Immuno-oncology focuses on harnessing the body’s immune system to mount an immune response against cancer.
At EMD Serono, we are deeply committed to changing the cancer landscape. Our immuno-oncology (iONC™) research and early development platform, integrating research, early development and biomarker strategies, focuses on discovering and developing potential new therapies that are intended to harness the immune system and activate or augment the body’s natural anti-tumor response.
Our comprehensive, science-driven strategy has been embodied within three focused areas of research:
- therapeutic cancer vaccines (also called antigen-specific cancer immunotherapy)
- tumor immunotolerance
- cancer stem cells
At EMD Serono, we believe that the combination of therapies targeting different tumor evasion mechanisms can change the way we treat a complex disease such as cancer in the future.
We are committed to delivering on the promise of immuno-oncology by combining creative thinking with strong research and clinical excellence, and, most importantly, by keeping patient needs at the heart of our efforts
The comprehensive, science-driven strategy of the immuno-oncology platform has been embodied within three focused areas of research, each called an innovation cluster:
Innovation Cluster: Therapeutic Cancer Vaccines (also called antigen-specific cancer immunotherapy)
Therapeutic cancer vaccines seek to stimulate a specific immune response against a tumor and generate immunological memory to keep the tumor in check.
The development of cancer vaccines involves first identifying tumor-associated antigens that are capable of generating anti-tumor immune responses and then formulating these antigens into investigational agents for clinical testing against the tumors.
Innovation Cluster: Tumor Immunotolerance
Tumors develop diverse mechanisms that allow them to stay unrecognized by natural immune surveillance and escape elimination by the immune system. As a consequence, tumors grow and metastasize unconstrained.
By modulating these immunosuppressive mechanisms, the tumor immune environment can be shifted from an “immune tolerant” state toward an “immune activated” state and the immune system may be redirected to eliminate the cancer cells.
EMD Serono is targeting specific mechanisms of tumor immune suppression for therapeutic intervention. These therapies are designed to attempt to eliminate or circumvent inhibitory mechanisms in the immune system.
Exploring mechanisms of tumor inflammation is another core component of this innovation cluster. The inflammatory signals present in a tumor directly influence the composition of the immune cell infiltrate, the way the immune cells interact with each other and with tumor cells, and the milieu of soluble factors that influence tumor growth, invasion and immunosuppression.
Innovation Cluster: Cancer Stem Cells
Cancer stem cells represent a rare population of tumor cells required for perpetuating tumor growth.
Cancer stem cells can migrate from a primary tumor into the blood stream and travel throughout the body, resulting in the formation of tumor metastases at distant sites. Cancer stem cells are thought to be a cause of disease recurrence due to their inherent drug-resistance and ability to lie dormant for long periods of time.
Therapies that eliminate cancer stem cells are an area of research and investigation.
The current immuno-oncology portfolio comprises therapeutic candidates in early clinical development and a pipeline of preclinical molecules. Lead investigational candidates in clinical development include:
Avelumab (also known as MSB0010718C) is an investigational fully human anti-PD-L1 IgG1 monoclonal antibody. By inhibiting PD-L1 interactions, avelumab is thought to enable the activation of T-cells and the adaptive immune system. By retaining a native Fc-region, avelumab is thought to engage the innate immune system and could induce antibody-dependent cell-mediated cytotoxicity (ADCC).
**avelumab = proposed International Non-proprietary Name (INN), formerly referred to as Anti-PD-L1 mAb (MSB0010718C)
NHS-IL12 (also known as MSB0010360) is an investigational cancer immunotherapy (immunocytokine) that is designed to target interleukin-12 to necrotic regions found in solid tumors.
A potential first-in-class, investigational, bifunctional immunotherapy, M7824 (also known as MSB0011359C), is designed to simultaneously block two immuno-inhibitory pathways that are commonly used by cancer cells to evade the immune system.
*Pipeline products are under clinical investigation and have not been proven to be safe and effective. There is no guarantee any product will be approved in the sought-after indication.
Alliance between Pfizer and Merck KGaA, Darmstadt, Germany
Immuno-oncology is a top priority for Merck, KGaA, Darmstadt, Germany and Pfizer. In November 2014, Merck, KGaA, Darmstadt, Germany and Pfizer announced a global strategic alliance enabling the companies to benefit from each other’s strengths and capabilities and further explore the therapeutic potential of avelumab, an investigational anti-PD-L1 antibody initially discovered and developed by Merck, KGaA, Darmstadt, Germany. As part of this immuno-oncology alliance the companies will co-develop and co-commercialize avelumab and advance Pfizer’s PD-1 antibody. The alliance will collaborate on up to 20 high priority immuno-oncology clinical development programs, including combination trials, many of which are expected to commence in 2015.