Genmab and Seattle Genetics Announce Tisotumab Vedotin Data to Be Presented at ESMO 2018 Congress

  • Data presented from updated analysis of full innovaTV 201 expansion
    cohort in recurrent or metastatic cervical cancer

COPENHAGEN, Denmark & BOTHELL, Wash.–(BUSINESS WIRE)–Genmab A/S (Nasdaq Copenhagen: GEN) and Seattle Genetics, Inc. (Nasdaq:
SGEN) announced today that updated clinical data from the innovaTV 201
Phase II study evaluating tisotumab vedotin in patients with recurrent
and/or metastatic cervical cancer will be presented as a poster at the
European Society for Medical Oncology (ESMO) 2018 Congress taking place
in Munich, Germany from October 19 to 23, 2018. Tisotumab vedotin is an
investigational antibody-drug conjugate (ADC) designed to target the
Tissue Factor antigen, which is expressed on a broad range of solid
tumors.


“We look forward to presenting an update on the expanded cervical cancer
cohort data showing that tisotumab vedotin continues to demonstrate
tolerability and clinical activity in heavily pretreated patients with
cervical cancer. We anticipate publishing the final data from this
cohort in the future,” said Jan van de Winkel, Ph.D., Chief Executive
Officer of Genmab. “In the past year, the development program of
tisotumab vedotin has also been expanded with additional trials and
indications, and we are excited about the continued growth of this
program.”

“In the recurrent and metastatic cervical cancer setting, there remains
an unmet need for new treatment options,” said Roger Dansey, M.D., Chief
Medical Officer at Seattle Genetics. “We are pleased to be collaborating
with Genmab to advance tisotumab vedotin in the potentially pivotal
innovaTV 204 clinical trial in cervical cancer and to evaluate its
potential in a broad range of other solid tumors.”

Details of Poster Presentation:

Title: A Phase IIa study of tisotumab vedotin in patients with
previously treated recurrent or metastatic cervical cancer: updated
analysis of full cervical expansion cohort
Presenter: Nicole
Concin, M.D. Medical University of Innsbruck, Austria
Abstract #:
963P
Session: Poster Display Session: Biomarkers, Gynaecological
cancers, Haematological malignancies, Immunotherapy of cancer, New
diagnostic tools, NSCLC – early stage, locally advanced & metastatic,
SCLC, Thoracic malignancies, Translational research
Date and Time:
October 20, 12:30-13:30 CEST
Location: Hall A3 Poster Area

The abstract is available on the ESMO website at www.esmo.org.

About the innovaTV 201 (GEN701) Study

The innovaTV 201 study is a 170 patient, two-part Phase I/II study of
tisotumab vedotin in eight types of solid tumors: ovarian, cervical,
endometrial, bladder, prostate, esophageal, lung, and head and neck.
Part 1 is 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. Part 2 of the study investigates all eight
indications in parallel expansion cohorts. The cervical cancer cohort
includes 55 patients. 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
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 cell 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 or planned Phase II trials in recurrent and/or metastatic
cervical cancer, ovarian cancer and other solid tumors. Tisotumab
vedotin is being co-developed by Genmab and Seattle Genetics.

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 and other blood cancers. 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, the HexaBody®
platform, which creates effector function enhanced antibodies and the
HexElect™ platform, which combines two co-dependently acting HexaBody
molecules to introduce selectivity while maximizing therapeutic potency.
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, Inc. is an emerging multi-product, global
biotechnology company that develops and commercializes transformative
therapies targeting cancer to make a meaningful difference in people’s
lives. ADCETRIS® (brentuximab vedotin) utilizes the company’s
industry-leading antibody-drug conjugate (ADC) technology and is
currently approved for the treatment of multiple CD30-expressing
lymphomas. Beyond ADCETRIS, the company has established a pipeline of
novel targeted therapies at various stages of clinical testing,
including three in ongoing pivotal trials for solid tumors. Enfortumab
vedotin for metastatic urothelial cancer and tisotumab vedotin for
metastatic cervical cancer utilize our proprietary ADC technology.
Tucatinib, a small molecule tyrosine kinase inhibitor, is in a pivotal
trial for HER2-positive metastatic breast cancer. In addition, we are
leveraging our expertise in empowered antibodies to build a portfolio of
proprietary immuno-oncology agents in clinical trials targeting
hematologic malignancies and solid tumors. The company is headquartered
in Bothell, Washington, and has a European office in Switzerland. For
more information on our robust pipeline, visit www.seattlegenetics.com
and follow @SeattleGenetics on Twitter.

Forward Looking Statement for Genmab

This Media Release 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 Media Release nor to confirm such statements
to reflect subsequent events or circumstances after the date made or in
relation to actual results, unless required by law.

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

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 benefits and uses as
monotherapy, and the referenced Phase I/II clinical trial. 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 the
risk of adverse events of tisotumab vedotin, including the potential for
newly-emerging safety signals, delays in planned clinical trial
initiations, enrollment and conduct, obtaining data from clinical
trials, and anticipated regulatory submissions and approvals in each
case for a variety of reasons, including the difficulty and uncertainty
of pharmaceutical product development, unexpected adverse events and/or
adverse regulatory action, possible required modifications to clinical
trials and the inability to provide information and institute safety
mitigation measures as required by the FDA or other regulatory
authorities from time to time, failure to properly conduct or manage the
company’s clinical trials and failure of clinical results to support
continued development or regulatory approvals, in which case our
clinical trials may be delayed or discontinued. 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 June 30, 2018 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, except as
required by law.

Contacts

Genmab A/S
Rachel Curtis
Gravesen, +45 33 44 77 20
Senior Vice President, Investor Relations
& Communication
M: +45 25 12 62 60
rcg@genmab.com
or
Seattle
Genetics

Media:
Monique Greer, 425-527-4641
mgreer@seagen.com
or
Investors:
Peggy
Pinkston, 425-527-4160
ppinkston@seagen.com

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