XOMA Corporation (Nasdaq:XOMA), a pioneer in the discovery and
development of therapeutic antibodies, announced today that
clinical data for its two hypoglycemia drug candidates, X358 and
X129, and a third drug candidate for hypercalcemic endocrine and
oncology conditions, will be presented at the Endocrine Society’s
99th Annual Meeting (ENDO 2017), taking place from April 1-4, 2017
in Orlando, Florida.
“We look forward to sharing additional efficacy and safety data
on X358 and X129 with the clinical endocrinology community at this
year’s ENDO meeting. We are also looking forward to discussing the
positive progress and development candidate selection for our
anti-PTH1R program targeting serious hypercalcemia associated with
hyperparathyroidism and certain malignancies,” said Jim Neal, Chief
Executive Officer of XOMA. “This continued positive data positions
each of these programs well for partnering activities. Once they
are successfully partnered, these programs would expand our
portfolio of fully funded programs producing future milestones and
royalties that contribute to our goal of delivering positive cash
flow and profitability.”
The Company will deliver one oral presentation and three poster
presentations, they include:
Oral Presentation Abstract
title: Single Administration of XOMA 358, an Insulin
Receptor Attenuator, Improves Post-Meal and Nighttime Hypoglycemia
Profiles in Post Gastric Bypass Hypoglycemia (PGBH) Patients
- Session: OR14: Glucose Metabolism and Post
Bariatric Surgery
- Date: Monday, April 3, 2017, 12:30 PM - 12:45
PM
- Location: OCCC - W224C
Poster Presentations Abstract
title: Activity of XOMA 358, an Inhibitor of Insulin
Action Following Short-Term Administration to Congenital
Hyperinsulinism Patients
- Session: MON 001-056 Pediatric Endocrine Case
Reports: Diabetes, Thyroid, and Beyond
- Poster number: MON 056
- Date: Monday, April 3, 2017, 1:00 PM - 3:00
PM
- Location: West Hall B (EXPO Hall)
Abstract title: XOMA 129, a Novel Insulin
Receptor Negative Modulator, Is Efficacious in Treating Insulin-
Induced Hypoglycemia in Minipigs
- Session: SAT 575-585 Cellular Signaling
Pathways and Regulation of Glucose Metabolism
- Poster number: SAT 583
- Date: Saturday, April 1, 2017, 1:00 PM - 3:00
PM
- Location: West Hall B (EXPO Hall)
Abstract title: A Novel Anti-PTH1R Receptor
Antagonist Monoclonal Antibody Reverses Hypercalcemia Induced By
PTH or PTHrP: A Potential Treatment of Primary Hyperparathyroidism
and Humoral Hypercalcemia of Malignancy
- Session: SAT 338-359 Innovations in Bone
Biology
- Poster number: SAT 339
- Date: Saturday, April 1, 2017, 1:00 PM - 3:00
PM
- Location: West Hall B (EXPO Hall)
More information about the ENDO program can be found at:
www.endocrine.org/endo-2017/meeting-program
About X358Insulin is the major physiologic
hormone for controlling blood glucose levels. Abnormal increases in
insulin secretion can lead to profound hypoglycemia (low blood
sugar), a state that can result in significant morbidities,
including brain damage, seizures and epilepsy. XOMA, leveraging its
scientific expertise in allosteric monoclonal antibodies, developed
the XMet platform, consisting of separate classes of selective
insulin receptor modulators (SIRMs) that could have a major effect
on treating patients with abnormal metabolic states.
X358 is a fully human negative allosteric modulating insulin
receptor antibody derived from the XMet platform. It is being
investigated as a novel treatment for non-drug-induced, endogenous
hyperinsulinemic hypoglycemia (low blood glucose caused by
excessive insulin production), as well as hypoglycemia after
bariatric surgery. XOMA is conducting Phase 2 development
activities for X358 in patients with congenital hyperinsulinism
(CHI) and in patients with hypoglycemia post-bariatric surgery
(PBS). A therapy that safely and effectively mitigates
insulin-induced hypoglycemia has the potential to address a
significant unmet therapeutic need for certain rare medical
conditions associated with hyperinsulinism. More information on the
X358 clinical trials may be found at www.clinicaltrials.gov and
www.clinicaltrialsregister.eu.
Open-label, Phase 2 studies established proof-of concept for
X358 in 14 patients with congenital hyperinsulinism (CHI) and 13
patients with hypoglycemia post-bariatric surgery (PBS). The CHI
studies were performed with expert disease centers in Philadelphia,
Magdeburg, Germany, and London, and top U.S. centers in Denver,
Baltimore, Boston, and Rochester, Minnesota conducted the PBS
study.
The Phase 2 studies were monitored for safety, and serial blood
samples were collected for pharmacokinetic and pharmacodynamic
assessments. Various markers of drug activity were assessed,
including changes in glucose, ketones, insulin, C-peptide and free
fatty acid levels. Controlled tests included monitored fasts,
protein challenges, and oral glucose tolerance.
About X129X129 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, X129 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.
About PTH1R Monoclonal AntibodiesXOMA has
developed several unique functional antibody antagonists targeting
PTH1R, a G-protein-coupled receptor involved in the regulation of
calcium metabolism. These antibodies have shown promising
efficacy in in vivo studies and could potentially address high
unmet medical needs, including primary hyperparathyroidism (PHPT)
and humoral hypercalcemia of malignancy (HHM).
About XOMA CorporationXOMA has an extensive
portfolio of products, programs, and technologies that are the
subject of licenses the Company has in place with other biotech and
pharmaceutical companies. Many of these licenses are the
result of the Company’s pioneering efforts in the discovery and
development of antibody therapeutics. There are more than 20
such programs that are fully funded by partners and could produce
milestone payments and royalty payments in the future. In
order to maximize its value in a licensing transaction, XOMA
continues to invest in X358, an allosteric monoclonal antibody that
reduces insulin receptor activity, as the antibody could have a
major impact on the treatment of hyperinsulinism. For more
information, visit www.xoma.com.
Forward-Looking Statements Certain statements
contained in this press release 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, including
statements regarding: our extensive portfolio of products and
technologies expected to generate substantial milestone payments
and royalties over time; the future progress of the X358 or X129
clinical programs and their successful outcomes to benefit
patients; our intent to maximize the value of X358 or X129 through
a licensing agreement; our belief that licensing X358 of X129 will
expedite patient access to X358 or X129; our portfolio of assets
that address unmet medical needs, particularly in orphan
indications and oncology; and our future growth potential. The
words "estimate," "anticipate," "intend," "expect," "potential" and
similar expressions are intended to identify forward-looking
statements. 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.
CONTACTS:
Investor contact:
Luke Heagle
Pure Communications
+1 910-726-1372
lheagle@purecommunications.com
Media contact:
Colin Sanford
Pure Communications
+1 415-946-1094
csanford@purecommunications.com
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