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Lineage Cell Therapeutics to Present at the 13th Annual LD Micro Main Event Conference on December 14, 2020 - Business Wire
09-Dec-2020 14:00:07CA-LINEAGE-CELL
For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20201209:nBw140kxFa&default-theme=true
Lineage Cell Therapeutics to Present at the 13(th) Annual LD Micro Main Event
Conference on December 14, 2020
Lineage Cell Therapeutics, Inc.
(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.lineagecell.com%2F&esheet=52345270&newsitemid=20201209005296&lan=en-US&anchor=Lineage+Cell+Therapeutics%2C+Inc.&index=1&md5=50ddf8c0c73df1635b8348608d2d1ae3)
(NYSE American and TASE: LCTX), a clinical-stage biotechnology company
developing three novel cell therapies for serious medical conditions, today
announced that Brian M. Culley, Chief Executive Officer, will be presenting at
the 13(th) Annual LD Micro Main Event
(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fve.mysequire.com%2F&esheet=52345270&newsitemid=20201209005296&lan=en-US&anchor=13th+Annual+LD+Micro+Main+Event&index=2&md5=e0c5b9e7285106e6aff34143d96bf328)
virtual conference on December 14, 2020 at 12:00 pm Eastern Time / 9:00am
Pacific Time. Interested investors can register and access the live
presentation on the 13(th) Annual LD Micro Main Event
(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fve.mysequire.com%2F&esheet=52345270&newsitemid=20201209005296&lan=en-US&anchor=13th+Annual+LD+Micro+Main+Event&index=3&md5=6fefe7affdc89241560b963ffd30ea54)
conference page as well as on the Events and Presentations
(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Finvestor.lineagecell.com%2Fevents-and-presentations%2Fupcoming-events&esheet=52345270&newsitemid=20201209005296&lan=en-US&anchor=Events+and+Presentations&index=4&md5=5197c93132342fdcdec5ad55b2b4e95d)
section of Lineage’s website.
The archived presentation will be available on the Events and Presentations
(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Finvestor.lineagecell.com%2Fevents-and-presentations%2Fupcoming-events&esheet=52345270&newsitemid=20201209005296&lan=en-US&anchor=Events+and+Presentations&index=5&md5=4512e2e1c21a27ddfd06ab1646b0a063)
section of Lineage’s website for 30 days. Additional videos are available on
the Media page of the Lineage website, located at www.lineagecell.com/media/
(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.lineagecell.com%2Fmedia%2F&esheet=52345270&newsitemid=20201209005296&lan=en-US&anchor=www.lineagecell.com%2Fmedia%2F&index=6&md5=46a6ea7b141aeebb6484a45148854ff2)
.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing
novel cell therapies for unmet medical needs. Lineage’s programs are based
on its robust proprietary cell-based therapy platform and associated in-house
development and manufacturing capabilities. With this platform Lineage
develops and manufactures specialized, terminally differentiated human cells
from its pluripotent and progenitor cell starting materials. These
differentiated cells are developed to either replace or support cells that are
dysfunctional or absent due to degenerative disease or traumatic injury or
administered as a means of helping the body mount an effective immune response
to cancer. Lineage’s clinical programs are in markets with billion dollar
opportunities and include three allogeneic (“off-the-shelf”) product
candidates: (i) OpRegen(®), a retinal pigment epithelium transplant therapy
in Phase 1/2a development for the treatment of dry age-related macular
degeneration, a leading cause of blindness in the developed world; (ii) OPC1,
an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the
treatment of acute spinal cord injuries; and (iii) VAC, an allogeneic
dendritic cell therapy platform for immuno-oncology and infectious disease,
currently in clinical development for the treatment of non-small cell lung
cancer. For more information, please visit www.lineagecell.com
(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.lineagecell.com&esheet=52345270&newsitemid=20201209005296&lan=en-US&anchor=www.lineagecell.com&index=7&md5=a799a6f5e65f54a7808e75cef60a408d)
or follow the Company on Twitter @LineageCell
(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Ftwitter.com%2FLineageCell&esheet=52345270&newsitemid=20201209005296&lan=en-US&anchor=%40LineageCell&index=8&md5=1024bdf10604bcd183c4878bbaad6e5f)
.
View source version on businesswire.com:
https://www.businesswire.com/news/home/20201209005296/en/
(https://www.businesswire.com/news/home/20201209005296/en/)
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(ir@lineagecell.com (mailto:ir@lineagecell.com) )
(442) 287-8963
Solebury Trout IR
Gitanjali Jain Ogawa
(Gogawa@troutgroup.com (mailto:Gogawa@troutgroup.com) )
(646) 378-2949
Russo Partners – Media Relations
Nic Johnson or David Schull
Nic.johnson@russopartnersllc.com
(mailto:Nic.johnson@russopartnersllc.com)
David.schull@russopartnersllc.com
(mailto:David.schull@russopartnersllc.com)
(212) 845-4242
Copyright Business Wire 2020Copyright Business Wire 2020
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Yes. But these are more technical things.....or am I wrong?
Sticking to hottest trends in biopharma, Oncologie gathers $80M for next leg of trans-Pacific clinical journey
https://endpts.com/sticking-to-hottest-trends-in-biopharma-oncologie-gathers-80m-for-next-leg-of-trans-pacific-clinical-journey/
DGAP-Adhoc: MOLOGEN AG to retain rights to lefitolimod - termination of negotiations without agreement - EQS Group
16-Nov-2018 15:25:19
To view this story on Eikon, click here
============
DGAP-Ad-hoc: MOLOGEN AG / Key word(s): Agreement
MOLOGEN AG to retain rights to lefitolimod - termination of negotiations
without agreement
16-Nov-2018 / 15:25 CET/CEST
Disclosure of an inside information acc. to Article 17 MAR of the
Regulation (EU) No 596/2014, transmitted by DGAP - a service of EQS Group
AG.
The issuer is solely responsible for the content of this announcement.
--------------------------------------------------------------------------
Publication of insider information as per Article 17 of (EU) Regulation
No. 596/2014
MOLOGEN AG to retain rights to lefitolimod - termination of negotiations
without agreement
Berlin, November 16^th, 2018 - The biopharmaceutical company MOLOGEN AG
(ISIN DE000A2LQ900, WKN A2LQ90) decided to terminate the negotiations with
ONCOLOGIE Inc. on the conclusion of definitive transaction documentation
for the global assignment of all intellectual property and other rights in
MOLOGEN's lead compound lefitolimod to ONCOLOGIE on the basis of the term
sheet agreed with ONCOLOGIE as announced by MOLOGEN with ad-hoc
notification dated August 15^th, 2018.
The negotiations with ONCOLOGIE did not result in a mutually satisfying
conclusion within the set time frame and were therefore terminated on
November 16^th, 2018; during the exclusivity period ONCOLOGIE presented
new financial terms for the transaction that were vastly inferior to those
agreed in the non-binding term sheet signed by the two companies on August
15^th, 2018. MOLOGEN assessed these new terms as being unjustified and
therefore rejected them. In addition, the top-line data from the pivotal
phase III IMPALA study are now expected to be available earlier than
initially expected - this could be as early as summer 2019 - which has
contributed to a change of MOLOGEN's assessment regarding the conclusion
of the contract. Based on these facts MOLOGEN has decided not to prolong
the exclusivity period for the negotiations with ONCOLOGIE and to assess
all potential strategic options moving forward. These include the
re-opening of discussions with other interested parties as well as
continuing the development of lefitolimod on its own. Upon availability of
top-line data from the ongoing Phase III clinical trial IMPALA the Company
will launch a campaign to partner or sell lefitolimod
Accordingly, MOLOGEN will not receive short-term payments and further
considerations as outlined in the term sheet, signed and announced through
ad-hoc notification on August 15^th, 2018. Based on the current cash
position, cash reach will be presumably until mid-2019. Beyond this point
in time the Company can use the available authorized and conditional
capital for further financing.
Irrespective of the fact that discussions with ONCOLOGIE on the assignment
of global rights for lefitolimod have not been successfully concluded,
MOLOGEN and ONCOLOGIE will continue to work together within the scope of
the existing license and co-development agreement for the lead compound
lefitolimod which was announced by MOLOGEN with ad-hoc notification on
February 13^th, 2018. This agreement covers the development, manufacturing
and commercialization of lefitolimod in the markets of China including
Hong Kong, Macao, Taiwan and Singapore as well as a potential global
development cooperation.
• End of the ad hoc notification -
Contact
Claudia Nickolaus
Head of Investor Relations & Corporate Communications
Tel: +49 - 30 - 84 17 88 - 38
Fax: +49 - 30 - 84 17 88 - 50
1 investor@mologen.com
Disclaimer
Certain statements in this communication contain formulations or terms
referring to the future or future developments, as well as negations of
such formulations or terms, or similar terminology. These are described as
forward-looking statements. In addition, all information in this
communication regarding planned or future results of business segments,
financial indicators, developments of the financial situation or other
financial or statistical data contains such forward-looking statements.
The company cautions prospective investors not to rely on such
forward-looking statements as certain prognoses of actual future events
and developments. The company is neither responsible nor liable for these
forward-looking looking statements. It is not responsible for updating
such information, which only represents the state of affairs on the day of
publication.
--------------------------------------------------------------------------
16-Nov-2018 CET/CEST The DGAP Distribution Services include Regulatory
Announcements, Financial/Corporate News and Press Releases.
Archive at www.dgap.de
--------------------------------------------------------------------------
Language: English
Company: MOLOGEN AG
Fabeckstraße 30
14195 Berlin
Germany
Phone: 030 / 841788-0
Fax: 030 / 841788-50
E-mail: presse@mologen.com
Internet: www.mologen.com
ISIN: DE000A2LQ900
WKN: A2LQ90
Regulated Market in Frankfurt (Prime Standard); Regulated
Listed: Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich,
Stuttgart, Tradegate Exchange
End of Announcement DGAP News Service
747217 16-Nov-2018 CET/CEST
2 fncls.ssp?fn=show_t_gif&application_id=747217&application_name=news&site_id=reuters6
References
Visible links
1. mailto:investor@mologen.com
============
The Nobel Prize in Physiology or Medicine 2018
Ill. Niklas Elmehed. © Nobel Media
James P. Allison
James P. Allison
Affiliation at the time of the award: University of Texas MD Anderson Cancer Center, Houston, TX, USA , Parker Institute for Cancer Immunotherapy, San Francisco, CA, USA
Prize motivation: "for their discovery of cancer therapy by inhibition of negative immune regulation."
Prize share: 1/2
Prize share: 1/2
Ill. Niklas Elmehed. © Nobel Media
Tasuku Honjo
Prize share: 1/2
The Nobel Prize in Physiology or Medicine 2018 was awarded jointly to James P. Allison and Tasuku Honjo "for their discovery of cancer therapy by inhibition of negative immune regulation."
https://www.nobelprize.org/prizes/medicine/2018/summary
Avid Bioservices to Exhibit at the 17th Annual Contracting & Outsourcing Conference - GNW
20-Sep-2018 14:05
For best results when printing this announcement, please click on link below: http://pdf.reuters.com/htmlnews/htmlnews.asp...
TUSTIN, Calif., Sept. 20, 2018 (GLOBE NEWSWIRE) -- Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, today announced that the company will exhibit at the upcoming 17(th) Annual Contracting & Outsourcing Conference. Avid will host a tabletop exhibit (#143) during the conference’s one-day tabletop exhibition, where it will showcase the company’s comprehensive range of process development, high quality cGMP clinical and commercial manufacturing services. The 17(th) Annual Contracting & Outsourcing Conference’s one-day tabletop exhibition is being held September 27, 2018 in New Brunswick, NJ.
As part of its exhibit, Avid will provide a virtual tour of the company’s 42,000 square foot state-of-the-art commercial biomanufacturing suite (Myford facility), which is in the unique position of being a validated facility with immediately available 2,000-liter scale bioreactor capacity. The company will also discuss the ongoing expansion of its process development capabilities and laboratories.
The Myford facility, located in Tustin, California, incorporates a variety of cutting-edge, single-use equipment with the goal of ultimately accommodating a fully disposable biomanufacturing process. A wide range of innovative features are incorporated into the facility including monolithic modular clean rooms, dedicated support utilities for each key processing area, and the industry’s most advanced single-use production systems and flexible solutions. Uni-directional process flows separate personnel and materials and provide assurance that the design meets the most stringent regulatory requirements for commercial biologics drug substance manufacturing. This facility complements Avid’s legacy commercial facility, located on the same campus, which continues to be responsible for the manufacture of multiple globally marketed commercial products.
For more information on the 17(th) Annual Contracting & Outsourcing Conference, please visit: http://conference.contractpharma.com/agenda/.
About Avid Bioservices, Inc.
Avid Bioservices is a dedicated contract development and manufacturing organization (CDMO) focused on development and cGMP manufacturing of biopharmaceutical products derived from mammalian cell culture. The company provides a comprehensive range of process development, high quality cGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. With 25 years of experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes, Avid's services include cGMP clinical and commercial product manufacturing, purification, bulk packaging, stability testing and regulatory strategy, submission and support. The company also provides a variety of process development activities, including cell line development and optimization, cell culture and feed optimization, analytical methods development and product characterization. www.avidbio.com
Contacts:
Kelly Pisarev Lord
Avid Bioservices, Inc.
(800) 987-8256
Stephanie Diaz (Investors)
Vida Strategic Partners
415-675-7401
sdiaz@vidasp.com
Tim Brons (Media)
Vida Strategic Partners
PM $8,73 vol. 70k
AVID BIOSERVICES SHARES UP 19.1 PCT PREMARKET AFTER SMALLER-THAN-EXPECTED LOSS - RTRS
Now back to $8,35 PM with vol 24.601
8,85 PM vol 20.000
AVID BIOSERVICES INC CDMO.O: H.C. WAINWRIGHT RAISES PRICE TARGET TO $11 FROM $6 - RTRS
8,25 PM vol 200
Some $7.5 calls Sept. and Oct. traded
The hepatocellular carcinoma market | Nature Reviews Drug ...
https://www.nature.com › ... › article
vor 6 Tagen · ... ramucirumab or sorafenib, and the phosphatidylserine-targeted mAb bavituximab (Oncologie) with pembrolizumab
https://www.nature.com/articles/nrd.2018.146
Maybe it's better to buy 10 CDMO instead this article - IMO
So he/she expects SP over $10.75
New 52 WH
Avid Bioservices to Exhibit at the 2018 BioProcess International Conference & Exhibition -GlobeNewswire
Corporate Booth to Include Virtual Tour of Myford Late-Stage Clinical and Commercial Biomanufacturing Facility Highlighting Immediately Available 2,000-Liter Scale Bioreactor Capacity --
TUSTIN, Calif., Aug. 28, 2018 (GLOBE NEWSWIRE) -- Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, today announced that the company will exhibit at the upcoming 2018 BioProcess International Conference & Exhibition. Avid will host a corporate booth (#938) in the conference’s exhibit hall, where it will showcase the company’s comprehensive range of process development, high quality cGMP clinical and commercial manufacturing services. The 2018 BioProcess International Conference & Exhibition is being held September 4-7, 2018 in Boston, MA.
As part of its exhibit, Avid will provide a virtual tour of the company’s 42,000 square foot state-of-the-art commercial biomanufacturing suite (Myford facility), which is in the unique position of being a validated facility with immediately available 2,000-liter scale bioreactor capacity. The company will also discuss the ongoing expansion of its process development capabilities and laboratories.
The Myford facility, located in Tustin, California, incorporates a variety of cutting-edge, single-use equipment with the goal of ultimately accommodating a fully disposable biomanufacturing process. A wide range of innovative features are incorporated into the facility including monolithic modular clean rooms, dedicated support utilities for each key processing area, and the industry’s most advanced single-use production systems and flexible solutions. Uni-directional process flows separate personnel and materials and provide assurance that the design meets the most stringent regulatory requirements for commercial biologics drug substance manufacturing. This facility complements Avid’s legacy commercial facility, located on the same campus, which continues to be responsible for the manufacture of multiple globally marketed commercial products.
For more information on the 2018 BioProcess International Conference & Exhibition, please visit:
https://lifesciences.knect365.com/bioprocessinternational/
About Avid Bioservices, Inc.
Avid Bioservices is a dedicated contract development and manufacturing organization (CDMO) focused on development and cGMP manufacturing of biopharmaceutical products derived from mammalian cell culture. The company provides a comprehensive range of process development, high quality cGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. With 25 years of experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes, Avid's services include cGMP clinical and commercial product manufacturing, purification, bulk packaging, stability testing and regulatory strategy, submission and support. The company also provides a variety of process development activities, including cell line development and optimization, cell culture and feed optimization, analytical methods development and product characterization. www.avidbio.com
Contacts:
Kelly Pisarev Lord
Avid Bioservices, Inc
(800) 987-8256
Stephanie Diaz (Investors)
Vida Strategic Partners
415-675-7401 sdiaz@vidasp.com
Tim Brons (Media)
Vida Strategic Partners
415-675-7402 tbrons@vidasp.com
GlobeNewswire, Inc. 2018
United States : Corporate Booth to Include Virtual Tour of Myford Late-Stage Clinical and Commercial Biomanufacturing Facility Highlighting Immedia... - EUCLID Procurement
10-Aug-2018 00:37
United States : Corporate Booth to Include Virtual Tour of Myford Late-Stage
Clinical and Commercial Biomanufacturing Facility Highlighting Immediately
Available 2,000-Liter Scale Bioreactor Capacity
Avid Bioservices, Inc. a dedicated biologics contract development and
manufacturing organization (CDMO) working to improve patient lives by
providing high quality development and manufacturing services to biotechnology
and pharmaceutical companies, today announced that the company will exhibit at
the upcoming Bioprocessing Summit 2018. Avid will host a corporate booth
(#310) in the conference?s exhibit hall, where it will showcase the company?s
comprehensive range of process development, high quality cGMP clinical and
commercial manufacturing services. The Bioprocessing Summit 2018 is being held
August 13-17, 2018 in Boston, MA.
As part of its exhibit at the Bioprocessing Summit 2018, Avid will provide a
virtual tour of the company?s 42,000 square foot state-of-the-art commercial
biomanufacturing suite (Myford facility), which is in the unique position of
being a validated facility with immediately available 2,000-liter scale
bioreactor capacity. The company will also discuss the ongoing expansion of
its process development capabilities and laboratories.
The Myford facility, located in Tustin, California, incorporates a variety of
cutting-edge, single-use equipment with the goal of ultimately accommodating a
fully disposable biomanufacturing process. A wide range of innovative features
are incorporated into the facility including monolithic modular clean rooms,
dedicated support utilities for each key processing area, and the industry?s
most advanced single-use production systems and flexible solutions.
Uni-directional process flows separate personnel and materials and provide
assurance that the design meets the most stringent regulatory requirements for
commercial biologics drug substance manufacturing. This facility complements
Avid?s legacy commercial facility, located on the same campus, which continues
to be responsible for the manufacture of multiple globally marketed commercial
products.
Copyright (c) 2018 Euclid Infotech Pvt Ltd.Copyright (c) 2018 Euclid Infotech Pvt Ltd.
nNRA6nnjgk
----------
(C) Thomson Reuters 2018. All rights reserved. The Thomson Reuters content received through this service is the intellectual property of Thomson Reuters or its third party suppliers. Republication or redistribution of content provided by Thomson Reuters is expressly prohibited without the prior written consent of Thomson Reuters, except where permitted by the terms of the relevant Thomson Reuters service agreement. Neither Thomson Reuters nor its third party suppliers shall be liable for any errors, omissions or delays in content, or for any actions taken in reliance thereon. Thomson Reuters and its logo are registered trademarks or trademarks of the Thomson Reuters group of companies around the world.
HTG Molecular, Oncologie Form Cancer Drug Biomarker Partnership
Aug 03, 2018 | staff reporter
NEW YORK (GenomeWeb) — HTG Molecular Diagnostics announced today that it has signed a master agreement to help Oncologie develop biomarkers for its immuno-oncology drug candidates.
Specific terms of the deal were not disclosed.
Oncologie currently has two drugs in its pipeline: the phase II immune-modulatory monoclonal antibody bavituximab, and the phase III immunomodulator and toll-like receptor 9 agonist lefitolimod. HTG offers next-generation sequencing-based molecular profiling instruments and assays, as well as related lab services.
"We believe HTG's technology and assay development capabilities will assist our clinical development efforts as we strive to bring innovative new medicines to cancer patients globally," Oncologie Founder and CEO Laura Benjamin said in a statement.
https://www.genomeweb.com/sequencing/htg-molecular-oncologie-form-cancer-drug-biomarker-partnership#.W2x6kno_81I
Mologen AG - MOLOGEN AG with positive developments in the first half of 2018: successful financing measures and continuation of clinical studies - Public Technologies
09-Aug-2018 07:24:07
• Ongoing clinical studies with lefitolimod on track, new studies in
preparation • License and development cooperation agreement signed with
ONCOLOGIE; initial revenues generated under license agreement • Dr Ignacio
Faus new Chief Executive Officer (CEO) since 1 August 2018 • Successful
financing measures • Forecast for fiscal year 2018 confirmed
In the first half of 2018 the biopharmaceutical company MOLOGEN AG recorded a
positive development in many respects. The 'Next Level' corporate strategy
continued to be implemented according to schedule in the first half of the
year. The most important strategic milestone was the conclusion of the license
and development cooperation agreement with the U.S. drug development company
ONCOLOGIE. Under the agreement, MOLOGEN received an initial license payment of
€3 million. The financing measures implemented in the fourth quarter of 2017
and in the reporting period - a frame-work agreement on convertible bonds of
up to €12 million and a cash capital increase with gross proceeds of around
€5 million - will initially secure the Company's financing plans until the
end of 2018. As a result of the reverse stock split in July 2018, MOLOGEN will
be able to make use of the financing instruments already agreed.
The clinical studies with MOLOGEN's lead compound, the immunotherapeutic
lefitolimod, also proceeded according to plan. In particular, the time of
evaluation of the colorectal cancer study IMPALA was substantiated and the
final evaluation of the explorative phase II study IMPULSE in the indication
of small cell lung cancer was performed. Here the positive signals of the
initial evaluation in predefined subgroups were confirmed. In addition, new
studies in various indications are in preparation, including the TITAN study
in the indication HIV. MOLOGEN also presented the first impressive preclinical
data on lefitolimod and its follow-up molecules EnanDIM® in the field of
immuno-
(https://www.mologen.com/en/investor-relations-press/news/press-releases/2018/detail-view/article/mologen-ag-mit-positiver-entwicklung-im-ersten-halbjahr-2018-erfolgreiche-finanzierungsmassnahmen-un.htmlen/service/glossary.html?gsuid=56&tip-pid=411#oncology)
and tumor microenvironment (TME).
Dr Ignacio Faus has taken over the CEO position of MOLOGEN AG since 1 August.
He succeeds Dr Mariola Söhngen, who decided not to extend her contract for
personal reasons.
'I'm delighted to be on board such an exciting company as MOLOGEN and to be
able to contrib-ute my experience in the pharmaceutical sector. In the last
six months, many positive things have happened at MOLOGEN: we concluded the
first license agreement for the lead compound lefito-limod, successfully
implemented important measures to secure corporate financing and continued to
drive the clinical trials forward as planned. My goal is to enter into further
partnerships with pharmaceutical companies and to bring MOLOGEN's innovative
products to market maturity as quickly as possible,' said Dr Ignacio Faus, CEO
of MOLOGEN AG.
Progress in ongoing clinical studies and further studies at the planning stage
In the first half of 2018, MOLOGEN's operating activities continued to focus
on clinical studies with its lead compound, the TLR9 agonist lefitolimod. The
preparatory activities for possible approval of the immunotherapeutic agent
have made progress. MOLOGEN also made further advances in its ongoing clinical
studies with lefitolimod: the pivotal study IMPALA in colorectal cancer (mCRC)
proceeded according to plan. In April 2018, a first data-based prediction of
the expected time of primary evaluation of the IMPALA study was announced.
Based on the patient data collected until April 2018 and using adequate
statistical methods, the timing of the results at the primary endpoint of the
study is predicted for April 2020 plus/minus five months. It is therefore
highly likely that the study results will be evaluated between the end of 2019
and summer of 2020.
The exploratory phase II study IMPULSE in the indication of small cell lung
cancer (SCLC), the main results of which MOLOGEN had already published in
April 2017, was finally evaluated in the first quarter of 2018. The positive
results already presented were confirmed in predefined patient subgroups. The
study showed remarkable overall survival results in two relevant patient
sub-groups compared to the
(https://www.mologen.com/en/investor-relations-press/news/press-releases/2018/detail-view/article/mologen-ag-mit-positiver-entwicklung-im-ersten-halbjahr-2018-erfolgreiche-finanzierungsmassnahmen-un.htmlen/service/glossary.html?gsuid=54&tip-pid=411#controlgroup).
The results support the hypothesis that activated B cells as biomarkers can
contribute to the future development of lefitolimod in this relevant subgroup
of patients with small cell lung cancer in advanced stages.
In the indication HIV, detailed study results from the extension phase of the
TEACH study, which was primarily evaluated in August 2017, were presented at
the Conference on Retroviruses and Opportunistic Infections (CROI) in Boston.
In accordance with the further development strategy in the indication HIV,
lefitolimod is to be used in combination therapies. The 'TITAN' combination
study already financed by the renowned U.S. pharmaceutical company Gilead
Sciences is cur-rently being prepared. As in the previous TEACH study, the
study will be conducted in collabora-tion with the Aarhus University Hospital
in Aarhus, Denmark. Further new studies in various indi-cations are also in
preparation.
Patient recruitment for the phase I combination study with the checkpoint
inhibitor Yervoy® in collaboration with the MD Anderson Cancer Center in
Texas is also making further progress. It is expected that the first part of
the study to evaluate the safety of the combination of lefitolimod with
checkpoint inhibitors and the determination of the highest tolerated dose of
lefitolimod will be completed by 2018. The study will then be continued in
2019 to explore further insights into the combination of lefitolimod with
checkpoint inhibitors.
In April, MOLOGEN presented impressive preclinical tumor microenvironment data
on lefitolimod and its follow-up molecules EnanDIM® at the AACR conference
(American Association for Cancer Research) in Chicago and at the ASCO GI
(Annual Gastrointestinal Cancers Symposium) in San Francisco in January.
Accordingly, monotherapy with lefitolimod leads to an advantageous modulation
of the tumor microenvironment, which is accompanied by reduced tumor growth in
a colorectal cancer model. These results underscore the strong potential of
lefitolimod as a cancer immunotherapeutic agent.
Most important strategic milestone reached: first license agreement for
lefitolimod
In February 2018, MOLOGEN reached a significant strategic milestone and signed
a license and development cooperation agreement for lefitolimod with the U.S.
drug developer ONCOLOGIE. This includes the development, production and
commercialization of lefitolimod in the markets of China including Hong Kong,
Macau as well as Taiwan and Singapore and a global development cooperation.
Under the terms of the contract concluded, MOLOGEN has already received an
initial payment of €3 million. In addition, a capital contribution of €2
million by February 2019 at the latest as well as development and
sales-related milestone payments and royalties have been agreed. Further
partnerships are to follow.
Successful financing measures and capital consolidation
Further corporate financing was also a focus of MOLOGEN's activities in the
first half of 2018. Three capital measures were implemented in the first
quarter: initially, a second capital increase took place in the course of the
exercise of the share subscription agreement entered into in October 2017 with
the US investor Global Corporate Finance (GCF). This second exercise generated
gross proceeds of €445,000 for MOLOGEN. In combination with the first
exercise, MOLOGEN thus received around €1 million.
This was followed by a rights issue of €5 million from authorized capital,
which was successfully completed and fully placed in March 2018.
On 20 February 2018, MOLOGEN concluded a contract with the Luxembourg-based
financing provider European High Growth Opportunities Securitization Fund
(EHGO), which is advised by Alpha Blue Ocean Advisors. Under this agreement,
MOLOGEN can call convertible bonds with a total value of up to €12 million
in 24 tranches of €500,000 each from the investor over a period of two
years. So far, MOLOGEN has drawn down two tranches (in March 2018). These have
al-ready been fully converted by EHGO. In total, the Company thus received
approx. €6.5 million in cash and cash equivalents in the reporting period.
In mid-July the 5:1 capital consolidation under a resolution adopted at the
MOLOGEN Annual General Meeting on 8 June 2018 was implemented. Since then, the
Company's share capital has reached €7,537,287, divided into 7,537,287
bearer shares (before capital consolidation: 37,686,439 shares). The reverse
stock split will make MOLOGEN financially viable again and the financing
measures already agreed can continue to be implemented.
The capital measures and framework agreements implemented in the fourth
quarter of 2017 and in the first quarter of 2018 are expected to allow the
financing of the Company until the end of 2018.
Lower research and development expenses and significant improvement in
earnings
Research & development costs in the first half of 2018 amounted to €5.6
million, 30 percent lower than in the same period last year (previous year:
€8.0 million). This development was due to lower R&D expenses due to the
completion of two of the clinical studies. The operating result (EBIT) also
improved significantly to €4.5 million (previous year: -€10.5 million) due
to the first licensing revenue resulting from the cooperation with ONCOLOGIE.
As at 30 June 2018, MOLOGEN AG had cash & cash equivalents amounting to €6.2
million (31 December 2017: €6.5 million).
Personnel changes on the Executive Board and Supervisory Board
At personnel level, MOLOGEN AG announced in April that the CEO Dr Mariola
Söhngen would not extend her contract, which expires on 31 October 2018, for
personal reasons. Her successor Dr Ignacio Faus was appointed to the Executive
Board as of 1 August 2018 and has assumed the role of CEO of MOLOGEN AG. Dr
Faus has gained more than 25 years' experience in the life sciences industry
and contributes valuable expertise in areas such as fundraising,
organizational planning, strategic project evaluation, operational efficiency,
business development & licensing (BD&L). In 2006 he was one of the founders of
PALAU PHARMA, a biopharmaceutical company in the field of inflammatory and
autoimmune diseases. In his function as CEO of MOLOGEN, Dr Faus is responsible
for Business Development, Investor Relations & Corporate Communications,
Partnering, Production and Strategy.
In addition, Dr Michael Schultz, independent expert and consultant for
pharmaceutical and bio-technology companies, was elected as a new member of
the Supervisory Board of MOLOGEN AG at the 2018 Annual General Meeting.
Forecast for full-year 2018 confirmed
Based on the progress planned for 2018 in all divisions, primarily in clinical
development pro-grams and commercialization, the Company expects positive
development in 2018. Overall, the Executive Board of MOLOGEN AG confirms the
statements made in the 2017 Annual Report regarding the targets in the areas
of research and development, cooperations and partnerships, earnings and
liquidity development as well as personnel for the entire 2018 financial year,
with the exception of subsequent additions. Due to its activities, some of
which were launched later, particularly in the area of contract manufacturing,
the Company now assumes that the financial requirements in the 2018 financial
year will be at a comparable level or below those of the pre-ceding year.
MOLOGEN AG's complete 2018 half-year report is available on the Company's
website at www.mologen.com.
MOLOGEN AG
MOLOGEN AG is a biopharmaceutical company and a pioneer in the field of
immunotherapy on account of its unique active agents and technologies.
Alongside a focus on immuno-
(https://www.mologen.com/en/investor-relations-press/news/press-releases/2018/detail-view/article/mologen-ag-mit-positiver-entwicklung-im-ersten-halbjahr-2018-erfolgreiche-finanzierungsmassnahmen-un.htmlen/service/glossary.html?gsuid=56&tip-pid=411#oncology),
MOLOGEN develops immunotherapies for the treatment of infectious diseases.
The focus of the development work is on the product family of DNA-based TLR9
agonists. This includes the lead compound lefitolimod and the next-generation
molecule family EnanDIM®.
The immunotherapeutic agent lefitolimod is the Company's lead compound and is
currently being investigated in a pivotal trial. It is regarded as the
best-in-class TLR9 agonist. Treatment with lefitolimod triggers a broad and
strong activation of the immune system. On account of this mode of action,
lefitolimod could potentially be used in various indications. Lefitolimod is
currently being developed within the framework of a pivotal study for first
line maintenance therapy for colorectal cancer. Key data of the phase II
IMPULSE study in small cell lung cancer have been announced in April 2017, and
the final analysis in the first quarter 2018 confirmed the data. Furthermore,
data from the extension phase of the TEACH study in HIV have also been
published in 2017. In addition, lefitolimod is currently being investigated in
a phase I combination study with the checkpoint inhibitor ipilimumab
(Yervoy®) in various cancer indications. Along with various checkpoint
inhibitors, lefitolimod, which is being investigated as part of a phase III
clinical trial currently, is one of the few near-to-market product candidates
in the field of immuno-
(https://www.mologen.com/en/investor-relations-press/news/press-releases/2018/detail-view/article/mologen-ag-mit-positiver-entwicklung-im-ersten-halbjahr-2018-erfolgreiche-finanzierungsmassnahmen-un.htmlen/service/glossary.html?gsuid=56&tip-pid=411#oncology).
MOLOGEN's pipeline focus is on new innovative immunotherapies to treat
diseases for which there is a great medical demand in particular.
MOLOGEN AG is a publicly listed Company, headquartered in Berlin. The shares
(ISIN, DE000A2LQ900/SIN: A2L Q90) are listed in the Prime Standard of the
German Stock Exchange.
www.mologen.com
Contact
Claudia Nickolaus
Head of Investor Relations & Corporate Communications
Tel: +49 - 30 - 84 17 88 - 38
Fax: +49 - 30 - 84 17 88 - 50
investor@mologen.com
Note about risk for future predictions
Certain information in this report contains forward-looking statements or the
corresponding statements with negation or versions deviating from this or
comparable terminology. These are described as forward-looking statements. In
addition, all of the information given here that refers to planned or future
results of business areas, key financial figures, developments of the
financial situation or other financial figures or statistical data, is to be
understood as such forward-looking statements. The company points out to
investors that they should not rely on these forward-looking statements as
predictions about actual future events. The company is not obligated and
refuses to accept any liability for the forward-looking statements and has no
obligation to update such statements in order to accurately reflect the
current situation.
Attachments
* Original document
(https://www.mologen.com/en/investor-relations-press/news/press-releases/2018/detail-view/article/mologen-ag-mit-positiver-entwicklung-im-ersten-halbjahr-2018-erfolgreiche-finanzierungsmassnahmen-un.html)
Disclaimer
Mologen AG published this content on 09 August 2018 and is solely responsible
for the information contained herein. Distributed by Public, unedited and
unaltered, on 09 August 2018 05:24:05 UTC
(C) Copyright 2018 - Mologen AG(C) Copyright 2018 - Mologen AG
nNDL4jJYPd
----------
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Avid Bioservices to Exhibit at the Bioprocessing Summit 2018 - GNW
08-Aug-2018 14:05
TUSTIN, Calif., Aug. 08, 2018 (GLOBE NEWSWIRE) -- Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, today announced that the company will exhibit at the upcoming Bioprocessing Summit 2018. Avid will host a corporate booth (#310) in the conference’s exhibit hall, where it will showcase the company’s comprehensive range of process development, high quality cGMP clinical and commercial manufacturing services. The Bioprocessing Summit 2018 is being held August 13-17, 2018 in Boston, MA.
As part of its exhibit at the Bioprocessing Summit 2018, Avid will provide a virtual tour of the company’s 42,000 square foot state-of-the-art commercial biomanufacturing suite (Myford facility), which is in the unique position of being a validated facility with immediately available 2,000-liter scale bioreactor capacity. The company will also discuss the ongoing expansion of its process development capabilities and laboratories.
The Myford facility, located in Tustin, California, incorporates a variety of cutting-edge, single-use equipment with the goal of ultimately accommodating a fully disposable biomanufacturing process. A wide range of innovative features are incorporated into the facility including monolithic modular clean rooms, dedicated support utilities for each key processing area, and the industry’s most advanced single-use production systems and flexible solutions. Uni-directional process flows separate personnel and materials and provide assurance that the design meets the most stringent regulatory requirements for commercial biologics drug substance manufacturing. This facility complements Avid’s legacy commercial facility, located on the same campus, which continues to be responsible for the manufacture of multiple globally marketed commercial products.
For more information on the Bioprocessing Summit 2018, please visit: http://www.bioprocessingsummit.com/
About Avid Bioservices, Inc.
Avid Bioservices is a dedicated contract development and manufacturing organization (CDMO) focused on development and cGMP manufacturing of biopharmaceutical products derived from mammalian cell culture. The company provides a comprehensive range of process development, high quality cGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. With 25 years of experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes, Avid's services include cGMP clinical and commercial product manufacturing, purification, bulk packaging, stability testing and regulatory strategy, submission and support. The company also provides a variety of process development activities, including cell line development and optimization, cell culture and feed optimization, analytical methods development and product characterization. www.avidbio.com
Contacts:
Kelly Pisarev Lord
Avid Bioservices, Inc.
(800) 987-8256
Stephanie Diaz (Investors)
Vida Strategic Partners
415-675-7401
sdiaz@vidasp.com
Tim Brons (Media)
Vida Strategic Partners
415-675-7402
tbrons@vidasp.com
GlobeNewswire, Inc. 2018
HTG Molecular Diagnostics and Oncologie, Inc. Complete Master Agreement to Partner on Biomarker Development for Immuno-oncology Drug Development- GlobeNewswire
TUCSON, Ariz., Aug. 03, 2018 (GLOBE NEWSWIRE) -- HTG Molecular Diagnostics (https://www.globenewswire.com/Tracker...), Inc. (Nasdaq: HTGM) (HTG), a provider of instruments, reagents, and services for molecular profiling applications and Oncologie, Inc. an innovative biotechnology company with operations in Boston and Shanghai, today announced the completion of a master agreement where the companies have agreed to partner on the development of biomarkers associated with Oncologie’s Immuno-oncology pipeline.
“We are honored to be working with Oncologie on biomarker development programs for their innovative pipeline of Immuno-oncology assets,” stated TJ Johnson HTG Chief Executive Officer. “HTG is committed to the development of NGS-based precision diagnostics to support biomarker driven drug development, and we share a common focus with Oncologie in the field of Immuno-oncology.”
Laura Benjamin Ph.D., Oncologie Chief Executive Officer and founder added, “We believe HTG’s technology and assay development capabilities will assist our clinical development efforts as we strive to bring innovative new medicines to cancer patients globally.”
About Oncologie, Inc.
ONCOLOGIE is an oncology therapeutics company committed to delivering better outcomes for cancer patients through an improved understanding of which patients will benefit from each drug in the pipeline. The current pipeline is focused on mid-stage clinical programs that modify the immune system to enhance efficacy of current standards of care and emerging immunotherapy agents. Headquartered in Boston, Massachusetts and Shanghai, China, Oncologie is working with global partners to acquire and develop innovative drugs for cancer patients around the world. WWW.ONCOLOGIE.INTERNATIONAL (https://www.globenewswire.com/Tracker...)
About HTG:
HTG is focused on next generation sequencing (NGS) based molecular profiling. The company’s proprietary HTG EdgeSeq technology automates complex, highly multiplexed molecular profiling from solid and liquid samples, even when limited in amount. HTG’s customers use its technology to identify biomarkers important for precision medicine, to understand the clinical relevance of these discoveries, and ultimately to identify treatment options. Our mission is to empower precision medicine at the local level.
Safe Harbor Statement:
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the expected development of biomarkers under the master agreement with Oncologie. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements necessarily contain these identifying words. These forward-looking statements are based upon management’s current expectations, are subject to known and unknown risks, and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation, the risk that development activities expected under the Oncologie master agreement may not be performed as expected, or at all, risks inherent in the development of custom profiling assays for specific indications, risks associated with the utility of our profiling panels, instruments and solutions, and risks associated with our ability to successfully manufacture and supply our products. These and other factors are described in greater detail in our filings with the Securities and Exchange Commission, including without limitation our Quarterly Report on Form 10-Q for the quarter ended March 31, 2018. All forward-looking statements contained in this press release speak only as of the date on which they were made, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Contact:
Ashley R. Robinson
LifeSci Advisors, LLC
Phone: (617) 535-7742
Email: arr@lifesciadvisors.com
TJ Johnson
CEO
HTG Molecular Diagnostics
Phone: (520) 547-2827 x130
Email: tjjohnson@htgmolecular.com
Laura Benjamin
CEO
Oncologie, Inc.
Phone: (781) 907-7810
Email: laura@oncologie.international
GlobeNewswire, Inc. 2018
IMO
Stolen from us SH and we payed for it all those years and now they got it for free....
IMO
Antibody targeting of phosphatidylserine for detection and immunotherapy of cancer
Abstract
Metrics
Get Permission
Authors Zohar DN, Shoenfeld Y
Received 27 March 2018
Accepted for publication 7 April 2018
Published 22 June 2018 Volume 2018:7 Pages 51—53
DOI https://doi.org/10.2147/ITT.S169383
Checked for plagiarism Yes
Editor who approved publication: Professor Michael Shurin
Daniela Noa Zohar, Yehuda Shoenfeld
Zabludowitz Centre for Autoimmune Diseases, Sheba Medical Centre, Tel-Hashomer, Israel
Belzile et al introduce a novel therapeutic approach for cancer by antibody targeting of phosphatidylserine (PS).1 As is well known, antiphospholipid autoantibodies are associated with hypercoagulability disorders, particularly antiphospholipid syndrome (APS).2 While the hallmark autoantibodies of APS are anti-beta2 glycoprotein and anticardiolipin, over 30 other non-classic autoantibodies were reported in correlation with APS. Particular attention was dedicated to antiphosphatidylserine (aPS) – a remarkable autoantibody that was detected in 68–86% of APS patients.2 aPS is associated with thrombosis, thrombocytopenia and hemolytic anemia.2 Previously, we have described the pathogenicity of aPS on experimental mice models by induction of APS, both through passive transfer of purified human IgG aPS antibodies3 and active immunization, whereas immunized mice with IgG aPS produced high titers of mouse aPS. The results demonstrated a clinical picture of APS by prolonged activated partial thromboplastin time, thrombocytopenia and increased rates of fetal resorptions.4
https://www.dovepress.com/aantibody-targeting-of-phosphatidylserine-for-the-detection-and-i-peer-reviewed-article-ITT
Download Article!!!
CVI Holdings LLC Invests $1.73 Million in Avid Bioservices (CDMO) Stock
https://www.americanbankingnews.com/2018/06/11/cvi-holdings-llc-invests-1-73-million-in-avid-bioservices-cdmo-stock.html
Mologen AG - MOLOGEN AG: Reverse stock split agreed at Annual General Meeting as basis for further funding measures - Public Technologies
11-Jun-2018 10:47:11
To view this story on Eikon, click here
• Shareholders agree to all draft proposals with large majority • Reverse stock split ratio of 5:1 • Generation of new capital
Shareholders have resolved the planned reverse stock split by a majority of 96.57% at the Annual General Meeting of MOLOGEN AG. The reverse stock split, which will be carried out at a ratio of 5:1, will serve to maintain MOLOGEN's financing capability.
Walter Miller, CFO at MOLOGEN: 'We are pleased that our shareholders have ratified the planned reverse stock split by such a large majority. The share price development over the past weeks and months has unfortunately not reflected the Company's quite positive development, with the result that we saw fit to implement this measure. After the reverse stock split has been carried out, the Company's solvency will once more be secured, meaning that pre-agreed funding instruments can continue to be implemented.'
In total, voting rights corresponding to almost 40% of the share capital were represented at the Annual General Meeting. A large majority approved the actions of the members of the Executive Board and also of the Supervisory Board, with all other items on the agenda agreed as well. The resolutions approved included, among other things, the election of Dr. Michael Schultz as a new member of the Supervisory Board. He is an independent expert and consultant to the pharma and biotechnology industries. The choice of Baker Tilly GmbH & Co. KG as auditors for fiscal year 2018 was also agreed. Furthermore, the decision to create a new authorized capital 2018 and authorization to issue convertible bonds and/or option bonds and creation of the relevant conditional capital 2018 was also ratified.
Prior to the voting process, the Executive Board presented an overview of the Company's current situation and most recent developments to the shareholders. The focus here was on the first licensing agreement for MOLOGEN's lead product, the immunotherapeutic lefitolimod, in addition to the implementation of the Next Level corporate strategy and current status with regard to findings from studies conducted with lefitolimod.
MOLOGEN AG
MOLOGEN AG is a biopharmaceutical Company and a pioneer in the field of immunotherapy on account of its unique active agents and technologies. Alongside a focus on immuno-, MOLOGEN develops immunotherapies for the treatment of infectious diseases.
The focus of the development work is on the product family of DNA-based TLR9 agonists. This includes the lead compound lefitolimod and the next-generation molecule family EnanDIM®.
The immunotherapeutic agent lefitolimod is the Company's lead compound and is currently being investigated in a pivotal trial. It is regarded as the best-in-class TLR9 agonist. Treatment with lefitolimod triggers a broad and strong activation of the immune system. On account of this mode of action, lefitolimod could potentially be used in various indications. Lefitolimod is currently being developed within the framework of a pivotal study for first line maintenance therapy for colorectal cancer. Key data of the phase II IMPULSE study in small cell lung cancer have been announced in April 2017, and the final analysis in the first quarter 2018 confirmed the data. Furthermore, data from the extension phase of the TEACH study in HIV have also been published in 2017. In addition, lefitolimod is currently being investigated in a phase I combination study with the checkpoint inhibitor ipilimumab (Yervoy®) in various cancer indications. Along with various checkpoint inhibitors, lefitolimod, which is being investigated as part of a phase III clinical trial currently, is one of the few near-to-market product candidates in the field of immuno-.
MOLOGEN's pipeline focus is on new innovative immunotherapies to treat diseases for which there is a great medical demand in particular.
MOLOGEN AG is a publicly listed Company, headquartered in Berlin. The shares (ISIN DE0006637200, SIN 663720) are listed in the Prime Standard of the German Stock Exchange.
www.mologen.com
Contact
Claudia Nickolaus
Head of Investor Relations & Corporate Communications
Tel: +49 - 30 - 84 17 88 - 38
Fax: +49 - 30 - 84 17 88 - 50
investor@mologen.com
Note about risk for future predictions
Certain information in this report contains forward-looking statements or the corresponding statements with negation or versions deviating from this or comparable terminology. These are described as forward-looking statements. In addition, all of the information given here that refers to planned or future results of business areas, key financial figures, developments of the financial situation or other financial figures or statistical data, is to be understood as such forward-looking statements. The company points out to investors that they should not rely on these forward-looking statements as predictions about actual future events. The company is not obligated and refuses to accept any liability for the forward-looking statements and has no obligation to update such statements in order to accurately reflect the current situation.
Sound familiar? China/US biotech hybrid lands rights to cancer drugs, cash and a team of development vets to launch Oncologie
https://endpts.com/sound-familiar-china-us-biotech-hybrid-lands-rights-to-cancer-drugs-cash-and-a-team-of-development-vets-to-launch-oncologie/
6/8/18 - Oncologie kicks off trans-Pacific operations with $16.5M in seed funding [All Iraq News Agency (AIN)]
Immuno-oncology startup Oncologie has formally launched its operations in Boston and Shanghai following $16.5 million in seed funding, with the goal of delivering new cancer therapies in the U.S. and Chinese markets simultaneously.
Founded by Eli Lillys former VP of oncology, Laura Benjamin, the biotech aims to advance a pipeline of novel, clinical-stage drug candidates through licensing and partnering, including multiple phase 2 and 3 programs designed to combine with checkpoint inhibitors.
Oncologie believes it can leverage recent regulatory changes in China to allow the use of foreign clinical trial data in new drug submissions in order to conduct parallel development on both sides of the Pacific.
We think these coordinated efforts will shorten the time between launching innovative drugs in the U.S. and China, said Jimmy Wei, managing partner of the Pivotal bioVenture Partners China Fund, which led the seed financing. Other investors included Nan Fung Life Sciences, China Merchant Bank Investments and Volcanics Ventures.
Since there are too many undifferentiated PD-1/PD-L1 programs in China with very few combination trials ongoing, Oncologie has positioned itself as the leader in immune combination therapies, Wei said.
Oncologie has been building out its pipeline since its inception in January, said Benjamin, who serves as president and CEO. That includes bavituximab, acquired from Avid Bioservices, and lefitolimod, a TLR-9 agonist picked up from Mologen.
Bavituximab, which blocks tumor-signaling that reduces the immune systems ability to recognize cancers, is being studied in combination with chemotherapy and radiation in both glioblastoma and liver cancer.
Lefitolimod, meanwhile, is paired with Yervoy (ipilimumab) in a trial in solid malignancies, and is also being studied as a single maintenance therapy following chemotherapy in first-line metastatic colorectal cancer.
Oncologie has built an all-star team of creative drug developers committed to revealing the full potential of our exciting pipeline that is positioned to maximize the benefits cancer immune therapy can bring, Benjamin said in a statement.
Last month, Pivotal bioVenture Partners, a member of Nan Fung Life Sciences, raised $150 million for a venture capital fund to support early-stage companies in China. The fund focuses on in-licensing products and technologies for unmet medical needs in the country. The year before, Pivotal announced a $300 million fund for biotechs in the U.S. and Europe.
https://www.pharmacychoice.com/news/article.cfm?Article_ID=2027030
Docetaxel Plus Bavituximab in Previously Treated Advanced Non-Squamous NSCLC
Published in Oncology
Journal Scan / Research · June 05, 2018
https://www.practiceupdate.com/content/docetaxel-plus-bavituximab-in-previously-treated-advanced-non-squamous-nsclc/68348
Clinical Research Scientist
Oncologie Inc.
Boston, MA
https://www.indeed.com/m/jobs?q=Oncologie&l=Boston%2C+MA&from=searchOnSerp
https://www.linkedin.com/jobs/view/clinical-trial-manager-at-oncologie-647203838
Avid Bioservices to Participate at BIO International Convention 2018 - GNW
29-May-2018 14:05
Corporate Booth to Include Virtual Tour of Myford Late-Stage Clinical and Commercial Biomanufacturing Facility Highlighting Immediately Available 2,000-Liter Scale Bioreactor Capacity --
Company’s Newly Appointed Director of Business Development for East Coast to Join Team at BIO 2018 --
TUSTIN, Calif., May 29, 2018 (GLOBE NEWSWIRE) -- Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, today announced that the company will participate at the upcoming 2018 BIO International Convention. The company’s activities will include hosting of a corporate booth (#1073) in the conference’s exhibit hall, delivering a presentation on single-use manufacturing of biopharmaceuticals, participating in a roundtable discussion on the topic of capacity strategies for the utilization of single-use systems vs. traditional stainless steel technology, and taking part in the conference’s one-on-one partnering meetings. The company will also hold a reception at its booth on the evening of Tuesday, June 5(th) as part of the exhibit hall activities taking place on opening day. BIO 2018 is being held June 4-7, 2018 in Boston, MA.
Details of Avid’s activities at BIO 2018 are as follows:
Avid will host corporate booth #1073 showcasing the company’s comprehensive range of process development, high quality cGMP clinical and commercial manufacturing services. Company representatives will provide a virtual tour of Avid’s 42,000 square foot state-of-the-art commercial biomanufacturing suite (Myford facility), which is in the unique position of being a validated facility with immediately available 2,000-liter scale bioreactor capacity. The company will also discuss the ongoing expansion of its process development capabilities and laboratories.
The Myford facility, located in Tustin, California, incorporates a variety of cutting-edge, single-use equipment with the goal of ultimately accommodating a fully disposable biomanufacturing process. A wide range of innovative features are incorporated into the facility including monolithic modular clean rooms, dedicated support utilities for each key processing area, and the industry’s most advanced single-use production systems and flexible solutions. Uni-directional process flows separate personnel and materials and provide assurance that the design meets the most stringent regulatory requirements for commercial biologics drug substance manufacturing.
Additionally, Avid will dedicate a portion of its booth to celebrating the company’s 25 years of experience in biopharmaceutical development and manufacturing, which dates back to 1993. This anniversary coincides with the 25-year anniversary of the Biotechnology Innovation Organization (BIO), which is also being celebrated this year.
Joining the Avid team at BIO 2018 will be Sandra C. Carbonneau, the company’s newly appointed director of business development for the East Coast. Mrs. Carbonneau has more than 26 years of relevant industry experience, including a 22-year tenure with Lonza, a global integrated solutions provider to the pharmaceutical and biotechnology industries. During her time with Lonza, she held positions of increasing responsibility spanning areas of manufacturing, quality assurance, compliance and contract management, culminating in her overseeing the company’s global commercial development for its mammalian business unit. Mrs. Carbonneau most recently served as director of business development in the New England region at Integrated Project Services (IPS), a leading consulting firm for technically complex facilities worldwide. At Avid, she will play a key role in the company’s new customer acquisition efforts on the east coast of the US, while supporting all its existing clients in the eastern half of the country.
Roger Lias, Ph.D., Avid’s president and chief executive officer, will participate in a roundtable discussion titled, “Capacity Strategies – The Strategy Behind the Large Scale SUS vs. Stainless Steel Investment.” The roundtable discussion will take place from 1:00 – 2:00 p.m. Eastern on Wednesday, June 6(th) at booth #375 within the BioProcess Zone’s BPI Theatre. It will be part of the BPI Theatre’s “Emerging Techniques, Technologies and Strategies” track.
Sun Ra Bullins, director of manufacturing at Avid, will make a presentation titled, “The Perks and Pitfalls of a Single-Use Biopharmaceutical Facility.” The presentation will take place from 3:40 – 4:00 p.m. Eastern on Wednesday, June 6th at booth #375 within the BioProcess Zone’s BPI Theatre. It will be part of the BPI Theatre’s “Emerging Techniques, Technologies and Strategies” track. For more information on the BIO International Convention, please visit: http://convention.bio.org/.
About Avid Bioservices, Inc.
Avid Bioservices is a dedicated contract development and manufacturing organization (CDMO) focused on development and cGMP manufacturing of biopharmaceutical products derived from mammalian cell culture. The company provides a comprehensive range of process development, high quality cGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. With 25 years of experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes, Avid's services include cGMP clinical and commercial product manufacturing, purification, bulk packaging, stability testing and regulatory strategy, submission and support. The company also provides a variety of process development activities, including cell line development and optimization, cell culture and feed optimization, analytical methods development and product characterization. www.avidbio.com
Contacts:
Kelly Pisarev Lord
Avid Bioservices, Inc.
(800) 987-8256
Stephanie Diaz (Investors)
Vida Strategic Partners
415-675-7401
sdiaz@vidasp.com
Tim Brons (Media)
Vida Strategic Partners
415-675-7402
tbrons@vidasp.com
AVID BIOSERVICES INC CDMO.O: H.C. WAINWRIGHT STARTS WITH BUY RATING; PRICE TARGET $5
Mologen AG / Onkologie
: MOLOGEN AG: significant progress in clinical studies and successful funding and licensing activities dominated first quarter of 2018 - EQS Group
15-May-2018 07:05:02
To view this story on Eikon, click here
============
Press Release N 13 / 2018 dated 05/15/2018
MOLOGEN AG: significant progress in clinical studies and successful
funding and licensing activities dominated first quarter of 2018
• Next Level corporate strategy being implemented according to plan
• Progress made in ongoing clinical trials and preparations underway for new studies in various indications
• A licensing and development cooperation contract signed with ONCOLOGIE; first payment received
• Additional capital measures successfully completed
• Confirmation of forecast for fiscal year 2018
Berlin, 15 May 2018 - In the first quarter of 2018, biopharmaceutical
company MOLOGEN AG has continued to consistently implement the Next Level
strategy, especially in relation to preparatory activities for the
potential market approval of lefitolimod. In addition, clinical studies
with the lead product candidate lefitolimod also continued successfully
and further strong pre-clinical data on the potential of lefitolimod and
the next-generation molecules EnanDIM^(R) in immuno-oncology were
presented.
Further successes were achieved in partnering activities and the
associated commercialization of lefitolimod: a licensing and development
contract was concluded with ONCOLOGIE, a U.S. drug development company,
with MOLOGEN receiving the first contractual payment of EUR3 million. The
ongoing financing requirements of the Company were also an important focus
over the first quarter of 2018: financing has presumably been secured
until the end of 2018 through the implementation of various capital
measures.
"Much has happened at MOLOGEN in the first three months of the year and we
were able to achieve some key targets. The greatest success was
undoubtedly the signing of a contract with ONCOLOGIE, which is a
significant step towards our primary aim - the licensing and international
commercialization of lefitolimod. However, securing the ongoing funding of
our Company through various capital measures was also a major achievement
in the first quarter of the year," comments Dr Mariola Soehngen, Chief
Executive Officer (CEO) of MOLOGEN AG.
Significant progress in current clinical studies and planning of new
trials
In the first quarter of 2018, MOLOGEN made further progress in the ongoing
clinical trials with the lead compound, the immunotherapy lefitolimod. In
fact, a final evaluation was completed of the results from the exploratory
IMPULSE phase II clinical trial in patients suffering from extensive stage
small cell lung cancer that had already been published in April 2017. This
confirmed the positive news from the initial evaluation for predefined
subgroups. The study delivered notable results with regard to overall
survival in two relevant patient groups when compared with the control.
These findings therefore support the hypothesis that activated B cells may
serve as a valid biomarker in the further development of lefitolimod in
small cell lung cancer.
MOLOGEN presented strong pre-clinical tumor microenvironment (TME) data on
lefitolimod's follow-up molecules EnanDIM^(R) at the AACR Annual Meeting
2018 (American Association for Cancer Research) which took place in
Chicago in April and at the ITOC-5 Immunotherapy of Cancer Conference in
Berlin in March. This showed that monotherapy in murine tumor models
resulted in beneficial modulation of the TME, translating into remarkable
anti-tumor effects with highly increased survival rates. In two cancer
models, complete tumor regression was observed in the majority of mice.
The presented data clearly reveals the enormous potential of the
EnanDIM^(R) product family in immuno-oncology.
The pivotal IMPALA study in the indication of colorectal cancer again
moved forward as planned. In April 2018, an initial data-based forecast
was published for the expected date for the primary analysis of the study.
Based on patient data collected and using adequate statistical
methodology, the results on the primary endpoint of the study are expected
to be available in April 2020. This statistical forecast involves a degree
of uncertainty, reflected in the 95% confidence interval of plus/minus
five months. This translates into a time window from year-end 2019 to
summer 2020 in which the time point for the analysis will fall with a high
probability.
Further progress was also made in patient recruitment for the phase I
combination study with the checkpoint inhibitor Yervoy^(R), which MOLOGEN
is carrying out in cooperation with the MD Anderson Cancer Center Texas,
U.S.
In 2018, MOLOGEN is starting a further clinical trial in the indication
HIV together with Aarhus University Hospital and other prominent
international centers, which is being funded by the U.S. biopharmaceutical
company, Gilead Sciences Inc. In this trial, lefitolimod will be tested in
combination with innovative virus-neutralizing antibodies. Preparatory
work for the start of this follow-up study, which is entitled TITAN is
currently underway. Other new studies in the area of immuno-oncology are
also in the pipeline.
First licensing and development cooperation with lead compound lefitolimod
In February 2018, MOLOGEN reached a key strategic milestone by concluding
a cooperation contract with ONCOLOGIE, a drug development company from the
U.S., regarding the licensing, development, manufacture and
commercialization of lefitolimod. The agreement with cancer drug
specialist ONCOLOGIE comprises the development, manufacturing and
commercialization of lefitolimod in China and further Asian countries as
well as a global development cooperation. Pursuant to the contract,
MOLOGEN has already received a first payment of EUR3 million. In addition,
an equity investment of EUR2 million which becomes due within 12 months of
contract signature, plus development and sales-related milestone payments
as well as royalties were agreed.
Additional capital measures successfully completed
In the reporting period, MOLOGEN successfully carried out additional
capital measures. In February, a second capital increase was carried out
in line with the Share Subscription Facility with the U.S. investor Global
Corporate Finance (GCF) concluded in October 2017 and raised gross
proceeds of EUR445,000. In conjunction with the first exercise in 2017,
MOLOGEN has now received a total sum of around EUR1 million.
Also in February, MOLOGEN entered into an agreement with the Luxembourg
financing provider European High Growth Opportunities Securitization Fund
(EHGO), a fund advised by Alpha Blue Ocean Advisors (ABO). Pursuant to
this agreement, MOLOGEN can place convertible bonds in an aggregate amount
of up to EUR12 million in up to 24 tranches of EUR500,000 each with the
investor over a period of two years. So far, MOLOGEN has obtained two
tranches in March 2018 and generated gross proceeds of EUR1 million as a
result.
In March, MOLOGEN also successfully concluded a further capital increase
from authorized capital. In the course of the capital increase that was
fully placed with national and international investors, MOLOGEN received
gross proceeds amounting to approximately EUR5 million.
The capital measures carried out in 2017 and in the first quarter of 2018
as well as the first payment of EUR3 million from ONCOLOGIE have probably
secured the financing of MOLOGEN until the end of 2018. Furthermore, other
measures for financing of the Company's business activities will be taken.
Research and development expenses
Expenses relating to research and development in the first quarter of 2018
amounted to EUR2.9 million and were therefore down on the previous year's
value (EUR3.9 million). In the reporting period, expenses were primarily
attributable to costs incurred in connection with conducting pivotal phase
III IMPALA study, while the prior year included expenses for trials that
have in the meantime been completed. At EUR-0.7 million, the operating
result (EBIT) was notably higher than in the first quarter of 2017, when
it totaled EUR-5.1 million. As of 31 March 2018, the liquid funds of
MOLOGEN AG amounted to EUR8.3 million (12/31/2017: EUR6.5 million).
Through the capital measures that were successfully completed, MOLOGEN
AG's shareholder's equity was positive and amounted to EUR0.2 million as
of reporting date of 31 March 2018 (12/31/2017:
EUR-4.9 million).
On the personnel side, MOLOGEN AG announced shortly after the end of the
reporting period that for personal reasons, CEO Dr Mariola Soehngen will
not extend her contract after the expiry date 31 October 2018. The
Executive Board and Supervisory Board accepted this decision with great
regret.
Confirmation of forecast for fiscal year 2018
Based on the planned progress for 2018 in all areas of the Company,
primarily regarding the clinical development programs as well as in
commercialization, the Company is expecting a positive development for the
current year. In overall terms, the Executive Board of MOLOGEN AG confirms
the statements made in the Annual Report 2017 on the objectives in the
areas of research and development, collaboration and partnerships,
earnings and liquidity development as well as personnel for fiscal year
2018.
The complete MOLOGEN AG report for the first quarter of 2018 is available
on the website: www.mologen.com.
MOLOGEN AG
MOLOGEN AG is a biopharmaceutical Company and a pioneer in the field of
immunotherapy on account of its unique active agents and technologies.
Alongside a focus on immuno-oncology, MOLOGEN develops immunotherapies for
the treatment of infectious diseases.
The focus of the development work is on the product family of DNA-based
TLR9 agonists. This includes the lead compound lefitolimod and the
next-generation molecule family EnanDIM^(R).
The immunotherapeutic agent lefitolimod is the Company's lead compound and
is currently being investigated in a pivotal trial. It is regarded as the
best-in-class TLR9 agonist. Treatment with lefitolimod triggers a broad
and strong activation of the immune system. On account of this mode of
action, lefitolimod could potentially be used in various indications.
Lefitolimod is currently being developed within the framework of a pivotal
study for first line maintenance therapy for colorectal cancer. Key data
of the phase II IMPULSE study in small cell lung cancer have been
announced in April 2017, and the final analysis in the first quarter 2018
confirmed the data. Furthermore, data from the extension phase of the
TEACH study in HIV have also been published in 2017. In addition,
lefitolimod is currently being investigated in a phase I combination study
with the checkpoint inhibitor ipilimumab (Yervoy^(R)) in various cancer
indications. Along with various checkpoint inhibitors, lefitolimod, which
is being investigated as part of a phase III clinical trial currently, is
one of the few near-to-market product candidates in the field of
immuno-oncology.
MOLOGEN's pipeline focus is on new innovative immunotherapies to treat
diseases for which there is a great medical demand in particular.
MOLOGEN AG is a publicly listed Company, headquartered in Berlin. The
shares (ISIN DE0006637200, SIN 663720) are listed in the Prime Standard of
the German Stock Exchange.
1 www.mologen.com
Contact
Claudia Nickolaus
Head of Investor Relations & Corporate Communications
Tel: +49 - 30 - 84 17 88 - 38
Fax: +49 - 30 - 84 17 88 - 50
investor@mologen.com
Note about risk for future predictions
Certain information in this report contains forward-looking statements or
the corresponding statements with negation or versions deviating from this
or comparable terminology. These are described as forward-looking
statements. In addition, all of the information given here that refers to
planned or future results of business areas, key financial figures,
developments of the financial situation or other financial figures or
statistical data, is to be understood as such forward-looking statements.
The company points out to investors that they should not rely on these
forward-looking statements as predictions about actual future events. The
company is not obligated and refuses to accept any liability for the
forward-looking statements and has no obligation to update such statements
in order to accurately reflect the current situation.
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Language: English
Company: MOLOGEN AG
Fabeckstraße 30
14195 Berlin
Germany
Phone: 030 / 841788-0
Fax: 030 / 841788-50
E-mail: presse@mologen.com
Internet: www.mologen.com
ISIN: DE0006637200
WKN: 663720
Regulated Market in Frankfurt (Prime Standard); Regulated
Listed: Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich,
Stuttgart, Tradegate Exchange
End of News DGAP News Service
Avid Bioservices Announces Appointment of Magnus Schroeder, Ph.D., as Vice President of Process Sciences - GNW
08-May-2018 14:05
Addition of Senior Executive with Significant Process Science Experience Supports Company’s Efforts to Expand and Enhance Process Development Capabilities --
TUSTIN, Calif., May 08, 2018 (GLOBE NEWSWIRE) -- Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a dedicated contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, today announced the appointment of Magnus Schroeder, Ph.D., as vice president of process sciences. Dr. Schroeder is an accomplished scientist with more than 16 years of experience spanning bioprocess development, cGMP manufacturing, CMC strategy and global project leadership. In his new role, he will be responsible for overseeing Avid’s process sciences function, including the development of compliant, robust and scalable processes, implementation of state-of-the-art, high-throughput process development technologies, and efficient “on-boarding” of new client programs. As part of these efforts, Dr. Schroeder will directly manage the company’s technology collaborations, as well as its completion of development of its novel CHO-based mammalian expression system.
Dr. Schroeder most recently served as a director at AGC Biologics, formerly CMC Biologics, a global contract development and manufacturing organization, where he participated in the successful commercial launch of multiple products. In that role, he successfully supported more than 25 client projects as they progressed toward first-in-human clinical trials, commercial product launch and ongoing commercial supply. These efforts included creative resolution of complex challenges related to commercial processes that directly impacted a range of regulatory interactions and filings. In directing AGC’s purification development team, Dr. Schroeder oversaw early-to-late phase development, process characterization, process control strategy, commercial process support and technology transfer/facility fit activities. Prior to AGC Biologics, Dr. Schroeder held multiple senior level positions with CSL Limited, a global leader in the field of biotechnology. During his tenure, he served as senior manager and senior scientist, leading process development activities for a range of CSL’s innovative biologics. He has also held key process science positions with Dynavax Technologies, in which he was responsible for supporting process development, characterization and validation for multiple programs. Dr. Schroeder earned his Ph.D. in biochemical engineering and his master of science in molecular biotechnology from Bielefeld University in Bielefeld, Germany. He has previously served as a visiting scientist for protein purification at Rensselaer Polytechnic Institute and a visiting scientist for cell culture engineering at the University of Minnesota.
“As we continue to strategically increase our focus on process development to best align with industry needs, we have prioritized supplementing our in-house process science talent. With Magnus joining our team as vice president of process sciences, we have significantly strengthened the company’s expertise in this critical area, positioning us to continue to deliver our customers industry-leading service and results,” said Roger Lias, Ph.D., Avid’s president and chief executive officer. “Importantly, we believe that the innovative process development insights and approaches that Magnus is bringing to Avid will further support our new customer acquisition efforts by highlighting additional unique competitive advantages that we can offer companies with biopharmaceutical development and manufacturing needs.”
About Avid Bioservices, Inc.
Avid Bioservices is a dedicated contract development and manufacturing organization (CDMO) focused on development and cGMP manufacturing of biopharmaceutical products derived from mammalian cell culture. The company provides a comprehensive range of process development, high quality cGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. With 25 years of experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes, Avid's services include cGMP clinical and commercial product manufacturing, purification, bulk packaging, stability testing and regulatory strategy, submission and support. The company also provides a variety of process development activities, including cell line development and optimization, cell culture and feed optimization, analytical methods development and product characterization. www.avidbio.com
Contacts:
Stephanie Diaz (Investors)
Vida Strategic Partners
415-675-7401
sdiaz@vidasp.com
Tim Brons (Media)
Vida Strategic Partners
AVID BIOSERVICES ANNOUNCES APPOINTMENT OF MAGNUS SCHROEDER, PH.D., AS VICE PRESIDENT OF PROCESS SCIENCES - RTRS
08-May-2018 14:05
IP/Bavituximab no longer in our hands. It's Oncologie who has the golden goose now. We payed them for so many years - BS. Criminals? They have OUR money. So I think they are......
Oncologie is a private company...... Mologen is listed......
Avid is..... no longer what it was....
IMO
Lias Roger stock options 50K at $3,38