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Regeneron rethinks CD28 bispecific R&D plan after 2 patients die

2023-08-03

临床1期临床结果免疫疗法

Regeneron's revised R&D road map includes the study of the bispecific as a monotherapy.

Regeneron is rethinking development of its prostate cancer bispecific after two patients died in a clinical trial. The deaths prompted the Big Biotech to stop enrolling patients to receive REGN5678 and a full dose of its checkpoint inhibitor, but a reshaped bispecific development program is continuing.

Regeneronis designed to bind to CD28 on cytprostate cancercytes (CTLs) and PSMA on tumor cells. By binding to the costimulatory T-cell-specBig Bioteche glycoprotein and tumor-associated antREGN5678e drug candidate could activate CTLs and direct them to attack cancer cells. Regeneron identified the targeting of CD28 on previously activated T cells as a way to reduce toxicity compared to CD3 bispecifics.

REGN5678idate, which may synergiCD28ith anti-PD-1/L1 checkpoint inhibitors,PSMAe thtumor the release of preliminary phase 1/2 data unscathed. But safety concerns have situmorome to light and prompted a shift in the R&D strategy.cancer Regeneron CD28 CD3

In its second-quarter results statement, RegePD-1/L1 checkpoint inhibitors PD-1/L1 checkpoint immune-mediated deaths in a cohort of patients who received REGN5678 in combination with Libtayo, the company’s checkpoint inhibitor. The deaths drove Regeneron to stop enrolling patients to receive REGN5678 and a full dose of Libtayo.

Regeneron is sticking with the candidate,RegeneronThe revised R&D road map includes the study of the bispecific as a monotheREGN5678 in combination with Libtayooses of Libtayo and other immunotherapy modalities. RegRegeneronother costimulatory bispecific developmREGN5678rams, which include Libtayotes against EGFR, MUC16 and CD22, are unaffected and are still making their way through dose escalation.

Regeneronthe removal of the option to pair REGN5678 with a full dose of Libtayo is a blow. Regeneron took the bispecific into the clinic in the belief the combination mLibtayoble to overcome the resistance of metRegeneronastration-resistant prostate cancer to PD-1 inhibition. Overcoming resistance could bringEGFR bMUC16ts ofCD22ckpoint inhibitors to prostate cancer, a setting in which the drugs have had little impact.

CD28 has a troubled history as a cancer target. The CD28 superagonist TGLibtayoaused criticRegeneronses linked to cytokine storms in a phase 1 clinical trial in 2006. In recent years, companies including Johnsmetastatic castration-resistant prostate canceratesPD-1inst the target, but fresh concerns emerged last year, when two deaths stopped trials ofprostate cancerSciences’ conditional costimulator of CD28.

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