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BioLineRx Begins Part 2 of Phase I/IIa Study on Solid Tumors

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BioLineRx Ltd. (BLRX - Free Report) announced the dosing of the first patient in the part 2 of the phase I/IIa study on AGI-134. AGI-134 is a synthetic alpha-Gal glycolipid in development for solid tumors and highly differentiated from other cancer immunotherapies. 

The study will evaluate the safety and tolerability of AGI-134 at doses up to the recommended dose in multiple solid tumor types and a wide array of biomarkers, and validate AGI-134's mechanism of action. Further, efficacy will be assessed by clinical and pharmacodynamic parameters. The company expects initial results from the part 2 of the study by 2020 end.

The company initiated the part 2 of the studyafter the successful completion of the part 1 and the determination of the recommended dose. In preclinical studies, AGI-134 led to regression of established primary tumors and prevented the growth of secondary tumors. The candidate also triggered a vaccine effect that may prevent the development of future metastases.

Shares of the company have plunged 59.2% year to date against the industry’s growth of 5.3%.

AGI-134 is the second leading oncology product in the company’s portfolio. However, its lead program,  BL-8040, is a cancer therapy platform currently being evaluated in a phase IIa study in pancreatic cancer, in combination with Merck & Co.’s (MRK - Free Report) Keytrudaand chemotherapy. The company has a collaboration agreement with Merck. It also has an ongoing collaboration agreement with Roche Holding AG’s (RHHBY - Free Report) subsidiary, Genentech, evaluating BL-8040 in combination with the latter’s Tecentriq (atezolizumab) in two phase Ib/II solid tumor studies.

 

 

Zacks Rank & A Stock to Consider

Currently, BioLineRxis a Zacks Rank #3 (Hold) stock.

A better-ranked stock in the same space is FibroGen Inc. (FGEN - Free Report) , carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

FibroGen’s loss per share estimates have narrowed from $1.09 to 37 cents for 2019 and from 32 cents to 18 cents for 2020 in the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, the average beat being 346.59%.    

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