FDA grants orphan drug status for Ichnos’ multiple myeloma antibody

Preview

来源: Pharmaceutical Technology

ISB 2001 is intended for patients with

multiple myeloma

. Credit: David A Litman via Shutterstock.com.

The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) for Ichnos Sciences’ ISB 2001 to treat patients with

multiple myeloma

.

ISB 2001 is a T-cell-engaging tri-specific antibody.

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View allCompanies IntelligenceIchnos Sciences IncView all

The company will commence a first-in-human Phase I dose-escalation, dose-expansion clinical trial of the antibody in 2023, once clearance has been given by the Australian Human Research Ethics Committee and the FDA’s approval has been received for its investigational new drug application.

ISB 2001 is the third clinical-stage asset of the company to obtain ODD status for

multiple myeloma

.

In March 2023, the company’s ISB 1442, a

CD38

x

CD47

biparatopic bispecific antibody innate cell modulator, also received ODD from the FDA.

Ichnos Sciences president and CEO Cyril Konto stated: “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.”

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