MOLOGEN AG: Results of the Extension Phase of the Exploratory Phase Ib/IIa Study in HIV
August 09 2017 - 5:28AM
Business Wire
The biopharmaceutical company MOLOGEN AG (ISIN DE0006637200;
Frankfurt Stock Exchange Prime Standard: MGN) announced the key
results of the extension phase of the exploratory phase Ib/IIa
TEACH trial to evaluate lefitolimod in HIV-positive (HIV: human
immunodeficiency virus) patients on antiretroviral therapy
(ART). The study, a cooperation with the Aarhus University
Hospital in Denmark, was extended based on the positive results
seen in the initial study phase as recently
published1. Findings from the extension phase of
TEACH suggest – although lefitolimod alone on top of ART did not
show the desired effect on the viral reservoir – the compound could
be an important combination partner for other interventions aiming
at HIV cure, such as monoclonal antibodies or vaccines.
This conclusion is supported by the main following study
results:
- Sustained increases in activation of
important immune cells (CD4 and CD8 T cells) were observed
throughout the dosing period of 24 weeks.
- Lefitolimod triggered maturation of
other important immune cells (B cells) towards antibody-producing
cells.
- After interruption of ART, one of the
nine patients who participated in that study part showed viral
control for more than 20 weeks, whereas the interval until viral
rebound is generally two weeks.
- The intervention had no detectable
effects on the size of viral reservoir in peripheral blood in the
total study population of 12 patients, which was defined as the
primary endpoint of the extension phase of the study.
- 24 weeks of lefitolimod treatment was
safe and well tolerated in HIV patients on ART, corroborating the
favourable safety profile already seen in cancer patients.
“The available T and B cell data together with its excellent
safety profile suggest that lefitolimod could be very well suited
to be combined with other promising HIV cure interventions such as
monoclonal antibodies or an HIV vaccine. Such a combination trial
has recently been funded and is expected to start in 2018 as a
collaboration between MOLOGEN, Aarhus University Hospital and other
international partners. Furthermore, the finding that one patient
controlled viral replication to below the limit of detection and
remained off ART for 22 weeks is very intriguing and is currently
under intensive evaluation”, said Ole Schmeltz Søgaard, MD, PhD,
Associate Professor at the Aarhus University Hospital and principal
investigator of the study, Department of Infectious Diseases,
Aarhus, Denmark.
The most common related adverse events in the extension phase of
the TEACH study were neutropenia, injection site reaction, fatigue,
dizziness, and headache. The majority of adverse events were of
mild or moderate intensity with no life-threatening or fatal
events. There were no discontinuations due to adverse events and no
related serious adverse events.
Dr Matthias Baumann, Chief Medical Officer of MOLOGEN AG
commented: “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. We are confident that
lefitolimod can be an important component of therapeutic approaches
aiming to cure HIV.”
A more extensive evaluation of the TEACH data is currently
ongoing. Detailed TEACH study results of the extension phase will
be presented at an international scientific conference.
MOLOGEN’s ongoing development programs, especially the pivotal
IMPALA study in the indication of colorectal cancer, are running
independently from these study results, given these are different
indications.
Reference: 1 Vibholm et al., Clinical
Infectious Diseases, 2017, 64, 1686-95 – Link to article.
About TEACH
TEACH (Toll-like receptor 9 enhancement of
antiviral immunity in chronic HIV infection)
is a non-randomized interventional phase Ib/IIa trial to evaluate
lefitolimod in HIV positive patients under antiretroviral therapy
(ART). In the first part of the study, 15 participants received
four weeks of lefitolimod therapy (60 mg s.c. twice weekly). The
extension phase included 12 patients under ART, who were treated
for 24 weeks with lefitolimod. After completion, nine of these
patients participated in an analytical antiretroviral treatment
interruption (ATI) until viral rebound. ATI is an established
procedure used to determine the size and reduction of the reservoir
of latent infected cells which is measured via time to viral
rebound. After viral rebound ART is reintroduced.
Aarhus University Hospital, Denmark conducted the trial in two
hospital centers in Denmark for which it received funding from the
American Foundation for AIDS research (amfAR). MOLOGEN provided the
Immune Surveillance Reactivator (ISR) lefitolimod.
The primary endpoint of the first study treatment phase is the
change in proportions of activated natural killer cells in
patients. Secondary study endpoints include, among others, a
collection of safety, virological, immunological and
pharmacodynamic data. In the extension phase the change in HIV-DNA
in circulating T cells was assessed as primary endpoint. Main
secondary endpoints were – besides safety evaluation – changes of
functional immune parameters.
HIV infects the immune system and destroys or affects the proper
function of immune cells. Without antiretroviral treatment, this
eventually leads to immune deficiency and the immune system can no
longer fend off a wide range of infections and diseases.
HIV remains a serious worldwide health issue. According to
estimates by WHO and UNAIDS (United Nations Programme on AIDS) 37
million people worldwide were living with HIV at the end of 2014.
Some 2 million people became newly infected in that same year, and
1.2 million died as a result of HIV-related causes globally.
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® (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.
www.mologen.com
Disclaimer
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terms referring to the future or future developments, as well as
negations of such formulations or terms, or similar terminology.
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information in this communication regarding planned or future
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updating such information, which only represents the state of
affairs on the day of publication.
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MOLOGEN AGClaudia NickolausHead of Investor
Relations & Corporate CommunicationsTel: +49 - 30 - 84 17 88 -
38Fax: +49 - 30 - 84 17 88 - 50investor@mologen.com