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Why Syndax Is Skyrocketing 55% Today

By Todd Campbell – Apr 28, 2020 at 11:52AM

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Initial data from an early-stage leukemia trial is promising.

What happened

This morning Syndax Pharmaceuticals (SNDX 2.23%) updated investors with initial data from a phase 1/2 trial evaluating its leukemia drug, and shares are soaring 55% at 12:05 pm EST on Tuesday.

So what

Syndax is a clincial-stage healthcare company developing cancer drugs, including SNDX-5613, a therapy for the treatment of leukemia caused by specific genetic abnormalities, including rearrangements of the MLL gene (MLL-r) and NPM1 mutation.

A doctor speaks through a megaphone.

IMAGE SOURCE: GETTY IMAGES.

On Monday, Syndax unveiled initial results of SNDX-5613 efficacy in a small handful of patients with MLL-r. So far six patients have been treated at increasing dose levels in its phase 1 trial. After 28 days, a clinical response was seen in two of three patients harboring MLL-r, including one complete response and one partial response. No dose-limiting toxicities were reported, suggesting the treatment may be safe. 

The initial results are particularly intriguing because patients with MLL-r and NPM1 mutations have a poor prognosis; thus new treatment options are needed. MLL-r is seen in between 5% to 10% of acute myeloid leukemia (AML) and acute lymphocytic leukemia cases, while NPM1 mutations are observed in 30% of adult AML cases. Sadly, the five-year survival rate for MLL-r acute leukemia patients is less than 55%.

Now what

Syndax is presenting SNDX-5613's early trial data at 4:50 pm EST today at the 2020 American Association for Cancer Research (AACR) virtual annual meeting. The trials are ongoing, with additional results to be announced in Q4 2020.  

SNDX-5613 isn't Syndax's most advanced drug currently in clinical trials, though. The company is also conducting a phase 3 study of entinostat plus Pfizer's Aromasin in HR+, HR2- breast cancer. Overall survival data from this trial is anticipated this quarter, and if the results are positive, a Food and Drug Administration filing for approval will soon follow. While there's no telling what survival data will show, phase 2 data showed a entinostat/exemestane combination produced clinically meaningful overall survival benefits versus Aromasin monotherapy.

 

Todd Campbell owns shares of Pfizer. His clients may have positions in the companies mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.

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