Y-mAbs Announces Positive Omburtamab Clinical Data
NEW YORK, Oct. 28, 2019 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the Company or Y-mAbs) (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced a clinical update on omburtamab for the treatment of central nervous system (CNS) leptomeningeal metastases from neuroblastoma and a number of additional cancer indications. Data was presented at the International Society of Pediatric Oncology (SIOP) Annual Congress in Lyon, France on October 26, 2019 by Dr. Kim Kramer from Memorial Sloan Kettering Cancer Center (MSK) in New York.
An updated data readout as of June 30, 2019 from a single-center study at MSK (Study 03-133), where patients with CNS/leptomeningeal metastases from neuroblastoma received up to two doses of radiolabeled omburtamab, showed that for the 107 evaluable patients, the median survival had increased to 50.8 months, with the final median not yet being reached. This compared well to a median survival of 47.1 months at the prior data readout based on the first 93 patients in the study.
In addition, 68 patients diagnosed with other CNS cancers, including metastatic tumors had received a total of 201 injections of omburtamab. Injections were routinely administered in an outpatient setting. Rare self-limited adverse events included grade 1 or 2 fever, headache, vomiting; 3 injections were associated with grade 3 toxicities requiring discontinuation of therapy including chemical meningitis and increasing communicating hydrocephalus. Although not a dose limiting toxicity, myelosuppression occurred in patients who had received craniospinal radiation and at dose levels exceeding 60mCi. The primary CNS diagnoses included medulloblastoma (n=27), ependymoma (n=9), and embryonal tumors with multilayered rosettes (n=4), while metastatic tumors included sarcoma (n=9), melanoma (n=5), and other tumors (n=14). As of today, 26 of the 68 patients with these highly lethal diagnoses remain alive.
“We are excited to announce this updated data for omburtamab in CNS/leptomeningeal metastases from high-risk neuroblastoma further confirming the importance of omburtamab in addressing this unmet medical need. Further very interesting proof of concept data for other CNS cancers suggests potential clinical utility for use of omburtamab beyond neuroblastoma. Overall survival data have already been accepted by the FDA as supportive for our Breakthrough Therapy Designation, and we still plan to initiate the rolling BLA submission for omburtamab in December this year,” said Thomas Gad, Founder, Chairman, President and Head of Business Development and Strategy.
Dr. Claus Moller, Chief Executive Officer further notes, “We are very pleased to see the variety of other CNS cancers and metastatic cancers treated in this trial at MSK. The experience gained from these 68 patients pave the way for future potential label expansion of compartmental use of the radiolabeled omburtamab as well as our new clinical program for omburtamab-DTPA, for which we expect to file an IND within the next few months.”
Researchers at MSK developed the therapeutic products referenced in this statement, which are exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the products and in Y-mAbs.
Y-mAbs is a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer. The Company has a broad and advanced product pipeline, including two pivotal-stage product candidates—naxitamab and omburtamab—which target tumors that express GD2 and B7-H3, respectively.
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