Time New York: Wed 22 May 10:37 am  |  Save 15% on H&R Block Online


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.

Today's Stocks from Zacks' Hottest Strategies

It's hard to believe, even for us at Zacks. But while the market gained +21.9% in 2017, our top stock-picking screens have returned +115.0%, +109.3%, +104.9%, +98.6% and +67.1%.

And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 – 2017, the composite yearly average gain for these strategies has beaten the market more than 19X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation.

See Them Free>>

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

To read this article on Zacks.com click here.

Zacks Investment Research
<-- You can share this post with your network,
or give us your opinion and leave a comment.
Be sure to check our RSS feeds for updates.