Genmab — Regulatory Filings 2017

Jun 16, 2017

Company Announcement

-- Preliminary data shows responses achieved in 11 of 34 evaluable patients
with cervical cancer treated with tisotumab vedotin
-- Next steps in clinical development of tisotumab vedotin in this indication
under active consideration

Copenhagen, Denmark; June 16, 2017 – Genmab A/S (Nasdaq Copenhagen: GEN)
announced today preliminary data from the ongoing Phase I/II study of tisotumab
vedotin in solid tumors (GEN701). In Part 2 of the study, 11 of 34 evaluable
patients in the cervical cancer cohort achieved a response; with a median time
of treatment of 4.9 months, 7 responders are still ongoing or in follow up for
progression. The safety profile of tisotumab vedotin was consistent with known
MMAE based antibody-drug conjugates (ADC), including peripheral neuropathy and
neutropenia. Additionally, conjunctivitis was identified as a tisotumab vedotin
specific toxicity, which led to introducing of prophylactic management. In the
cervical cancer cohort, 15 patients experienced one or more Grade 3 adverse
events: gastro-intestinal related (5 patients), anemia (2 patients), infections
(1 patient), neuropathy (2 patients), bleeding (2 patients), other (10
patients). Genmab is considering plans for further clinical development of
tisotumab vedotin in cervical cancer. The GEN701 study is ongoing and further
data in both cervical cancer and other solid tumor indications will be
published at a later date.

“The preliminary data we see in patients with cervical cancer treated with
tisotumab vedotin are encouraging. We believe further development of this
novel antibody-drug conjugate may be warranted in cervical cancer and are
actively looking into possible next steps,” said Jan van de Winkel, Ph.D.,
Chief Executive Officer of Genmab.

Genmab intends to submit data from this study for presentation at an upcoming
medical conference.

About the GEN701 study
The GEN701 study is a 173 patient, two-part Phase I/II study of tisotumab
vedotin in seven types of solid tumors: ovarian, cervical, endometrium,
bladder, prostate, esophageal, and lung. Part 1 was a classical 3+3 dose
escalation design testing various doses of tisotumab vedotin once every three
weeks to establish the recommended Phase II (RP2D) and maximum tolerated dose
as well as the safety profile of tisotumab vedotin. The still ongoing Part 2
of the study investigates all seven indications in parallel expansion cohorts.
Patients receive 2.0 mg/kg (=RP2D) of tisotumab vedotin once every three weeks.
The primary objective of this part of the study is to further investigate the
safety profile of tisotumab vedotin and preliminary efficacy.

About tisotumab vedotin
Tisotumab vedotin is an antibody-drug conjugate (ADC) composed of a human
antibody that binds to tissue factor (TF) conjugated to Seattle Genetics’
clinically validated cytotoxic drug 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 in Phase I/II clinical development for solid tumors in two
studies (GEN701 and GEN702). Genmab has a license and collaboration agreement
for tisotumab vedotin with Seattle Genetics under which Seattle Genetics has
the right to exercise a co-development option at the end of Phase I clinical
development.

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.

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.

Company Announcement no. 22
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122

Genmab A/S
Bredgade 34E
1260 Copenhagen K
Denmark