NEW YORK, May 14, 2019 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, is pleased to announce a development update on its cancer vaccine program, the GD2-GD3 Vaccine.
At the Advances in Neuroblastoma Research (ANR) conference in San Francisco in May 2018, Phase 2 data utilizing GD2-GD3 Vaccine for Stage 4 high-risk neuroblastoma was presented. A total of 84 pediatric patients received the GD2-GD3 Vaccine, all of whom had prior relapses and finally regained second or later remissions before vaccine treatment. An interim analysis shows a progression free survival (PFS) of 51% and overall survival (OS) of 90% at 2 years. The GD2-GD3 Vaccine appears to be well tolerated, with no reported grade 3 or grade 4 toxicities. To date, more than 230 patients have been treated with the GD2-GD3 Vaccine at Memorial Sloan Kettering Cancer Center (MSK) in New York under a MSK sponsored IND.
“Since Y-mAbs licensed the GD2-GD3 Vaccine in June 2018, we have explored our options to establish commercial scale cGMP production. We believe we now have a viable route forward for manufacturing, and plan to begin using the newly manufactured cGMP drug product in the fourth quarter of 2019. Establishment of a clear path towards approval has been a prerequisite for advancing the GD2-GD3 Vaccine program and we are very excited to move the program forward. We believe the GD2-GD3 Vaccine for relapsed high-risk neuroblastoma may offer meaningful improvement in the long-term treatment paradigm for pediatric patients, serving as a natural extension post immunotherapy treatment with our naxitamab antibody based product candidate,” stated Thomas Gad, Founder, Chairman, President and Head of Business Development and Strategy.
Dr. Claus Møller, Chief Executive Officer continued, “We believe that the more than 230 patients treated to date represents the largest population ever to receive a neuroblastoma vaccine. The 84 patients reported on at ANR received seven subcutaneous injections of the GD2-GD3 Vaccine in the outpatient clinic without any measurable pain or significant adverse side effects. We are very encouraged with the two year OS of approximately 90% in these 84 patients. We hope to replicate these data with the newly manufactured cGMP drug product in a multicenter trial.”
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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Y-mAbs Therapeutics, Inc.
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