article thumbnail

Designing antibodies to think before they bind

Drug Target Review

By designing the antibody to activate CD137 only in the presence of p95HER2, the team created a more controlled immune response and reduced the risk of off-target effects. This approach not only reduces the risk of CRS but also changes how immune engagement is defined.

article thumbnail

Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development

Alta Sciences

Regulatory Considerations for Oligonucleotide Drug Development and Safety In 2024, the U.S. It also outlines recommendations for drug-drug interaction assessments during clinical development, such as the assessment of appropriate biomarkers that reflect modulation of the target protein.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

POLB 001: tackling cytokine storms before they start

Drug Target Review

As the biotech sector races to improve the tolerability of these revolutionary treatments, Poolbeg Pharma has a novel solution: an oral therapy, POLB 001, to block the development of CRS, by limiting inflammation without affecting the anti-cancer immune responses that are vital for effective immunotherapies.

article thumbnail

Outsmarting immune suppression through GPCR innovation

Drug Target Review

These CCR8+ Tregs are known to suppress immune responses in the tumour microenvironment (TME), allowing cancers to grow unchecked. “DT-7012 DT-7012 retains its depletion activity even in high CCL1-concentrated environments – an essential property not shared by most competitor antibodies currently in clinical development.”

article thumbnail

U.S. FDA Grants Orphan Drug Designation to Riliprubart for Treating Antibody-Mediated Rejection in Solid Organ Transplant Recipients

The Pharma Data

The compound is being studied as a next-generation precision immunotherapy , offering the potential to more effectively preserve transplanted organs by modulating specific immune responses rather than broadly suppressing the immune system.

FDA
article thumbnail

ISSUE 44 — The Importance of Cytokine Release Assays to Derisk the Development of Immunomodulatory Drugs

Alta Sciences

One important aspect of toxicity studies is determining whether the drug produces undesired immune effects. The focus is to ensure that the drug does not have any potential to induce an excessive immune response, particularly cytokine storm, which can lead to severe adverse effects and impede clinical development.

article thumbnail

ISSUE 44 — The Importance of Cytokine Release Assays to Derisk the Development of Immunomodulatory Drugs

Alta Sciences

One important aspect of toxicity studies is determining whether the drug produces undesired immune effects. The focus is to ensure that the drug does not have any potential to induce an excessive immune response, particularly cytokine storm, which can lead to severe adverse effects and impede clinical development.