June 9, 2016
By Mark Terry, BioSpace.com Breaking News Staff
Berlin, Germany-based Mologen announced today that it is restructuring its company, reviewing its portfolio, with some programs receiving more focus and others being shelved. The entire program has been dubbed “Next Level,” and is an attempt to shift from a research-focused biotech company toward a product-oriented company.
The primary focus will be on continuing development of its lead product, lefitolimod, a TLR9 agonist. It is currently involved in four clinical trials in colorectal cancer, small-cell lung cancer, and HIV, and a combination study that’s starting shortly with Bristol-Myers Squibb ’s immunotherapy Yervoy (ipilimumab) in patients with solid tumors.
In addition, the company will focus on developing EnanDIM, which is in preclinical development. It is a linear DNA-based TLR9 agonist, which activates the immune system and has potential in various cancer indications as monotherapy or in combination with other targeted therapies. It also has potential in infectious diseases.
Mologen is also halting its MGN1601 program. MGN1601 is a vaccine against renal cancer. The company indicates that if lefitolimod or the complete lefitolimod product group was successfully out-licensed, they would consider restarting the MAN1601 program.
It also wants to sell or spin-off its non-viral vector system MIDGE. This has two compounds in preclinical development for infectious diseases. One is a prophylactic and therapeutic vaccine against leishmaniasis (MGN1331) and against hepatitis (MGN1333). It is also in a Phase I study in malignant melanoma (MGN1404).
“The ‘Next Level’ strategy will define the goalposts for Mologen’s continued successfully development,” said Marola Söhngen, Mologen AG’s chief executive officer, in a statement. “We will focus on the company’s value drivers, especially on the promising cancer immunotherapy lefitolimod, for which we now plan to press on with approval and market preparation activities in view of the mature stage of development reached by the product. These are also important and value-driving activities as regards the out-licensing of the product which we are pursuing as a top priority. We are convinced that we will create real added value for our shareholders with the implementation of this strategy.”
In addition to the realignment of the company’s priorities, it has streamlined its organizational structure. The company states, “Production along with large parts of the research will therefore be discontinued and outsourced to subcontractors and cooperation partners. The company’s growing ‘virtualization’ is making its development activities more efficient and is linked with a variabilization of costs.”
“By outsourcing our production and research activities,” said Walter Miller, Mologen’s chief financial officer, in a statement, “we create structures which are more flexible and geared to products and the market. This will lead to less complexity, a reduction in fixed costs and increasing operating flexibility, which in turn should also contribute to increasing the value of our product portfolio.”
The company provided an update on its clinical trials on May 12. Its focus was on three ongoing clinical trials of Immune Surveillance Reactivator lefitolimod (MGN1703). In the first quarter 2016, patient recruitment continued for the colorectal cancer study. The Phase I TEACH trial in HIV was expanded after promising early results, with the next section of the trial to have more patients and last longer.
The company plans to start analysis of data from its IMPULSE trial in small-cell lung cancer in the second half of this year.
