FDA Grants Accelerated Approval of JEMPERLI (dostarlimab-gxly) for dMMR Recurrent or Advanced Solid Tumors
August 17 2021 - 4:32PM
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
the U.S. Food and Drug Administration (FDA) approved a second
indication for GSK’s JEMPERLI (dostarlimab-gxly) for the treatment
of adult patients with mismatch repair deficient (dMMR) recurrent
or advanced solid tumors, as determined by an FDA-approved test,
that have progressed on or following prior treatment and who have
no satisfactory alternative treatment options.
JEMPERLI was generated by AnaptysBio using its proprietary
somatic hypermutation (SHM) antibody platform and subsequently
developed by TESARO, Inc., now a part of GSK, under a collaboration
agreement. Eight AnaptysBio-generated therapeutic antibodies have
advanced into clinical development to date. JEMPERLI is the first
AnaptysBio-generated antibody to obtain FDA approval, and this is
the second indication for JEMPERLI to be approved by the FDA in
2021. This indication is approved under accelerated approval based
on tumor response rate and durability of response. Continued
approval for these indications may be contingent upon verification
and description of clinical benefit in a confirmatory trial(s).
“We are pleased that JEMPERLI has been FDA-approved for a second
indication and will be available to a broader cohort of solid tumor
patients,” said Hamza Suria, president and chief executive
officer of AnaptysBio. “AnaptysBio’s capital-efficient
business model is focused upon advancing our wholly-owned
first-in-class antibodies to multiple clinical catalysts over the
upcoming 18 months and is supported by milestone and royalty
revenues under our GSK collaboration.”
AnaptysBio has earned a $20 million milestone payment as a
result of this second FDA approval for JEMPERLI in dMMR recurrent
or advanced solid tumors. Earlier in 2021, AnaptysBio received a
milestone payment of $10 million from GSK for acceptance of the BLA
filing with the FDA for this second indication. AnaptysBio also
received $20 million and $10 million milestone payments in April
2021 for FDA and European Medicines Agency (EMA) approvals of
JEMPERLI for adult patients with a certain type of endometrial
cancer, after having received a total of $15 million from GSK
during 2020 for the FDA’s and EMA’s acceptances of these BLA and
Marketing Authorisation Application (MAA) filings for JEMPERLI. We
anticipate an additional $15 million and $165 million in milestone
payments upon achievement of certain JEMPERLI regulatory and
commercial milestones, respectively. Royalties due to AnaptysBio
for JEMPERLI range from 8% to 25% of global net sales, where
AnaptysBio will receive 8% of annual global net sales below $1
billion, and 12-25% of net sales above $1 billion. GSK has recently
disclosed peak year annual sales estimates of £1-2 billion for
JEMPERLI.1
JEMPERLI is also being developed by GSK for the treatment of
other tumor types and treatment settings, including currently
ongoing phase III trials in recurrent or primary advanced
endometrial cancer in combination with chemotherapy standard of
care (RUBY) and the phase III FIRST study of platinum-based therapy
with JEMPERLI and niraparib versus standard of care platinum-based
therapy as first-line treatment of stage III or IV non-mucinous
epithelial ovarian cancer. In addition, JEMPERLI is being evaluated
as monotherapy and in combination therapy across multiple tumor
types and other cancers, including platinum-resistant ovarian
cancer, non-small cell lung cancer, multiple myeloma and
melanoma.
In the US, prevalence of dMMR across solid tumors has been
estimated at 14%. Mismatch repair-deficient status is a biomarker
that has been shown to predict response to immune checkpoint
blockade with PD-1 therapy. Tumors with this biomarker are most
commonly found in endometrial, colorectal and other
gastrointestinal cancers, but may also be found in other solid
tumors.
GSK continues to develop additional antibodies partnered with
AnaptysBio, including cobolimab, an AnaptysBio-generated anti-TIM-3
antagonist antibody, and GSK4074386, an anti-LAG-3 antagonist
antibody. Under the terms of the collaboration, AnaptysBio is due
to receive development and regulatory milestone payments for each
of the first two indications for each of these antibodies.
AnaptysBio can potentially receive a total of $1.1 billion in
aggregate milestone payments under this collaboration. In addition,
AnaptysBio will receive royalties ranging from 4% to 8% on global
net sales of cobolimab and GSK4074386 and 1% of GSK’s global net
sales of ZejulaTM.
________________________1 New GSK: new ambitions for patients
and shareholders. June 23, 2021.
Please see full Prescribing
Information here
About AnaptysBio
AnaptysBio is a clinical-stage biotechnology company developing
first-in-class antibody product candidates focused on unmet medical
needs in inflammation. The Company’s proprietary anti-inflammatory
pipeline includes imsidolimab, its anti-IL-36R antibody, previously
referred to as ANB019, for the treatment of dermatological
inflammatory diseases, including generalized pustular psoriasis, or
GPP, acne, hidradenitis suppurativa, EGFRi skin toxicity and
ichthyosis; rosnilimab, its anti-PD-1 agonist program, previously
referred to as ANB030, for the 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 GSK, including an anti-PD-1 antagonist antibody (JEMPERLI
(dostarlimab-gxly) GSK4057190), an anti-TIM-3 antagonist antibody
(cobolimab, GSK4069889) 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 Statements
This 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 milestones and royalty payments to be received
under the GSK partnership. 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.
Contact:Dennis MulroyAnaptysBio,
Inc.858-732-0201dmulroy@anaptysbio.com
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