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

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. www.oncologie.international.

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.

www.mologen.com

Disclaimer

Certain statements in this communication contain formulations or terms referring to the future or future developments, as well as negations of such formulations or terms, or similar terminology. These are described as forward-looking statements. In addition, all information in this communication regarding planned or future results of business segments, financial indicators, developments of the financial situation or other financial or statistical data contains such forward-looking statements. The company cautions prospective investors not to rely on such forward-looking statements as certain prognoses of actual future events and developments. The company is neither responsible nor liable for these forward-looking 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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