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Mologen AG. (11/16/18). "Press Release: 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".

Organisations Organisation Mologen AG
  Group Mologen (Group)
  Organisation 2 Oncologie Inc. (US/CN)
Products Product lefitolimod (MGN1703)
  Product 2 drug development
Index term Index term Oncologie–Mologen: lefitolimod, 201808–201811 term sheet for acquisition of ww rights to lefitolimod by Oncologie TERMINATED 11/18
Persons Person Faus, Ignacio (Mologen 201808–201903 CEO former CEO + Co-Founder of Palau Pharma LEFT EARLY 3/19)
  Person 2 Nickolaus, Claudia (Mologen 201407– Head Investor Relations)

- 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

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 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.


Claudia Nickolaus
Head of Investor Relations & Corporate Communications
Tel: +49 - 30 - 84 17 88 - 38
Fax: +49 - 30 - 84 17 88 - 50


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.

Record changed: 2018-11-22


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