a new antibody in development
for atopic dermatitis


an investigational antibody
for blood cancer


A drug candidate for mesothelioma


An antibody developed by
Janssen Research & Development, LLC
based on MorphoSys’s HuCAL
antibody library

Annual Report 2016

Engineering the Medicines
of Tomorrow


Phase 2

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The compound:
Anetumab ravtansine – A HuCAL-based antibody drug conjugate targeting mesothelin

The investigational antibody drug conjugate (ADC) anetumab ravtansine is being developed by MorphoSys’s partner Bayer in a range of cancer types. The lead indication is malignant pleural mesothelioma, a type of lung cancer with a very poor prognosis. Final data collection from an ongoing phase 2 clinical study is expected in late 2017. This study, although billed as being phase 2, is designed to support registration of anetumab ravtansine.

Anetumab ravtansine (BAY 94-9343) is an antibody-drug conjugate (ADC) based on MorphoSys’s HuCAL technology. An ADC comprises an antibody linked to a cytotoxin which is targeted to the cancer cells by the antibody’s binding to its antigen at the surface of cancer cells. Anetumab ravtansine targets mesothelin, a tumor specific antigen, which has been found on several cancer types including mesothelioma as well as ovarian and pancreatic adenocarcinomas.

  1. mesothelioma
    When breathed in, asbestos fibers can enter deeply into the lungs and aggregate there. Asbestos is extremely stable and cannot be biologically degraded by the body. Thus asbestos can become the cause of chronic inflammation that may ultimately lead to the onset of cancer, often many decades after the actual exposure. The exact molecular mechanism for the formation of malignant pleural mesothelioma is not yet fully understood. Experts assume that immunological processes which are caused by a permanent irritation through the asbestos fibers play a role here.

The therapeutic field: Targeting mesothelioma

Malignant pleural mesothelioma (MPM) is a rare cancer disease affecting parts of the lung and the thorax, in particular the membrane that covers the surface of each lung. The disease is typically caused by asbestos exposure. The tumor is characterized as very aggressive leading to a poor prognosis in affected patients. Treatment options are very limited and there is currently no cure available. After first diagnosis, patients are reported to have a mean survival of between 12 and 21 months depending on the stage of disease at diagnosis. Only about 8% of patients are reported to survive for 5 years from the time of diagnosis. In 2013, about 50,000 people worldwide had mesothelioma while 34,000 died from the disease in 2013. The incidence of malignant mesothelioma currently ranges from about 7 to 40 new cases per million in industrialized Western nations, depending on the amount of asbestos exposure of the populations during the past several decades.

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Dr. Cem Elbi, MD, PhDGlobal Clinical Leader for Anetumab Ravtansine at Bayer

Dr. Elbi, MorphoSys announced in early 2016 that Bayer started a clinical Phase 2 study with the antibody drug conjugate anetumab ravtansine in pleural mesothelioma. What are you investigating in the study?
Mesothelioma is a rare, aggressive and rapidly fatal cancer. Current treatment options are limited and, therefore, the medical need is very high. The clinical phase 2 study will evaluate the safety and efficacy of anetumab ravtansine in comparison to the chemotherapeutic agent vinorelbine in approximately 210 patients with mesothelin overexpression in their tumors that have progressed on a first-line platinum/pemetrexed-based chemotherapy.
Bayer said the study results could possibly support a regulatory filing. When are first results expected? When could the drug be on the market?
The trial has been designed to support registration and trial results are expected towards the end of 2017. We currently estimate a first launch of anetumab ravtansine to be possible in 2019.
If approval is granted, how would MorphoSys benefit? What is the estimated sales potential for anetumab ravtansine?
MorphoSys is entitled to success-based milestone payments and royalties. Exact royalty rates are not disclosed, but royalties on net sales are generally in a mid-single digit range. We currently estimate an overall peak sales potential of about EUR 2 billion for the compound.
Is the compound only being developed for mesothelioma or do you see potential for other indications as well?
The mesothelin antigen which anetumab ravtansine is targeting is also expressed on various other cancer types including pancreatic and ovarian cancer. Bayer is investigating the compound in a number of studies and indications. Further trials are planned to start in 2017. We are excited about broadening the study program for anetumab ravtansine and we hope for a lot of interesting news flow from this compound in the future.

as of March 2017

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