Regeneron Pharmaceuticals, Inc. REGN announced positive early-stage data for pipeline candidate, REGN1979. The data will be presented at the 24th Congress of the European Hematology Association (EHA).
REGN1979, an investigational bispecific monoclonal antibody, is being evaluated in patients with relapsed or refractory (R/R) B-cell non-Hodgkin lymphoma (B-NHL). The data also includes patients with R/R diffuse large B-cell lymphoma (DLBCL), who had progressed after CAR-T therapy.
The primary objective was to assess the safety, tolerability and dose-limiting toxicities of the candidate.
High response rates observed with REGN1979 in both relapsed or refractory diffuse large B-cell lymphoma and follicular lymphoma were encouraging.
Moreover, two patients, who failed CAR-T therapy and received REGN1979 80 mg, achieved complete responses.
The R/R follicular lymphoma (FL) grades 1 to 3a treatment arm showed an overall response rate of 93% (13 of 14 patients) in patients, who received doses of 5 mg or more, with a complete response rate of 71% (10 of 14 patients).
In DLBCL patients treated with REGN1979 80 mg to 160 mg, an overall response rate of 57% was observed.
In R/R DLBCL patients, whose disease progressed after CD-19 directed CAR-T therapy, 2 of 4 achieved a complete response.
As of the March 2019 data cutoff, safety was evaluated in 81 patients. The most common treatment-emergent adverse events (AEs) were pyrexia (83%), cytokine release syndrome (CRS; 57%), chills (54%), infections and infestations (49%), increased C-reactive protein (38%), fatigue (38%), anemia (36%) and thrombocytopenia (30%). Six patients experienced Grade 3 or higher CRS (7%).
The company will initiate a phase II program later in the month for a potential registration, and proactively evaluate active REGN1979 doses in indolent and aggressive non-Hodgkin lymphoma.
We remind investors that REGN1979 was granted Orphan Drug designation by the FDA for the treatment of DLBCL in 2017.
Regeneron currently has four different bispecific antibodies in clinical trials for both solid tumors and blood cancers. Among these, the first costimulatory bispecific antibody is REGN5678, which will be investigated in combination with Libtayo for prostate cancer.
The company is developing REGN1979 and REGN5678 for B-NHL and prostate cancer, respectively.
We note that Libtayo is being developed in collaboration with Sanofi SNY.
Regeneron’s stock has lost 17.3% in the past six months compared with the industry’s decline of 2.9%.
The company’s efforts to develop its pipeline and diversify its revenues base are impressive. The company earlier extended its collaboration agreement with Alnylam Pharmaceuticals, Inc. ALNY to discover, develop and commercialize new RNA interference (RNAi) therapeutics for a broad range of diseases by addressing disease targets expressed in the eye and central nervous system (CNS), in addition to a select number of targets expressed in the liver.
Zacks Rank & A Stock to Consider
Regeneron currently carries a Zacks Rank #3 (Hold).
A better-ranked stock in the healthcare sector is Celgene Corporation CELG, which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Celgene’s earnings estimates have moved up by a cent to $10.72 over the past 60 days.
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