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Pharmaceutical compositions comprising bispecific antibodies for cd3 and cd20 and uses thereof

A technology of bispecific antibodies and compositions, which can be applied to drug combinations, medical preparations containing active ingredients, antibodies, etc., can solve problems such as reducing T cells

Pending Publication Date: 2022-05-27
健玛保
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, there is an unmet need for attenuating or reducing the systemic cytokine release profile of T cell redirecting bispecific antibodies following their administration to humans or animals

Method used

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  • Pharmaceutical compositions comprising bispecific antibodies for cd3 and cd20 and uses thereof
  • Pharmaceutical compositions comprising bispecific antibodies for cd3 and cd20 and uses thereof
  • Pharmaceutical compositions comprising bispecific antibodies for cd3 and cd20 and uses thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment approach

[0696] 1. A pharmaceutical composition comprising or consisting essentially of:

[0697] a. 0.5 to 120 mg / mL bispecific antibodies that bind human CD3 and human CD20,

[0698] b. 20 to 40 mM acetate,

[0699] c. 140 to 160 mM sorbitol,

[0700] d. Surfactant,

[0701] wherein the pH of the composition is from 5 to 6 and wherein the bispecific antibody comprises a first binding region that binds human CD3 and a second binding region that binds human CD20, the first binding region comprising the CDR sequences:

[0702] VH-CDR1: SEQ ID NO: 1

[0703] VH-CDR2: SEQ ID NO: 2

[0704] VH-CDR3: SEQ ID NO: 3

[0705] VL-CDR1: SEQ ID NO: 4

[0706] VL-CDR2: GTN, and

[0707] VL-CDR3: SEQ ID NO: 5

[0708] The second binding region comprises CDR sequences:

[0709] VH-CDR1: SEQ ID NO: 8

[0710] VH-CDR2: SEQ ID NO: 9

[0711] VH-CDR3: SEQ ID NO: 10

[0712] VL-CDR1: SEQ ID NO: 11

[0713] VL-CDR2: DAS, and

[0714]VL-CDR3: SEQ ID NO:12.

[0715] 2. The pharmaceutical compo...

Embodiment 1

[0884] Example 1: Stability of Duobody-CD3xCD20 in different formulations

[0885] abbreviation

[0886] Abbreviations / Terms definition A 280

Absorbance at 280nm A 550

Absorbance at 550nm BCM center of gravity average CE capillary electrophoresis DSF Differential Scanning Fluorescence DLS dynamic light scattering HC heavy chain HMW high molecular weight HPLC high performance liquid chromatography icIEF Imaging capillary isoelectric focusing LC light chain LMW low molecular weight NaCl Sodium chloride NGHC aglycosylated heavy chain RH Relative humidity Ppm parts per million %Pd Polydispersity percentage SDS Sodium dodecyl sulfate SEC size exclusion chromatography SLS static light scattering T agg

onset of aggregation temperature T onset

onset of unfolding temperature T m

Melting temperature (= midp...

Embodiment 2

[0967] Example 2: Stability study of Duobody-CD3xCD20 (5 mg / mL) formulations with and without surfactant

[0968] Duobody-CD3xCD20 was formulated at 5 mg / mL and the method was as described in Example 1. To further stress the formulation further, the inventors performed freeze-thaw studies on the formulation. Samples were frozen in a -75°C chamber for at least 2 hours and thawed at room temperature (23°C) for 2 hours. This process was repeated 5 times. The freeze-thaw test revealed some microparticles by visual inspection in a formulation containing 5 mg / mL of DuoBodyCD3xCD20 in 30 mM acetate, 150 mM sorbitol, pH 5.5. When the inventors added 0.04% w / v polysorbate 80 to the formulation, only a very small amount of microparticles were visible by visual inspection after five freeze-thaw cycles. Further samples were compared after 2, 4, 8 and 12 weeks at 2-8°C, 25°C and 40°C. The results of these studies are shown in Table 10. As can be seen from the results, the addition of ...

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Abstract

The present invention relates to improved pharmaceutical compositions and dosage unit forms of bispecific CD3xCD20 antibodies and to routes of administration.

Description

technical field [0001] The present invention relates to pharmaceutical compositions and unit dosage forms of bispecific antibodies directed against CD3 and CD20 and uses thereof. Background technique [0002] CD3 has been known for many years and is therefore a subject of interest in many ways. In particular, antibodies raised against CD3 or the T cell receptor complex (of which CD3 is a part) are known. [0003] A promising approach to improving targeted antibody therapy is through the specific delivery of cytotoxic cells to antigen-expressing cancer cells. The concept of using T cells to effectively kill tumor cells has been described by Staerz et al., 1985, Nature 314:628-631. However, initial clinical studies were rather disappointing, mainly due to low efficacy, severe side effects (cytokine storm) and the immunogenicity of bispecific antibodies (Muller and Kontermann, 2010, BioDrugs 24:89-98). Advances in bispecific antibody design and application have partially ove...

Claims

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Application Information

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IPC IPC(8): A61K39/395A61P35/00C07K16/46
CPCC07K16/2809C07K16/2887A61P35/00C07K2317/31C07K2317/51C07K2317/56C07K2317/565C07K2317/94A61K2039/545A61K2039/54A61K2039/505A61K39/39591A61K9/0019A61K47/14A61K47/26
Inventor J.瓦尔布约恩L.S.哈洛J.D.克劳森M.H.詹森C.西曼德J.帕斯P.J.马德森S.任M.A.C.瓦尔博姆B.比耶雷加德
Owner 健玛保
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