Glycostem announces it has received the FDA’s Orphan Drug Designation (ODD) for treatment of Multiple Myeloma (MM) patients with its investigational product oNKord®. The designation will provide Glycostem with certain incentives, like eligibility for 7 years of market exclusivity and clear FDA guidance on specific aspects of development for rare diseases. These pave an accelerated path towards market access and treatment of patients suffering from this relatively rare form of cancer.
oNKord®is Glycostem’s first-generation off-the-shelf Natural Killer (NK) cellular immunotherapy product. Over the coming months, AML patients will receive this form of treatment as part of a phase I-IIa (pivotal) trial in AML. A phase II trial for MM patients isexpected to start in 2021.
Glycostem (Press release)