl.com/ye9v7jq
…SK: "And then we have a real interesting part of the portfolio, which is our Bavi VHF pgm. This is completely funded by the DOD… evaluating Bavi for the treatment or prevention of VHF. What's interesting about this compound is this would not take a typical Phase1-2-3 approval approach, but rather likely go thru the FDA's "Animal Rule", which means that it basically would have animal efficacy data, combined with human safety data, which we're obviously generating a lot of, and then it would be applied for approval based on those 2 things. So this could be a much shorter entry point into an actual product that could be acquired by the gov't to stockpile as part of its biodefense efforts."
3-11-10 Qtly. Conf. Call (King/Lytle/Shan/Eso) Transcript http://tinyurl.com/yl4befh
…SK (resp. to Joe Pantginis question re: bus.dev. strategy for Bavi): "Clearly there is a lot of interest in the bavituximab pgm - novel monoclonal antibody therapies with an interesting target that has broad-spectrum capabilities in multiple indications - clearly there are not a lot of those out there… we have a lot of interested parties; we will continue to keep those potential partners updated on our clinical trial progress."
2-9-10: CEO Steve King's 23min. talk at BIO-CEO/2010 (NYC) http://tinyurl.com/ykxznha
…SK: "what we're most intrigued about is Bavi's potential in Refractory Disease, which of course is the fastest route to product approval."
1-13-10: CEO Steve King's 16min. talk at OneMedForum2010 (SanFran) http://tinyurl.com/yb7v2u4
…SK: "The [next] study we have discussed with the FDA is Bavi+Doce in 2nd-line NSCLC. In this patient population, they have about a 6% resp. rate; so, a high unmet medical need, and we think an excellent opportunity for development. The trial design we've agreed to with the FDA is essentially a registrational Ph.2 design; it's going to be about a 120 patient study, double-blinded, placebo-controlled… the goal being, if we see positive results & excellent results, that we really want to be able to take advantage of that and potentially approach the agency about Accelerated Approval."
1-11-10: Dr. Marvin Garovoy (Ex-XOMA VP) joins PPHM as Head/Clin.Science http://tinyurl.com/yz4fwyv
…Dr. Garovoy will have primary responsibility for establishing & supervising an Investigator-Sponsored Trials (IST) pgm, as well as expanding scientific outreach & assisting with clinical trial design for the Bavi & Cotara pgms.
…CEO SK: "These ISTs can be a very important part of our overall clinical dev. pgm, potentially providing invaluable info. that might not otherwise be obtained from our company-initiated trials."
…Dr. Garovoy, "Bavituximab is a promising new approach with broad potential for the treatment of solid cancers and other diseases. Based on the encouraging results seen in early clinical trials, I welcome the opportunity to collaborate with clinical researchers to establish the investigator-sponsored studies that will enhance our understanding of the clinical potential of this exciting new agent."
ARTICLES, ANNUAL SHM'S, & CC'S - Archive 2005-2009: http://tinyurl.com/6pjqt27
BAVITUXIMAB ANTI-CANCER NEWS (see above for Trials Info):
4-4-17: AACR'17: 5 posters, incl. new 2nd MSKCC/Wolchok Bavi+ACT study - http://tinyurl.com/m7868sx
4-20-16 AACR'16 & 4-4-16/Cancer-Immunology-Res.(AACR) article - preclin. data: Bavi combo w/anti-PD-1/anti-CTLA-4 “induces a shift in tumor microenvironment from immunosuppressive to immune active” http://tinyurl.com/jyox458
6-1-15 ASCO’15: 3 Bavi/AntiPS Posters (NSCLC, Melanoma, Breast, Liver) & Plans to add Ph2/3 Bavi Trials (NSCLC/Optivo, Her2- Breast) http://tinyurl.com/qxu4w2x
4-20-15 AACR’15: 3 Abstracts/2 PR’s - Bavi Clinical TransData/Lung & PreClinData/Melanoma/Breast – Moffitt/S.Antonia, UTSW/R.Brekken, UC-Irvine/CW.Hughes, Peregrine http://tinyurl.com/n7e7r7p
4-2014 AACR'14: Peregrine's 3 preclin. posters http://tinyurl.com/k4fl8z6
...about Bavi as an “Upstream PS Checkpoint Inhibitor”; notably, “when combined with downstream immune checkpoint inhibitors such as anti-CTLA-4 and anti-PD-1, PS targeting mediates an improved protective tumor-specific immunity following tumor rechallenge”, and, “combination of bavituximab with the anti-PD-1 checkpoint blockade should synergistically induce potent long-lasting antitumor immunity.”
4-2013 AACR'13: Peregrine's 3 preclin. posters http://tinyurl.com/cnqx9oh
..."data on the immune stimulating moa of Bavi, anti-tumor & imaging potential of other PS-targeting constructs"
10-31-12, New PS-Targeting Preclin. Data - Mabs Stimulate Cancer-Fighting Immune Responses & Specifically Target Tumors http://tinyurl.com/cw9odb8
…10-25-12 SITC Poster describes Bavi's 3-pronged MOA, and 10-10-12 Nuclear Medicine & Biology article on "ImmunoPET Imaging of PS" using 89Zr-PGN635.
8-2-12: Texas CPRIT grants Philip Thorpe $1.4mm in $4.1mm Lung Cancer Project (SRBT/Rad+AntiPS) http://tinyurl.com/clhzbx2
. . .Dr. Thorpe's Project4 "Lay Summary" => http://www.cprit.state.tx.us/files/funded-grants/RP120670-P4.pdf
5-1-12 Audio replays of the NYAS Anti-PS Symposium (NYC) now at NYAS.org: http://tinyurl.com/7w3kpuc
…The 5 Speakers were: Alan Schroit, David Ucker, Ari Helenius, Chris Reutelingsperger, Philip Thorpe => Dr.Thorpe's 46min talk: http://tinyurl.com/d6vtsrr
4-2012: UPenn & Dr.Thorpe Neoplasia article on PGN635 vs. Lung Cancer http://tinyurl.com/7dynlzr
…on the potential benefits of treating with fhBavi+Chemo (PGN635+cis) AFTER Surgery - an approach offering "significant promise to prevent lung cancer recurrences."; also contrasts Bavi vs. Avastin on side effects.
4-2012 AACR'12: 7 Posters (3 Bavi/IST's, 3 Bavi/antiPS pre-clin, 1 TNT-Imaging) http://tinyurl.com/7yrwqm7 (see #2452)
…Peregrine Launches PS-Targeting Clinical Imaging Pgm. (fully-human 124I-PGN650), IND recently filed.
8-2011: Gerber/Thorpe IMMUNOTHERAPY article on Bavi+Chemo/NSCLC http://tinyurl.com/3gzd6g5
...Obviously resulting from: 6-10-09 ASCO $200k Grant to UTSW's David Gerber for New Bavi/NSCLC Study: http://tinyurl.com/nt4na9
6-2011 Dr. Philip Thorpe article in VACCINE on the "Anti-PS Fusion Protein" 2aG4-IL2: http://tinyurl.com/3o6aq7p
…"Enhancing The Potency of a Whole-Cell Breast Cancer Vaccine in Mice with an Antibody-IL-2 Immunocytokine that Targets Exposed PS"
5-26-11: Dr. Philip Thorpe Keynotes Bavi/PS MOA at Recombinant-Antibodies Conf. in Barcelona http://tinyurl.com/3klpodc
…Dr. Thorpe, "What is especially exciting is that administration of PS-targeting antibodies like bavituximab breaks the grip of the tumor on the immune system."
...A few of the more illustrative slides from Dr. Thorpe's 5-26-11 talk: http://tinyurl.com/3m33h33 . . .PT's entire 53-pg PDF: http://tinyurl.com/3ck56gr
4-5-11 AACR'11 #3643: Sorafenib Enhances Anti-tumor Effects of Bavi in Liver Cancer (HCC) http://tinyurl.com/3fzubz3
…Dr.Thorpe: "These data suggest that the growth-blocking mechanisms of sorafenib combined with the vascular-targeting & immune-reactivation mechanisms of bavituximab may offer additive anti-tumor effects for patients with HCC."
4-6-11 AACR'11: Peregrine's 4 PS-Targeting Presentations http://tinyurl.com/68p9zs4
…#621/ADT-Prostate, #3651/AntiPS-MOA, #3643/Sorafenib-Liver, #4880/FH-Bavi-Imaging
3-24-11: Phil Thorpe, E.Ward, R.Ober, R.Mason awarded $6.0mm by Texas CPRIT http://tinyurl.com/4c2sm4k & http://tinyurl.com/65fjmpw
…"to develop a new class of [Anti-PS] therapeutics to treat cancers involving the brain & nervous systems, breast, liver, interhepatic bile duct, lung, bronchs, and prostate."
...…8-2011: UTSW Article about 3-2011 $6.0mm CPRIT Award to Thorpe/etal for AntiPS dev. http://tinyurl.com/4339hwp
......11-2011: UT-Dallas Article about Dr. Raimund Ober's role in 3-2011 $6.0mm CPRIT Award for AntiPS dev. http://tinyurl.com/3prrkm3
12-1-10: Dr. Phil Thorpe co-author of J.Clin.Investigation article about "novel therapies" for APS thrombus issues http://tinyurl.com/24ddq8h
…APS (antiphospholipid syndrome) can cause life-threatening clotting disorders. One of the mabs tested was 2aG4 (mouse model of Bavi).
4-12-10: IST program (Investigator Sponsored Trials) launched: http://tinyurl.com/y3yh5h3 & PeregrineInc/IST's
AACR'10 #1919 4-19-10: PS-Targeting Mabs Can Reverse Tumor-Induced Immune Suppression http://tinyurl.com/y266azk
…Dr. Thorpe, "This study shows that the immunosuppressive effects of PS exposed on apoptotic tumor cells can be reversed by PS-targeting antibodies, specifically by reversing the suppression of DC maturation caused by the exposed PS. This finding is important since reactivation of the immune system after the primary tumor has been removed is a critical line of defense in fighting cancer recurrence. Additionally, we showed that PS-targeting antibodies have the ability to confer tumor-specific immunity, which could lead to the future development of new cancer vaccine regimens."
4-21-10, AACR'10, 3 Wed. Posters (#5337,5330,5232) http://tinyurl.com/y65nyfc
BAVITUXIMAB ANTI-CANCER NEWS - Archive 2004-2009: http://tinyurl.com/6pjqt27
IMAGING APPLICATIONS Of PS-TARGETING MABS:
5-25-16/OncoTarget, “PS-Targeted Liposome [PGN635=Fhu-Bavi] For Enhanced Glioma-Selective Imaging” - Wake Forest's Dawen Zhao & UTSW's Liang Zhang http://tinyurl.com/z6lzkqm
6-2014: Two Bavi-Imaging abstracts by UTSW at Society of Nuclear Med+Molecular Imaging (SNMMI) Annual Mtg http://tinyurl.com/kemdu2d
11-26-13: PGN635 (Fhu-Bavi) Imaging article in Molecules2013 by UTSW’s Liang Zhang & Dawen Zhao http://tinyurl.com/mxzodta
12-19-13/PLOS/Philip Thorpe: “Highly Specific PET Imaging of Prostate Tumors in Mice with an Iodine-124-Labeled Antibody Fragment That Targets PS” https://doi.org/10.1371/journal.pone.0084864
10-31-12, New PS-Targeting Preclin. Data - Mabs Stimulate Cancer-Fighting Immune Responses & Specifically Target Tumors http://tinyurl.com/cw9odb8
…10-25-12 SITC Poster on Bavi's MOA, and 10-10-12 NMBA article on "ImmunoPET Imaging of PS" using 89Zr-PGN635 (see Genentech below)
10-12-12: Genentech studying Imaging using PGN635(Fhu-Bavi) for the potential "detection of tumor response to therapy". http://tinyurl.com/8wvem9y
…Nuclear Medicine & Biology, Genentech's Jan Marik, "ImmunoPET Imaging of PS in Pro-Apoptotic Therapy Treated Tumor Models"
4-3-12: Peregrine Launches PS-Targeting Clinical Imaging Program (AACR'12 #2452) http://tinyurl.com/7p7jovt & http://tinyurl.com/7yrwqm7
…PPHM "recently filed an IND" with FDA for an Imaging trial using 124I-PGN650, ~12pts.
...6-28-12: Trial added to trials.gov: http://clinicaltrials.gov/ct2/show/NCT01632696 - see CANCER TRIALS ABOVE for more details.
12-2011: Thorpe Article on FH-Bavi/Optical-Imaging in Translational Oncology http://tinyurl.com/7vcnbz2
11-14-11: Dr. Bruce Freimark presents PS IMAGING poster at AACR-NCI-EORTC Conf./SanFran http://tinyurl.com/89hpydn
9-12-11: Drs. Thorpe & Freimark present PS IMAGING posters at World Imaging Congress/S.Diego http://tinyurl.com/3uv5rgr
9-9-11: PS IMAGING potential discussed in Qtly. Conf. Call: http://tinyurl.com/3q7hzjh
4-2011/Neoplasia: Dr. Thorpe 9-pg. article on Exposed-PE/Imaging http://tinyurl.com/5uoy6fh
…Dr. Thorpe: "PE also has potential as a marker for Imaging human malignancies."
4-6-11/AACR'11: Tumor Imaging Applications of PS-Targeting Antibodies http://tinyurl.com/68p9zs4
…Steve King: "Molecular imaging is a growing field and represents an entirely new development opportunity for our first-in-class PS-targeting antibody platform… our antibodies labeled with imaging tracers hold potential for illustrating exposed PS in a clinical oncology setting, imaging PS as a companion diagnostic with bavituximab therapy, as well as ultimately assessing patient response to a range of cancer therapies."
3-14-11: Dr. Thorpe discusses PS IMAGING in Conf. Call: http://tinyurl.com/4p4hqr5
…Dr. Thorpe: "The quality of the images is quite extraordinary. The antibody homes to tumor blood vessels beautifully in all tumors that we've seen with really very, very little of a staining seen in other tissues, and that's just what you'd like to see in a diagnostic - we are looking at that very seriously. And also, that binding is correlated to response, both with radiotherapy & chemotherapy. So again, we have the possibility of making a diagnostic that would be predictive of response. We are evaluating that possibility at this time... Duramycin binds PE; binding PE expands our coverage of our broad aminophospholipid-targeting platform, so it really dovetails very beautifully with the existing antibody portfolios. It's expanding our desire to explore different phospholipids as potential targets for therapy & diagnosis… PE is phosphatidylethanolamine and it is the brother of PS. So where PE goes, so does PS and vice versa. So the 2 lipids co-segregate normally on the inside surface of the plasma membrane, but in activated cells or apoptotic cells or stress cells, both lipids flip, and both are potential targets for therapeutics or diagnostics… Duramycin is a little peptide, that's a small molecule and has quite different qualities from an antibody in terms of penetrants. So we're intrigued to see how it plays out, too."
6-24-09 U.S. Patent #7,550,141 granted: Anti-PS for Tumor Imaging: http://tinyurl.com/ln9ub8
3-3-08: Thorpe/Mason C.C.R. (AACR) article on Arsenic-labeled Bavi for Imaging Tumors: http://tinyurl.com/32jbfl
…3-5-08 Chemistry World followup article on CCR Bavi+Arsenic/IMAGING: http://tinyurl.com/4m4lbse
2006/SMI: Thorpe/Mason, "Optical Imaging of Exposed PS in Tumors" http://tinyurl.com/42nh7d9
…"We believe optical imaging with Bavituximab holds great promise for assessing PS expression, and therapeutic activity in vivo and optimizing treatment protocols."
OCULAR APPLICATIONS Of PS-TARGETING MABS:
11-1-15-UTSW/Mayo/Tulane/PRC: “PS-Targeting Mabs Inhibit Choroidal Angiogenesis InVivo & ExVivo” [CNV/Macular Degen] http://www.ncbi.nlm.nih.gov/pubmed/26529048
5-2012: Two Anti-PS (PGN632 + PGN635) Ocular posters at ARVO'12 Annual Mtg./FtLaud http://tinyurl.com/cax9a4p
..5-6-12/Thorpe+Mayo, "Anti-PS (PGN632 & PGN635) as Potential New Therapy Against Choroidal Neovascularization (CNV) - AMD"
..5-10-12/PPHM+LSU, "Efficacious Clinical Outcome of an Ophthalmic Formulation of PS-binding mab (PGN632) in a Rabbit Model of Acute HSV-1 Keratitis"
4 COMPLETED BAVITUXIMAB HEP-C PHASE1+2 TRIALS (2005-2011):
These 4 completed Ph.1/2 Bavi HCV Trials archived to: http://tinyurl.com/ycclu974
4. Phase II Bavi+Riba vs. Frontline-HEPC (randomized, open-label - 2011)
3. Phase 1B HCV-HIV Co-Infected's Mono Repeat-Dose Trial (2007-2011)
2. Phase 1B Bavi/Mono Repeat-Dose HCV Trial: (init=6-2006 comp=1-2007 n=24)
1. Phase 1A Bavi/Mono Single-Dose HCV Trial: (init=8-2005 comp=2-2006 n=30)
BAVITUXIMAB ANTI-VIRAL NEWS:
I: THE 2008-2011 DTRA/TMT Gov't Contract for Anti-PS vs. Hemorrhagic Fevers http://tinyurl.com/5dxpup
DTRA: www.dtra.mil FPDS.gov: http://tinyurl.com/4jbmkcg
3-11-11: TMT/DTRA will not extend VHF Contract - expires 3-15-11 (total revs. rec'd=$24.2mm): http://tinyurl.com/4p4hqr5
…Steve King (3-11-11 CC): "While this news is certainly disappointing, we are grateful to the TMT & DTRA for the opportunity to work together to evaluate bavituximab in this unique potential indication. We received nearly $24mm in funding over the past 33 mos… In the studies we have conducted to date under this contract, our antibodies have demonstrated a significant increase in survival in advanced preclinical models of the highly lethal Ebola virus. However in these specific studies, we weren't able to achieve an adequate dose response correlation to support advancing the program to the next stage. In no way does this dampen our enthusiasm for bavituximab and the PS-targeting platform for infectious diseases, where we believe there is still significant unrealized potential."
11-16-11: Two AntiPS posters presented at DTRA's 2011 CBD S&T/Vegas http://tinyurl.com/7pc76qd
...1) Argentine Hemorrhagic Fever/UTexas. . .2) Bacteria Infections/DSTL Porton Down/UK & Thorpe/King/C.Empig/PPHM
11-16-10: PPHM Presents AntiPS/VHFs pre-clin. data at CBDS&T BioDef Conf./Orlando http://tinyurl.com/4ve6xcl
10-2009: U-Pitt report for DARPA on Biologics Demand references Bavi http://tinyurl.com/yaefb4j
11-18-09: PPHM Presents AntiPS/VHFs pre-clin. data at DTRA/TMT Conf. http://tinyurl.com/ycrrwub
7-3-08 BioWorld Today article on PPHM's DTRA Deal: http://tinyurl.com/5kr6xk
...FULL ARCHIVE OF 2008-2011 DTRA GOV'T CONTRACT: http://tinyurl.com/6pjqt27
II: THE DUKE/HAYNES/CAVD/GATES/CHAVI/NIAID HIV COLLABORATION:
Duke's B.Haynes 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."
3-2014: Keystone Conf./Alberta PS-Targeting/HIV Poster by PPHM’s Cyril Empig & Duke/Peregrine Co-Authors Haynes/Moody/etc http://tinyurl.com/m6kuqpr
…”We expanded the characterization of PGN632 in the current study; PGN631 & PGN633, “sister clones” of PGN632, are also able to inhibit HIV-1 in the PBMC assay.”
12-29-11: Duke patent app#20110318360 "Anti-Lipid Antibodies" describes using PGN632 to inhibit HIV infection http://tinyurl.com/84vluj7
Sept'10: LWW article by Barton Haynes ref's 4-2010 Duke/PPHM JEM antiPS article: http://tinyurl.com/2bsgv8m
......"HIV vaccines after STEP: Strategies for Eliciting HIV-1 Inhibitory Antibodies"
4-11-10: CHAVI Newsletter highlights PPHM-Duke JEM article http://tinyurl.com/35eelvw
..."The study is significant because it shows that components of the adaptive immune system can activate antiviral innate immunity. Investigators believe that a vaccine that elicits polyreactive anti-PS antibodies could potentially be used to engage both the innate and adaptive immune response against HIV."
4-5-10: DukeHealth announces the 1st Duke/PPHM HIV Collab. article in JEM: http://tinyurl.com/yzr2tax
...Duke's Bart Haynes: "While the findings still have to be tested clinically, they do suggest a new way the immune system might be manipulated to thwart HIV."
...The full 4-5-10 JEM Duke-PPHM HIV article (23pgs) posted to PPHM's homepage: http://tinyurl.com/ydqdk59
2005-July2009: All Peregrine Public Statements on the Duke HIV Collab: http://tinyurl.com/m4aggy
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
.....1-6-09: NIAID reviews CapeTown AIDS'08, commenting on the Tony Moody Anti-Lipids/PGN632 talk: http://tinyurl.com/7dnmpe
...FULL ARCHIVE OF DUKE-PPHM-CHAVI-CAVD HIV COLLABORATION: http://tinyurl.com/6pjqt27
III. OTHER ANTI-PS ANTI-VIRAL NEWS:
10-15-14: Public-Health-England/PPHM article on Bavi/Ebola in Hindawi’s Jrnl-of-Immunology-Res http://tinyurl.com/mg3va35 (also see: http://tinyurl.com/ofa5zlt )
6-2013: NIAID is “particularly interested how PS & PE expression… which is key to regulation of the immune response.” http://tinyurl.com/mvzqn26
…the above from John Coligan’s (PhD, Chief, Receptor Cell Biology Section) NIAID lab webpage.
11-16-12: 'Antiviral-Research' article by Bavi-AV collaborator HPA/UK & PPHM researchers on Bavi vs. EBOLA http://tinyurl.com/aa98xl3
…"Virus induced externalization of PS raises the possibility that PGN401 (Bavi) has broad spectrum antiviral activity."
11-16-12: 'Parasite Immunology' article by Dr. Phillip Thorpe & Brazilian Bavi-AV collaborators on AntiPS vs. Leishmania http://tinyurl.com/a8xtmny
..." This study provides new information regarding the mechanism of immune suppression in Leishmania infection."
8-2011: Brazilian collab's (INCA) studying PS-targeting vs. Leishmaniais, a protozoan parasitic disease http://tinyurl.com/435j8u2
11-4-09: 2nd Patent (7,611,704) Granted for AntiPS Broad AV apps http://tinyurl.com/y9jmsod
..."noteworthy since it includes methods for treating all viruses in humans & animals."
10-7-09: PPHM forms 'Anti-Viral Research Group' http://tinyurl.com/yan3fws
…"Peregrine's broad-spectrum PS-targeting antibodies are being assessed in anti-infective applications by more than a dozen leading research institutions… Peregrine and its collaborators have already secured over $60 million in research funding to evaluate the potential of the company's PS-targeting platform in a wide range of viral infections…"
9-10-09: PPHM's 7 Anti-PS Collaborators (S.King, R&R Healthcare Conf/NYC) http://tinyurl.com/nn4w8t
8-26-09: $763k NIAID Grant to Dr. Thorpe to Expand Anti-PS/VHF Studies: http://tinyurl.com/lxtuo3
…"The objective of the newly funded research is to evaluate a panel of new fully human anti-PS antibodies with different binding & functional properties as potential 2nd-gen. treatments."
8-5-09: 'New Scientist' Article Highlights Peregrine/Thorpe/BaviAV http://tinyurl.com/mp2aku
...Dr. Thorpe, "We were doing something that was quite extraordinary. We had let the animals progress in their disease until they were heavily symptomatic, and then started treatment. It was a major accomplishment to knock that disease back."
...7-11-09 Dr. Thorpe Interview on Bavi-AV in BMED Report: http://tinyurl.com/ltudso
3-31-09: 3rd (Conjugated) Anti-PE Patent (#7,511,124) Granted: http://tinyurl.com/dmkw6y
1-6-09: New 'Anti-PS Anti-viral Factsheet' on the PPHM Website: http://tinyurl.com/759qyw
11-24-08: Dr.Thorpe publishes in Dec.2008 NATURE Medicine on BaviAV vs. Lassa/CMV: http://tinyurl.com/9ktvsb
...Dr. Thorpe, "This is a whole new strategy for making antiviral drugs." . . . CEO S.King, "We think it has tremendous potential."
...Dr. B.Haynes, "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."
...ARCHIVE OF OTHER ANTI-PS ANTI-VIRAL NEWS (2005-6/2008): http://tinyurl.com/6pjqt27
TUMOR NECROSIS THERAPY (TNT/COTARA/VEA's) NEWS:
This defunct 1998-2012 pgm. archived to: http://tinyurl.com/yc4ye6m4
AFFITECH-PPHM Collab: Fully-Human Mabs, Anti-PS & Anti-VEGF/2C3
This defunct 2005-2012 pgm. archived to: http://tinyurl.com/yc4ye6m4
Dr. Phillip Thorpe Discusses BAVITUXIMAB at 2004 ASM (Bavi was formerly brand-named "Tarvacin"):
10-25-04 SHM Presentation: "Understanding Tarvacin", incl. his first-ever public comments about Tarvacin's ANTI-VIRAL capabilities:
"OK, this is Tarvacin.. the cleanest tumor vessel marker of which we are aware.. If you look here at the 3G4 slide, you'll see, most remarkably, that it's absolutely chock full with macrophages; they're beginning to outnumber the tumor cells... . So, the conclusions with Tarvacin are that it has a unique mechanism of action, there's nothing else like it out there; it homes specifically to tumor blood vessels and induces white blood cells to attack the tumor." http://tinyurl.com/38qjug
Dr. Thorpe's APT (AntiPS/3G4/BAVITUXIMAB patent app #20040161429 (pub. USPO 8-19-04):
"Compositions for treating Viral Infections using Immunoconjugates to Aminophospholipids": http://tinyurl.com/6pdny
 "the 3G4 antibody has enormous potential as a broad spectrum anti-viral agent."
 "...The inhibitory activities of 3G4 on cell division, angiogenesis, tumor growth & viral infectivity, taken together with lack of apparent toxicity, show broad therapeutic indications for this antibody, including in the treatment of angiogenic disorders, cancer, diabetes and viral infections."
 "the anti-viral methods and uses of the invention are suitable for treating all viruses... as exemplified by treating CMV, RSV, arenavirus and HIV infections, and the diseases hepatitis, influenza, pneumonia, Lassa fever and AIDS."
 "The 3G4 antibody has also been administered to monkeys in safety studies and no side effects have been observed."
Thorpe's Aug03-Jan08 $1.68mm NIH/NIAID Grant for research using PPHM's APTs (Anti-PS/3G4) as "Novel Anti-Viral Agents for Treating Lassa Fever":
Thorpe: "We are developing drugs to use against Lassa fever that operate on a new principle in virology. They exploit the fact that viruses coat themselves with an outer membrane where some of the lipids are inside-out. The drugs direct our immune responses to the inside-out components of the viral membrane, or envelope. These drugs potentially could be effective against numerous viruses that have similar outer membranes… We have raised mabs to PS and other anionic phospholipids that block the spread of several viruses to uninfected cells in vitro, essentially completely. The phospholipids that they recognize have the same structure & cellular distribution in different mammalian species, simplifying the transition from experimental animals into humans. The antibodies are not toxic to mice, even when administered in high doses for prolonged periods of time."
GRANT LINK: http://tinyurl.com/5ntcm . . .11-3-03 Grant PR: http://tinyurl.com/5aulds
###8-26-09: $763k 2yr expansion NIAID grant (8/14/09-7/31/11) to Dr. Thorpe for 2nd-gen. anti-PS/VHF studies: http://tinyurl.com/lxtuo3
The Inventor of the PS-Targeting Mabs, like 3G4/bavituximab, is Dr. Philip E. Thorpe of UTSW-MC/Dallas.
4-2-13: Peregrine Mourns Loss of Dr. Philip E. Thorpe (1951-2013) http://tinyurl.com/l9gqmt5
…2013: Dr. Thorpe’s lab taken over by UTSW’s Dr. Rolf A. Brekken: http://www.utsouthwestern.edu/labs/brekken
Dr. Thorpe's Patents: GRANTED: http://tinyurl.com/m232k PENDING: http://tinyurl.com/845p2
…Dr. Thorpe's Articles: http://tinyurl.com/csjsl Also see: http://www.researchgate.net/profile/Philip_Thorpe
Dr. Brekken’s Patents: GRANTED: http://tinyurl.com/q2joy3v PENDING: http://tinyurl.com/l5jngmw
…Dr. Brekken’s Articles: http://tinyurl.com/oyf5r9p Also see: http://www.researchgate.net/profile/Rolf_Brekken
Dr. Alan Schroit's Patents (MDA/UTSW, PPHM SAB, “Clipped B2GP1”, PS-Exosomes): GRANTED: http://tinyurl.com/n4pnk8p PENDING: http://tinyurl.com/mrf2nsb
…Dr. Schroit’s Articles: http://tinyurl.com/lqbd8kt Also see: http://tinyurl.com/yaqnvcvq (UTSW profile)
PPHM BOARD RULES: http://tinyurl.com/zx2qa - DISCLAIMER: This msg board is not affiliated with Peregrine; no endorsement by Peregrine or any other org. is implied.