MOR106

a new antibody in development
for atopic dermatitis

MOR208

an investigational antibody
for blood cancer

Anetumab
ravtansine

A drug candidate for mesothelioma

Guselkumab

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

Annual Report 2016

Engineering the Medicines
of Tomorrow

MOR106
MOR208
ANETUMAB RAVTANSINE
GUSELKUMAB

Phase 1

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The compound:
MOR106 – an investigational antibody targeting IL-17C

Our investigational therapeutic antibody MOR106 is a premiere in many ways.

MOR106 is the first antibody from MorphoSys’s novel Ylanthia technology to reach clinical development and, overall, the fifth antibody from MorphoSys’s Proprietary Development segment to enter the clinic. In addition, it is the first publicly disclosed antibody in clinical development worldwide targeting the IL-17C antigen. Last but not least, it is the first clinical-stage therapeutic antibody arising from the joint discovery and development collaboration with our Belgian partner Galapagos.

MOR106 binds to the cytokine IL-17C, a potential novel target for treatment of inflammatory skin disorders such as atopic dermatitis. Based on findings from preclinical models, IL-17C is assumed to play an important and pro-inflammatory role in certain skin disorders. At the same time, IL-17C has been shown to be distinct from other members of the IL-17 cytokine family. Results in rodent inflammatory skin models support clinical development of MOR106.

MorphoSys and its partner Galapagos are currently investigating MOR106 in a phase 1 study in healthy volunteers and patients with atopic dermatitis.

  1. Mode of action MOR106
  1. KERATINOCYTES (EPITHELIAL CELLS) TISSUE INJURY / PATHOGENS INFLAMMATORY MEDIATORS IL-17C (PRO-INFLAMMATORY MEDIATOR) IL-17RA / IL-17RE (RECEPTOR) BLOOD VESSEL CHEMOKINES & CYTOKINES RECRUITMENT & ACTIVATION OF WHITE BLOOD CELLS INFLAMMATION MOR106
    In inflammatory skin disorders, IL-17C has been identified as an important pro-inflammatory mediator. IL-17C is a cytokine expressed by epithelial cells, such as skin keratinocytes, and binds to its receptor consisting of the subunits IL17-RA and IL17-RE. Binding of IL17C to its receptor is assumed to trigger an inflammatory cascade that plays a role in skin diseases. By specifically binding to IL-17C, MOR106 inhibits the binding of the cytokine to its receptor, thus blocking its biological activity.

The therapeutic field: Targeting inflammatory skin diseases such as atopic dermatitis

There is a high unmet medical need for novel therapies in chronic inflammatory skin disorders such as atopic dermatitis, also known as atopic eczema. The disease most frequently starts in early childhood and often persists into adulthood, but may also have an adult onset. The main features of atopic dermatitis are the impairment of the skin barrier and dysfunction of the immune system accompanied with dry skin and severe itching. The disease is also associated with cutaneous hyperactivity to various environmental stimuli. The pruritus (itching) may lead to sleep loss, anxiety, depression and impaired social life, and is therefore considered as the highest therapeutic need in atopic dermatitis. According to GlobalData, sales of atopic dermatitis therapies in the seven major healthcare markets may reach US$ 4 billion in 2016, with 35 million patients diagnosed with the disease and 10 million patients being treated in those markets.

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Interview

Interview Dr. Stefan SteidlHead of Preclinical Development, MorphoSys

Dr. Steidl, in 2016 MorphoSys started the clinical development of MOR106, making it the Company´s fifth proprietary clinical candidate. What is so special about MOR106?
We see a lot of special features. As far as we know, MOR106 is the first antibody targeting IL-17C in clinical development worldwide. IL-17C is considered to be an interesting potential therapeutic target for inflammation. According to our preclinical findings, it plays an important pro-inflammatory role in certain skin disorders and it has been shown to be distinct from other members of the already established IL-17 cytokine family. Plus, it is the first clinical stage compound from our strategic alliance with Galapagos, which aims to discover and co-develop novel antibodies for diseases with high unmet need.
What is the role of each partner in the collaboration?
Within the alliance between our companies, both parties contribute their core technologies and expertise. Galapagos identifies the target molecules through use of its target discovery platform. MorphoSys contributes its Ylanthia antibody technology to generate fully human antibodies directed against the target, and contributes full CMC development. Galapagos and MorphoSys have combined their development know-how successfully to co-develop MOR106 from discovery phase to clinical development and consequentially all risks and benefits are equally shared.
In 2016 clinical development with MOR106 was started. What exactly is being investigated? When do you expect results from the current trial?
As in all first-in-human studies, safety is the main focus. The phase 1 trial that we started in April 2016 consists of two parts. In part 1, we have investigated safety, tolerability and pharmacokinetics of MOR106 in single ascending doses in 56 healthy volunteers. After favorable safety results were observed, we initiated part 2 of the study in atopic dermatitis patients in September 2016. Here we are investigating multiple ascending doses of MOR106 compared to placebo in patients with moderate-to-severe atopic dermatitis in several European study centers. We expect topline results from the study in the second half of 2017.
Why have you chosen atopic dermatitis as the indication?
Importantly, preclinical results in rodent disease models of atopic dermatitis and psoriasis support clinical development of MOR106. Over the past decade, we have generally observed a great therapeutic value of biologics and antibody-based therapies in inflammatory skin disorders, such as psoriasis. We see interesting parallels to atopic dermatitis, an indication that is currently still untapped by biologics. Atopic dermatitis, in particular its moderate-to-severe form, is a serious and, in the past, an often underestimated disease. Affected patients are waiting for novel promising therapies. Physicians claim a growing need for long-term systemic treatments with the potential to adequately control the disease. At the moment we see the first investigational antibodies paving the way in this indication. The market potential is substantial: according to GlobalData, sales of atopic dermatitis therapies in the seven major healthcare markets may reach US$ 4 billion in 2016, with 35 million patients diagnosed with the disease and 10 million patients being treated in those markets.

as of March 2017

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