BERLIN--(BUSINESS WIRE)--The biopharmaceutical company MOLOGEN AG (ISIN DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) announced today the signing of a binding term sheet that defines the framework for the collaboration between MOLOGEN and iPharma, a China-based drug development company. The collaboration would be defined in a final agreement that will consist of two parts: First, a license agreement including sublicense rights under which MOLOGEN grants iPharma an exclusive license for the development, manufacturing and commercialization for MOLOGEN’s lead compound lefitolimod in oncology in the following territory: China including Hong Kong and Macao, Taiwan and Singapore. Under the licensing agreement MOLOGEN would receive an upfront payment, milestone payments as well as royalties and an equity investment. With this licensing deal MOLOGEN is homing in on one of its key objectives: partnering. Second, a co-development agreement under which the two parties shall jointly develop lefitolimod in one or more mutually agreed indications in oncology following a development plan to be agreed on and subject to further funding, in the defined territory and on a global level. MOLOGEN and iPharma will share the economic returns from this joint development pursuant to both parties contributions.
“This binding term sheet offers the potential to translate into a licensing deal for lefitolimod. Thereby, we have reached a key milestone in the implementation of our strategy – a clear way to partnering. We have been putting a lot of effort into achieving this long-desired goal. We are proud to have iPharma, a young dynamic development company backed by a NASDAQ-listed biotech firm and a relevant Chinese Fund, as partner who will strongly support us in our oncology development program, especially in China and in Asian regions. So, it will be much easier to unleash the Asian market potential of lefitolimod,” said Dr Mariola Soehngen, Chief Executive Officer of MOLOGEN.
“We are delighted to potentially partner with MOLOGEN, a pioneer in the field of immunotherapy, to bring its proprietary compound lefitolimod, a toll-like receptor (TLR) 9 agonist, currently in a phase III clinical trial to China as first line maintenance therapy for the treatment of metastatic colorectal cancer (mCRC) and potentially other indications with a large unmet medical need and very limited treatment options,” said Dr. Binhui (Ben) Ni, CEO of iPharma. “In addition, we are excited and looking forward to our joint effort in accelerating global development of lefitolimod potentially in combination with immune checkpoint inhibitors for one or more indications, where a toll-like receptor (TLR) 9 agonist is becoming an increasing focus of immune combination therapy based on recent clinical studies.”
“We are very pleased about the intended cooperation with iPharma and its team of seasoned drug developers with experience in Western Big Pharma and a focus on in-licensing compounds and technologies in the field of immunotherapy,” said Dr Matthias Baumann, Chief Medical Officer of MOLOGEN. “We look forward to advancing the development of our lead compound lefitolimod and to starting new collaborative trials in oncology.”
Under the terms of the final agreement, to be signed by the end of this year, iPharma is to make an upfront payment of EUR 3 million and warrants an equity investment in MOLOGEN amounting to EUR 2 million within a period of 12 months following the execution of the final license agreement. Further milestones are defined as development milestones which are due upon reaching predefined development steps and the market approval of the compound and commercial milestones which are due upon reaching certain sales thresholds. The total package can amount to EUR 100 million and would be paid over several years after having reached the milestones. In addition MOLOGEN would receive low double digit royalties on sales.
All costs relating to development, registration, marketing and commercialization of lefitolimod in the territory would be covered by iPharma.
With this final agreement MOLOGEN would achieve one of the main milestones in implementing its strategy: a licensing deal for its lead compound lefitolimod, a toll-like receptor (TLR) 9 agonist currently in a pivotal trial. By executing the final agreement MOLOGEN will receive, among others, cash inflows for milestones achieved and it would secure the marketing of its lead compound lefitolimod in the defined territory. Once the licensing agreement has materialized, MOLOGEN will achieve a first external commercial validation of the value of its lead compound lefitolimod. The licensing part of the agreement will allow to advance the development of lefitolimod in the territory with the clear aim to achieve marketing approval. The co-development part of the agreement will support MOLOGEN´s efforts to potentially develop lefitolimod on a global level in one or more further indications. Further licensing deals are in preparation.
iPharma Ltd. is a joint venture between I-Bridge Capital, a leading Chinese Investor and BioLineRx Ltd. (NASDAQ:BLRX), a publicly-listed biotech company based in Israel. iPharma is focusing on innovative approaches and assets in immunotherapy via in-licensing those programs and further developing the assets for the Chinese market and globally.
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 (MGN1703) is an immune surveillance reactivator (ISR) and could potentially be used in various indications. The ISR lefitolimod (MGN1703) is currently being developed within the framework of a pivotal study for first line maintenance therapy for colorectal cancer. The phase II IMPULSE study in small cell lung cancer is showing positive results in two previously defined and clinically relevant patient sub-groups, even though the primary endpoint “Overall Survival” in the overall study population was not met in this very challenging indication. Detailed analyses of IMPULSE data and the recently published TEACH data of the extension phase are currently being conducted. In addition, lefitolimod (MGN1703) is currently being investigated in a phase I combination study with the checkpoint inhibitor ipilimumab (Yervoy®) in various cancer indications. Alongside 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.
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