Biolinerx Ltd (NASDAQ:BLRX) will publish key data readouts of its drug candidates in Stem Cell Mobilization, Pancreatic Cancer and AML before the end of this year.
Combination therapy to cure cancer
CEO of BiolineRx, Philip Serlin, said the company awaits survival data from the clinical trial of motixafortide to treat pancreatic cancer. The company is confident that data obtained in December 2019 from a trial conducted on 22 patients helps it cure the most difficult cancers using motixafortide, chemotherapy, and KEYTRUDA.
Stem cell mobilization
BiolineRx will continue its GENESIS Phase III clinical trial. It is the most efficient path for registration. The company will use G-CSF and motixafortide against G-CSF alone in a placebo-controlled and double-blind clinical trial to mobilize stem cells for autologous transplantation in several patients with myeloma. BiolineRX’s primary endpoint of this clinical trial is to mobilize more than 6 million CD34 positive cells for each kg in two apharesis sessions.
BiolineRX will conduct an interim analysis of this Phase III clinical study in H2 2020. If it achieves the primary endpoint, it will stop recruitment. The company will reveal the topline results of this clinical study in H1 2021.
BiolineRX is also conducting a Phase 2b BLAST consolidation trial in AML and expects to report interim analysis in H2 2020.
COVID-19 pandemic impacts development of AGI-134
The ongoing coronavirus crises impacted the development of BiolineRx’s clinical candidate – AGI-134. BiolineRx suspended the enrollment process for Phase 1/ 2a clinical study temporarily. It will commence the trial in H2 2021 with recruitment in H1 2021.
BiolineRx suffered a lot of disruptions in the timelines of its drug development programs because of COVID-19.
Raises $13.4 million
BiolineRx mobilized funds of $13.4 million in Q2 2020 to achieve the milestones outlined above.
Serlin said mortixafortide can cure multiple cancer indications according to the data generated from several clinical trials as of now.
R&D spending of BiolineRx is declined by 12.5% to $4.6 million in Q2 2020. Its marketing and sales expenses are $0.2 million. The company posted an operating loss of $5.6 million in Q2 2020.
BiolineRx holds short term deposits, cash equivalents, and a cash balance of $27.3 million by the end of in June 2020.