MorphoSys To Release Myelofibrosis Trial Data This Year

Shares of MorphoSys AG (MOR), which have been experiencing strong momentum this year, touched a new 52-week high of $6.85 during intraday trading yesterday.

This global commercial-stage biopharmaceutical company is focused on developing therapies for difficult-to-treat and debilitating types of blood cancer.

The company has one marketed drug by the name Monjuvi, which in combination with Lenalidomide (Revlimid), was granted accelerated approval by the FDA in August 2020 for the treatment of relapsed or refractory diffuse large B-cell lymphoma. Monjuvi, generically known as Tafasitamab, is marketed outside the U.S. by Incyte Corp. (INCY) as Minjuvi.

Monjuvi plus Lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) is also being explored in a phase III trial as a first-line treatment for high-intermediate and high-risk patients with diffuse large B-cell lymphoma, dubbed frontMIND.

The frontMIND trial is fully enrolled with more than 880 patients.

The other ongoing trials with Monjuvi are:

— A phase III study comparing Monjuvi plus Lenalidomide and Rituximab against placebo plus Lenalidomide and Rituximab in patients with relapsed/refractory (r/r) follicular lymphoma or marginal zone lymphoma, dubbed InMIND.

— A phase II/III trial evaluating the efficacy and safety of Monjuvi with Bendamustine compared to Rituximab with Bendamustine in adult patients with relapsed or refractory diffuse large B-cell lymphoma, dubbed B-MIND.

Also in the pipeline is Pelabresib, which is designed to promote anti-tumor activity by inhibiting the function of bromodomain and extra-terminal domain (BET) proteins to decrease the expression of abnormally expressed genes in cancer.

A phase III trial of Pelabresib in combination with *Ruxolitinib in patients with myelofibrosis who have not previously been treated with a JAK inhibitor (JAK inhibitor-naïve), dubbed MANIFEST-2, is underway. *Ruxolitinib, a Janus kinase inhibitor, is marketed under the brand name Jakafi by Incyte.

Myelofibrosis is a difficult-to-treat form of blood cancer with limited treatment options. JAK inhibitors, like Incyte’s Jakafi, are a current standard of care treatment for myelofibrosis.

MorphoSys is of the view that a combination of both BET inhibition and JAK inhibition holds significant promise in myelofibrosis, as it is expected to produce synergistic effects.

GlobalData, a data analytics company, estimates that the myelofibrosis market will grow from $2.39 billion in 2021 to $2.89 billion in 2031 within the eight key markets comprising France, Germany, Italy, Spain, the UK, Japan, and China.

Recent Quarterly Scorecard

Total revenues for the first quarter ended Mar.31, 2023, were €62.3 million compared to €41.5 million for the same period in 2022. Revenue is comprised of Monjuvi product sales, royalties, licenses, milestone payments and others.

The company’s consolidated net loss for the first quarter 2023 shrunk to €44.4 million from €122.7 million in the year-ago quarter.

As of March 31, 2023, MorphoSys had €791.5 million in cash and other financial assets.

Anticipated Milestones

— The phase III MANIFEST-2 trial completed the enrollment target of over 400 myelofibrosis patients who were naïve to JAK inhibitors in April of this year. Topline data from this study are expected by the end of 2023.

— Primary analysis data from the phase III inMIND study are expected in 2024.

— Primary analysis data from the phase III frontMIND study are expected in the second half of 2025.

MorphoSys’ American Depositary Shares began trading on the Nasdaq Global Market on April 19, 2018, under the symbol “MOR”, priced at $25.04 each.

MOR has traded in a range of $3.17 to $6.85 in the last 1 year. The stock closed yesterday’s trading at $6.75, up 2.58%.

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