In an exclusive interview with The Fly, MorphoSys (MOR) CEO Jean-Paul Kress talked about the company, its goals, its pipeline, M&A and partnerships, and much more.
COMPANY GOALS: Looking ahead, MorphoSys' ambition is to "become a leader in hematology and oncology," CEO Jean-Paul Kress explained to The Fly. The company expects that by 2025, it will have two commercial products available - Monjuvi and pelabresib – across several indications. "Monjuvi, our cancer immunotherapy, is already available to treat relapsed or refractory diffuse large B-cell lymphom, and we are driving the penetration in the second line setting where we are currently the only approved therapy and have leading market share. Beyond the currently approved indication, we are developing Monjuvi in first line DLBCL, where we see the biggest opportunity, and in additional hematological indications. Pelabresib, one of the compounds we acquired from Constellation Pharmaceuticals, has the potential to enhance the standard of care in myelofibrosis, a rare bone marrow cancer for which only limited treatment options are available," the executive explained.
MorphoSys also had three Phase 3 trials currently underway between Monjuvi and pelabresib, with pivotal read-outs expected over the next few years. "We also have two other promising therapies in mid-stage clinical development. This is a robust pipeline for a company of our size. Our priorities are to accelerate momentum with Monjuvi and get our late-stage pivotal assets over the finish line, all while exercising a disciplined capital allocation approach," the CEO added.
MANIFEST STUDY: Recent positive data at ASH pointed to the potential of MorphoSys’ mid-to-late-stage portfolio with newly acquired pelabresib for the treatment of myelofibrosis. "The data presented at ASH 2021 from the ongoing MANIFEST study reconfirmed previously published results and reinforced the role pelabresib may play, if approved, in overcoming some of the challenges we face in treating myelofibrosis. These latest data evaluated pelabresib as a first-line combination with ruxolitinib, the current standard of care, for patients with myelofibrosis who had not previously been treated with a JAK inhibitor. As of September 10, 2021, the data cut-off, a total of 84 JAK inhibitor-naïve patients have been enrolled and received the combination. The data showed 68 percent of patients treated with the combination achieved a >=35 percent reduction in spleen volume from baseline at week 24 and 60 percent maintained SVR35 at week 48. Most patients also saw their symptoms reduced, with 56 percent achieving >=50 percent reduction in total symptom score from baseline at week 24. At the time of the data cut-off, 53 patients (63 percent of the 84 patients) were still on treatment. No new safety signals were identified in the study," Kress said.
The executive also explained to The Fly that, "Additionally, analyses from an exploratory endpoint presented at ASH 2021 showed a reduction of megakaryocyte clustering in bone marrow and correlation with spleen volume reduction. Megakaryocytes are the cells in the bone marrow responsible for making platelets, and the clustering of these cells are one of the signs of myelofibrosis. The exploratory data, which require further evaluation, suggest the potential pelabresib may have in changing the course of myelofibrosis treatment, if approved."
MorphoSys are further exploring the effectiveness and safety of pelabresib as a first-line treatment for myelofibrosis in MANIFEST-2, an ongoing, registration-enabling Phase 3 study. "The latest results reaffirm our confidence in the MANIFEST-2 study, and we look forward to sharing findings from this trial once they become available," the executive added.
MONJUVI LAUNCH: Discussing the Monjuvi launch, CEO Kress said that, "Despite COVID headwinds in the first half of 2021, feedback we have received to date from physicians is overwhelmingly positive and our confidence remains strong. Monjuvi achieved $23.6 million in preliminary sales in the U.S. in Q4 – driven primarily by demand. We expect continued growth and forecast $110 – $135 million in U.S. sales in 2022." Monjuvi is being co-commercialized by Incyte (INCY) and MorphoSys in the United States. Incyte has exclusive commercialization rights outside the United States.
M&A ON THE BIOPHARMA AGENDA IN 2022: Last year, the company announced deals with both Constellation and Royalty Pharma (RPRX). Discussing potential M&A and partnerships in the space, the executive said that, "M&A will stay firmly on the Biopharma agenda in 2022. With that, it will be important for companies to find a strategic mix between acquisitions, in-licensing, and partnerships to maximize value for all their stakeholders. Acquiring a company or asset is higher cost with more risks and rewards. For example, through MorphoSys’ acquisition of Constellation Pharmaceuticals, we were able to quickly enhance and expand our pipeline with highly promising advanced drug candidates."
"A partnership allows other organizations to put capital and focus behind an asset in its next stage of development, structuring the partnership to retain a meaningful stake that is value-creating for both parties. For example, MorphoSys partners with Incyte to market Monjuvi. This partnership has been extremely positive experience, giving us access to more capital and helping to fuel the development of this important medicine for other indications," he explained to The Fly.
"Meet the Company" is The Fly's recurring series of exclusive short interviews with Executive Officers to offer a deeper look inside the company.
MorphoSys
-0.34 (-4.56%)
Incyte
-1.11 (-1.47%)
Royalty Pharma
-0.495 (-1.25%)