Ichnos Sciences announces initiation of first-in-human study for ISB 1442

First patient dosed with novel biparatopic 2+1 BEAT® bispecific antibody targeting CD38 and CD47

NEW YORK, NY, USA I September 28, 2022 I Ichnos Sciences Inc., a global clinical-stage biotechnology company developing innovative multispecific immune cell engager antibodies in oncology, today announced dosing of the first patient in the Phase 1/2 dose escalation and expansion study of ISB 1442, a CD38 x CD47 biparatopic bispecific antibody for the treatment of relapsed/refractory multiple myeloma.

"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," said Cyril Konto, M.D., President and Chief Executive Officer of Ichnos Sciences. "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 tumors."

ISB 1442 is a biparatopic bispecific antibody that combines two proprietary anti-CD38 binding arms, each targeting different regions on CD38, with an antagonistic anti-CD47 arm, making it equivalent to a trispecific antibody. It is the first product based on Ichnos' BEAT® 2.01, a proprietary protein engineering platform that allows maximal flexibility and manufacturability of full length multispecific antibodies, to advance to clinical development. The potency and anti-tumor activity of ISB 1442 were demonstrated in multiple in vitro and in vivo models. Additionally, the ability of ISB 1442 to simultaneously bind to CD38 and block CD47, and its enhanced signaling of FcR (fragment crystallizable receptors) on immune cells, differentiate it from anti-CD38 monospecific targeting therapeutics.

"ISB 1442, developed on Ichnos' cutting-edge BEAT 2.0 platform, has a unique mechanism relative to other CD38 or CD47-targeted antibodies, and has potential as a treatment for patients with both myeloma and myeloid malignancies," said Eric Feldman, M.D., Chief Medical Officer of Ichnos Sciences.

This clinical trial will be conducted in two parts. During Phase 1, subjects with confirmed relapsed/refractory myeloma will be treated at escalating dose levels until a maximum tolerated dose is identified and the recommended Phase 2 Dose (RP2D) is established. The Phase 2 expansion part of the study will then be initiated to assess overall response rates and durability of responses.

The study will enroll approximately 121 participants across sites in Australia and the United States. Detailed information about the trial, including investigational site locations, site-specific contacts and eligibility criteria for participants, are available on ClinicalTrials.gov.

About Ichnos Sciences Inc.

A fully integrated, global biotech with the spirit of a start-up, Ichnos is shifting the way the world thinks about innovation in medicine through its research and development of transformative, disease-centric treatments in oncology. The company, with headquarters in New York, N.Y., is rapidly advancing a clinical-stage pipeline of novel, first-in-class candidates designed to address complex diseases and to treat patients holistically. With its patented BEAT® technology platform and pioneering teams, Ichnos Sciences has a mission to provide breakthrough, curative therapies that will extend and improve lives, writing a new chapter in healthcare.

1 BEAT®Bispecific Engagement by Antibodies based on the TCR

SOURCE: Ichnos Sciences

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