Avid Bioservices Inc (CDMO)

[cjgaddy]

UTSW’s Dr.David.Gerber (SUNRISE ESMO’16/LeadAuthor) quoted in MOONSHOT article… Recall, Dr. Gerber is the Lead Author (presumably he’ll be the speaker) of the upcoming Oct. 10th ESMO’16 late-breaking Proffered Paper (Oral Presentation) of Topline data from the Phase III SUNRISE trial, including initial results from ongoing biomarker analysis, which CEO Steve King described in the 9-8-16 CC as “already highly encouraging”.

9-8-16/SciNews: “Panel Outlines Research Priorities for Cancer Moonshot”
https://www.sciencenews.org/article/panel-outlines-research-priorities-cancer-moonshot
...”Recommendations emphasize importance of data sharing, promise of immunotherapy” ...For treatment, the report singles out immunotherapy, which harnesses a patient’s own immune system to fight cancer. The strategy is widely regarded as one of the most significant advances in cancer care, even though so far only 10-20% of patients receiving such treatments show long-term benefit. “When I speak to my patients, I tell them that the greatest risk is disappointment,” says medical oncologist David Gerber of the Univ. of Texas SW Medical Center/Dallas. Nonetheless, he and others remain optimistic about immunotherapy’s potential, and he agrees with recommendations to speed up research. In proposing an immunotherapy clinical trials network, the report states that current treatments “represent only the tip of the iceberg of what is possible.”
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1-13-16: “JP Morgan - Jumping In Front Of The Cancer Immunotherapy Parade”
EP Vantage Newsletter Provider
Steven King, CEO of Peregrine Pharmaceuticals, sees the potential for this (Cancer MoonShot 2020) initiative to offer an opportunity for smaller companies to run more combination trials. While Peregrine is planning a trial in combination of its immuno-oncology agent bavituximab with AstraZeneca’s durvalumab and is collaborating with the National Comprehensive Cancer Network (NCCN) for other combination trials, this coalition might serve to stimulate an expansion of clinical work. “It’s often access to drugs. If you want to run a combination with Keytruda or Opdivo, you’re going to have to buy the drug,” he told EP Vantage in an interview on the sidelines of the JP Morgan meeting. “It becomes a cost issue. You’re not going to be able to run as many studies.”
MORE: http://investorshub.advfn.com/boards/read_msg.aspx?message_id=119836127

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9-8-16/CC/Steve King: “Topline data from our Phase III SUNRISE trial have been accepted for a late-breaking oral presentation [10-10-16, Dr. David Gerber, UTSW, Lead Author – see below] at the upcoming European Society of Medical Oncology (ESMO) Congress to be held in Copenhagen in early October [Oct7-11]. ESMO is the premier European oncology meeting, attended by thousands of oncologists. The presentation at ESMO will be a great opportunity to share clinical data from the study in conjunction with initial results from ongoing biomarker analysis, which are already highly encouraging. Biomarker analysis was built into the SUNRISE trial from the beginning, including the collection of thousands of patient samples that could be analyzed once of the trial was unblinded. The primary goal the biomarker analysis is to identify a biomarker pattern, present in patients that receive the most benefit from a bavituximab containing therapeutic regimen, and we look forward to sharing the results of the ongoing analysis, with more data expected later in the year. The impact of the effective biomarker identification is already quite evident in oncology drug development, with the latest evidence being PD1/PD-L1 in the development of Keytruda. These types of biomarkers can only be identified through analysis of larger patient populations, such as in the SUNRISE trial. The results of identifying effective biomarkers can potentially have a huge impact on clinical development, potentially reducing the size of future trials, including making possible biomarker-driven clinical designs which could provide even more rapid readouts. Taken together, these developments are setting the stage for new data throughout the rest of 2016 and into 2017.” http://tinyurl.com/jmy77g3

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Oct7-11 2016: “41st ESMO European Cancer Congress”, Copenhagen, Denmark
http://www.esmo.org/Conferences/ESMO-2016-Congress
ESMO = European Society for Medical Oncology
ECCO = European CanCer Organization
Pgm: http://www.esmo.org/Conferences/ESMO-2016-Congress/Programme
I. 10-9-16 1:00-2:00pm: POSTERS - Topic: Immunotherapy of Cancer
#1074P: “Antibody Mediated Blockade of Phosphatidylserine Improves Immune Checkpoint Blockade by Repolarizing Immune Suppressive Mechanisms of the Tumor Microenvironment” - Jeff Hutchins(VP/PreClin.Res), Peregrine Pharmaceuticals (pg.165)
9-8-16/CC/JeffH: “Exciting new internal work on PPHM’s I-O preclin. studies (Jeff Hutchins) will be presented.”
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II. 10-10-16 Type: Proffered Paper Session* - “NSCLC/Metastatic2”
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*Proffered Paper Session = Oral presentations by authors presenting original data of superior quality, followed by expert discussion and perspectives.
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Chairs: Fiona Blackhall(GB); Tony S.K. Mok(Hong Kong)
10-10-16 9:15-9:30am #LBA45: “Top-line Results from SUNRISE: A Phase III, Randomized, Double-Blind, Placebo-Ctl’d Multicenter Trial of Bavituximab + Docetaxel in Patients with Previously Treated Stage IIIb/IV Non-Squamous NSCLC”
D. Spigel 1, I. Bondarenko 2, G. Losonczy 3, J. Mezger 4, H. Kalofonos 5, M. Reck 6, R. Palmero 7, T. Jang 8, R. Natale 9, R. Sanborn 10, J. Lai 11, N. Kallinteris 12, M. Tang 11, J. Shan 13, David E. Gerber(MD, UTSW – Lead Author)** 14
1=Nashville TN; 2=Dnepropetrovsk, UA, 3=Budapest, HU, 4=Karlsruhe, DE, 5=Patras, GR, 6=Grosshansdorf, DE, 7=Barcelona, ES, 8=Busan, KR, 9=Los Angeles CA, 10=Portland OR, 11/12/13=Tustin CA; 14=UTSW/Dallas
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**UTSW’s Dr. David Gerber presented Prelim. SUNRISE Data 5-31-14 at ASCO’14 – see http://tinyurl.com/nv4jloo )
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BAVITUXIMAB "SUNRISE" PHASE III TRIAL: http://www.SunriseTrial.com
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
...2 ARMS: A=BAVI/3mg+DOCE(Weekly), B=Doce+Placebo(Weekly)
...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
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
5-31-14 ASCO’14: David Gerber/Joe Shan Poster on Ph3/SUNRISE Trial (#TPS8129) http://tinyurl.com/nv4jloo
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3 NCCN Bavituximab Trials Announced 9-6-16 – "Early 2017" (Moffitt, MassGEN, JohnHopkins) http://tinyurl.com/hj8yeuz

#1: Ph1/HepC-Related Hepatocellular (Bavi+RAD+Sorafenib), MOFFITT CANCER CENTER - PI: Jessica Frakes, MD
"A Phase I Trial of Sorafenib & Bavituximab + Stereotactic Body Radiation Therapy (SBRT) for Unresectable Hepatitis C Associated Hepatocellular Carcinoma"
=> 9-8-16/CC/JoeShan: “The 1st award is for a Phase I trial of Sorafenib [Bayer’s Nexavar] and bavituximab + radiation in Hepatocellular Carcinoma. This will build on a previously reported investigator sponsored Phase II trial of bavituximab & sorafenib in Liver Cancer. [3-25-15/Dr.Adam.Yopp(UTSW)/Ph2data, N=38: http://tinyurl.com/opkh5qy ]”

#2: P1-2/Newly Diag. Glioblastoma (Bavi+RAD+Merck’s Temodar), MASS-GEN. CANCER CENTER - PI: Elizabeth Gerstner, MD
"Phase I/II Clinical Trial of Bavituximab with Radiation & Temozolomide(Temodar) for Patients with Newly Diagnosed Glioblastoma"
=> 9-8-16/CC/JoeShan: “The 2nd award is for a Phase I/II trial of bavituximab with radiation + temozolomide [Merck’s Temodar] in newly diagnosed Glioblastoma. This trial is supported by some of our most impressive preclinical data demonstrating long-term survival in a lethal brain cancer model and that surviving rats were immune from tumor re-challenge.”

#3: Ph2/Progressive Squamous Head+Neck (Bavi+Merck’s Keytruda), JOHN-HOPKINS(Sidney Kimmel CC) - PI: Ranee Mehra, MD
”Phase II Study of Pembrolizumab & Bavituximab for Progressive Recurrent/Metastatic Squamous Cell Carcinoma of the Head & Neck"
=> 9-8-16/CC/JoeShan: “The 3rd award is for a Phase II study of pembrolizumab [Merck’s Keytruda, anti-PD-1] & bavituximab in Head & Neck Cancer. We are particularly excited about this project, as it will be the first clinical trial of bavituximab with a checkpoint inhibitor. In multiple previous preclin. studies, we have observed bavituximab's potential to work synergistically with PD1 inhibitors such as pembrolizumab.”