Regeneron Pharmaceuticals Inc. (REGN), a biotechnology company, on Thursday released positive Phase 1/2 LINKER-AL2 results for Lynozyfic in the treatment of second line-plus systemic amyloid light chain (AL) amyloidosis.
Systemic AL amyloidosis is a rare hematological disorder wherein the body's clonal plasma cells produce light chain proteins that can clump together to form amyloid deposits in vital organs. The disease can be fatal, and there are no approved therapies following failure of standard-of-care treatments. Currently, first-line treatment involves a daratumumab-and-chemotherapy-containing quadruple combination, which shows a 53% hematologic complete response rate.
Lynozyfic is a full human, bispecific BCMAxCD3 antibody developed using the company's VelociImmune technology. It received approval from the FDA in 2025, and in the European Union for the treatment of refractory/relapsed multiple myeloma (R/R MM).
The Phase 1/2 LINKER-AL2 trial recruited patients who received at least one prior therapy, and were either relapsed, refractory or had a suboptimal response before dosing with lynozyfic monotherapy. The hematological complete response (CR) rate was 71% in patients in the lower-dosed group, and 100% showed a very good partial response (VGPR). In the higher dosed group, 100% patients achieved a CR in a median time of 47 days.
Additionally, there was a rapid reduction in involved free light chain (iFLC) levels as the drug eliminated aberrant plasma clonal cells. There was notable improvement in renal and cardiac organ function as well.
Adverse events were observed among patients, including cytokine-free release, infusion-related reactions and infections, but these were resolved. One patient discontinued due to a neurotoxicity response. One patient death and another fibrillation were found to be unrelated to lynozyfic treatment, as per the investigator.
The company is also advancing lynozyfic in various trials:
a) LINKER-MM1 - Phase 1/2 dose-escalation trial evaluating the anti-tumor activity of Lynozyfic monotherapy in R/R MMb) LINKER-MM2 - Phase 1b open-label trial evaluating Lynozyfic in combination with other cancer treatments in patients with R/R MMc) LINKER-MM3 - Phase 3 confirmatory trial evaluating Lynozyfic monotherapy compared to the combination of elotuzumab, pomalidomide and dexamethasone in R/R MMd) LINKER-MM4 - Phase 1/2 trial evaluating Lynozyfic monotherapy in newly diagnosed multiple myeloma (NDMM)e) LINKER-MM5 - Phase 3 trial evaluating Lynozyfic monotherapy or in combination with carfilzomib patients with R/R MMf) LINKER-MM6 - Phase 3 trial evaluating standard-of-care therapies followed by Lynozyfic monotherapy in NDMM g) Phase 1 Trial - evaluating Lynozyfic in combination with a Regeneron CD38xCD28 antibody in R/R MMh) Phase 1 Trial - evaluating Lynozyfic in combination with a Regeneron anti-GPRC5D x antibody in R/R MMi) LINKER-SMM1 - Phase 2 trial evaluating Lynozyfic monotherapy in high-risk smoldering MMj) LINKER-MGUS1 - Phase 2 dose-ranging trial evaluating Lynozyfic monotherapy in high-risk monoclonal gammopathy of unknown significance and non-high-risk smoldering MM
REGN closed Thursday at $642.59, down 1.10%. In the pre-market, shares are trading at $642, down 0.09%.
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