Dapirolizumab pegol

In September, Biogen named HI-Bio’s former chief medical officer, Uptal Patel, M.D., as leader of its new western outpost.\n On its face, Biogen’s May 2024 acquisition of Human Immunology Biosciences (HI-Bio) looks just like many other deals in the biopharma world. A $1.15 billion upfront payment to secure a phase 3-ready monoclonal antibody is notable, but hardly unprecedented. Most observers would expect Biogen to bring the late-stage prize into its pipeline and scrap the rest of the biotech\'s assets. But Biogen didn\'t do that. Instead, it decided to use the HI-Bio buy for more, morphing the absorbed biotech into a West Coast Hub that has restored the company’s presence in California and brought the pharma closer to its scientific origins. And, in September, Biogen named HI-Bio’s former chief medical officer, Uptal Patel, M.D., as leader of its new western outpost.Patel’s mandate is to lead an expansion into immunology, primarily through a trifecta of phase 3 trials for felzartamab, the anti-CD38 antibody that Biogen bagged by buying HI-Bio. But while felzartamab’s late-stage development “takes up most of the energy and oxygen,” Patel told Fierce in an interview, his team is also looking to expand the asset into new indications alongside other, earlier-stage candidates that Biogen has brought in, like a preclinical C5aR1 antagonist from Vanqua Bio.“Biogen has probably acquired a reputation for being a neuroscience-focused company, but really its roots are in immunology,” Patel said. The launch of the West Coast Hub has “catalyzed a doubling down” on that history.  Looking back to move ahead Since taking the helm of Biogen in November 2022, Christopher Viehbacher has aimed to spread the pharma’s wings and expand into new therapeutic areas beyond the neuroscience field that had once proved a fertile source of new medicines.“While we remain committed to neuroscience, my personal view is that is not diversified enough for a company of our size,” the CEO said in an April 2024 earnings call. “The reality of neuroscience is that this is a high-risk area.” This risk was clearly demonstrated when Biogen shelved three neuro programs due to a “lower quality of success” just before Viehbacher took over.By launching an immunology-focused West Coast Hub, Biogen hopes to channel the science that first sparked the company’s Swiss founding in 1978.“Early on, cytokine signaling, all sorts of pathways that were relevant to immune-related diseases, became important,” Patel explained to Fierce. “Then they became targets in the neuro-immunology space, particularly with multiple sclerosis.”Two of Biogen’s founding scientists went on to win the Nobel Prize: Walter Gilbert, Ph.D., in 1980 for developing DNA sequencing and Phillip Allen Sharp, Ph.D., in 1993 for the discovery of gene regions called introns.Biogen ran some of the first studies of an antibody targeting CD40, a well-known immunology target, as did Idec Pharmaceuticals, which merged with Biogen in 2003. But the trials of both companies’ assets were halted by the FDA due to a risk of dangerous blood clots.“They learned from that, developed better assets, and have found really promising molecules that I think have a huge opportunity,” Patel said.One of these molecules, dapirolizumab pegol, has been jointly developed with UCB since 2003 and is currently being tested in a pair of phase 3 trials for systemic lupus erythematosus.It was the Idec merger that originally gave Biogen a home in California, but the company shuttered the San Diego campus in 2010.“Since then, the biotech ecosystem in the Bay Area and California sort of matured, but there hasn\'t been a real West Coast presence for Biogen,” Patel said. “It was really intentional to not just acquire us and have our team stay intact and continue to work on the West Coast, but to really develop a presence for Biogen here in South San Francisco,” the leader explained.HI-Bio’s Bay Area digs were modest, Patel added, with the hub since expanding to occupy an entire floor of Gateway of the Pacific’s Traverse center. There, Patel’s team works closely with Biogen’s bicoastal immunology research unit, led by San Francisco-based Nick Wilson, Ph.D., and can also benefit from the local talent pool.“This provided an opportunity to tap into the fantastic research and basic science infrastructure and talent on the West Coast,” Patel said.The hub has now grown to about 120 employees, a company spokesperson told Fierce, and Biogen plans to double the office space by the end of 2026 to make room for the still-expanding team.And while some turnover is always expected when one company buys another, Patel said, more than 90% of HI-Bio staff were retained in the first year after the acquisition.“What began as a 50-person site to cultivate HI-Bio’s culture and capabilities has grown into a 100-plus employee hub,” Jane Grogan, Ph.D., Biogen’s head of research, told Fierce in a statement. “Having an outpost in the region broadens our ability to attract top talent and take advantage of new opportunities both within and outside our walls to accelerate innovation for our pipeline.” Test trifecta Biogen’s leadership is convinced Patel is the right person to guide the pharma’s foray into immunology.“Dr. Patel brings a unique combination of clinical, development and research expertise that has deepened our understanding of immune-mediated diseases and advanced promising science into registrational studies,” CEO Viehbacher told Fierce in a statement. “His leadership in building the teams and global infrastructure necessary to launch three phase 3 trials this year reflects the speed and scale at which we aim [to] advance our immunology pipeline,” the CEO added.Those three phase 3 trials are for felzartamab, the star asset of Biogen’s HI-Bio acquisition. The pharma’s Pacific Coast outpost is now leading studies of the anti-CD38 antibody in the kidney conditions immunoglobulin A nephropathy, primary membranous nephropathy and antibody-mediated rejection of kidney transplants.CD38 is a well-established target for multiple myeloma, with Johnson and Johnson’s Darzalex (daratumumab) and Sanofi’s Sarclisa (isatuximab-irfc) fixtures on the market. German biopharma MorphoSys originally developed felzartamab to compete in the myeloma arena. Celgene struck a deal for the antibody in 2013, but walked away less than two years later without saying why, though investors speculated Celgene was unimpressed by the asset’s phase 1 data. HI-Bio came knocking in 2022, licensing the ex-China rights to felzartamab and global rights to an anti-C5aR1 antibody except for greater China and South Korea. The company settles on felzartamab as its anti-CD38 choice after surveying the broader field, Patel said, and finding that MorphoSys’ candidate had the most compelling safety profile.“It was developed specifically for immune-related diseases, not people with myeloma,” Patel explained. While other anti-CD38 antibodies tend to destroy blood cells when given to macaques, felzartamab doesn’t, so MorphoSys was able to collect long-term preclinical safety data on its molecule.“That chronic safety package is really important, because some of these patients with immune diseases are younger and potentially have childbearing potential,” Patel said. Though Patel is convinced that felzartamab has best-in-class potential, the hub team is also working to fashion longer-lasting, more effective versions of the antibody that can be delivered subcutaneously.When it comes to felzartamab and the rest of the immunology program, the West Coast Hub has a certain level of autonomy from broader Biogen influence, Patel said. But when it comes to expanding the pipeline, those choices are made with input from the entire company.“We have to work closely and be aligned as an organization, with commercial, with business development, with the research and development organizations broadly,” Patel said. “Because I report to Chris, [who is] part of the team that\'s evaluating all of the company\'s portfolio, we\'re able to have those discussions as they come up.”It’s obvious what attracted Biogen to HI-Bio last year: a promising late-stage asset, deep expertise in immunology and the chance to reestablish a presence on the West Coast. But HI-Bio, too, has highlighted advantages to being acquired by the historic pharma.“What drew us to this acquisition by Biogen as a partner is their commitment to foundational science that really gets at the underlying causes of disease,” Patel said. Now “it\'s just a matter of having the kind of growth that everybody”—including patients, shareholders and the company itself—“wins from.”