- WKN: A2LQ90
- ISIN: DE000A2LQ900
- Land: Deutschland
Nachricht vom 14.08.2019 | 19:32
MOLOGEN AG: Funding measures successfully implemented and important operational milestones achieved in H1 2019
DGAP-News: MOLOGEN AG / Key word(s): Half Year Results
Press release N 14 2019 of 14 August 2019
- Successful implementation of two capital measures secure funding
- Lefitolimod: Preparatory measures for read-out of the top-line data of the IMPALA pivotal study: Negative findings regarding efficacy announced after reporting period
- EnanDIM(R): Preclinical trials for the first clinical product candidates carried out as planned
- Strategic focus on combination therapies with lefitolimod and EnanDIM(R) in the indications of oncology and HIV/AIDS
- Advanced plans with strategic partner company Oncologie Inc. to conduct a first joint clinical project
- Phase IIa TITAN study in the indication HIV about to start
- Dr med Stefan M. Manth assumed office as CEO on 01 May
Berlin, 14 August 2019 - The biopharmaceutical company MOLOGEN AG (ISIN DE000A2LQ900 / WKN A2LQ90) has advanced its study program according to plan in the first half of 2019 and successfully implemented capital measures to secure funding for the Company. Following a diligent approach to processing the study data for the initial evaluation of the Phase III IMPALA pivotal study with lefitolimod in the indication of metastatic colorectal cancer, the read-out of the top-line data was announced at the beginning of August. The primary study goal - a significant prolongation of overall survival of the patients - was not achieved. The beneficial safety profile and good tolerability of lefitolimod were again confirmed. Based on these results, MOLOGEN's future strategy will focus on developing combination therapies. In the indication of HIV/AIDS the Phase IIa TITAN combination study, for which Gilead is providing the funding, is about to start enrolling patients. In the indication of oncology, the combination study with the checkpoint inhibitor ipilimumab (Yervoy(R)) is continuing after the dosing escalation phase was successfully concluded. Furthermore, great progress has been made in plans for a clinical combination study with another checkpoint inhibitor. This would be conducted in collaboration with the strategic partner Oncologie Inc., which is based in Boston, USA.
The preclinical program for the first TLR9 agonist from the next-generation EnanDIM(R) technology will shortly be completed. The preparations for production of the investigational drug have advanced according to plan, with the first clinical trials expected to be initiated at the end of 2019.
During the first six months of 2019, there were personnel changes at the level of Executive Board and Supervisory Board: Chief Financial Officer (CFO) Walter Miller left the Company upon expiration of his contract as planned. Dr Faus terminated his contract prematurely and was replaced as Chief Executive Officer (CEO) by Dr med Stefan M. Manth, a long-standing member of the Supervisory Board. Gerhard Greif was legally appointed by a court to fill the vacancy on the Supervisory Board that arose as a result of Dr med Manth's appointment as CEO until the end of the Annual General Meeting on 29 August 2019.
"The initial evaluation of our phase III IMPALA study, which ultimately delivered a disappointing result, was a key event over the last few months. We had all been hoping for different news. Nevertheless, we can take encouragement from the fact that the biological activity in addition to the exceptional safety profile and good tolerability of lefitolimod were once again proven, allowing us to continue along our chosen path of innovative combination therapies in the area of HIV/AIDS. In the indication of oncological diseases, we will also be focusing exclusively on combination approaches for the first clinical candidates from the EnanDIM(R) family", Dr med Stefan M. Manth, CEO of MOLOGEN AG, commented.
Lefitolimod is currently being investigated in a clinical phase I/II study in combination with the checkpoint inhibitor Yervoy(R) (ipilimumab) across a broad spectrum of solid tumors. The study is being carried out at the renowned MD Anderson Cancer Center, Texas, USA. The most recent, encouraging findings on the desired therapeutic immuno-oncological modulation of the TME were presented at the ASCO Congress in Chicago at the beginning of June 2019.
Initial promising data from the preclinical trials with lefitolimod follow-up molecules EnanDIM(R)
Strategic focus on combination therapies
Successful capital measures secure funding
With regard to the previously issued convertible bond 2017/2025, a meeting of creditors on 28 February 2019 approved the agreement reached at the end of October 2018 with the main bond creditor and the associated adjusted bond conditions. The resolutions put forward by the Company were accepted by a large majority.
Lower research and development expenses
The focus of MOLOGEN's development is on DNA-based TLR9 agonists, where it has consistently been ahead of the course. This includes the lead compound, the immunotherapy lefitolimod, and its next generation molecules EnanDIM(R), building the foundation for a next generation immunotherapy platform in areas of unmet need.
Forthcoming milestones include: the start of the TITAN study in HIV, the start of the clinical development of EnanDIM(R) and additional combination studies in cancer, including one with our strategic partner Oncologie Inc., which are in an advanced planning stage.
MOLOGEN AG is a publicly listed Company, headquartered in Berlin. The shares (ISIN, DE000A2LQ900/SIN: A2L Q90) are listed in the Prime Standard of the German Stock Exchange.
|Phone:||030 / 841788-0|
|Fax:||030 / 841788-50|
|Listed:||Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange|
|EQS News ID:||857801|
|End of News||DGAP News Service|
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