LONDON – Morphosys AG finally has some heft to put behind its U.S. commercialization ambitions following FDA approval for its long-nurtured anti CD19 antibody, Monjuvi (tafasitamab-cxix) in relapsed or refractory diffuse large B-cell lymphoma (r/rDLBCL).
The FDA decision to grant accelerated approval on the basis of an 81-patient open-label phase II study is the first for a second-line treatment in patients who have progressed during or after initial therapy, and who are too weak for an autologous stem cell transplant.
That gives Morphosys and its commercialization partner, Incyte Corp., a U.S. market of approximately 10,000 patients per year to address.
The two companies have a 50:50 interest after the signing in January of a deal in which Incyte paid $750 million up front, bought $150 million of Morphosys stock and agreed to pay up to $1.1 billion in milestones. In addition to a 50% share of the U.S. market, Incyte acquired 100% of the ex-U.S. rights.
The approval marks an important step in Morphosys’ transformation from R&D focused into a fully-fledged biopharmaceutical company, Jean-Paul Kress, CEO of the Planegg, Germany-based company told BioWorld.
“This is what we are achieving today with the launch of Monjuvi,” he said.
Krees has been preparing the company for approval of Monjuvi since taking up the role of CEO in September 2019, when his predecessor and co-founder of Morphosys, Simon Moroney stepped down after 17 years at the helm.
U.S. commercial infrastructure is in place, as are supplies of Monjuvi, which is manufactured in Germany by Boehringer Ingelheim. Germany’s deft management of the COVID-19 pandemic meant there has been no disruption to the supply chain, and while marketing and promotion will now have to be more digital than face-to-face, preparations are complete, Krees said. “We have a team in Boston ready to launch.”
For Incyte this is the chance to pick up some pace after the phase III failure in January of its JAK1 inhibitor itacitinib in acute graft-vs.-host disease. The approval of Monjuvi is the beach head to a larger franchise, with the partners also developing the product in first line DLBCL, as well as follicular lymphoma, marginal zone lymphoma and chronic lymphocytic leukemia.
Wilmington, Del.-based Incyte will also conduct combination studies of its investigational PI3K-delta inhibitor parsaclisib and tafasitamab in r/r B-cell malignancies.
For the discoverer of Monjuvi, Xencor Inc., the approval triggers a $25 million milestone payment from Morphosys, under a 2010 license agreement between the two. Monjuvi follows Alexion Inc.’s Ultomiris (ravulizumab-cwvz) as the second product based on Monrovia, Calif.-based Xencor’s cytotoxic antibody platform.
The technology involves an engineered Fc domain that mediates B-cell lysis through apoptosis, antibody dependent cell mediated cytotoxicity and antibody dependent cellular phagocytosis. Xencor also is eligible to receive sales royalties and is in line for additional milestones based on further approvals and extensions of the label.