Genmab — Regulatory Filings 2017

Oct 10, 2017

Company Announcement

-- Phase II study of tisotumab vedotin in patients with advanced cervical
cancer
-- Study provides opportunity for accelerated approval and is expected to
begin in the coming months

Copenhagen, Denmark and Bothell, Washington; October 10, 2017 – Genmab A/S
(Nasdaq Copenhagen: GEN) and Seattle Genetics, Inc. (NASDAQ: SGEN) announced
today a decision to start a Phase II study of tisotumab vedotin in patients
with recurrent and/or metastatic cervical cancer. The study could provide the
basis for a regulatory application for approval. Tisotumab vedotin consists of
a tissue factor (TF)-targeted antibody linked to the cell-killing agent
monomethyl auristatin E (MMAE). TF is a protein expressed on a broad range of
solid tumors. The Phase II trial is single arm and includes about 100 patients
with recurrent or metastatic cervical cancer who relapsed or progressed after
standard of care treatment. The companies plan to start enrolling patients by
the first half of 2018.

“We are very pleased to see the clinical development of tisotumab vedotin
progress in patients with cervical cancer – an area with a strong unmet medical
need. The study provides an opportunity for accelerated registration. We look
forward to the continuing development of this promising first-in-class
antibody-drug conjugate,” said Jan van de Winkel, Ph.D., Chief Executive
Officer of Genmab.

“Standard therapies for previously treated recurrent and/or metastatic cervical
cancer generally result in response rates of less than 15 percent and a median
overall survival of six to eight months,” said Clay Siegall, Ph.D., President
and Chief Executive Officer of Seattle Genetics. “Based on promising data from
the Phase I/II clinical trial of tisotumab vedotin in recurrent and/or
metastatic cervical cancer and feedback from the Food and Drug Administration
(FDA) on the planned trial, we and Genmab are advancing the program into a
potentially registrational study for these patients with high unmet medical
need.”

About the Phase II study
The single arm, multicenter Phase II study (GCT1015-04) of tisotumab vedotin
monotherapy is expected to enroll about 100 patients with recurrent or
metastatic cervical cancer who have experienced disease progression on or after
platinum containing chemotherapy and who have received or are ineligible for
bevacizumab. The primary endpoint of the study is overall response rate (ORR)
as assessed by independent review of RECIST v1.1 criteria. The main secondary
endpoints are duration of response (DoR) and safety.

About Cervical Cancer
Cervical cancer originates in the cells lining the cervix, which connects the
uterus to the birth canal. About 13,000 women are expected to be diagnosed with
cervical cancer in the US in 2017, with an estimated 4000 deaths.1 Globally, it
was estimated that 527,000 people would be diagnosed and 265,000 would die from
the disease in 2012, the vast majority of these patients being in the
developing world.2 Routine medical examinations and the human papillomavirus
(HPV) vaccine have had a positive impact on the incidence of cervical cancer in
the developed world. Despite these advances, women are still diagnosed with
cervical cancer, which can have a devastating impact, particularly in the
recurrent or metastatic setting. Standard therapies for previously treated
recurrent/metastatic cervical cancer generally result in response rates of less
than 15 percent and a median overall survival of 6 to 8 months.3-10

About Tisotumab Vedotin
Tisotumab vedotin is an antibody-drug conjugate (ADC) composed of Genmab’s
human antibody that binds to tissue factor (TF) and Seattle Genetics’ ADC
technology that utilizes a cleavable linker and the cytotoxic drug monomethyl
auristatin E (MMAE). TF is a protein involved in tumor signaling and
angiogenesis. Based on its high expression on many solid tumors and its rapid
internalization, TF was selected as a target for an ADC approach. Tisotumab
vedotin is being evaluated in ongoing Phase I/II clinical studies for solid
tumors and a Phase II trial in recurrent and/or metastatic cervical cancer is
planned to start by the first half of 2018. Tisotumab vedotin is being
co-developed by Genmab and Seattle Genetics, under an agreement in which the
companies share all future costs and profits for the product on a 50:50 basis.

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,
DARZALEX® (daratumumab) for the treatment of certain multiple myeloma
indications, and Arzerra® (ofatumumab) for the treatment of certain chronic
lymphocytic leukemia indications. Daratumumab is in clinical development for
additional multiple myeloma indications, other blood cancers, and solid tumors.
A subcutaneous formulation of ofatumumab is in development for relapsing
multiple sclerosis. 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.

About Seattle Genetics
Seattle Genetics is an innovative biotechnology company dedicated to improving
the lives of people with cancer through novel antibody-based therapies. The
company’s industry-leading antibody-drug conjugate (ADC) technology harnesses
the targeting ability of antibodies to deliver cell-killing agents directly to
cancer cells. Seattle Genetics commercializes ADCETRIS® (brentuximab vedotin)
for the treatment of several types of CD30-expressing lymphomas. The company
is also advancing a robust pipeline of novel therapies for solid tumors and
blood-related cancers designed to address significant unmet medical needs and
improve treatment outcomes for patients. More information can be found at
www.seattlegenetics.comand follow @SeattleGenetics on Twitter

Forward Looking Statement for Genmab
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.

Forward Looking Statement for Seattle Genetics
Certain of the statements made in this press release are forward-looking, such
as those, among others, relating to the therapeutic potential of tisotumab
vedotin, its possible use in treatment of cervical cancer, the timing, size or
conduct of the Phase II clinical trial, and the possibility that the trial and
resulting data could support registration or accelerated approval of tisotumab
vedotin. Actual results or developments may differ materially from those
projected or implied in these forward-looking statements. Factors that may
cause such a difference include the inability of tisotumab vedotin to show
sufficient activity in the clinical setting referenced above and in future
potential clinical trials, the risk of adverse events associated with tisotumab
vedotin and regulatory actions which may affect the future development of our
drug candidates or those of our collaborators. More information about the risks
and uncertainties faced by Seattle Genetics is contained under the caption
“Risk Factors” included in the company’s Quarterly Report on Form 10-Q for the
quarter ended August 1, 2017 filed with the Securities and Exchange Commission.
Seattle Genetics disclaims any intention or obligation to update or revise any
forward-looking statements, whether as a result of new information, future
events or otherwise.

Genmab 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

Seattle Genetics Contacts:
Investors: Peggy Pinkston, Vice President, Investor Relations
(425) 527-4160; ppinkston@seagen.com

Media: Kavita V. Shah, Ph.D., Associate Director, Corporate Communications
(425) 527-4188; kshah@seagen.com

References:

1 National Cancer Institute SEER. “Cancer Stat Facts: Cervix Uteri Cancer.”
Available at https://seer.cancer.gov/statfacts/html/cervix.html. Accessed
September 2017.

2 Cancer Research UK. “Cervical cancer statistics.” Available at
http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics
-by-cancer-type/cervical-cancer/mortality#heading-Five.
Accessed September 2017.

3 Miller et al., Gynecol Oncol 2008; 110:65

4 Bookman et al., Gynecol Oncol 2000; 77:446

5 Garcia et al.,Am J Clin Oncol 2007; 30:428

6 Muggia et al., J Clin Oncol 2009; 27:1069

7 Monk et al., J Clin Oncol 2009; 27:1069

8 Santin et al., Genecol Oncol 2011; 122:495

9 Schellens, J Clin Oncol 35, 2017 (suppl; abstr 5514)

10 Hollebecque et al., J Clin Oncol 35, 2017 (suppl; abstr 6025)

Company Announcement no. 33
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122

Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V
Denmark