InvestorsHub Logo

biopharm

12/11/15 5:47 PM

#245353 RE: cjgaddy #245350

Thanks CJ! now I have some reading to do : ) Peregrine sure did sound confident on this conference call and no way they start a breast cancer trial unless the stars are all aligning properly at this time.

cjgaddy

12/13/15 10:26 AM

#245467 RE: cjgaddy #245350

Avid's New Customer – hints from 9/2014 on – definitely hit the revenue stream in Q2. We do not know who this new customer is at this point (at least I don't!). ...And now on 12-10-15, Rob Garnick discloses, “We are already contemplating our options to increase further our mfg. capacity [beyond Myford=Avid II]”, due to ”what appears to be a growing opportunity in this important area of our business.”
 
Q/E10-31-15 Q/E7-31-15 FY4-30-15 FY4-30-14
Halozyme 56% 84% 79% 91%
Cust-A U.S. 41% 15% 12% 1%
Other Custs 3% 1% 9% 8%

• 9-9-14 PR/P.Lytle: "Avid has been successful in expanding its client roster, while also continuing to evaluate options that would create new mfg. capacity...” http://tinyurl.com/ktrfswj
• 9-9-14 CC/S.King: “Avid has begun 2015 strongly… and the expansion of our client base…” http://tinyurl.com/ktrfswj
• 12-10-14 CC/S.King(Q&A): “The bottom line is that we have seen expansion of our mix of customers, which is absolutely driving a lot of the need for considering new capacity...”
...P.Lytle: “this facility can more than double our existing capacity.” http://tinyurl.com/kmdgq8t
• 6-17-15 PR/S,King: “We've seen tremendous interest for production in the new facility, both from new & existing clients.” http://tinyurl.com/pnlquu3

FOOTNOTE - 12-10-15 CC: http://tinyurl.com/jkp885g
12-10-15 ROB GARNICK: “With the Myford site (Avid II) now in the initial phase of GMP manufacturing, we have seen a significant increase in demand for production capacity. Although, we have just opened the doors at Myford, we are already contemplating our options to increase further mfg. capacity. Although no decisions have been made, we are pleased to have what appears to be a growing opportunity in this important area of our business.”
12-10-15 STEVE KING(Q&A): “The [further Avid] expansion really is driven by our existing and new clients that have come in, and so obviously primarily that’s driven in the bulk drug substances area not necessarily the fill/finish area. So that'll probably be the primary focus; we have considered and eventually would like to move into the fill/finished business, it's just we’ve been so busy expanding our drug substances business, we really haven’t had the option to do that. For the question of space, there’s space in the current buildings that we’re in, but we’re also looking at other opportunities nearby that fit the same model as we did for the Myford facility and allows us to most efficiently grow the business. At the end of the day it will be a business decision and we’ll take on space as needed to expand the business. Again, it’s all really right now supported by the client base, which has had an extremely positive response to the Myford facility and that’s really driving we think even beyond what we expected going into it.
...G.Zavoico: ”Would you finance that further expansion as sort of debt against the revenue coming in or are you just keeping all your options open for that?”
STEVE KING: “We’re keeping our options wide open. At this point, we’ll do what’s best for the business itself. It’s a nice growing backlog of future revenue, it’s really a change in the way the Avid business can be viewed, as more a long-term go-forward business. So, we just need to make the right business decision based on the cost of capital, whatever avenue that takes, and then we’ll make the right decision.”

= = = = = = = = = = = = = = = = = = = = = = = = = = = =
Updated PPHM REVS-BY-QTR TABLE, now thru FY16'Q2(qe 10-31-15), per the 10-31-15 10-Q ( http://tinyurl.com/ocrtkuj ) issued 12-10-15.
• Total Revs since May’06: ($148.1mm/Avid + $24.1mm/Govt + $2.4mm/Lic.) = $174.7mm
• 12-10-15: FY'16 (May'15-Apr'16) Avid revs guidance raised to $35-40M from $30-35M.
Deferred-Revs at 10-31-15 total $9.7mm, UP from $8.3mm at 7-31-15.
Cust.Deposits at 10-31-15 total $14.9mm, UP from $9.6mm at 7-31-15.
Avid’s Gross-Profit over last 3 qtrs: $14.1mm on revs of $28.2mm (GP%=50%)
• Recall, Avid Rev$ from Gov’t DTRA Contract work (6/30/08 – 4/15/11, totaling $24.15mm), went into GOVT-REVS, not AVID-REVS, in the Financials.
Avid’s website: http://www.avidbio.com
  
AVID PROFITABILITY (GROSS*) BY QTR:
QTR Avid-Rev$ CostofMfg$ Gross-Profit$ GP%
FY13Q1 7-31-12 4,135,000 2,024,000 2,111,000 51%
FY13Q2 10-31-12 6,061,000 3,703,000 2,358,000 39%
FY13Q3 1-31-13 6,961,000 3,651,000 3,310,000 47%
FY13Q4 4-30-13 4,176,000 3,217,000 959,000 23%
FY14Q1 7-31-13 4,581,000 2,670,000 1,911,000 42%
FY14Q2 10-31-13 7,354,000 4,195,000 3,159,000 43%
FY14Q3 1-31-14 3,885,000 2,416,000 1,469,000 38%
FY14Q4 4-30-14 6,474,000 3,829,000 2,645,000 41%
FY15Q1 7-31-14 5,496,000 3,583,000 1,913,000 35%
FY15Q2 10-31-14 6,263,000 4,139,000 2,124,000 34%
FY15Q3 1-31-15 5,677,000 3,113,000 2,564,000 45%
FY15Q4 4-30-15 9,308,000 4,758,000 4,550,000 49%
FY16Q1 7-31-15 9,379,000 4,608,000 4,771,000 51%
FY16Q2 10-31-15 9,523,000 4,741,000 4,782,000 50%

FY13 TOTAL: 21,333,000 12,595,000 8,738,000 41%*
FY14 TOTAL: 22,294,000 13,110,000 9,184,000 41%*
FY15 TOTAL: 26,744,000 15,393,000 11,151,000 42%*

*Avid Net-Profit (ie, incl. Selling, G&A) not split out from PPHM-Corp. in the financials.

cjgaddy

12/16/15 10:00 AM

#245751 RE: cjgaddy #245350

12-15-15: BioWorld quotes Steve.King in “Immuno-onc Boost” article

12-15-15/BioWorld: “If You Can't Beat 'em, Join 'em; Looking for Immuno-onc Boost”
By Brian Orelli, BioWorld Staff Writer
http://www.bioworld.com/content/if-you-cant-beat-em-join-em-looking-immuno-onc-boost-1
Last week, Threshold Pharmaceuticals Inc. announced the failure of 2 phase III evofosfamide trials (See BioWorld Today, Dec. 8, 2015)…
ENHANCING ACTIVITY - Aduro Biotech's CRS-207...
MULTIPLE CHECKPOINTS
Likewise, Peregrine Pharmaceuticals Inc. said it makes sense to test its drug, bavituximab, with a drug targeting the PD-1 pathway. Bavituximab targets phosphatidylserine, a molecule released during apoptosis that down-regulates the immune cells to keep the immune system from mounting a major response against a few cells that have died.

"Tumors hijack this pathway," Steven King, President & CEO of Tustin, Calif.-based Peregrine told BioWorld Insight. Tumors can outgrow their blood supply causing cells to die, but phosphatidylserine acts as a checkpoint, dampening the immune response against a tumor.

Peregrine is currently testing bavituximab with docetaxel compared to docetaxel alone in SUNRISE, a phase III trial in previously treated NSCLC patients that is scheduled to read out next year.

Earlier this year, Peregrine partnered up with Astrazeneca to test the pharma's anti-PD-L1 immune checkpoint inhibitor, durvalumab, with bavituximab, after preclinical data suggested that the combination might help even if tumors don't initially express PD-L1. By removing the phosphatidylserine checkpoint, the immune system is activated, but the tumor can then use PD-L1 to inhibit the immune system. Durvalumab should help perpetuate the bavituximab-induced immune response, while boosting the opportunity for durvalumab in tumors that are not expressing PD-L1 until the bavituximab treatment. "It's sort of a win-win situation," King said.

King said he thinks that bavituximab will likely work with any of the drugs targeting the PD-1 pathway, but decided to work with London-based Astrazeneca rather than one of the FDA-approved drugs, in part, because Astrazeneca was willing to provide the drug free of charge. "We save probably as much as we're spending because of the cost of these drugs," King said.
CHANGING COURSE - Heat Biologics's HS-110...
WE LIKE YOU A LOT - Bavarian Nordic's Prostvac...
*end*

cjgaddy

01/04/16 6:12 PM

#247621 RE: cjgaddy #245350

Somebody posted this today to the Bus./Investing section of some gun site (??weird!) – just a very nice, summary of all aspects of Peregrine at the moment. Very professionally done - I don't see a single inaccuracy or stretch. Whoever wrote this follows the company very carefully.

1-4-16/user=CKA, "BIO Stock, 2016 Play Out: Peregrine Pharma": All IMO, please do your own due diligence when inventing your own coin. BIO stocks are high risk/high yield.

I've started following this stock in early 2015. I'm long on this stock and have a positive feel for what could be in store for 2016. It will very likely be making or breaking this year, the company Peregrine Pharmaceuticals (PPHM). Would welcome anyone's thoughts regarding this stock, or just use this as a heads up. The summary below is a bit long (I could easily add more), sorry tl/dr crowd, take it or leave it.

Their lead molecule, Bavituximab, is an immunotherapy MAB that targets PS (phosphatidylserine) exposed on all cancer and most, if not all, viruses (HIV, HepC, Ebola, etc.). Bavi is a checkpoint inhibitor like Opdivo (as see on TV ads recently) and Keytruda (cured Jimmy Carter's Melanoma) in that it blocks PS which causes suppression of the immune system. However, it has a component that none of the others have, an immune stimulating side that generates/promotes cancer killing cells in the tumor environment. For a quick video on the method of action of bavi see here ( https://vimeo.com/84073332 ), a bit wordy on medical speak, but explains much more thoroughly.

In the lab there also have been tests confirmed that due to the immune stimulating component of bavi adaptive immunity is achieved, at least as shown in lab mice where tumors in mice have been stopped after given bavi (complete remission), were reintroduced to the same cancer and "ended up living of old age". In other words the immune system recognized the cancer when it came back and was able to successfully attack it without being given bavi; adaptive immunity (like your body does with a virus; i.e. flu vaccine). Very exciting if proven true in humans with cancer too.

Peregrine is in the 25th month of their stage III clinical trial (named SUNRISE) for non squamous NSCLC (double blind trial; bavi+chemo vs. chemo+placebo), which has been given fast track designation with 2 early look-ins by the FDA. They announced on their last quarterly conference they are more than 90% enrolled in SUNRISE (~582 total patients) and have enough patients enrolled to generate their 1st and 2nd look-ins (huge risk removed), complete enrollment is said to be in the coming weeks.

In addition they have a version of bavi in testing for PET imaging of tumors. They own all their IP and patents targeting PS in U.S. and Europe and are in final stages of patenting their next generation PS targeting molecule, named for now, Betabodies.

Beyond any early collaboration PRs, PPS drivers could come from 1st look-in when the independent monitoring committee checks the SUNRISE trial for safety/futility (estimated Feb/Mar, a trial continue is expected), much more so by 2nd look-in for trial efficacy (estimated mid year) where the trial could be stopped if bavi shows significant extension of overall patient survive vs. the placebo arm, and if not stopped by the 2nd look-in for sure by final trial data unblinding due at the end of 2016 if bavi's arm shows statistically significant overall survival vs. the placebo arm.

Highlights in 2015 were announced collaborations by Peregrine with Memorial Sloan Kettering for combination studies with bavi (ranked 2015's world #1 cancer institute) as well as with AstraZeneca in which they announced 2 trials with their PD-L1 checkpoint inhibitor Durvalumab set to start in 2016. Both big name collaborations should give some degree of confidence for what they have seen behind the curtains in bavi to associate their name with such a small clinical trail company; not forgetting to mention that AstraZeneca is letting small Peregrine run both trials and is providing free Durvalumab ($100K/patient)... A stage III breast cancer trial with bavi and chemo should also be starting in next coming days/weeks, which was recently announced.

If SUNRISE is stopped at either of the early look-ins for efficacy (to start new drug application) it will confirm its MOA (method of action) and its stock price should begin a very interesting and sustained accent due to the likely hood of bavi being a cornerstone molecule with extraordinary safety profile that combines with many others and can be used for many indications due to how universal a target PS is... could it be the perfect suitor for Gilead's ( http://www.fool.com/investing/general/2015/06/30/the-overlooked-reason-why-i-think-gilead-sciences.aspx ) now 20+ billion in cash burning a hole in their pocket shopping for their next cornerstone molecule?
*end*
http://www.ar15.com/forums/t_1_133/1824245_.html

cjgaddy

01/06/16 9:44 AM

#247822 RE: cjgaddy #245350

PPHM's Jeff Hutchins(VP/PreClinRes) speaking 3-16-16 at Immune Checkpoint Inhibitors Conf. (Boston).

Mar15-17 2016: Immune Checkpoint Inhibitors Conf., Boston
http://immune-checkpoint.com (Peregrine is 1 of 8 Corp. Sponsors)
3-16-16: Clinical Stream: “Enhance Combination Strategies to Maximize Efficacy”
11am: Patrick Ott, DANA-FARBER, “Critically Evaluate Mult. CI's in Combination”
11:30am: David Kaufman, MERCK, “Next-Gen.Biomarkers for the Era of Combo Cancer Immunotherapy”
12pm: Jon Wigginton, MACROGENICS, “Releasing the Brake: Enhancing Immunotherapy Through Rational Combos w/CI's”
-------
2pm: Jeff Hutchins (PEREGRINE/VP-PreClinRes), “Enhancing the Power of Checkpoint Inhibition by Simultaneously Blocking Upstream & Downstream Targets: The Role of Phosphatidylserine (PS), a Novel, Global Immune Checkpoint”
* Inhibiting PS using Bavituximab, a novel PS-signaling pathway inhibitor, blocks the immunosuppressive signal within the tumor microenvironment
* Assessing impact of immune stimulation through Fc?-receptor interaction on immune modulating cells
* Effects on multiple other immune effector cells will be presented
-------
2:30pm: Dirk Brockstedt, ADURO BIOTECH, “Discovery & Validation of the Next Generation of ICI's”

cjgaddy

01/16/16 10:43 AM

#249414 RE: cjgaddy #245350

Summary of Peregrine's New Collab's: Mem.Sloan-Kettering, AstraZeneca, NCCN

Post in 3 sections:
I. Memorial Sloan Kettering (MSKCC)_ – 5-2015/Investigate Novel PS-Targeting Immunotherapy Combos
II. AstraZeneca (Bavi+Durvalumab) - 8-2015/multiple solid tumors, 10-2015/expanded to NSCLC
III. Natl-Comprehensive-Cancer-Network (NCCN) – 1-2016/$2mm grant to NCCN's Oncology Res. Pgm (ORP), “26 of the world's leading cancer centers”

= = = = = = = = = = = = = =
I. MEMORIAL SLOAN KETTERING CANCER CENTER
5-29-15: Peregrine Pharmaceuticals Enters Into Research Collaboration to Investigate Novel PS-Targeting Immunotherapy Combinations
• Research Collaboration to Focus on Exploring Potential Combinations of PS-Targeting Agents Including Bavituximab With Other Immune Modulators
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=915472

TUSTIN, May 29, 2015: Peregrine Pharmaceuticals, Inc., a biopharmaceutical company focused on advancing bavituximab, a novel immuno-oncology agent in Phase III development for the treatment of lung cancer, today announced that the company has entered into a sponsored research agreement with Memorial Sloan Kettering Cancer Center (MSK) to explore the potential of Peregrine's proprietary phosphatidylserine (PS)-targeting antibody platform. The goal of the research is to identify effective treatment combinations based on Peregrine's PS-targeting agents, including Peregrine's lead clinical agent bavituximab, with other checkpoint inhibitors or immune stimulating agents that will further guide the bavituximab clinical development program.

The studies at MSK will be performed under the direction of Taha Merghoub, PhD, [ http://www.mskcc.org/research-areas/labs/members/taha-merghoub-01 ] Associate Attending Biologist, Melanoma and Immunotherapeutics Service, Ludwig Collaborative and the Swim Across America Laboratory, a part of the laboratory of Jedd D. Wolchok, MD, PhD [ http://www.mskcc.org/research-areas/labs/jedd-wolchok ], a leader in the field of cancer immunotherapy. Dr. Wolchok serves as the Chief, Melanoma and Immunotherapeutics Service, Lloyd J. Old Chair for Clinical Investigation as well as an Associate Director of the Ludwig Center for Cancer Immunotherapy at MSK.

"The phosphatidylserine (PS) signaling pathway is a very interesting target for modulating the immune system's response to cancer. We look forward to exploring the potential of PS-targeting agents alone and with other immune modulators that may lead to novel advances in cancer therapy," said Dr. Wolchok.

As part of the collaboration, researchers at MSK will conduct research to further explore the combination of PS-targeting agents, including bavituximab, that block a primary immunosuppressive pathway thereby allowing anti-tumor immune responses with other immuno-stimulatory agents that enhance immune responses. Specifically, MSK researchers will examine the combination of bavituximab alongside models of checkpoint blockade that are unresponsive to inhibition or co-stimulation given the ability of bavituximab to reprogram myeloid derived suppressor cells (MDSC) and increase tumoricidal T-cells in tumors, a mechanism of action that is complementary to checkpoint blockade and T-cell activation.

"A key focus of the Wolchok Lab's research is studying novel immunotherapy combinations that work together to enable the immune system to recognize and destroy cancer. This collaboration will allow us to focus on the role and contribution of PS blockade therapy in determining which combination of the current and next generation of immune modulators is likely to increase the extent and amplitude of anti-tumor response. This important pre-clinical and translational work will potentially guide the design of the next generation of clinical studies with bavituximab," said Dr. Merghoub.

"We are delighted to be working with a world-renowned pioneer and leader in the immuno-oncology space, recognizing that there remains significant research in order for more cancer patients to realize the benefits of combination immune therapy," said Jeff T. Hutchins, PhD, VP of Preclinical Research at Peregrine. ”Our internal and collaborative research presented over the last year has established a robust foundation of PS-targeting activity on which to initiate this next chapter in PS research and development."

"This collaboration is an important extension of our established research efforts to further explore and understand the potential of our PS-targeting platform including bavituximab our lead clinical candidate. This research will focus on better understanding how treatment with PS-targeting agents can assist other anti-tumor immunotherapies in order to work better," said Steven King, CEO of Peregrine. ”Our goal is to change the way cancer patients are treated by allowing their immune system to recognize and fight their disease. This collaboration will undoubtedly assist us in identifying potential new opportunities to better treat patients with cancer."

Peregrine's antibodies target and bind to phosphatidylserine (PS), a highly immunosuppressive molecule normally located on the interior of cellular membranes, but, following stresses in the tumor environment, becomes exposed on tumor cells and cells that line tumor blood vessels, helping tumors to evade immune detection. PS-targeting antibodies block this immunosuppressive signal, thereby enabling the immune system to better recognize and fight the tumor. Preclinical data show that the combination of bavituximab and inhibitors of immune checkpoints reduce tumor-suppressive factors including myeloid-derived suppressor cells and confer increased tumor-specific immunity when compared to either treatment alone.
*snip*
- - - - - - - - - - - -
5-31-15: ASCO’15 Roundtable (webcast), “Raising the Immuno-Oncology Bar - The Next Wave of Immune Modulating Checkpoint Inhibitors” - 7 panel members, incl. 3 Sloan Kettering researchers http://tinyurl.com/qxu4w2x
- - - - - - - - - - -
1-11-16 PR, “Peregrine Provides Update on Planned Expansion of Bavi Clinical Pgm in Lung, Breast and Other Cancers”… http://tinyurl.com/zhdy37a
PLANNED TRIALS...
#4. Phase II Trial in Early Stage TNBC in Combination with Chemotherapy
Peregrine is planning to initiate a Phase II trial of bavituximab in combination with neoadjuvant chemotherapy in early stage TNBC. The primary endpoint of this study is to determine the pathologic complete response rate (pCR), an accepted surrogate endpoint in early stage TNBC. The concept for this neoadjuvant setting trial, which will be conducted at a few select U.S. sites, originated from Peregrine's ongoing collaboration with Memorial Sloan Kettering Cancer Center (MSKCC). The company has filed a study protocol to its existing bavituximab IND application in the U.S. and is currently working to open clinical trial sites, including one that will be led by David B. Page, M.D., at the Providence Cancer Center in Oregon. http://tinyurl.com/zhdy37a
- - - - - - - -DR. DAVID PAGE: note his prior work with Dr. Jedd Wolchok, chief of Mem.Sloan's Melanoma & Immunotherapeutics Service who “investigates novel approaches for cancer immunotherapy and mechanisms of tumor cell–immune cell interactions”… http://www.bcrfcure.org/researchers/david-page

= = = = = = = = = = = = = = = = = = = = = = = = = =
II. ASTRAZENECA
8-24-15: AstraZeneca and Peregrine Pharmaceuticals to Collaborate on Immuno-Oncology Combination Clinical Trial
• Collaboration to Focus on Cancer Immunotherapy Combination of Peregrine's PS-Targeting Bavituximab and AstraZeneca's PD-L1 Inhibitor MEDI4736
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=928488
TUSTIN, Aug. 24, 2015: AstraZeneca (NYSE:AZN) and Peregrine Pharmaceuticals, a biopharmaceutical company focused on developing therapeutics to stimulate the body's immune system to fight cancer, today announced that they have entered into a cancer immunotherapy clinical trial collaboration. The collaboration will evaluate Peregrine's investigational phosphatidylserine (PS)-signaling pathway inhibitor, bavituximab, in combination with AstraZeneca's investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736). The planned Phase I/Ib trial will evaluate the safety and efficacy of bavituximab in combination with durvalumab in multiple solid tumors.

Peregrine and AstraZeneca will collaborate on a non-exclusive basis, to evaluate the combination of bavituximab and durvalumab with chemotherapy as a potential treatment in various solid tumors. The Phase I part of the trial is expected to establish a recommended dose regimen for the combination and the Phase Ib part of the trial will assess the safety and efficacy of the investigational combination. Under the terms of the agreement, the initial trial will be conducted by Peregrine.

Robert Iannone, Head of Immuno-Oncology, Global Medicines Development, at AstraZeneca said, "We believe that combination therapy in immuno-oncology has the potential to be a novel and highly effective approach to treating cancer. 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."

Bavituximab and durvalumab are investigational immunotherapies with different mechanisms that assist the body's immune system in fighting cancer. Bavituximab targets and modulates the activity of phosphatidylserine, a highly immune-suppressive molecule expressed broadly on the surface of cells in the tumor microenvironment. The treatment increases activated T-cells in tumors and fights cancer by reversing the immunosuppressive environment that many tumors establish in order to proliferate. MEDI4736 is a monoclonal antibody directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumors avoid detection by the immune system. Preclinical data have demonstrated that combining the enhanced T-cell mediated anti-tumor activity of bavituximab with checkpoint inhibitors, like PD-L1 antibodies, prolong the ability of tumor-specific T-cells to continue attacking the tumor.

”Data generated to date have shown significant potential for combining bavituximab with agents targeting the PD-1/PDL-1 pathway and we're excited to further explore this approach in studies with AstraZeneca's durvalumab," said Steven W. King, President and CEO of Peregrine. "AstraZeneca is a recognized leader in the immuno-oncology field and this collaboration will play a key role as we continue to fully explore the potential of bavituximab in combination immunotherapies for a variety of clinical applications."

ABOUT BAVITUXIMAB: A Targeted Investigational Immunotherapy
Bavituximab is an investigational chimeric monoclonal antibody that targets phosphatidylserine (PS). Signals from PS inhibit the ability of immune cells to recognize and fight tumors. Bavituximab, the lead compound in Peregrine's immuno-oncology development program, blocks PS to remove this immunosuppressive signal and sends an alternate immune activating signal. Targeting PS with bavituximab has been shown to shift the functions of immune cells in tumors, resulting in robust anti-tumor immune responses.

ABOUT DURVALUMAB (MEDI4736)
MEDI4736 is an investigational human monoclonal antibody directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumors avoid detection by the immune system. MEDI4736 blocks these signals, countering the tumor's immune-evading tactics. MEDI4736 is being developed, alongside other immunotherapies, to empower the patient's immune system and attack the cancer.
*snip*
- - - - - - - - - - - - -
10-15-15: AstraZeneca and Peregrine Pharmaceuticals Expand Ongoing Immuno-Oncology Collaboration to Include Phase II Lung Cancer Combination Clinical Trial
Global, Randomized Phase II Trial to Evaluate Immunotherapy Combination of Peregrine's PS-Targeting Bavituximab and AstraZeneca's PD-L1 Inhibitor Durvalumab (MEDI4736) in Previously Treated NSCLC
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=936766
TUSTIN, Oct. 15, 2015: Peregrine Pharmaceuticals, Inc., a biopharmaceutical company focused on developing therapeutics to stimulate the body's immune system to fight cancer, today announced that it has expanded its ongoing cancer immunotherapy clinical collaboration with AstraZeneca to include a second, later-stage trial. The companies will now also evaluate the immunotherapy combination of Peregrine's phosphatidylserine (PS)-targeted immune-activator, bavituximab, and AstraZeneca's anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736), in a global Phase II study in patients with previously treated squamous or non-squamous non-small cell lung cancer (NSCLC). The randomized Phase II trial will be conducted by Peregrine.

As part of the Phase II bavituximab and durvalumab combination trial, patients will be evaluated retrospectively for the correlation between their PD-L1 levels and clinical outcomes. This new study builds on the non-exclusive collaboration initiated between the companies in August 2015 [8-24-15: http://tinyurl.com/owlxpsf ] to conduct a Phase I/Ib basket clinical trial evaluating the combination of bavituximab and durvalumab with chemotherapy in multiple solid tumors.

Bavituximab and durvalumab are investigational immunotherapies with different mechanisms that assist the body's immune system in fighting cancer. Bavituximab targets and modulates the activity of phosphatidylserine, a highly immune-suppressive molecule expressed broadly on the surface of cells in the tumor microenvironment. In pre-clinical and translational clinical studies, the treatment increases activated T-cells in tumors and fights cancer by reversing the immunosuppressive environment that many tumors establish in order to proliferate. Durvalumab is a monoclonal antibody directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumors avoid detection by the immune system. Preclinical data have demonstrated that combining the enhanced T-cell mediated anti-tumor activity of bavituximab with checkpoint inhibitors, like PD-L1 antibodies, prolong the ability of tumor-specific T-cells to continue attacking the tumor.

"In the short period of time that we have been working with AstraZeneca, we have been very impressed with the company's commitment to innovative translational efforts that will help us better understand the dynamics of tumor immunity and clinical response to durvalumab and bavituximab combination in a range of cancers," said Joseph Shan, MPH, VP, Clinical and Regulatory Affairs of Peregrine. "We expect this extension of our collaboration with AstraZeneca will allow us to run a much more cost-effective and time-efficient trial than would have been possible under our previously planned study using Opdivo as the combination drug in the same lung cancer population. This Phase II study offers several key advantages including a supply of durvalumab that will enable us to conduct a global trial that can enroll patients more rapidly. In addition, the expanded collaboration provides for a more cohesive clinical program utilizing the same PD-L1 and other biomarker analysis across both the new Phase II trial and the already planned Phase I/Ib study combining durvalumab and bavituximab in multiple indications."
*snip*
- - - - - - - - -
From the 1-11-2016 PR Update on New Bavi Trials ( http://tinyurl.com/zhdy37a ):
PLANNED TRIAL: Phase II NSCLC Trial in Combination with AstraZeneca's Durvalumab
Peregrine expects to initiate a global Phase II study of bavituximab in combination with AstraZeneca's durvalumab, an anti-PD-L1 immune checkpoint inhibitor, in patients with previously treated squamous or non-squamous NSCLC during the first quarter of 2016. The goal of this trial is to generate data on the combination of bavituximab & durvalumab to inform the potential advancement of this treatment regimen into later stage clinical trial. The study's primary endpoints are overall response rate (ORR) and safety. The trial is also designed to retrospectively evaluate patients for the correlation between their PD-L1 levels and clinical outcomes, providing further critical data to guide future development. The randomized, open-label trial will evaluate approx. 200 patients at sites in the U.S. & Europe. The company has filed a study protocol to its existing investigational new drug (IND) application for bavituximab in the U.S. and is currently working to open clinical trial sites.

= = = = = = = = = = = = = = = = = = = = = = = = = =
III. NATL-COMPREHENSIVE-CANCER-NETWORK (NCCN)
1-6-16: Peregrine Pharmaceuticals and National Comprehensive Cancer Network (NCCN) Form Clinical Collaboration to Evaluate Novel Cancer Treatment Combinations With Bavituximab
• NCCN Alliance Includes 26 Leading Cancer Centers and World-Class Thought Leaders on Innovative Cancer Combination Therapies
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=949024
TUSTIN, Jan. 6, 2016: Peregrine Pharmaceuticals, Inc., a biopharmaceutical company focused on developing therapeutics to stimulate the body's immune system to fight cancer, today announced a new research collaboration with the National Comprehensive Cancer Network (NCCN) [ http://www.nccn.org ] to expand the company's ongoing clinical research and development of bavituximab for the treatment of a range of tumors. NCCN, a not-for-profit alliance of 26 of the world's leading cancer centers devoted to patient care, research, and education, is dedicated to improving the quality, effectiveness, and efficiency of cancer care so that patients can live better lives. Peregrine will fund multiple investigator-initiated clinical and correlative studies with bavituximab in multiple cancers at NCCN Member Institutions and their affiliate community hospitals through a $2 million research grant to NCCN's Oncology Research Program (ORP). NCCN will be responsible for oversight and monitoring of the clinical studies through the research grant.

Bavituximab is an investigational immunotherapy designed to assist the body's immune system by targeting and modulating the activity of phosphatidylserine (PS), a highly immune-suppressive signaling molecule expressed broadly on the surface of cells in the tumor microenvironment. Peregrine's PS targeted inhibitor, bavituximab, is thought to reverse the immunosuppressive environment that many tumors establish in order to proliferate and spread, while also fighting cancer by activating immune cells that target and fight cancer. According to Peregrine, a broad set of preclinical and translational data has been assembled that supports the ability of bavituximab to improve the therapeutic activity of a range of cancer treatments, from traditional approaches, such as chemotherapy and radiation, to novel immuno-oncology agents such as checkpoint inhibitors.

"This collaboration with NCCN will allow us to significantly expand our clinical evaluation of bavituximab and augment Peregrine's internal investigator sponsored trial (IST) program," said Steven W. King, President and CEO of Peregrine. "Importantly, NCCN shares our strong research interest in evaluating unique bavituximab combination therapies for the treatment of cancer, and the group's oversight of the program will allow for the conducting of many more studies than would have been otherwise possible."

"NCCN is very pleased to collaborate with Peregrine Pharmaceuticals on their first-in-class novel targeted monoclonal antibody, bavituximab," said Robert C. Young, MD, Interim Vice President, ORP, NCCN. "We look forward to a productive interaction in both clinical and pre-clinical studies undertaken at the NCCN Member Institutions."

Peregrine expects results from this collaboration to further support the ongoing development of bavituximab as a key component of various combination cancer treatments. Bavituximab is currently being evaluated in combination with docetaxel (chemotherapy) for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) in the ongoing Phase III SUNRISE trial. In addition, as part of its recently formed collaboration with AstraZeneca, Peregrine expects to initiate a global Phase II study of bavituximab in combination with AstraZeneca's investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736), in patients with previously treated squamous or non-squamous NSCLC. The company will also be evaluating bavituximab with chemotherapy combinations in HER2-negative breast cancer.
*snip*
ABOUT THE NATIONAL COMPREHENSIVE CANCER NETWORK [ http://www.nccn.org ]
The National Comprehensive Cancer Network (NCCN), a not-for-profit alliance of 26 of the nation's leading cancer centers devoted to patient care, research, and education, is dedicated to improving the quality, effectiveness, and efficiency of cancer care so that patients can live better lives. Through the leadership and expertise of clinical professionals at NCCN Member Institutions, NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. As the arbiter of high-quality cancer care, NCCN promotes the importance of continuous quality improvement and recognizes the significance of creating clinical practice guidelines appropriate for use by patients, clinicians, and other health care decision-makers.

THE NCCN MEMBER INSTITUTIONS ARE: Fred & Pamela Buffett Cancer Center, Omaha, NE; Case Comprehensive Cancer Center/Univ. Hospitals Seidman Cancer Center and Cleveland Clinic Taussig Cancer Institute, Cleveland, OH; City of Hope Comprehensive Cancer Center, Los Angeles, CA; Dana-Farber/Brigham and Women's Cancer Center | Massachusetts General Hospital Cancer Center, Boston, MA; Duke Cancer Institute, Durham, NC; Fox Chase Cancer Center, Philadelphia, PA; Huntsman Cancer Institute at the Univ. of Utah, Salt Lake City, UT; Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance, Seattle, WA; The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Robert H. Lurie Comprehensive Cancer Center of Northwestern Univ., Chicago, IL; Mayo Clinic Cancer Center, Phoenix/Scottsdale, AZ, Jacksonville, FL, and Rochester, MN; Memorial Sloan Kettering Cancer Center, New York, NY; Moffitt Cancer Center, Tampa, FL; The Ohio State Univ. Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute, Columbus, OH; Roswell Park Cancer Institute, Buffalo, NY; Siteman Cancer Center at Barnes-Jewish Hospital and Washington Univ. School of Medicine, St. Louis, MO; St. Jude Children's Research Hospital/The Univ. of Tennessee Health Science Center, Memphis, TN; Stanford Cancer Institute, Stanford, CA; Univ. of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, AL; UC San Diego Moores Cancer Center, La Jolla, CA; UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA; Univ. of Colorado Cancer Center, Aurora, CO; Univ. of Michigan Comprehensive Cancer Center, Ann Arbor, MI; The Univ. of Texas MD Anderson Cancer Center, Houston, TX; Vanderbilt-Ingram Cancer Center, Nashville, TN; and Yale Cancer Center/Smilow Cancer Hospital, New Haven, CT.
Clinicians, visit http://NCCN.org . Patients and caregivers, visit http://NCCN.org/patients .
Safe Harbor *snip*
- - - - - - -NCCN's 1-6-16 PR: NCCN Awarded $2 Million in Research Funding from Peregrine Pharmaceuticals to Study Bavituximab in Various Cancers
• The NCCN Oncology Research Program (ORP) was awarded a $2-million grant from Peregrine Pharmaceuticals, Inc. to facilitate studies of bavituximab in various cancers.
http://www.nccn.org/about/news/newsinfo.aspx?NewsID=565
FORT WASHINGTON, PA —The National Comprehensive Cancer Network (NCCN) Oncology Research Program (ORP) has been awarded a $2-million grant from Peregrine Pharmaceuticals, Inc. to study bavituximab, a first-in-class treatment approach for various cancers.

“NCCN is very pleased to collaborate with Peregrine Pharmaceuticals on their first-in-class novel targeted monoclonal antibody, bavituximab,” said Robert C. Young, MD, Interim VP, ORP, NCCN. “We look forward to a productive interaction in both clinical and pre-clinical studies undertaken at the NCCN Member Institutions.”

“This collaboration with NCCN will allow us to significantly expand our clinical evaluation of bavituximab and augment Peregrine’s internal IST program,” said Steven W. King, Peregrine's CEO. “Importantly, NCCN shares our strong research interest in evaluating unique bavituximab combination therapies for the treatment of cancer, and the group’s oversight of the program will allow for the conducting of many more studies than would have been otherwise possible.”

Bavituximab is an investigational immunotherapy designed to assist the body's immune system by targeting and modulating the activity of phosphatidylserine (PS), a highly immune-suppressive signaling molecule expressed broadly on the surface of cells in the tumor microenvironment. Peregrine’s PS targeted inhibitor, bavituximab, is thought to reverse the immunosuppressive environment that many tumors establish in order to proliferate and spread, while also fighting cancer by activating immune cells that target and fight canceri. According to Peregrine, a broad set of pre-clinical and translational data has been assembled that supports the ability of bavituximab to improve the therapeutic activity of a range of cancer treatments, from traditional approaches, such as chemotherapy and radiation, to novel immuno-oncology agents such as checkpoint inhibitors.

The first phase of the program will involve the establishment of an NCCN Bavituximab Request for Proposals Development Team to evaluate existing data and to discuss and define the data and type of studies necessary to further characterize the safety and clinical effectiveness of bavituximab.

The NCCN ORP draws on the expertise of the investigators of the NCCN Member Institutions and NCCN Affiliate Research Consortium (ARC) to facilitate all phases of clinical research. This research is made possible by collaborations with pharmaceutical and biotechnology companies in order to advance therapeutic options for patients with cancer.

The NCCN ORP will utilize the grant from Peregrine Pharmaceuticals to support investigator-initiated clinical and correlative studies at NCCN Member Institutions and their affiliate community hospitals for bavituximab. To date, this successful research model has received approximately $58 million in research grants and supported more than 132 studies that have produced a number of publications in peer-reviewed journals.

To learn more about the NCCN ORP and ongoing clinical trials, visit http://NCCN.org/ORP .
*end*
- - - - - - - - - - - - - - - -
From the 1-11-2016 PR Update on New Bavi Trials ( http://tinyurl.com/zhdy37a ):
PLANNED TRIAL: Multiple Clinical and Translational Studies in Collaboration with NCCN
Peregrine recently announced a new research collaboration with NCCN to expand the company's ongoing clinical research and development of bavituximab for the treatment of a range of tumors. NCCN, a not-for-profit alliance of 26 of the world's leading cancer centers devoted to patient care, research, and education, is dedicated to improving the quality, effectiveness, and efficiency of cancer care so that patients can live better lives. Multiple investigator-initiated clinical and correlative studies with bavituximab in multiple cancers will be initiated at NCCN Member Institutions and their affiliate community hospitals through a $2mm research grant to NCCN's Oncology Research Program (ORP). NCCN will be responsible for oversight and monitoring of the clinical studies through the research grant. The company expects results from this collaboration to further support the ongoing development of bavituximab as a key component of various combination cancer treatments.

cjgaddy

01/24/16 1:35 PM

#250242 RE: cjgaddy #245350

Website Pipeline Chart updated 1-24-16
http://www.peregrineinc.com/pipeline/overview.html


= = = = = = = = = = = = = = = = = = =
1-16-16: Summary of Peregrine's New Collab's: Mem.Sloan-Kettering, AstraZeneca, NCCN – see: http://tinyurl.com/zkvebh6

I. Memorial Sloan Kettering (MSKCC) – 5-2015/Investigate Novel PS-Targeting Immunotherapy Combos
II. AstraZeneca (Bavi+Durvalumab) - 8-2015/multiple solid tumors, 10-2015/expanded to NSCLC
III. Natl-Comprehensive-Cancer-Network (NCCN) – 1-2016/$2mm grant to NCCN's Oncology Res. Pgm (ORP), “26 of the world's leading cancer centers”

...??Cancer Moonshot 2020 http://www.cancermoonshot2020.org – see S.King's 1-14-16 EP-Vantage comments: http://tinyurl.com/z59pc6a

= = = = = = = = = = = = = = = = = = =
1-11-16/PR: Update on 4 New Bavi Clinical Trials (Lung/AZN, Breast/1Co./1MSKCC, Other Cancers/AZN). SUNRISE estimates: Interim1=Early'16, Interim2=Mid'16, FinalUnblinding=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+durvalumab(MEDI4736), 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+Durvalumab Ph1/1B Trial for “multiple solid tumors” http://tinyurl.com/owlxpsf
...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/qxu4w2x explore other potential applications of bavituximab and other agents that target PS-signaling pathway.”

cjgaddy

01/25/16 4:11 PM

#250348 RE: cjgaddy #245350

Futility=Inferiority, Efficacy=Superiority – these are official FDA clinical trial words. For SUNRISE, the 1st-Look-in (33%/Events) will test ONLY for “Futility”(inferiority), meaning the trial will be Stopped IF very bad (statistical) results to date vs. Control. The 2nd-Look-in (50%/Events) will again test for Futility, and also for “Efficacy”(superiority), meaning the trial will be Stopped IF very excellent (statistical) results to date vs. Control. Of course, SAFETY is always looked at by the DMC. These Look-in rules happen to the ones Dr. Garnick & Mr. Shan & Peregrine Team negotiated with the FDA.

= = = = = = = = = = = = = = = = =
3 Types of Interim Analyses: SAFETY, FUTILITY, EFFICACY. (SAFETY being a continuous DMC concern).
During a clinical trial, we can perform interim analysis (or DMC, DSMB review) for 3 different reasons:
Interim analysis for SAFETY:
1) with pre-specified stopping rule (for example stop the trial if we see # of cases of Serious Adverse Events)
2) without pre-specified stopping rule (rely on DMC members to review the overall safety)
Interim analysis for FUTILITY ["INFERIORITY"]: To see if the new treatment is unlikely to beat the control – then stop the trial for futility - this is called ‘futility analysis’.
Interim analysis for EFFICACY ["SUPERIORITY"]: To see if the new treatment is overwhelmingly better than control - then stop the trial for efficacy.
In situations 2 & 3, the criteria for stopping rule for efficacy could be different from the stopping rule for futility, but need to be pre-specified.
More: http://onbiostatistics.blogspot.com/2012/03/futility-analysis-in-clinical-trials.html

= = = = = = =
6-1-15 PR: BAVI CLINICAL TRIALS EXPANSION http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=915699
SUNRISE Phase III Pivotal Trial
The company's Phase III SUNRISE (Stimulating ImmUne RespoNse thRough BavItuximab in a PhaSE III Lung Cancer Study) is an approximately 600 patient trial that continues to enroll at over 150 sites worldwide. Completion of enrollment is anticipated by calendar year-end. This Phase III, randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the safety, tolerability and efficacy of bavituximab as a second-line treatment in patients with non-squamous NSCLC. Enrollment is proceeding according to plan with 2 planned interim efficacy analyses which will be reviewed by the trial's Independent Data Monitoring Committee (IDMC). The 1st interim analysis, which will be conducted when 33% of the targeted overall survival events are reached, is for futility and the 2nd interim analysis, for futility or superiority [Superiority=EFFICACY], will be conducted at 50% of events. As these analyses are event driven, the exact timing of each is unknown, however the company plans to provide updates as these events are reached. For additional information about the SUNRISE trial, please visit http://www.sunrisetrial.com or ClinicalTrials.gov using the Identifier NCT01999673. => http://www.clinicaltrials.gov/ct2/show/NCT01999673

12-10-15: “Sunrise >90% enrolled; sufficient to allow the 2 planned interim looks (33%/50%) and final readout based on PrimEndPt=OS”
“The next milestones are the interim analyses that will be conducted when 33% & 50% of the targeted number of deaths are reached. While these are event driven, it is our expectation that the 1st interim analysis will read out in early 2016 and the 2nd interim analysis around mid-2016. The final analysis, which will trigger study unblinding, is currently projected to occur at the end of 2016.
http://tinyurl.com/jkp885g

cjgaddy

02/25/16 8:00 PM

#254656 RE: cjgaddy #245350

2-25-16/PR: IDMC Halts SUNRISE at 1st Look-in. Bavi+Doce arm “OS performing as expected”; Doce arm “dramatically outperforming OS expectations”…

2-25-16: Peregrine Pharmaceuticals Provides Update on Phase III SUNRISE Trial of Bavituximab
- Conference Call With Management Scheduled for 4:30pm ET
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=957281
TUSTIN, Feb. 25, 2016: Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM, PPHMP), a biopharmaceutical company focused on developing therapeutics to stimulate the body's immune system to fight cancer, today announced that it is discontinuing the company's Phase III SUNRISE trial of bavituximab in patients with previously treated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). The decision to stop the trial was based on the recommendation of the study's Independent Data Monitoring Committee (IDMC) following a pre-specified interim analysis performed after 33% of targeted overall events (patient deaths) in the study were reached. Results of the analysis demonstrated that the bavituximab plus docetaxel group did not show a sufficient improvement in overall survival as compared to the docetaxel group to warrant continuation of the study. The interim analysis showed that the bavituximab combination group is performing as expected according to the original trial assumptions in terms of overall survival, while the docetaxel group is dramatically outperforming overall survival expectations based on the original trial assumptions and as compared to recently published studies.

"Let me start by taking this opportunity to thank all of the patients, their families, and the physicians who participated in the SUNRISE trial. While we are deeply disappointed by this early outcome from the SUNRISE trial, we plan to take a deliberate and detailed approach in reviewing and verifying all available data from the trial in order to understand what subgroups or other patient characteristics may have impacted the performance of the study. While we perform this analysis, we plan to put our other chemotherapy combination studies on hold until we have a clear understanding of the SUNRISE study results," said Steven W. King, President & CEO of Peregrine. "While this is an unexpected and disappointing setback for the bavituximab chemotherapy combination clinical program, we have not seen anything in this trial result that diminishes our enthusiasm for advancing our immuno-oncology (I-O) combination trials. The I-O combination studies are based on different mechanistic synergies that are clearly separate from the chemotherapy combination being evaluated in the SUNRISE study. In addition, it is important to note that in no way do these results have any impact on our contract manufacturing business conducted through our wholly owned subsidiary, Avid Bioservices. This business has shown consistent revenue growth and has been instrumental in maintaining a strong cash position and our plan is to continue growing this business."

As of February 1, 2016, Avid Bioservices had a revenue backlog in excess of $58 million under committed contracts from existing clients. In addition, Peregrine had $67.5 million in cash and equivalents as of January 31, 2016.

Conference Call Today
Peregrine will host a conference call today beginning at 4:30PM ET (1:30PM PT). To listen to the conference call, please dial (877) 312-5443 or (253) 237-1126 and request the Peregrine Pharmaceuticals conference call. To listen to the archived webcast please visit: http://ir.peregrineinc.com/events.cfm .

About Bavituximab: A Targeted Investigational Immunotherapy
Bavituximab is an investigational chimeric monoclonal antibody that targets phosphatidylserine (PS). Signals from PS inhibit the ability of immune cells to recognize and fight tumors. Bavituximab is believed to override PS mediated immunosuppressive signaling by blocking the engagement of PS with its receptors as well as by sending an alternate immune activating signal. PS targeting antibodies have been shown to shift the functions of immune cells in tumors, resulting in multiple signs of immune activation and robust anti-tumor immune responses.

About Peregrine Pharmaceuticals, Inc.
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing therapeutics to stimulate the body's immune system to fight cancer. Bavituximab is the company's lead immunotherapy candidate. In addition to its drug development programs, Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. ( http:/www.avidbio.com ), which provides development and biomanufacturing services for both Peregrine and third-party customers. For more information, please visit http://www.peregrineinc.com .
Safe Harbor*snip*
Contacts: Jay Carlson, Peregrine Pharmaceuticals, Inc., (800) 987-8256 info@peregrineinc.com
Stephanie Diaz (Investors), Vida Strategic Partners, 415-675-7401 sdiaz@vidasp.com
Tim Brons (Media), Vida Strategic Partners, 415-675-7402 tbrons@vidasp.com

= = = = = = = = = = = = = = =
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
...EU/EEA Registries: (pts world=582, pts/EU=345, planned EU sites=100) http://www.clinicaltrialsregister.eu/ctr-search/search?query=2013-003953-13
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
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."