Pharma’s first multi-specific antibody hit the market more than a decade ago. Now, the drug category is seeing a surge of interest as pharma companies and investors embrace the more-is-better approach for cancer or autoimmune diseases.
The msABs drug category, which includes bispecifics, builds on the therapeutic power of monoclonal antibodies by targeting two or more sites instead of one.
The first bispecific therapy hit the market after the FDA OK’d Amgen’s Blincyto in 2014. Since then, a steady trickle of more than a dozen other bispecific drugs has followed. But several tri-specific and higher-order msAbs are being navigated through the pipeline.
This newer generation of drugs has ramped up industry interest, due to their results in the clinic and improved safety profiles and pharmacokinetics, according to a report from Back Bay Life Science Advisors. The field has already generated two blockbusters: Genentech’s 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 report’s authors.
While all of the approved msAbs — aside from Hemlibra and Vabysmo — are cancer treatments, there’s been a sizable shift in the pipeline toward autoimmune disease, thanks in part to the head-turning successes seen with CAR-T cell therapies in this space.
“Lupus 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.
Experts believe that T cell engagers, which harness the immune system to target 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 didn’t 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. “It’s going to be very indication specific.”
Investment influx
The potential to tap into this rising market with multibillion-dollar potential has drawn a flurry of investments. In the first half of 2025, immunology and inflammation msAb companies outraised oncology companies by $269 million, according to the report.
Nearly 250 msAb candidates are now in trials, including 24 late-stage drugs, and dealmaking has accelerated. In fact, msAb-related transactions have been on par with antibody drug conjugates (180 vs. 192 deals, respectively) for about the last five years, according to the report.
Several companies are testing msAbs for autoimmune conditions. Roche’s Lunsumio, a CD20/CD3 bispecific, 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 the Cullinan trials is expected in the first half of 2026.
“The other asset that people are looking at that’s in late-stage development is MoonLake [Immunotherapeutics] bispecific against two forms of IL-17,” Bak said.
Primary endpoint results for Moonlake’s 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 drug-stability-related challenges to overcome. These drugs will also need to prove their clinical chops to ensure a competitive edge other rising modalities including radiopharmaceuticals, protein degraders, CAR-T cell therapies and ADCs.
“In hematology/oncology it’s already there. It’s very much a commercial market where people are trying to optimize the dosing profiles and how it’s being delivered to patients,” Bak said.
As companies move through the clinic, they’re vying for market share in up-and-coming indications, including autoimmune diseases.
“It’s very much a race to market right now,” he said.
