XOMA Presented First Data from Novel Antibody Fragment to Address Severe Acute Hypoglycemia at the ENDO Meeting
April 04 2016 - 9:00AM
XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and
development of therapeutic antibodies, announced the presentation
of data from XOMA 129, the lead compound in the Company’s XMetD
antibody fragment (Fab) program, at the Endocrine Society’s Annual
Meeting – ENDO 2016. A senior scientist at XOMA presented the
Company’s poster titled “XOMA 129, a Novel Insulin Receptor
Negative Modulator, is Efficacious in Treating Insulin- and
Glibenclamide-induced Hypoglycemia in Animals.”
“Severe acute hypoglycemia is a common
complication with diabetes therapies that requires prompt
recognition and treatment to prevent severe toxicity and
potentially mortality. XOMA 129, our novel Fab that binds to
an allosteric site on the insulin receptor, was designed to have a
rapid onset and limited duration of action, two important clinical
requirements in reversing an acute hypoglycemic event,” stated Paul
Rubin, M.D., Senior Vice President, Research and Development, and
Chief Medical Officer at XOMA. “The data presented at ENDO
2016 demonstrate our Fab exhibits the rapidity of effect and
clearance traits required, thereby leading us to believe XOMA 129
represents a novel potential treatment approach for these severe
hypoglycemic episodes.”
The poster outlines XOMA 129’s performance in
separate pre-clinical models: cell culture and animal pharmacology
studies. In vitro assays showed XOMA 129 decreases the
activity of insulin on mammalian cells over-expressing human, rat
and minipig insulin receptor (INSR) in a dose-dependent
manner. Further studies confirmed XOMA 129 binds to the INSR
and acts as a negative allosteric modulator. In animal
studies, potential rescue of insulin or sulphonylurea-induced
hypoglycemia was modeled in normal rats. Administration of
insulin or glibenclamide (a sulfonylurea) produced abnormally low
glucose levels. Intravenous administration of XOMA 129 at
time points wherein the drug-induced glucose levels were falling
below normal levels rapidly stabilized blood glucose levels thereby
preventing hypoglycemia. In normal minipigs, intramuscular
administration yielded significant elevation of blood glucose
lasting for several hours thereby confirming the activity in
mammals.
About XOMA 129XOMA 129 is a
fully human, high affinity monoclonal antibody fragment that
specifically targets the human insulin receptor (INSR).
Insulin is the major hormone for lowering blood glucose
levels. Profound hypoglycemia (low blood sugar) can result in
significant morbidities, including organ damage and potentially
death. There are acute and more persistent hypoglycemia
conditions associated with abnormally high insulin levels, which
represent unmet medical needs. As a negative allosteric modulator,
XOMA 129 binds with high affinity to a site distinct from insulin
binding and dampens insulin signaling. This drug candidate
has been designed to provide a rapid onset of action and a duration
of action tailored to meet the pharmacotherapy needs in certain
conditions. The Company intends to pursue an Investigational
New Drug (IND) application in the US for XOMA 129 upon completion
of its IND-enabling nonclinical development activities.
About XOMA CorporationXOMA
Corporation is a leader in the discovery and development of
therapeutic antibodies. The Company's innovative product candidates
result from its expertise in developing ground-breaking monoclonal
antibodies, including allosteric antibodies, which have created new
opportunities to potentially treat a wide range of human diseases.
XOMA's scientific research has produced a portfolio of five
endocrine assets, each of which has the opportunity to address
multiple indications. The Company's lead product candidate, XOMA
358, is an allosteric monoclonal antibody that reduces insulin
receptor activity, which could have a major impact on the treatment
of hyperinsulinism. The Company recently initiated Phase 2
development activities for XOMA 358 in patients with congenital
hyperinsulinism. For more information, visit www.xoma.com.
Forward-Looking
StatementsCertain statements contained in this press
release including, but not limited to, statements related to
anticipated timing of clinical trials, anticipated timing of the
release of clinical data, regulatory approval of unapproved product
candidates, the anticipated process of clinical data analysis, the
anticipated success of any clinical trial, cash usage, or
statements that otherwise relate to future periods are
forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933 and Section 21E of the Securities Exchange
Act of 1934. These statements are based on assumptions that may not
prove accurate, and actual results could differ materially from
those anticipated due to certain risks inherent in the
biotechnology industry and for companies engaged in the development
of new products in a regulated market. Potential risks to XOMA
meeting these expectations are described in more detail in XOMA's
most recent filing on Form 10-K and in other SEC filings. Consider
such risks carefully when considering XOMA's prospects. Any
forward-looking statement in this press release represents XOMA's
views only as of the date of this press release and should not be
relied upon as representing its views as of any subsequent date.
XOMA disclaims any obligation to update any forward-looking
statement, except as required by applicable law.
Company and Investor Contact:
Ashleigh Barreto
510-204-7482
barreto@xoma.com
Juliane Snowden
The Oratorium Group, LLC
jsnowden@oratoriumgroup.com
Media Contact:
Ryan Flinn
W2O Group
415-946-1059
rflinn@w2ogroup.com
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