Advanced Assays to Accelerate Immunotherapy Development

For Cancer Vaccines, Checkpoint Inhibitors, Other Immuno-Oncology Drugs, and More

An immunotherapy program has the potential to change lives through more effective treatments — with better quality of life — than ever before. At Nexelis, a Q² Solutions Company, we provide extensive scientific expertise with a wide range of assay development services with advanced instrumentation to support your efforts, from exploration onward. Partner with us to increase efficiency and accelerate your novel therapies to patients who need them.

Immunotherapy Is a Crucial, Wide-Open Field

The immunotherapy field has rapidly evolved as a promising avenue for cancer treatment, with drugs and therapeutic vaccines that amplify the immune response to disease or help the body identify and target cancer cells. Immunotherapies have been developed to treat many neoplasms, including breast cancer, multiple myeloma, and neuroblastoma.

Beyond oncology, recent work on immunotherapies for infectious diseases includes treatments for human immunodeficiency virus (HIV), tuberculosis (TB), human papillomavirus (HPV), and SARS-CoV-2.

Types of Immunotherapy

Immunomodulators follow a variety of strategies to affect the body’s immunologic response to disease. Categories include:

Naked monoclonal antibodies (mAb) are the most common type of immunotherapy used in cancer treatment. These lab-made proteins attack specific parts of a cancer cell or block antigens that stimulate cancer proliferation. Bispecific antibodies present multiple epitopes on one molecule, facilitating novel functionalities. Verified high purity, specificity, and neutralizing activity are crucial to ensure success with all these agents.

One example of this type of therapy is immune checkpoint inhibitors. Immune checkpoints are a normal regulatory mechanism to down-regulate the body’s response to an immunologic stimulus. Some cancers stimulate checkpoint targets, weakening the normal immune response. Checkpoint inhibitors prevent proteins from binding with the checkpoint targets, thus maintaining a strong immune response. The next generation of checkpoint inhibitors combine two targets for greater efficacy. For example, a checkpoint target may be combined with a T-cell target, crosslinking T-cells to tumor cells for increased T-cell tumor infiltration and activation.

T-cells can be modified to be more effective at targeting disease, cultured, and reintroduced to the patient. For example, in CAR-T cell therapy, T-cells with chimeric antigen receptors (CAR) that target the cancer are created. Tumor-infiltrating lymphocyte (TIL) therapy is another example of an adoptive cell therapy.

Common viruses are modified to infect and kill cancer cells, reproducing in the process, for an amplified effect. These viruses may also elicit an anti-tumor immune response on the part of the host. An HSV-based oncolytic virus has been approved as a treatment for melanoma.

Some vaccines prevent the development of a disease by eliciting an immune response against infectious diseases that cause cancer. For instance, the human papillomavirus (HPV) vaccine protects against several types of cancer. Similarly, the hepatitis B vaccine helps prevent liver cancer.

Therapeutic Vaccine Expertise at Nexelis

In contrast to prophylactic vaccines, therapeutic vaccines are given after the patient has contracted the disease. These vaccines stimulate the patient’s immune system to mount a stronger, more specific defense against a particular disease. Therapeutic vaccines may also be used to treat infectious diseases, such as HIV, cholera, and SARS-CoV-2. Nexelis’ dedication help clients develop the next class of promising immunotherapeutic agents.

Early Development Explorations in Immunogenicity

Monoclonal antibody (mAb) development is challenging, and bispecific antibodies are exponentially more so. Success depends on immunology-focused, early-stage product characterization. Assess immunogenicity with our in vitro T-cell activation and proliferation assays using human immune cells and our epitope prediction services. With more than 20 years of experience in immunogenicity, Nexelis can help you reduce risk and ensure the candidate you advance is efficacious and developable with low immunogenicity for the best outcomes. 

In Vivo Models to Fit Your Needs

Whatever you need, whether it’s infectious disease, or tumor models in species ranging from hamsters to NHPs, we created models that we tailor to our clients’ needs or our skilled team will develop them with you.

Tailored Protein Sciences

At Nexelis, high-throughput technology enables rapid recombinant protein expression and purification to produce a large number of antibodies in parallel, allowing for the best candidate selection. We are experts in purification of a wide range of complex proteins produced by a variety of expression platforms. From sequence to well-planned and executed scale-up, our multitalented, flexible scientific team will work with you to ensure quality and consistency in material delivered to suit your needs.

Bioanalysis: ADA Detection and High-Resolution Mass Spectrometry (HRMS)

Nexelis offers state-of-the-art, robust, bioanalytical testing to support your immunotherapy programs in a variety of matrices. To complement our protein science services, we offer HRMS assays for antibodies and antibody drug conjugates (ADCs). In addition to conventional LC-MS/MS methods, our, HRMS offers faster method development time and greater sensitivity.

In other applications of our bioanalytical platform, we provide assays to evaluate cytokine release syndrome following monoclonal antibody or CAR T-cell therapy.

Biomarkers: Cytokines, Growth Factors, and More

Nexelis offers numerous biomarkers related to cell-mediated immunity and the tumor environment. These can all be customized and validated as needed to support your studies. Biomarker assays we offer include BAFF (B-cell activating factor), BCMA (B-cell maturation antigen), CA-125, interferons, interleukins, M-CSF-1 (macrophage colony stimulating factor), MCP-1 (monocyte chemotactic protein-1), TGF β-1 (transforming growth factor β-1, multiple formats), and VCAM-1 (vascular adhesion molecule-1).

Cellular Assays for Exploring Immunomodulatory Functionality

Early evaluation of the therapeutic potential of your immunomodulatory drug candidate is crucial for efficient development. We’ll help you gain better insights through analysis of immune cell subpopulations such as CD4+/CD8+. Readouts include multiplex flow cytometry, Luminex, ELISpot/Fluorospot, Incucyte®, and more. Our experts provide customized assays using high-quality human immune cells for in vitro screening of monoclonal and bispecific antibodies, proteins, peptides, RNA/DNA vaccines, viruses, etc.