Avid Bioservices Inc (CDMO)

[cjgaddy]

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 [phone] or [phone] 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., [phone] [e-mail]
Stephanie Diaz (Investors), Vida Strategic Partners, 415-675-7401 [e-mail]
Tim Brons (Media), Vida Strategic Partners, 415-675-7402 [e-mail]

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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."