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Combination therapy for treating myelodysplastic syndrome and acute myelogenous leukemia

A cancer treatment, cloning technology, applied in chemical instruments and methods, drug combinations, immunoglobulins, etc., can solve the problems of poor prognosis and high risk

Pending Publication Date: 2022-05-27
FORTY SEVEN INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Additionally, patients with newly diagnosed intermediate- or high-risk myelodysplastic syndromes (MDS) and those who relapse after standard care have a poor prognosis and a high risk of developing AML

Method used

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  • Combination therapy for treating myelodysplastic syndrome and acute myelogenous leukemia
  • Combination therapy for treating myelodysplastic syndrome and acute myelogenous leukemia
  • Combination therapy for treating myelodysplastic syndrome and acute myelogenous leukemia

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0650] Example 1: Hu5F9-G4 combined with azacitidine in patients with hematological malignancies

[0651] Introduction

[0652] Acute myeloid leukemia (AML) is a common hematological malignancy with an incidence rate that rises from 3:100,000 in young adults to more than 20:100,000 in older adults. Overall survival (OS) was 40% to 50% for patients younger than 60 years, but only 5% for patients older than 60 years. Most newly diagnosed AML patients are over the age of 60. In this patient population, standard induction chemotherapy is generally not an option due to increased treatment-related mortality due to age and comorbidities. The standard of care for AML patients who are ineligible for combination chemotherapy is treatment with a hypomethylating agent (azacitidine or decitabine) or low-dose cytarabine. Despite these first-line treatments, the median overall survival (OS) is only about 10 months. In all types of AML, disease recurrence is common and is the most com...

Embodiment 2

[0788] Example 2: Human Results

[0789] Safety of Hu5F9-G4 plus azacitidine

[0790] Forty-three patients were treated with Hu5F9-G4 plus azacitidine; 18 patients with MDS and 25 patients with AML. One patient (1 / 43: 2%) discontinued due to an adverse event (AE) of Hu5F9-G4 plus azacitidine (1DLT: G4 hemagglutination). The most common treatment-related adverse effects (TRAEs) were >15%: anemia (37%), neutropenia (26%), thrombocytopenia (26%). TRAE: Febrile neutropenia occurred in 1 patient (2%). No treatment-related infections were observed.

[0791] Efficacy of Hu5F9-G4 plus azacitidine

[0792] Shown in Table 5 are the MDS efficacy parameters and the number of responding patients in each parameter in the efficacy evaluable cohort and total treated patients.

[0793]

[0794] Shown in Table 6 are the AML efficacy parameters and the number of responding patients in each parameter in the efficacy evaluable cohort.

[0795]

[0796] Summarized in Table 7 is th...

Embodiment 3

[0815] Example 3: Hu5F9-G4 and azacytidine reduce disease in AML patients with TP53 mutations

[0816] Clinical efficacy was shown in 9 untreated AML patients with TP53 mutations treated with Hu5F9-G4 and azacitidine. The overall response rate was 78%, of which 44% achieved CR and 33% achieved CRi. Additionally, deep responses were observed, as evidenced by a 67% CR rate by cytogenetics and 57% of patients achieving minimal residual disease negativity by flow cytometry. The median duration of response has not been reached, with a median follow-up of 6.9 months. Three additional AML patients with TP53 mutations treated with Hu5F9-G4 and azacitidine were identified. Clinical efficacy was also shown in these 12 treatment-naive AML patients with TP53 mutations. The overall response rate of n=12 TP53-mutant AML patients was 78%, of which 44% achieved CR and 33% achieved CRi.

[0817] Clinical efficacy was shown in 4 MDS patients with TP53 mutations treated with Hu5F9-G4 and aza...

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Abstract

Provided herein are methods, kits, and compositions that can be used to treat hematopoietic disorders using an anti-CD47 agent, such as an antibody, and a hypomethylating agent, such as azacitidine.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS [0002] This application claims the benefit of the following US provisional applications: US Provisional Application No. 62 / 916,949, filed October 18, 2019; US Provisional Application No. 62 / 944,851, filed December 6, 2019; and May 28, 2020 US Provisional Application No. 63 / 031,438; each of these provisional applications is hereby incorporated by reference in its entirety for all purposes. [0003] sequence listing [0004] This application contains a Sequence Listing, which was filed via EFS-Web and is hereby incorporated by reference in its entirety. Said ASCII copy was created on October 9, 2020, is named FSI-006_P3F_SL, and is 145,290 bytes in size. Background technique [0005] CD47 has been identified as a key molecule that mediates cancer cells to escape phagocytosis by the innate immune system. CD47 appears to be an important means by which cancer cells, including cancer stem cells, often overcome their intrinsic expre...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K45/06A61K39/395A61K31/706A61K39/39A61P35/02
CPCA61K45/06A61K39/3955A61K31/706A61K39/39A61K9/0019A61P35/02C07K16/2803C07K16/2896A61K2039/545A61K2039/585A61K2039/575A61K2039/572C07K2317/24C07K2317/76A61K2300/00A61K2039/505A61K39/395
Inventor Y.曹M.P.赵R.马杰蒂R.L.莫特C.H.M.塔基莫托K.特兰
Owner FORTY SEVEN INC
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