CMC ICOS Biologics and Implicit Bioscience Ltd Announce IC14 Antibody
Manufacturing Agreement and Patent License
BOTHELL, Wash. and BRISBANE, Australia, May 8 /PRNewswire/ -- Implicit
Bioscience Ltd and CMC ICOS Biologics today announced the execution of a
manufacturing contract to support the next stage of development and
commercialization of IC14, a clinical-stage monoclonal antibody for acute lung
injury (ALI). IC14 has a demonstrated safety profile in over 150 patient
exposures, and initial data from a pilot clinical trial in
mechanically-ventilated patients has provided a clear rationale for clinical
development in ALI.
CMC ICOS is a company dedicated to contract development and manufacturing for
the biotechnology sector. The company's previous experience manufacturing
IC14 makes them the ideal company to move the manufacturing process forward
for this program.
The two companies have concluded agreements for the accelerated manufacturing
of drug substance, in anticipation of Phase II trials beginning early next
year. In addition, Implicit has negotiated a non-exclusive license to utilize
the CMC proprietary CHEF1(R) expression technology, a system that rapidly
generates production cell lines and provides the flexibility to quickly
increase manufacturing capacity as needed. Both agreements have been
structured with an eye to future partnering for later stage clinical trials
and commercialization.
Garry Redlich, Implicit Bioscience CEO, commented, "We are pleased to be
working with CMC ICOS on the IC14 program, and appreciate their particular
insights gained over their years of experience in the earlier development of
this antibody. We believe that the accelerated timelines that are part of
this agreement will be important assets to the value of the program, and will
facilitate future partnering activities."
Gustavo Mahler, CMC ICOS President, noted "We are pleased to be able to
continue our significant role in the IC14 program, and to continue to expand
our leadership role in the field of protein production. The Implicit and CMC
ICOS teams are already well integrated and working closely to move this
program forward on an accelerated basis."
About Acute Lung Injury
Acute lung injury (ALI) is a severe inflammatory disease which can rapidly
progress to acute respiratory distress syndrome, multi-organ dysfunction and
death. The incidence of this disorder is estimated at around 200,000 cases per
annum in the US and is responsible for over 75,000 deaths - more than breast
cancer and HIV AIDS combined. It is diffuse heterogeneous lung injury
characterized by hypoxemia, non-cardiogenic pulmonary edema, low lung
compliance and widespread capillary leakage. ALI is caused by any stimulus of
local or systemic inflammation and commonly occurs after acute insults to the
body, such as trauma, severe pneumonia and sepsis. ALI is a key factor on the
pathway to mortality following severe influenza infection.
About IC14
IC14 is a clinical stage recombinant chimeric monoclonal antibody which
recognizes and blocks the function of human CD14, an essential component of
the innate inflammatory response to bacterial infection. CD14 triggers
activation of the innate immune response to bacterial components including
lipopolysaccharide via the Toll-like receptor (TLR) pathway. Lung inflammation
in response to innate immune activation through the TLR pathway is a primary
factor in the early pathogenesis of ALI.
About CMC ICOS Biologics
CMC ICOS Biologics is a leading contract development and manufacturing
organization that provides fully integrated biopharmaceutical development and
manufacturing services to clients around the world. The company specializes
in custom services for the scale-up and cGMP manufacture of protein-based
therapeutics for pre-clinical, clinical trials and commercial production. CMC
ICOS' wide range of integrated services includes cell line development using
its proprietary CHEF1(R) expression system, process development, analytical
and formulation development, and comprehensive analytical testing including
long-term stability studies.
As part of CMC Biologics A/S, CMC ICOS offers both stirred tank and perfusion
production processes. CMC ICOS is located near Seattle, WA and CMC Biologics
is located in Copenhagen, Denmark. www.cmcbio.com
About Implicit Bioscience Ltd
Implicit Bioscience Ltd is a public unlisted Australian biopharmaceutical
company based in Brisbane (Australia) and Seattle, WA that develops drugs
which modulate the host immune response to disease. Its business model is to
mitigate both product risk and capital risk, through the in-licensing and
development of clinical stage programs that have known safety profiles in man,
and present opportunity for third party non-dilutive funding. Implicit is
currently developing oglufanide disodium for the treatment of serious
infections including those caused by a variety of biothreat agents (under a
contract with the US Defense Threat Reduction Agency).
www.implicitbioscience.com
This news release contains forward-looking statements. These statements are
subject to known and unknown risks and uncertainties that may cause actual
future experience and results to differ materially from the statements made.
Factors that might cause such a difference include, among others, the
completion of clinical trials, the FDA review processes and other governmental
regulation, Implicit's ability to successfully develop and commercialize drug
candidates, competition from other pharmaceutical companies, the ability to
effectively market products, and other factors described in Implicit's filings
with the Australian Securities and Investment Commission. Implicit does not
undertake any duty to update forward-looking statements.
SOURCE Implicit Bioscience Ltd
Dick Haiduck, Chief Business Officer of Implicit Bioscience, Inc.,
+1-650-851-3133, dick.haiduck@implicitbioscience.com, or Garry Redlich, Chief
Executive Officer of Implicit Bioscience Ltd, +61 (0) 417 728 583,
garry.redlich@implicitbioscience.com; or Mark Honda of CMC ICOS Biologics,
+1-425-489-8895, mhonda@cmcbio.com
