“We are pleased that the FDA has removed the partial clinical hold,” said
MTEM will be focusing development of MT-0169 on extramedullary myeloma, a form of myeloma that is less responsive to current therapies and carries a worse overall prognosis. Up to 20% of patients with relapsed/refractory multiple myeloma have extramedullary disease.
About MT-0169
MT-0169 was designed to destroy CD38+ tumor cells through internalization of CD38 and cell destruction via a novel mechanism of action (enzymatic ribosomal destruction and immunogenic cell death). The MT-0169 study completed the 5 mcg/kg dose escalation cohort (N=4) and the 10 mcg/kg dose escalation cohort (N=3) without any cardiac AEs or dose-limiting toxicities. A stringent Complete Response was seen in a patient with extramedullary IgA myeloma dosed with MT-0169 at 5 mcg/kg. The patient had a marked reduction in IgA serum protein, conversion from immunofixation positive to negative, and resolution of uptake on bone scan of skeletal lesions. The patient’s disease was quad-agent refractory including CD38-targeting, proteosome inhibitor, IMiD, and a BCMA bispecific antibody. The patient continues on study for 10 months. To date, no instances of capillary leak syndrome or other manifestations of innate immunity have been observed with any next-generation ETB.
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Contacts:
Dr. Grace Kim
Head of Investor Relations
grace.kim@mtem.com
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