Mologen (ETR:MGN) is halting most of its in-house research activities and shelving development of a clutch of programs to free up money for the advance of its lead candidate, lefitolimod. The revised strategy ties the fate of Mologen to the success of lefitolimod, a TLR9 agonist that is being tested in a late-phase colorectal cancer trial.
Berlin, Germany-based Mologen unveiled the major changes to its operation following a review of its portfolio. Mologen is presenting the overhaul as part of its transition from being a research-focused biotech to a market-orientated company. In practice, this means Mologen is cutting away at nearly every part of the business that isn’t primarily focused on advancing lefitolimod through clinical trials and toward a payday of one sort or another.
Research is one victim of the strategic shift. Mologen is set to stop “large parts” of its research work, an action that will result in the company relying on CROs and partners for support. The same shift from in-house to outsourced work is underway at the manufacturing unit. A contract manufacturer is stepping in to handle activities previously performed in-house and help Mologen to prepare for the anticipated commercialization of lefitolimod.
Those activities will step up a gear if a Phase III trial of lefitolimod in patients with colorectal cancer yields positive data. The trial is one of four lefitolimod studies that form the sum total of Mologen’s clinical trial activities following the rethink of its strategy. A Phase II lung cancer study and two Phase I trials, one in HIV, the other pairing lefitolimod to Bristol-Myers Squibb’s ($BMY) Yervoy, make up the rest of the clinical trial programs.
Prior to the strategic shift, Mologen had also been working on a clutch of other candidates, two of which had made it as far as Phase I. Mologen has now halted all of those programs. The company is keeping hold of one of the assets, cell-based therapeutic vaccine MGN1601, so it has something to develop in the event lefitolimod is acquired. Another three candidates and accompanying technology are up for sale.
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