Was nog niet hier gemeld, persbericht van 1 aug jl. Een nieuwe studie, klinische fase, gericht op solid tumors. Weer een potentieel pareltje aan de r&d ketting. En, op 13 augustus de halfjaarcijfers, benieuwd naar de tussentijdse update.
"Op de plank hebben en houden".
Tel Aviv, Israel – August 1, 2018 - BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, announced today that it has initiated a Phase 1/2a clinical study for AGI-134, a novel compound that evokes a direct anti-tumor response, as well as a vaccine effect, via a unique, universally applicable, multi-arm mechanism that targets patient-specific tumor neoantigens.
AGI-134 is a synthetic, intratumorally administered glycolipid designed to label cancer cells with alpha-Gal, which then become the target of pre-existing anti-Gal antibodies, effectively triggering an immediate local anti-tumor response, as well as a follow-on systemic anti-tumor response targeting both the primary injected tumor and distal secondary tumors.
The Phase 1/2a study is a multicenter, open-label study that will take place in the UK and Israel, with possible expansion to the US and additional countries in Europe in 2019. The study is primarily designed to evaluate the safety and tolerability of AGI-134, given both as monotherapy and in combination with an immune checkpoint inhibitor, in unresectable metastatic solid tumors. Additional objectives are to perform a wide array of biomarker studies and to demonstrate the mechanism of AGI-134. Furthermore, efficacy will be assessed by clinical and pharmacodynamic parameters.
The study will be comprised of two parts: (i) an accelerated dose-escalation part to assess the safety and tolerability of intratumorally injected AGI-134 as a monotherapy, as well as to determine the maximum tolerated dose and the recommended dose for part 2 of the study; and (ii) a dose expansion part at the recommended dose, comprised of three cohorts and designed to assess the safety, tolerability and anti-tumor activity of AGI-134 as a monotherapy in a basket cohort of multiple solid tumor types, as well as in two additional cohorts in combination with an immune checkpoint inhibitor – in metastatic colorectal cancer and head and neck squamous cell carcinoma.
Prof. Mark Middleton of the University of Oxford, the study’s principal investigator, stated, "We are very excited to be launching a first-in-human clinical trial assessing AGI-134 for the treatment of solid tumors. AGI-134 represents a new mechanistic class of cancer immunotherapies, with a unique and highly differentiated mode of action, harnessing pre-existing immune machinery to trigger a systemic anti-tumor response and create a pro-inflammatory tumor microenvironment. More treatment options are urgently needed for cancer patients and we are optimistic that AGI-134’s encouraging pre-clinical results are going to translate to an efficacious and safe treatment for humans.”
"We are pleased to enter the clinic with our second lead oncology project,” said Philip Serlin, Chief Executive Officer of BioLineRx. "Numerous pre-clinical studies to date have demonstrated that treatment with AGI-134 leads to regression of established primary tumors, prevents growth of untreated distal secondary tumors, and triggers a vaccine effect that may prevent the development of future metastases. Furthermore, a combination of AGI-134 and an anti-PD-1 immune checkpoint inhibitor has demonstrated synergistic effect in protection from secondary tumor growth. We look forward to the first results of the Phase 1/2a study expected by the end of 2020.”