Gilead and Tubulis Enter Into Exclusive Option and License Agreement to Develop ADC Candidate for Select Solid Tumor Target
03 Diciembre 2024 - 6:00AM
Business Wire
– Single-Asset Focused Collaboration,
License, and Option Agreement Combines Tubulis’ Differentiated ADC
Platform Technologies with Gilead’s Oncology Research and
Development Expertise –
– Agreement Provides Gilead with Exclusive
Option to License the Resulting ADC Program for Further Development
–
Gilead Sciences, Inc. (Nasdaq: GILD) and Tubulis today announced
that they have entered into an exclusive option and license
agreement to discover and develop an antibody-drug conjugate (ADC)
against a solid tumor target.
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the full release here:
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Through this agreement, Gilead will gain access to Tubulis’
proprietary Tubutecan and Alco5 platforms. The companies will
collaborate to select the best technology to utilize, with Tubulis
leading discovery and development efforts to design a Topoisomerase
I inhibitor-based ADC candidate with superior biophysical
properties and stability to address current treatment challenges
such as durability and off-target toxicity.
“As we expand our oncology portfolio to address the greatest
gaps in care, accessing novel technologies is critical to advancing
our pipeline,” said Flavius Martin, MD, Executive Vice President,
Research, Gilead Sciences. “With Gilead’s ongoing focus on
innovating with next-generation therapies and combinations, we are
excited to partner with Tubulis to explore a range of solutions
that may help increase the therapeutic value of the ADC
modality.”
“Gilead has established a long track record of developing drugs
that provide a significant step-up in therapeutic value, making
them a great collaborator for leveraging our technology platforms,
in line with our vision of fundamentally changing the ADC
landscape,” said Dominik Schumacher, PhD, CEO and co-founder of
Tubulis. “Tubulis remains primarily focused on driving value
through our own clinical development programs while selectively
building partnerships with leaders in the industry.”
Terms of the Agreement
Under the terms of the agreement, Tubulis will receive an
upfront payment of $20 million and, if Gilead exercises its option,
a separate option exercise fee of $30 million. In addition, Tubulis
will be eligible for development and commercialization milestone
payments totaling up to $415 million, plus mid-single to low
double-digit tiered royalties on sales of marketed products
resulting from the collaboration. Tubulis will lead early-stage
research and development activities for the ADC program. If Gilead
exercises its option to exclusively license the program, Gilead
will be responsible for further development and commercialization
activities for all products resulting from the collaboration.
Gilead does not exclude acquired IPR&D expenses from its
non-GAAP financial measures. This transaction with Tubulis is
expected to reduce Gilead’s GAAP and non-GAAP 2024 EPS by
approximately $0.01.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has
pursued and achieved breakthroughs in medicine for more than three
decades, with the goal of creating a healthier world for all
people. The company is committed to advancing innovative medicines
to prevent and treat life-threatening diseases, including HIV,
viral hepatitis, COVID-19, and cancer. Gilead operates in more than
35 countries worldwide, with headquarters in Foster City,
Calif.
About Tubulis
Tubulis generates uniquely matched antibody-drug conjugates with
superior biophysical properties that have demonstrated durable
on-tumor delivery and long-lasting anti-tumor activity in
preclinical models. Our first NaPi2b-targeting program, TUB-040, is
being evaluated in the clinic in ovarian and non-small cell lung
cancer. The second candidate from our growing pipeline, TUB-030,
targeting 5T4, is set to follow imminently. We will solidify our
leadership position by continuing to innovate on all aspects of ADC
design leveraging our proprietary platform technologies. Our goal
is to expand the therapeutic potential of this drug class for our
pipeline, our partners and for patients. Visit www.tubulis.com or
follow us on LinkedIn.
Gilead Forward-Looking
Statements
This press release includes forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
that are subject to risks, uncertainties and other factors,
including Gilead’s ability to realize the anticipated benefits from
the collaboration; difficulties or unanticipated expenses in
connection with the collaboration and the potential effects on
Gilead’s earnings; the ability of the parties to initiate, progress
or complete clinical trials within currently anticipated timelines
or at all, and the possibility of unfavorable results from ongoing
or additional trials, including those involving programs developed
pursuant to the collaboration; the ability of the parties to file
applications for regulatory approval or receive regulatory
approvals in a timely manner or at all for the investigational
programs developed pursuant to the collaboration, and the risk that
any such approvals may be subject to significant limitations on
use; the possibility that the parties may make a strategic decision
to discontinue development of any of the investigational programs
developed pursuant to the collaboration, and therefore these
programs may never be successfully commercialized; and any
assumptions underlying any of the foregoing. These and other risks,
uncertainties and other factors are described in detail in Gilead’s
Quarterly Report on Form 10-Q for the quarter ended September 30,
2024, as filed with the U.S. Securities and Exchange Commission.
These risks, uncertainties and other factors could cause actual
results to differ materially from those referred to in the
forward-looking statements. All statements other than statements of
historical fact are statements that could be deemed forward-looking
statements. The reader is cautioned that any such forward-looking
statements are not guarantees of future performance and involve
risks and uncertainties and is cautioned not to place undue
reliance on these forward-looking statements. All forward-looking
statements are based on information currently available to Gilead,
and Gilead assumes no obligation and disclaims any intent to update
any such forward-looking statements.
Gilead and the Gilead logo are trademarks of
Gilead Sciences, Inc., or its related companies. The Tubulis name
and logo are trademarks of Tubulis.
For more information about Gilead, please visit
the company’s website at www.gilead.com, follow Gilead on X/Twitter
(@Gilead Sciences) and LinkedIn (@Gilead-Sciences).
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Tubulis Info
Dominik Schumacher, CEO & Co-Founder Phone: + 49 (0) 175 800
5594 Email: contact@tubulis.com
Media Requests for Tubulis Trophic
Communications Stephanie May, PhD Phone: +49 (0) 171 185 56 82
Email: tubulis@trophic.eu
Gilead Info
Jessica Smith, Media public_affairs@gilead.com
Jacquie Ross, Investors investor_relations@gilead.com
Gilead Sciences (NASDAQ:GILD)
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