samalizumab (ALXN 6000) / The Leukemia & Lymphoma Society, AstraZeneca - LARVOL DELTA

Beat AML: Study of Biomarker-Based Treatment of Acute Myeloid Leukemia (clinicaltrials.gov) - P1/2 | N=3000 | Recruiting | Sponsor: Beat AML, LLC | N=2000 ➔ 3000 | Trial completion date: Dec 2026 ➔ Dec 2028 | Trial primary completion date: Dec 2026 ➔ Dec 2028

Biomarker • Enrollment change • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

The significance of CD200R1 on NK cells in the endometrial cancer tumor microenvironment (AACR 2025) - "Altogether, our findings suggest that a CD200/CD200R1 axis modulates NK cell differentiation and function within the EC TME, potentially downstream of TGF-β signaling. Ongoing studies seek to determine whether blocking this axis enhances ICB efficacy, and potentially support clinical trials using Samalizumab (humanized monoclonal anti-CD200 antibody)."

Biomarker • Tumor microenvironment • Endometrial Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor • CD200 • CD200R1 • KLRD1 • TGFB1

The Leukemia & Lymphoma Society (LLS) Data at ASH Provides Glimpse into the Future of Blood Cancer Treatment (PRNewswire) - "The Leukemia & Lymphoma Society (LLS) will present new data from its Beat AML Master Clinical Trial and Pediatric Acute Leukemia (PedAL) Master Clinical Trial at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition....Additional data indicate that IDH inhibitors as single agent or in combination with low-intensity therapies may be a viable treatment option for older adults with acute leukemias....Beat AML also recently opened its first clinical subtrial to investigate the safety and efficacy of lomonitinib (ZE46-0134) in patients with FLT3-mutated relapsed or refractory AML in partnership with Eilean Therapeutics."

Diagnostic • P1/2 data • Acute Myelogenous Leukemia • Hematological Malignancies • Oncology

Beat AML: Study of Biomarker-Based Treatment of Acute Myeloid Leukemia (clinicaltrials.gov) - P1/2 | N=2000 | Recruiting | Sponsor: Beat AML, LLC | Trial completion date: Dec 2023 ➔ Dec 2026 | Trial primary completion date: Dec 2023 ➔ Dec 2026

Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Targeting CD200 in Acute Myeloid Leukemia with CAR NK-92 Cells (EBMT-EHA 2024) - "An antibody-based CD200-specific CAR (CD200CAR) was constructed using the antigen recognition domain of samalizumab, an anti-CD200-blocking antibody... / Clinical Trial Registry: /"

Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • CD200 • CD200R1

The immunoregulatory protein CD200 as a potentially lucrative yet elusive target for cancer therapy. (PubMed, Oncotarget) - "However, while the CD200 blocking antibody samalizumab is still in the early stages of clinical testing, alternative mechanisms for the pro-tumorigenic role of CD200 have recently emerged that extend beyond direct suppression of anti-tumor T cell responses and, as such, may not be susceptible to CD200 antibody blockade. Herein, we will summarize the current understanding of CD200 expression and function in the tumor microenvironment as well as alternative strategies for potential neutralization of multiple CD200 mechanisms in human cancers."

IO biomarker • Journal • Immune Modulation • Inflammation • Oncology • CD200 • CD200R1

Study of Biomarker-Based Treatment of Acute Myeloid Leukemia (clinicaltrials.gov) - P1/2; N=2000; Recruiting; Sponsor: Beat AML, LLC; Trial completion date: Dec 2021 ➔ Dec 2023; Trial primary completion date: Dec 2021 ➔ Dec 2023

Biomarker • Clinical • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Phase I study of samalizumab in chronic lymphocytic leukemia and multiple myeloma: blockade of the immune checkpoint CD200. (PubMed, J Immunother Cancer) - P1/2 | "Samalizumab had a good safety profile and treatment was associated with reduced tumor burden in a majority of patients with advanced CLL. These preliminary positive results support further development of samalizumab as an immune checkpoint inhibitor."

IO Biomarker • Journal • P1 data • Chronic Lymphocytic Leukemia • Hematological Malignancies • Immune Modulation • Inflammation • Leukemia • Multiple Myeloma • Oncology

Safety and Dose Ranging Study of Samalizumab to Treat Relapsing or Refractory CLL or MM (clinicaltrials.gov) - P1/2; N=26; Terminated; Sponsor: Alexion Pharmaceuticals; Completed ➔ Terminated; The study was terminated by the Sponsor for administrative reasons and not due to any safety concerns.

Clinical • Trial termination

Study of Biomarker-Based Treatment of Acute Myeloid Leukemia (clinicaltrials.gov) - P1/2; N=2000; Recruiting; Sponsor: Beat AML, LLC; N=500 ➔ 2000

Biomarker • Clinical • Enrollment change