Felzartamab

CAMBRIDGE, Mass., July 02, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) has completed the acquisition of Human Immunology Biosciences (HI-Bio™), a privately-held clinical-stage biotechnology company focused on targeted therapies for patients with severe immune-mediated diseases (IMDs). “We are very excited about the addition of felzartamab into our pipeline, further strengthening our presence in immunology with a promising late-stage therapeutic candidate being studied in multiple indications,” said Priya Singhal, M.D., M.P.H., Head of Development at Biogen. “With the transaction now complete, we will begin working together with our colleagues from HI-Bio on plans to advance felzartamab to phase 3 and ultimately deliver innovative treatments to patients with unmet needs across a range of rare diseases.” “I’m looking forward to the important progress HI-Bio will make as part of Biogen, and the power of combining our talented HI-Bio team with Biogen’s global infrastructure to support the development of felzartamab and accelerate Biogen’s expanding immunology portfolio,” said Travis Murdoch, M.D., CEO of HI-Bio. “It’s clear from our engagement over many months – as we considered how HI-Bio programs could progress in the best possible way – that our teams share many of the same values, including being science-led and execution-focused, and a core mission to positively impact patients with severe diseases.” Felzartamab demonstrated positive interim results from the Phase 2 IgA nephropathy (IgAN) study and from the completed Phase 2 antibody-mediated rejection (AMR) study. These data were presented at the recent European Renal Association Congress in Stockholm. The AMR study data were also published in the New England Journal of Medicine. Felzartamab has also demonstrated proof-of-concept in a Phase 2 study in primary membranous nephropathy (PMN) and there are plans to advance felzartamab to Phase 3 in AMR, IgAN, and PMN. About Felzartamab Felzartamab is an investigational therapeutic human monoclonal antibody directed against CD38, a protein expressed on mature plasma cells. 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. 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). 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 Antibody-Mediated Rejection (AMR) in Kidney Transplant Recipients Antibody-mediated rejection (AMR) is a major cause of kidney transplant failure, with chronic AMR affecting ~12% of patients that receive kidney transplants annually in the U.S.1 AMR has emerged as the leading cause of late graft loss in kidney transplant recipients. Effective treatment options for chronic AMR are currently limited.2 About Primary Membranous Nephropathy (PMN) Primary membranous nephropathy (PMN) is a rare IMD affecting the kidneys, with an estimated incidence rate of ~1/100K per year in the United States.3 There are currently no therapies specifically approved for PMN. Standard of care comprises off-label use of a variety of agents, including immunosuppressive therapies like cyclophosphamide, and CD20-targeted B-cell depleting agents such as rituximab.4 Even with these strategies, approximately one third of patients do not achieve remission.4 About IgA Nephropathy (IgAN) Immunoglobulin A nephropathy (IgAN) is the most common primary glomerulonephritis worldwide. It is a leading cause of chronic kidney disease with up to 40% of IgAN patients progressing to end stage kidney disease about 20 years after diagnosis. IgAN accounts for about 40% of all native-kidney biopsies in Japan, 25% in Europe, 12% in the United States, but less than 5% in central Africa.5 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 . Follow us on social media - Facebook, LinkedIn, X, YouTube. Biogen Safe Harbor This press release contains forward-looking statements, relating to: the anticipated and potential benefits of the acquisition of HI-Bio; including with respect to retention; the potential of, and relating to, the felzartamab program and HI-Bio’s other pipeline programs; expected financing of the proposed acquisition; costs and other anticipated financial impacts of the proposed transaction; our strategy and plans; clinical development programs, clinical trials, and data readouts and presentations; regulatory discussions, submissions, filings, and approvals; the potential benefits, safety, and efficacy of products and investigational therapies; actions to augment our pipeline, collaborations, and business development activities; and our future financial and operating results. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “potential,” “possible,” “prospect,” “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 these statements. All forward-looking statements contained in this press release speak only as of the date made and, except to the extent required by law, we undertake no obligation to publicly update or revise any forward-looking statements. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including: the impact of the announcement and pendency of the acquisition on HI-Bio’s business, including on relationships with its employees, business partners and government entities; uncertainties as to the timing and completion of the merger; the risk that required regulatory approval or other condition to closing may not be satisfied; the diversion of management time on transaction-related issues; costs and potential litigation, settlements and investigations relating to the proposed merger; the ability to retain management and other personnel; our dependence on sales from our products; uncertainty of long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; failure to compete effectively; failure to successfully execute or realize the anticipated benefits of the acquisition or our strategic and growth initiatives; difficulties in obtaining and maintaining adequate coverage, pricing, and reimbursement for our products; our dependence on collaborators and other third parties for the development, regulatory approval, and commercialization of products and other aspects of our business, which are outside of our full control; risks associated with current and potential future healthcare reforms; risks related to commercialization of biosimilars; failure to obtain, protect, and enforce our data, intellectual property, and other proprietary rights and the risks and uncertainties relating to intellectual property claims and challenges; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including the ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, or that regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our or HI-Bio’s drug candidates; the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; risks relating to technology failures or breaches; problems with our manufacturing processes; risks relating to management, personnel and other organizational changes, including attracting and retaining personnel; failure to comply with legal and regulatory requirements; the risks of doing business internationally, including currency exchange rate fluctuations; risks relating to investment in our manufacturing capacity; risks relating to the distribution and sale by third parties of counterfeit or unfit versions of our products; risks relating to the use of social media and artificial intelligence based software for our business; results of operations, and financial condition; fluctuations in our operating results; risks related to investment in properties; risks relating to access to capital and credit markets; risks related to indebtedness; the market, interest, and credit risks associated with our investment portfolio; risks relating to share repurchase programs; change in control provisions in certain of our collaboration agreements; fluctuations in our effective tax rate; environmental risks; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission. References: Schinstock et al. (2018) Kidney Transplant with Low Levels of DSA or Low Positive B-Flow Crossmatch: An Underappreciated Option for Highly-Sensitized Transplant Candidates (Page 8). Available at: ; Ciancio et al. 2018 Antibody-Mediated Rejection Implies a Poor Prognosis in Kidney Transplantation: Results From a Single Center. Available at: Rodriguez-Ramirez et al. 2022 Antibody-mediated rejection: prevention, monitoring and treatment dilemmas (Page 1). Available at: Swaminathan et al. (2006) Changing incidence of glomerular disease in Olmsted County, Minnesota: a 30-year renal biopsy study. Available at Dahan et al. (2017) Rituximab for Severe Membranous Nephropathy: A 6-Month Trial with Extended Follow-Up. Available at Rajasekaran et al. (2021) IgA nephropathy: An interesting autoimmune kidney disease. Available at Hastings et al (2018) Clinical Research, Life Expectancy for Patients From the Southeastern United States With IgA Nephropathy. Available at (17)30362-5/fulltext MEDIA CONTACTS: Biogen Jack Cox + 1 781 464 3260 public.affairs@biogen.com INVESTOR CONTACT: Biogen Chuck Triano +1 781 464 2442 IR@biogen.com

Pictured: Biogen's signage at its headquarters in Massachusetts/iStock, JHVEPhoto With the global immunology market projected to grow from nearly $103.2 billion in 2024 to $257.4 billion by 2032, second only to oncology in terms of the largest therapy area by value, it’s not surprising that immunology has attracted major investment recently from biopharma companies. Add the fact that drugmakers are facing losses from looming patent expirations and immunology drugs have a relatively high chance of success in clinical trials, it’s clear to see why the market is so attractive. In April, Vertex acquired Alpine Immune Sciences for $4.9 billion, the largest acquisition so far in 2024, giving it access to potential treatments for autoimmune and inflammatory diseases. That same month, Bristol Myers Squibb announced a potential $1.8 billion, multi-year collaboration with Repertoire Immune Medicines to create up to three vaccines for autoimmune diseases. Biogen is the latest big player to join the fray with its acquisition of privately held Human Immunology Biosciences, also known as HI-Bio. Last month, Biogen announced it would acquire the company, which is focused on severe immune-mediated diseases, paying $1.15 billion upfront and with the potential for $650 million in milestone payments. Analysts see the deal as part of CEO Chris Viehbacher’s plan to move the company away from riskier plays in the neurological space and expand Biogen’s immunology and rare diseases pipeline. Specifically, Biogen is looking to expand its pipeline beyond its current crop of drugs, such as the Friedreich’s ataxia drug Skyclarys and the Alzheimer’s disease treatment Leqembi, Myles Minter, a research analyst at William Blair, told BioSpace. The move aims to “de-risk” their pipeline and avoid clinical trials with higher bars for success, he said. “They want to create a pipeline that is more de-risked. I think you get that in immunology. They don’t want to be this company where they’re relying on a pivotal trial in stroke or [a] very, very risky study in relapsing MS.” The buy gives Biogen access to drug candidate felzartamab, an anti-CD38 antibody being developed by HI-Bio for several chronic kidney conditions with large unmet medical needs, including IgA nephropathy, primary membranous nephropathy and antibody-mediated rejection in kidney transplant recipients. In a note to investors last month on Biogen’s HI-Bio deal, Bank of Montreal Capital Markets analysts made the case that felzartamab’s mechanism of selectively depleting CD38+ cells could give Biogen “applicability across a range of immune-mediated diseases.” Indeed, immunology and inflammation (I&I) is a particularly attractive market because of its “pipeline-in-a-product” potential of expanding into “adjacent indications and build a monster brand,” biotech entrepreneur Andrew Pannu told BioSpace in February. Other Moves in the I&I Space For other large biopharma companies, the role model in the immunology space is AbbVie’s blockbuster Humira, one of the highest grossing drugs of all time. Used to treat Crohn’s disease, plaque psoriasis and rheumatoid arthritis, among other inflammatory conditions, it brought in about $200 billion over the last two decades. Minter sees the I&I market, which attracts relatively high valuations, as an appropriate sector to target as part of Biogen’s and other companies’ de-risking strategies as they look to hedge their bets on more uncertain pipelines. While Biogen has been focused on its Alzheimer’s medicines, it has not been an easy path. Aduhelm faced intense scrutiny over its efficacy and pricing, making it perhaps one of the most controversial FDA approvals. Ultimately, Biogen in January discontinued Aduhelm and halted a post-approval study, deciding to focus its efforts instead on Leqembi with partner Eisai. The loss of patent protections is another factor fueling Biogen’s pipeline realignment. Minter contends that Biogen is being “forced” into de-risking its business strategy as the oral therapy for relapsing-remitting multiple sclerosis Tecfidera, a multibillion-dollar earner, is teetering on the patent cliff. Tecfidera’s patent will expire in the E.U. in 2025 and efforts to restore patent protections in the U.S. have been defeated. At the same time, Biogen’s combined expertise in immunology and rare diseases with products such as Skyclarys and the spinal muscular atrophy drug Spinraza, are a big leg up for the company as it targets the I&I market, according to Minter. New product launches, such as Skyclarys and Leqembi, are part of Biogen’s plan to bring revenue back up as well as investments in expanding markets. Startups are also looking to challenge the big players in the I&I space. Inflammatory disease-focused Mirador Therapeutics landed the largest early-stage venture capital investment in biopharma last quarter, launching with $400 million in financing. Alumis recently raised $259 million in a Series C round, while AltruBio and Attovia secured $225 million and $105 million in Series Bs, respectively. Alumis, a potential rival to Bristol Myers Squibb and Takeda in autoimmune diseases, in an SEC filing last week for an initial public offering said it plans to start Phase III trials of a TYK2 inhibitor in plaque psoriasis. Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.