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FDA Clears IND for SystImmune's BL-M11D1 in Relapsed/Refractory AML

• The FDA has cleared SystImmune's Investigational New Drug (IND) application for BL-M11D1, an antibody-drug conjugate (ADC), for relapsed/refractory Acute Myeloid Leukemia (AML). • BL-M11D1 targets CD33, a protein expressed on myeloid cells, and is designed to trigger antibody-dependent cellular cytotoxicity (ADCC) and induce tumor cell death. • A Phase 1 clinical trial, BLM11D1-HM-101, is set to begin in the United States to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of BL-M11D1. • BL-M11D1 comprises a monoclonal antibody binding CD33 and a topoisomerase I inhibitor payload, potentially offering a novel therapeutic option for AML patients.

SystImmune, a clinical-stage biopharmaceutical company, has received FDA clearance for its Investigational New Drug (IND) application for BL-M11D1, an antibody-drug conjugate (ADC) intended for the treatment of relapsed/refractory Acute Myeloid Leukemia (AML). The clearance paves the way for a Phase 1 clinical trial to evaluate the drug's safety and efficacy.
The Phase 1 study, named BLM11D1-HM-101, will assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of BL-M11D1 in patients with relapsed or refractory AML in the United States. AML is an aggressive blood cancer with poor prognosis, especially in patients who relapse or do not respond to initial treatment.

Mechanism of Action

BL-M11D1 is designed to target CD33, a protein found on myeloid cells, including AML cells. The ADC comprises a monoclonal antibody that binds to CD33 and a topoisomerase I inhibitor payload linked by a stable, enzyme-cleavable linker. Upon binding to CD33, BL-M11D1 triggers antibody-dependent cellular cytotoxicity (ADCC) and is internalized by the cancer cell. The release of the topoisomerase I inhibitor payload then induces tumor cell death.

Clinical Development and Potential

"We are excited to receive the FDA Study-May-Proceed letter enabling the initiation of our Phase 1 study with BL-M11D1. We believe that this novel, potentially best-in-class ADC can offer an important therapeutic option for patients with relapsed/refractory AML and look forward to implementing this study," said Dr. Jonathan Cheng, Chief Medical Officer at SystImmune.
The company believes that BL-M11D1 has the potential to be a best-in-class ADC for AML treatment. SystImmune is also evaluating BL-M11D1 for the treatment of other hematologic malignancies. The company focuses on developing innovative cancer treatments using bi-specific, multi-specific antibodies, and ADCs.

About SystImmune

SystImmune is dedicated to bringing therapies that can provide clinical benefit to patients. The initiation of clinical development for BL-M11D1 emphasizes that commitment. SystImmune has several assets in various stages of clinical trials for solid tumor and hematologic indications.
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Reference News

[1]
FDA Clears IND of Novel ADC in AML Treatment - Targeted Oncology
targetedonc.com · Oct 14, 2024

The FDA has cleared the IND application for BL-M11D1, a CD33-binding ADC for AML, enabling a phase 1 study. BL-M11D1, de...

[2]
SystImmune, Inc. Announces FDA Clearance of IND Application for BL-M11D1 in Relapsed ...
kilgorenewsherald.com · Oct 14, 2024

SystImmune, Inc. announced FDA clearance of its IND application for BL-M11D1, an ADC targeting CD33 in relapsed/refracto...

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