Research & Development
Ichnos Sciences' ISB 1442 receives US FDA orphan drug designation
22 March 2023 -

Ichnos Sciences Inc., a US-based global clinical-stage biotechnology company, announced on Tuesday that it has received orphan drug designation from the US Food and Drug Administration (FDA) for its ISB 1442, the first-in-class biparatopic 2+1 BEAT bispecific antibody aimed at CD38 and CD47, intended to treat relapsed/refractory multiple myeloma (MM).

ISB 1442, which is Ichnos' second clinical-stage asset to receive ODD in MM, began dosing patients in a first-in-human Phase 1 study in Australia in September 2022, and US sites are expected to open in the second quarter of this year (NCT05427812). ISB 1442 is based on Ichnos' proprietary BEAT multi-specific antibody platform, which enables the development of immune cell engagers.

Cyril Konto, M.D., Ichnos Sciences president and CEO, said, 'Receiving orphan drug designation for ISB 1442 is an important milestone on Ichnos' journey to developing potentially curative therapies for patients with multiple myeloma. Reported new cases are on the rise year over year, making the potential clinical applications for ISB 1442 more relevant than ever before. It feels fitting to share this milestone during Multiple Myeloma Awareness Month, when our industry joins with patients and healthcare providers to highlight our shared commitment to curing this disease.'



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