Avid Bioservices Inc (CDMO)

[cjgaddy]

Roth (Joe Pantginis) 1-16-15 PPHM update (Liver Data)…

1-16-15/PPHM:
”Positive HCC Data are the Kickoff for IST Data Driven 2015”
PPHM announced presentation of data from the Phase II IST of bavituximab with sorafenib in HCC at GI ASCO. These are promising data, particularly given the patient population and we believe they open the door to future randomized studies in HCC patients using bavituximab in combination with sorafenib as well as with anti-PD-1 inhibitors. Reiterate Buy.

EVENT
PPHM announced data from the Phase II single-center, single-arm, open-label IST of bavituximab with sorafenib in 38 HCC patients at GI ASCO. The data showed that time to progression (primary endpoint) was 6.7 mos, disease control rate was 58% (22/38), 4-mo. PFS was 62%, DSS was 8.7 mos and median OS was 6.2 mos. Two patients (5%) achieved PR and 20 (53%) achieved SD. The drug combination was well tolerated and there were no autoimmune AEs reported.

IMPACT
We're impressed with the continued positive data coming out of this HCC study. Despite this being an open-label, single-arm study, these positive data are impressive given that these are heavily pre-treated patients with poor prognosis. Translational data from tumor biopsies of 6 patients from this study at SITC 2014 showed increased tumor infiltration of CD8+ T cells and induction of PD-1 expression in the tumor following treatment, giving additional support for combination study with anti-PD-1 inhibitors. These correlated with longer time on study and longer time to progression. With these promising data, we believe the door is open to future randomized studies in HCC patients using bavituximab in combination with sorafenib as well as with anti-PD-1 inhibitors. The pivotal Phase III SUNRISE study continues to enroll patients at over 150 global centers and we look forward to a data-driven 2015 with catalysts from multiple ISTs in NSCLC, breast cancer, melanoma, rectal adenocarcinoma and additional data from the Phase II IST in HCC. We believe that data from the Phase Ib of bavituximab with ipilimumab in melanoma will garner interest and increase visibility. This study, set to enroll up to 24 patients, should provide further support for combination of bavituximab with checkpoint inhibitors. We believe these ISTs will not only increase visibility for PPHM but also expand bavituximab's potential treatment profile.

ACTION
We reiterate our Buy rating and $5 target. With Peregrine being a pivotal stage company, we view the risk/reward profile as favorable, and we believe visibility from the broadening bavituximab profile and partnering potential should drive the stock in 2015.

Roth Capital /Joe Pantginis - init. 7-15-10 Buy/PT=$10, CURR: Buy/$5 http://www.roth.com
. . .Universe (click link bottom right): http://roth.bluematrix.com/docs/pdf/BLUE.pdf

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H. 1st Investigator-Sponsored (IST) Ph.I/II Trial (Bavi+Sorafenib vs. Liver Cancer/HCC, open-label, n=9+38=47)
...Note: Sorafenib = Onyx/Bayer's Nexavar - see http://www.nexavar.com
Protocol: http://clinicaltrials.gov/ct2/show/NCT01264705 UTSW: http://tinyurl.com/mwdc2ql (5 sites: 3/UTSW, Parkland-Hosp, Dallas/VA, PI=Dr. Adam Yopp)
...1-16-15 ASCO Gastro-Symposium: Ph.2 data/n=38 (Adam Yopp), “These clinical outcomes of TTP=6.7/DCR=58%/PFS=4mo are quite encouraging…” http://tinyurl.com/m9uz9mo
…11-8-14: SITC'14 Ph.2 Correlative Studies data (biopsies B4/After) on 6pts, incl. KOL Dimitry Gabrilovich’s comments: http://tinyurl.com/pchzr6h
...9-9-14 Enrollment complete. http://tinyurl.com/ktrfswj (ph2=38 Ph1=9)
...4-4-12 AACR'12: Dr. Adam Yopp, "promising safety profile to-date" http://tinyurl.com/7yrwqm7 (see #5591)
...Feb'12-Sep'14 10+ times: CEO Steve King hints of future ex-US partner-driven Bavi+Sorafenib/LIVER trial in Asia-Pacific: http://tinyurl.com/nkaxtcc
......Articles & Data describe Liver Cancer challenges in Asian populations: http://tinyurl.com/7z7o8j9 & http://tinyurl.com/7z99cy4
...12-1-10: PPHM's 1st IST (Liver Cancer) initiated at UTSW, ~56 patients - http://tinyurl.com/3xd3e6c
…Per S.King, 5-18-10/R&R, "We've had a lot of interest in running clinical trials with the compound from investigators who have either had prior experience with the drug or would like to study the drug in various settings. Potential IST indications include all the major solid tumor types. Of particular interest is Liver Cancer, in which we have a natural tie-in with our HCV program, Ovarian Cancer and Pancreatic Cancer, also very nicely supported by the prior data."

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KNOWN UPCOMING…

Jan15-17: Gastrointestinal Cancers Symposium (ASCO/ASTRO/SSO), SanFran - PR+Poster: http://tinyurl.com/m9uz9mo
…Jan16 12-2pm/poster: Adam C. Yopp/Poster (MD/UTSW/Dallas): Ph.2 Data from Bavi+Sorafenib Liver IST

Jan27-29/Avid: WCBP 19th Symposium on the Interface of Regulatory & Analytical Sciences, WashDC http://www.casss.org/?page=WCBP1500

Jan29-30: GTC’s 7th Immunotherapeutics & Immunomonitoring Conf., SanDiego http://tinyurl.com/lqnb3ou (GTC = Global Technolology Community http://www.gtcbio.com )
…Jan30 2:25-2:50pm, Dr. Bruce Freimark (PPHM’s Dir/PreClin.Res) speaks in session=“Combinatorial Immunotherapies”: "Blockade of PS Enhances the Anti-tumor Activity of Targeted Therapy & Immune Checkpoint Inhibitors by Reducing Immunosuppressive Inflammatory Cells in the Tumor Microenvironment”

Feb8-13: Keystone Tumor Immunology Conf., Banff, Alberta http://tinyurl.com/mwkzoxz
…Feb9 Dr. Bruce Freimark [Dir./Pre-Clin.Res.Oncology], “Antibody-Mediated Blockade of PS Enhances the Anti-Tumor Activity of Immune Checkpoint Inhibitors by Affecting Myeloid Derived Suppressor Cells (MDSC) and Lymphocyte Populations in the Tumor Microenvironment”

~Mar10: FY'15/Q3 (q/e 1-31-15) Financials & Conf. Call http://ir.peregrineinc.com/events.cfm

Mar25-28 2015: Society of Surgical Oncology's 68th Annual Cancer Symposium (SSO 2015), Houston http://tinyurl.com/q667hua
…Mar28 12:45pm/Oral-Pres: Adam C. Yopp (MD/UTSW/Dallas), Ph.2 Data) from Bavi+Sorafenib Liver IST, ”A Phase II Study of Bavituximab & Sorafenib in Advanced Hepatocellular Carcinoma (HCC)”

Mar30-Apr2/Avid/Booth114: IBC's Biopharm. Dev. & Prod. Week, Huntington Beach http://www.ibclifesciences.com/BDPWeek