No need to stay in cdmo. They have what they want - IP and Babvi and BB.......for nothing.......

So tell me who stands behind Oncologie..... The same guys?

IMO

Something from Mologen and Oncologie

Press Release N 11 / 2018 dated 04/25/2018
MOLOGEN reached key strategic milestones and successfully implements
capital measures in 2017
• First licensing agreement for lead compound lefitolimod concluded
• Significant progress in studies
• Company funding secured until the end of 2018 through successful capital measures
Berlin, 25 April 2018 - The biopharmaceutical Company MOLOGEN AG reached
key strategic milestones in 2017: one major development was the
preparation of a first licensing and cooperation contract for the further
development and commercialization of the lead compound lefitolimod in
China, which was successfully concluded with the U.S. company ONCOLOGIE
Inc. beginning of 2018. The sustainable funding of the Company was once
again a focus in 2017: following the successful issuance of a convertible
bond in January 2017 as well as the Share Subscription Facility with the
U.S. investor Global Corporate Finance, further convertible bonds were
issued after the end of the reporting period to the Luxembourg-based
European High Growth Opportunities Securitization Fund (EHGO) and a
further successful capital increase was carried out. As a result, the
financing of MOLOGEN has been presumably secured until the end of 2018.
Alongside the financial and strategic successes, the Company also made
some significant progress in the area of research and development in 2017.
Key data was presented for two clinical studies: the phase II IMPULSE
study in the indication of small cell lung cancer and the phase Ib/IIa
TEACH extension study in HIV, which has been conducted in collaboration
with the Aarhus University Hospital in Denmark. In 2018, MOLOGEN is
planning to start a further clinical study in the indication HIV together
with the partners in Aarhus and further prominent international centers,
and which will be funded by the U.S. biopharmaceutical company Gilead
Sciences Inc.. In this study, lefitolimod will be tested in combination
with innovative virus-neutralizing antibodies.
"We have had an eventful and productive 2017, a year in which we have
continued to consistently implement the Next Level corporate strategy and
made sustained progress in our product development program. We were
particularly pleased that we were able to conclude a licensing contract
for our lead compound lefitolimod for the first time at the beginning of
2018. In ONCOLOGIE, we have found a right partner to further develop our
product candidate and prepare it for market entry. The focus will continue
to be on the ongoing development of our product pipeline and the
international commercialization of lefitolimod in 2018," comments Dr
Mariola Soehngen, Chief Executive Officer (CEO) of MOLOGEN AG.
The successful further product development is above all owing to the
efforts of the new Chief Medical Officer, Dr Matthias Baumann, who joined
the Executive Board of MOLOGEN in May 2017.
Signing of first licensing contract for lead compound lefitolimod
Fiscal year 2017 was characterized by activities relating to the potential
out-licensing of the lead compound lefitolimod. In February 2018, this
important milestone was reached on conclusion of the contract with
ONCOLOGIE Inc., which has operations established in Boston, Massachusetts
U.S., as well as in Shanghai, China. The company specializes in cancer
treatments and intends to develop innovative personalized drugs in the
area of immuno-oncology. The contract with ONCOLOGIE comprises the
development, manufacturing and commercialization of lefitolimod in the
markets of China and other regions in Asia as well as a global development
cooperation. On conclusion of the contract, MOLOGEN received a first
payment in the amount of EUR3 million. A capital contribution of EUR2
million becomes due to MOLOGEN within 12 months of the contract being
signed. Furthermore, the agreement sets out further milestone payments,
which are paid on reaching certain development targets, on attaining
market approval for lefitolimod and on achieving certain sales thresholds.
The total of these payments could amount to more than EUR100 million over
the course of several years. Additionally, MOLOGEN will be receiving low
double-digit royalties on sales.
First notable results in the TEACH and IMPULSE clinical studies
At the beginning of August, MOLOGEN presented key findings from the phase
Ib/IIa TEACH extension study in the indication HIV, which was carried out
in collaboration with the Aarhus University Hospital in Denmark. The study
provided positive findings with regard to the safety profile and the
effects o the reactivation of the immune system in HIV. This suggests that
lefitolimod could play an important role in combination therapies for the
treatment of HIV in the future. In January 2017, the Danish Aarhus
University had already received a grant of US$2.75million from the U.S.
biopharmaceutical company Gilead Sciences, Inc. to finance a clinical
study in patients with HIV on antiretroviral therapy, in which MOLOGEN's
TLR9 agonist lefitolimod will be investigated in combination with
innovative virus-neutralizing antibodies. Preparations are currently
underway for the study to start presumably in 2018.
The key data from the exploratory phase II IMPULSE clinical trial in
patients suffering from an extensive disease stage of small cell lung
cancer presented for the first time in April 2017 was confirmed in a final
evaluation in the first quarter of 2018: the study showed notable results
with regard to overall survival in two patient subgroups when compared
with the control group. These findings indicate that activated B cells may
serve as a valid biomarker in the potential further development of
lefitolimod in patients with extensive-disease small cell lung cancer. The
clinical phase III IMPALA pivotal study in the indication of metastatic
colorectal cancer progressed as planned. Patient recruitment was completed
in May 2017. The evaluation of the study results is expected to commence
in 2019.
In addition, lefitolimod is being tested in a phase I combination study
with the checkpoint inhibitor Yervoy^(R), which MOLOGEN is conducting in
cooperation with the MD Anderson Cancer Center Texas, U.S.. In 2017,
progress continued to be made with patient enrollment.
MOLOGEN has also successfully carried out preclinical combination studies
with lefitolimod and other immuno-oncological approaches, which are known
as checkpoint inhibitors, as well as with the next-generation molecules
from the EnanDIM^(R) family. In discussions with potential partners, it is
currently reviewing the option of conducting clinical combination trials.
In November 2017, an international consortium to which MOLOGEN belongs was
awarded a grant from Global Health Innovative Technology (GHIT) Fund,
Tokyo, for the further development of a leishmaniasis vaccine based on
MIDGE^(R) technology. Of this grant, MOLOGEN is to receive around EUR2.2
million. Pursuant to the Next Level strategy, MOLOGEN continued with the
planned spin-off or sale of the MIDGE^(R) technology.
Funding secured until the end of 2018: first-time involvement of U.S.
investor
Following the successful issuance of a convertible bond at the beginning
of 2017, which had an issuance volume of EUR4.99 million, a further
important step was taken in October 2017 with regard to the financing of
the Company: with Global Corporate Finance, a relevant investor for the
Company was found in the U.S. for the first time and a Share Subscription
Facility signed for the commitment to purchase up to 10% of the share
capital of MOLOGEN. MOLOGEN has the right to draw down shares in the
amount of up to EUR1 million each for a period of up to 30 months. By
drawing the first two tranches at the end of 2017 and beginning of
February 2018, MOLOGEN has already raised around EUR1 million from this
capital increase. After the end of the reporting period, MOLOGEN concluded
a contract with the Luxembourg-based financing provider European High
Growth Opportunities Securitization Fund. Pursuant to this agreement,
MOLOGEN can place convertible bonds in an aggregate amount of up to EUR12
million with the investor over a period of two years. To date, EUR1
million in convertible bonds have been issued. In March 2018, MOLOGEN
successfully concluded a further capital increase from authorized capital
and generated gross proceeds in the amount of EUR4.99 million.
"We have successfully diversified the funding of MOLOGEN and, by means of
capital measures in 2017 and early 2018 as well as the licensing
agreement, we have secured financing presumably until the end of 2018,
based on current planning," comments Walter Miller, Chief Financial
Officer (CFO) of MOLOGEN AG.
Reduced expenses for research and development
In fiscal year 2017, research and development expenses amounted to EUR14.0
million and were therefore down year on year (previous year: EUR17.0
million). This development was above all owing to the lower study costs
for the concluded IMPULSE study and the IMPALA study, which has recruited
all payments required. Owing to the lower research and development
expenses, EBIT improved to EUR-18.7 million (previous year: EUR-21.0
million).
Cash and cash equivalents amounted to EUR6.5 million as of 31 December
2017 (31 December 2016: EUR20.5 million). This decrease is due to the cash
utilized within the scope of operating activities. As a result of the
increased accumulated deficit, MOLOGEN AG's shareholder's equity amounted
to EUR-4.9 million as at the reporting date of 31 December 2017 (31
December 2016: EUR11.8 million).
Confident outlook for Full Year 2018
The successful development of the product pipeline so far, the further
steps in the implementation of the Next Level corporate strategy and the
commencement of commercialization activities provide the foundation for
the continued positive development of MOLOGEN.
The development of the financial performance and financial position of
MOLOGEN AG in fiscal year 2018 essentially depends on the continued
success of commercialization activities for the product candidate
lefitolimod as well as (pre-)clinical progress and the successful
execution of market preparation. The required additional expenditure in
the area of clinical development is expected to remain at a high level,
but down on the costs of the financial year under review. Alongside the
further funding of the Company, the commercialization, specifically the
conclusion of further license agreement for additional regions, will
therefore continue to be a central task for 2018.
The capital measures and the additionally concluded framework agreements
in 2017 and the first quarter of 2018 together with the first payment from
the licensing and development cooperation contract concluded with
ONCOLOGIE in February 2018 have presumably secured the financing of the
Company until the end of 2018.
The full 2017 Annual Report of MOLOGEN AG 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-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.
--------------------------------------------------------------------------
25.04.2018 Dissemination of a Corporate News, transmitted by DGAP - a
service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
The DGAP Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Archive at www.dgap.de

Avid Bioservices Provides Update on Ongoing Expansion of Process Development Capabilities and Laboratory Infrastructure - GlobeNewswire
24-Apr-2018 14:05:01


Enhancements Support New Customer Acquisition Efforts, Highlighted by Recent Signing of Three New Process Development and Manufacturing Agreements

TUSTIN, Calif., April 24, 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 provided an update on the company’s ongoing efforts to expand and optimize its process development capabilities and laboratory space within its CDMO campus in Orange County, California. Avid has successfully commenced these efforts which include expanding its total available process development laboratory space to more than 6,000 square feet, upgrading the infrastructure and equipment within its existing process development laboratories, and implementing new state-of-the-art technologies and equipment designed to facilitate efficient, high-throughput development of innovative upstream and downstream manufacturing processes. The company is strategically conducting this work in phases to avoid disruption to current customer programs, with the first new laboratories expected to be operational during the third quarter of calendar 2018.

Process development represents a vital CDMO function and one through which Avid provides a critical competitive advantage to customers in both early and late stages of development. Importantly, the planned improvements are designed to accelerate the company’s creation and delivery of cost-effective, robust, scalable and compliant processes and to drive efficient and rapid “on-boarding” of new customer programs progressing to manufacturing. Additionally, these enhancements will directly improve Avid’s cell line development capabilities, supporting the ongoing evaluation and optimization of the company’s novel CHO-based expression system, which is expected to provide further unique benefits to its customers.

Avid is committed to strengthening its position as one of the CDMO industry’s process development leaders to further support its new customer acquisition efforts. In recent weeks, the company has signed new agreements with three additional undisclosed international drug development companies, which are focused on Avid providing process development and manufacturing services to support the rapid advancement of each company’s novel biologic candidate into clinical development. The drug candidates involved in these agreements are being developed for application in certain cell therapy, respiratory and oncology indications. Avid has already commenced work on each of these projects. With these recent agreements, the company has now executed Master Service Agreements with four new clients in calendar 2018, as compared with four similar agreements during the entire 2017 calendar year.

“We are proud of our 25-year history of expertise in developing and manufacturing biologics and remain committed to continuing to serve as a leader in this space by developing, implementing and operating state-of-the-art manufacturing processes. By increasing focus on process development, we are aligning with market needs and requirements for clients ranging from emerging biotechs to multinational pharmaceutical companies and creating a strong pipeline of future additional manufacturing opportunities,” said Roger Lias, Ph.D., Avid’s president and chief executive officer. “These ongoing enhancements will provide essential additional support for our business development efforts which continue to operate under the dual strategy of capturing early-stage customers, which are immediately revenue generating, as well as larger, late-stage programs. Calendar year 2018 is off to an excellent start with regard to growing and diversifying our customer base. In just a few months, we have already matched the total new client wins for all of calendar 2017, and we are continuing to work to convert a strong pipeline of additional opportunities.”

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

Forward-Looking Statements
Statements in this press release which are not purely historical, including statements regarding Avid Bioservices' intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements involve risks and uncertainties including, but not limited to, the risk the company may experience delays in engaging new clients, the risk that the company may experience technical difficulties in processing customer orders which could delay delivery of products to customers, revenue recognition and receipt of payment or the loss of the customer, the risk that one or more existing customers terminates its contract prior to completion or reduces or delays its demand for development or manufacturing services, the risk that the company may experience delays in completing the expansion of its process development capabilities and laboratory infrastructure. Our business could be affected by a number of other factors, including the risk factors listed from time to time in our reports filed with the Securities and Exchange Commission including, but not limited to, our annual report on Form 10-K for the fiscal year ended April 30, 2017 and subsequent quarterly reports on Form 10-Q, as well as any updates to these risk factors filed from time to time in our other filings with the Securities and Exchange Commission. We caution investors not to place undue reliance on the forward-looking statements contained in this press release, and we disclaim any obligation, and do not undertake, to update or revise any forward-looking statements in this press release except as may be required by law.

Contacts:
Stephanie Diaz (Investors) Tim Brons (Media)
Vida Strategic Partners Vida Strategic Partners
415-675-7401 415-675-7402
sdiaz@vidasp.com tbrons@vidasp.com




GlobeNewswire, Inc. 2018

nGNXc7dRgm

AVID BIOSERVICES INC - FIRST NEW LABORATORIES ARE EXPECTED TO BE OPERATIONAL DURING Q3 OF CALENDAR 2018 - RTRS

AVID BIOSERVICES PROVIDES UPDATE ON ONGOING EXPANSION OF PROCESS DEVELOPMENT CAPABILITIES AND LABORATORY INFRASTRUCTURE
AVID BIOSERVICES PROVIDES UPDATE ON ONGOING EXPANSION OF PROCESS DEVELOPMENT CAPABILITIES AND LABORATORY INFRASTRUCTURE - RTRS

MOLOGEN AG: Collaboration with licensing partner ONCOLOGIE gains momentum - EQS

20-Apr-2018 12:51
============

DGAP-News: MOLOGEN AG / Key word(s): Alliance
MOLOGEN AG: Collaboration with licensing partner ONCOLOGIE gains momentum

20.04.2018 / 12:51
The issuer is solely responsible for the content of this announcement.

--------------------------------------------------------------------------

PRESS RELEASE N 9 / 2018 of 20/04/2018

MOLOGEN AG: Collaboration with licensing partner ONCOLOGIE gains momentum

Berlin, 20 April 2018 - The biopharmaceutical company MOLOGEN AG announced
today that the collaboration with ONCOLOGIE, agreed on in February 2018,
is making good progress. The collaboration includes a license agreement
for the development, manufacturing and commercialization for MOLOGEN's
lead compound lefitolimod in East Asian markets and a global
co-development leveraging novel biomarker know-how from ONCOLOGIE. In this
context lefitolimod is initially planned to be developed in oncological
indications with high unmet medical need.

"We are excited about the forthcoming collaboration with ONCOLOGIE: Under
the partnership we will implement ONCOLOGIE's innovative biomarker-driven
development strategy for our TLR9 agonist lefitolimod to unleash its full
potential in different oncological indications and support our development
efforts in China and also globally", said Dr Mariola Soehngen, Chief
Executive Officer of MOLOGEN.

"ONCOLOGIE's novel biomarker-driven approach allows us to conduct targeted
basket or umbrella trials with lefitolimod. Therefore we will be able to
unleash lefitolimod's potential as single agent and especially in
combination with other immunotherapeutics and develop tailor-made
therapies against different kinds of tumors", said Dr Matthias Baumann,
Chief Medical Officer of MOLOGEN.

"With our operations now firmly established in the U.S. and China,
ONCOLOGIE is excited to collaborate globally with MOLOGEN and leverage the
unmet needs as well as the new opportunities available for clinical
development in China. We believe that we have synergy with MOLOGEN that
will help lefitolimod reach its full potential as a best-in-class cancer
therapeutic," said Dr Laura Benjamin, Chief Executive Officer of
ONCOLOGIE.

Within the framework of the contract MOLOGEN has received an initial
payment of EUR 3 million and a EUR 2 million equity investment by
ONCOLOGIE is to follow within the next 12 months after the signing of the
contract. Besides the initial payment and the equity investment, the
parties agreed on further development and commercialisation milestones.
They are due upon reaching predefined development steps as well as market
approval. In addition, commercial milestones are defined which are due
upon reaching certain sales thresholds. The total payments can amount to
above EUR 100 million and will be paid over several years. Additionally,
MOLOGEN will receive low double digit royalties on sales. MOLOGEN and
ONCOLOGIE will share the economic returns from global joint development
pursuant to both parties' contributions.

All costs relating to development, registration, marketing and
commercialization of lefitolimod in the territory are to be covered by
ONCOLOGIE.

ONCOLOGIE Ltd.
ONCOLOGIE is an oncology therapeutics company committed to delivering
improved outcomes for cancer patients by leveraging innovative compounds
and biomarker-driven clinical development. The current pipeline is focused
on mid-stage clinical programs that modify the tumor microenvironment.
ONCOLOGIE has operations established in Boston, Massachusetts, US, and
Shanghai, China. ONCOLOGIE is working with global partners to acquire and
develop innovative drugs for cancer patients around the world.
1 www.oncologie.international.

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 product candidate lefitolimod and
the next-generation molecule family EnanDIM^(R).

The immunotherapeutic agent lefitolimod is the company's lead product
candidate 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.

2 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.



--------------------------------------------------------------------------

20.04.2018 Dissemination of a Corporate News, transmitted by DGAP - a
service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

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: 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
677065 20.04.2018
3 fncls.ssp?

Phosphatidylserine is not just a cleanup crew but also a well-meaning teacher

http://jpharmsci.org/article/S0022-3549(18)30200-4/pdf

Reclassify cancers to improve treatment, researchers say
By Alex Therrien
Health reporter, BBC News


http://www.bbc.com/news/health-43659760

Phosphatidylserine-exposing cells contribute to the hypercoagulable state in patients with multiple myeloma.
Guo L1, Tong D1, Yu M1, Zhang Y1, Li T1, Wang C1, Zhou P2, Jin J2, Li B3, Liu Y3, Liu R4, Novakovic VA5, Dong Z6, Tian Y6, Kou J4, Bi Y6, Zhou J1, Shi J1.
Author information
Abstract
Multiple myeloma (MM) is characterized by an increased incidence of thromboembolic events, particularly when treated with immunomodulatory drugs (IMiDs) in combination with dexamethasone. The optimal prophylactic strategy to prevent the hypercoagulable state of patients with MM is still debated. The aim of the current study was to investigate the definitive role of phosphatidylserine (PS) in supporting procoagulant activity (PCA) in patients with MM. Patients with MM (n=20) and healthy subjects (n=15) were recruited for the present study. PS analyses were performed by flow cytometry and confocal microscopy. The PCA was evaluated by clotting time, purified coagulation complex assays and fibrin production assays. The percentage of PS+ blood cells was significantly higher in patients with MM than in healthy subjects. Additionally, the patient serum induced more PS exposure on endothelial cells (ECs) in vitro than serum from healthy subjects. Isolated blood cells from patients with MM and ECs cultured with patient serum in vitro demonstrated significantly shortened coagulation time, greatly intrinsic/extrinsic factor Xa generation and increased thrombin formation. In addition, the levels of PS+ erythrocytes, platelets, leukocytes, and ECs incubated with IMiDs and dexamethasone were higher than with IMiDs alone. The findings support the hypothesis that increased PS exposure on blood cells and ECs participates in the hypercoagulable state in patients with MM. Thus, blocking PS may be a novel therapeutic target for the prevention of thrombosis in these patients.

https://www.ncbi.nlm.nih.gov/pubmed/29620266

Boston and China hmmmmm..... Oncologie???

From 01 2018 - Old???

A combination of p53-activating APR-246 and phosphatidylserine-targeting antibody potently inhibits tumor development in hormone-dependent mutant p53-expressing breast cancer xenografts

https://www.dovepress.com/a-combination-of-p53-activating-apr-246-and-phosphatidylserine-targeti-peer-reviewed-article-BCTT

and:

Combination Breast Cancer Therapy Targets Both Tumor Cells and the Blood Vessels That Supply Them

https://www.dddmag.com/news/2018/03/combination-breast-cancer-therapy-targets-both-tumor-cells-and-blood-vessels-supply-them

Wolchok is back.....

Cancer immunotherapy using checkpoint blockade
Antoni Ribas1,*, Jedd D. Wolchok2,3,*
See all authors and affiliations

Science 23 Mar 2018:
Vol. 359, Issue 6382, pp. 1350-1355
DOI: 10.1126/science.aar4060

http://science.sciencemag.org/content/359/6382/1350.long

Avid Bioservices Receives Six 2018 CMO Leadership Awards - GNW


TUSTIN, Calif., March 22, 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 that the company has been named a recipient of six 2018 Contract Manufacturing Organization (CMO) Leadership Awards. Presented by the industry publication Life Science Leader and based on market research and surveys conducted by Industry Standard Research (ISR), these awards are intended to honor those companies in the contract manufacturing space that provide their customers with the industry’s highest level of service. Now in its 7th year, Life Science Leader’s CMO Leadership Awards aim to provide industry insiders with accurate and reliable customer feedback to assist them in choosing a reputable partner for their development and manufacturing needs.

Avid received awards in the following categories:
Quality
Reliability
Capabilities
Expertise
Compatibility
Service
“We believe that one of the greatest competitive differentiators helping to drive the growth of Avid’s CDMO business is the company’s long-standing reputation for excellence within the industry. With the CMO Leadership Award winners selected, in part, based on surveys of customers of CDMO services, our receipt of six awards highlights the meaningful impact our focus on quality, reliability, capabilities, expertise, compatibility and service is having on industry sentiment,” said Roger Lias, Ph.D., president and chief executive officer of Avid Bioservices. “We’d like to take this opportunity to thank all of our employees who strive for excellence every day, as well as those individuals who championed Avid as being worthy of each of the CMO awards we received.”

For more information about Life Science Leader’s CMO Leadership Awards, please visit: http://cmoleadershipawards.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 nearly 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

Avid Bioservices to Participate at Upcoming CDMO Industry Conferences - GlobeNewswire
13-Mar-2018 13:05:03


TUSTIN, Calif., March 13, 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 that the company will participate at two upcoming CDMO industry conferences. These include KNect365 Life Sciences’ BioProcess International West 2018, being held March 19-22, 2018 in San Francisco, CA, and DCAT Week 2018, being held March 19-22, 2018 in New York, NY.

Details of these activities are as follows:

KNect365 Life Sciences' BioProcess International West:

Avid will host corporate booth #415 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 40,000 square foot state-of-the-art commercial biomanufacturing suite (Myford facility). The Myford facility is designed with cutting-edge, single-use equipment to accommodate 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 API manufacturing.

DCAT Week:

Avid representatives will also be onsite at DCAT Week, an event hosted by the Drug, Chemical & Associated Technologies Association (DCAT). In addition to participating in related networking events, the company is hosting a table at the DCAT Annual Dinner on Thursday, March 22.

For additional details on these events, please visit: https://lifesciences.knect365.com/bpi-west/ and https://dcatweek.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 nearly 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

What a great BS.

IMO

Avid Bioservices to Present at the 30th Annual ROTH Conference - GlobeNewswire





TUSTIN, Calif., March 06, 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 that its president and chief executive officer, Roger J. Lias, Ph.D., will deliver a corporate presentation at the 30(th) Annual ROTH Conference.  The conference is being held March 11-14, 2018 at the Ritz-Carlton Laguna Niguel in Dana Point, CA.


Details of this presentation are as follows:

30(th) Annual ROTH Conference 
Time/Date: 2:00 p.m. PT on Tuesday, March 13, 2018 Location: Ritz-Carlton Laguna Niguel, Dana Point, CA Room: Yellow Salon 6 
Avid’s presentation at the ROTH conference will be webcast live and available for replay at: http://ir.avidbio.com/events.cfm.

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 nearly 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

415-675-7402 tbrons@vidasp.com





GlobeNewswire, Inc. 2018

Avid Bioservices to Report Financial Results for Third Quarter of Fiscal Year 2018 After Market Close on March 12, 2018 - GNW

05-Mar-2018 14:05

TUSTIN, Calif., March 05, 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 that it will report financial results for the third quarter of fiscal year 2018 ended January 31, 2018 on March 12, 2018 after market close and will host a conference call and webcast at 1:30 PM Pacific Time (4:30 PM Eastern Time). Avid's senior management will discuss financial results for the third quarter and review recent corporate developments.

To listen to the live webcast, or access the archived webcast, please visit: http://ir.avidbio.com/events.cfm.

To listen to the conference call, please dial (877) 312-5443 or (253) 237-1126 and request the Avid Bioservices call.

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 nearly 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
415-675-7402
tbrons@vidasp.com




GlobeNewswire, Inc. 2018

Phosphatidylserine-Liposomes Promote Tolerogenic Features on Dendritic Cells in Human Type 1 Diabetes by Apoptotic Mimicry.

https://www.ncbi.nlm.nih.gov/pubmed/29491866

Avid Bioservices Selected by Acumen Pharmaceuticals to Lead Process Development and Clinical Manufacture of Novel Alzheimer’s Disease Candidate - GNW

01-Mar-2018 14:05



TUSTIN, Calif., March 01, 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 that Acumen Pharmaceuticals, Inc. has selected Avid to provide process development and clinical manufacturing services in support of ACU193, which is being developed for the treatment of Alzheimer’s disease. ACU193 is a fully humanized IgG2 monoclonal antibody that selectively binds soluble Aß oligomers, potentially blocking their toxic effects. Avid and Acumen will immediately commence process development work with the goal of creating a robust, cost-effective and scalable process to support cGMP manufacture of ACU193.

Process development and clinical manufacture of ACU193 will take place in facilities on Avid Bioservices’ CDMO campus in Orange County, CA. These include the company’s Myford facility, which is designed with cutting-edge, single-use equipment to accommodate a fully disposable biomanufacturing process. A wide range of innovative features are incorporated into this new 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 API manufacturing.

“This agreement with Acumen is the latest of what we expect will be several near-term client wins arising from our dedicated efforts to expand and diversify our customer base. The opportunity to work with Acumen and support the important work they are undertaking in the field of Alzheimer’s disease is gratifying for the entire Avid team,” said Roger Lias, Ph.D., president and chief executive officer of Avid Bioservices. “We look forward to delivering exceptional results to Acumen based on our proven ability to work efficiently and creatively to support the rapid advancement of novel therapeutics through process development and into cGMP clinical manufacturing.”

Dan O’Connell, president and chief executive officer of Acumen, commented, “In choosing to partner with Avid, we were particularly impressed by the group’s nearly 25 years of experience in successfully producing monoclonal antibodies like ACU193. We believe that their extensive experience, coupled with the Avid team’s creativity and problem-solving expertise, positions them as an ideal partner to support the ongoing advancement of this important program. Alzheimer’s disease represents one of the healthcare industry’s most underserved therapeutic areas and this work with Avid will be critical to our continued development of ACU193 as a potential treatment option for these patients.”

In winning this process development and clinical manufacturing project, Avid was selected by Acumen from a competitive field of internationally recognized contract development and manufacturing organizations.

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 nearly 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

Forward-Looking Statements
Statements in this press release which are not purely historical, including statements regarding Avid Bioservices' intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements involve risks and uncertainties including, but not limited to, the risk the company may experience delays in engaging new clients. Our business could be affected by a number of other factors, including the risk factors listed from time to time in our reports filed with the Securities and Exchange Commission including, but not limited to, our annual report on Form 10-K for the fiscal year ended April 30, 2017 and subsequent quarterly reports on Form 10-Q, as well as any updates to these risk factors filed from time to time in our other filings with the Securities and Exchange Commission. We caution investors not to place undue reliance on the forward-looking statements contained in this press release, and we disclaim any obligation, and do not undertake, to update or revise any forward-looking statements in this press release except as may be required by law.

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

Because the bavi/PS story is gone.

We are more or less out of the Bavi-PS-game.

That's it. IMO

Introducing a New Series: Immunotherapy Facts and Hopes

Ignacio Melero, Mario Sznol, Marlowe S. Tessmer, Theresa L. Whiteside and Jedd D. Wolchok


http://clincancerres.aacrjournals.org/content/early/2018/02/23/1078-0432.CCR-18-0408.long

IMO

They all work together at Oncologie - Old and New, the whole Family......

Bavituximab, BB,.... the whole IP is there .....gone from us....

IMO

Avid Bioservices Announces Resignation of Chief Financial Officer - GNW

26-Feb-2018 14:05


TUSTIN, Calif., Feb. 26, 2018 (GLOBE NEWSWIRE) -- Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a company working to improve patient lives by providing high quality biologics manufacturing services to biotechnology and pharmaceutical companies, today announced that on February 23, 2018, Paul J. Lytle notified the company of his intent to resign his position as chief financial officer, effective May 24, 2018, to spend more time with his family prior to returning to work in the drug development sector. A search for Mr. Lytle’s replacement has been initiated, and Mr. Lytle will support the transition.

“Paul has been a principal member of management for over 20 years, and his leadership was critical in the founding of the company’s contract development and manufacturing business in 2002,” said Roger Lias, Ph.D., president and chief executive officer of Avid Bioservices. “We are grateful for Paul’s many contributions to Avid and we wish him well in his future endeavors.”

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 nearly 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
415-675-7402
tbrons@vidasp.com




GlobeNewswire, Inc. 2018

New job at Oncologie Inc.?

NOT NEW:

Avid Bioservices Raises USD23.2 Million in Public Offering of Shares - MarketLine
21-Feb-2018 23:58:49
Avid Bioservices, Inc., a contract development and manufacturing organization (CDMO), has completed the underwritten public offering of 10,294,445 shares including underwriters' exercise of option to purchase additional 1,294,445 shares at a price of USD2.25 per share, for gross proceeds of USD23.16 million. The company intends to use the proceeds for the expansion of its contract manufacturing business and general corporate purposes. Wells Fargo Securities acted as sole book-running manager, H.C. Wainwright & Co. and Roth Capital Partners acted as co-managers; while K&L Gates LLP acted as legal advisor to the company for the offering. Deal History: Pricing: On February 15, 2018, Avid Bioservices priced the underwritten public offering of 9,000,000 shares of its common stock at a price of USD2.25 per share, for gross proceeds of USD20.25 million. In addition, the company granted the underwriters a 30 day option to purchase up to 1,350,000 additional shares at the offer price to cover over-allotments, if any. Announced: On February 14, 2018, Avid Bioservices announced the public offering of shares of its common stock. In addition, the company intended to grant underwriters a 30 day option to purchase up to an additional shares representing 15% of the shares of common stock offered in the public offering to cover over-allotments, if any. Filing: On January 25, 2018, Avid Bioservices filed a registration statement with the US Securities and Exchange Commission (SEC) for public offering of securities, to raise aggregate gross proceeds of up to USD125 million. Pursuant to the offering, the company from time to time may issue common stock, preferred stock, debt securities, warrants, rights and units in one or more offerings.
The company intends to use the proceeds for the expansion of its contract manufacturing business and general corporate purposes.
Deal In Brief
Deal Value (US$ Million) 23.16
Deal Type IPO
Sub-Category Secondary Offering,Completed
Deal Status Completed: 2018-02-20
Deal Participants
Target (Company) Avid Bioservices Inc
Deal Rationale
Offer Price ($ per share) 2.25
No. Shares Issued 9000000

Copyright (c) 2001-2016 Marketline.

PS, It's Complicated: The Roles of Phosphatidylserine and Phosphatidylethanolamine in the Pathogenesis of Candida albicans and Other Microbial Pathogens.
Cassilly CD1, Reynolds TB2.
Author information
1
Department of Microbiology, University of Tennessee, Knoxville, TN 37996, USA. ccassill@vols.utk.edu.
2
Department of Microbiology, University of Tennessee, Knoxville, TN 37996, USA. treynol6@utk.edu.
Abstract
The phospholipids phosphatidylserine (PS) and phosphatidylethanolamine (PE) play important roles in the virulence of Candida albicans and loss of PS synthesis or synthesis of PE from PS (PS decarboxylase) severely compromises virulence in C. albicans in a mouse model of systemic candidiasis. This review discusses synthesis of PE and PS in C. albicans and mechanisms by which these lipids impact virulence in this fungus. This is further compared to how PS and PE synthesis impact virulence in other fungi, parasites and bacteria. Furthermore, the impact of PS asymmetry on virulence and extracellular vesicle formation in several microbes is reviewed. Finally, the potential for PS and PE synthases as drug targets in these various kingdoms is also examined.


https://www.ncbi.nlm.nih.gov/pubmed/29461490

Hmmmm....same procedure as every year.....

PM $3,09 vol 40 LOL

Avid Bioservices Selected as Commercial Manufacturer for Critical Enzyme Replacement Therapy by Enzyvant, a Subsidiary of Roivant Sciences - GNW

21-Feb-2018 14:05


TUSTIN, Calif., Feb. 21, 2018 (GLOBE NEWSWIRE) -- Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a company working to improve patient lives by providing high quality biologics manufacturing services to biotechnology and pharmaceutical companies, today announced that Enzyvant, a subsidiary of Roivant Sciences, has selected Avid as the commercial drug substance manufacturer for RVT-801, its recombinant human acid ceramidase enzyme replacement therapy being developed as a potential treatment for Farber disease. Successful technology transfer and clinical manufacturing have been underway since mid-2017 and Avid will complete process characterization and optimization followed by process validation in support of Enzyvant’s ongoing development and regulatory activities for RVT-801, which include the initiation of a first-in-human clinical study.

RVT-801 will be manufactured in Avid Bioservices’ Myford facility, which is designed with cutting-edge, single-use equipment to accommodate a fully disposable biomanufacturing process. A wide range of innovative features are incorporated into this new 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 API manufacturing.

“We are delighted to add Enzyvant to the growing list of companies that recognize Avid Bioservices’ ability to move critically important therapeutic products very rapidly into commercial manufacture,” said Roger Lias, Ph.D., president and chief executive officer of Avid Bioservices. “We take great pride in our more than 12-year track record of successfully manufacturing and releasing commercial biologic products for the US, EU and numerous other important international markets.”

Alex Tracy, Ph.D., vice president of pharmaceutical development and manufacturing for Roivant Sciences, added, “We presented Avid with very ambitious timelines for RVT-801 manufacturing work and we were extremely impressed with the ability of their team to work creatively with us to design and deliver a program that meets our needs and contributes significant value. We look forward to advancing the development of RVT-801 as a potential therapeutic for Farber’s disease.”

In winning this manufacturing project, Avid Bioservices was selected by Enzyvant from a large field of internationally recognized contract development and manufacturing organizations.

About Farber Disease
Farber disease is a rare lysosomal storage disease caused by mutations in the ASAH1 gene, resulting in deficiency of the lysosomal enzyme acid ceramidase. This deficiency leads to the accumulation of the pro-inflammatory sphingolipid ceramide, and a macrophage-driven inflammatory process causing the development of typical clinical symptoms.

Farber patients typically present with the cardinal symptoms of:
Joint contractures or arthritis
Subcutaneous nodules
Weak or hoarse voice
Patients may also present with systemic inflammation (including fever), severe pain, peripheral osteolysis, failure to thrive, and developmental delay. Like other lysosomal storage diseases, Farber disease has a broad phenotypic spectrum and is likely underdiagnosed.

About RVT-801
RVT-801 is a recombinant form of human acid ceramidase (rhAC) that Enzyvant is developing for potential use as an enzyme replacement therapy in acid ceramidase deficiency, manifesting as Farber disease. Enzyvant is currently conducting preclinical studies to enable a clinical trial of rhAC in patients with Farber disease. Orphan drug designation for RVT-801 has been granted by regulatory agencies in the United States and the European Union.

About Enzyvant
Enzyvant is a biopharmaceutical company focused on developing innovative treatments for patients with rare diseases. Enzyvant is conducting a natural history study of patients with Farber disease to better define the natural course of disease and the relationship between specific symptoms, biomarkers, and prognosis. Enzyvant is simultaneously preparing a clinical trial of RVT-801, an investigational enzyme replacement therapy for the treatment of Farber disease.

Enzyvant is also advancing the development of RVT-802, an investigational tissue-based biologic therapy for the potential treatment of primary immune deficiency associated with complete DiGeorge Syndrome. RVT-802 has been granted orphan drug designation, Breakthrough Therapy designation, Regenerative Medicine Advanced Therapy designation, and pediatric rare disease designation by the U.S. Food and Drug Administration. Enzyvant anticipates a potential BLA filing for RVT-802 later this year. Enzyvant plans to develop treatments for additional rare diseases with high unmet need. For more information, please visit www.enzyvant.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 nearly 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

Forward-Looking Statements
Statements in this press release which are not purely historical, including statements regarding Avid Bioservices' intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding the expected closing of the offering and the intended use of the net proceeds from the offering, and involve risks and uncertainties. Our business could be affected by a number of other factors, including the risk factors listed from time to time in our reports filed with the Securities and Exchange Commission including, but not limited to, our annual report on Form 10-K for the fiscal year ended April 30, 2017 and subsequent quarterly reports on Form 10-Q, as well as any updates to these risk factors filed from time to time in our other filings with the Securities and Exchange Commission. We caution investors not to place undue reliance on the forward-looking statements contained in this press release, and we disclaim any obligation, and do not undertake, to update or revise any forward-looking statements in this press release except as may be required by law.



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

PS. It was me all along! Emergence of phosphatidylserine in the procoagulant state in atrial fibrillation

http://www.internationaljournalofcardiology.com/article/S0167-5273(18)30663-6/fulltext

Oncologie snaps up Avid's cancer assets

https://www.biopharmadive.com/news/oncologie-snaps-up-avids-cancer-assets/516947/

Is there something wrong with my data?

Investor Rank Investor Name Latest Filing Date % O/S Position Position Change
1 Tappan Street Partners LLC 06-11-2017 8,47% 3,83M +0,96M
2 Eastern Capital, Ltd. 27-11-2017 8,35% 3,78M 0
3 Ronin Trading, L.L.C. 06-02-2018 6,28% 2,84M -1,33M

Back to the level where Ronin bought 2017 - Hmmmmm....

Who is buying now - Ronin????

IMO

Avid Bioservices: Plunges on steeply discounted stock deal - Reuters News
15-Feb-2018 12:58:12
** Avid Bioservices CDMO leading Thursday's premarket losers, with a 26 pct drop to $2.35
** Co's $20.3 mln follow-on offering with 9 mln shares prices at $2.25 each, a steep 31 pct discount to Wednesday's close (Full Story)
** Pricing at low end of marketed range of $2.25-$2.50, per market sources (Full Story)
** Offering size equates to about 20 pct of Avid's 45.2 mln shares outstanding, per Thomson Reuters data
** Avid plans to use net proceeds for expansion of its contract manufacturing business and general corp purposes
** Wells Fargo is sole book-runner; H.C. Wainwright and Roth Capital are co-managers
** CDMO fell ~20 pct last night on news of offering; shares have fallen ~16 pct this year through Wednesday's close

Avid Bioservices Announces Pricing of Public Offering of Common Stock - GNW

15-Feb-2018 11:00
TUSTIN, Calif., Feb. 15, 2018 (GLOBE NEWSWIRE) -- Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP) today announced the pricing of an underwritten public offering of 9,000,000 shares of its common stock at a price to the public of $2.25 per share. The gross proceeds from this offering are expected to be $20,250,000, before deducting underwriting discounts and commissions and estimated offering expenses payable by Avid Bioservices. The offering is expected to close on or about February 20, 2018, subject to customary closing conditions. Avid Bioservices has also granted the underwriters a 30-day option to purchase up to 1,350,000 additional shares of its common stock at the public offering price, less the underwriting discounts and commissions. Avid Bioservices intends to use the net proceeds from the offering for the expansion of its contract manufacturing business and general corporate purposes.

Wells Fargo Securities is acting as sole book-running manager. H.C. Wainwright & Co. and Roth Capital Partners are acting as co-managers.

The shares described above are being offered by us pursuant to a shelf registration statement on Form S-3 previously filed with and subsequently declared effective by the Securities and Exchange Commission (“SEC”). A preliminary prospectus supplement relating to the offering has also been filed with the SEC and is available on the SEC’s website at http://www.sec.gov. Copies of the preliminary prospectus supplement and accompanying base prospectus relating to this offering may be obtained from Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, New York, New York 10152, or by email at cmclientsupport@wellsfargo.com, or by telephone at (800) 326-5897.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any offer, sale or solicitation of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful.

About Avid Bioservices, Inc.
Avid Bioservices is a contract development and manufacturing organization (CDMO) focused on development and manufacturing of biopharmaceutical products derived from mammalian cell culture. The company provides process development, clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries.

Forward-Looking Statements
Statements in this press release which are not purely historical, including statements regarding Avid Bioservices' intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding the expected closing of the offering and the intended use of the net proceeds from the offering, and involve risks and uncertainties. Our business could be affected by a number of other factors, including the risk factors listed from time to time in our reports filed with the Securities and Exchange Commission including, but not limited to, our annual report on Form 10-K for the fiscal year ended April 30, 2017 and subsequent quarterly reports on Form 10-Q, as well as any updates to these risk factors filed from time to time in our other filings with the Securities and Exchange Commission. We caution investors not to place undue reliance on the forward-looking statements contained in this press release, and we disclaim any obligation, and do not undertake, to update or revise any forward-looking statements in this press release except as may be required by law.

Contacts:

Stephanie Diaz (Investors)
Vida Strategic Partners
415-675-7401
sdiaz@vidasp.com

Tim Brons (Media)
Vida Strategic Partners
415-675-7402
tbrons@vidasp.com

China - Shanghai......CAR-T.....

In Race For Cancer Therapy, a Chinese Biotech Surges 500%

https://www.swissinfo.ch/eng/in-race-for-cancer-therapy--a-chinese-biotech-surges-500-/43898386

https://www.ocbj.com/news/2018/feb/13/avid-sells-oncology-drug/

Oncologie Acquires Phosphatidylserine-Targeting Program from Avid Bioservices - MarketLine
14-Feb-2018 00:29:09
Oncologie, Inc, an oncology therapeutics company, has acquired phosphatidylserine (PS)-targeting program including bavituximab, from Avid Bioservices, Inc. (formerly Peregrine Pharmaceuticals, Inc.), a biotechnology company. Pursuant to the transaction, in addition to bavituximab, the deal includes Avid Bioservices' other PS-targeting antibodies, including betabodies, as well as certain other assets and licenses useful and/or necessary for the potential commercialization of bavituximab. In connection with the transaction, Avid Bioservices will receive an aggregate of USD8 million in upfront payments from Oncologie over a period of six months from the execution of the agreement and will be eligible to receive up to USD95 million in development, regulatory and commercialization milestones. Oncologie will be responsible for all future research, development and commercialization of bavituximab, and related intellectual property costs, with Avid Bioservices receiving royalties on net sales that are upward tiering into the mid-teens. Bavituximab is an investigational immune-modulatory monoclonal antibody that targets PS, a phospholipid that inhibits the ability of immune cells to recognize and fight tumors. This transaction enables Oncologie to to evaluate the immune modulating potential of bavituximab. ROTH Capital Partners LLC acted as financial advisor to the Avid Bioservices for the transaction.
This transaction enables Oncologie to to evaluate the immune modulating potential of bavituximab.

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MOLOGEN SIGNS LICENSE DEAL FOR CHINA AND GLOBAL CO-DEVELOPMENT AGREEMENT WITH ONCOLOGIE FOR LEAD COMPOUND LEFITOLIMODBSW

13/02/2018 6:09 PM

MOLOGEN Signs License Deal for China and Global Co-Development Agreement with ONCOLOGIE for Lead Compound lefitolimod



MOLOGEN to receive a EUR 3 million initial payment as well as a EUR 2 million equity investment

Milestone payments of above EUR 100 million and double digit royalties on net sales

Strong support for global development program of lefitolimod, especially in China and other Asian regions




The biopharmaceutical company MOLOGEN AG (ISIN DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) announced today the signing of a license deal for the Chinese territory and a global co-development agreement between MOLOGEN and ONCOLOGIE Inc. for its lead compound lefitolimod. The signed agreement is conditional upon an initial payment of EUR 3 million received by MOLOGEN. ONCOLOGIE is an oncology-focused drug development company with headquarters in Boston and operations in Shanghai. The company is backed by top-tier international investors and has the objective to develop novel personalized medicines in the field of immuno-oncology. The signed agreement with ONCOLOGIE includes the development, manufacture and commercialization of lefitolimod in China and a planned global co-development program.


“We are delighted to partner our lead compound lefitolimod with ONCOLOGIE. Their approach of an innovative biomarker-driven development strategy for novel cancer immunotherapies has convinced us that partnering with them will expand the opportunities for success of lefitolimod. With the combined licencing and co-development deal for our flagship compound lefitolimod we have achieved one of the main milestones in implementing our strategy. In ONCOLOGIE we have found a partner with a highly dedicated and experienced international team who will not only drive lefitolimod development in China to achieve market approval but will also strongly support our global development efforts. Together we will strive to unleash lefitolimod’s full market potential in China and on a global level”, said Dr Mariola Soehngen, Chief Executive Officer of MOLOGEN.


“We are happy to partner with MOLOGEN on lefitolimod, a best-in-class TLR9 agonist with exciting potential. This program complements ONCOLOGIE’s strategy for biomarker-driven global development and has multiple opportunities for treating indications prevalent in the Asian market”, said Dr Laura Benjamin, Chief Executive Officer of ONCOLOGIE.


As previously announced, MOLOGEN had started negotiations on such a deal with the Chinese iPharma. After a certain exclusivity period had expired, MOLOGEN opened the licencing process also for additional parties. Discussions and negotiations with ONCOLOGIE have now been successfully completed and the deal could be signed. The terms of the signed agreement with ONCOLOGIE describe development, manufacture and commercialization of lefitolimod in China and a planned global co-development program.


The contract comprises two parts: First, a license agreement including sublicense rights under which MOLOGEN grants ONCOLOGIE an exclusive license for the development, manufacturing and commercialization for MOLOGEN’s lead compound lefitolimod in the following territory: China, Hong Kong and Macao, Taiwan and Singapore. Second, a commitment for global co-development leveraging novel biomarker plans from ONCOLOGIE. MOLOGEN is to receive an initial payment of EUR 3 million as well as a EUR 2 million equity investment by ONCOLOGIE within the next 12 months. Besides the initial payment and the equity investment, the parties agreed on further development and commercialisation milestones. They are due upon reaching predefined development steps as well as market approval. In addition, commercial milestones are defined which are due upon reaching certain sales thresholds. The total payments can amount to above EUR 100 million and will be paid over several years. Additionally, MOLOGEN will receive low double digit royalties on sales. MOLOGEN and ONCOLOGIE will share the economic returns from global joint development pursuant to both parties’ contributions.


All costs relating to development, registration, marketing and commercialization of lefitolimod in the territory are to be covered by ONCOLOGIE.


ONCOLOGIE Inc.


ONCOLOGIE is an oncology therapeutics company committed to delivering improved outcomes for cancer patients by leveraging innovative compounds and biomarker-driven clinical development. The current pipeline is focused on mid-stage clinical programs that modify the tumor microenvironment. Headquartered in Boston, Massachusetts, US, with operations also in Shanghai, China, ONCOLOGIE is working with global partners to acquire and develop innovative drugs for cancer patients around the world.http://www.oncologie.international ;
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MOLOGEN AG


MOLOGEN AG is a biopharmaceutical company and considered 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 immunotherapy lefitolimod (MGN1703) is the company’s lead product and 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 action mechanism, lefitolimod is an immune surveillance reactivator (ISR) and could potentially be used in various indications. The ISR 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. Detailed analyses of IMPULSE data and data from the extension phase of the TEACH study in HIV, published in August, are currently being conducted. 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-oncology.


MOLOGEN’s pipeline focus is on new innovative immunotherapies to treat diseases for which there is a great medical demand in particular.


http://www.mologen.com ;
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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 statements. It is not responsible for updating such information, which only represents the state of affairs on the day of publication.




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MOLOGENClaudia NickolausHead of Investor Relations & Corporate CommunicationsTel: +49 - 30 - 84 17 88 - 38Fax: +49 - 30 - 84 17 88 - 50mailto:investor@mologen.com(mailto:investor@mologen.com)



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