Genmab — Regulatory Filings 2016

Mar 21, 2016

Company Announcement

-- Phase Ib studies of daratumumab in combination with Roche’s immune
checkpoint inhibitor atezolizumab in a solid tumor and multiple myeloma to
be started
-- Studies conducted under a clinical trial collaboration agreement between
Janssen and Roche

Copenhagen, Denmark; March 21, 2016 – Genmab A/S (Nasdaq Copenhagen: GEN)
announced today that daratumumab will be investigated in early stage clinical
studies in combination with atezolizumab (anti-PD-L1 antibody), in a solid
tumor and multiple myeloma. The studies will be conducted under a clinical
trial collaboration agreement between Genmab’s licensing partner for
daratumumab, Janssen Biotech, Inc., and Genentech, a member of the Roche Group.
Atezolizumab is an investigational monoclonal antibody designed to bind to a
protein called PD-L1, which is expressed on tumor cells and tumor-infiltrating
immune cells. Janssen will conduct a Phase Ib study of daratumumab in
combination with atezolizumab to treat a solid tumor. Genentech will amend an
ongoing Phase Ib study to assess atezolizumab in combination with daratumumab,
with daratumumab and lenalidomide, and with daratumumab and pomalidomide in
relapsed/refractory multiple myeloma (NCT02431208). The studies are expected
to start enrolling patients later this year and information about the studies
will be posted on www.clinicaltrials.gov.

“We are very excited about the start of the first study to investigate
daratumumab in a solid tumor, potentially expanding its clinical utility beyond
hematological cancers. We are equally excited about testing daratumumab in
combination with an immune checkpoint inhibitor, such as Roche’s anti-PDL1,
atezolizumab, in multiple myeloma. Both studies mark a key next step in the
expansive clinical development of daratumumab in the hope to find even more
effective treatment options for cancer patients,” said Jan van de Winkel,
Ph.D., Chief Executive Officer of Genmab.

About DARZALEX® (daratumumab)
DARZALEX® (daratumumab) injection for intravenous infusion is indicated in the
United States for the treatment of patients with multiple myeloma who have
received at least three prior lines of therapy, including a proteasome
inhibitor (PI) and an immunomodulatory agent, or who are double-refractory to a
PI and an immunomodulatory agent.1 DARZALEX is the first monoclonal antibody
(mAb) to receive U.S. Food and Drug Administration (FDA) approval to treat
multiple myeloma. For more information, visit www.DARZALEX.com.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high
affinity to the CD38 molecule, which is highly expressed on the surface of
multiple myeloma cells. It is believed to induce rapid tumor cell death through
programmed cell death, or apoptosis,1,2 and multiple immune-mediated
mechanisms, including complement-dependent cytotoxicity,1,2 antibody-dependent
cellular phagocytosis3,4 and antibody-dependent cellular cytotoxicity.1,2 In
addition, daratumumab therapy results in a reduction of immune-suppressive
myeloid derived suppressor cells (MDSCs) and a subset of regulatory T cells
(Tregs) and B cells (Bregs), all of which express CD38. These reductions in
MDSCs, Tregs, and Bregs were paralleled by increases in CD4+ and CD8+ T cell
numbers in both the peripheral blood and bone marrow.1

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive
worldwide license to develop, manufacture and commercialize daratumumab from
Genmab. Five Phase III clinical studies with daratumumab in relapsed and
frontline settings are currently ongoing, and additional studies are ongoing or
planned to assess its potential in other malignant and pre-malignant diseases
on which CD38 is expressed, such as smoldering myeloma and non-Hodgkin’s
lymphoma.

About Genmab
Genmab is a publicly traded, international biotechnology company specializing
in the creation and development of differentiated antibody therapeutics for the
treatment of cancer. Founded in 1999, the company has two approved antibodies,
Arzerra® (ofatumumab) for the treatment of certain chronic lymphocytic leukemia
indications and DARZALEX® (daratumumab) for the treatment of heavily pretreated
or double refractory multiple myeloma. Daratumumab is in clinical development
for additional multiple myeloma indications and for non-Hodgkin’s lymphoma.
Genmab also has a broad clinical and pre-clinical product pipeline. Genmab's
technology base consists of validated and proprietary next generation antibody
technologies - the DuoBody® platform for generation of bispecific antibodies,
and the HexaBody® platform which creates effector function enhanced antibodies.
The company intends to leverage these technologies to create opportunities for
full or co-ownership of future products. Genmab has alliances with top tier
pharmaceutical and biotechnology companies. For more information visit
www.genmab.com.

Contact:
Rachel Curtis Gravesen, Senior Vice President, Investor Relations &
Communications
T: +45 33 44 77 20; M: +45 25 12 62 60; E: r.gravesen@genmab.com

This Company Announcement contains forward looking statements. The words
“believe”, “expect”, “anticipate”, “intend” and “plan” and similar expressions
identify forward looking statements. Actual results or performance may differ
materially from any future results or performance expressed or implied by such
statements. The important factors that could cause our actual results or
performance to differ materially include, among others, risks associated with
pre-clinical and clinical development of products, uncertainties related to the
outcome and conduct of clinical trials including unforeseen safety issues,
uncertainties related to product manufacturing, the lack of market acceptance
of our products, our inability to manage growth, the competitive environment in
relation to our business area and markets, our inability to attract and retain
suitably qualified personnel, the unenforceability or lack of protection of our
patents and proprietary rights, our relationships with affiliated entities,
changes and developments in technology which may render our products obsolete,
and other factors. For a further discussion of these risks, please refer to the
risk management sections in Genmab’s most recent financial reports, which are
available on www.genmab.com. Genmab does not undertake any obligation to update
or revise forward looking statements in this Company Announcement nor to
confirm such statements in relation to actual results, unless required by law.

Genmab A/S and its subsidiaries own the following trademarks: Genmab®; the
Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo™;
the DuoBody logo®; the HexaBody logo™; HuMax®; HuMax-CD20®; DuoBody®; HexaBody®
and UniBody®. Arzerra® is a trademark of Novartis AG or its affiliates.
DARZALEX® is a trademark of Janssen Biotech, Inc.

1 DARZALEX Prescribing Information, November 2015.
2 De Weers et al. Daratumumab, a Novel Therapeutic Human CD38 Monoclonal
Antibody, Induces Killing of Multiple Myeloma and Other Hematological Tumors.
The Journal of Immunology. 2011; 186: 1840-1848.
3 Overjijk MB, et al. Antibody-mediated phagocytosis contributes to the
anti-tumor activity of the therapeutic antibody daratumumab in lymphoma and
multiple myeloma. MAbs. 2015; 7: 311-21.
4 Khagi and Mark. Potential role of daratumumab in the treatment of multiple
myeloma. Onco Targets Ther. 2014; 7: 1095–1100.

Company Announcement no. 15
CVR no. 2102 3884

Genmab A/S
Bredgade 34E
1260 Copenhagen K
Denmark