This ODD comes as Ichnos, with approval from the HREC in Australia and FDA’s IND clearance, gears up to begin a Phase 1 first-in-human dose-escalation dose-expansion trial with ISB 2001 later this summer
A 3D depiction of myeloma cells. (Credit: www.scientificanimations.com from Wikimedia Commons)
Biotechnology company Ichnos Sciences has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its T-cell engaging trispecific antibody, ISB 2001.
ISB 2001 is said to be the company’s first BCMA x CD38 x CD3 TREAT trispecific antibody designed for the treatment of multiple myeloma.
It is based on Ichnos’s proprietary BEAT platform, which enables the development of immune cell engagers.
Ichnos Sciences president and CEO Cyril Konto said: “The FDA’s decision to grant orphan drug designation to ISB 2001 – our third clinical-stage asset to receive that designation in five years – underscores the importance of the work our team is doing to develop potentially curative therapies for the treatment of multiple myeloma.
“As new multiple myeloma diagnoses continue to climb, our charge of providing patients more innovative, novel therapies that can overcome the limitations of options available to them today becomes that much more urgent.”
This ODD comes as Ichnos, with approval from the Human Research Ethics Committee (HREC) in Australia and IND clearance from the FDA, gears up to begin a Phase 1 first-in-human dose-escalation dose-expansion trial with ISB 2001 later this summer.
ISB 2001 includes three proprietary Fab arms that bind to multiple myeloma cells, BCMA, and CD38, as well as CD3 on T cells.
Ichnos said that the trispecific antibody has boosted binding specificity to multiple myeloma cells due to improved avidity-based binding through targeting two tumour-associated antigens.
It has also shown increased tumour cell killing in vitro across a range of BCMA and CD38 expression levels when compared to teclistamab, alnuctamab, and EM-801.
Additionally, ISB 2001 is more potent in vitro than the combination of daratumumab and teclistamab that is currently being studied in clinical trials, the biotechnology company claimed.
ISB 2001 is said to be the Ichnos’ third clinical-stage asset to receive ODD for the treatment of multiple myeloma.
This designation closely follows the FDA’s ODD in March 2023 for Ichnos’ first-in-class CD38 x CD47 biparatopic bispecific antibody innate cell modulator, ISB 1442.