The US Food and Drug Administration grants orphan drug designation to ISB 1442 for the treatment of multiple myeloma.
Ichnos Sciences Inc., a global clinical-stage biotechnology company developing innovative multispecific antibodies in oncology, today announced the company has been granted orphan drug designation (ODD) by the U.S. Food and Drug Administration (FDA) for its first-in-class biparatopic 2+1 BEAT® bispecific antibody targeting CD38 and CD47 for the treatment of 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 U.S. sites are expected to open in the second quarter of this year (NCT05427812). ISB 1442 is based on Ichnos’ proprietary BEAT® multispecific antibody platform1, which enables the development of immune cell engagers.
“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,” said Cyril Konto, M.D., President and Chief Executive Officer of Ichnos Sciences. “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.”
Preclinical data demonstrating the potency and anti-tumor activity of ISB 1442 in multiple in vitro and in vivo tumor models relative to daratumumab and magrolimab were featured at an oral presentation at the 63rd ASH Annual Meeting in December 2021. Posters describing the design of the ongoing dose escalation and expansion study and additional preclinical data that support potential applications for ISB 1442 for the treatment of acute myeloid leukemia (AML) and T-cell acute lymphoblastic leukemia (T-ALL) were presented at the 64th ASH Annual Meeting in December 2022.
The FDA grants ODD to therapies that show promise in the treatment, prevention, or diagnosis of rare disease or conditions that affect fewer than 200,000 people in the United States. MM is a rare, cancerous blood disease with an estimated 162,201 patients currently in the U.S.2 While progress has been made in the treatment of MM, there remains a significant unmet need for therapies that can overcome developed resistance and decreased effectiveness over time.
