FDA Clears IND of Novel ADC in AML Treatment
BL-M11D1, a CD33-binding antibody-drug conjugate, is being evaluated for the treatment of patients with acute myeloid leukemia.
Microscopic, photorealistic image of leukemia cells - Generated with Adobe Firefly
- The FDA has cleared the investigational new drug (IND) application of BL-M11D1 in acute myeloid leukemia (AML).
- BL-M11D1 is an antibody-drug conjugate (ADC) that binds to CD33.
- With this clearance, a phase 1 study will commence.
The IND application of BL-M11D1, a CD33-binding ADC, has been cleared by the FDA, and a phase 1 study will commence to evaluate the agent in AML.1
"Our mission at SystImmune is to continue to bring therapies that can provide clinical benefit to patients. The initiation of clinical development for BL-M11D1 emphasizes that commitment,” said Jie D'Elia, MD, chief executive officer of SystImmune, BL-M11D1’s developer, in a press release.
BL-M11D1 is an ADC composed of a CD33 binder and a topoisomerase I inhibitor payload with a stable enzyme-cleavable linker. It is based on the drug gemtuzumab ozogamicin (Myotarg),2 which is already approved by the FDA for the treatment of patients with AML.3
"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 Jonathan Cheng, MD, chief medical officer at SystImmune, in the press release.1
According to SystImmune, BL-M11D1 is also being evaluated for the treatment of other hematologic malignancies.2
REFERENCES:
1. SystImmune, Inc. announces FDA clearance of IND application for BL-M11D1 in relapsed/refractory acute myeloid leukemia. News release. SystImmune, Inc. October 14, 2024. Accessed October 14, 2024. https://tinyurl.com/3z2757m7
2. BL-M11D1-ADC. SystImmune, Inc. Accessed October 14, 2024. https://www.systimmune.com/cd33
3. Gemtuzumab receives new FDA approval for acute myeloid leukemia. News release. National Cancer Institute. September 28, 2017. Accessed October 14, 2024. https://tinyurl.com/3ak5e4ks
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