Israeli biopharmaceutical firm BioLineRx has launched a Phase Ib/II clinical trial (BATTLE) of BL-8040 in combination with Genentech’s anti-PDL1 immunotherapy atezolizumab (Tecentriq) in patients suffering from acute myeloid leukaemia (AML).
BL-8040 is a short peptide, high-affinity antagonist of CXCR4 chemokine receptor reported to be involved in tumour progression, angiogenesis, metastasis and cell survival.
The multi-centre, single arm, open-label BATTLE trial will investigate the safety, tolerability, relapse-free survival and minimal residual disease status of the combination as a maintenance treatment.
Approximately 60 intermediate and high-risk patients who experienced a complete response (CR) after treatment with induction and consolidation therapy will be enrolled into the trial.
BioLineRx CEO Philip Serlin said: “The BATTLE study is the first study under our collaboration in hematologic malignancies, and we are hopeful that combining atezolizumab with BL-8040 will demonstrate the potential to establish a new treatment for AML patients that would extend the duration of remission following induction treatment, in particular for patients for whom stem-cell transplantation is inappropriate.”
Planned to be conducted at 22 sites in the US, Europe and Israel, the trial’s primary endpoint is assessment of the combination’s ability to prolong relapse-free survival.
The impact of the therapy on minimal residual disease, various immunological parameters and potential biomarkers will also be monitored.
In September last year, BioLineRx and Genentech entered cancer immunotherapy collaboration to evaluate the combination in different Phase Ib/II trials for various types of cancer.
Under this partnership, the firms intend to launch additional combination trials by the end of this year.