Avid Bioservices Inc (CDMO)

[cjgaddy]

PPHM SRB/KOL David Carbone (Ohio-St) speaking 11-22-14, ESMO Symposium on Immuno-Oncology, in session titled, “Immune Checkpoint Inhibitors in Lung Cancer”…

Nov21-22 2014: “2nd ESMO Symposium on Immuno-Oncology 2014”, Geneva
”Advances in Cancer Immunotherapy; From Vaccines to Antibodies & Cell Therapies”
• The interaction between the immune system & cancer cells has long been recognised and now there is growing evidence that recent results from clinical trials are leading to exciting new therapeutic possibilities for cancer patients.
http://www.esmo.org/Conferences/Immuno-Oncology-2014
ESMO = European Society for Medical Oncology http://www.esmo.org
11-22-14 Session 9: “Immuno-Oncology Clinical Studies Across Tumor Type II”
11:30-11:50am: David Carbone, MD/PhD (PPHM KOL/SRB** http://www.peregrineinc.com/about-us/medical-and-scientific-advisors.html )
“Immune Checkpoint Inhibitors in Lung Cancer”
**Dr. Carbone: Director, James Thoracic Center, James Cancer Hospital and Solove Research Institute (Ohio State Univ., Columbus OH)
• http://cancer.osu.edu/mediaroom/releases/Pages/Internationally-Renowned-Lung-Cancer-Expert-Comes-To-Ohio-State.aspx
• http://internalmedicine.osu.edu/medicaloncology/directory/dcarbone

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12-10-2013 QTLY FINANCIALS PRESS RELEASE
. . . BAVITUXIMAB IMMUNOTHERAPY DEVELOPMENT PROGRAM
Data from preclinical studies showing that tumor growth inhibition of a PS-targeting antibody equivalent to bavituximab and an anti-CTLA-4 combination therapy in a mouse melanoma model was superior to either antibody alone were recently presented at Society for Immunotherapy of Cancer (SITC) Annual Meeting [BAVI MOA 11-9-13: Annual SITC (WashDC) – 2 posters about Bavi’s Immunostimulatory MOA http://tinyurl.com/mjaweu5 ]. Peregrine is exploring the potential to combine bavituximab with other immunotherapies such as PD-1 antibodies & CTLA-4 targeted approaches and has initiated several proof-of-concept studies to support recent mechanism data. In advance of this, multiple proof-of-concept preclinical studies are now underway with data anticipated over the next few months. Peregrine anticipates the initiation of a single-center Phase Ib IST of bavituximab plus an approved anti-CTLA-4 antibody in patients with advanced melanoma in early CY2014. With recent scientific insights highlighting bavituximab's immunostimulatory MOA, Peregrine announced today the following additions to its Scientific Advisory Board. The company plans to utilize the expertise of its new advisors to help guide the development of its novel immunotherapeutic candidate bavituximab:

Dimitry I. Gabrilovich, MD, PhD
Dr. Gabrilovich is currently the Christopher M. Davis Professor in Cancer Research and Program Leader, Translational Tumor Immunology at The Wistar Institute, Philadelphia, Pennsylvania. Prior to joining Wistar, Dr. Gabrilovich was the Robert Rothman Endowed Chair in Cancer Research and Head, Section of Dendritic Cell Biology at the Moffitt Cancer Center in the Department of Immunology and a Professor of Oncologic Sciences and Molecular Medicine at the University of South Florida. Prior to this, Dr. Gabrilovich was a Research Fellow at the Imperial College in London, United Kingdom and at the Univ. of Texas SW Medical Center in Dallas, Texas. Dr. Gabrilovich earned his M.D. from Kabardino-Balkarian State University Medical School in Nalchik, Russia and his Ph.D. in Immunology from the Central Institute of Epidemiology in Moscow.

Scott J. Antonia, MD, PhD
Dr. Antonia is currently the Dept. Chair & Program Leader of the Thoracic Oncology Department Associate Professor in the Department of Interdisciplinary Oncology and Program Leader of the Immunology Program at the H. Lee Moffitt Cancer Center> and Research Institute in Tampa, Florida. He is also a Professor of Oncology at the Univ. of South Florida College of Medicine in Tampa. Dr. Antonia received his M.D. and his Ph.D. in Immunology from the Univ. of Connecticut Health Center in Farmington, Connecticut. In addition, Dr. Antonia completed an internal medicine residency at Yale University School of Medicine and pursued additional training at Yale through a medical oncology fellowship and post-doctoral fellowship in Immunobiology.

DAVID CARBONE, MD, PhD
Dr. Carbone is currently a Professor of Medicine in the Division of Medical Oncology at The Ohio State University's Ohio State's Comprehensive Cancer Center at the James Cancer Hospital and the Solove Research Institute both in Columbus, Ohio. Prior to joining Ohio State University, he served on the faculty of the Univ. of Texas SW Medical Center in Dallas, Texas and Vanderbilt University's Thoracic & Head & Neck Cancer Program at the Vanderbilt-Ingram Cancer Center in Nashville, Tennessee. Dr. Carbone received his M.D. and Ph.D. degrees in Molecular Biology and Genetics from Johns Hopkins Univ. in Baltimore, Maryland.

Hakan Mellstedt, MD, PhD
Dr. Mellstedt, is currently a Professor of Oncologic Biotherapy at the Karolinska Institute and Cancer Centre Karolinska at the Karolinska Univ. Hospital in Stockholm, Sweden. Prior to this, he was Professor of Experimental Oncology at Uppsala Univ. and head of the Department of Experimental Oncology, Department of Oncology, Uppsala University Hospital in Uppsala, Sweden. He was also the Administrative Director of Cancer Center Karolinska. Dr. Mellstedt has served as a Consultant in Internal Medicine to the Seraphimer Univ. Hospital in Stockholm, Sweden as a Senior Consultant to the Department of Oncology, Karolinska Univ. Hospital, Sweden and as a Senior Consultant to the Sophiahemmet Hospital in Stockholm. Dr. Mellstedt received his M.D. and his Ph.D. degrees from the Karolinska Institute. He is Board Certified in Internal Medicine, Hematology & Oncology.
http://www.peregrineinc.com/about-us/medical-and-scientific-advisors.html

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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 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
. . .CRI launches “Answer to Cancer” (cancer immunotherapy) website http://www.theanswertocancer.org
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
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

O. 6th IST Trial: Bavi+Ipilimumab(Yervoy) vs. Adv.Melanoma (Ph1b, random, open-label, 2arms, n=24)
Protocol (UTSW): http://www.clinicaltrials.gov/ct2/show/NCT01984255 (PI: Dr. Arthur Frankel - see "Researching for Cures" http://youtu.be/0zLAxjFny5Q )
UTSW's listing: http://www.utsouthwestern.edu/research/fact/detail.html?studyid=STU%20102013-007
…Note: Ipilimumab = BMS’s “Yervoy” (anti-CTLA-4) http://www.yervoy.com
...4-23-14: Bavi+Yervoy IST trial initiated: http://tinyurl.com/km7krcm

F. LEAD IND: Phase IIb Bavi+Doce vs. 2nd-Line NSCLC (randomized, double-blinded, placebo-ctl'd, n=120, 'registrational')
Protocol: http://clinicaltrials.gov/ct2/show/NCT01138163 (24 U.S. + 15 India + 2 RepGA + 7 RussianFED + 5 Ukraine = 53 as of 8-12-11)
Enrolled Oct2010 - Oct2011 at 40 global sites (per J.Shan 9-7-12 webcast ( http://tinyurl.com/8cn87la )
8-2012: Compare Bavi+Doce's MOS=11.7mos (Bavi/3mg) to the 4 Curr-Approved 2Line/NSCLC Drugs http://tinyurl.com/cgnkvpa
• Taxotere/docetaxel => MOS=6.3mos (meta-analysis of 5 trials, 865 pts)
• Altima/pemetrexed => No diff. vs. Docetaxel (Ph.3 non-inferiority vs. Doce, 571 pts)
• Tarceva/erlotinib => MOS=5.3mos (TITAN Ph.III n=424 trial - see http://tinyurl.com/8w8lo93 )
• Iressa/gefitinib => "Iressa does not improve OS"
6-3-13/ASCO’13: Final Data Ph.II 2L/NSCLC http://tinyurl.com/my8qxw7
…60% improvement in MOS: Bavi/3mg=11.7mos. vs. 7.3mos. for CTL-arm(combined Bavi/1mg + DoxyOnly arms), HR=.662, P=.113

ONGOING BAVITUXIMAB PHASE III TRIAL: (see http://PeregrineTrials.com => http://www.SunriseTrial.com )
A. Phase III Bavi+Doce vs. 2nd-Line NSCLC "SUNRISE" (randomized, double-blind, placebo-ctl'd, n=582) (Start=Dec’13 Est PrimaryComp=Dec’16)
USA Protocol: http://www.clinicaltrials.gov/ct2/show/NCT01999673 - 115 sites a/o 7-28-14 (USA/34 Aus/6 Bel/7 Fr/9 Ger/9 Greece/5 Hungary/7 Korea/7 Rom/6 Rus/6 Spain/15 Taiwan/7) - Growth: http://tinyurl.com/xxxx
…EU/EEA Registries: (pts world=582, pts/EU=345, planned EU sites=100) http://www.clinicaltrialsregister.eu/ctr-search/search?query=2013-003953-13
• GER: http://www.clinicaltrialsregister.eu/ctr-search/trial/2013-003953-13/DE (planned sites=14, pts=43)
• SPAIN: http://www.clinicaltrialsregister.eu/ctr-search/trial/2013-003953-13/ES (planned sites=16, pts=100)
• HUNGARY: http://www.clinicaltrialsregister.eu/ctr-search/trial/2013-003953-13/HU (planned sites=9, pts=28)
• GREECE: http://www.clinicaltrialsregister.eu/ctr-search/trial/2013-003953-13/GR (planned sites=9, pts=120)
...EU= European Union (29 countries – see http://www.gov.uk/eu-eea ), EEA=European Economic Area (all the EU, plus Iceland, Liechtenstein, Norway)
…Regions where sites are planned: Australia, Belgium, France, Germany, Greece, Hungary, Italy, Korea, Romania, Russia., Spain, Taiwan, Ukraine, USA
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."