The trial will assess the safety and efficacy of ISB 1442 in R/R MM patients. Credit: www.scientificanimations.com /commons.wikimedia.org.

Ichnos Sciences has dosed the first subject in the Phase I/II dose escalation and expansion clinical trial of ISB 1442 to treat relapsed/refractory multiple myeloma (R/R MM).

To be carried out in two parts, the open-label, first-in-human trial will assess the safety and efficacy of ISB 1442 in R/R MM patients. 

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Phase I of the trial will enrol confirmed relapsed/refractory myeloma patients. 

It will assess escalating dose levels until the identification of a maximum tolerated dose, and also establish the recommended Phase II Dose (RP2D).

The Phase II expansion portion will then analyse the overall response rates and response durability.

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Ichnos plans to enrol nearly 121 subjects across sites in the US and Australia.

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ISB 1442 is a CD38 x CD47 biparatopic bispecific antibody.

Merging two anti-CD38 binding arms, it acts on separate areas on CD38 with an antagonistic anti-CD47 arm, resulting in a tri-specific antibody equivalent. 

ISB 1442 is the first product based on the BEAT 2.0 protein engineering platform of the company that permits the utmost manufacturability and flexibility of full-length multi-specific antibodies.

In various in vitro and in vivo models, the antibody showed potency and anti-tumour activity.

Ichnos Sciences president and CEO Cyril Konto said: “The start of our first clinical study of ISB 1442 and dosing of the first patient are important milestones not only for patients with relapsed/refractory multiple myeloma, but also for Ichnos. 

“Our work at Ichnos is built on the core belief that cure is possible, and we look forward to advancing ISB 1442 and other immune cell engaging antibodies, with the aim of providing new treatment options for patients with hematologic malignancies and solid tumours.”