Regeneron (REGN) Posts Upbeat Data on Myeloma Candidate at ASH
Regeneron Pharmaceuticals, Inc. REGN announced updated data on its pipeline candidate REGN5458 from the phase I portion of a phase I/II study in an oral presentation at the virtual 2020 American Society of Hematology (ASH) Annual Meeting.
REGN5458 monotherapy is being investigated in an open-label, phase I/II dose-escalation study in patients with relapsed or refractory (R/R) multiple myeloma who are at least triple refractory to the existing therapeutic options including proteasome inhibitors, immunomodulatory drugs and CD38 antibody treatments. The phase I portion of the study is primarily assessing safety, tolerability and dose-limiting toxicities of REGN5458 with its efficacy rate as the secondary endpoint.
The candidate continues to show early, deep and durable anti-tumor responses across all dose levels in patients with relapsed and refractory multiple myeloma.
The response rate is 63% in patients treated with the highest reported dose. Among all patients responding to this treatment, 95% experienced a very good partial response or better.
Among the responding patients with a follow up of six months or less, 83% have ongoing responses for up to 13 months at the time of analysis.
The top-line results bode well as the majority of patients were heavily pretreated and if the candidate can prove its efficacy rate further in the mid and late-stage studies, then the concerned patient population will have a few more treatment options in hand.
The company is currently enrolling patients in the potentially registrational phase II portion of this REGN5458 study. Additionally, it is expanding its odronextamab program with multiple pivotal studies planned for 2021. Updated results from the phase I odronextamab study for the treatment of R/R follicular lymphoma, diffuse large B-cell lymphoma and other B-cell non-Hodgkin lymphomas were also shared at ASH.
Regeneron is looking to build a pipeline in the oncology space and diversify its portfolio. It already has Libtayo in its portfolio for the treatment of patients with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation.
The stock has rallied 31.4% in the year so far compared with the industry’s growth of 5.8%.
Ophthalmology drug Eylea, developed in collaboration with Bayer BAYRY, and Dupixent in collaboration with Sanofi SNY maintain the momentum for the company.
Moreover, the company has been in news since the onset of the pandemic as it is developing an antibody cocktail for COVID-19. The FDA granted Emergency Use Authorization (EUA) to its antibody cocktail comprising casirivimab and imdevimab, which are administered together (formerly known as REGN-COV2 or REGEN-COV2).
Regeneron currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech space is Halozyme Therapeutics, Inc. HALO, which presently has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Halozyme’s earnings per share estimates have been up 18 cents for 2020 in the past 30 days.
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