MorphoSys

Last updated
MorphoSys AG
Type Public Company
Industry Biotechnology
Founded1992;31 years ago (1992)
Headquarters
Planegg, Germany
Key people
Dr. Jean-Paul Kress, Chief Executive Officer
Sung Lee, Chief Financial Officer
Dr. Malte Peters, Chief Research & Development Officer
Dr. Roland Wandeler, Chief Commercial Officer
Dr. Marc Cluzel, Chairman of Supervisory Board
Products Immunotherapy
Revenue€327.7 million (2020) [1]
€27.4 million (2020) [1]
€97.9 million (2020) [1]
Total assets €1,659.5 million (end 2020) [1]
Total equity €621.3 million (end 2020) [1]
Number of employees
615 (end 2020) [1]
Website www.morphosys.com

MorphoSys AG is a biopharmaceutical company founded in 1992. The company is headquartered near Munich, Germany and has a wholly owned subsidiary, MorphoSys US Inc., in Boston MA in the US. The company has various antibody, protein and peptide technologies that it uses to discover and develop both proprietary and partnered drug candidates. The company has more than 100 drugs in its wider pipeline that are being investigated for a variety of diseases. [1] [2] [3] While many of these are being developed in partnership with pharma and biotech companies, MorphoSys also has a proprietary pipeline with a focus on cancer and autoimmune diseases.

Contents

MorphoSys AG is listed on the Frankfurt Stock Exchange and on the US Nasdaq stock exchange.

History

The Company was founded in 1992. In 1999, MorphoSys listed on the Frankfurt Stock Exchange under the ticker symbol "MOR".

In 2004, MorphoSys and Novartis entered into a strategic partnership for the research and development of biopharmaceuticals, which was expanded in 2007. [1] Additional discovery partnerships included: Bayer (1999), Roche (2000), Centocor (now Janssen Biotech, 2000), Schering AG (2001) and Pfizer (2003).

In 2008, the company’s first proprietary antibody MOR103 (now otilimab) entered clinical development. [4] Following the publication of promising results in rheumatoid arthritis, MorphoSys signed a license agreement with GlaxoSmithKline for otilimab. [5] In 2019, GlaxoSmithKline initiated a phase 3 clinical development program with otilimab (now GSK3196165). [6]

In 2010, MorphoSys signed a license agreement with Xencor Inc. for MOR208 (now tafasitamab). [7]

In July 2017, the first of MorphoSys’ platform drugs received US marketing approval. Guselkumab (brand name Tremfya), which was developed and is being commercialized by Janssen Biotech a subsidiary of Johnson & Johnson, was first approved for the treatment of moderate-to-severe plaque psoriasis in the United States, the European Union and Canada. [8] [9]

In April 2018, following a US initial public offering in which the company raised $239 million, American depositary shares of MorphoSys began trading on the Nasdaq stock exchange, also under the symbol "MOR." [10] [11]

In 2018, the company established a wholly owned US subsidiary, MorphoSys US Inc..

In December 2019, based on positive clinical trial results, the company submitted a Biologics License Application (BLA) to the FDA for tafasitamab in combination with lenalidomide for the treatment of relapsed/refractory diffuse large B-cell lymphoma. [12] The submission was accepted for filing in February 2020, and a decision on the filing is expected in August 2020. [13]

In January 2020, MorphoSys and Incyte Corporation signed a collaboration and license agreement for the global development and commercialization of tafasitamab. [14] On March 3, 2020, the agreement received antitrust clearance and thus became effective. [15]

In March 2020, MorphoSys announced that the FDA had accepted the Biologics License Application (BLA) for filing and granted priority review for tafasitamab, setting a Prescription Drug User Fee Act (PDUFA) goal date of August 30, 2020. [16]

On July 31, 2020, Monjuvi (tafasitamab-cxix) was approved by the U.S. FDA in combination with lenalidomide for the medical treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). [17] [18]

Pipeline

As of December 2020, MorphoSys had 116 drug candidates which are developed by MorphoSys and other pharmaceutical companies, 28 of which were in clinical development. Two antibodies developed by MorphoSys are already approved and marketed. [1] [3]

Tafasitamab (MOR208) is a humanized monoclonal antibody directed against CD19 in clinical development for the treatment of B-cell malignancies. [2] [19] Tafasitamab is being evaluated in several clinical trials, alone and in combination with other anti-cancer drugs. [1] [3] [19]

Felzartamab (MOR202)is a humanized monoclonal antibody directed against CD38 for the treatment of anti-PLA2R-positive membranous nephropathy, an autoimmune disease affecting the kidneys. [2] In 2017, MorphoSys entered into a regional licensing agreement with I-Mab Biopharma to develop and commercialize Felzartamab (called TJ202 by I-Mab) in Greater China. [20] Felzartamab (MOR202/TJ202) is currently under investigation by I-Mab in three clinical trials. [21]

Otilimab (MOR103/GSK3196165) is a fully human monoclonal antibody directed against GM-CSF. [2] The program is outlicensed to GlaxoSmithKline. [4] [5] Otilimab is currently under investigation in a Phase 3 trial in rheumatoid arthritis that started in July 2019. [6]
On March 2nd, 2023, MorphoSys announced that the company would end its preclinical research programs and cease all related activities. According to the press release, this step is justified by challenges in the pharmaceutical market, which are forcing the company to optimize its cost structure and to focus all resources more on oncology products in the mid to late stage of development [22] .

Technology

MorphoSys has discovered a number of antibody technologies that are use for drug development.

MorphoSys’ main technology is HuCAL (Human Combinatorial Antibody Library), which is a collection of more than ten billion fully human antibodies in the form of a phage display bank and a system for their optimization. [23]

Another technology recently developed is the OkapY bispecific antibody technology. MorphoSys’ OkapY technology is a new proprietary “2+1” bispecific antibody format with the hysicochemical properties to simplify the development and large-scale production of such molecules. [1] [24]

Related Research Articles

<span class="mw-page-title-main">Lenalidomide</span> Pair of enantiomers

Lenalidomide, sold under the trade name Revlimid among others, is a medication used to treat multiple myeloma, smoldering myeloma, and myelodysplastic syndromes (MDS). For multiple myeloma, it is used after at least one other treatment and generally with dexamethasone. It is taken by mouth.

<span class="mw-page-title-main">Diffuse large B-cell lymphoma</span> Type of blood cancer

Diffuse large B-cell lymphoma (DLBCL) is a cancer of B cells, a type of lymphocyte that is responsible for producing antibodies. It is the most common form of non-Hodgkin lymphoma among adults, with an annual incidence of 7–8 cases per 100,000 people per year in the US and UK. This cancer occurs primarily in older individuals, with a median age of diagnosis at ~70 years, although it can occur in young adults and, in rare cases, children. DLBCL can arise in virtually any part of the body and, depending on various factors, is often a very aggressive malignancy. The first sign of this illness is typically the observation of a rapidly growing mass or tissue infiltration that is sometimes associated with systemic B symptoms, e.g. fever, weight loss, and night sweats.

Tositumomab is a murine monoclonal antibody which targets the CD20 antigen produced in mammalian cell. It was combined with iodine-131 to produce a radiopharmaceutical for unsealed source radiotherapy, Iodine-131 Tositumomab, for the treatment of non-Hodgkins lymphoma. It is classified as a IgG2a lambda antibody.

<span class="mw-page-title-main">Ofatumumab</span>

Ofatumumab is a fully human monoclonal antibody to CD20, which appears to provide rapid B-cell depletion. Under the brand name Kesimpta, it is approved for the treatment of multiple sclerosis in the United States as well as in the European Union and other regions. Under the brand name Arzerra, it is approved for the treatment of certain types of chronic lymphocytic leukemia (CLL) in the United States. It is sold by Novartis under license from Genmab.

Genmab A/S is a Danish biotechnology company, founded in February 1999 by Florian Schönharting, at the time managing director of BankInvest Biomedical venture fund. The company is based in Copenhagen, Denmark – internationally, it operates through the subsidiaries Genmab B.V. in Utrecht, The Netherlands, Genmab U.S., Inc. in Princeton, USA, and Genmab K.K. in Tokyo, Japan. It's a dual listed company with shares traded on the Copenhagen Stock Exchange in Denmark, and on NASDAQ Global Select Market in the US.

Brentuximab vedotin, sold under the brand name Adcetris, is an antibody-drug conjugate medication used to treat relapsed or refractory Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (ALCL), a type of T cell non-Hodgkin lymphoma. It selectively targets tumor cells expressing the CD30 antigen, a defining marker of Hodgkin lymphoma and ALCL. The drug is being jointly marketed by Millennium Pharmaceuticals outside the US and by Seattle Genetics in the US.

<span class="mw-page-title-main">Daratumumab</span>

{{Drugbox | Verifiedfields = changed | Watchedfields = changed | verifiedrevid = 458638612 | type = mab | image = Daratumumab CD38 7DHA.png | width = | alt = | caption =Fab fragment of daratumumab (teal/green) binding CD38. From PDB entry 7DHA

<span class="mw-page-title-main">Incyte</span> American pharmaceutical company

Incyte is an American multinational pharmaceutical company with headquarters in Wilmington, Delaware, and Morges, Switzerland. The company was created in 2002 through the merger of Incyte Pharmaceuticals, founded in Palo Alto, California in 1991 and Incyte Genomics, Inc. of Delaware. The company currently operates manufacturing and R&D locations in North America, Europe, and Asia.

Seagen Inc. is an American biotechnology company focused on developing and commercializing innovative, empowered monoclonal antibody-based therapies for the treatment of cancer. The company, headquartered in Bothell, Washington, is the industry leader in antibody-drug conjugates or ADCs, a technology designed to harness the targeting ability of monoclonal antibodies to deliver cell-killing agents directly to cancer cells. Antibody-drug conjugates are intended to spare non-targeted cells and thus reduce many of the toxic effects of traditional chemotherapy, while potentially enhancing antitumor activity.

ImmunoGen, Inc. is a biotechnology company focused on the development of antibody-drug conjugate (ADC) therapeutics for the treatment of cancer. ImmunoGen was founded in 1981 and is headquartered in Waltham, Massachusetts.

Kite Pharma is an American biotechnology company that develops cancer immunotherapy products, with a primary focus on genetically engineered autologous CAR T cell therapy, a cell-based therapy which relies on chimeric antigen receptors and T cells. Founded in 2009 and based in Santa Monica, California, it was acquired by Gilead Sciences in 2017.

Polatuzumab vedotin (INN; brand name Polivy, is an antibody-drug conjugate or ADC designed for the treatment of cancer. The US Food and Drug Administration approved polatuzumab vedotin in June 2019 for treatment of diffuse large B-cell lymphoma when used in combination with bendamustine and rituximab after at least two prior therapies. The drug was developed by Genentech.

<span class="mw-page-title-main">PD-1 and PD-L1 inhibitors</span>

PD-1 inhibitors and PD-L1 inhibitors are a group of checkpoint inhibitor anticancer drugs that block the activity of PD-1 and PDL1 immune checkpoint proteins present on the surface of cells. Immune checkpoint inhibitors are emerging as a front-line treatment for several types of cancer.

Tisagenlecleucel, sold under the brand name Kymriah, is a CAR T cells medication for the treatment of B-cell acute lymphoblastic leukemia (ALL) which uses the body's own T cells to fight cancer.

Axicabtagene ciloleucel, sold under the brand name Yescarta, is a medication used for the treatment for large B-cell lymphoma that has failed conventional treatment. T cells are removed from a person with lymphoma and genetically engineered to produce a specific T-cell receptor. The resulting chimeric antigen receptor T cells (CAR-Ts) that react to the cancer are then given back to the person to populate the bone marrow. Axicabtagene treatment carries a risk for cytokine release syndrome (CRS) and neurological toxicities.

<span class="mw-page-title-main">Umbralisib</span> Chemical compound

Umbralisib, sold under the brand name Ukoniq, is an anti-cancer medication for the treatment of marginal zone lymphoma (MZL) and follicular lymphoma (FL). It is taken by mouth.

Lisocabtagene maraleucel, sold under the brand name Breyanzi, is a cell-based gene therapy used to treat large B-cell lymphoma.

Otilimab is a fully human antibody which has been developed by the biotechnology company MorphoSys. It can also be referred to as HuCAL antibody, HuCAL standing for Human Combinatorial Antibody Library and being a technology used to generate monoclonal antibodies. Otilimab is directed against the granulocyte-macrophage colony stimulating factor (GM-CSF), a monomeric glycoprotein functioning as a cytokine promoting both proliferation and activation of macrophages and neutrophils.

<span class="mw-page-title-main">Selinexor</span> Anti-cancer drug

Selinexor sold under the brand name Xpovio among others, is a selective inhibitor of nuclear export used as an anti-cancer medication. It works by blocking the action of exportin 1 and thus blocking the transport of several proteins involved in cancer-cell growth from the cell nucleus to the cytoplasm, which ultimately arrests the cell cycle and leads to apoptosis. It is the first drug with this mechanism of action.

Tafasitamab, sold under the brand name Monjuvi, is a medication used in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

References

  1. 1 2 3 4 5 6 7 8 9 10 11 "Annual Report 2020". MorphoSys. Retrieved 29 April 2021.{{cite web}}: CS1 maint: url-status (link)
  2. 1 2 3 4 "MorphoSys' therapeutic pipeline". MorphoSys.
  3. 1 2 3 "Form 20-F". U.S. Securities and Exchange Commission.{{cite web}}: CS1 maint: url-status (link)
  4. 1 2 "otilimab (MOR103/GSK3196165)". MorphoSys. 2014-10-27. Retrieved 2018-06-23.
  5. 1 2 "MorphoSys Signs Global License Agreement with GlaxoSmithKline for Anti-Inflammatory Program MOR103". MorphoSys. 2013-06-03. Retrieved 2020-04-29.
  6. 1 2 "MorphoSys's Licensing Partner GSK Initiates Phase 3 Clinical Program With Otilimab (MOR103/GSK3196165) in Rheumatoid Arthritis". dgap.de. 2019-07-03. Retrieved 2020-04-29.
  7. ↑ "MorphoSys and Xencor Sign License and Collaboration Agreement for Clinical Antibody Program". MorphoSys. 2010-06-27. Retrieved 2020-04-29.
  8. ↑ "MorphoSys' licensee Janssen receives Japanese approval for Tremfya to treat moderate to severe forms of psoriasis & psoriatic arthritis". pharmabiz.com. Retrieved 2018-06-05.
  9. ↑ Guselkumab BLA Approval Letter
  10. ↑ "Nasdaq Welcomes MorphoSys AG (Nasdaq: MOR) to The Nasdaq Stock Market". Nasdaq. 2018-04-19. Retrieved 2020-04-29.
  11. ↑ "MorphoSys Announces Closing of Nasdaq IPO through an ADS Offering and Exercise of the Underwriters' Option to Purchase Additional ADSs, Leading to Total Gross Proceeds of USD 239 million". dgap.de. 2018-04-24. Retrieved 2020-04-29.
  12. ↑ "MorphoSys Announces Submission of Biologics License Application for Tafasitamab in r/r DLBCL to the FDA". dgap.de. 2019-12-30. Retrieved 2020-04-29.
  13. ↑ "MorphoSys Initiates Expanded Access Program for Tafasitamab in the U.S." dgap.de. 2020-01-13. Retrieved 2020-04-29.
  14. ↑ "MorphoSys and Incyte Sign Global Collaboration and License Agreement, including U.S. Co-Commercialization and Ex-U.S. Commercialization Rights, for Tafasitamab". dgap.de. 2020-01-13. Retrieved 2020-04-29.
  15. ↑ "MorphoSys and Incyte Announce Antitrust Clearance of Global Collaboration and License Agreement for Tafasitamab". dgap.de. 2020-03-03. Retrieved 2020-04-29.
  16. ↑ "FDA Accepts MorphoSys' Biologics License Application (BLA) and Grants Priority Review for Tafasitamab and Lenalidomide for the Treatment of Relapsed/Refractory DLBCL". dgap.de. 2020-03-02. Retrieved 2020-04-29.
  17. ↑ "FDA Approves Monjuvi(R) (tafasitamab-cxix) in Combination with Lenalidomide for the Treatment of Adult Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)". dgap.de. 2020-08-01. Retrieved 2021-04-30.
  18. ↑ "FDA grants accelerated approval to tafasitamab-cxix for diffuse large B-cell lymphoma". FDA.gov. 2020-08-03. Retrieved 2021-04-30.
  19. 1 2 "tafasitamab". MorphoSys.{{cite web}}: CS1 maint: url-status (link)
  20. ↑ "MorphoSys Signs Regional License Agreement for Antibody MOR202 with I-Mab". dgap.de. 2017-11-30. Retrieved 2020-04-29.
  21. ↑ "I-Mab Biopharma's therapeutic pipeline". I-Man Biopharma.
  22. ↑ "MorphoSys Stops Work and Operations on Pre-Clinical Research Programs" . Retrieved 2023-03-02.
  23. ↑ "HuCaL". MorphoSys.{{cite web}}: CS1 maint: url-status (link)
  24. ↑ MorphoSys (January 13, 2021). Engineering theMedicinesofTomorrow (PDF) (Speech). J.P. Morgan HealthcareConference. Retrieved April 29, 2021.
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