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New HIV Eradication Combo Study
  The cancer immunotherapy lefitolimod (MGN1703) is the company's lead product and best-in-class TLR9 agonist.
MOLOGEN AG: Grant to collaboration partner for combination study in HIV with lead product lefitolimod
⋅Gilead Sciences, Inc. grant for Aarhus University Hospital
⋅Funding for a novel "kick-and-kill" concept of HIV eradication
⋅Lefitolimod to be combined with new virus-neutralizing antibodies
January 10, 2017 11:50 AM Eastern Standard Time
BERLIN--(BUSINESS WIRE)--The biotech company MOLOGEN AG (ISIN DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) announced today that its partner, the Danish Aarhus University Hospital, has received a grant of USD 2.75 million from the biopharmaceutical company Gilead Sciences, Inc., Foster City, US. The grant should fund a planned clinical study in HIV-positive patients on antiretroviral therapy (ART) evaluating MOLOGEN's TLR9 agonist, the Immune Surveillance Reactivator (ISR) lefitolimod in combination with novel virus-neutralizing antibodies developed by Rockefeller University, New York, US. MOLOGEN would provide lefitolimod for the study. This novel combination to be investigated in the planned study would offer the latest variant of the "kick-and-kill" concept to treat HIV. Dr. Mariola Sšhngen, CEO of MOLOGEN, said: "In addition to our ongoing TEACH study this innovative approach could help us to further evaluate the potential of lefitolimod in HIV. Lefitolimod would be combined with novel antibodies. Due to its mode of action we strongly believe that the combination of different compounds could be of benefit in a number of patients."
New approach of the "kick-and-kill" concept
The rationale for the novel combination is that the two compounds with their different modes-of-action synergize to generate a more effective attack and killing of the HIV reservoir compared to current standard HIV treatment regiments, i.e. antiretroviral therapy (ART). The efficacy of lefitolimod in "kick-and-kill" is currently established in the ongoing phase I TEACH study in HIV-infected patients at Aarhus University Hospital with Associate Professor Ole S¿gaard as principal investigator. Treatment with lefitolimod leads to broad immune system activation as shown by the increased activation of antiviral immunity. The broadly neutralizing antibodies act via inactivation of the virus and virus producing cells in the patient's body to prevent further infection and eliminate infected cells. Lefitolimod and the new antibodies have been tested individually; no combination studies were conducted so far.
HIV infects the immune system and destroys or affects the proper function of immune cells. Without antiretroviral treatment, this eventually leads to acquired immune deficiency syndrome (AIDS) 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 2015. Some 2 million people became newly infected in that same year, and 1.1 million died as a result of HIV-related causes globally.
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 lefitolimod (MGN1703) triggers a broad and strong activation of the immune system. Due to this mode of action, namely to reactivate the monitoring function of the immune system, lefitolimod (MGN1703) can be recognized as an Immune Surveillance Reactivator (ISR). It has the potential to be applied to various indications. ISR 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 an extended phase I study in HIV and a phase I combination study with the checkpoint inhibitor ipilimumab (Yervoy®). Next to checkpoint inhibitors, lefitolimod is one of the few product candidates that are in a phase III clinical trial (IMPALA) in the field of immuno-oncology and close to reaching the market.
MOLOGEN's pipeline focus is on new, innovative immunotherapies to treat diseases for which there is a high medical need.
A New HIV Therapy uses DNA and Antibodies to fight Viral Reservoirs
Mologen's partner in the development of an HIV therapy has received a 2.6M grant to evaluate a promising new combination therapy in the clinic.
Berlin-based Mologenis working with the Aarhus University Hospital in Denmark to developlefitolimod, an immunomodulatory HIV treatment.The candidate willnow be tested in combination with neutralizing antibodies developed by Rockefeller University in New York thanks to a 2.6M ($2.75M) grant from Gilead, which is also working on its own HIV therapy.
Mologen's lefitolimod is a DNA molecule designed to bind to the toll-like receptor 9 (TLR9), which activates a broad response from the innate immune system. Unlike most of its competitors, the company's HIV therapy uses double-stranded DNA, eliminating the need to protect vulnerable single-stranded molecules from rapid degradation.


Lefitolimod's structure
The candidate has already returned preliminary results demonstrating its safety and efficacy as an HIV treatment in an ongoing Phase I study. The new trial will use lefitolimod's immunomodulatory activity to help neutralizing antibodies to detect and kill the virus and infected cells. This kind of strategy, which other companies developing an HIV cure like Abivax or InnaVirvax alsofollow, targets the reservoir of viruses hiding inside immune cells, which the standard antiretroviral therapies cannot attack.
Mologen is also testing lefitolimod's ability to boost the immune system as a cancer therapy. In fact, the treatment is one of the few immuno-oncology programs besides checkpoint inhibitors that have reached Phase III.


Mologen's pipeline
Unlike most biotechs, the company is carrying out late-phase trials without a funding partner. As its 70M market cap hints at, Mologen doesn't seem to have big funds for a late-stage clinical company. However, it seems to have managed to raise enough funds and obtain promising results so far.
A move uncommon in European biotechs, the companywent public from the first day of its foundation, back in 1998's IPO bubble.Now, if its lead candidate proves effective as a combination therapy, the biotech might finally attract a lucrative partnership.

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