Replies to post #317246 on Avid Bioservices Inc (CDMO)

[JamesGMS]

CJ, thanks for posting the SITC information. Your contributions to the greater understanding of the science is greatly appreciated. It's worth restating and highlighting the most salient points.

RESULTS

Pre-treatment (pre-tx) samples were evaluable by qPACC for 62 (32 D+B, 30 D+P) out of the 93 pts who received ICI as next line therapy after the SUNRISE assigned treatment. High pre-tx (>=median) levels correlated with statistically significant OS benefit favoring D+B for the following biomarkers: CD3+ (HR=.37, p=.023), CD4+ (HR=.32, p=.012), CD8+ (HR=.42, p=.036), PD-1 (HR=.33, p=.017), GNLY (HR=0.25, p=.011), FoxP3 (HR=.34, p=.032), naïve CD8+ (HR=.32, p=.034), B-cells (HR=.24, p=.007), MDSC (HR=.33, p=.037) NK56+ (HR=.29, p=.026). Low (<) pre-tx levels of THF correlated with OS favoring D+B (HR=.34, p=.033). No OS difference was observed for pre-tx high or low levels for TH17, CCR6, or CD14+.

CONCLUSIONS

High pre-tx levels (>=median) of circulating immune cells including T cells, B-Cells, MDSCs, NK cells correlated with significant improvement of OS in patients who received D+B then ICI compared to D+P then ICI in the SUNRISE trial.

These results support further investigation of these markers in future bavituximab clinical trials.

RESULTS
In this study, we show that irradiation of B16 melanoma causes an increase in PS expression on the surface of viable tumor and immune infiltrates. We subsequently examined the effects of combining RT with an antibody that targets PS and anti-PD-1. We found that treatment with mch1N11 synergizes with RT to improve anti-tumor activity and overall survival in tumor bearing mice.

In addition, the triple combination of mch1N11, RT and anti-PD-1 treatment displayed even greater anti-tumor and survival benefit. Analysis of the immune response in the tumors of treated animals revealed an increase in M1-like macrophages in the tumors after treatment with RT and mch1N11. In addition, analysis of the systemic immune responses revealed an increase in antigen-specific CD8 T cell infiltration in the tumors as well as increased activation, effector function and differentiation in the triple combination therapy.

CONCLUSIONS
This finding highlights the potential of combining these agents to improve outcome in patients with advanced-stage melanoma and may inform the design of future clinical trials with PS targeting in multiple cancers.

And then a brief - but very important observation from a few days ago posted by North in response to one of my prior posts.

Your quotations hit the high points of current basis for our investment in the PPHM technology. . . . .

Quiet periods abound.

Have a great day.

James

[biopharm]

Nikoletta L. Kallinteris 1, Thomas O. Kleen 2, Min Tang 1, Shen Yin 1, Tobi Guennel 3, Jennifer Lai 1, Victor Nowakowski 2, Steven Olek 2, Steve King 1, Joseph S. Shan 1
1 Peregrine Pharmaceuticals
2 Epiontis GmbH, Berlin, Germany
3 Precision Medicine, Frederick MD
SITC’17 #P87 ABSTRACT:
BACKGROUND
SUNRISE (NCT01999673 ...
...

That is a must read post for anyone who has not read it yet...and thanks CJ!

An amazing set of data looks to be presenting this weekend and how often that you have a few companies such as above and the streak continues where those collaborators with Peregrine seem to attract much attention....in this case Bird&Bird advised Precision For Medicine to move ahead with a buyout of Epiontis and a show of hands that believe it is ALL to do with PS Targeting data that has extracted some statistically significant and powerful Biomarkers that will become very valuable to BPs that want to be able to stop trials successfully early, based on the Biomarkers that were discovered (new knowledge based on PS Targeting data...)

Epiontis info
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=134746427

Digging deeper...
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=134747702

-----

...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.
..


https://investorshub.advfn.com/boards/read_msg.aspx?message_id=135546947

[biopharm]

1. #P87: “Results of Epigenetic-Based Quantitative PCR Assisted Immune Cell Counting Analysis in Bavituximab SUNRISE Trial Subgroup”
https://www.sitcancer.org/2017/abstracts/titles/biomarkers-immune-monitoring
Nikoletta L. Kallinteris 1, Thomas O. Kleen 2, Min Tang 1, Shen Yin 1, Tobi Guennel 3, Jennifer Lai 1, Victor Nowakowski 2, Steven Olek 2, Steve King 1, Joseph S. Shan 1
1 Peregrine Pharmaceuticals
2 Epiontis GmbH, Berlin, Germany
3 Precision Medicine, Frederick MD
SITC’17 #P87 ABSTRACT:
BACKGROUND
SUNRISE (NCT01999673 https://www.clinicaltrials.gov/ct2/show/NCT01999673 ), a global, double-blind, randomized Phase III trial of docetaxel bavituximab (D+B) or docetaxel+placebo (D+P) in previously treated non-squamous NSCLC, demonstrated similar OS in the intent-to-treat population (n=597). In the subgroup of 93 pts who received subsequent Immune Checkpoint Inhibitors (ICI), mOS was not reached ..

So Peregrine hires Epiontis and Precision For Medicine

What do you think Sven learned from the IP held by Peregrine and in phase III Sunrise trial ? Looks like Sven learning the correct order of operations and it includes PS TARGETING because you think the laast patents filed by Sven just appeared out of great luck? No way and pay attention to "..identification of immune cells.." aka Sunrise analysis of Biomarkers would likely help the latest patents filed by Sven

https://patents.justia.com/inventor/sven-olek

Why did EPIONTIS get bought out?

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=137852390

"P87
Results of epigenetic-based quantitative PCR assisted immune cell counting analysis in bavituximab SUNRISE trial subgroup "
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=135686573

"Christopher J. Hadley
Managing Director

Chris joined Berkshire Partners in 1998 and became a Managing Director in 2006. Prior to Berkshire, Chris worked at Bain & Co. Earlier in his career, he worked as a consultant to the consumer products industry. Chris is a Trustee of Dana-Farber Cancer Institute."
http://m.berkshirepartners.com/bio_hadley

"“Precision has built a unique and compelling set of services that address the most important challenges facing biopharmaceutical and diagnostic companies,” said Chris Hadley, a Managing Director at Berkshire Partners. “We are thrilled to participate in the next leg of growth and expansion focused on accelerating development and demonstrating value for customers.”
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=137341358