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Regeneron Announces Positive Early-stage Data For REGN1979 - Quick Facts

Biotechnology company Regeneron Pharmaceuticals, Inc. (REGN) announced Friday positive early-stage data for REGN1979 in patients with relapsed or refractory (R/R) B-cell non-Hodgkin lymphoma (B-NHL).

The emerging data, which includes patients with R/R diffuse large B-cell lymphoma (DLBCL) who had progressed after CAR-T therapy, will be presented tomorrow at the 24th Congress of the European Hematology Association (EHA).

REGN1979 is an investigational bispecific monoclonal antibody and is designed to trigger tumor killing by binding to both a B-cell tumor protein (CD20) and an immune system T-cell receptor (CD3).

The company observed continued high response rates with REGN1979 in both relapsed or refractory diffuse large B-cell lymphoma and follicular lymphoma, cancers with typically poor outcomes.

The primary objective of the trial was to assess the safety, tolerability and dose-limiting toxicities of REGN1979. Secondary objectives included an evaluation of the pharmacokinetics, immunogenicity and antitumor activity of REGN1979. In the trial, there were no dose-limiting toxicities.

The overall response rate was 93% (13 of 14 patients) in those who received doses of REGN1979 5 mg to 320 mg, with a complete response rate of 71% (10 of 14 patients), in patients with R/R follicular lymphoma (FL) grades 1 to 3a.

There was also 57% (4 of 7 patients) overall response rate in patients with R/R DLBCL treated with REGN1979 80 mg to 160 mg, with all responses ongoing. These included 2 complete responses in 4 patients whose disease had progressed after CAR-T treatment.

In this trial, two patients who failed CAR-T therapy and received REGN1979 80 mg achieved complete responses. There is currently no approved therapy for patients who progress on CAR-Ts.

REGN1979 was granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of DLBCL in 2017. It was invented by Regeneron using its proprietary VelocImmune technology and proprietary Veloci-Bi bispecific platform.

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