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Mologen AG. (8/10/17). "Press Release: Important Milestones Achieved in Clinical Trials during the First Half 2017". Berlin.

Organisations Organisation Mologen AG
  Group Mologen (Group)
  Organisation 2 Aarhus University Hospital
  Group Aarhus University
Products Product lefitolimod (MGN1703)
  Product 2 EnanDIM® technology
Persons Person Baumann, Matthias (Mologen 201705– CMO before Noxxon + Focus Clinical Drug Development + Roche + BM)
  Person 2 Söhngen, Mariola (Mologen 201511– CEO before Paion 2000–201510 CMO + Co-Founder)
     


• Results from the TEACH (HIV) and IMPULSE (small cell lung cancer) clinical trials with lefitolimod

• Completion of patient recruitment for the IMPALA pivotal study (colorectal cancer)

• Promising results obtained from pre-clinical combination studies using lefitolimod and EnanDIM®

• Forecast for 2017 confirmed


In the first six months of the financial year 2017, MOLOGEN AG (ISIN DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) made further important progress in its ongoing clinical trials with the close-to-market lead product candidate lefitolimod. Further positive results were also achieved in pre-clinical trials with lefitolimod and the follow-up molecules EnanDIM®, in each case in combination with checkpoint inhibitors. There were also future-oriented personnel changes during the first half of the year: Dr. Matthias Baumann was appointed as new Chief Medical Officer of MOLOGEN AG effective 1 May 2017 and is responsible for the areas of research, pre-clinical and clinical development, drug authorization and clinical strategy.

In the first half of 2017, the lead product candidate lefitolimod, a TLR9 agonist and immunotherapy, was the clear focus of the company’s operating activities in line with its defined strategy. In this regard, intensive work was carried out focusing on the objective of potential approval and marketing of lefitolimod. In particular, this included preparatory measures for the planned outsourcing of production in order to upscale production to the market standard. Furthermore, MOLOGEN also made intensive progress to the out-licensing process.

The necessary financial resources for the further implementation of the company strategy and continuation of studies were secured most recently with MOLOGEN raising €4.99 million by successfully placing convertible bond 2017/2025 at the start of the year. Together with the successful capital increase of €13.6 million in the fourth quarter of 2016 and the convertible bond 2016/2024 amounting to €2.54 million, funding has been therewith provisionally secured until the start of 2018. These additional cash inflows will provide the company with greater financial scope to implement further key strategic and operating measures in the current financial year.

Dr. Mariola Söhngen, CEO of MOLOGEN AG: “In the first half year we achieved important milestones. Our clinical trials with lefitolimod are particularly worth highlighting: promising results in sub-groups of the IMPULSE study were already presented back in April, while just two days ago we received the main results from the extension phase of the TEACH study in HIV.”


Results from clinical trials with lefitolimod

Shortly before the half-year financial report was published, the Company presented main results from the extension phase of the phase Ib/IIa TEACH study in HIV, which has been conducted by the Aarhus University Hospital in Denmark. A more extensive evaluation of the TEACH data is currently ongoing and detailed study results of the extension phase will be presented at an international scientific conference.

The extension phase of TEACH (Toll-like receptor 9 enhancement of antiviral immunity in chronic HIV infection) evaluated lefitolimod in HIV-infected patients under antiretroviral therapy (ART). Lefitolimod on top of ART did not show the desired effect on the viral reservoir. However, this study provides important positive findings with regard to the effects of the reactivation of the immune system, also in HIV. These data together with the favorable safety profile of lefitolimod now confirmed also in HIV, form the basis for our future development strategy for lefitolimod in combination therapies. The Company is confident that lefitolimod can be an important component of therapeutic approaches aiming to cure HIV, such as monoclonal antibodies or vaccines.

Already in January 2017, the Danish Aarhus University received a grant of US$2.75 million from the biopharmaceutical company Gilead Sciences, Inc, Foster City, USA. The grant was to fund a planned clinical trial in HIV positive patients using ART in which MOLOGEN’s TLR9 agonist will be investigated in combination with innovative virus-neutralizing antibodies. The antibodies have been developed by the Rockefeller University in New York, USA. MOLOGEN would be providing lefitolimod for the study.

In February 2017, the Aarhus University Hospital in Denmark presented new data at the annual Conference of Retroviruses and Opportunistic Infections (CROI) in Seattle, USA. For the first time, colon biopsies proved that lefitolimod can trigger a local antiviral immune response in patients with HIV who undergo ART.

In April 2017, MOLOGEN presented initial findings of the exploratory phase II IMPULSE study in small cell lung cancer: Positive results were obtained with regard to overall survival in comparison with the control group in two patient sub-groups, patients with a low activated B cell count and patients with chronic obstructive pulmonary disease (COPD), a common underlying illness in cancer patients. However, the primary endpoint in the total population was not achieved. A more in-depth analysis of the data is currently taking place. The final read-out is likely to be in the first quarter of 2018.

In May 2017, patient recruitment was completed for the phase III IMPALA pivotal study in colorectal cancer. The aim of the study is to verify whether what is known as “switch maintenance therapy” with the immunotherapy lefitolimod leads to a prolongation of overall survival. Analysis of the study is expected to begin in 2019.


Promising: Use of lefitolimod in combination studies

In cooperation with the MD Anderson Cancer Center at the University of Texas the lead product lefitolimod is being tested with the already commercially available immunotherapy Yervoy® (ipilimumab), and therefore for the first time clinically together with a checkpoint inhibitor, in patients with advanced solid tumors as part of a phase I combination study. Should it be proven that lefitolimod enhances the efficacy of checkpoint inhibitors without significantly increasing toxicity levels, this could substantially expand the potential application spectrum of lefitolimod.

Furthermore, a study with MOLOGEN`s TLR9 agonist in combination with innovative virus-neutralizing antibodies in HIV is planned to start presumably in 2018.

Regarding EnanDIM®, the follow-up molecules to lefitolimod, MOLOGEN has also carried out initial pre-clinical examinations in combination with checkpoint inhibitors and presented initial results at the ASCO Clinical Immuno-Oncology Symposium (SITC) in February 2017: The pre-clinical data from a murine colorectal cancer model revealed that EnanDIM® can significantly improve the anti-tumor effect of an anti-PD-1 checkpoint inhibitor in comparison with the monotherapeutic approach, thereby prolonging survival. For the first time, the potential efficacy of a combination approach using EnanDIM® with checkpoint inhibitors for cancer therapy was confirmed in pre-clinical terms.


As expected, higher R&D and business development costs dampen EBIT

The studies in progress precipitated increased R&D costs, which, at €8.0 million, were above the previous year’s amount of €7.1 million. In addition, results were influenced by expenses for business development in connection with targeting partnerships or licensing agreements for lefitolimod. Accordingly, at €-10.5 million, EBIT was under the previous year’s value of €-9.8 million. In the period under review, interest expenses were incurred for the first time due to the issued convertible bonds 2016 and 2017. The net loss for the period was €-10.7m (H1 2016: €-9.8 million).

MOLOGEN’s cash and cash equivalents amounted to €14.2 million as of 30 June 2017 (31 Dec 2016: €20.5 million) MOLOGEN AG’s shareholder’s equity as of 30 June 2017 amounted to €1.8 million (31 Dec 2016: €11.8 million), while the equity ratio was 12% (31 Dec 2016: 55%).


Outlook for full-year 2017 confirmed

MOLOGEN can look back on a positive first half of 2017 overall. The successful capital measures at the end of 2016 and beginning of 2017 have provisionally secured MOLOGEN AG’s funding until the start of 2018. Moreover, the company is in a position to confirm the statements made in the Annual Report 2016 with regard to the objectives in the fields of research and development, cooperations and partnerships, earnings and liquidity development as well as personnel.

MOLOGEN AG’s 2017 half-year report is available on the Company’s website under: www.mologen.com. [geholt als APPENDIX, s. u., ML]


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 (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. In tandem 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


Contact

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

[ Half-year Report pdf version at http://www.mologen.com/fileadmin/user_upload/Berichte/EN/170810_MGN_H1_2017_Interim_Report.pdf ]



   
Record changed: 2017-08-18

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