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BiTE* platform and the evolution toward off-the-shelf immuno-oncology approaches

By Peter Kufer

Not everyone has access to innovative therapies designed specifically to treat their disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients – but many patients still need other therapeutic options.

Amgen Oncology, one of the leading developers of innovative therapies for novel targets in difficult-to-treat cancers, is working to bring new hope for transforming clinical outcomes for patients with very few options. One technology that has the potential to advance the field of immuno-oncology is Amgen’s versatile Bispecific T cell Engager or BiTE platform. Amgen brought the first approved BiTE molecule targeting CD19 to patients and we continue to pioneer the bispecific space by exploring this technology across solid tumors, such as small-cell lung and prostate cancers, as well as haematological malignancies.

The BiTE technology is a targeted immuno-oncology platform engineered to engage against cancer, not only the minority of T cells naturally directed against malignant cells, but also the majority of a patient’s T cells naturally not capable of fighting cancer.

The reason the molecule is called ‘bispecific’ is that it is engineered from not one but two antibodies: one is designed to engage with CD3, which is found on T cells; the other is designed to engage with any tumour-specific antigen, for example DLL3 in small-cell lung cancer, PSMA in prostate cancer and CLDN18.2 and MUC17 in gastric or gastroesophageal junction cancer. T cells only become activated and proliferate, with the goal of staying activated, if they encounter cancer cells in the presence of BiTE molecules.

BiTE technology has been studied in thousands of patients, including individuals who have been followed for as long as five years.

One potential of the BiTE immuno-oncology platform is that patients may be able to initiate treatment promptly (while also allowing for re-treatment) because the BiTE products do not depend on the ex vivo manipulation of a patient's T cells. The propriety structure of this technology is designed to treat tumours through many tumour-associated antigens, and as a result, Amgen is advancing more than a dozen BiTE molecules across solid tumours and haematological malignancies. Researchers are studying these molecules in patients with high and low tumour burden across different age groups, in those with rapidly progressing disease and across different treatment lines.They hope these molecules can be used with the potential to enhance activity in combination with other treatments.

Committed to bringing alternative therapeutic options to patients, Amgen is expanding the benefits of the BiTE platform by developing half-life extended (HLE) versions – which aim to improve the patient experience through flexible dosing. The ultimate goal is to provide patients with long-term, quality survival that is both disease free and treatment free.

Current immuno-oncology therapies aren’t effective in all patients and tumour types, and many people with solid tumours and haematological malignancies need different and targeted treatment options.A known leader in the manufacturing of complex biologic therapies, Amgen is leveraging this expertise to meet this growing need. The therapeutic potential that immuno-oncology hopes to deliver is always expanding, fueled by the vision that drives ambitious research. Knowing that connection, and the stakes for patients and their families, keeps Amgen focused on developing and delivering the next frontier of both off-the-shelf and patient-friendly transformative therapies.

Visit to learn more about the BiTE platform and Amgen’s pursuit of innovative targets in difficult-to-treat tumour types.

*'BiTE' is a registered trademark of Amgen Inc.

Peter Kufer is Vice President & Innovator of BiTE Technology, Amgen,

Article by
Peter Kufer

In association with

15th October 2020

From: Research, Healthcare


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