AnaptysBio Announces Portfolio Update Across Best-in-Class Immune Cell Modulating Antibodies
06 January 2023 - 8:05AM
AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology
company focused on delivering innovative immunology therapeutics,
today announced a portfolio update including initiating development
of its wholly owned best-in-class immune cell modulating antibodies
in autoimmune and inflammatory diseases with large and
significantly underserved patient populations. With cash, cash
equivalents and investments greater than $575 million as of
December 31, 2022, the company anticipates having approximately 4
years of capital to execute against its non-risk adjusted research
and development plan, excluding potential future royalties from its
GSK immuno-oncology financial collaboration.
“We have continued to progress our strategic portfolio review
and are excited to announce the near-term initiation of two global
Phase 2b trials across rosnilimab, our PD-1 agonist, in rheumatoid
arthritis and ANB032, our BTLA agonist, in atopic dermatitis. We
believe their mechanisms of action, with the potential to restore
immune balance by acting directly on cell types mediating disease
pathology, have the potential to meaningfully impact large and
significantly underserved patient populations,” said Daniel Faga,
interim president and chief executive officer of AnaptysBio. “We’re
well capitalized to deliver on multiple Phase 2b readouts across
our wholly owned checkpoint agonists as well as to advance ANB033,
our anti-CD122 antagonist, through clinical proof-of-concept.”
Rosnilimab (PD-1 agonist antibody)
- Rosnilimab, its investigational
wholly owned PD-1 agonist, demonstrates best-in-class activity in
vitro with superior inhibition of T cell proliferation, reduction
in inflammatory cytokine secretion (Th1, Th2, Th17) and depletion
of PD-1+ T cells via effector function compared to Lilly PD-1
agonist
- PD-1+ T cells are clinically validated drivers of disease in
rheumatoid arthritis (RA)
- RA patient synovial biopsies have dense T cell infiltrates,
with >80% of T cells expressing PD-1 and insufficient PD-L1
expression to down-regulate T cell activity
- Rosnilimab targets multiple distinct
inflammatory mechanisms addressed by approved therapies to treat
RA
- Initiation in Q3 2023 of a global Phase 2b trial in
moderate-to-severe RA
- Multi-hundred patient placebo-controlled trial assessing three
dose levels of subcutaneously administered rosnilimab for
approximately 6 months on well-established endpoints including
ACR20/50/70 and DAS28
- Top-line interim data anticipated by
mid-year 2025
- Second global Phase 2 trial, in an
indication to be announced, with study initiation anticipated by
year-end 2023
- Conducted a blinded interim review
of alopecia areata Phase 2a data in December 2022
- Enrolled 51 patients in a placebo-controlled trial assessing a
single 400mg Q4W dosage of subcutaneously administered rosnilimab
(randomized 2:1)
- Study remains blinded with 100% of
patients (n=38) through both week 20 dosing period and week 24
primary endpoint and 61% of patients (n=18) through week 32
follow-up period
- Demonstrated rosnilimab “proof of
mechanism” with robust reductions in peripheral PD-1+ T cells,
including PD-1 high T cell reduction of >80%, across blinded
pooled rosnilimab treated and placebo patients, which is consistent
with observations in the healthy volunteer Phase 1 trial of >90%
in rosnilimab treated patients
- Suggests rosnilimab administration
was generally safe and well tolerated
- Severity of Alopecia Tool (SALT) scores were not supportive of
achieving the target product profile and further development in
alopecia areata will not be pursued
- While select patients observed changes from baseline SALT
scores at week 24, no patients achieved an absolute SALT score
<20
- Interim results suggest that target efficacy was not achieved
potentially due to an inadequate tested dose level, limited
duration of treatment, and/or complexity of disease biology
including the hair growth cycle
- Unblinded week 32 results, tissue biopsies and additional
translational data defining the extent of PD-1 modulation in the
periphery and hair follicle will be available in H2 2023
ANB032 (BTLA agonist antibody)
- ANB032, its investigational wholly
owned BTLA agonist, demonstrates best-in-class activity in vitro
with superior inhibition of T cell proliferation and reduction in
inflammatory cytokine secretion (Th1, Th2, Th17) compared to Lilly
BTLA agonist
- While Th2 targeted therapies provide benefit to patients with
chronic moderate-to-severe atopic dermatitis (AD), there is
compelling evidence that AD is broader than a Th2 driven disease,
as Th1, Th17 and other cell types, including dendritic cells, may
contribute significantly to its pathogenesis
- ANB032 inhibits inflammatory
activity of Th1, Th2 and Th17 and modulates additional cell types
such as B cells and dendritic cells, with the potential for
broader, deeper and more durable responses than more narrowly
targeted interventions
- Initiation in Q2 2023 of a global Phase 2b trial in
moderate-to-severe AD
- IND cleared by the FDA in December 2022
- 160 patient placebo-controlled trial assessing three dose
levels of subcutaneously administered ANB032 (randomized 1:1:1:1)
for 12 weeks on well-established endpoints, including EASI75 and
IGA 0/1
- Top-line interim data anticipated by year-end 2024
ANB033 (anti-CD122 antagonist antibody)
- ANB033, its investigational wholly owned anti-CD122 antagonist
antibody, targets the common beta subunit shared by the IL-15 and
IL-2 receptors
- IL-15 signaling mediates the survival and maintenance of tissue
resident memory T cells (TRM)
- The presence of long-lived and
persistent TRM have been shown to drive tissue-specific
immune-mediated inflammation
- IND anticipated H1 2024
Legacy clinical-stage cytokine antagonist programs
available for outlicensing
- Imsidolimab, its investigational wholly owned anti-IL-36r
antagonist antibody, is in Phase 3 trials for generalized pustular
psoriasis (GPP)
- Top-line data from the GEMINI-1 Phase 3 trial anticipated Q4
2023
- Plan to outlicense imsidolimab prior
to potential FDA approval
- Etokimab, its investigational wholly owned anti-IL-33
antagonist antibody, is Phase 2/3-ready for the treatment of
respiratory disorders
- No further internal investment in etokimab is being
pursued
GSK immuno-oncology financial collaboration
- Dostarlimab, an anti-PD-1 antagonist
antibody, cobolimab, an anti-TIM-3 antagonist antibody, and
GSK4074386, an anti-LAG-3 antagonist antibody, were discovered
at AnaptysBio and licensed by GSK
- JEMPERLI (dostarlimab-gxly) has the potential for a
first-in-class approval in primary advanced or recurrent
endometrial cancer after meeting the primary endpoint in the
pivotal RUBY Phase 3 trial demonstrating JEMPERLI plus chemotherapy
significantly improved PFS versus chemotherapy plus placebo
- Regulatory submissions anticipated H1 2023
- GSK expects to publish full results
in a medical journal and present at an upcoming scientific
meeting
- Dostarlimab plus ZEJULA in the
pivotal FIRST Phase 3 trial in 1st line ovarian cancer is ongoing
with an interim analysis expected in H2 2023
- Dostarlimab plus cobolimab plus chemotherapy vs. dostarlimab
plus chemotherapy is in the pivotal COSTAR Lung Phase 3 trial in
advanced non-small cell lung cancer in patients who have progressed
on prior anti-PD-(L)1 therapy
About AnaptysBio
AnaptysBio is a clinical-stage biotechnology company focused on
delivering innovative immunology therapeutics. It is developing
immune cell modulating antibodies, including two checkpoint
agonists in clinical-stage development, for autoimmune and
inflammatory diseases: rosnilimab, its PD-1 agonist, in a planned
Phase 2b trial for the treatment of moderate-to-severe rheumatoid
arthritis; and ANB032, its BTLA agonist, in a planned Phase 2b
trial for the treatment of moderate-to-severe atopic dermatitis.
Its preclinical immune cell modulator portfolio includes ANB033, an
anti-CD122 antagonist antibody for the treatment of autoimmune and
inflammatory diseases. AnaptysBio has developed two cytokine
antagonists available for outlicensing: imsidolimab, an anti-IL-36r
antagonist, in Phase 3 for the treatment of generalized pustular
psoriasis, or GPP, and etokimab, an anti-IL-33 antagonist that is
Phase 2/3 ready. AnaptysBio has also discovered
antibodies licensed to GSK in a financial collaboration for
immune-oncology, including an anti-PD-1 antagonist (JEMPERLI
(dostarlimab-gxly)), an anti-TIM-3 antagonist (cobolimab,
GSK4069889) and an anti-LAG-3 antagonist (GSK4074386).
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 timing of initiation of the company’s clinical
trials, including rosnilimab’s clinical trials in rheumatoid
arthritis and in a second indication and ANB032’s clinical trial in
atopic dermatitis; the timing of the release of data from the
company’s clinical trials, including imsidolimab’s Phase 3 clinical
trial in GPP, rosnilimab’s Phase 2b clinical trial in rheumatoid
arthritis and ANB032’s Phase 2b clinical trial in atopic
dermatitis; the timing of ANB033’s IND filing; statements regarding
efficacy, safety and proof of mechanism from blinded data from
rosnilimab’s clinical trial in alopecia areata; the company’s
ability to find a licensing partner for imsidolimab or etokimab and
the timing of any such transaction; and the company’s projected
cash runway. 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 its
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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