Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1226 |
| INN | Ersodetug |
| Status | Clinical |
| Drug code(s) | RZ358, XOMA 358, XMetD |
| Brand name | None |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG2 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Phage display (Xmet platform) |
| Target(s) | Insulin receptor |
| Indications of clinical studies | Hypoglycemia after gastric bypass surgery, Congenital Hyperinsulinism, Hypoglycemia; Phase 1 in healthy volunteers |
| Primary therapeutic area | Metabolic disorders |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | October 01, 2014 |
| Start of Phase 2 | October 15, 2015 |
| Start of Phase 3 | December 15, 2023 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | XOMA |
| Licensee/Partner | Rezolute Inc |
| Comments about company or candidate | Dec. 03, 2024: Rezolute, Inc. announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ersodetug for the treatment of hypoglycemia due to tumor hyperinsulinism. Phase 3 registrational trial for ersodetug in patients with tumor hyperinsulinism (HI) expected to commence in 2025 Aug 5, 2024: Food and Drug Administration (FDA) clearance for its Investigational New Drug (IND) application for Phase 3 study of RZ358 (ersodetug) to treat hypoglycemia in patients with tumor hyperinsulinism (HI). December 14, 2023 I Rezolute, Inc. announced the initiation of sunRIZE, a pivotal Phase 3 clinical study of RZ358 in patients with congenital hyperinsulinism RZ358 has been granted a priority medicines (PRIME) designation by the European Medicines Agency (EMA) and an Innovation Passport designation by the U.K. Innovative Licensing and Access Pathway (ILAP) Steering Group for the treatment of cHI. RZ358 also received orphan drug and rare pediatric disease designation in the U.S., and orphan drug designation in the European Union for the treatment of insulinoma, the primary cause of islet cell tumor hypoglycemia NCT04538989 Phase 2 study started in Feb 2020 completed in Aug 2022. Oct 2020: XOMA Corporation announced it has earned $1.9 million in payments from two partners. The Company earned $1.4 million in accelerated payments from Rezolute, Inc., in connection with its recent private placement to continue advancing RZ358 for congenital hyperinsulinism. July 24, 2019: Rezolute, Inc. announced today that Handok, Inc. (“Handok”) and Genexine, Inc. (“Genexine”), exercised their combined full $20 million option to purchase shares of Rezolute common stock, increasing their combined aggregate investment in Rezolute to $45 million. Each share of common stock was priced at $0.29 in this offering. “We are very appreciative of the continued support of Genexine and Handok. The additional capital has us well positioned to commence our Phase 2b study for RZ358 later this year,” said Nevan Elam, CEO of Rezolute. Dec. 07, 2017 XOMA Corporation announced it has licensed the global development and commercialization rights for XOMA 358 to Rezolute, Inc., formerly AntriaBio, Inc., a biopharmaceutical company that specializes in developing therapies for metabolic and orphan diseases. NCT02772718 Phase 2 study in Patients With Hypoglycemia After Gastric Bypass Surgery started in April 2016 completed in May 2021. NCT02604485 Phase 2 in Congenital Hyperinsulinism patients started in Oct 2015 completed in January 2017. Orphan drug status in the U.S. and European Union |
| Full address of company | Emeryville, California, United States North America United States of America https://www.xoma.com/ |
Allosteric antibody that reduces both binding of insulin to receptor and downstream insulin signaling. XOMA 358 is a negative allosteric IgG2 mAb
| Anticipated events | Topline data in Phase 3 congenital HI study expected nid-2025 |
| Factor(s) contributing to discontinuation | None |