BERLIN--(BUSINESS WIRE)--In the first quarter of 2016, the biotechnology company MOLOGEN (ISIN DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) made further progress in its clinical studies. The focus of operative business continues to be on the three ongoing clinical studies investigating the lead product, namely the Immune Surveillance Reactivator lefitolimod (MGN1703). Patient recruitment for the colorectal cancer pivotal study continued further in the first quarter. The phase I study TEACH (indication HIV) was expanded following first promising results and the next part of the study will continue with more patients and a longer duration. The analysis stage of the IMPULSE study investigating small cell lung cancer is intended to begin in late 2016. A phase I combination study of lefitolimod with a checkpoint inhibitor is expected to start soon. In addition, the finalization of a currently ongoing pipeline review is scheduled for mid-2016. The results are expected to be presented to the shareholders at this year’s Annual General Meeting, most likely in August 2016. The forecast for the current financial year remains unchanged.
“In the first few months of the year, the focus of our activities remained on the further development of our lead product lefitolimod. We are delighted that lefitolimod will soon also be tested in a combination study with a checkpoint inhibitor and that the HIV study was able to be expanded on the basis of good initial results. In addition, we are currently working on a strategically important pipeline review and consider corresponding possible financing options”, said CEO Dr. Mariola Söhngen.
Successful continuation of clinical studies with lefitolimod (MGN1703)
In the first three months of 2016, MOLOGEN concentrated on driving the clinical studies with the Immune Surveillance Reactivator (ISR) lefitolimod (MGN1703) forward. As part of the TEACH study in the indication HIV conducted in collaboration with Aarhus University, the first study results displayed significant activation of the immune system in HIV patients through treatment with lefitolimod (MGN1703). After the first phase of the study, which was conducted with a total of 15 patients and over a period of one month, an expansion study phase with a further 10 to 11 patients and a duration of six months is planned. The final results are expected in the first half of 2017.
Patient recruitment for the phase III IMPALA study in colorectal cancer, which began in September 2014, also progressed in the first quarter of 2016. The recruitment of around 540 patients, in more than 100 centres in eight European countries, should be concluded by the end of 2016. The aim of the study is to show that a so-called “switch maintenance” therapy involving the cancer immunotherapy lefitolimod (MGN1703) for metastatic colorectal cancer patients leads to an increase in the overall survival rate.
The analysis stage of the phase II IMPULSE study investigating small cell lung cancer will begin at the end of 2016. First results are expected to be available at the beginning of 2017 and will be presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO) in June 2017. The IMPULSE study tests the effectiveness and safety of lefitolimod (MGN1703) in the treatment of patients with small cell lung cancer. The primary end point of the study is overall survival.
The signing of a cooperation agreement with the MD Anderson Cancer Center at the University of Texas, US, (MD Anderson) in January represented a further success for MOLOGEN. A phase I study with lefitolimod (MGN1703) in combination with the commercially available immunotherapy Yervoy® (ipilimumab) is planned in patients with advanced solid tumours. This is the first time lefitolimod (MGN1703) will be tested in combination with a checkpoint inhibitor.
New generation of immune-activating TLR9 agonists
EnanDIM® belong to the same platform technology as lefitolimod, and represents a new generation of TLR9 agonists and successor substances from MOLOGEN`s TLR9 technology with longer patent terms. Comprehensive immune activation together with a good level of tolerability is also expected from the Immune Surveillance Reactivator EnanDIM® family. The preclinical data presented at ASGCT 2016 in early May 2016 show that substances from the EnanDIM® family provoke a broad activation of immune cells, such as monocytes, natural killer cells (NK cells), and plasmacytoid dendritic cells (pDCs) in vitro. Furthermore, the data do not indicate any signs of toxicity following the administration of the highest possible dosage of the active EnanDIM® compound and confirms immunomodulatory effects in vivo. The mode of action of EnanDIM® should allow its application in a number of cancer indications, either as a monotherapy or in combination with other targeted therapies, checkpoint inhibitors, and other therapeutic approaches. In addition, different members of the EnanDIM® family will also be able to be used in the area of infectious diseases, including HIV, in future.
Presentation of the latest research and development results at international scientific conferences
In January 2016, MOLOGEN presented data about ISR lefitolimod (MGN1703) at the 2016 Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco, US. The design of the IMPALA study, including the preliminary data, as well as stratification factors of the first 200 randomised colorectal cancer patients from the study, were presented.
This was followed by the presentation of the first results at the Keystone HIV Symposium (Keystone Symposia on Molecular and Cellular Biology Conference) in Olympic Valley, CA, US in March 2016. Also, at the 19th Annual Conference of the American Society of Gene and Cell Therapy (ASGCT) in Washington, US, MOLOGEN presented the described preclinical data on the ISR EnanDIM® in early May 2016.
Study progress leads to the planned increase in R&D costs
The financial data of MOLOGEN AG were also characterized by the study progress in the first quarter of 2016. Accordingly, expenditure for research and development amounted to €3.7 million in total, which exceeded the total in the previous year (Q1 2015: €2.4 million), and at -€4.5 million, the EBIT was, as expected, below the reference period in the previous year (Q1 2015: -€3.2 million). As of 31 March 2016, the available cash and cash equivalents amounted to €20.1 million (Q1 2015: €24.6 million). MOLOGEN AG’s equity amounted to €15.0 million as at 31 March 2016 (31 December 2015: €19.5 million). This corresponded to an equity ratio of 70 percent (31 December 2015: 74 percent). The decline was a result of current losses from the first quarter of 2016.
Ongoing portfolio review
Potential and value-added developments of the pipeline are being analyzed and evaluated as part of an ongoing portfolio review. In connection with the portfolio review, further considerations are also made in terms of necessary future financing. The results of this are expected to be available in mid-2016. In coordination with the Supervisory Board, the Executive Board therefore resolved to postpone this year’s Annual General Meeting, which was originally planned for 31 May, to August 2016 in order to allow the shareholders to receive comprehensive information as part of the Annual General Meeting.
Forecast for full year 2016 confirmed
The statements made in the 2015 Annual Report on the objectives in the fields of research and development, collaboration and partnerships, earnings and liquidity development, and personnel still apply. The company assumes that the R&D expenses for 2016 will be higher than those for the 2015 financial year as a result of the advances in clinical research, and that the annual profit will be lower than in the previous year.
The full report for the first quarter of 2016 for MOLOGEN AG is available on the company’s website www.mologen.com.
MOLOGEN AG
With new and unique technologies and active substances, the biotech company MOLOGEN is one of the pioneers in the field of immunotherapy. Alongside a focus on immuno-oncology, MOLOGEN also develops immunotherapies for the treatment of infectious diseases.
The cancer immunotherapy lefitolimod (MGN1703) is the company’s lead product and best-in-class TLR9 agonist. Treatment with the Immune Surveillance Reactivator (ISR) lefitolimod (MGN1703) triggers a broad and strong activation of the immune system. Due to this mechanism of action, lefitolimod (MGN1703) has the potential to be applied to various indications. Lefitolimod (MGN1703) is currently being developed for first-line maintenance treatment of colorectal cancer (pivotal study) and small cell lung cancer (randomized controlled trial). Furthermore, it is also being investigated in a phase I study in HIV and a phase I combination study with the checkpoint inhibitor Yervoy® (ipilimumab) is expected to start within the first half 2016.
MOLOGEN’s pipeline focus is on new innovative immunotherapies to treat diseases for which there is a high medical need.
Memberships in associations:
Biotechnologieverbund Berlin-Brandenburg (bbb) e.V. | BIO Deutschland e.V. | DECHEMA - Society for chemical technology and biotechnology e.V. | German industrial association of biotechnology (DIB) | Association for the Promotion of Science and Humanities in Germany | Association of German biotechnology companies (VBU) | Association of researching manufacturers of pharmaceuticals e.V. (VFA) | Association of the chemical industry e.V. (VCI)
MIDGE®, dSLIM®, EnanDIM® and MOLOGEN® are registered trademarks of MOLOGEN AG.
Note about risk for future predictions
Certain information in this report contains forward-looking statements or the corresponding statements with negation or versions deviating from this or comparable terminology. These are described as forward-looking statements. In addition, all of the information given here that refers to planned or future results of business areas, key financial figures, developments of the financial situation or other financial figures or statistical data, is to be understood as such forward-looking statements. The company points out to investors that they should not rely on these forward-looking statements as predictions about actual future events. The company is not obligated and refuses to accept any liability for the forward-looking statements and has no obligation to update such statements in order to accurately reflect the current situation.
