(kropekk_pl, Pixabay)
9 Oct. 2018. Two clinical trials testing synthetic antibodies designed to treat blood-related cancers were stopped by their developer after a participant in one trial died from adverse effects. Affimed N.V. in Heidelberg, Germany, developer of the antibodies, announced the clinical hold earlier today.
Affimed is developing highly targeted synthetic antibodies with a technology it calls redirected optimized cell killing, or Rock. The Rock platform, says Affimed, enables its antibodies to engage two types of immune system cells: natural killer and T-cells. Natural killer cells are lymphocytes, white blood cells that are part of the innate immune system, protecting against infections from birth. T-cells are also lymphocytes, but are part of the adaptive immune system that develops protections against invading pathogens. T-cells are broadly grouped into helper cells that release enzymes regulating immune responses, and killer cells that destroy infected cells, including cancer cells.
The company says its Rock platform makes it possible to design synthetic antibodies with a modular structure, which provides a common architecture. The antibodies aim for two specific targets, which the company says enables the antibodies to establish a bridge between natural killer or T-cells and their cancer cell targets. The antibodies have 4 binding sites, which Affimed says makes their connections to targets tight and enduring.
The clinical trials are early-stage studies testing the safety of one of the company’s lead products code-named AFM11. This therapy candidate targets CD19, an antigen protein on the surface of B-cells in the immune system when malignancies in these cells occur in cases of acute lymphocytic leukemia and non-Hodgkin lymphoma. Affimed says in preclinical studies, AFM11 completely removed malignant B-cells expressing CD19, with little sign of minimal residual disease.
The clinical trials are testing AFM11 in small groups of patients with relapsed or stubborn acute lymphoblastic leukemia and B-cell non-Hodgkin lymphoma, recruiting 50 participants in each trial. The studies are primarily assessing the safety of the treatments, given intravenously, looking for any adverse effects. But the trials are also watching for indicators of activity in the body, such as lymphocyte counts and immune-system response, and maximum tolerated dose in non-Hodgkin lymphoma patients.
Affimed says 33 patients were already treated with AFM11, when 3 patients reported serious adverse effects. Two of these serious events occurred in the non-Hodgkin lymphoma trial, while the third event took place in the leukemia trial and ended in the patient’s death. The company says it is working with the researchers leading the studies, their safety monitoring committees, and public health authorities to review these cases and decide how to proceed.
In August, Affimed and biopharmaceutical company Genentech, a subsidiary of drug maker Roche, agreed to collaborate on development of synthetic antibodies from the Rock platform for treating multiple, but undisclosed, solid tumor and blood-related cancers. As reported in Science & Enterprise, Affimed received an initial payment and research support of $96 million from Genentech, and is eligible for further milestone payments and royalties on sales that could reach as high as $5 billion.
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