Biogen Announces Late Breaker and New Data Presentations at American Society of Nephrology (ASN) Kidney Week 2024

Rhea-AI Summary

Biogen Inc. (Nasdaq: BIIB) announced upcoming data presentations at the American Society of Nephrology's Kidney Week 2024 in San Diego, California. The presentations will focus on felzartamab, an investigational anti-CD38 monoclonal antibody being developed for rare immune-mediated diseases.

Key highlights include:

• A late-breaking oral presentation featuring final results from the Phase 2 IGNAZ study of felzartamab for IgA nephropathy (IgAN)
• An oral presentation examining felzartamab's impact on key disease-relevant biomarkers
• A poster presentation on felzartamab's mechanisms of action

Biogen is planning to advance felzartamab into Phase 3 development as a potential first-in-class therapeutic for various rare immune-mediated indications.

Positive

• Biogen is presenting final results from the Phase 2 IGNAZ study of felzartamab for IgA nephropathy
• Felzartamab is being developed as a potential first-in-class therapeutic for rare immune-mediated diseases
• Biogen is planning to advance felzartamab into Phase 3 development
• Multiple presentations at a major nephrology conference indicate strong progress in felzartamab's development

Negative

• None.

• Late breaker oral presentation to feature final results of the Phase 2 IGNAZ study of felzartamab for IgA nephropathy
• Additional oral presentation to examine the impact of felzartamab on key disease-relevant biomarkers
• Felzartamab, an investigational anti-CD38 monoclonal antibody, is a potential first-in-class therapeutic candidate for a range of rare immune-mediated indications with planning underway for Phase 3 development
  

CAMBRIDGE, Mass., Oct. 22, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) – announced the company will present a variety of new data from its felzartamab clinical development program at Kidney Week 2024, the American Society of Nephrology’s (ASN) annual meeting, taking place October 23-27 in San Diego, California. Felzartamab, an investigational anti-CD38 monoclonal antibody, is a potential first-in-class therapeutic candidate for a range of rare immune-mediated diseases.

"We are excited to participate in Kidney Week 2024 and share new research findings that inform how we aim to address rare immune diseases with high unmet need," said Travis Murdoch, M.D., Head of HI-Bio at Biogen. "Now as part of Biogen, our team is focused on rapidly advancing felzartamab into multiple to Phase 3 studies, and this meeting is a great platform to highlight the clinical profile of felzartamab in IgAN."

Biogen presentations include a late breaking oral presentation highlighting the conclusive data from the Phase 2 IGNAZ study of felzartamab for IgA nephropathy (IgAN). A second oral presentation will examine exploratory analyses evaluating the impact of felzartamab on key biomarkers associated with IgAN. In addition, attendees can explore a poster presentation offering insights into the mechanisms of action for felzartamab.

Abstract details:

• Late Breaking Oral Presentation: “Felzartamab for IgA Nephropathy: Final Results of the IGNAZ Study,” on Saturday, October 26^th at 5:10 p.m. PST
• Oral Presentation: “Felzartamab durably reduces disease relevant biomarkers through targeting of CD38+ plasma cells and plasmablasts, the upstream drivers of IgA nephropathy (IgAN),” on Friday, October 25^th at 5:20 p.m. PST
• Poster Presentation: “Felzartamab selectively and potently targets CD38+ antibody secreting cells from patients with immune-mediated kidney diseases,” on Saturday, October 26^th from 10:00 a.m. to 12:00 p.m. PST
  

About Felzartamab
Felzartamab is an investigational therapeutic human monoclonal antibody directed against CD38, a protein expressed on mature plasma cells. Felzartamab is a potential first-in-class therapeutic candidate with promise as a pipeline-in-a-product across a range of immune-mediated diseases. Felzartamab has been shown in clinical studies to selectively deplete CD38+ plasma cells, which may allow applications that ultimately improve clinical outcomes in a broad range of diseases driven by pathogenic antibodies. Felzartamab was originally developed by MorphoSys AG for multiple myeloma. Human Immunology Biosciences (HI-Bio) exclusively licensed the rights to develop and commercialize felzartamab across all indications in all countries and territories excluding China (including Macau and Hong Kong and Taiwan). Biogen acquired HI-Bio in July 2024.

Felzartamab is an investigational therapeutic candidate that has not yet been approved by any regulatory authority and its safety and effectiveness have not been established.

About Biogen
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.

We routinely post information that may be important to investors on our website at www.biogen.com. Follow us on social media - Facebook, LinkedIn, X, YouTube.

Biogen Safe Harbor 
This news release contains forward-looking statements, including related to the potential clinical effects of felzartamab; the potential benefits, safety and efficacy of felzartamab; the clinical development program for felzartamab; the identification and treatment of AMR, IgAN and PMN; our research and development program for the treatment of AMR, IgAN and PMN; the potential of our commercial business and pipeline programs, including felzartamab; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “potential,” “possible,” “will,” “would” and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on our forward-looking statements.

These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation, uncertainty of success in the development and potential commercialization of felzartamab; the risk that we may not fully enroll our clinical trials or enrollment will take longer than expected; unexpected concerns may arise from additional data, analysis or results obtained during our clinical trials; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of our drug candidates, including felzartamab; the occurrence of adverse safety events; the risks of unexpected hurdles, costs or delays; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in our most recent annual or quarterly report and in other reports we have filed with the U.S. Securities and Exchange Commission. These statements speak only as of the date of this news release.

We do not undertake any obligation to publicly update any forward-looking statements.

MEDIA CONTACT: Biogen Jack Cox + 1 781 464 3260 public.affairs@biogen.com

INVESTOR CONTACT: Biogen Stephen Amato +1 781 464 2442 IR@biogen.com

FAQ

What is Biogen presenting at ASN Kidney Week 2024?

Biogen is presenting data from its felzartamab clinical development program, including final results from the Phase 2 IGNAZ study for IgA nephropathy, an analysis of felzartamab's impact on disease-relevant biomarkers, and insights into its mechanisms of action.

What is felzartamab and what is it being developed for by Biogen (BIIB)?

Felzartamab is an investigational anti-CD38 monoclonal antibody being developed by Biogen as a potential first-in-class therapeutic candidate for a range of rare immune-mediated diseases, with a focus on IgA nephropathy (IgAN).

When and where is Biogen (BIIB) presenting the IGNAZ study results for felzartamab?

Biogen is presenting the final results of the Phase 2 IGNAZ study of felzartamab for IgA nephropathy in a late-breaking oral presentation on Saturday, October 26th at 5:10 p.m. PST at ASN Kidney Week 2024 in San Diego, California.

What are Biogen's (BIIB) plans for felzartamab after the Phase 2 IGNAZ study?

Following the Phase 2 IGNAZ study, Biogen is planning to advance felzartamab into Phase 3 development for various rare immune-mediated indications.