AnaptysBio Announces Positive ANB032 (anti-BTLA agonist) Top-Line Phase 1 Data and Provides Pipeline Updates
April 27 2022 - 4:15PM
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 positive top-line data from a Phase 1 trial
of ANB032, its investigational wholly owned
anti-BTLA agonist antibody. Top-line data
demonstrated favorable safety, tolerability, and a rapid and
sustained pharmacokinetic and pharmacodynamic profile that supports
advancement of ANB032 into subsequent patient trials.
AnaptysBio has a strategic portfolio review ongoing
while continuing to execute on the development of its three wholly
owned clinical stage antibody programs:
- Imsidolimab
(anti-IL-36R Ab) top-line data from the GEMINI-1 Phase 3 trial in
GPP is anticipated in the fourth quarter of 2023
- Imsidolimab top-line
data from the HARP Phase 2 trial in moderate-to-severe hidradenitis
suppurativa is anticipated in the third quarter of 2022
- Rosnilimab
(anti-PD-1 agonist Ab) top-line data from the AZURE Phase 2 trial
in moderate-to-severe alopecia areata is anticipated in the first
half of 2023
- ANB032 (anti-BTLA
agonist Ab) IND filing of a Phase 2 clinical trial is anticipated
in the second half of 2022
“We are pleased
to report promising results for ANB032 in
this Phase 1 trial, as we continue to execute across our three
wholly owned clinical stage antibody programs,” said
Dr. Paul F. Lizzul, chief medical officer
of AnaptysBio. “We believe ANB032’s mechanism is
broadly applicable to T and B cell driven inflammatory
diseases and look forward to further clinical development with
this important immune checkpoint modulator.”
A total of 96 subjects were enrolled in
the randomized, double-blind,
placebo-controlled healthy volunteer Phase 1 trial, where
single ascending dose (SAD) cohorts received subcutaneous or
intravenous single doses of ANB032 or placebo,
while multiple ascending dose (MAD) cohorts received four
weekly subcutaneous doses of ANB032 or placebo.
ANB032 was generally well-tolerated, no dose limiting
toxicities were observed and there were no discontinuations due to
adverse events, other than one patient quarantined for potential
COVID infection. No serious adverse events (SAEs) were
reported. Most adverse events were considered to be
mild-to-moderate, of short duration, resolved without sequelae and
occurred sporadically in a dose-independent manner.
Three severe adverse events (2 blood creatine phosphokinase (CPK)
increase and 1 aspartate aminotransferase (AST) increase), none of
which were treatment-related, were reported in two subjects in the
lowest dose MAD cohort. Three subjects had mild-to-moderate single
injection site reactions (ecchymosis; erythema; and pain) of short
duration.
Pharmacokinetic analyses demonstrated a favorable profile for
ANB032 including an approximate two-week half-life for
subcutaneous and intravenous routes of administration. Full
BTLA receptor occupancy was observed rapidly within
hours and was maintained for greater
than 30 days following IV or subcutaneous ANB032 dosing.
ANB032 pharmacodynamic activity resulted in reduction of
cell surface BTLA expression on T cells and B cells following
dosing. A portion of the cell surface
BTLA was shed from the cells
as soluble BTLA (sBTLA), while the residual
approximately 60% of baseline BTLA on T cells and B cells
remained occupied by ANB032. The duration of reduced BTLA
expression correlated with receptor occupancy in a dose-dependent
manner and was maintained for greater than 30
days following IV or subcutaneous ANB032 dosing.
“ANB032 demonstrated rapid and sustained target engagement on
both T cells and B cells. Importantly, reduction of cell surface
BTLA expression and the shedding of a portion of the cell surface
BTLA as soluble BTLA, which was previously demonstrated to occur
with ANB032 treatment in animal models of inflammation where robust
efficacy was observed, confirmed the pharmacodynamic activity of
ANB032 in humans,” said Dr. Martin Dahl, SVP Discovery Biology of
AnaptysBio. “Based upon these data, we believe ANB032’s in vivo
mechanism has the potential to broadly treat T and B-cell driven
human inflammatory diseases.”
About ANB032ANB032, a wholly owned
anti-BTLA agonist antibody developed by
AnaptysBio, demonstrated favorable safety, tolerability and a
rapid and sustained pharmacokinetic and pharmacodynamic profile in
a Phase 1 healthy volunteer trial. ANB032 is anticipated to
down-modulate the activity of T cells, B cells and BTLA
expressing myeloid dendritic cells via several potential
mechanisms: direct BTLA agonistic activity, stabilization of the
interaction of BTLA and HVEM in cis which prevents pro-inflammatory
signaling mediated by HVEM ligands such as LIGHT, and abrogation of
pro-inflammatory HVEM signaling mediated by BTLA in
trans. Genetic studies have demonstrated
that BTLA pathway mutations increase human susceptibility
to multiple autoimmune diseases and
insufficient BTLA signaling can lead to dysregulated
T or B cell responses.
About AnaptysBioAnaptysBio 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, and
moderate-to-severe hidradenitis suppurativa; rosnilimab, its
anti-PD-1 agonist program, previously referred to as ANB030, for
the treatment of moderate-to-severe alopecia areata; and its
anti-BTLA agonist 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).
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 timing of top-line data
for our Phase 2 clinical trial of imsidolimab in moderate-to-severe
hidradenitis suppurativa, our Phase 3 clinical trial of imsidolimab
in GPP and our Phase 2 clinical trial of rosnilimab in
moderate-to-severe alopecia areata; the timing of an IND filing for
ANB032; and the potential of ANB032 to treat T and/or B
cell-mediated human inflammatory diseases. 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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