Crucell <> DSM & Patrys.

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flosz
22
Crucell<>DSM&Patrys/Crucell<>DSM<>Sanofi&Patrys.

Nieuw draadje, dit is veel te leuk imo.

West Coast PER.C6®Technology Seminar-San Francisco

11:00 AM, Tuesday Oct 28, 2008 -- 05:30 PM, Oct 28, 2008

Met dank tav speurneus go:
3:45 PM – 4:15 PM Case Study: - A PER.C6® Licensee's Perspective
Michael Conner, Vice President Manufacturing
Patrys Limited

Patrys Limited?
www.patrys.com/
Patrys – the natural human antibody based company
Patrys Vision - to become the world leader in developing novel therapies for patients with cancer and other diseases, including natural human antibody-based therapies for the treatment of lung, pancreatic and gastric cancers.

Michael Conner, Vice President, Manufacturing
Mr. Conner was most recently Director of Clinical Manufacturing at ImClone Systems and was responsible for the manufacture of Phase I and II monoclonal antibody clinical products. He also participated in new process development and tech transfer of internal antibody products from process development through commercial manufacturing. Mr Conner's more than 20 years' experience in the biotech industry includes cGMP manufacturing, process development, and tech transfer activities. He joined ImClone, from Baxter Healthcare where he managed the manufacture of two licensed vaccine products, Cephalon where he supervised the production of IGF-1, and the University of Maryland Engineering Research Centre where he managed a fermentation and cell culture pilot facility.
*************************************************

Type of Transaction
Licensor
Licensee
Date
Stage
Completed
Disease
Upfront Per Antibody US$*
Milestones Per Antibody US$*

LicenseSanofi-Aventis
Crucell
Jan-08
PhaseI Rabies
$24,800,000
$104,500,000

www.patrys.com/newsletter/newsletter2...

www.iex.nl/forum/topic.asp?forum=228&...

**********************

30/09/2008 Annual Report to shareholders

Ik kom niet door de beveiliging…dan maar even tikken.

In may of 2007, Patrys entered into contracts with DSM Biologics Company and Crucell Holland BV, covering the evaluation of Crucell’s human antibody production Technologies for potential use for Patrys’products..
The contract was at the risk of DSM and Crucell in that no payments would be due from Patrys short of successful result. In august of 2008, DSM and Crucell reported significantly positive results from this work ( which was completed at a DSM/Crucell joint venture laboratory at DSM/Crucell cost) and the Crucell Technologies are now being used to facilitate the production of the Company’s natural antibodies. In return for the use of these Technologies, Patrys is obligated to pay certain fees and low royalty payments to Crucell.

(Tussen haakjes, lic. Patrys/Sanofi/Crucell-rabiës is van jan., 2008).

June 2008,
Production of natural human antibodies at commercial yields.
Patrys researchers and their collaborators achieved production yields for natural human antibodies that were in excess of any yields previously reported, and should support the development and commercialisation of the Company’s lead clinical candidates PAT-LM1 and PAT-SM6. Importantly, the technology developed applies to Patrys’ complete pipeline, meaning that this achievement adds significantly to the overall value of the Company.

www.asx.com.au/asxpdf/20080930/pdf/31...
MeawandMoo1
0
quote:

flosz schreef:


Crucell&lt;&gt;DSM&Patrys/Crucell&lt;&gt;DSM&lt;&gt;Sanofi&Patrys.

Nieuw draadje, dit is veel te leuk imo.

Patrys Vision - to become the world leader in developing novel therapies for patients with cancer and other diseases, including natural human antibody-based therapies for the treatment of lung, pancreatic and gastric cancers.

30/09/2008 Annual Report to shareholders

Ik kom niet door de beveiliging…dan maar even tikken.

In may of 2007, Patrys entered into contracts with DSM Biologics Company and Crucell Holland BV, covering the evaluation of Crucell’s human antibody production Technologies for potential use for Patrys’products..
The contract was at the risk of DSM and Crucell in that no payments would be due from Patrys short of successful result. In august of 2008, DSM and Crucell reported significantly positive results from this work ( which was completed at a DSM/Crucell joint venture laboratory at DSM/Crucell cost) and the Crucell Technologies are now being used to facilitate the production of the Company’s natural antibodies. In return for the use of these Technologies, Patrys is obligated to pay certain fees and low royalty payments to Crucell.


Patrys lijkt me momenteel nog even een heel mager kuikentje.
Cash burn bij Patrys ligt nogal hoog, zeker ten op zichte van de geboekte progressie. De beoogde doelstelling is wel heel optimistisch.
Op zich lijkt Patrys in een vroeg staudium afhankelijk wordt gemaakt van de "Crucell technologie".
[verwijderd]
0
Is gewoon een boevenbende. Publiek geld opmaken aan meer directeuren als overig personeel en naar de US sluizen als aankoop preferente aandelen. 12 cent per aandeel te veel
maxen
1
quote:

flosz schreef:


...

LicenseSanofi-Aventis
Crucell
Jan-08
PhaseI Rabies
$24,800,000
$104,500,000

www.patrys.com/newsletter/newsletter2...

...

(Tussen haakjes, lic. Patrys/Sanofi/Crucell-rabiës is van jan., 2008).
...
[/quote]

Volgens mij is er hier een foutje ingeslopen. Patrys heeft niets te maken met Rabies/Sanofi.
Op pagina 6 van de hierboven newsletter2 schrijft Patrys bij een tabelletje:
[quote=Patrys]
Patrys’ deep pipeline will facilitate new partnering opportunities going forward. In this regard, Patrys will benefit from industry demand for antibody-based therapeutics that showed strong growth in the 1HCY08:
...
tabel
...
The growing industry demand for antibody products firmly establishes that significant commercial outcomes for Patrys’ antibody pipeline technologies are obtainable, and immune to the macroeconomic factors that have impacted the world’s equity markets. As a result, Patrys maintains a very high level of confidence in the value we can offer our shareholders through the execution of our business plan.

De tabel, waarin ook de Crucell/Sanofi rabies vermeld staat, betreft een aantal grote antibody deals die in de eerste helft van 2008 zijn afgesloten in de bio/pharma industrie. Dit slechts als illustratie van de grote bedragen in deze tak van sport, en dus van de grote mogelijkheden voor Patrys. Patrys ZELF speelt bij al deze deals geen rol.

Het andere item, waarbij Crucell/DSM/Percivia succesvol Per.C6 toepast op productie van kankerbestrijdende antibodies, ontwikkeld door Patrys, is natuurlijk al interessant genoeg.
flosz
7
Highlights From Newsletter
PAB’s recent newsletter has highlighted the significant progress the company has made in the last 6 months including:
High yielding production process now established
8 new patents filed on targets, products & production process
Solid progress with partnered programs
Ongoing commercial demand for antibody technologies
The company has confirmed that it is still on track to have clinical data on two of its internal lead antibody products by 4Q 2009.
In our view, the establishment of a high yielding production process addresses one of the key technology risks that faced PAB with its unique natural human antibody technology. As this is no longer an issue and the global demand for antibody therapeutics continuing to be strong, PAB may start to attract the interest of additional potential commercial partners. We maintain our price target of $1.00 for PAB with a BUY recommendation.
Its All In The Production
The unique qualities of PAB’s natural human antibodies meant that there was some technical risk in terms of being able to commercially produce them in large quantities.
Most antibody therapeutics belong to a class called IgG and are produced in rodent cell lines using well established production processes. PAB’s lead antibodies (PAT-SM6 and PAT-LM1) belong to the IgM class (which are like 5 IgGs joined up in a ring) and are made in human cell lines. As routine procedures for the large scale production of antibodies in this system (IgMs in human cell lines) had not been established, there was a possibility that it would be difficult to achieve commercially viable production yields. This would have had a significant impact both from a development and a commercial perspective and was one of the key technical risks.
The update reported in PAB’s newsletter regarding production is extremely positive for a number of reasons:
Good yields: non-optimised production yields exceeded industry standards which will provide commercially viable cost of goods
Broadly applicable: the production process is applicable for all of PABs antibodies which de-risks the entire pipeline
Standardised process: many of the key steps in PAB’s production process (fermentation) have been through regulatory approval
New intellectual property: PAB has filed a patent on a proprietary method for purifying the antibodies that they have developed.

With the production process established, the company will now undertake generate a batch under GMP (Good Manufacturing Process) that will be used for the remaining preclinical and the scheduled Phase-I clinical trials.
The development of a broadly applicable, commercially viable production process that is in line with standards acceptable by the regulators represents a major technical milestone which significantly improves the development and commercial prospects for the company.
www.patrys.com/whattheysay/wts13-0806...

28 January 2007
Patrys Pty Limited Acquires Leading Human Antibody Technology and Anti-Cancer Pipeline from OncoMab GmbH and Acceptys, Inc.
Melbourne , Australia , January 28, 2007 – Patrys Pty Limited has announced the acquisition of leading human antibody technology and deep pipeline of anti-cancer antibody product candidates from Acceptys, Inc. and OncoMab GmbH.
The acquisitions by Patrys from OncoMab and Acceptys represent a consolidation of the assets and technologies of the two leaders in natural human antibody discovery and development. The assets acquired by Patrys include three lead product candidates that have been shown to be effective in fighting cancer in animal models of human pancreatic, lung and gastric cancers. In addition, the acquisitions provide Patrys with a very deep pipeline of anti-cancer antibodies, and the underlying proprietary technology used to generate those candidates. Finally, Patrys is especially pleased to announce that Mr. Daniel Devine, formerly CEO of Acceptys, will now become CEO of Patrys, and that Dr. Frank Hensel, former CEO of OncoMab, will become Managing Director of Patrys GmbH, a wholly owned subsidiary of Patrys Pty Limitied that will conduct all of the Company's internal research and development activities.
Patrys has also entered into a research agreement with the University of Würzburg and Dr. Peter Vollmers, whose work led to the discovery of OncoMab's lead therapeutic candidates. Under these agreements, Dr. Vollmers and his research team at the University will further characterize Dr. Vollmers' existing library of anti-cancer human antibodies, with an aim of identifying additional therapeutic candidates.

Acceptys and Seattle Biomedical Research Institute Join in Fight Against Malaria
January 31, 2008 Acceptys, Inc. announced today collaboration with Seattle Biomedical Research Institute (SBRI) focused on the
development of vaccines and antibody-based therapies against malaria.
www.patrys.com/mediareleases/31%2031J...

Takeda Expands Collaboration with Patrys
Natural human antibody company Patrys Limited (Patrys) (ASX Code: PAB) advises that Takeda Pharmaceutical
Company Limited (Takeda), a world-leading drug development company, has chosen to expand its collaboration
with Patrys to cover the evaluation and advancement by Takeda of five Patrys antibody candidates.
Pursuant to the terms of a March 2007 collaboration, Takeda was granted the right to evaluate and advance a
number of Patrys’ anticancer antibodies for a 12 month period (excluding Patrys internal lead candidates PATLM1,
PAT-SM6 and PAT-CM1). Earlier this year Takeda elected to advance three Patrys antibodies under the
collaboration. Today, Patrys received notice from Takeda that it has chosen to advance two additional Patrys
antibodies, bringing the total collaboration antibodies to five.
Takeda will advance all five antibodies in its Osaka based R&D facilities in Japan.
www.patrys.com/mediareleases/20-28Sep...
www.patrys.com/company.php
www.patrys.com/technology-naturalhuma...

Ik krijg helaas technology-factsheet-pdfje niet open. www.patrys.com/technologyfactsheet.pdf

flosz
0
quote:

maxen schreef:



De tabel, waarin ook de Crucell/Sanofi rabies vermeld staat, betreft een aantal grote antibody deals die in de eerste helft van 2008 zijn afgesloten in de bio/pharma industrie. Dit slechts als illustratie van de grote bedragen in deze tak van sport, en dus van de grote mogelijkheden voor Patrys. Patrys ZELF speelt bij al deze deals geen rol.

Het andere item, waarbij Crucell/DSM/Percivia succesvol Per.C6 toepast op productie van kankerbestrijdende antibodies, ontwikkeld door Patrys, is natuurlijk al interessant genoeg.

Idd. maxen, wel goed wakker!
Met slaapkop-groeten.
gocrucellgo
5
High level expression of functional human IgMs in human PER.C6® cells

Authors
Anna Tchoudakova, Frank Hensel, Alec Murillo, Bernie Eng, Marketa Foley, Lakee Smith, Frank Schoenen, Antonia Hildebrand, Arndt‐René Kelter, Leodevico L. Ilag, H. Peter Vollmers, Stephanie Brandlein, Jane McIninch, John Chon, Gene Lee and Marco Cacciuttolo

Journal reference
mAbs, 2009, 1, 162‐170
Summary of paper

About the study
The study was a collaboration between Percivia and Patrys. It describes the generation of human cell lines producing recombinant IgM to commercially viable levels.

Background
The IgM class of antibody has been neglected as a therapeutic, largely because there was no effective system for the production of this complex molecule. In the past, attempts to produce IgM relied on hybridoma cell lines. A reliable high‐yield system was needed to overcome the obstacle to the clinical use of IgM of insufficient material.

Protocol
The genes for the components of PAT‐SM6, PAT‐LM1 and PAT‐CM1 were cloned and introduced into PER.C6 cells to produce stable cell lines. Several methods were used to confirm the correct structure and function of the recombinant antibodies.
Results
PAT‐SM6, PAT‐CM1 and PAT‐LM1.were produced at yields ranging from 0.5 to 2.0 grams per litre of culture and showed correct pentameric structure when J‐chain was co‐expressed.
All three of the IgMs produced using PER.C6® showed biological activity comparable to the parental hybridoma‐derived IgM. In addition, recombinant PAT‐SM6 and PAT‐LM1 showed cytotoxic activity on target cells.


Conclusions
This is one of the first reports showing the generation of recombinant IgM cell lines with expression levels which are close to industry standard for recombinant IgG.
Interesting facts
• Correctly assembled IgM can be produced in a recombinant cell line
• Production levels of recombinant cell lines are close to industry standard even before media and fermentation optimisation.
• Recombinant IgM show identical properties compared to original hybridoma‐derived IgM.
Link to the paper
Click on the link above to access the full paper.
If you have trouble downloading, please send an email to info@patrys.com and refer to article PAT043.
www.patrys.com/investor-scientificpub...
flosz
7
Patrys Announces Initiation of Safety Studies for Lead Products PAT-LM1 and PAT-SM6

Melbourne, Australia; 25 May, 2009: Patrys Limited (ASX: PAB), Australia’s natural human antibody therapy company, advises that it has initiated preclinical safety studies for lead products PAT-LM1 and PAT-SM6.
PAT-LM1 and PAT-SM6 are each natural human antibody products that have shown potential across a number of cancer applications.
The preclinical safety studies, which are expected to last approximately one month, are being conducted at Maccine Pte Ltd, a Singapore based contract research organisation. Following conclusion of the studies, it is anticipated that a further period of up to two months may be required to evaluate the results of the trial. These studies have commenced after a delay due to capacity reductions at the Company’s contract manufacturing organisation that were announced to the market in December 2008.
The safety studies being conducted by Patrys have been designed to generate information that is typically required prior to obtaining approval to test a therapeutic product candidate in human clinical trials.

The advancement of PAT-LM1 and PAT-SM6 to preclinical safety studies also means that Patrys has achieved its production goals at this stage in the products’ development. In the first instance, the quality standards met by the products selected for these preclinical safety studies are similar to the typical standards that have to be met to advance products of this type to human clinical trials. In addition, the productivity of the system, meaning yield, is expected to be sufficient to support the further development and commercialisation of the products.

“Historically, the production of antibodies naturally made by the human body to fight cancer has proven very difficult in terms of producing material of sufficient quality and at sufficient yields to support advanced development as therapeutics,” said Patrys Vice President, Manufacturing, Michael Conner. “The Patrys’ team considers the achievement of this milestone a significant step in the ongoing development of our pipeline.”


www.patrys.com/mediareleases/66-Patry...
aossa
2
"In addition, the productivity of the system, meaning yield, is expected to be sufficient to support the further development and commercialisation of the products."

Commerciele doorbraak!

“Historically, the production of antibodies naturally made by the human body to fight cancer has proven very difficult in terms of producing material of sufficient quality and at sufficient yields to support advanced development as therapeutics,” said Patrys Vice President, Manufacturing, Michael Conner. “The Patrys’ team considers the achievement of this milestone a significant step in the ongoing development of our pipeline.”

Uit eerder bericht:
PAT‐SM6, PAT‐CM1 and PAT‐LM1.were produced at yields ranging from 0.5 to 2.0 grams per litre of culture and showed correct pentameric structure when J‐chain was co‐expressed.

All three of the IgMs produced using PER.C6® showed biological activity comparable to the parental hybridoma‐derived IgM. In addition, recombinant PAT‐SM6 and PAT‐LM1 showed cytotoxic activity on target cells.
flosz
6
quote:

flosz schreef:


Patrys Announces Initiation of Safety Studies for Lead Products PAT-LM1 and PAT-SM6

Melbourne, Australia; 25 May, 2009: Patrys Limited (ASX: PAB), Australia’s natural human antibody therapy company, advises that it has initiated preclinical safety studies for lead products PAT-LM1 and PAT-SM6.
PAT-LM1 and PAT-SM6 are each natural human antibody products that have shown potential across a number of cancer applications.
The preclinical safety studies, which are expected to last approximately one month, are being conducted at Maccine Pte Ltd, a Singapore based contract research organisation. Following conclusion of the studies, it is anticipated that a further period of up to two months may be required to evaluate the results of the trial. These studies have commenced after a delay due to capacity reductions at the Company’s contract manufacturing organisation that were announced to the market in December 2008.
The safety studies being conducted by Patrys have been designed to generate information that is typically required prior to obtaining approval to test a therapeutic product candidate in human clinical trials.

The advancement of PAT-LM1 and PAT-SM6 to preclinical safety studies also means that Patrys has achieved its production goals at this stage in the products’ development. In the first instance, the quality standards met by the products selected for these preclinical safety studies are similar to the typical standards that have to be met to advance products of this type to human clinical trials. In addition, the productivity of the system, meaning yield, is expected to be sufficient to support the further development and commercialisation of the products.

“Historically, the production of antibodies naturally made by the human body to fight cancer has proven very difficult in terms of producing material of sufficient quality and at sufficient yields to support advanced development as therapeutics,” said Patrys Vice President, Manufacturing, Michael Conner. “The Patrys’ team considers the achievement of this milestone a significant step in the ongoing development of our pipeline.”


www.patrys.com/mediareleases/66-Patry...


Crucell today announces a non-exclusive PER.C6® research license
agreement with Australian-based Patrys Ltd. for the production of several
undisclosed antibodies. Financial details of the agreement were not
disclosed. [July 2009]
hugin.info/132631/R/1333770/316267.pdf

www.landesbioscience.com/journals/mab...
www.iex.nl/forum/topic.asp?forum=228&...
aossa
2
In herhaling:

gocrucellgo - 16 mei 09, 09:33 |

High level expression of functional human IgMs in human PER.C6® cells

Authors
Anna Tchoudakova, Frank Hensel, Alec Murillo, Bernie Eng, Marketa Foley, Lakee Smith, Frank Schoenen, Antonia Hildebrand, Arndt‐René Kelter, Leodevico L. Ilag, H. Peter Vollmers, Stephanie Brandlein, Jane McIninch, John Chon, Gene Lee and Marco Cacciuttolo

Journal reference
mAbs, 2009, 1, 162‐170
Summary of paper

About the study
The study was a collaboration between Percivia and Patrys. It describes the generation of human cell lines producing recombinant IgM to commercially viable levels.

Background
The IgM class of antibody has been neglected as a therapeutic, largely because there was no effective system for the production of this complex molecule. In the past, attempts to produce IgM relied on hybridoma cell lines. A reliable high‐yield system was needed to overcome the obstacle to the clinical use of IgM of insufficient material.

Protocol
The genes for the components of PAT‐SM6, PAT‐LM1 and PAT‐CM1 were cloned and introduced into PER.C6 cells to produce stable cell lines. Several methods were used to confirm the correct structure and function of the recombinant antibodies.
Results
PAT‐SM6, PAT‐CM1 and PAT‐LM1.were produced at yields ranging from 0.5 to 2.0 grams per litre of culture and showed correct pentameric structure when J‐chain was co‐expressed.
All three of the IgMs produced using PER.C6® showed biological activity comparable to the parental hybridoma‐derived IgM. In addition, recombinant PAT‐SM6 and PAT‐LM1 showed cytotoxic activity on target cells.
[verwijderd]
2
Hier zien we dus een resultaat waar Percivia bij betrokken was.
Te zijner tijd komen hier, voor Crucell en DSM, mooie royalties uit.
[verwijderd]
2
quote:

oudje schreef:


Hier zien we dus een resultaat waar Percivia bij betrokken was.
Te zijner tijd komen hier, voor Crucell en DSM, mooie royalties uit.


Hoop dat je jong genoeg bent omdat nog mee te maken, alleen nog maar preklinisch.
[verwijderd]
0
Dat ben ik met je eens, hoop alleen dat binnenkort eens een groot farmabedrijf met een klapper komt in relatie tot Crucell, mag ook een grote internationale investeerder zijn overigens.
[verwijderd]
9
quote:

oudje schreef:


Hier zien we dus een resultaat waar Percivia bij betrokken was.
Te zijner tijd komen hier, voor Crucell en DSM, mooie royalties uit.


Met PER.C6 een stap dichter bij de genezing van o.m. kanker.
Nu kan op het platform van PER.C6 naast IgG (27/gr p/ltr) met meer succes ook verschillende soorten IgM-eiwitten op PER.C6 geproduceerd worden (0,5 tot 2 gr per liter).
IgG eiwitten zij klein en komen overal in het lichaam voor.
IgMs zijn zwaarder en hebben meer volume waardoor ze moeilijker te produceren zijn.
Vooral ook de glycocylering(suikergroepering) van IgMs is complexer
De glycosylering van IgMs die zijn geproduceerd op niet menselijke cellijnen zijn in de klinische fase heel vaak de oorzaak van onaanvaardbare bijwerkingen
PER.C6 produceert eiwitten met een menselijke glycosylering waardoor de kans van welslagen beter voorspelbaar is.
Met IgMs kunnen kankercellen doeltreffender bestreden worden dan met IgGs, o.m. omdat IgMs meer receptoren hebben.

Er liggen “bergen” eiwitsequenties in koelcellen te wachten op een platform dat ze voordelig kan produceren en op wetenschappers die ze relatief snel kan maken tot een betaalbaar, effectief en veilig product.

Crucell heeft het in huis en staat te trappelen.

Dus niet alleen royalty's.
Maar in eerste instantie vooral ook aanvangs- en milestonebetalingen
Crucell kan sneller, van meer IgM-sequenties, producten maken die veiliger, effectiever en voordeliger zijn dan tot voorheen mogelijk was.

Zomaar een interpretatie van een leek

Louis

aossa
0
Bedankt Louis

Ik vroeg me reeds af waarom slechts 0,5 à 2 g/L.
Maar jij gaf me het antwoord, niet slechts van een leek voor leken.
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