BioLineRx Moves A Regulatory Submission For BL-8040 Trial

BioLineRx Ltd (NASDAQ:BLRX) announced a regulatory submission for commencement of a phase III study, evaluating the lead pipeline candidate, BL-8040 (a CXCR4 antagonist), in combination with granulocyte colony-stimulating factor (G-CSF).

Notably, BL-8040 is a short peptide indicated to mobilize the hematopoietic stem cells for autologous transplantation in patients with multiple myeloma.

BioLineRx’s shares have significantly outperformed the industry so far this year. The stock has rallied 19.6% versus the broader industry’s decrease of 4%.

The randomized, controlled phase III (GENESIS) study is designed to evaluate the safety, tolerability and efficacy of the combination therapy as compared to the combination of placebo and G-CSF. The study will be conducted in two parts.

The first part of the study will evaluate the efficacy and safety of treatment with BL-8040 and G-CSF to be conducted on 10-30 patients. This part will be followed by a randomized, placebo-controlled, multi-center study to be conducted on approximately 180 patients.

We remind investors that in September 2016, BioLineRx had entered into a collaboration agreement with Genentech, a member of Roche Holding (SIX:ROG) AG (OTC:RHHBY) , to support several phase Ib studies, investigating BioLineRx’s BL-8040 combined with Tecentriq (atezolizumab).

It’s significant to note that the collaboration is part of Roche’s novel cancer immunotherapy development platform MORPHEUS, a phase Ib/II adaptive platform to assess the efficacy and safety of combination cancer immunotherapies.

Importantly, BL-8040 is BioLineRx’s one of the leading therapeutic candidates, having successfully completed a phase IIa study for relapsed/refractory AML and is amid a phase IIb study as an AML consolidation treatment.

In July, BioLineRx had announced that its partner Genentech, has initiated a phase Ib/II trial, evaluating BL-8040 in combination with Roche’s Tecentriq for treatment of patients with metastatic pancreatic ductal adenocarcinoma.

In September 2016, BioLineRx had announced initiation of the first phase IIa COMBAT study for evaluating the efficacy of BL-8040 in combination with Merck’s (NYSE:MRK) Keytruda on patients with pancreatic cancer. Subsequently, in January, BioLineRx announced onset of the second phase IIa study on the given combination.

Per the American Cancer Society provided data, more than 50,000 patients will be diagnosed with pancreatic cancer in the United Stated in 2017. Pancreatic cancer accounts for about 3% of all cancers across the country and about 7% of all cancer deaths, with pancreatic adenocarcinoma accounting for about 95% of the cases. This indicates a huge market potential for this combination therapy.

Zacks Rank & Key Picks

BioLineRx currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the pharma sector is Aduro Biotech, Inc. (NASDAQ:ADRO) , carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Aduro Biotech’s loss per share estimates narrowed from $1.46 to $1.32 for 2017 and from $1.41 to $1.24 over the last 30 days. The company delivered positive surprises in two of the trailing four quarters with an average beat of 2.53%.

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