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Orphan Drug Designation for KappaMab transferred to HaemaLogiX

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29 January 2021

On 22 June 2011, the US Food and Drug Administration (FDA) granted the IgG1 chimeric monoclonal antibody, KappaMab, an Orphan Drug Designation (ODD) to treat multiple myeloma. At that time KappaMab was owned by Immune System Therapeutics (IST). HaemaLogiX purchased IST’s assets in late 2014/early 2015, and FDA has now transferred this ODD to HaemaLogiX as Sponsor.

About ODD: An ODD from the FDA enables companies to develop treatments for specific patient populations with rare diseases or serious conditions potentially through access to tax credits, grants, and 7 years of marketing exclusivity.

About KappaMab: The KappaMab antibody targets the Kappa Myeloma Antigen, which is expressed exclusively on the surface of Kappa-restricted MM cells. KappaMab is currently being tested in a Phase 2b clinical trial as a single agent or in combination with lenalidomide and low-dose dexamethasone (len/dex) to treat patients with kappa-restricted Multiple Myeloma (MM). This trial is fully recruited, and the interim results presented at the 2019 EHA meeting showed that KappaMab combined with len/dex was well tolerated with an overall response rate of 67.5%. Further trial data is anticipated in the first half of 2021. (Australian New Zealand Clinical Trial Registry #ACTRN12616001164482). 

About HaemaLogiX: HaemaLogiX is an Australian-based immune-oncology development company researching immune-based treatments that target novel antigens on malignant B cells.

Reference: Kalff,A., Shortt, J., Yuen, F., et al. (2019). A sequential cohort study comparing KappaMab alone to KappaMab, lenalidomide and low dose dexamethasone in kappa-restricted relapsed refractory (RR) multiple myeloma (AMaRC 01-16). HemaSphere, 3(S1): 633-34. Found at:

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