BiTE Platform and the Evolution Toward Off-The-Shelf Immuno-Oncology Approaches

Amgen Oncology is committed to investigating innovative approaches to fighting cancer, across both hematological malignancies and solid tumors.

Peter Kufer

Peter Kufer

Dr. Peter Kufer, Vice President and Innovator of BiTE Technology, Amgen

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her 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.3

The pharma industry strives to improve clinical benefit, enhance tolerability and maximize access in tumors where advances have demonstrated activity.1,2 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 with the potential to advance immuno-oncology is Amgen’s Bispecific T Cell Engager or BiTE®— platform. At Amgen we are exploring this technology across both solid tumor and hematological malignancies.

Although T cells seek out malignant cells, cancer cells have developed sophisticated mechanisms to evade detection and escape T cells.4,5 Moreover, the majority of T cells are not directed against malignant cells and thus naturally not capable of fighting cancer. BiTE® 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.6 The reason the molecule is called “bispecific” is that it’s 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 a selected tumor antigen, such as BCMA, CD19, CD33, DLL3, MUC17, FLT3, CLDN18.2 or PSMA. T cells only become activated and proliferate with the release of cytokines, with the goal of only staying activated if they encounter cancer cells in the presence of BiTE®.

BiTE® technology has been studied in thousands of patients, including individuals who have been followed for as long as five years.8,9

Clearly, the unmet need to enhance patient outcomes remains significant. Amgen is committed to delivering new therapies for patients with complex cancers. One potential of the BiTE® immuno-oncology platform is that patients may be able to initiate treatment promptly, because BiTE® does not depend on the ex vivo manipulation of a patient's T cells.7 This versatile technology is designed to treat tumors through many tumor associated antigens, so Amgen is investigating dozens of BiTE® molecules across both solid and hematological malignancies—including a DLL3-targeted BiTE® molecule in small-cell lung cancer, a BCMA-targeted BiTE® molecule in multiple myeloma, a PSMA targeted BiTE® molecule in prostate cancer, and CD33 and FLT3-targeted BiTE® molecules in acute myeloid leukemia.10 Researchers are investigating these molecules in patients with high and low tumor burden across different age groups, in those with rapidly progressing disease and across different treatment lines.6 They hope these molecules can be used with the potential to enhance activity in combination with other treatments.11

Current immuno-oncology therapies still aren’t effective in all patients and tumor types, and many people with hematologic malignancies and solid tumors need different and targeted treatment options.1 Amgen is working to meet that need. The therapeutic potential that immuno-oncology hopes to deliver is always growing, fueled by the vision that drives ambitious research. Knowing that connection, and the stakes for patients and their families, keeps Amgen focused on the next frontier.

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



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