XOMA Announces Four Presentations at the 2017 ENDO Meeting
Oral and Poster Presentations to Highlight Preclinical and Clinical Program Advances for Hypoglycemia and Hypercalcemia
BERKELEY, Calif., March 23, 2017 (GLOBE NEWSWIRE) -- 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
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Session: OR14: Glucose Metabolism and Post Bariatric Surgery
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Date: Monday, April 3, 2017, 12:30 PM - 12:45 PM
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Location: OCCC - W224C
Poster Presentations
Abstract title: Activity of XOMA 358, an Inhibitor of Insulin Action Following Short-Term Administration to Congenital Hyperinsulinism Patients
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Session: MON 001-056 Pediatric Endocrine Case Reports: Diabetes, Thyroid, and Beyond
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Poster number: MON 056
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Date: Monday, April 3, 2017, 1:00 PM - 3:00 PM
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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
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Session: SAT 575-585 Cellular Signaling Pathways and Regulation of Glucose Metabolism
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Poster number: SAT 583
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Date: Saturday, April 1, 2017, 1:00 PM - 3:00 PM
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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
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Session: SAT 338-359 Innovations in Bone Biology
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Poster number: SAT 339
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Date: Saturday, April 1, 2017, 1:00 PM - 3:00 PM
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Location: West Hall B (EXPO Hall)
More information about the ENDO program can be found at: www.endocrine.org/endo-2017/meeting-program
About X358
Insulin 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 X129
X129 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 Antibodies
XOMA 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 Corporation
XOMA 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
Released March 23, 2017