BioLineRx Ltd. (BLRX - Free Report) announced that its partner Genentech, a member of Roche Holding AG (RHHBY - Free Report) , has initiated a phase Ib/II study to evaluate its lead pipeline candidate, BL-8040, in combination with Roche’s Tecentriq (atezolizumab) for treating patients with gastric cancer.
Shares of BioLineRx have outperformed the industry so far this year. The stock has gained 22.3% versus the broader industry’s 1.1% increase.
The phase Ib/II multicenter, randomized, controlled, open-label combo therapy trial was designed to evaluate the safety, tolerability and multiple pharmacodynamic parameters of the combination therapy. The study will be conducted on approximately 40 patients.
In the study, patients will be administered with BL-8040 injections as priming monotherapy. Thereafter, they will receive both BL-8040 and Tecentriq injections and continue with multiple treatment cycles for up to two years or until disease progression.
We remind investors that in September 2016, BioLineRx had entered into a collaboration agreement with Genentech, to support several phase Ib studies that are investigating BioLineRx’s BL-8040 combined with Tecentriq. This is marked as the third trial to commence under BioLineRx’s collaboration with Genentech.
It’s significant to note that this joint endeavor 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.
Significantly, BL-8040 is BioLineRx’s one of the leading therapeutic candidates, having successfully completed a phase IIa study for relapsed/refractory AML (acute myeloid leukemia) and is in the midst of a phase IIb program as an AML consolidation treatment. It is expected to initiate a phase III study on stem cell mobilization for autologous transplantation. Earlier in May, BioLineRx had announced that it has submitted a regulatory filing for commencing the phase III study.
Importantly, in July, BioLineRx had announced that Genentech has initiated another phase Ib/II trial, assessing BL-8040 in combination with Tecentriq to cure patients with metastatic pancreatic ductal adenocarcinoma.
BioLineRx had announced beginning of the first phase IIa COMBAT study for evaluating the efficacy of BL-8040 in combination with Merck's (MRK - Free Report) Keytruda on patients with pancreatic cancer, back in September 2016. Subsequently, earlier in January, BioLineRx had announced the onset of a second phase IIa study on the given combination.
Zacks Rank & Key Picks
BioLineRx currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the healthcare sector is Ionis Pharmaceuticals, Inc. (IONS - Free Report) , sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Ionis’ loss per share estimates fell from 18 cents to 17 cents for 2017 and from 35 cents to 29 cents, over the last 60 days. The company delivered positive earnings surprises in all the trailing four quarters with an average beat of 21.90%. Ionis’ shares have rallied 33.1% so far this year.
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