Replies to post #287123 on Avid Bioservices Inc (CDMO)

[hutschi]

For our german speaking friends:

http://www.spiegel.de/gesundheit/diagnose/liquid-biopsy-den-krebs-durchs-blut-aufspueren-a-1036738.html

[stoneroad]

So what's it worth? Astronomical?

[revenue_monster]

thanks CP while i agree exosomes could hold great potential it might be a little late to the game to save current shareholders from pending RS. a little more than 3 weeks out. only a deal will prevent this from occurring. for a team that doesn't operate with any sense of urgency it's likely that they won't close anything soon. although given the moderate price improvement we can hope that they do a 3:1 and not the max 5:1

[itsabouttime]

Sure makes holding shares of PPHM extra worthwhile.

[ku]

CP, lets put all retail shareholders aside for this question. Do you see any benefit for BOD and institutional holders to make sure that the stock goes thru a Reverse Split at this point in time ? Thanks in advance.

[swg_tdr]

detecting type of cancer, HUGE if it can displace need for initial biopsy in at least a few types.

real life occurance: to establish if a patient with stage 4 and a lung cancer mass adjacent to the heart and its blood vessels was suited for a certain drug took over 3 hours of life threatening pinpoint biopsy work (2 attempts with patient's escalating reaction) to extract two small samples which then took several days to grow before the lab had a mass large enough to test. EXPENSIVE AND TIME DELAY.

So it was six days before the patient knew she had a chance to be successfully treated (it was the only sub type, at 12% of all lung cancers, best treated with one specific drug -- for a 18 months survival chance versus six to eight weeks to death otherwise).

best,
N

[keep_trying]

CP, Impressive exosome pipeline analysis. Thanks for sharing.

Also, thanks for your answer to my questions about preferred and common. The bundling of common with preferred seems to me to behave too much like a fire sale of PPHM shares. Perhaps, I shouldn't use a derogatory term like fire sale, but PPHM would be moving their limited authorized shares to clear them out of inventory to raise funds. The bundling suggests the 8.33 shares of common conversion rate is not enough to entice new preferred share issues. That is the reality when the common is trading under $3 pps, I suppose. The 10.5% dividend doesn't seem to offset the common stock pps difference from $3, at current levels. We need to see the common stock rise above $3 pps where everyone ought to be happy with their PPHM holdings.

Best wishes and IMO.
KT

[Wernaaa]

Let's see whether this will happen....!!

From #7 we can see that PPHM doesn't need to go through clinical trials but also that they are currently not certified (that we know) to sell the exosome test. They need, and they said they would in H1 2017, partner with one of the companies that have such FDA certification to manufacture and commercialise such tests.

[biopharm]

Exosomes Largely Underestimated....
...
#10: Illumina CEO Jay Flatley statement (from jbainseky's post)
Quote:
Former Illumina CEO Jay Flatley has estimated the total addressable market for a test capable of detecting Stage 2 cancer to be between $20 billion and $40 billion. If a test can detect Stage 1 cancer in addition to the tissue of origin, Flatley said in Jan. 2016 presentation the market could be worth a staggering $100 billion to $200 billion.

CP, after rereading your post and now seeing Jay Flatley ties with Illumina and MSK and JUNO..... One has to ponder the value that could immediately place PPHM in another league of their own

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Sept 16 2015
Memorial Sloan Kettering Cancer Center and Illumina Launch Comprehensive Circulating Tumor DNA Program
....
...

Collaboration Aims to Determine Range of Opportunities for Non-Invasive Cancer Diagnosis and Monitoring

NEW YORK & SAN DIEGO--(BUSINESS WIRE)--Sep. 16, 2015-- Memorial Sloan Kettering Cancer Center (MSK) and Illumina, Inc. (NASDAQ: ILMN) today announced a collaboration to conduct research studies that are critical to understanding the biology of circulating tumor DNA (ctDNA). The studies aim to inform the development of new strategies to diagnose and monitor cancer and to help establish ctDNA as an important marker in the study and eventual treatment of cancer.

Traditional biopsies for acquiring tumor DNA are typically invasive and risky and are often not possible. Additionally, single biopsies may not be able to measure the heterogeneity that is often present in tumors. Fortunately, scientists have discovered that dying tumor cells release small pieces of their DNA into the bloodstream. These pieces are called cell-free circulating tumor DNA (ctDNA)1 and can be detected in a blood sample via DNA sequencing2.

As global leaders in cancer care and in next-generation sequencing, MSK and Illumina will conduct research trials designed to answer biological and clinical questions about ctDNA in multiple cancer types. MSK will collect samples, and Illumina will apply its best-in-class sequencing technology to detect ctDNA in those samples. The program will work to validate a ctDNA assay to demonstrate correlation between ctDNA signal and cancer burden.

“The possibility of reducing the number of invasive and expensive diagnostic and monitoring procedures with a simple blood draw is a game-changer for cancer patients and for oncology,” said Jose Baselga, MD, PhD, Physician-in-Chief and Chief Medical Officer at MSK.

“This relationship between Illumina and MSK will create important data regarding the value, the significance and the potential applications of measuring ctDNA via deep sequencing,” said Dr. Rick Klausner, SVP and Chief Medical Officer of Illumina. “Is ctDNA not simply equivalent to, but superior to current methods of cancer diagnosis and monitoring? Can we replace expensive and invasive monitoring with a blood test? Does ctDNA reflect the total burden of cancer clones, and is it equivalent to or better than biopsies at predicting outcome and therapeutic response? These are the types of questions we will work towards answering.”
...
...
https://www.illumina.com/company/news-center/press-releases/press-release-details.html?newsid=2088159

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April 6 2016
Bezos, Gates Chase Dream of a Blood Test That Detects Cancer
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Illumina’s CEO Jay Flatley told investors that the market opportunity, if the test is everything it promises to be, would be $100 to $200 billion, and told Bloomberg News that an initial pan-cancer test should be ready by 2019. Illumina has a majority stake in closely held Grail.
....
....
https://www.google.com/amp/s/www.bloomberg.com/amp/news/articles/2016-04-06/cancer-blood-test-is-either-200-billion-market-or-a-pipe-dream

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May 23 2017
Juno Therapeutics Appoints Jay Flatley to Board of Directors
...
...

“Juno has great science, a talented team, and a compelling mission,” said Mr. Flatley. “I am looking forward to bringing my experience to the Juno Board and working with management to help the company meet its goals of bringing transformative medicine to patients.”
..
...
http://www.businesswire.com/news/home/20170523005349/en/Juno-Therapeutics-Appoints-Jay-Flatley-Board-Directors

[biopharm]

CP, it looks like LabCorp (and which bought Covance) could use PS Targeting patents and related Biomarkers to shore up their future collaborations with BMS.

Hopefully CEO Roger Lias still has his contacts at Covance handy....because Covance would likely see the value in PS Targeting IP and Exosomes related Biomarkers....more than just residual values.

FRI SEP 2, 2016 / 7:28 AM EDT
Judge invalidates LabCorp unit's genetic testing patents

A federal judge has invalidated four patents on genetic tests to be used in cancer treatment belonging to a Laboratory Corporation of America Holdings unit, finding they claimed unpatentable laws of nature.

The ruling, handed down Wednesday by U.S. District Judge Allison Burroughs in Boston, is a victory for German diagnostics company Qiagen NV, which had challenged the patents. It follows an order from Burroughs in the same case last September invalidating a similar patent on the same grounds.

To read the full story on Westlaw Practitioner Insights, click here: bit.ly/2bVuGx8


https://www.google.com/amp/mobile.reuters.com/article/amp/idUSL1N1BE0D4

[biopharm]

EXOSOMES, largely under estimated!

I myself deeply under estimated the exosome pipeline, i mean its commercial potential and the fact that it would not only be partnered in H1/2017 but that it is ready to start manufacturing and sales after partnering with an FDA certified manufacturer, for this kind of tests, is signed.

Interesting post and CP, did you have the link for the Exosomes patent you were pointing to in item#2 ?

I was curious if the patent was assigned to Peregrine, now CDMO....and another party ....

[Wernaaa]

"I myself deeply under estimated the exosome pipeline, i mean its commercial potential and the fact that it would not only be partnered in H1/2017 but that it is ready to start manufacturing and sales after partnering with an FDA certified manufacturer, for this kind of tests, is signed. "

So where are our exosome-data, our partnership (as you indicate H1/2017)

Don't get it, that they fooled you the whole time!!!

[swg_tdr]

the Pereg Exosome, HUGE? not exactly.

the flaw is the "kit" is not a stand-alone system. read the patent.

CP and I were wrong. Co PR had a misleading couple of words in the header, never mind King's subsequent...

best

[biopharm]

That is quite a long list of potential surprise news to the upside to come and Illumina CEO Jay Flatley making deals with Qiagen in regards to patents ....

Has anyone noticed the ties to Qiagen and Oncologie, the same Oncologie with last minute made behind the scene deals for the PS Patents and now this becomes clear how the new BODs have not in any way attempted to fulfill fiduciary Duties with IP assets under their control

[biopharm]

Avid BOD have not updated shareholders yet on any communications with their decision to allow Oncologie to advance PS Trgetinh IP / Biomarkers etc and now with ongoing FBI investigation regarding IP related to cancer researchers...updates should be coming

Flipped PS travels the bloodstream and breaks the blood brain barrier ....looks like Independent BOD Catherine Mackey will be confronted with questions

__________________

Regulating the interaction between tam ligands and lipid membranes with exposed phosphatidylserine

Inventor
Greg E. Lemke
Lawrence C. Fritz
Benedikt Vollrath
Carla V. Rothlin

https://patents.google.com/patent/WO2014018535A1/ar

___________________

Lipid membranes with exposed phosphatidylserine as tam ligands, use for treating autoimmune diseases

Inventor
Greg E. Lemke
Lawrence C. Fritz
Benedikt Vollrath
Carla V. Rothlin

Current Assignee Salk Institute for Biological Studies
Celldex Therapeutics Inc

https://patents.google.com/patent/EP3184121A2/en

_____________________

Patents Assigned to AMPRION, INC.
DETECTION OF MISFOLDED TAU PROTEIN
Publication number: 20180335438
Abstract: Methods and kits are provided for amplifying and detecting misfolded tau protein from samples, for example, from patients having tauopathies such as Alzheimer's Disease, Progressive Supranuclear Palsy, and the like.

Type: Application
Filed: May 16, 2018
Publication date: November 22, 2018
Applicants: Amprion, Inc., BOARD OF REGENTS OF THE UNIVERSITY OF TEXAS SYSTEM
Inventors: Claudio Soto-Jara, Russell M. Lebovitz, Benedikt K. Vollrath, Mohammad Shahnawaz, Nicolas Mendez Dinamarca
DETECTION OF MISFOLDED PROTEINS
Publication number: 20180196069
Abstract: Methods and kits are provided for amplifying and detecting misfolded proteins from samples, for example, from patients having Alzheimer's Disease, Parkinson's Disease, and the like. For example, a method for determining a presence of soluble, misfolded protein in a sample may include contacting the sample with a monomeric, folded protein to form an incubation mixture; conducting an incubation cycle two or more times effective to form an amplified portion of misfolded protein; incubating the incubation mixture effective to cause misfolding and/or aggregation of at least a portion of the monomeric, folded protein; physically disrupting the incubation mixture effective to break up at least a portion of any protein aggregate present; and determining the presence of the soluble, misfolded protein in the sample by detecting at least a portion of the soluble, misfolded protein. The monomeric, folded protein and the soluble, misfolded protein may exclude prion protein (PrP) and isoforms thereof.

Type: Application
Filed: March 8, 2018
Publication date: July 12, 2018
Applicants: Board of Regents of the University of Texas System, Amprion, Inc.
Inventors: Claudio Soto-Jara, Russell M. Lebovitz, Benedikt K. Vollrath, Mohammad Shahnawaz
Detection of misfolded amyloid beta protein
Patent number: 9910049
Abstract: Methods and kits are provided for amplifying and detecting A? proteins from samples, for example, from patients having Alzheimer's Disease. For example, a method for determining a presence of a soluble, misfolded A? protein may include contacting the sample with a monomeric, folded A? protein to form an incubation mixture; conducting an incubation cycle two or more times on the incubation mixture effective to form an amplified portion of misfolded A? protein; incubating the incubation mixture effective to cause misfolding and/or aggregation of at least a portion of the monomeric, folded A? protein; physically disrupting the incubation mixture effective to at least partly de-aggregate at least a portion of a misfolded A? aggregate present; and determining the presence of the soluble, misfolded A? protein in the sample by detecting at least a portion of the amplified portion of misfolded A? protein.

Type: Grant
Filed: September 11, 2015
Date of Patent: March 6, 2018
Assignees: AMPRION, INC., THE BOARD OF REGENTS OF THE UNIVERSITY OF TEXAS SYSTEM
Inventors: Claudio Soto Jara, Mohammad Shahnawaz, Russell M. Lebovitz, Benedikt K. Vollrath

https://patents.justia.com/assignee/amprion-inc

_______________________

Exosomes help track effectiveness of experimental Parkinson's disease drug

March 21, 2019

..
...
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This study confirms the value of exosomes as an additional analytical tool to show target engagement in clinical trials. The investigators are optimistic about future work to examine how exosomes could help speed up validation in clinical trials of potential new drugs for PD, Alzheimerâ??s disease, and other neurological disorders.

https://www.nia.nih.gov/news/exosomes-help-track-effectiveness-experimental-parkinsons-disease-drug

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NIA Small Business funding seeks to find blood-based diagnostic for Alzheimerâ??s disease

July 30, 2019

A test for early detection of Parkinsonâ??s disease, which recently received Breakthrough Device Designation by the FDA, may have the potential to become an early measure for Alzheimerâ??s disease as well. With NIH funding that includes Small Business grants from NIA, Amprion, a California-based biotech company, has developed a technology to detect very small amounts of proteins in the cerebrospinal fluid and bloodstream that could be used to detect the diseases.

Having an effective, accurate, and easy-to-administer test for diagnosing Alzheimerâ??s and Parkinsonâ??s diseases is crucial to help develop treatments and potentially find cures for these diseases. Currently, the use of biomarkers for Alzheimerâ??s disease in a clinical setting, such as a doctorâ??s office, is limited.

The FDAâ??s Breakthrough Devices Program is designed to speed up development, assessment, and review of medical devices that could provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The FDA designation puts Amprionâ??s Protein Misfolding Cyclic Amplification (PMCA) system a step closer to approval for early detection of the alpha-synuclein protein, which would help diagnose Parkinsonâ??s disease. Amprion anticipates market rollout within 18 months. Ongoing efforts funded by NIA grants are dedicated to similarly detecting proteins associated with Alzheimerâ??s disease.

The ongoing NIA funding is specific to detecting traces of amyloid and tau aggregates. Amprion hypothesizes that detection of misfolded amyloid and tau oligomers circulating in cerebrospinal fluid and blood may be the basis for an early Alzheimerâ??s biomarker. With the funding, the company plans to adapt the PMCA technology for specific and highly sensitive detection in human cerebrospinal fluid and blood plasma, perform studies of specificity and sensitivity using a large number of samples from people with Alzheimerâ??s, and evaluate the utility of PMCA for monitoring Alzheimerâ??s disease progression.

The PMCA technology has been under development, with the support of several NIH grants from NIA, the National Institute of Neurological Disorders and Stroke, and the National Institute of Allergy and Infectious Diseases, for the past 15 years. PMCA, also known as RT-QuIC, is a platform technology to detect misfolded protein oligomers implicated in various neurodegenerative diseases, including Alzheimer's, Parkinson's, and prion diseases. The technique harnesses the way proteins misfold, aggregate, and spread in the brain and then amplifies their quantity so small amounts can be found in biological fluids. The PMCA/RT-QuIC assay to detect misfolded prion protein is already being used to diagnose prion diseases. Amprion was founded, with funding from several Small Business Innovation Research (SBIR)/Small Business Technology Transfer (STTR) grants, to facilitate the commercialization of these assays.

This research is funded in part by NIA grants R42AG049562 and R42AG058333.

https://www.nia.nih.gov/news/nia-small-business-funding-seeks-find-blood-based-diagnostic-alzheimers-disease

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Flipped PS travels the bloodstream and breaks the blood brain barrier ....looks like Independent BOD Catherine Mackey will be confronted with questions