- Assets expand immunology portfolio to
include B-cell therapy (BAFF/APRIL) and macrophage modulation
-
- IND-enabling studies are ongoing and will
support the transition of these assets to clinical development in
2022/2023 -
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the
Company) today announced the addition of two novel assets that will
expand the Company’s rare autoimmune and kidney-related disease
pipeline.
“Over the past year, in anticipation of building out and
diversifying our development pipeline, we have brought on
additional large and small molecule expertise that uniquely aligns
with Aurinia’s focus on immunology and nephrology,” said Peter
Greenleaf, President and Chief Executive Officer of Aurinia. “These
transactions are transformational for Aurinia as they allow us to
leverage our existing R&D capabilities and commercial
experience to support a balanced pipeline and advance innovative
therapeutic solutions to help people living with rare autoimmune
diseases.”
AUR200: Recombinant Fc Protein Targeting BAFF/APRIL
The first program, AUR200, was acquired by way of Aurinia
purchasing all of the common stock of Thunderbolt Pharma, Inc.
(Thunderbolt), a private company. AUR200 is a recombinant Fc fusion
protein designed to specifically block B-cell Activating Factor,
known as BAFF, and A Proliferation-Inducing Ligand, known as APRIL.
BAFF and APRIL promote B cell survival and differentiation and have
been shown to play a prominent role in the pathogenesis of certain
autoimmune and nephrology conditions.
For the acquisition, Aurinia made an aggregate upfront payment
of $750,000 USD to the shareholders of Thunderbolt and will be
responsible for future regulatory milestones upon investigational
new drug (IND) acceptance by the United States’ Food and Drug
Administration (FDA) or any equivalent authority. Additionally,
Thunderbolt shareholders will receive low single digit royalties on
any future net sales. AUR200 is currently undergoing pre-clinical
development with projected submission of an IND to the FDA by the
end of 2022.
“BAFF/APRIL inhibition has been extensively studied and
established as an important approach to managing immunologic
response,” said Neil Solomons, MD, Chief Medical Officer, Aurinia.
“We are encouraged by AUR200’s unique profile and best-in-class
potential and look forward to sharing further data and updates on
this exciting program.”
AUR300: M2 macrophage modulation via CD206 binding
The second program, AUR300, was secured through a global
licensing and research agreement with Riptide Bioscience Inc.
(Riptide), a private company. AUR300 is a novel peptide therapeutic
that modulates M2 macrophages (a type of white blood cells) via the
macrophage mannose receptor CD206. Dysregulation of M2 macrophages
drives fibrosis. AUR300 acts to reduce M2 dysregulation and
decrease inflammatory cytokines, and therefore may have significant
clinical applications for autoimmune and fibrotic diseases.
Riptide has longstanding expertise in interpreting the etiology
of fibrosis, including the discovery of lysyl oxidase and
procollagen. As part of the agreement, Aurinia paid Riptide an
upfront fee of $6 million USD. Additional milestone payments are
due upon certain development, clinical and regulatory milestones,
and royalties will be payable upon commercialization. It is
anticipated that clinical development for AUR300 will commence
during the first half of 2023.
“Both of these programs are rooted in strong science and at the
leading edge of approaches for the treatment of autoimmune,
fibrotic, and kidney diseases,” said Rob Huizinga, PhD, RN,
CNeph(C), Executive Vice President of Research, Aurinia.
“Significant research has been done to date in both BAFF/APRIL
inhibition and macrophage modulation and we are confident both of
these approaches offer high potential across multiple autoimmune
diseases as we advance them into the clinic.”
About Aurinia
Aurinia is a fully integrated biopharmaceutical company focused
on delivering therapies to treat targeted patient populations that
are impacted by serious diseases with a high unmet medical need.
The Company recently introduced the first FDA-approved oral therapy
indicated for the treatment of adult patients with active lupus
nephritis (LN). Aurinia’s head office is in Victoria, British
Columbia; its U.S. commercial hub is in Rockville, Maryland; and
the Company focuses development efforts globally.
Forward-Looking Statements
Certain statements made in this press release may constitute
forward-looking information within the meaning of applicable
Canadian securities law and forward-looking statements within the
meaning of applicable United States securities law. These
forward-looking statements or information include but are not
limited to statements or information with respect to: the timing of
transitioning AUR200 and AUR300 into clinical development; that the
acquisitions of AUR200 and AUR300 are transformational for Aurinia;
Aurinia’s belief that the mechanism of action of the AUR300 peptide
may have significant clinical applications for autoimmune or
fibrotic diseases; the timing for filing an IND for AUR200 and
AUR300; Aurinia’s belief that AUR200 has the potential to be a
unique and best in class BAFF/APRIL inhibitor; Aurinia’s belief
that AUR200 and AUR300 are at the leading edge of approaches for
the treatment of autoimmune, fibrotic and kidney diseases; and
Aurinia’s belief that macrophage modulation and BAFF/APRIL
inhibition offer high potential across multiple autoimmune
diseases. It is possible that such results or conclusions may
change. Words such as “anticipate”, “will”, “believe”, “estimate”,
“expect”, “intend”, “target”, “plan”, “goals”, “objectives”, “may”
and other similar words and expressions, identify forward-looking
statements. We have made numerous assumptions about the
forward-looking statements and information contained herein,
including among other things, assumptions about: assumptions
relating to the burn rate of Aurinia’s cash for operations; and
that Aurinia’s third party service providers will comply with their
contractual obligations. Even though the management of Aurinia
believes that the assumptions made, and the expectations
represented by such statements or information are reasonable, there
can be no assurance that the forward-looking information will prove
to be accurate.
Forward-looking information by their nature are based on
assumptions and involve known and unknown risks, uncertainties and
other factors which may cause the actual results, performance, or
achievements of Aurinia to be materially different from any future
results, performance or achievements expressed or implied by such
forward-looking information. Should one or more of these risks and
uncertainties materialize, or should underlying assumptions prove
incorrect, actual results may vary materially from those described
in forward-looking statements or information. Such risks,
uncertainties and other factors include, among others, the
following: Aurinia’s actual future financial and operational
results may differ from its expectations; Aurinia may have to pay
unanticipated expenses; unknown impact and difficulties imposed by
the COVID-19 pandemic on Aurinia’s business operations including
nonclinical, clinical, regulatory and commercial activities; the
future prospects for AUR200 and AUR300 may not be as Aurinia has
anticipated, or Aurinia may not be able to fully capitalize on the
opportunities presented by AUR200 and AUR300; Aurinia’s third party
service providers may not, or may not be able to, comply with their
obligations under their agreements with Aurinia; and Aurinia’s
assets or business activities may be subject to disputes that may
result in litigation or other legal claims. Although Aurinia has
attempted to identify factors that would cause actual actions,
events, or results to differ materially from those described in
forward-looking statements and information, there may be other
factors that cause actual results, performances, achievements, or
events to not be as anticipated, estimated or intended. Also, many
of the factors are beyond Aurinia’s control. There can be no
assurance that forward-looking statements or information will prove
to be accurate, as actual results and future events could differ
materially from those anticipated in such statements. Accordingly,
you should not place undue reliance on forward-looking statements
or information.
All forward-looking information contained in this press release
is qualified by this cautionary statement. Additional information
related to Aurinia, including a detailed list of the risks and
uncertainties affecting Aurinia and its business, can be found in
Aurinia’s most recent Annual Report on Form 10-K available by
accessing the Canadian Securities Administrators’ System for
Electronic Document Analysis and Retrieval (SEDAR) website at
www.sedar.com or the U.S. Securities and Exchange Commission’s
Electronic Document Gathering and Retrieval System (EDGAR) website
at www.sec.gov/edgar, or on Aurinia’s website at
www.auriniapharma.com.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210817005285/en/
Investors: Glenn Schulman, PharmD, MPH Investor Relations
& Corporate Communications, Aurinia
gschulman@auriniapharma.com
Media: Dana Lynch Corporate Communications, Aurinia
dlynch@auriniapharma.com
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