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MOLOGEN AG: Positive subgroup results of the exploratory phase II IMPULSE study of lefitolimod in extensive-disease small-cell lung cancer (SCLC)

(April 24, 2017)

DGAP-News: MOLOGEN AG / Key word(s): Study results

24.04.2017 / 07:26
The issuer is solely responsible for the content of this announcement.


Press Release N 9 / 2017 on 24 April 2017

MOLOGEN AG: Positive subgroup results of the exploratory phase II IMPULSE study of lefitolimod in extensive-disease small-cell lung cancer (SCLC)

- Clinically relevant subgroups benefit from the treatment with lefitolimod in this study



- Results are indicative for the further development of lefitolimod in SCLC

Berlin, 24 April 2017 - The biopharmaceutical company MOLOGEN AG (ISIN DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) announced the key results of the exploratory phase II IMPULSE study. The randomized study evaluated the efficacy and safety of lefitolimod in patients with extensive-disease small-cell lung cancer (SCLC). IMPULSE shows positive results regarding overall survival (OS) in two subgroups of patients in comparison to the control group (standard therapy). Additional, potentially promising subgroups will be identified. The results of this SCLC study provide significant guidance for defining patient populations that, even beyond this study, are most likely to benefit from the immune surveillance reactivator lefitolimod, even though in this highly challenging indication the primary endpoint OS was not met in the overall study population.

"Lung cancer, and especially small-cell lung cancer, is an indication for which the benefit of current standard treatment is very limited. We are therefore very pleased to see initial evidence of clinical efficacy for lefitolimod in small-cell lung cancer, an indication known for its setbacks in other drug development programs," said Dr Mariola Soehngen, CEO of MOLOGEN AG. "The data of the IMPULSE study, especially from the two identified subgroups, show that lefitolimod has the potential to become an important treatment option - also for patients with a disease as difficult to treat as small-cell lung cancer. Notably, these positive study results will be an important asset in the ongoing partnering discussions."

The IMPULSE study shows positive results in two pre-defined and clinically relevant subgroups of patients. Notably, a strong overall survival (OS) benefit was shown in comparison to the control arm (local standard of care) in patients with a low count of activated B cells (hazard ratio 0.59, 95% confidence interval 0.29-1.21), an important immune parameter. Moreover, a benefit was seen in patients with reported Chronic Obstructive Pulmonary Disease (COPD), a frequent underlying disease (hazard ratio 0.54, 95% confidence interval 0.21-1.38).

The safety profile of lefitolimod is favorable. The most common adverse events in the IMPULSE population were cough, asthenia, headache, nausea, and back pain. Adverse events may also be due to underlying diseases and/or adjunctive therapy.

"We have seen promising efficacy signals in subgroups of patients in this very difficult-to-treat- indication. We are committed to further analyze the data and to continue the development of lefitolimod in small-cell lung cancer, where there are no better current treatment options than chemotherapy. Therefore, an important medical need exists for new and/or complementary combination treatment alternatives. Moreover, it would also be helpful to evaluate lefitolimod in patients with SCLC in combination with other immuno-oncological drugs," said Dr Ronald Carter, Acting CMO of MOLOGEN AG.

The present findings from IMPULSE provide additional key insights into the role of TLR9 agonists in the treatment of cancer, and confirm there is significant opportunity to improve outcomes for patients in this therapeutic area.

A more extensive evaluation of the IMPULSE data is currently ongoing. The full IMPULSE study results will be presented at international scientific conferences.

MOLOGEN's ongoing development programs, especially the pivotal IMPALA study, are running independently from these study results, given these are different indications.

Three more clinical studies with lefitolimod
Further to the IMPULSE study, lefitolimod is currently being evaluated in the pivotal phase III IMPALA study for first-line maintenance treatment of metastatic colorectal cancer (mCRC); recruitment for this trial is expected to be finalized soon. Furthermore, a phase I study of lefitolimod in combination with the commercially available checkpoint inhibitor Yervoy(R) (ipilimumab) in other solid tumors is being conducted in collaboration with MD Anderson Cancer Center, Texas. In addition, lefitolimod is also being investigated in a phase I study in HIV-infected patients (TEACH). Top-line results are expected in summer 2017.

Background to the IMPULSE small-cell lung cancer (SCLC) study
The trial titled "Randomized Clinical Study of Maintenance Therapy with Immunomodulator MGN1703 in patients with Extensive Disease Small Cell Lung Cancer after Platinum-Based First-Line Therapy" (IMPULSE study) is an explorative study and has overall survival as the primary endpoint. It compares lefitolimod (MGN1703) versus standard therapy (chemotherapy). The study included 102 patients suffering from extensive-disease small-cell lung cancer, and showing at least partial response to four cycles of first-line chemotherapy (n=102). They were randomized in a ratio of 3:2 to switch-maintenance therapy with lefitolimod (60mg injected subcutaneously twice weekly) or standard therapy until disease progression.

There will be a final read-out probably in the first quarter of 2018, approximately 24 months following the recruitment of the last patient.

Small-cell lung cancer (SCLC)
Lung cancer is one of the most common cancers. The estimated number of new lung cancer cases per year is around 230,000 in the U.S. and in Europe more than 400,000 with an estimated number of deaths per year of approximately 170,000 and more than 350,000 respectively.

The two main types are non-small-cell lung cancer (NSCLC) and small-cell lung cancer (SCLC). SCLC is a fast-growing type of lung cancer that usually spreads more quickly than NSCLC and represents approximately 15-20% of all lung cancer cases.

When first diagnosed, approx. 60-80% of SCLC-patients already have distant metastases or extensive local spreading of the disease called "extensive-disease" SCLC. The prognosis for extensive-disease SCLC is still very poor: median overall survival (OS) is less than 12 months and only few patients survive more than two years. Thus, there is a high unmet medical need for new treatment options.

For more information on the clinical development program including IMPULSE, IMPALA, the combination study, and TEACH please visit www.clinicaltrials.gov.

MOLOGEN AG
As a biopharmaceutical company, MOLOGEN AG is considered a pioneer in the field of immunotherapies on account of its unique compounds and technologies. Alongside a focus on immuno-oncology, MOLOGEN develops immunotherapeutic agents for the treatment of infectious diseases.
The immunotherapeutic agent lefitolimod is the company's lead product and 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 is an immune surveillance reactivator (ISR) and has the potential to be used in a variety of different indications. At present, the ISR lefitolimod is being developed for first-line maintenance treatment of colorectal cancer (pivotal study). The phase II IMPULSE study shows positive results in two pre-defined and clinically relevant subgroups of patients. A more extensive evaluation of the IMPULSE data is currently ongoing. In addition, the ISR lefitolimod is currently being investigated in an extended phase I trial in HIV and a phase I combination study with the checkpoint inhibitor Yervoy(R) (ipilimumab). Alongside checkpoint inhibitors, lefitolimod is one of the few product candidates in the field of immuno-oncology that is close to market. MOLOGEN's pipeline focuses on new innovative immunotherapies to treat diseases for which there is great medical demand.

Contact

Claudia Nickolaus
Head of Investor Relations & Corporate Communications
Tel: +49 - 30 - 84 17 88 - 38
Fax: +49 - 30 - 84 17 88 - 50
[email protected]

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 updating such information, which only represents the state of affairs on the day of publication.



24.04.2017 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.
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