US FDA grants orphan drug designation to oNKord from Glycostem for multiple myeloma
The designation will provide Glycostem with eligibility for seven years of market exclusivity and clear FDA guidance on specific aspects of development for rare diseases
Glycostem Therapeutics has received the US 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 seven years of market exclusivity and clear FDA guidance on specific aspects of development for rare diseases.
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 is expected to start in 2021.
Troels Jordansen, CEO of Glycostem said, “It is great to experience that after receiving FDA and EMA ODD designation for AML, the FDA has also granted us this designation for MM. This allows us to accelerate oNKord’s access to the US market and our ultimate ambition: curing cancer.”