Replies to post #314733 on Avid Bioservices Inc (CDMO)

[revenue_monster]

your million points of unconnected light have been extinguished

[geocappy1]

Wonder how much they paid. Probably could buy pphm IP and all the patents for less

[biopharm]

Bird & Bird advises Precision Medicine Group on the acquisition of Epiontis
09 October 2017

Bird & Bird LLP advises Precision Medicine Group, a scientific services company helping life science innovators develop medical products, on the acquisition of all shares in Epiontis GmbH, a leading immune monitoring and epigenetic technology service provider based in Berlin.

The acquisition will allow Precision for Medicine to expand on its immune monitoring capabilities with Epiontis’s epigenetic technology, and strengthen its global footprint in the rapidly expanding precision medicine sector.

The Bird & Bird team advised Precision for Medicine on the due diligence, signing and closing of the transaction, including IP patent due diligence and regulatory advice regarding the life sciences aspects of the deal.

Stefan Münch (Corporate/M&A, Munich) led the transaction on the German law aspects, assisted by counsel Stephan Kübler and associates Michael Gassner and Benedikt Weiss (both Corporate/M&A, Munich), partner Ralph Panzer and associate Julia Gottinger (both Employment, Munich), counsel Gerrit Wiedow (Employment, Hamburg), partners Michael Alt, Christopher Maierhöfer and associate Marie-Theres Schmid (all Patents, Munich), partner Markus Körner and counsel Thomas Urband (both Trademarks, Munich), partner Alexander Csaki and associate Clarissa Junge-Gierse (both Life Sciences/Regulatory, Munich) and partner Michael Jünemann (Finance, Frankfurt). Bird & Bird London partner Ali Ramadan and associate Hannah Fletcher (both Corporate/M&A, London) also assisted on the UK law issues. Legal in-house advisors were General Counsel John Mariano and Senior Counsel Rita Khoobchandani.

https://www.twobirds.com/en/news/press-releases/2017/germany/bird-and-bird-advises-precision-medicine-group-on-the-acquisition-of-epiontis

So in the midst of collaborations and data to be released Nov 8 2017....Precision for Medicine all of a sudden advised to buy out Epiontis (where Ivana Turbachova suddenly passed away....) and did she want to sell out ?? ....very strange as we see Nov 8 just a week or so away....and can Bird/Bird advise to buy out a company based upon PS Targeting collaborations data and/or based on undisclosed info..........hmmmm.

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P18 and P35 also withdrawn and P87 below .....with Precision for Medicine that buys out Epiontis

SITC 2017 Abstract Titles – Biomarkers and Immune Monitoring - SITC 2017 - Society for Immunotherapy of Cancer
https://www.sitcancer.org
1Peregrine Pharmaceuticals, Tustin, CA, USA 2Epiontis GmbH, Berlin, Germany 3Precision Medicine ...

P87
Results of epigenetic-based quantitative PCR assisted immune cell counting analysis in bavituximab SUNRISE trial subgroup

Nikoletta L. Kallinteris1, Thomas O. Kleen2, Min Tang1, Shen Yin1, Tobi Guennel3, Jennifer Lai1, Victor Nowakowski2, Steven Olek2, Steve King1, Joseph S. Shan1

1Peregrine Pharmaceuticals, Tustin, CA, USA

2Epiontis GmbH, Berlin, Germany

3Precision Medicine, Frederick, MD, USA
Biomarkers | Clinical trial | Antibody | Monocyte/Macrophage | MDSC | Checkpoint blockade | Immune suppression | T cell | NK/NK T cell | Regulatory T cell (Treg)
P88

https://www.sitcancer.org/2017/abstracts/titles/biomarkers-immune-monitoring

[biopharm]

Epiontis scooped up by Precision for Medicine for PS Targeting biomarkers related reasons.....

Now, pay close attention to the words of David Parker at Precision For Medicine as he states "All of those are informatics technologies, that are enabling measurements and correlations to be drawn that couldn’t be drawn previously. "

.....that couldn't be drawn previously......hmmmm, as both, PFM and Epiontis were working with Biomarker data with Peregrine ....so what couldn't be drawn previously, I say.....is becoming obvious was related to Biomarkers etc discovered while ongoing colorations with Peregrine Pharmaceuticals now called Avid Bioservices. Remember also...Bird/Bird goes on record as the reason why the purchase of Epiontis was made by PFM and possibly for legal reasons.

Genetic Engineering & Biotechnology

Sept/Oct 2017
....
....

Clinical OMICs: What do you see as the big issues in the complementary and companion diagnostic area in the next few years?

David Parker, Ph.D.
David Parker, Ph.D., SVP, Diagnostics Solutions, Precision for Medicine: There are a number of things. It will be technologies that, when applied to biological specimens, allow multiple markers to be assayed simultaneously. I’m thinking specifically about mass spec. It’s been around a long time. It is not typically applied to biomarker analysis, but increasingly it is, in part because it allows multiple analytes to be assayed in the same sample and the same assay. So enabling technologies like that that allow multiple biomarkers to be assayed simultaneously is one.

The other is informatics in a couple of dimensions. It is applications of digital technologies that allow correlation and measurements to be made that never could be previously. Another could be identifying biomarker signatures out of multiple streams of omic data: proteomic, genomic, and the like. They are disparate streams, but can you find patterns that are in and of themselves a biomarker. And the third is the Foundation [Medicine] deep curation. Can we correlate every single piece of scientific knowledge known about this mutation in a way that might reveal some clinical utility?

All of those are informatics technologies, that are enabling measurements and correlations to be drawn that couldn’t be drawn previously.

https://www.genengnews.com/gen-exclusives/of-biomarkers-and-cdxes/77900989

[biopharm]

The Bird & Bird team advised Precision for Medicine on the due diligence, signing and closing of the transaction, including IP patent due diligence and regulatory advice regarding the life sciences aspects of the deal.

Stefan Münch (Corporate/M&A, Munich) led the transaction on the German law aspects, assisted by counsel Stephan Kübler and associates Michael Gassner and Benedikt Weiss (both Corporate/M&A, Munich), partner Ralph Panzer and associate Julia Gottinger (both Employment, Munich), counsel Gerrit Wiedow (Employment, Hamburg), partners Michael Alt, Christopher Maierhöfer and associate Marie-Theres Schmid (all Patents, Munich), partner Markus Körner and counsel Thomas Urband (both Trademarks, Munich), partner Alexander Csaki and associate Clarissa Junge-Gierse (both Life Sciences/Regulatory, Munich) and partner Michael Jünemann (Finance, Frankfurt). Bird & Bird London partner Ali Ramadan and associate Hannah Fletcher (both Corporate/M&A, London) also assisted on the UK law issues. Legal in-house advisors were General Counsel John Mariano and Senior Counsel Rita Khoobchandani.

https://www.twobirds.com/en/news/press-releases/2017/germany/bird-and-bird-advises-precision-medicine-group-on-the-acquisition-of-epiontis

Peregrine Pharmaceuticals / Avid Bioservices as they worked with Epiontis and Precision For Medicine and has anyone been paying attention to legal parties here....and would Mark Ziebell not be required to be involved with this if PS Targeting Biomarker data was part of the reasons for why Epiontis was bought out ?

Has anyone emailed Epiontis / PFM / Avid Bioservices and Bird & Bird about concerns of what information was disclosed to some parties and not retail shareholders of PPHM, now CDMO

[biopharm]

Biomarkers, PS Targeting hedge funds to John Springs Stafford to Sard Verbinnen

Sometimes ....one can't control everything but ask oneself this, those that spend time on a company that likely is positioning itself for paradigm shifts across Big Pharma as we now know it....either want PS Targeting to advance or they will lose out in other ways and want it delayed as long as possible

Sard Verbinnen was brought on board for a reason

John Springs Stafford was brought on board for reasons as well

Nothing happens for no reason and Biomarkers are here for good

The following from the FDA and how quickly things change once scientifically proven Biomarkers rise up and lead the way that some in Big Pharma will not like

Data used to establish the relationship between a biomarker and an outcome of interest, to
support biomarker qualification, can come from a variety of sources including the following:

Randomized controlled trial Single-arm/historical control trial Cohort study
Case-control study (including nested) Cross-sectional study
Case series or case reports Registry information Meta-analysis
Contains Nonbinding Recommendations

- Randomized controlled trial
- Single-arm/historical control trial - - Cohort study
- Case-control study (including nested)
- Cross-sectional study
- Case series or case reports
- Registry information
- Meta-analysis

The strongest level of evidence to support the association of a biomarker with an outcome of interest comes from prospective studies that are specifically designed and powered to assess the association. In many settings, however, data from studies conducted for other purposes are used to support biomarker qualification. Ultimately, the COU, with its associated potential benefits and risks, determines what types of data may be acceptable to support qualification; clinical trial
data is not critical for all COUs. Regardless of the data sources proposed to support the biomarkerâ??s COU, biomarker developers should consider the potential methodological limitations that could lead to overestimation of any actual associations, including lack of proper control for bias, confounding, and multiplicity, and address these limitations in their analysis plan. Verification of the results with an independent data source increases the credibility of the results.