The latest in the long spree of partnerships to pair PD1 and PD-L1 inhibitors with other approaches to improve their oncology efficacy has arrived with a deal between Roche’s Genentech ($RHHBY) and BioLineRx ($BLRX).
The partners will test BL-8040, BioLineRx's lead oncology candidate that is a CXCR4 antagonist, in combination with Genentech’s atezolizumab in multiple cancer indications in Phase 1b testing designed to assess the safety and tolerability of the combo, as well as its pharmacodynamic parameters in hematologic malignancies and solid tumors.
"This collaboration agreement in multiple cancer indications with Genentech marks our second collaboration with a world leader in cancer immunotherapy for the combination of BL-8040 with an approved immune checkpoint inhibitor," stated BioLineRx CFO and COO Philip Serlin in a statement. "Immune checkpoint inhibitors are a new class of promising drugs that have revolutionized anti-cancer treatment; however, it is becoming clear that certain tumor types will require a combination of immunotherapy with other classes of drugs.”
CXCR4 antagonists can mobilize immune cells and induce direct tumor cell death. This class may also be effective in inducing the migration of antitumor T cells into the tumor microenvironment. That’s expected to fit well with atezolizumab, which is thought to activate T cells once the migration to the tumor has been enhanced by BL-8040.
Atezolizumab, known by the brand name Tecentriq, is Genentech’s cornerstone immunotherapy. It just had positive Phase III data in second-line, non-small cell lung cancer (NSCLC) and has an Oct. 19 review date in NSCLC under a priority review with the FDA.
It’s up for review specifically to treat NSCLC patients whose disease has progressed during or after platinum-based chemotherapy and for those with an EGFR mutation-positive or ALK-positive tumor; the agency has also granted the drug breakthrough therapy designation in that indication.
Tecentriq, approved by the FDA in May to treat a type of bladder cancer, was the first PD-L1 inhibitor to be approved.
Under the new deal, Genentech will pay for and conduct several Phase Ib trials in several solid tumor indications. BioLineRx will also support and execute another Phase Ib study in acute myeloid leukemia patients. All the studies are expected to be open-label, single-arm trials.
Micro cap BioLineRx was up a bit on the news, but its valuation remains only a bit above $50 million.