BioLineRx ($BLRX) has become the latest company to stake its claim for a spot on the burgeoning roster of immuno-oncology combinations. The small biotech is aiming to muscle into the sector by showing its CXCR4 antagonist BL-8040 can boost the effectiveness of Merck's ($MRK) Keytruda in metastatic pancreatic adenocarcinoma.BioLineRx VP Arnon Aharon
Tel Aviv, Israel-based BioLineRx views the Phase II trial as the start of a program to use BL-8040 to expand the number of indications in which Keytruda is effective. In recent years, multiple research groups have tested combinations of CXCR4 inhibitors and PD-1/PD-L1 immunotherapies in preclinical models of various types of cancer. And, having generated some preclinical evidence of its own, BioLineRx has decided pancreatic cancer is the ideal proving ground for the combination of BL-8040 and Keytruda. An open-label, single-arm Phase II trial is due to start by the middle of this year.
The scientific rationale for pursuing the combination lies in the potential for BL-8040 to sensitize the tumor to Keytruda. "Infiltration is one of the key elements," BioLineRx VP of Medical Affairs Arnon Aharon said on a call with investors to discuss the deal. Aharon sees the inability for T cells to breach the tumor as one of the factors limiting the effect of Keytruda on pancreatic cancer and some other forms of the disease. With research linking the CXCR4 receptor to the movement of T cells, BioLineRx thinks BL-8040 could be the drug that overcomes the infiltration issue.
BioLineRx is putting up its own money to test the idea. "BioLineRx is the sponsor of the study and will fund the clinical cost," BioLineRx VP of Business Development David Malek said. "Merck just provide the product Keytruda--which is actually quite substantial if you look at the cost of obtaining this particular molecule--and also is funding the activities done in terms of investigating some of the samples and other aspects of the study." For Merck, the deal is a low-risk way to see if BL-8040 is the molecule that will open another indication for Keytruda.
More is resting on the trial for BioLineRx, a tiny biotech with a handful of clinical-phase programs. If the combination appears to be effective, BioLineRx and Merck have the option to expand the deal to cover a pivotal trial. But, as it stands, BL-8040 is just one of many unproven partners for PD-1/PD-L1 immunotherapies.
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