Alpine Immune Sciences Announces Amendment of Acazicolcept Option and License Agreement with AbbVie
21 Dicembre 2023 - 10:15PM
Business Wire
-- Enrollment in the phase 2 study of
acazicolcept in systemic lupus erythematosus (Synergy) will be
stopped to allow for early assessment of data --
-- Final analysis after last patient completes
study protocol expected to occur by the end of 2024 --
Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading
clinical-stage immunotherapy company focused on developing
innovative treatments for autoimmune and inflammatory diseases,
announced today that the Company has amended the previously
announced 2020 option and license agreement with AbbVie for
acazicolcept.
Key terms of the amended
agreement:
- Company will stop enrollment under the amended agreement in the
phase 2 study of acazicolcept in systemic lupus erythematosus
within 30 days. Currently enrolled patients will be allowed to
complete the study. Patients who are currently in the screening
process and meet eligibility requirements will be allowed to enter
and complete the study.
- Final analysis will be conducted after the last patient
completes the study protocol which is expected to occur by the end
of 2024.
- AbbVie retains an exclusive option to obtain an exclusive
worldwide license to acazicolcept which is exercisable by AbbVie at
any time and will expire 90 days from delivery of an agreed upon
data package by the Company to AbbVie.
- The previously disclosed option exercise fee of $75 million has
been reduced to $10 million and the remaining pre-option
development milestone has been removed.
- Potential future development, commercial, and sales-based
milestones and sales-based royalties have been reduced by 25
percent from the originally agreed upon amounts.
- Company has received $105 million in non-refundable upfront and
milestone payments to-date as part of the option and license
agreement.
“AbbVie has been a tremendous partner, and we appreciate their
flexibility in amending our agreement for the development of
acazicolcept. While enrollment in the Synergy study will be stopped
early, we still anticipate that sufficient clinical and
pharmacodynamic data will be available to enable a thorough
evaluation of the study,” said Mitchell H. Gold, MD, Executive
Chairman and Chief Executive Officer. “We plan to focus our
development resources to advance povetacicept into a broad
development plan.”
About Acazicolcept and the Synergy
Study
Acazicolcept is a first-in-class, dual inhibitor of the CD28 and
ICOS T-cell costimulatory pathways being developed for treatment of
systemic lupus erythematosus (SLE). By simultaneously blocking two
key costimulatory pathways, acazicolcept has the potential to
improve outcomes in patients suffering from severe
autoimmune/inflammatory diseases. Preclinical studies have
demonstrated efficacy in models of SLE, Sj�gren’s syndrome,
arthritis, inflammatory bowel disease, multiple sclerosis, type 1
diabetes, uveitis, and graft versus host disease.
Synergy (NCT04835441) is a global, randomized, double-blind,
placebo-controlled Phase 2 clinical study of acazicolcept in
moderate-to-severe systemic lupus erythematosus (SLE) that
initiated enrollment in June 2021.
About Alpine Immune
Sciences
Alpine Immune Sciences is committed to leading a new wave of
immune therapeutics. With world-class research and development
capabilities, a highly productive scientific platform, and a proven
management team, Alpine is seeking to create first- or
best-in-class multifunctional immunotherapies via unique protein
engineering technologies to improve patients’ lives. Alpine has
entered into strategic collaborations with leading global
biopharmaceutical companies and has a diverse pipeline of clinical
and preclinical candidates in development. For more information,
visit www.alpineimmunesciences.com. Follow @AlpineImmuneSci on X
and LinkedIn.
Forward-Looking
Statements
This release contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, Section 21E
of the Securities Exchange Act of 1934 and the Private Securities
Litigation Reform Act of 1995. These forward-looking statements are
not based on historical fact and include statements regarding our
platform technology and potential therapies; the potential
efficacy, safety profile, future development plans, addressable
market, regulatory success, and commercial potential of our product
candidates; the timing of and results from clinical trials and
pre-clinical development activities; clinical and regulatory
objectives and the timing thereof; our ability to achieve
milestones in our collaboration with AbbVie; the efficacy of our
clinical trial designs; and our ability to successfully develop and
achieve milestones in our development programs. Forward-looking
statements generally include statements that are predictive in
nature and depend upon or refer to future events or conditions and
include words such as “may,” “will,” “should,” “would,” “expect,”
“plan,” “intend,” and other similar expressions, among others.
These forward-looking statements are based on current assumptions
that involve risks, uncertainties, and other factors that may cause
actual results, events, or developments to be materially different
from those expressed or implied by such forward-looking statements.
These risks and uncertainties, many of which are beyond our
control, include, but are not limited to: clinical trials may not
demonstrate safety and efficacy of any of our product candidates;
our ongoing discovery and preclinical efforts may not yield
additional product candidates; our discovery-stage and preclinical
programs may not advance into the clinic or result in approved
products; any of our product candidates may fail in development,
may not receive required regulatory approvals, or may be delayed to
a point where they are not commercially viable; we may not achieve
additional milestones in our proprietary or partnered programs; the
impact of competition; adverse conditions in the general domestic
and global economic markets; we may be unable to advance
povetacicept directly into a pivotal trial in IgA nephropathy or a
phase 2 study in systemic lupus erythematosus in 2024; the impact
of pandemics, or other related health crises on our business,
research and clinical development plans and timelines and results
of operations, including the impact on our clinical trial sites,
collaborators, and contractors who act for or on our behalf; as
well as the other risks identified in our filings with the
Securities and Exchange Commission. These forward-looking
statements speak only as of the date hereof and we undertake no
obligation to update forward-looking statements, and readers are
cautioned not to place undue reliance on such forward-looking
statements.
Source: Alpine Immune Sciences, Inc.
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version on businesswire.com: https://www.businesswire.com/news/home/20231221900461/en/
Media and Investor Relations
Contact: Temre Johnson Alpine Immune Sciences, Inc.
ir@alpineimmunesciences.com media@alpineimmunesciences.com
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