ADRO Awaits Data In Q2, All Abuzz At OMER, RDHL Triumphs In H.pylori Study

(RTTNews) - Aduro Biotech Inc. (ADRO) has a couple of clinical trial catalysts to watch out for in the coming months.

The company is scheduled to report top line results from its phase IIb trial, dubbed ECLIPSE, evaluating a combination immunotherapy of CRS-207 and GVAX Pancreas in pancreatic cancer in the second quarter of 2016.

Another phase IIb trial, named STELLAR, evaluating CRS-207 in combination with GVAX Pancreas and nivolumab in patients with metastatic pancreatic cancer who have received only one prior line of therapy in the metastatic setting, is also underway - with interim results expected in the second half of 2016.

CRS-207 is also being explored in the indication of mesothelioma. The top line results from a single-arm phase Ib trial of CRS-207 in combination with standard-of-care chemotherapy in patients with unresectable malignant pleural mesothelioma who have not received prior therapy are anticipated in the first half of 2016.

ADRO closed Tuesday's trading at $15.04 down 9.40%. In after hours, the stock was up 13.03% to $17.00.

Bio-Path Holdings Inc. (BPTH) has entered into a sponsored research agreement with The University of Texas MD Anderson Cancer Center. This collaboration is meant to evaluate Bio-Path's clinical pipeline for its ability to modulate pancreatic cancer.

Included in the evaluation will be BP1001 (Liposomal Grb2 antisense), Bio-Path's lead product candidate, which is currently in a phase II study for blood cancers.

BPTH closed Tuesday's trading at $1.72, up 1.18%.

Shares of Omeros Corp. (OMER) were up over 16% on Tuesday, following the initiation of the company's phase III OMS721 program for the treatment of atypical hemolytic uremic syndrome.

The OMS721 phase III program will consist of one clinical trial - a single-arm, open-label trial in patients with newly diagnosed or ongoing atypical hemolytic uremic syndrome. Enrollment is expected to begin later this year.

Based on guidance from the FDA, Omeros plans to pursue accelerated approval for OMS721 in aHUS.

OMER closed Tuesday's trading at $15.07, up 16.01%.

RedHill Biopharma Ltd.'s (RDHL) first phase III study results of RHB-105 for the eradication of H.pylori have been encouraging.

The trial, dubbed ERADICATE Hp study, successfully met its primary endpoint, with RHB-105 demonstrating superiority over historical standard-of-care (SoC) eradication rate levels of 70%, with high statistical significance.

A meeting with the FDA is scheduled for next month to discuss the planned confirmatory phase III study with RHB-105 for the treatment of H.pylori infection. RedHill intends to initiate the confirmatory phase III study in the third quarter of 2016, subject to regulatory and other approvals.

RDHL closed Tuesday's trading at $12.28, up 7.34%.

XBiotech Inc. (XBIT) has now submitted its Marketing Authorization Application for its cancer drug candidate Xilonix for advanced colorectal cancer to the European Medicines Agency.

In the U.S, Xilonix is under a pivotal phase III study in metastatic colorectal cancer, dubbed XCITE. The company expanded the XCITE cancer study into Europe last August. Interim data from this global phase III Xilonix study are expected in late 2016.

XBIT closed Tuesday's trading at $8.27, down 0.72%.

Xenon Pharmaceuticals Inc. (XENE), which initiated a phase II trial of XEN801 in moderate to severe acne last month, expects to report results in the fourth quarter of this year.

Given the encouraging results from early in vivo studies of its Nav1.6 sodium channel inhibitor for the treatment of rare childhood epilepsy disorders - such as Dravet Syndrome, an orphan disease of severe childhood epilepsy, the company expects to file an investigational new drug (IND) application in the first half of 2017.

XENE closed Tuesday's trading at $7.33, down 1.48%.