Oppenheimer reiterates Outperform rating on BioLineRx after positive data from GENISIS study of BL-8040

Analysts at Oppenheimer reiterated their Outperform rating Tuesday on Israel-based BioLineRx Ltd’s (NASDAQ:BLRX) after positive results from the GENESIS trial backed the oncology-focused biotech’s BL-8040 and G-GSF combination therapy as a stem cell mobilizer for cancer patients undergoing bone marrow transplants.

The double-blind, placebo-controlled Phase 3 trial compared BL-8040 in combination with granulocyte colony-stimulating factor (G-CSF), to G-CSF alone, for hematopoietic stem cells transplants in multiple myeloma patients.

“GENESIS is evaluating whether the addition of a single injection of BL-8040 can improve harvests relative to standard-of-care mobilization (five days of G-CSF),” wrote Oppenheimer analysts Mark Breidenbach and Matthew Biegler.  

“The lead-in cohort of GENESIS was designed to enroll up to 30 patients, but results from the first 11 patients prompted the Data Monitoring Committee to terminate the lead-in cohort early and advance the trial into its randomized, double-blinded stage,” they added.

READ: BioLineRx’s collaboration with Merck supports the potential of BL-8040 in ‘difficult to treat cancers,’ says Maxim

The positive data prompted the Data Monitoring Committee to recommend moving forward into the “randomized segment of the study,” slated to enroll 177 patients.

“Importantly, optimal cell yields were collected in 9 of 11 patients (82%), reinforcing our belief that GENESIS could hit its primary endpoint,” wrote the Oppenheimer analysts. “Management indicates GENESIS remains on track to deliver top line results in 2020, and we reiterate our Outperform rating and US$3 price target.”

BioLineRx stock rose 1.3% to US$0.89 Tuesday.

Maxim bullish

Analysts at Maxim were also pleased with the GENESIS study of BL-8040 moving ahead of schedule.

“BL-8040 continues to demonstrate efficacy across multiple clinical programs. The early data from the GENESIS trial and the recommendation from the Data Monitoring Committee is a significant positive for BioLineRx,” wrote Maxim Group analysts Jason McCarthy and Caroline Palomeque.

Separately, BioLineRx’s BL-8040 is a novel, short peptide that functions as a high-affinity antagonist for CXCR4, which the cancer specialist is developing for the treatment of acute myeloid leukemia as well as solid tumors.

READ: BioLineRx reports rosy results from Phase2a trial for its cancer drug BL-8040

Analysts at Maxim are bullish that the BL-8084 platform continues to make progress across multiple indications and data from several studies is expected over the remainder of 2018 which, if positive, should represent catalysts for the stock.

“Besides the GENESIS Trial, BL-8040 is also involved in several phase two trials which could report data in 2018,” wrote the Maxim analysts.

BioLineRx Ltd recently expanded its collaboration with Merck & Co Inc (NYSE:MRK) to evaluate its peptide for “difficult to treat cancers.” The triple combo trial evaluates BL-8040 in combination with Keytruda and MSD’s anti-PD-1 therapy, in patients with metastatic pancreatic cancer.  

BioLineRx earlier initiated a Phase 2a study, known as the COMBAT study, focusing on evaluating the safety and efficacy of BL-8040 in combination with Keytruda, Merck’s anti-PD-1 therapy.

Separately, Maxim recently announced results from a Phase 2a trial which suggest that its drug BL-8040 lifts survival rates in patients with relapsed or refractory acute myeloid leukemia.

The study reveals that when BL-8040 is taken in combination with the chemotherapy drug Cytarabine, the life of patients with relapsed acute myeloid leukemia is extended by several months.

Maxim is keeping a Buy rating and a US$2 price target on the stock.

Contact Uttara Choudhury at [email protected]
Follow her on Twitter: @UttaraProactive

Story by ProactiveInvestors