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Ichnos Sciences Announces Initiation of First-In-Human Clinical Trial for ISB 2001

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 first-in-human clinical trial of ISB 2001, a BCMA x CD38 x CD3 TREAT™ trispecific antibody1, for the treatment of multiple myeloma. This milestone follows the company’s approval from the Human Research Ethics Committee (HREC) in Australia and IND clearance from the U.S. Food and Drug Administration (U.S. FDA). Additionally, the trispecific antibody received orphan drug designation (ODD) from the U.S. FDA in July, making it Ichnos’ third clinical-stage asset to receive the designation.

ISB 2001 is the company’s first T-cell engaging trispecific antibody based on the company’s proprietary BEAT® platform2,which enables the development of immune cell engagers. It features three proprietary Fab arms binding to CD3 on T cells, as well as BCMA and CD38 on multiple myeloma cells. By targeting two tumor-associated antigens, ISB 2001 exhibits heightened specificity in recognizing and binding to tumor cells. This avidity-based binding demonstrates increased tumor cell killing in vitro compared to teclistamab, alnuctamab, and EM-801 across variable levels of BCMA and CD38 expression.

Additionally, ISB 2001 exhibits higher potency in vitro when compared to the combination of daratumumab and teclistamab currently under clinical investigation, as demonstrated by data presented at the American Association for Cancer Research’s (AACR) 2023 Annual Meeting.

“We are proud to advance our third oncology asset to clinical trials—a milestone made more significant because it is our first clinical-stage trispecific antibody,” said Cyril Konto, M.D., president and CEO of Ichnos. “Our novel approach to targeting multiple molecules intends to enhance specificity, engage the immune system, and offer potential synergistic effects in our ongoing pursuit of groundbreaking cancer treatments.”

“Not only does the advancement of ISB 2001 demonstrate our shared commitment to providing curative therapies that may extend and improve lives, but it’s also a testament to the operational excellence that enables us to run concurrent clinical programs in pursuit of our vital mission,” Konto added.

This study is a first-in-human, Phase 1, open-label study that will evaluate safety and anti-myeloma activity of ISB 2001 in an estimated 80 participants with relapsed/refractory multiple myeloma (R/R MM) across multiple centers, including the U.S. and Australia. The multicenter study will be conducted in two parts: dose escalation and dose expansion.

“The unique triple targeting of BCMA, CD38, and CD3 showcases Ichnos’ scientific ingenuity underlying ISB 2001, offering a promising approach in the treatment of multiple myeloma,” said Lida Pacaud, M.D., Chief Medical Officer of Ichnos. “We look forward to advancing our understanding of its safety and efficacy profile as we progress through this first-in-human study, driven by a commitment to pushing the boundaries of what is possible in the field of hemato-oncology.”

More information about the trial, including investigational site locations, site-specific contacts and eligibility criteria for participants, is available on ClinicalTrials.gov.

With the start of this first-in-human clinical study of ISB 2001, Ichnos now has three clinical-stage oncology assets under investigation for the treatment of relapsed/refractory multiple myeloma and has initiated one new Phase 1 clinical study per year for three consecutive years.


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