個別化がんワクチンの第1相試験で有望な結果(Personalized Cancer Vaccine Proves Promising in a Phase 1 Trial at Mount Sinai)

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2025-03-17 マウントサイナイ医療システム(MSHS)

個別化がんワクチンの第1相試験で有望な結果(Personalized Cancer Vaccine Proves Promising in a Phase 1 Trial at Mount Sinai)

マウントサイナイの研究者たちは、複数のがん種に対して強力な免疫応答を誘発する多ペプチドネオアンチゲンがんワクチンの第1相試験で有望な結果を得ました。 この個別化ワクチンは、患者の腫瘍から特定された少数のネオアンチゲンを標的とし、免疫系ががん細胞を認識し攻撃するよう設計されています。試験では、複数のがん種の患者に投与され、安全性と免疫原性が確認されました。これらの結果は、個別化がんワクチンの将来性を示唆しており、今後の臨床試験での検証が期待されます。

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PGV001, a multi-peptide personalized neoantigen vaccine platform: Phase I study in patients with solid and hematological malignancies in the adjuvant setting

Mansi Saxena;Thomas U. Marron;Julia Kodysh;John P. Finnigan;Sayali Onkar;Anna Kaminska;Kevin Tuballes;Ruiwei Guo;Rachel Lubong. Sabado;Marcia Meseck;Timothy J. O’Donnell;Robert P. Sebra;Samir Parekh;Matthew D. Galsky;Ana Blasquez;Gustavo Gimenez;Mesude Bicak;Cansu Cimen Bozkus;Daniela Delbeau-Zagelbaum;Denise Rodriguez;Ana Acuna-Villaorduna;Krzysztof J. Misiukiewicz;Marshall R. Posner;Brett A. Miles;Hanna Y. Irie;Amy Tiersten;Deborah B. Doroshow;Andrea Wolf;John Mandeli;Rachel Brody;Andres M. Salazar;Sacha Gnjatic;Jeff Hammerbacher;Eric Schadt;Philip Friedlander;Alexander Rubinsteyn;Nina Bhardwaj
Cancer Discovery  Published:March 17 2025
DOI:https://doi.org/10.1158/2159-8290.CD-24-0934

Abstract

Immunotherapies like immune checkpoint inhibitors (ICIs) have changed the standard of care for cancer patients, often leading to durable responses. However, many patients remain or become refractory to ICIs owing to factors such as a lack of primed neoantigen-reactive T cells. We developed a peptide-based vaccination platform that utilizes fully personalized genome vaccines (PGV) and targets neoantigens predicted by our OpenVax computational pipeline. Here we report results from PGV001 study (NCT02721043) targeting up to 10 neoantigens, administered in the adjuvant setting to patients with both solid and hematological malignancies who have high risk of recurrence. Our data indicates that PGV001 is feasible and safe, with 13 out of 14 enrolled patients receiving the vaccine and 11 completing the treatment. 100% of vaccinated patients developed targeted T cell and B cell responses highlighting the capacity of OpenVax to predict immunogenic neoantigens and the potential of PGV001 for safely inducing targeted immunity.

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