MOLOGEN AG
MOLOGEN AG: Successful financing and continuation of clinical studies with the lead product lefitolimod in the first quarter 2017
DGAP-News: MOLOGEN AG / Key word(s): Quarterly / Interim Statement Press release N 10 / 2017 as of 11 May 2017
– Ongoing implementation of the “Next Level” corporate strategy – Funding secured until the start of 2018 through additional capital measure – Further progress in clinical studies with lead product lefitolimod – Preparations for possible out-licensing of lefitolimod – Dr Matthias Baumann appointed as new Chief Medical Officer – Outlook for 2017 confirmed
The company’s primary objectives remain the preparation of a possible market launch of lefitolimod and to find the right partner for its licensing and marketing. In this regard, MOLOGEN has already undertaken various preparatory activities, including the planned outsourcing of production to contract manufacturer and upscaling production to the market standard. Dr Matthias Baumann has been the Chief Medical Officer of MOLOGEN AG since 1 May 2017. MOLOGEN secured the necessary financial resources – both for the implementation of the corporate strategy and for the continuation of the clinical trials with lefitolimod and the follow-up molecules EnanDIM(R) – by successfully completing two capital measures in 2016. As a result, the company generated total gross proceeds of EUR16.1 million. In January 2017, MOLOGEN placed a further convertible bond, which resulted in an additional cash inflow of just below EUR5 million. Dr Mariola Soehngen, Chief Executive Officer (CEO) of MOLOGEN AG, comments: “We are delighted to maintain last year’s positive trend in our Company development over the first months of fiscal year 2017. We not only reached further important milestones in our clinical trial with the lead compound lefitolimod and secured our funding presumably until 2018, but have also taken a number of significant steps towards the potential out-licensing of lefitolimod. In particular, we have rigorously continued to pursue our partnering activities in the first quarter of 2017. To this end, our management team has visited international partnering conferences in Asia, Europe and the U.S. and held discussions with potential partners. We are also particularly pleased to have gained an extremely competent new Executive Board member in Dr Matthias Baumann, who will support us with his profound expertise as we effectively further develop lefitolimod.” Key milestones reached in clinical studies MOLOGEN reached an important milestone in the IMPULSE study in the indication for small cell lung cancer. After the data analysis of the study was completed in the reporting period, the first findings were presented in April: these showed that lefitolimod delivers positive results with regard to overall survival in two of the previously defined subsets of patient groups when compared with the control group. The results of the study also delivered important evidence for the definition of patient groups which can benefit from treatment with lefitolimod beyond the IMPULSE study, even though in this highly challenging indication the primary endpoint OS was not met in the overall study population. A comprehensive evaluation of data is currently still being carried out. MOLOGEN will be presenting the full study results at an international scientific conference. The phase I/II TEACH study in the indication HIV that MOLOGEN is conducting in collaboration with the Danish Aarhus University Hospital will be continuing in an extension phase where patients will receive treatment over a longer time frame owing to the favorable results in the first phase of the study, in which a broad activation of the immune system triggered by lefitolimod was observed. According to data presented by Aarhus University at the annual Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle, U.S., in February of this year, it was revealed through colon biopsies that lefitolimod can trigger a local antiviral immune response in patients with HIV who undergo antiretroviral treatment (ART) without inducing inflammation. Consequently, lefitolimod could be used to eradicate the virus, HIV, through the “kick and kill” concept. In addition, the U.S. biopharmaceutical company Gilead Sciences, Inc. issued a grant of US$ 2.75 million to Aarhus University for a further combination trial in which lefitolimod will be investigated together with innovative virus-neutralizing antibodies that have been developed by the Rockefeller University in New York, U.S.. This innovative combination will be the latest approach in the “kick and kill” approach for the treatment of HIV. The first combination study of lefitolimod with the checkpoint inhibitor Yervoy(R) (ipilimumab), which MOLOGEN is carrying out in cooperation with the MD Anderson Cancer Center, Texas, is being conducted since summer 2016. Through the combination of these two immunotherapies, the aim is to generate a broader activation of the immune system and leverage synergy effects. MOLOGEN presented preclinical data on further combination studies in a mouse model at the Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco, U.S., in January 2017 and at the Clinical Immuno-Oncology Symposium (ASCO SITC) in Orlando, U.S., in February of this year. The data on tumor models in mice revealed that the combination of checkpoint inhibitors and the respective TLR9 agonists lefitolimod and EnanDIM(R) can significantly boost the immune system, noticeably slow tumor growth and effectively prolong life for the animals. These results are a confirmation for the combination approach of TLR9 agonists with checkpoint inhibitors. Progress in clinical studies with only slight increase in R&D expenses Outlook for 2017 as a whole confirmed The quarterly statement of MOLOGEN AG for the first quarter of 2017 is available on the company’s website at: www.mologen.com. MOLOGEN AG www.mologen.com Contact
11.05.2017 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG. |
Language: | English |
Company: | MOLOGEN AG |
Fabeckstraße 30 | |
14195 Berlin | |
Germany | |
Phone: | 030 / 841788-0 |
Fax: | 030 / 841788-50 |
E-mail: | presse@mologen.com |
Internet: | www.mologen.com |
ISIN: | DE0006637200 |
WKN: | 663720 |
Listed: | Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange |
End of News | DGAP News Service |