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The pharmaceutical industrys first multispecificantibody hit the market more than a decade ago. Now, the medicines are seeing a surge of interest as drugmakers and investors embrace the more-is-better approach for cancer or autoimmune diseases.These drugs,which include bispecifics and other multi-pronged approaches, builds on the therapeutic power of monoclonal antibodies by targeting two or more sites instead of one.The first bispecific therapy hit the market when the Food and Drug Administration cleared Amgens Blincyto in 2014. Since then, more than a dozen others have followed. Behind them in development are several tri-specific and higher-order multispecific antibodies, or msAbs.This newer generation of drugs has attracted industry interest due to promising clinical results and potentially improved safety profiles and pharmacokinetics, according to a report from Back Bay Life Science Advisors. The field has already generated two blockbusters: Genentechs Hemlibra, a hemophilia treatment, and Vabysmo, used to treat eye diseases. But more are expected to reach that billion-dollar threshold, said Peter Bak, a managing director at Back Bay and one of the reports authors.While all of the approved msAbs aside from Hemlibra and Vabysmo are cancer treatments, theres been a sizable shift in the pipeline toward autoimmune disease, thanks in part to the encouraging, albeit early findings seen with cell therapies.msABs' growing market potential250msAB candidates in clinical trials, 24 of which are in late-stage registrational studies.14msABs approved by the FDA (as of August 2025), including eight that have been approved since 2023.7msAB drugs in oncology on track to become blockbusters by 2030.Back Bay Life Science AdvisorsLupus is an area where there's been some interesting data generated by a couple academic groups, and now a lot of companies are rethinking their strategy, said Bak.Some believe that T cell engagers, which draw immune defenders to cancer cells, can also be used to tame the wayward B-cells that drive autoimmune disease. The hope is that these drugs will produce similar results to CAR-T, but at a lower cost, giving them a potential market advantage. In some cases, msAbs could treat patients who didnt respond to these other treatments, Bak said.In an area like systemic lupus erythematosus where there's not much activity, and there is pretty big unmet need, one could see it being used as a first line biologic, he added. Its going to be very indication specific.Investment influxThe potentially lucrative opportunity has drawn a flurry of investments. In the first half of 2025, immunology and inflammation msAb companies outraised their cancer-focused counterparts by $269 million, according to the report.Nearly 250 msAb candidates are now in trials, including 24 late-stage drugs, and dealmaking has accelerated. And transactions involving these drugs have been on par with deals for antibody drug conjugates (180 vs. 192 deals, respectively), another popular approach,for about the last five years, according to the report.Several companies are testing msAbs for autoimmune conditions. Roches Lunsumio, a bispecific targeting CD20 and CD3 and already approved for lymphoma, recently finished an early-stage trial in lupus, Bak noted.Amgen is testing Blincyto, its anti-CD19 x anti-CD3 bispecific T cell engager in phase 2 for both lupus with nephritis and refractory rheumatoid arthritis. Meanwhile, Cullinan Therapeutics bispecific T-cell engager,CLN-978, is in phase 1 trials for lupus and rheumatoid arthritis. Initial data from Cullinans trials are expected in the first half of 2026.The other asset that people are looking at thats in late-stage development is MoonLake [Immunotherapeutics] bispecific against two forms of IL-17, Bak said.Primary endpoint results for Moonlakes phase 3 program for hidradenitis suppurativa, a chronic autoimmune skin condition, are expected this month. If all goes as planned the company could file for approval in mid-2026.While interest in autoimmune research has accelerated, oncology indications are still garnering attention, including the bispecific and potential Keytruda rival, ivonescimab, which was developed by China-based Akeso and licensed to Summit Therapeutics. Companies are also exploring msAbs in neurology, neurodegenerative diseases and solid tumors.But there are manufacturing and other challenges to overcome. These drugs will also need to prove their worth compared to other ascending drugmaking strategies, such as radiopharmaceuticals,protein degradersand cell therapies.In hematology/oncology its already there. Its very much a commercial market where people are trying to optimize the dosing profiles and how its being delivered to patients, Bak said.Elsewhere, in areas such as autoimmune conditions,its very much a race to market right now, he added. '

Amgen was put on the hook to pay $50.3 million in damages in December when a Delaware federal jury found that the company had infringed two Lindis Biotech immunotherapy patents. After taking a $50 million hit in a patent lawsuit targeting its leukemia med Blincyto last year, Amgen has convinced a Delaware federal judge to negate the verdict.In a decision issued Thursday, U.S. District Judge Gregory Williams concluded that two patents held by Lindis Biotech “are unenforceable due to inequitable conduct.” The development strikes down the $50.3 million jury verdict Lindis won in December over allegations that Amgen’s Blincyto violated Lindis-held intellectual property.  Amgen and Lindis now have two weeks to attempt to either reach an agreement or propose suggestions on how the case should proceed, the judge wrote in his decision.Neither company responded to Fierce’s comment request by the time of publication.Amgen was put on the hook to pay $50.3 million in damages in December when a Delaware federal jury found that the company had infringed two Lindis immunotherapy patents. The jury also determined that Amgen had infringed those patents willfully, which could have led the court to increase Lindis’ award up to $150.9 million, Reuters reported late last year.Amgen subsequently made the case that Lindis’ patents were invalid because their named inventor allegedly provided false information in his patent application, Reuters noted in a separate report Thursday.The patent litigation odyssey dates back to 2022, when Lindis first sued Amgen over claims that the California drugmaker’s leukemia med Blincyto violated three Lindis patents surrounding the use of steroid hormones to curb side effects when using a bispecific antibody in a cancer immunotherapy regimen. Lindis further contended that Amgen was well aware of its patents by 2014—as evinced by efforts to strike down counterpart IP in Europe—and chose to flaunt them regardless.Amgen quickly hit back with a motion to dismiss the case in April 2022, arguing against the way Lindis’ legal team defined Blincyto and suggesting that the plaintiff failed to demonstrate how its intellectual property was being stepped on.The California biotech giant also took issue with the fact that one of the Lindis patents at the heart of the case, dubbed the ‘149 patent, specifically concerns the treatment of lymphoma. All of Blincyto’s FDA nods are in acute lymphoblastic leukemia (ALL).Subsequently, in a decision by judge Williams in March 2024, Amgen’s motion to dismiss the case was both granted and denied in part, providing room for Lindis to amend its claims.Lindis then filed an amended complaint, which Amgen again parried with its own legal filing last May.Blincyto won its first ALL green light in December 2014 and has since racked up a number of additional nods in the indication. The drug generated $800 million in U.S. sales last year and $1.2 billion across all regions where Amgen operates, a 41% jump over the total sum the drug delivered in 2023.Despite now being more than a decade old, Blincyto continues to deliver wins on the sales front and in the clinic for Amgen. Late last year, Amgen reported that a Blincyto-chemotherapy cocktail helped 96% of newly diagnosed pediatric patients with B-cell acute lymphoblastic leukemia (B-ALL) in a phase 3 trial remain alive and disease-free for three years, versus 87.9% of patients who received chemotherapy alone.The data also pointed to a 61% reduction in the risk of disease relapse, remission or death by secondary malignant neoplasm in the Blincyto arm, with one of the study’s co-chairs calling the results “truly practice-changing.”