Expediting SEND Datasets for an International Regulatory Submission

A case study with Peg Biomedical Co., Ltd

Peg Biomedical Co., Ltd. (Peg Bio), is a Suzhou, China-based biopharmaceutical company specialized in developing innovative medicines for metabolic diseases including type 2 diabetes, obesity, and non-alcoholic hepatitis.

While business between Peg Bio and Covance first started in 2014, the strength and depth of our relationship was highlighted in Spring 2019.  In May that year, more than 400 Covance employees relocated to a new facility – the Aland Center in Zhangjiang Hi-Tech Park of Shanghai’s Pudong District-  and Dr. Michael Xu, CEO of Peg Bio, was invited to deliver a speech for the new site opening ceremony. In his address, Dr. Xu expressed his gratitude for Covance’s service delivery, “among all of the collaborators, Covance is probably the best time‑keeping CRO we have worked with.”

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5 Different Kinds of Cytokine Release Assays: Weathering the Storm | CRA Post II

In our previous post, we outlined the dangers of Cytokine Release Syndrome (CRS) and the importance of preclinical Cytokine Release Assays (CRAs) when developing monoclonal antibodies (mAbs) that interact with the patient’s immune system. In this second post, we describe the different kinds of assays in use and how these may fit into your drug development program. An alternative type of CRA, peripheral blood mononuclear cell (PBMC) blood outgrowth endothelial cell (BOEC) co-culture, will be discussed in more detail in our next blog post.

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In Vitro Cytokine Release Assays: Is There Calm After the Storm? | CRA Post I

What is a cytokine storm? 

Cytokine Release Syndrome (CRS), otherwise known as cytokine storm, is a systemic inflammatory response caused by complications due to disease, infection or an adverse effect of biologic therapy. The clinical symptoms of a cytokine storm are massive release of a potent cocktail of pro-inflammatory cytokines into the general circulatory system, leading to severe multi-organ damage, failure or potentially death. This is an extremely unwanted immunotoxicological side effect in drug development.

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An Introduction to Dendritic Cell Biology and Analysis Using Syngeneic Immuno-Oncology Models

Productive immunotherapy driven anti-tumor responses rely on the activation of T cells that target tumor-associated antigens (TAA). The dendritic cell (DC) plays an essential role in the activation of T cell antigen-specific responses, which occurs naturally in the context of infection. However, this same process supports tumor immune surveillance as well as active anti-tumor responses. Research into new approaches that harness DC TAA presentation to T cells to boost anti-tumor immunity has received much attention. In this blog, we will discuss DC subsets in the tumor-microenvironment and mechanisms that tumors use to suppress their function. We will explore how pre-clinical models can be used to investigate DC responses to immunotherapy. Furthermore, we will highlight recent advances in the field of DC immunotherapy, including different approaches to upregulate DC activity, such as STING pathway activators.

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Drug Discovery is Not Black and White—Why Should Your Studies Be?

Medical imaging is a powerful tool that allows for in vivo and ex vivo quantification of various endpoints which can aid in oncology research and drug discovery. With a myriad of imaging options, how do you know which method is the most appropriate for your needs? The purpose of this blog is to bring clarity to the use of several preclinical imaging modalities available at Covance.

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Immuno-Metabolism Impacts on T Cell Populations

We are all familiar with cellular metabolism and how the production of ATP (cell energy) is critical for cell development, proliferation, and survival. Understanding the impact of immuno-metabolism and how this area can enhance the ever-evolving immuno-oncology research is a new and exciting field. Since the cells of the immune system are a fundamental component of the tumor microenvironment (TME), cancer immunotherapy continues to be a powerful therapeutic approach to use the immune system to produce an anti-tumor response. Increasing evidence suggests that down regulation of cellular metabolism plays a pivotal role in inhibiting the ability of the immune system to inhibit tumor growth. In the TME, the immune cells are forced to operate with a metabolic disadvantage since they are subjected to a lack of energy resources. This is mainly due to the competition between the immune cells and the tumor cells for limited nutrients.1

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Strategies for Selecting the Right Immuno-Oncology Tumor Model

In our June 2017 blog post, we described advantages and challenges of using syngeneic, GEM, and humanized mouse models for preclinical immuno-oncology (I/O) drug development. In this blog, we expand on this idea and offer thoughts on choosing the most appropriate I/O tumor model for one’s study. While there are benefits and limitations of any model, one can use these considerations, as well as others, as a foundation for preclinical in vivo efficacy study design. Understanding tumor placement, immune composition, response to treatment, and molecular characterization for the model of interest can be invaluable when designing the most appropriate study for your research goals.

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Advancements and Challenges of Imaging in the Immuno-Oncology Space

Immunotherapy agents (IO) are increasingly being used to treat solid tumors due to their dramatic effects on tumor response. However, the assessment of tumor response is not always straightforward given their unique mechanisms of action which include enhancing immune cell infiltration and activation in tumors. Current standard imaging techniques such as fluorinated deoxy-glucose (18F-FDG) PET cannot differentiate between cancer and immune cells. These tumor immune responses can lead to radiographic pseudo-progression whereby there can be an initial “worsening” of radiographic lesions. While IO therapies can be incredibly successful, understanding when a given treatment is successful or if the regimen needs to be augmented, is paramount.1 This confounding, radiographic evidence can lead to patients continuing therapy when no benefit is present or removal of therapy prematurely due to a delay in response time.

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Utilization of Radiation in the Preclinical Oncology Setting

The American Cancer Society estimates that in 2017 over 1.6 million people will be diagnosed with non-skin cancers in the United States. It is known that more than 50% of all cancer patients will receive some sort of radiation therapy as part of their treatment plan. Why is it then that preclinical evaluation of drugs in combination with radiation is not mainstay in the industry?

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An Introduction to Immunohistochemistry

Immunohistochemistry (IHC) is an assay that utilizes the biological collaboration of Histology and Immunology. The biochemical interactions between an antibody and antigen permit visual distribution and localization of antibody–antigen interactions. This allows morphology, antigen intensity, and spatial relationships to be determined.

Covance offers high-quality IHC assays onsite to give you a time-efficient read-out on quantitative and qualitative data. With our in-house IHC services, data can be produced expeditiously that reveals the following:

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