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The Hope and Promise of Immuno-Oncology

The immune system is rapidly emerging as a lead area of scientific discovery and holds vast potential for novel cancer treatments

Cancer has long been the most feared of diseases, the “emperor of all maladies,” as one 19th-century surgeon described it.

Scientists throughout the ages have worked to develop the tools we now use to fight this brutal disease. Most current cancer treatments act through external agents like chemotherapy or radiation to kill cancer cells. Early immuno-oncology therapies worked by activating the adaptive immune system – the body’s second line of defense – which eradicates pathogens by limiting their growth.

Innate immunity therapies, in contrast, restore the innate immune system’s own ability to recognize and destroy tumor cells. Until recently, the innate immune system has been largely overlooked as a therapeutic approach to cancer. Today, it is emerging as a lead area of scientific discovery due to its potential to present multiple options for patients. Engaging the innate immune system, which is inherently powerful, opens new opportunities for long-lasting, multilayered tumor control. We believe it is one of the most valuable components for fighting many types of cancer and may be the key to building a safe and curative approach.

Unlocking the power of the innate immune system

The innate immune system is the body’s first line of defense against any detected foreign invaders and abnormal cells, including tumor cells. It attacks these invaders by activating white blood cells which are made up of macrophages, natural killer cells and others. These innate immune cells then recruit cells of the adaptive immune system, such as T cells, enabling a multi-layered immune response.

Recognizing the need for new and better therapies for cancer, Affimed has harnessed what we know about the innate immune system to develop a diverse pipeline of novel innate cell engagers (ICE®). These molecules, developed through our proprietary Redirected Optimized Cell Killing (ROCK®) platform technology, create a bridge between innate immune cells and tumor cells.

This bridge is imperative to fighting cancer as it gives the innate immune cells the ability to kill cancer. Often, when a person is battling cancer, his or her immune system can be dysfunctional, hindering the body’s ability to effectively fight off diseases. Our ICE® molecules are designed to support the body’s immune system in fighting cancer by binding to specific antigens on tumor cells, as well as to a receptor called CD16A on innate immune cells. When the innate immune cell and tumor cell are joined, the innate immune cell can successfully destroy the tumor cell.

Our ICE® molecules deliver promising results for patients

This groundbreaking work has come to life in the form of our leading ICE® molecules: AFM13 and AFM24.

Our most clinically-advanced molecule, AFM13 works by recognizing the antigen CD30 on lymphatic tissue tumor cells and has been designed for treatment of patients with Hodgkin lymphoma and certain T-cell lymphomas.

We have seen promising results with this ICE® molecule, including recent data our partners at MD Anderson Cancer Center presented during the American Association for Cancer Research Annual Meeting 2021. The Phase 1 study is evaluating natural killer cells pre-complexed with AFM13 to treat people with Hodgkin lymphoma. The initial data was promising, showing a 100% objective response rate among the first four patients given the therapy, indicating AFM13 may have the potential to help natural killer cells target and destroy tumor cells.

We are also evaluating AFM13 as a monotherapy in people battling CD30-positive lymphomas such as peripheral T-cell lymphoma (PTCL) and transformed mycosis fungoides. The U.S. Food and Drug Administration granted orphan drug designation for AFM13 in April 2020 for people with PTCL, which we are hopeful will accelerate the eventual delivery of this novel therapy.

AFM24, our second ICE® molecule in a clinical trial, targets a protein called epidermal growth factor receptor (EGFR). EGFR plays a role in the development of numerous solid cancers, including colorectal, lung, head and neck. AFM24’s mechanism of action is distinct from other approaches in the area as it works through the engagement of innate immune cells rather than signal inhibition. In contrast to current therapies, AFM24 has the potential to treat all patients with EGFR, including those who are resistant to current treatments, with a more acceptable safety profile.

Affimed is collaborating with NKGen Biotech., the maker of SNK01 natural killer cells, to study the combination of AFM24 and SNK01 in patients with EGFR-expressing tumors. AFM24 is also being studied as a monotherapy in patients with advanced EGFR-expressing tumors whose disease has worsened after treatment with other therapies.

Affimed is currently evaluating AFM13 and AFM24 as monotherapies and targeted combination therapies with natural killer cells. We are also exploring additional synergistic combination therapies that have the potential to supplement a dysregulated immune system.

Paving the way for transformative treatments

Affimed was the first company with a clinical-stage ICE®, and we have strengthened our capabilities by partnering with other leading innovators in the industry, like Roche, Genentech, Merck, NKGen Biotech, Artiva and Roivant Sciences, who share our same commitment to developing better treatments for patients.

Together, we believe we can accomplish one common goal: to create therapeutics that give patients back their innate ability to fight cancer.


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