Affimed N.V. is pioneering innovative cancer treatments through its proprietary technology known as Innate Cell Engagers (ICE®). This approach leverages the innate immune system, specifically natural killer (NK) cells and macrophages, to target and destroy tumor cells. The ICE® molecules function by binding to the CD16A receptor on innate immune cells and a specific receptor on tumor cells, effectively bridging the two and activating the immune response. This mechanism allows for the direct killing of tumor cells without competing with the body's own antibodies, thus enhancing the efficacy of the immune response against cancer.

The company’s pipeline includes several promising ICE® molecules, such as acimtamig (AFM13), AFM24, and AFM28, each targeting different cancer types. Acimtamig has shown significant clinical activity in treating CD30-positive lymphomas, while AFM24 targets EGFR-expressing tumors, demonstrating a unique mechanism that bypasses resistance mechanisms associated with traditional therapies. AFM28 is being developed for acute myeloid leukemia (AML) and has shown potential in depleting both leukemic blasts and stem cells. Collectively, these advancements highlight Affimed's commitment to transforming cancer treatment by harnessing the innate immune system's capabilities.

Germany

At Affimed, we are committed to improving outcomes for patients with cancer. Our scientific team has been devoted to unlocking the power of the innate immune system for nearly two decades to provide a unique approach to fighting cancer. With our unparalleled expertise in innate immunity and innate cell engager-based medicines, we aim to overcome the limitations and challenges faced by current immuno-oncology (I-O) therapies.

Affimed N.V.

Cancer

Non-small cell lung carcinoma

Solid tumor/s

AFM24 is a tetravalent, bispecific EGFR- and CD16A-binding innate cell engager generated from Affimed’s fit-for-purpose ROCK® platform. AFM24 uses the cytotoxic potential of the innate immune system by redirecting and activating NK cells and macrophages to kill EGFR-positive cancer cells through antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), respectively. Due to its unique mechanism of action, AFM24 is potentially not limited to patient subtypes based on mutational status. Toxicology studies in cynomolgus monkeys with AFM24 showed a favorable safety profile, even when the animals were treated at high dose levels, demonstrating AFM24’s potential to have lower toxicities in humans compared to other EGFR-targeted therapies.

AFM24 (tumor target EGFR)  w/ SNK01 & atezolizumab

Hodgkin Lymphoma

Lymphoma

Peripheral T-cell Lymphomas

At Affimed, our approach is to restore the innate immune system’s own ability to recognize and destroy tumor cells. Through our proprietary ROCK® platform, we can generate multivalent, multispecific innate cell engagers that activate the body’s innate immune cells to overcome the tumors’ immune evasion mechanism. Our CD16A-based innate cell engagers are highly effective in activating innate cells (NK cells and macrophages) to kill tumor cells.
CD16A-targeting innate cell engagers establish a bridge between innate immune cells and tumor cells and activate tumor cell killing.
<a href="https://www.affimed.com/rock-platform/">Source</a>
AFM13 is a first-in-class CD30/CD16A ROCK®-derived bispecific innate cell engager (ICE®) that induces specific and selective killing of CD30-positive tumor cells by engaging and activating natural killer (NK) cells and macrophages, thereby leveraging the power of the innate immune system. AFM13 is Affimed’s most advanced ICE® clinical program, and it is currently being evaluated as a monotherapy in a registration-directed trial in patients with relapsed/refractory peripheral T-cell lymphoma (REDIRECT). The study is actively recruiting and can be found at www.clinicaltrials.gov using the identifier NCT04101331.

AFM13 (Acimtamig) + AB-101

Eosinophilic granulomatosis with polyangiitis

AFM13 is a first-in-class tetravalent, bispecific innate cell engager that specifically binds to CD30 on tumor cells and to CD16A on NK cells and macrophages. AFM13 is being developed in peripheral T cell lymphoma (pTCL) and in other CD30-positive lymphomas. AFM13 has shown a favorable safety profile and signs of therapeutic efficacy as a monotherapy in CD30-positive non-Hodgkin lymphoma with cutaneous manifestation. In addition, data from a combination study of AFM13 with Merck’s anti-PD-1 antibody Keytruda® (pembrolizumab) in Hodgkin lymphoma (HL) supports proof of principle for the combination of NK cell engagement with checkpoint inhibition. AFM13 has been granted orphan drug designation by the U.S. Food and Drug Administration for HL.

AFM13 (Acimtamig)

Non-Hodgkin lymphoma

AFM13 (Acimtamig)+ cbNK cells

Acute myeloid leukemia

Blood cancer

Leukemia

AFM28, a tetravalent bispecific CD123- and CD16A-binding innate cell engager (ICE®) developed on Affimed’s Redirected Optimized Cell Killing (ROCK®) platform, is designed to bring a new immunotherapeutic approach to patients with CD123-positive myeloid malignancies, including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) by engaging natural killer (NK) cells to initiate tumor cell killing via antibody-dependent cellular cytotoxicity (ADCC), even at low CD123 expression levels. Clinical development is planned as both monotherapy and in combination with allogeneic NK cells in patients with relapsed/refractory CD123-positive leukemias.

AFM28

Colorectal cancer

AFM24 (tumor target EGFR) Monotherapy

Multiple myeloma

The data presented on Genentech’s RO7297089 provided preclinical characterization of a novel BCMA/CD16A ICE, also based on the ROCK® platform, for the treatment of multiple myeloma. It was shown that RO7297089 is a potent therapeutic agent in vitro and selectively kills BCMA expressing multiple myeloma tumor cells by activating innate immunity (ADCC and ADCP). The in vitro assessment demonstrated that, unlike T cell redirecting therapies, RO7297089 is unlikely to have a risk of acute cytokine release. In a one-month repeat-dose study in cynomolgus monkeys, RO7297089 was well tolerated, and there were no test article-related adverse effects at up to 50 mg/kg, with no significant cytokine release. RO7297089 represents a novel and promising MOA with a favorable safety profile, distinct from the T cell-based BCMA-targeting modalities in the clinic.

Affimed N.V.

Company Details