Starts phase 3 study of ferusaltamab for the treatment of late antibody-mediated rejection (AMR) in renal transplant patients

As previously published, in addition to the launch of Phase 3 study of Ferzaltamab for Ferzaltamab at AMR, Biogen plans to begin Phase 3 trials of Ferzaltamab for Iga nephropathy and primary membrane in 2025. Felzartamab was originally developed by Morphosys AG. Morphosys, a Phase 3 exam for Felzartamab, will earn a one-time milestone payment of $35 million from Biogen.

About Ferzaltamab
Ferzaltamab is a therapeutic human monoclonal antibody directed against CD38, a protein expressed in mature plasma cells. Ferzaltamab is a potential class of treatment candidates that are promising as a pipeline of production across a variety of immune-mediated diseases. Ferzaltamab selectively depletes CD38+ plasma cells in clinical studies. This allows applications that ultimately improve clinical outcomes for a wide range of pathogenic antibodies driven diseases. Felzartamab was originally developed by Morphosys AG (now Morphosys Gmbh of Novartis Company). Human Immunological Student Science (HI-BIO) has exclusively authorized the right to develop and commercialize ferusalutamab across all indications in all countries and territories except China (including Macau, Hong Kong and Taiwan). Biogen won Hi-Bio in July 2024.

Felzartamab is a treatment candidate that has not yet been approved by regulatory authorities, and its safety and efficacy has not been established.

On antibody-mediated rejection (AMR) in kidney transplant recipients
Antibody-mediated rejection (AMR) is the main cause of kidney transplant failure. AMR in kidney transplants is caused by the immune system that recognizes the donor kidney as a foreign body. This can generate antibodies against the donor kidney, potentially leading to its destruction and ultimate rejection. AMR is early (6 months after implantation)<6か月）か遅い（> 6 months) Shows different characteristics depending on whether it occurs. Late AMR is associated with early and at a higher risk of graft loss.³ Currently, effective treatment options for late AMR are limited.⁴

About Biogen
Founded in 1978, Biogen is a leading biotech company that offers new medicines to pioneer innovative science, transform patients' lives, and create value for shareholders and our communities. We apply a deep understanding of human biology and leverage a variety of modalities to advance treatments or treatments in class that provide excellent results. Our approach is to take bold risks and balance the return on investment to bring about long-term growth.

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Biogen Safe Harbor
This press release contains forward-looking statements relating to: The expectations for design, timing and the outcome of the Transcend Study, and the ability of Felzartamab to treat AMR, PMN, or Igan, the capabilities of our commercial business and pipeline programs. Capital allocation and investment strategies. Clinical development programs, clinical trials, data reading and presentation. Regulatory discussion, submission, submission and approval. Potential profits, safety, future financial and operating results. These forward-looking statements may be accompanied by words such as “objective,” “expected,” “assumption,” “believe,” “consideration,” “continuation,” “possible,” “estimate,” “forecast,” “forecast,” “goal,” “guidance,” “hope,” “hope,” “intention,” “intention,” “May,” “possibility,” “possible,” “possibility,” “possibility,” “possibility,” “hope,” “possibility,” “hope,” “possibility,” “hope,” “hope,” “possibility,” “hope,” “hope,” “hope,” “hope,” “hope,” “hope.” 'should', 'target', 'will', 'will', and other words and terms with the same meaning. Drug development and commercialization require high risks, and only a small number of research and development programs lead to product commercialization. Results in early stage clinical trials do not represent the complete or results of late or large clinical trials and may not ensure regulatory approval. We should not rely on these statements undue. Given the nature of their future appearance, these statements contain substantial risks and uncertainties that may be based on inaccurate assumptions, which could lead to actual results being substantially different from those reflected in such statements. These forward-looking statements are based on current beliefs and assumptions of management and information currently available. Given their nature, we cannot guarantee that the results expressed in these forward-looking statements will be realized in whole or in part.

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References:

1. SRTR; National Institute of Diabetes and Gastrointestinal Diseases and Kidney Diseases; Ministry of Health; Hart, Singh. Clin Transplant 2021; Crew. AM J. Ported. 2016

2. Sablik et al. (2024) Kidney allografts and clinical outcomes microvasculature inflammation. Available at https://www.nejm.org/doi/full/10.1056/nejmoa2408835

3. Fernando et al. (2023) Comparison of treatment approaches and outcomes from the early and late acute AMR-ANZDATA registry in kidney transplant recipients. Available at https://pubmed.ncbi.nlm.nih.gov/37322595/

4. Schinstock et al. (2018) Kidney transplants with low levels of DSA or low positive Blow cross-match: Underestimated options for highly sensitive transplant candidates (page 8). https://www.ncbi.nlm.nih.gov/pmc/articles/pmc5481511/pdf/nihms837168.pdf#page = 8; Ciancio et al. Antibody-mediated rejection in 2018 means a poor prognosis for kidney transplants. The result of a single center. Available at https://onlinelibrary.wiley.com/doi/10.1111/ctr.13392