IP Library › Granted Patent US 12,274,746
Granted Patent B2
US 12,274,746 · App. 17/468,265 · Granted Apr 15, 2025

Dosing parameters for CD47 targeting therapies to hematologic malignancies

Inventors: Ravindra Majeti (Stanford, CA); Mark P. Chao (Mountain View, CA); Jie Liu (Palo Alto, CA); Jens-Peter Volkmer (Menlo Park, CA); Irving L. Weissman (Stanford, CA)
Assignees: The Board of Trustees of the Leland Stanford Junior University; Forty Seven, LLC
A61K39/3955A61K31/17A61K45/06A61P35/02C07K16/2803A61K2039/505A61K2039/545C07K2317/24
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Quick Facts
Patent No.
US 12,274,746
App. No.
17/468,265
Granted
Apr 15, 2025
Kind
B2
Abstract

Methods are provided herein for determining and administering optimized dosing of therapeutic anti-D47 agents, in a schedule that provides safe escalation of dose while achieving a therapeutic level in a clinically effective period of time. The methods can comprise the steps of clearance, escalation, and maintenance. In one embodiment the dosing regimen administers an initial (i) sub-therapeutic dose of an anti-CD47 agent or (ii) a cytoreductive therapy to achieve a safe level of circulating tumor cells for subsequent treatment (clearance); escalating the dose of an anti-CD47 agent until a therapeutic dose is reached (escalation); and maintaining the therapeutic dose for a period of time sufficient to reduce tumor cells in the bone marrow of the patient (maintenance). In an alternative dosing regimen, a patient determined to have a safe level of circulating tumor cells at presentation is treated by the steps of escalation and maintenance without initial clearance.

Claims (15)

1. A method of treating a patient for Acute Myeloid Leukemia (AML), wherein the method comprises:

(a) administering to said patient an effective dose of Hu5F9-G4,

(b) administering to said patient an effective dose of azacitidine, and

(c) administering to said patient an effective dose of a Bcl-2 inhibitor, wherein the Bcl-2 inhibitor is selected from obatoclax, venetoclax, and gossypol,

thereby treating said patient for AML.

2. The method of claim 1 , wherein the Bcl-2 inhibitor is venetoclax.

3. The method of claim 1 , wherein the Hu5F9-G4 is administered intravenously.

4. The method of claim 2 , wherein the venetoclax is administered orally.

5. The method of claim 1 , wherein the azacitidine is administered subcutaneously or intravenously.

6. The method of claim 2 , wherein the Hu5F9-G4, venetoclax, and azacitidine are administered over one or more cycles of 28 days each.

7. The method of claim 1 , wherein said patient is unfit or ineligible for induction chemotherapy.

8. The method of claim 2 , wherein the venetoclax is administered at one or more doses of 100 to 2,400 mg.

9. The method of claim 1 , wherein the Hu5F9-G4 is administered at one or more priming doses of 1 mg/kg.

10. The method of claim 1 , wherein the Hu5F9-G4 is administered at one or more therapeutically effective doses of 15 to 30 mg/kg.

11. The method of claim 1 , wherein the azacitidine is administered at one or more doses of 75 mg/m 2 .

Assignments (4)
CHANGE OF NAME Recorded Oct 22, 2024
From: FORTY SEVEN, INC.
To: FORTY SEVEN, LLC
Reel/Frame 069213/0526 →
CORRECTIVE ASSIGNMENT TO CORRECT THE THE SECOND INVENTOR'S NAME PREVIOUSLY RECORDED AT REEL: 058130 FRAME: 0205. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Dec 13, 2021
From: MAJETI, RAVINDRA; WEISSMAN, IRVING L.
To: THE BOARD OF TRUSTEES OF THE LELAND STANFORD JUNIOR UNIVERSITY
Reel/Frame 058495/0380 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 16, 2021
From: CHAO, MARK P.; LIU, JIE; VOLKMER, JENS-PETER
To: THE BOARD OF TRUSTEES OF THE LELAND STANFORD JUNIOR UNIVERSITY; FORTY SEVEN, INC.
Reel/Frame 058130/0176 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 16, 2021
From: MAJETI, RAVINDRA; WEISSMANN, IRVING L.
To: THE BOARD OF TRUSTEES OF THE LELAND STANFORD JUNIOR UNIVERSITY
Reel/Frame 058130/0205 →
Continuity (3)
Division 16619387
Provisional Application 62523182 · Jun 21, 2017
Related Publication 20210401979A1 · Dec 30, 2021
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