Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 2130 |
| INN | Omburtamab |
| Status | Terminated |
| Drug code(s) | I131-8H9 |
| Brand name | OMBLASTYS® |
| mAb sequence source | mAb murine |
| General Molecular Category | Radioimmunotherapy, RIC |
| Format, general category | Full length Ab conjugate |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | I-131 |
| Discovery method/technology | Mouse origin |
| Target(s) | B7-H3 |
| Indications of clinical studies | Refractory Leptomeningeal Metastasis from Neuroblastoma (pediatric) |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Terminated at regulatory review |
| Status | Inactive |
| Start of clinical phase (IND filing or first Phase 1) | July 15, 2004 |
| Start of Phase 2 | |
| Start of Phase 3 | October 15, 2018 |
| 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 | Y-mAbs Therapeutics Inc. |
| Licensee/Partner | Memorial Sloan Kettering |
| Comments about company or candidate | Aug 2023 Q2 results: Company claims they have one product candidate at the registration stage, OMBLASTYS® (omburtamab). Mar 2023: Terminated at regulatory review. The company's March 2023 press release states: We assume no new partnerships or other new business development, and no further development of the omburtamab program. Jan 2023: Y-mAbs Therapeutics, Inc. is restructuring following receipt of a Complete Response Letter from FDA for omburtamab. The company has assumed a deprioritization of the omburtamab program, including all indications, in designing its restructuring plan and in its estimates for 2023. Dec 15, 2022: CHMP issues a negative opinion. Nov 30, 2022: FDA has issued a complete response letter for the Biologics License Application for the investigational medicine 131I-omburtamab for the treatment of CNS/leptomeningeal metastasis from neuroblastoma. Y-mAbs Therapeutics, Inc. announced that the letter indicates FDA completed the review of the application and determined that it is unable to approve the BLA in its current form. This is consistent with the outcome of the Oncologic Drugs Advisory Committee Meeting in October. The CRL includes a recommendation for meeting with the agency to discuss adequate and well-controlled trial design to demonstrate substantial evidence of effectiveness and a favorable benefit-risk profile. Oct 28, 2022. Y-mAbs Therapeutics, Inc. announced the FDA's Oncologic Drugs Advisory Committee, which reviewed investigational 131I-omburtamab for the treatment of CNS/leptomeningeal metastasis from neuroblastoma, voted 16 to 0 that the Company had not provided sufficient evidence to conclude that omburtamab improves overall survival. ODAC reviewed data from omburtamab’s clinical development program with a focus on study 03-133 (a pivotal phase 1 study) and study 101 (a pivotal phase 2 study) as well as the historical control group. Y-mAbs Therapeutics, Inc. announced that the Biologics License Application for OMBLASTYS® (omburtamab) for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma has been accepted for priority review by the U.S. Food and Drug Administration. The FDA set an action date of November 30, 2022, under the Prescription Drug User Fee Act (“PDUFA”). The Agency also indicated in the BLA filing communication letter that it is planning to hold an advisory committee meeting in October 2022 to discuss the application. April 01, 2022 I Y-mAbs Therapeutics, Inc. announced that on March 31, 2022, the Company completed the resubmission of its Biologics License Application for 131I-omburtamab (“omburtamab”) to the FDA. On April 27, 2021, Y-mAbs Therapeutics, Inc. announced that the company has submitted its Marketing Authorization Application to the European Medicines Agency for omburtamab for the treatment of pediatric patients with central nervous system (CNS)/leptomeningeal metastasis from neuroblastoma. The company aims to resubmit a Biologics License Application for omburtamab to the FDA late in the second quarter or in the third quarter of 2021. Oct. 05, 2020: Y-mAbs Therapeutics, Inc. announced that Y-mAbs has received a Refusal to File letter from the U.S. Food and Drug Administration regarding the Biologics License Application for omburtamab for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma, which was submitted in August 2020. Y-mAbs Therapeutics announced that the Company has initiated the submission of its Biologics License Application for omburtamab under the U.S. Food and Drug Administration’s (FDA) Rolling Review process. Omburtamab is an investigational, monoclonal antibody that targets B7-H3, an immune checkpoint molecule that is widely expressed in tumor cells of several cancer types. The omburtamab BLA is for the treatment of pediatric patients with CNS/leptomeningeal metastases from neuroblastoma. The non-clinical portion and a part of the CMC portion of the rolling BLA were submitted during June 2020, and completion of the BLA submission is currently expected to take place over the next four to six weeks. The clinical submission will be based on the safety and efficacy results of the pivotal Phase II studies 101 and 03-133, which the Company expects to present later in 2020. Company plans a rolling submission which they expect to complete in May 2020. NCT04315246 Phase 1/2 in Leptomeningeal Metastasis From Solid Tumors not yet recruiting when posted on March 19, 2020. Feb 26, 2020. At the pre-BLA meeting, the Company reached alignment with the FDA on an Accelerated Approval Pathway for omburtamab along with a rolling BLA submission. The Company expects to complete the rolling BLA within approximately 10 weeks. NCT03275402 Phase 2/3 study in children with a neuroblastoma diagnose and central nervous system (CNS)/leptomeningeal metastases started in Oct 2018 still recruiting as of last record update in Aug 2019. June 2017: Positive top line results from a pivotal study (NCT00089245, listed on clinicaltrials.gov as Phase 1) of 131I-burtomab in Refractory Leptomeningeal Metastasis from Neuroblastoma were announced. Results showed a 58 months average survival for the patients treated with 131I-burtomab in the study, compared to an average of 4.7 month and no long term survival or cure, for a contemporary cohort in the Central German Childhood Cancer Registry. After more than a decade of follow-up, data shows more than 40% overall long term survival indicating that the treated children have been cured. Has rare pediatric disease and Breakthrough therapy designations from FDA; US and EU orphan designations. Collab. with MSK announced in October 2015. As of June 2017, clinical studies are all sponsored by MSK. Pursuant to a December 2007 agreement with Memorial Sloan-Kettering Cancer Center, United Therapeutics obtained certain license rights to an investigational monoclonal antibody, 8H9, for the treatment of metastatic brain cancer. 8H9 is a mouse IgG1 MAb that is highly reactive with a range of human solid tumors, including human brain cancers |
| Full address of company | 230 Park Avenue, Suite 3350 New York, NY 10169 USA North America United States of America https://ymabs.com/contact-us |
Immune checkpoint target. The murine IgG1 8H9 was produced by hyperimmunizing BALB/c mice with human neuroblastoma, then radiolabeled. Target is expressed by the vast majority of human glial tumors and not normal neurons or glia Omburtamab formerly named burtomab - I131.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | Commercial/business decision |