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Visualization of HER2 expression in human patients

A patient-human technology applied in the field of visualization to solve problems such as false positive diagnoses

Pending Publication Date: 2022-03-18
HOBER BIOTECH AB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

In addition, large amounts of antibodies tend to accumulate in tumors in a non-specific manner, creating a risk of false-positive diagnoses

Method used

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  • Visualization of HER2 expression in human patients
  • Visualization of HER2 expression in human patients
  • Visualization of HER2 expression in human patients

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Experimental program
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Embodiment

[0167] In a human study, an imaging agent has been evaluated in patients with primary HER2-positive and HER2-negative breast cancer (hereinafter referred to as " 99m Tc-ADAPT6").

[0168] The main objectives of the study are:

[0169] a.evaluation 99m Distribution of Tc-ADAPT6 over time in normal tissues and tumors;

[0170] b.evaluation 99m Dosimetry of Tc-ADAPT6;

[0171] c. Obtaining information about the post-injection of a single IV 99m Preliminary information on the safety and tolerability of Tc-ADAPT6:

[0172] A secondary objective was to compare tumor imaging data with data on HER2 expression obtained by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH) analysis of biopsy samples.

[0173] In this study, human patients were injected with 250, 500 or 1000 μg of 99m Tc-ADAPT6. Evaluation was performed by planar scintigraphy and PET imaging at 2, 4, 6, and 24 hours post-injection. However, patients injected with 250 μg were assessed only af...

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PUM

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Abstract

There is provided a use of an imaging agent, a method for visualizing HER2 expression in a human patient, the method comprising administering to the patient a dose of the imaging agent from 400 to 700 [mu] g, and subsequently scanning the patient to visualize HER2 expression, wherein the imaging agent is a conjugate of an HER2 binding protein (HBP) comprising a radionuclide and a specific amino acid sequence. Further provided are unit doses comprising an imaging agent in an amount of 400-700 [mu] g.

Description

technical field [0001] The present disclosure relates to the field of visualization of HER2 expression in human patients. Background technique [0002] Human epidermal growth factor receptor 2 (HER2) is the molecular target of multiple therapies for the effective treatment of breast and gastroesophageal cancer. Response to such treatments depends on HER2 expression levels, thus accurate assessment of HER2 status in tumors is required to avoid undertreatment and overtreatment (Wolff 2013; Bartley 2017). The current standard of care involves collecting biopsy material and then assessing HER2 status using immunohistochemistry (IHC) and in situ hybridization (ISH) analysis. Tumors with a 3+ IHC score or 2+ IHC with positive ISH were considered HER2-positive and eligible for HER2-targeted therapy. A major problem with this approach is the heterogeneity of HER2 expression, and breast cancer patients often have both HER2-positive and HER2-negative metastases ( 2016; Gebhart 201...

Claims

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Application Information

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IPC IPC(8): A61K51/08
CPCA61K51/088A61K51/08
Inventor 索菲娅·霍伯贾瓦德·加鲁西弗拉基米尔·托尔马乔夫布拉金娜·奥尔加萨拉·林博弗拉基米尔·切尔诺夫
Owner HOBER BIOTECH AB
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