Atara Biotherapeutics (NASDAQ:ATRA)
On Monday December 14, 2015 shares of Atara Biotherapeutics tanked 37% after the company reported that a phase 2 trial in patients with kidney disease failed to produce statistically significant results. The patients in the trial had kidney disease, but had a problem with protein energy Wasting — PEW. The phase 2 clinical trial, used the company’s drug PINTA 745, to treat these patients with end-stage renal disease.
The final conclusion of the study was that the drug failed to meet on the primary endpoint of the study. The primary endpoint of the trial was defined as the percent change in baseline in Lean Body Mass. The Lean Body Mass was measured using a Dual Energy X-Ray Absorptiometry at week 12. The trial failing on the primary endpoint is bad enough as it is, but the trial also failed to improve other secondary measures.
Such other secondary measures the drug failed to improve upon are: markers of inflammation, glycemic control, physical function. The good thing about the trial was the drug was safe and well tolerable for patients to take. One thing to keep in mind is that the company is not totally finished. This is because it has $334 million in cash, and will use these resources towards other drug candidates in the pipeline. The company has chosen to terminate this trial completely, which makes tons of sense considering that the trial failed miserably.
Arry Biopharma (NASDAQ:ARRY)
On Wednesday December 16, 2015 shares of Arry soared 20% on positive phase 3 results for Melanoma. More specifically the company achieved positive phase 3 results in patients with Melanoma who had the NRAS mutation. The phase 3 trial was known as the NEMO trial that recruited a total of 402 patients. The primary endpoint of trial was to determine progression-free survival — PFS. There are currently no FDA approved drugs used to treat this rare form of Melanoma with the NRAS mutation.
The drug, known as Binimetinib, met on the primary endpoint of the clinical trial compared to the Decarbazine treatment arm. The median PFS for the Binimetinib drug was 2.8 months versus the Decarbazine arm being only 1.5 months. This means the trial was statistically significant, and now the company expects to file an NDA For this indication by the first half of 2016. The company is also evaluating the same drug in two other indications. One indication is for Melanoma with the BRAF muation, and low-grade Ovarian cancer.
On Thursday December 17, 2015 AstraZeneca announced that it bought a $4 billion stake in a private pharmaceutical company known as Acerta Pharma. The probable main reason for such a huge stake is for AstraZeneca to attempt to boost its blood cancer drug pipeline. That is because Acerta has a blood cancer drug in clinical development known as Acalabrutinib.
Like many other new drugs in clinical development that target many types of cancers, this drug is being made as an immunotherapy drug. Immunotherapy drugs are specifically made to illicit a T-cell response, so that the body’s T-cells can target and kill cancerous cells. This allows healthy cells to be left alone, and for treatments to be more targeted in nature. This, opposed to chemotherapy which kills all cells good and bad.
AstraZeneca is making an upfront payment of $2.5 billion for Acerta, while the other $1.5 billion will be put forward under two circumstances:
- Acalabrutinib receives U.S. regulatory approval
- Payment occurs in 2018 whether Acalabrutinib is approved or not
[Image Courtesy of Wikipedia]
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