License submitted to FDA for drug to help those with large B-cell lymphoma

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A biologics license application has been submitted to the US Food and Drug Administration (FDA) for an antibody to treat patients with B-cell lymphoma.

Genmab A/S is a biotechnology company that says its core purpose is to improve the lives of people with cancer. Recently it announced its intent to submit the application for subcutaneous epcoritamab (DuoBody-CD3xCD20), an investigational bispecific antibody, for those with relapsed/refractory large B-cell lymphoma (LBCL), in the second half of this year (2022).

Oncology collaboration

Epcoritamab is being co-developed by Genmab and AbbVie, a biopharma company that develops and delivers new medicines, as part of their oncology collaboration.

It is an investigational immunoglobulin 1 (the most abundant IgG subclass in human sera and is important for mediating antibody responses against viral pathogens) bispecific antibody created using Genmab’s proprietary DuoBody technology. The technology is designed to direct cytotoxic T cells selectively to elicit an immune response towards target cell types.

The submission is supported by results from the large b-cell lymphoma (LBCL) cohort of a trial called the EPCORE NHL-1 open-label, multi-center trial which has evaluated the safety and preliminary efficacy of epcoritamab in patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin lymphoma (B-NHL).

In April 2022, Genmab and AbbVie announced the results from the trial, and in June 2022, the primary results were presented with a presentation as part of the Presidential Symposium at the 27th Annual Meeting of the European Hematology Association in Vienna, Austria.

B-cell lymphoma

Jan van de Winkel, CEO at Genmab, said: “Relapsed or refractory large B-cell lymphoma is often difficult to treat, and patients are in need of novel therapies that are effective, tolerable and accessible. The results from the EPCORE NHL-1 trial, and other clinical trials evaluating epcoritamab in a variety of patients and treatment settings, have demonstrated that epcoritamab has the potential to offer people living with LBCL a new therapeutic advance with a manageable safety profile.”

The companies say they are committed to evaluating epcoritamab as a monotherapy, as well as in combination, across lines of therapy in a range of hematologic malignancies, including an ongoing phase 3, open-label, randomized trial evaluating epcoritamab as a monotherapy in patients with relapsed/refractory.

In 2020, AbbVie and Genmab announced a €3.4B collaboration deal that ranked as the second biggest strategic alliance in European biotech that year. At that point, the partners aim was to commercialize three phase I-stage antibody drugs for undisclosed types of solid and liquid cancer.

Explore other topics: Antibody technologyCancerGenmab

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