Stockholm, Sweden (Press Release) – XNK Thera­peutics AB ("XNK") to­day an­nounced it has re­ceived Orphan Drug Desig­na­tion (ODD) from the U.S. Food and Drug Admin­istra­tion (FDA) for its lead­ing inves­ti­ga­tional drug can­di­date in the treat­ment of mul­ti­ple myeloma (MM).

Receiving ODD status from the FDA for the treat­ment of mul­ti­ple myeloma is a crit­i­cal next step for the de­vel­op­ment of XNK's lead­ing inves­ti­ga­tional drug can­di­date. XNK has already re­ceived ODD status in the EU.

"Obtaining an ODD by the FDA is a sig­nif­i­cant mile­stone for XNK and our goal of taking the present drug can­di­date to the next level," said Johan Liwing, CEO of XNK Thera­peutics. "This is the start­ing point for us to ex­pand clin­i­cal de­vel­op­ment into the most im­por­tant mar­ket globally for can­cer treat­ment."

XNK has already com­pleted its first-in-human Phase I/II clin­i­cal trial (ACP-001) in mul­ti­ple myeloma at the Karolinska Uni­ver­sity Hospital in Stock­holm, Sweden, showing a very good safety profile, and promising ef­fi­cacy data. The com­pany is continuing the clin­i­cal de­vel­op­ment in mul­ti­ple myeloma in Europe and plans to ini­ti­ate a Phase II clin­i­cal trial in the near future.

About XNK Thera­peutics AB

XNK Thera­peutics is a clin­i­cal stage, im­mu­no­ther­apy com­pany focusing its efforts on preventing and treating can­cer by devel­op­ing novel NK cell-based ther­a­pies. The com­pany has estab­lished a lead­er­ship position in the clin­i­cal de­vel­op­ment and manu­fac­ture of au­tol­o­gous NK cell-based prod­ucts using its pro­pri­e­tary tech­nology plat­form. The com­pany's plat­form tech­nology and lead­ing inves­ti­ga­tional drug can­di­date have ideal properties for targeting can­cers, in­clud­ing settings where allo­geneic cell prod­ucts are not readily appli­cable. It is foreseen that the prod­uct will bring a crit­i­cal component to tomorrow's can­cer treat­ment strategies. XNK Thera­peutics is head­quar­tered in Stock­holm, Sweden. For more info, please visit www.xnktherapeutics.com.

About XNK Thera­peutics's tech­nology plat­form

The plat­form has ideal properties to pro­duce au­tol­o­gous NK cell-based drug can­di­dates for targeting malignant dis­eases across a wide range of in­di­ca­tions in mono- and com­bi­na­tion ther­apy. It en­com­passes a unique closed manu­fac­tur­ing sys­tem for de­vel­op­ment of the NK cell-based prod­ucts. The process in­cludes a sel­ective ex­pan­sion and ac­ti­va­tion of NK cells from periph­eral blood of patients with can­cer. The prod­uct is pro­duced in less than three weeks. It is de­liv­ered to the clinic upon need, where the prod­uct is thawed and in­fused into the patient without any fur­ther processing. The prod­uct has dem­onstrated an up to 10-year stability in liquid nitrogen. The assets of XNK Thera­peutics are pro­tected by pat­ents in the US, Europe and cer­tain other jurisdictions. Addi­tional pat­ent appli­ca­tions have been filed.

About Our Therapy

The lead­ing drug can­di­date from XNK Thera­peutics' tech­nology plat­form was pre­vi­ously clin­i­cally tested in a first-in-human Phase I/II clin­i­cal trial (ACP-001). The study was per­formed at the Karolinska Uni­ver­sity Hospital, Stock­holm, Sweden in a setting of con­sol­i­da­tion treat­ment fol­low­ing high dose stem cell trans­plan­ta­tion in patients newly diag­nosed with mul­ti­ple myeloma. The study was an open, single-arm, triple es­ca­lat­ing dose/patient clin­i­cal trial with the pri­mary objective of studying the prod­uct's safety and tol­er­a­bil­ity. In the study, the ther­apy showed a very good safety profile, and promising ef­fi­cacy data. XNK Thera­peutics is continuing its clin­i­cal de­vel­op­ment in mul­ti­ple myeloma and plans to ini­ti­ate a Phase II clin­i­cal trial in the near future.

About mul­ti­ple myeloma

Multiple myeloma, the com­pany's first target, is the third most fre­quent hema­to­logical malig­nan­cy world­wide. Multiple myeloma treat­ment has im­proved over the last two decades with the de­vel­op­ment and in­tro­duc­tion of new agents lead­ing to more ef­fec­tive treat­ments. Still, it re­mains a fatal dis­ease in the majority of cases.

Source: XNK Thera­peutics.