WuXi Biologics and Immune Pharmaceuticals Announce Late-phase Development and Manufacturing Partnership for a First-In-Class ...
July 09 2018 - 7:00AM
WuXi Biologics (2269.HK), a leading global open-access biologics
technology platform company offering end-to-end solutions for
biologics discovery, development and manufacturing, and Immune
Pharmaceuticals (Nasdaq:IMNP) (“Immune”), a biopharmaceutical
company developing novel therapeutic agents for the treatment of
immunologic and inflammatory diseases, today announced a
development and manufacturing agreement for the production of
bertilimumab, Immune’s first-in-class anti-eotaxin-1 monoclonal
antibody. Bertilimumab is designed to block the protein eotaxin-1,
which is responsible for causing inflammation in a significant
number of diseases. Immune recently completed a phase 2a trial of
bertilimumab in patients with moderate-to-extensive bullous
pemphigoid (BP), plans to launch a pivotal study in BP in 2019 and
is continuing to enroll subjects in an ongoing phase 2 trial in
ulcerative colitis.
The new partnership between the companies
combines Immune’s leading expertise in immunology research and
development with WuXi Biologics’ expertise in biologics late-stage
development and commercial manufacturing to expedite the program
towards potential global product approval. WuXi Biologics will
scale the new bertilimumab manufacturing process to 2,000 liters,
which can support the planned clinical development program and
potential future commercial needs. WuXi Biologics will also serve
as the fill/finish manufacturer for bertilimumab. Current timelines
call for initiating Good Manufacturing Practice (GMP) production in
the second quarter of 2019, with supplies released for clinical use
in the third quarter of 2019.
“This is an extremely important milestone for
the bertilimumab program, as we have secured clinical manufacturing
not only for our planned pivotal phase 2/3 trial in bullous
pemphigoid, but for future trials in ulcerative colitis, asthma and
other indications,” commented Tony Fiorino, MD, PhD, Chief Medical
and Operating Officer of Immune. “We are pleased to be working with
WuXi Biologics on the scale-up and production of bertilimumab,
given its extensive experience in the manufacture of monoclonal
antibodies and its vast production capacity. We believe WuXi
Biologics is well-positioned to meet foreseeable bertilimumab
production demand. We have hit the ground running with WuXi
Biologics and have already begun working on the technology
transfer.”
“We are excited that our partner Immune
Pharmaceuticals switched from a global CMO leader to WuXi Biologics
to bring this innovative first-in-class therapy to patients
suffering from immuno-inflammatory diseases,” said Dr. Chris Chen,
CEO of WuXi Biologics. “Our integrated development and
manufacturing service across both biologics drug substance and fill
finish will expedite development of this important late-stage
clinical program. In addition, our robust and premier-quality
global supply chain in four countries including China, Ireland,
Singapore and the United States will ensure that every patient who
needs this critical medicine will have access.”
About WuXi Biologics
WuXi Biologics, a Hong Kong-listed company, is
the only open-access biologics technology platform in the world
offering end-to-end solutions to empower organizations to discover,
develop and manufacture biologics from concept to commercial
manufacturing. Our company history and achievements demonstrate our
commitment to providing a truly ONE-stop service offering and value
proposition to our global clients. For more information on WuXi
Biologics, please visit www.wuxibiologics.com.
About Immune Pharmaceuticals,
Inc.
Immune Pharmaceuticals, Inc. is a
biopharmaceutical company developing novel therapeutic agents for
the treatment of immunologic and inflammatory diseases. Immune’s
lead program, bertilimumab, is a first-in-class, human monoclonal
antibody that binds eotaxin-1, a chemokine that attracts
eosinophils to the site of inflammation. By blocking eotaxin-1,
bertilimumab may prevent the migration and activation of
eosinophils and other cells, thus blocking an important
inflammatory pathway active in a variety of allergic and immune
diseases. Bertilimumab has shown promising clinical activity in
bullous pemphigoid and has been studied in other conditions
including allergic rhinitis and ulcerative colitis, and may have
application in other diseases, including atopic dermatitis, asthma,
and other diseases. Immune is also developing NanoCyclo, a
nano-encapsulated formulation of cyclosporin, which is in late
stage preclinical development for atopic dermatitis and psoriasis.
For more information on Immune Pharmaceuticals, please visit
www.immunepharma.com.
Safe Harbor Statements Regarding Forward
Looking Statements
The statements in this news release made by
representatives of Immune relating to matters that are not
historical facts, including without limitation, those regarding
future performance or financial results, the timing or potential
outcomes of research collaborations or clinical trials, any market
that might develop for any of Immune’s product candidates and the
sufficiency of Immune’s cash and other capital resources, the
continued development by Immune of bertilimumab or its
determination to seek Orphan Drug designation for the
pharmaceutical product of bertilimumab are forward-looking
statements that involve risks and uncertainties, including, but not
limited to, the likelihood that actual performance or results could
materially differ, that future research will prove successful, the
likelihood that any product in the research pipeline will receive
regulatory approval in the United States or abroad, or Immune’s
ability to fund such efforts with or without partners. Immune
undertakes no obligation to update any of these statements. Readers
are cautioned not to place undue reliance on these forward-looking
statements, which speak only as to the date hereof. Accordingly,
any forward-looking statements should be read in conjunction with
the additional risks and uncertainties detailed in Immune’s filings
with the Securities and Exchange Commission, including those
discussed in Immune’s Annual Report on Form 10-K, Quarterly Reports
on Form 10-Q, and periodic reports filed on Form 8-K.
WuXi Biologics:Jia
Li+86-21-2066-4528li_jia0102@wuxiapptec.com
Immune
Pharmaceuticals:Investors@immunepharma.com