AnaptysBio and GlaxoSmithKline Amend Strategic Immuno-Oncology Collaboration
October 26 2020 - 8:00AM
AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology
company developing first-in-class antibody product candidates
focused on emerging immune control mechanisms applicable to
inflammation and immuno-oncology indications, today announced that
AnaptysBio and GlaxoSmithKline (GSK) have amended their
immuno-oncology collaboration agreement. The amended agreement
provides AnaptysBio with increased royalties on dostarlimab sales
under the collaboration, a royalty on GSK’s Zejula™ and a
one-time cash payment. GSK receives freedom to conduct combination
development and commercialization of Zejula™ with third party
molecules.
“We are pleased to continue our strategic immuno-oncology
collaboration with GSK and look forward to the anticipated first
FDA approval of dostarlimab,” said Hamza Suria, chief executive
officer of AnaptysBio. “The three clinical-stage antibodies
under this collaboration were generated by AnaptysBio using our
somatic hypermutation technology platform. While our internal focus
is the advancement of AnaptysBio’s wholly-owned first-in-class
anti-inflammatory antibody pipeline, we are pleased to partner with
GSK in advancing novel immuno-oncology therapies for patients
suffering with cancer.”
Originally signed with Tesaro in March 2014, the GSK
collaboration is focused on advancing checkpoint receptor
antagonist antibodies against PD-1, TIM-3 and LAG-3 in oncology.
Dostarlimab is an anti-PD-1 antagonist antibody currently under
development by GSK for multiple oncological disorders, including
endometrial cancer, non-small cell lung cancer, ovarian cancer,
colorectal cancer and mismatch repair deficient solid tumors.
Cobolimab, an anti-TIM-3 antagonist antibody, and GSK4069889A, an
anti-LAG-3 antagonist antibody, are also under development under
this collaboration for various solid tumors. Dostarlimab is being
combined with certain antibodies and small molecule agents,
including cobolimab, GSK4069889A and Zejula™. First US FDA approval
of dostarlimab is anticipated in Q4 2020 for the treatment of
endometrial cancer, while MAA review is also underway for the same
indication. A second BLA filing for dostarlimab, for the treatment
of mismatch repair deficient cancers on a pan-tumor basis, is
anticipated in the first half of 2021. Zejula™ is an oral,
once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, which has
received US approval for the maintenance treatment of adult
patients with advanced epithelial ovarian, fallopian tube, or
primary peritoneal cancer who are in a complete or partial response
to first-line platinum-based chemotherapy regardless of biomarker
status, and is under development for additional cancer
indications.
Under the terms of the amended agreement, GSK has agreed to
increase the royalties due to AnaptysBio upon net sales of
dostarlimab. Previously, royalties ranged from 4-8%, where the 8%
royalty tier was applicable to global net sales above $1 billion.
The amended royalty terms range from 8-25%, where AnaptysBio will
receive 8% of annual global net sales below $1 billion, and 12-25%
of net sales above $1 billion. The $1.1 billion in cash milestone
payments due under the collaboration agreement remain unchanged,
and AnaptysBio anticipates receiving $75 million in such cash
milestones over the next 18 months as dostarlimab obtains FDA and
EMA regulatory approval for the first two indications. An
additional $165 million in sales milestones is anticipated by
AnaptysBio upon achievement of certain dostarlimab annual sales
revenues. GSK has also agreed, starting January 1, 2021, to pay
AnaptysBio a 1% royalty on all of GSK’s global net sales of
Zejula™. In addition, GSK has agreed to pay AnaptysBio a one-time
cash payment of $60 million within 30 days.
In exchange, AnaptysBio has provided GSK with freedom to conduct
development and commercialization of Zejula™ in combination
with any third-party molecules.
About AnaptysBioAnaptysBio is a
clinical-stage biotechnology company developing first-in-class
antibody product candidates focused on emerging immune control
mechanisms applicable to inflammation and immuno-oncology
indications. The Company’s proprietary anti-inflammatory pipeline
includes its anti-IL-36R antibody imsidolimab, previously referred
to as ANB019, for the treatment of rare inflammatory diseases,
including generalized pustular psoriasis, or GPP, palmoplantar
pustulosis, or PPP, EGFRi-mediated skin toxicities and ichthyosis;
its anti-IL-33 antibody etokimab, previously referred to as ANB020,
for the treatment of chronic rhinosinusitis with nasal polyps, or
CRSwNP, and eosinophilic asthma; its anti-PD-1 agonist program,
ANB030, for treatment of certain autoimmune diseases where immune
checkpoint receptors are insufficiently activated; and its BTLA
modulator program, ANB032, which is broadly applicable to human
inflammatory diseases associated with lymphoid and myeloid immune
cell dysregulation. AnaptysBio’s antibody pipeline has been
developed using its proprietary somatic hypermutation, or SHM
platform, which uses in vitro SHM for antibody discovery and is
designed to replicate key features of the human immune system to
overcome the limitations of competing antibody discovery
technologies. AnaptysBio has also developed multiple
therapeutic antibodies in an immuno-oncology collaboration with
GlaxoSmithKline, including an anti-PD-1 antagonist antibody
(dostarlimab, GSK4057190A), an anti-TIM-3 antagonist antibody
(cobolimab, GSK4069889A) and an anti-LAG-3 antagonist antibody
(GSK4074386), and an inflammation collaboration with Bristol-Myers
Squibb, including an anti-PD-1 checkpoint agonist antibody
(CC-90006) currently in clinical development.
Forward-Looking StatementsThis press release
contains forward-looking statements within the meaning of the "safe
harbor" provisions of the Private Securities Litigation Reform Act
of 1995, including, but not limited to: the royalties, milestone
payments and cash payments payable to the company, and the timing
or outcome of any regulatory submission or approval of dostarlimab.
Statements including words such as “plan,” “continue,” “expect,” or
“ongoing” and statements in the future tense are forward-looking
statements. These forward-looking statements involve risks and
uncertainties, as well as assumptions, which, if they do not fully
materialize or prove incorrect, could cause our results to differ
materially from those expressed or implied by such forward-looking
statements. Forward-looking statements are subject to risks and
uncertainties that may cause the company’s actual activities or
results to differ significantly from those expressed in any
forward-looking statement, including risks and uncertainties
related to the company’s ability to advance its product candidates,
obtain regulatory approval of and ultimately commercialize its
product candidates, the timing and results of preclinical and
clinical trials, the company’s ability to fund development
activities and achieve development goals, the company’s ability to
protect intellectual property and other risks and uncertainties
described under the heading “Risk Factors” in documents the company
files from time to time with the Securities and Exchange
Commission. These forward-looking statements speak only as of the
date of this press release, and the company undertakes no
obligation to revise or update any forward-looking statements to
reflect events or circumstances after the date hereof.
Contacts:Dennis
MulroyAnaptysBio, Inc.858.732.0201dmulroy@anaptysbio.com
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