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Methods of treating tumors

a tumor and tumor technology, applied in the field of tumor treatment methods, can solve problems such as negative impact on the patient's experien

Pending Publication Date: 2022-07-28
HALOZYME
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The patent describes a method for treating a subject with a pharmaceutical composition that includes an anti-PD-1 or anti-PD-L1 antibody and an endoglycosidase hydrolase enzyme. The method involves subcutaneously administering the antibody to the subject in one or more subcutaneous unit doses. The dose can range from 250 mg to 2000 mg, with a recommended dose of about 250 mg to about 600 mg. The antibody can be administered every week or every two weeks. The method can also involve administering the antibody in combination with other substances, such as other antibodies or other enzymes. The technical effect of the patent is to provide a more effective and efficient method for treating subjects with the pharmaceutical composition.

Problems solved by technology

The inconvenience and invasiveness of the treatment can negatively impact the patient's experience.

Method used

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  • Methods of treating tumors
  • Methods of treating tumors
  • Methods of treating tumors

Examples

Experimental program
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Effect test

example 1

ous Injection Formulation Development

[0461]The present example discusses the development of a stable, robust subcutaneous (SC) formulation of nivolumab and a manufacturing process suitable for commercial scale production. As a part of the formulation studies, the effects of various different pharmaceutically acceptable excipients on the stability of nivolumab were evaluated. Studies were also undertaken to select processing and packaging components compatible with the selected formulation. In addition, use time studies were conducted to support administration of the drug product via subcutaneous injection.

[0462]The objectives of these studies conducted for the development of nivolumab SC injection include: 1. identification and development of a stable injectable formulation for nivolumab SC injection that would be suitable for clinical use and eventual commercialization; 2. identification of manufacturing equipment and packaging components that are compatible with nivolumab SC injec...

example 2

ous Nivolumab with or without rHuPH20

[0577]In an ongoing Phase 1 / 2 study the PK, safety, efficacy, and tolerability was evaluated for nivolumab monotherapy administered subcutaneously (SC) with or without the hyaluronidase rHuPH20 in patients across solid tumors (metastatic melanoma, RCC, NSCLC, HCC, and CRC) where PK, efficacy, safety, and immunogenicity of nivolumab following IV administration have been well-characterized. Other solid tumors where PK of IV nivolumab was well-characterized (gastroesophageal junction [GEJ], gastric cancer (GC), metastatic urothelial carcinoma (mUC) and SCCHN were permitted).

[0578]The starting SC dose selected for Part A was 720 mg Q4W. Based on preliminary PK from Part A and subsequent modeling, this study proceeded as planned with a second dose of 960 mg Q4W for Part B.

[0579]For Parts A and B, PK of single dose SC nivolumab (with and without rHuPH20) was characterized, followed by IV nivolumab 480 mg Q4W at Week 4. These SC PK data were used to upd...

example 3

ous Nivolumab in Combination with Recombinant Human Hyaluronidase in Previously Treated Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer

[0616]A phase 3 study will be performed to evaluate the administration of subcutaneous (SC) nivolumab coformulated with recombinant human PH20 (rHuPH20) versus intravenous (IV) nivolumab in participants with previously treated advanced, recurrent, or metastatic non-small cell lung cancer (NSCLC). This study seeks to establish pharmacokinetic (PK) and efficacy non-inferiority of 1200 mg of nivolumab coformulated with 20,000 Units of rHuPH20 administered SC every 4 weeks (Q4W) compared with 3 mg / kg nivolumab administered IV every 2 weeks (Q2W). Throughout the protocol, the coformulation of nivolumab and rHuPH20 will be referred to as SC nivolumab and the IV formulation of nivolumab will be referred to as IV nivolumab.

[0617]Males or females 18 years of age or older (or local age of majority) with histologically confirmed Stage IIIB / IIIC / IV...

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PUM

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Abstract

The disclosure provides pharmaceutical compositions comprising an anti-PD-1 antibody or an anti-PD-L1 antibody. In some aspects, the pharmaceutical compositions are formulated for subcutaneous delivery. In some aspects, the pharmaceutical compositions further comprise an endoglycosidase hydrolase enzyme. Other aspects of the present disclosure are directed to methods of subcutaneously delivering a pharmaceutical composition comprising an anti-PD-1 antibody or an anti-PD-L1 antibody.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application claims priority to and benefit of U.S. Provisional Application No. U.S. 63 / 131,240, filed on Dec. 28, 2020; U.S. 63 / 150,420, filed on Feb. 17, 2021; and U.S. 63 / 184,082, filed on May 4, 2021; each of which is hereby incorporated by reference herein in its entirety.REFERENCE TO SEQUENCE LISTING SUBMITTED ELECTRONICALLY VIA EFS-WEB[0002]The content of the electronically submitted sequence listing (Name: 3338_2250004_Seqlisting_ST25.txt; Size: 1,011,280 bytes; and Date of Creation: Dec. 27, 2021) is herein incorporated by reference in its entirety.FIELD OF THE DISCLOSURE[0003]The present disclosure provides a method for treating a subject afflicted with a tumor using a checkpoint inhibitor, e.g., an immunotherapy.BACKGROUND OF THE DISCLOSURE[0004]Human cancers harbor numerous genetic and epigenetic alterations, generating neoantigens potentially recognizable by the immune system (Sjoblom et al., Science (2006) 314(5797):268-...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K39/395A61K38/47A61K9/00A61K47/26A61K47/22A61K47/18
CPCA61K39/3955A61K38/47A61K9/0019A61K2039/545A61K47/22A61K47/183A61K47/26C07K16/2818C07K16/2827A61K2039/505C12N9/2474A61P35/00A61K39/39591A61K47/20A61K47/42A61K2039/54
Inventor HUANG, MASANOHABY, THOMAS ARTHURKHOSSRAVI, MEHRNAZHART, SCOTT AARONMANTRI, RAO VENKATRAMANAVEZINA, HEATHER ELIZABETHROY, AMITMURTHY, BINDU PURNIMAARAS, URVI ASHISHSANGHAVI, KINJALZHAO, XIAOCHENBELLO, AKINTUNDE
Owner HALOZYME
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