Roth Positive on BioLineRx (BLRX) Amid Latest BL-8040 Phase 2a Data in r/r AML
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Roth Capital affirms its Buy rating and $7 price target on BioLineRx Ltd. (Nasdaq: BLRX) after the company announced the presentation of successful final results of BL-8040's Phase 2a clinical trial in relapsed or refractory acute myeloid leukemia (r/r AML).
Analyst Joseph Pantginis commented today,
The final r/r AML data continue to point to a bright path forward for the drug, in our belief. Recall this study tested '8040 alone or in combination with Ara- C and data from the study, to date, have shown the ability to produce the "one-two punch," 1) mobilizing leukemic cells from the bone marrow (chemoresistant) to the periphery making them accessible to killing by Ara-C and 2) also having direct killing effect on leukemic cells. With studies ongoing in earlier disease, the goal is to significantly impact minimal residual disease. In AML, the key focus will be on the consolidation setting, with the ongoing randomized Phase IIb study (up to 194 patients), with emphasis on bringing patients to MRD negativity.
With enrollment and expectations of 12-18 month patient follow-up, complete data are expected in 2019 with a potential interim look in 1H18. A Phase Ib study will also be initiated based on the newly announced Roche collaboration in the AML maintenance setting. The BL-8040 program in pancreatic cancer program will also get running this quarter, first with the Phase IIa combo with Keytruda and then an IST with MDAnderson in a Phase IIa by year-end. Partial data from the ongoing Phase II in stem cell mobilization are expected by year-end (full data by end of 2017).
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