Regeneron Reports Initial Data For Multiple Myeloma Drug
Zacks Investment Research | Dec 09, 2019 04:31AM ET
Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) announced initial data for REGN5458, a BCMAxCD3 bispecific antibody, in patients with relapsed or refractory (R/R) multiple myeloma — the second most common blood cancer. Results were presentedat the American Society of Hematology (ASH) Annual Meeting from the first two dose groups (3 mg and 6 mg weekly doses).
Patients had a median of seven lines of prior systemic therapy, and all had failed in the CD38 antibody treatment arm. Responses were observed in 4 of 7 (57%) patients, including 3 of 4 (75%) in the 6 mg dose group. In the 6 mg dose group, 2 patients (50%) were also minimal residual disease (MRD) negative, which means no cancer cells were detectable in their bone marrow.
Two patients achieved the high bar of MRD negativity, and another patient attained a very good partial response despite entering the trial with difficult-to-treat plasmacytomas outside of the bone marrow.
As of data cut-off, there were no neurotoxicity, dose-limiting toxicities or treatment discontinuations due to adverse events.
Shares of Regeneron decreased 0.3% year to date against the industry ’s growth of 6.6%.
The company is actively recruiting patients into higher dose groups of this study and expects to provide results in 2020. Further, the company also initiated a study for its second BCMAxCD3 bispecific, REGN5459, which has different binding characteristics.
Regeneron has a deep pipeline, including fully human monoclonal antibodies generated using the VelocIimune technology. REGN5458 and REGN5459 were invented using this technology, together with the company’s VelociBi platform.
Other promising candidates in the pipeline include fasinumab, which is being developed in a phase III study that is enrolling patients for osteoarthritis pain and another phase III study to treat chronic lower-back pain. Another significant pipeline candidate is evinacumab, which is in a phase I/II study for the treatment of homozygous familial hypercholesterolemia and severe forms of hyperlipidemia, and a phase III study for the treatment of homozygous familial hypercholesterolemia (HoFH).
In August, Regeneron announced positive top-line results from the phase III study on evinacumab in patients with HoFH. The company plans to submit a BLA in mid-2020.
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Zacks Rank & Stocks to Consider
Regeneron currently carries a Zacks Rank #2 (Buy).
A few better-ranked stocks in the biotech sector are Alkermes Plc. (NASDAQ:ALKS) , Anika Therapeutics Inc. (NASDAQ:ANIK) and Innoviva Inc. (NASDAQ:INVA) , all sporting a Zacks Rank #1 (Strong Buy). You can see .
Alkermes’ earnings per share estimates have increased from 36 cents to 52 cents for 2019 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters by 236.80%, on average.
Anika’s earnings per share estimates have increased from $1.75 to $2.03 for 2019 and from $1.38 to $1.62 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters by 53.31%, on average.
Innoviva’s earnings per share estimates have increased from $1.59 to $2.03 for 2019 and from $1.22 to $1.34 for 2020 in the past 60 days.
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