Replies to post #329923 on Avid Bioservices Inc (CDMO)

[biopharm]

Another BOD shakeup , going after CEO to replace with Roche backed Stefan M Manth,

It will become easy for a jury to see once all the mudslinging stops and the IP assets that Stafford Ronin Hedge Fund group once said had not much value will one day become the biggest, almost heist...big pharma has witnessed

I would say Steve King was right on, with astronomical value with the IP assets, as astronomical events unfold and the probability is zero for it all to happen surrounding those involved with ties to Peregrine / Avid / Ronin Hedge Fund / Oncologie / Xencor

Top Pharma Manager Stefan M. Manth, MD, to become CEO of MOLOGEN AG

- To turn therapeutic value created into commercial success

- Read-out of pivotal phase III trial ahead

Berlin, 27 March 2019 - Stefan M. Manth, MD, MBA, will take over as the new CEO of MOLOGEN AG (ISIN: DE000A2LQ900, SIN A2L Q90) shortly with effect after the completion of the ongoing capital increase, to lead the Company together with Chief Medical Officer (CMO) Dr Matthias Baumann. Dr Manth is a medical doctor with an MBA from the prestigious European Business School INSEAD in Fontainebleau, France, and brings over 35 years of international pharma- und biotech industry experience with him. He has been following MOLOGEN since its inception some 20 years ago and was a member of the Scientific Advisory Board of the Company since 2011. In 2014 he was elected to the Supervisory Board and has since served as Vice Chairman.

"We are delighted, that Stefan Manth has accepted to move into the CEO position. Together with our CMO, we now have the ideal team to head the organization", says Oliver Krautscheid, Chairman of the Supervisory Board at MOLOGEN AG. The new CEO will also become responsible for Finance and Accounting.

Dr Stefan Manth: "MOLOGEN is a pioneer in immunotherapy. The Company is developing promising new medicines which activate the patients' own immune defense to identify and eliminate malignant cells. MOLOGEN is rapidly approaching a decisive milestone this year with its key asset lefitolimod: the highly anticipated read-out of the primary endpoint of our pivotal phase III clinical trial IMPALA in patients with metastatic colorectal cancer." He will strive to maximize the potential value of this trial as well as value created from the other pipeline projects of the Company.

Two decades of management experience within the Roche Group

Dr Stefan M. Manth spent 20 years of his career in different management positions with increasing responsibility within the Roche Group. He was instrumental in building and expanding the oncology franchise at Roche, Genentech and Chugai, the uncontested leader worldwide in this therapeutic field since then. In 2011, Dr Manth joined the Scientific Advisory Board at MOLOGEN AG and was elected to the Supervisory Board in 2014. His successor as Supervisory Board member will be announced in due course.

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 extensive-stage small cell lung cancer (ES-SCLC) and the data from the extension phase of the TEACH study in HIV have been published.
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, DE000A2LQ900/SIN: A2L Q90) are listed in the Prime Standard of the German Stock Exchange.

www.MOLOGEN.com

Now, many will begin to see WHY FC domain re: IP assets of PS Targeting was the puppet show to remove SK and get Xencor backed John Stafford III to shake things up at Peregrine

Xencor and Roche finalized as well

Xencor filed with SEC Feb 5, 2019
Roche & Xencor effective as of March 8, 2019

https://m.marketscreener.com/XENCOR-INC-14917391/news/Xencor-Announces-Closing-of-Research-Collaboration-and-License-Agreement-with-Genentech-28133255/

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October 04, 2017
Selexis SA and Pelican Therapeutics Sign Agreement to Advance Pelican’s Immunotherapy Clinical Programs
....
....
....

Rahul Jasuja, CEO of Pelican, added: “We chose Selexis for their expertise in cell line expression technologies for recombinant protein therapeutics for the CMC development of our two molecules, PTX-35 and PTX-15. We look forward to advancing our TNFRSF25 agonist program with both KBI Biopharma and Selexis as we prepare for our first-in-human clinical trial.”

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Heck, maybe JSR Holdings or Selexis or KBI can get together next and break the mole story wide open

Much more to come

[biopharm]

Looks like Mologen needs PS Targeting as well

All know it except John Springs Stafford that seems to play a good puppet role

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German Cancer Immunotherapy Flops in Phase III

Aug 6, 2019

"It now appears that for successful anti-cancer immunotherapies, a combination approach is of paramount importance,” stated Matthias Baumann, CMO of Mologen.

https://labiotech.eu/medical/mologen-cancer-immunotherapy-colorectal/

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Now with the failure of Mologen just disclosed above ...that $80 Million to Oncologie recently looks to add Bavituximab to the combination but Oncologie seems to have known from the beginning that Bavi / PS Targeting required and now they own both pipelines with deal structures in place as milestones / royalties / biomarker data etc so important and Avid Bioservices awaits those royalties / milestones etc etc

Imagine that, John Springs Stafford had no clue of the value of PS Targeting or someone did and brought in Stafford for a mission to break up the BOD and shift the IP to Oncologie? More like it...criminal

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Aug 20, 2018

Mologen to sell lead immuno-oncology compound to Oncologie

Mologen AG agreed to sell its lead immunotherapy and oncology compound lefitolimod to Boston's Oncologie Inc. for a near-term consideration of €23 million.

The agreement has a total potential total value of over €1 billion, plus low double digit royalties on net sales. Mologen may receive up to about €200 million in development and regulatory milestone payments, as well as up to more than €900 million depending on potential future sales. Oncologie will also pay tiered royalties with a peak rate of 16%.

The deal will cover the major part of the funding for a study called Impala, a phase 3 trial in colorectal cancer, which has a data read-out projected for 2020. Further, the transaction will allow further combination studies of lefitolimod to explore its potential in immuno-oncology.

After the sale, which covers all intellectual property and know-how related to lefitolimod, Oncologie will be solely responsible for the drug's global development, manufacturing and commercialization.

The deal remains subject to Mologen and Oncologie agreeing to a definitive transaction documentation.

Additionally, the companies expanded their global co-development agreement, under which Berlin-based Mologen will carry out certain manufacturing activities to supply lefitolimod. Oncologie would also obtain a right of first refusal to license certain optioned products.

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PRESS RELEASE N 27 / 2018 of 11/16/2018

MOLOGEN AG to retain rights to lefitolimod - termination of negotiations with ONCOLOGIE Inc. and assessment of all strategic options in the light of a likely read-out of the pivotal phase III IMPALA trial in 2019



- Three-month exclusivity period for negotiations with ONCOLOGIE on the global assignment of lefitolimod expired without agreement

- 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 15th, 2018; MOLOGEN assessed the new terms as being unjustified and therefore rejected them

- Earlier than expected availability of top-line data from the IMPALA study opens new strategic options for the monetization of lefitolimod

- License agreement with ONCOLOGIE for Greater China remains valid

Berlin, November 16th, 2018 - The biopharmaceutical company MOLOGEN AG announced that the three-month exclusivity period for further negotiations with the US biopharmaceutical company ONCOLOGIE regarding a global assignment of all intellectual property and other rights in MOLOGEN's lead molecule, lefitolimod, has expired on November 15th, 2018. A non-binding term sheet on the global assignment was signed between the two companies on August 15th, 2018. The negotiations with ONCOLOGIE did not result in a mutually satisfying conclusion within the set time frame and were therefore terminated. Particularly with regard to the fact that the top-line data from the pivotal phase III IMPALA study are now expected to be available earlier than initially predicted - this could be as early as summer 2019 - MOLOGEN has decided not to prolong the exclusivity period for the negotiations with ONCOLOGIE and to assess all potential strategic options. These include the re-opening of discussions with other parties that in the past have shown interest in lefitolimod as well as continuing the development of lefitolimod on its own.

"As lefitolimod is MOLOGEN's most valuable asset, we strive to realize its full potential and value. Unfortunately, during the exclusivity period our partner ONCOLOGIE presented us with new terms for the transaction that were much inferior to those previously negotiated. After extensive discussions between the management teams of the two companies, and an internal assessment of the new proposed terms, MOLOGEN decided to not pursue this potential transaction. In these three months we have also learnt that the read-out from IMPALA may come much earlier than expected. We have therefore decided to not execute a corporate transaction with ONCOLOGIE at this point and to retain the rights to the asset. By doing so, we are keeping the potential upside of the product for the Company and upon availability of top-line data from IMPALA we will launch a campaign to out-license or sell lefitolimod," said Dr Ignacio Faus, CEO of MOLOGEN AG.

In February 2018 MOLOGEN signed a license agreement for its lead compound lefitolimod with ONCOLOGIE Inc. This contract 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. This license agreement with ONCOLOGIE remains valid and MOLOGEN will collaborate with the partner in order to ensure the success of lefitolimod in China. In addition both parties are exploring the possibility of executing the global co-development agreement that is contemplated in the current Greater China license contract. In particular MOLOGEN and ONCOLOGIE have entered into discussions to jointly develop combination products that contain lefitolimod and a checkpoint inhibitor.

So far, MOLOGEN has received overall payments of EUR5 million as part of the cooperation with ONCOLOGIE.

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 extensive-stage small cell lung cancer (ES-SCLC) and the data from the extension phase of the TEACH study in HIV have been published. 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, DE000A2LQ900/SIN: A2L Q90) are listed in the Prime Standard of the German Stock Exchange.

http://mobile.dgap.de/dgap/News/corporate/mologen-retain-rights-lefitolimod-termination-negotiations-with-oncologie-inc-and-assessment-all-strategic-options-the-light-likely-readout-the-pivotal-phase-iii-impala-trial-in/?newsID=1109895