MOLOGEN AG: Collaboration with licensing partner ONCOLOGIE gains momentum

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. 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^®.

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^®) 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.

www.mologen.com

Note about risk for future predictions

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