Genmab Takes Full Control of Acasunlimab Development Program
2024年8月5日 - 6:50PM
Company Announcement
- Genmab to assume sole responsibility for the continued
development and potential commercialization of
acasunlimab
- BioNTech has opted not to participate in the further
development of the acasunlimab program under the parties’ existing
collaboration agreement
- The overall collaboration between the companies to
continue unchanged
COPENHAGEN, Denmark; August 5, 2024 –
Genmab A/S (Nasdaq: GMAB) announced today
that it will assume sole responsibility for the continued
development and potential commercialization of acasunlimab.
BioNTech SE (BioNTech) has opted not to participate in the further
development of the acasunlimab program under the parties’ existing
collaboration agreement. The program will be subject to payment of
certain milestones and a tiered single-digit royalty on net sales
by Genmab to BioNTech. Genmab plans to initiate the Phase 3 study
in the second half of this year. While the emerging
clinical profile of acasunlimab is encouraging, BioNTech informed
the company that it has taken this decision for reasons relating to
its portfolio strategy. The companies’ long-standing collaboration
in antibody science remains in place, and both parties will
continue with the existing programs under development under their
existing agreements, which were expanded in 2022.
“Genmab’s partnership with BioNTech is a highly successful one.
Together, we have demonstrated acasunlimab’s potential to impact
patients with metastatic non-small cell lung cancer, as evidenced
by the promising initial results presented at the 2024 American
Society of Clinical Oncology Meeting,” said Jan van de Winkel,
Ph.D., Chief Executive Officer of Genmab. “Genmab is exceptionally
well-positioned to maximize the potential of acasunlimab, and we
are confident about the prospect of taking acasunlimab into
late-stage development as our second wholly owned Genmab asset in
addition to Rina-S. We look forward to our continued partnership
with BioNTech on other pipeline programs.”
The decision by BioNTech to not participate in the further
development of the acasunlimab program is not expected to impact
Genmab’s 2024 financial guidance.
About Acasunlimab (GEN1046)Acasunlimab
(GEN1046) is an investigational PD-L1x4-1BB bispecific antibody
fusing Genmab's proprietary DuoBody® technology platform and
BioNTech’s proprietary immunomodulatory antibodies. Acasunlimab is
designed to elicit an antitumor response via conditional activation
of 4-1BB on T cells and natural killer (NK) cells, which is
strictly dependent on simultaneous binding of the PD-L1 arm.The
candidate is currently being investigated in three clinical trials:
(1) a Phase 1/2 safety and PK trial in patients with multiple solid
tumors, (2) a Phase 1 dose escalation trial in patients with
advanced solid tumors in Japan, and (3) a randomized Phase 2 safety
and efficacy trial with acasunlimab as a monotherapy and in
combination with pembrolizumab in patients with non-small cell lung
cancer (NSCLC) who have failed previous standard of care treatments
with immune checkpoint inhibitors. Please visit
www.clinicaltrials.gov for more information.
About Genmab Genmab is an international
biotechnology company with a core purpose of guiding its
unstoppable team to strive toward improving the lives of patients
with innovative and differentiated antibody therapeutics. For 25
years, its passionate, innovative and collaborative team has
invented next-generation antibody technology platforms and
leveraged translational, quantitative and data sciences, resulting
in a proprietary pipeline including bispecific T-cell engagers,
antibody-drug conjugates, next-generation immune checkpoint
modulators and effector function-enhanced antibodies. By 2030,
Genmab’s vision is to transform the lives of people with cancer and
other serious diseases with knock-your-socks-off (KYSO®) antibody
medicines.
Established in 1999, Genmab is headquartered in Copenhagen,
Denmark, with international presence across North America, Europe
and Asia Pacific. For more information, please visit Genmab.com and
follow us on LinkedIn and
X.Contact: Marisol
Peron, Senior Vice President, Global Communications & Corporate
AffairsT: +1 609 524 0065; E: mmp@genmab.com
Andrew Carlsen, Vice President, Head of Investor RelationsT: +45
3377 9558; E: acn@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 preclinical 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 or technologies 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 and the risk factors included
in Genmab’s most recent Annual Report on Form 20-F and other
filings with the U.S. Securities and Exchange Commission (SEC),
which are available at www.sec.gov. Genmab does not undertake any
obligation to update or revise forward looking statements in this
Company Announcement 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®; HexaBody®; DuoHexaBody®, HexElect®
and KYSO®.
Company Announcement no. 51 CVR no. 2102 3884 LEI Code
529900MTJPDPE4MHJ122
Genmab A/SCarl Jacobsens Vej 302500 Valby Denmark
- 050824_CA51_Acasunlimab_Update
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