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Amgen's BiTE Immunotherapies Show Promise in Early Studies

Amgen Inc. AMGN announced first clinical data from the early-stage studies on its two investigational novel bispecific T cell engager (BiTE) immunotherapies — AMG 420 and AMG 330.

Two separate phase I studies evaluated AMG 420, which targets B-cell maturation antigen (BCMA) and AMG 330, which targets CD33 in heavily pre-treated patients with multiple myeloma and acute myeloid leukemia (AML).

Data from the studies showed that both AMG 420 and AMG 330 demonstrated anti-tumor activity and early evidence of tolerability in patients with relapsed and/or refractory multiple myeloma and relapsed or refractory AML, respectively.

The phase I study evaluating AMG 420, showed that seven out of 10 patients who were administered with 400 µg/d dose of AMG420 experienced complete response, while four patients showed no detectable cancer. Six patients were still responding at 7.5 months of follow-up.

The findings were presented at the annual meeting of American Society of Hematology (ASH).

Notably, the FDA granted a fast track designation to AMG 420 based on this positive result from the early-stage dose escalation study. The FDA grants a fast track designation to expedite development and the review process of a candidate, which is being developed to treat serious and unmet medical conditions.

Shares of Amgen have rallied 16.7% so far this year versus the industry’s decline of 15.3%.

 

The positive data seen in these early-stage studies on the investigational BiTE immunotherapies is encouraging, especially when considered in the context of heavily pre-treated patients, who have exhausted all available treatment options.

Amgen is developing approximately a dozen novel molecules leveraging its BiTE platform across hematologic and solid tumor targets. Its only marketed BiTE immunotherapy, Blincyto, gained an earlier-than-expected FDA approval in December 2014 and has now become a key top-line driver for Amgen.

The drug recorded worldwide sales of $167 million during the first nine months of 2018 an increase of 29.5% year over year.

Blincyto has the potential to be developed for other hematologic malignancies.

Zacks Rank & Stocks to Consider

Amgen currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the healthcare sector include Alexion Pharmaceuticals, Inc. ALXN, Vanda Pharmaceuticals Inc. VNDA and Gilead Sciences, Inc. GILD, all sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Alexion’s earnings estimates have been revised 5.3% upward for 2018 and 2.1% for 2019 over the past 60 days. The stock has gained 4.9% year to date.

Vanda Pharmaceuticals’ earnings estimates have been raised 112.5% for 2018 and 11.1% for 2019 over the past 60 days. The stock has skyrocketed 107% year to date.

Gilead Sciences’ earnings estimates have moved 5% north for 2018 and 4.8% for 2019 over the past 60 days.

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