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Macrophage cell therapy: a new hope for chronic liver disease patients

Drug Target Review

Once a patient develops advanced cirrhosis/end-stage liver disease there are no specific therapies to significantly avoid major decompensations and death in the next few years. Could you describe the platform of macrophage biology and cell engineering used by Resolution Therapeutics in developing their cell therapies?

Therapies 114
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Targeting the immunotherapy potential of cytokines IL-12 and IL-18 with new advancements in protein engineering

Drug Target Review

We are in an era of immuno-oncology (IO) revolution with many approved therapies now available to treat a broad range of cancers. For the last several years, the field has worked to unlock the potential of IO therapies for additional tumour types, and has explored options beyond checkpoint inhibitors.

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Enhancing gene therapy with Circio

Drug Target Review

Secondly, circRNAs can be engineered for more efficient protein expression by carefully selecting and optimising the IRES element, a sequence motif derived from viruses and used to initiate cap-independent translation from circRNA. There are three major reasons for why Circio has selected AATD as its lead gene therapy program.

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Regulatory Trends in Cell and Gene Therapies

Advarra

The field of cell and gene therapies (CGT) is constantly evolving, and there has been significant progress in this area of research. However, despite the promise of these therapies, the regulations governing them lag the science, which in turn hinders the clinical translation of these novel medicines.

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OTAT Town Hall on Cell Therapy CMC – The Recording is Available but Here’s an Appetizer

FDA Law Blog: Drug Discovery

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC).

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A2 Biotherapeutics Entered Into Collaboration Agreement With Merck to Develop Allogeneic Cell Therapy for Solid Tumor Cancers

The Pharma Data

Merck will assist with preclinical development and has the option to exclusively develop, manufacture and commercialize the candidate following Phase 1. A2 Biotherapeutics is using its next-generation cell therapy Tmod platform to revolutionize the treatment of solid tumor cancers. About A2 Biotherapeutics.

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FDA approves Phase 1 trial for HIV gene therapy

The Pharma Data

The FDA has approved a request from American Gene Technologies to begin a clinical study into its HIV gene therapy. This requires an 11-day programme which involves extracting blood from an HIV patient and separating their T cells, which are then engineered in a lab to make them immune to HIV. Conor Kavanagh. Source link.