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Process for preparing vaccine compositions

A composition and drug technology, applied in the field of vaccine composition preparation, can solve the problems of low ratio of anti-tumor T cell response, no proven efficacy, etc.

Pending Publication Date: 2021-09-10
特雷斯生物有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Despite promise, current immunotherapies are only effective in a subset of individuals
Furthermore, most cancer vaccine trials have not demonstrated statistically significant efficacy due to low rates of tumor regression and antitumor T-cell responses in individuals

Method used

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  • Process for preparing vaccine compositions
  • Process for preparing vaccine compositions
  • Process for preparing vaccine compositions

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0333] Example 1 HLA epitope binding prediction method and verification

[0334] Prediction of binding between specific HLAs and epitopes (9mer peptides) was based on the ImmunoEpitope Database tool for epitope prediction (www.iedb.org).

[0335] The HLA I epitope binding prediction process was validated by comparison with HLA I epitope pairs determined by laboratory experiments. Datasets of HLA I epitope pairs reported in peer-reviewed publications or public immunology databases were compiled.

[0336] The rate of agreement with the experimentally determined data set (Table 6) was determined. Binding HLA I epitope pairs for the dataset were correctly predicted with 93% probability. Coincidentally, non-binding HLA I epitope pairs were also predicted correctly with a probability of 93%

[0337] Table 6 Analytical specificity and sensitivity of HLA epitope binding prediction methods

[0338]

[0339] The accuracy of predicting multiple HLA binding epitopes was also dete...

example 2

[0343] Example 2 Epitope Presentation of Multiple HLAs Predicts Cytotoxic T Lymphocyte (CTL) Response

[0344] This study investigated whether an individual's presentation of one or more epitopes of a polypeptide antigen by one or more HLA class I molecules is predictive of a CTL response.

[0345] The study was performed by a retrospective analysis of 6 clinical trials conducted in 71 cancer patients and 9 HIV-infected patients (Table 8). Patients from these studies were treated with HPV vaccines, three different NY-ESO-1-specific cancer vaccines, an HIV-1 vaccine, and a CTLA-4-specific monoclonal antibody (ipilimmab), the Antibodies shown to reactivate CTLs against NY-ESO-1 antigen in melanoma patients. All of these clinical trials measure antigen-specific CD8+ CTL responses (immunogenicity) in study subjects after vaccination. In some cases, a correlation between CTL response and clinical response was reported.

[0346] No patients were excluded from the retrospective ...

example 4

[0367] Example 4 Clinical Validation of PEPI3+ Threshold as a New Biomarker for PEPI Test

[0368] Vaccine design based on PEPI3+ biomarkers has been tested for the first time in a phase I clinical trial in patients with metastatic colorectal cancer (mCRC) in the OBERTO phase I / II clinical trial (NCT03391232). In this study, we evaluated the safety, tolerability, and immunogenicity of single or multiple doses of PolyPEPI1018 as an add-on to maintenance therapy in patients with mCRC. PolyPEPI1018 is a peptide vaccine containing 12 unique epitopes from 7 conserved TSAs frequently expressed in mCRC (WO2018158455A1). These epitopes are designed to bind at least three autologous HLA alleles that are more likely to induce T cell responses than epitopes presented by a single HLA (see Examples 2 and 3). mCRC patients in the first-line setting received the vaccine (dose: 0.2 mg / peptide) immediately after transition to maintenance therapy with fluoropyrimidine and bevacizumab. Vacci...

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Abstract

The disclosure relates to polypeptides, polynucleic acids and pharmaceutical compositions comprising polypeptides that find use in the prevention or treatment of cancer. The disclosure also relates to methods of inducing a cytotoxic T cell response in a subject or treating cancer by administering pharmaceutical compositions comprising the peptides, and companion diagnostic methods. The disclosure also relates to a method of preparing a peptide or polynucleic acid for use in a method of inducing a T cell response against a target polypeptide, wherein the method comprises identifying epitopes in the antigen that bind to multiple HLA alleles of the highest proportion of subjects in a target population.

Description

[0001] sequence listing [0002] This application contains a Sequence Listing, which has been filed electronically in ASCII format, and is hereby incorporated by reference in its entirety. Said ASCII copy, created on August 29, 2019, is named N414322WO_SL.txt and is 1,450,065 bytes long. technical field [0003] The present disclosure relates to peptides and compositions useful in vaccines and immunotherapy, to nucleic acids and vectors encoding such peptides, to methods of designing and producing such peptides, to predicting whether an individual subject will respond to treatment with such peptides Methods of responding, to subject-specific compositions comprising such peptides, and to methods of treatment using such peptides. Background technique [0004] For decades, scientists have believed that chronic disease goes beyond people's natural defenses. More recently, however, the field of cancer immunotherapy has been accelerated by the dramatic tumor regression observed ...

Claims

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Application Information

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IPC IPC(8): C07K14/47
CPCC07K14/4748A61K39/001102A61K39/0011A61K39/39C07K14/70539C07K16/2818C07K16/2827C12Q1/6881A61P35/00A61P37/04A61K2039/55505A61K2039/55566A61K2039/55572A61K2039/55577
Inventor 朱丽安娜·利兹维奇列文特·莫尔纳埃尼科·托克约瑟夫·托特奥索利亚·洛林茨若尔特·塞斯佐夫斯基埃斯特·索莫吉卡塔林·潘蒂亚莫妮卡·梅格耶西彼得·帕莱斯
Owner 特雷斯生物有限公司
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