– GENESIS trial achieved statistical significance (p<0.0001) throughout all major and secondary endpoints –
– Nature Drugs publication describes how GENESIS trial included sufferers consultant of present a number of myeloma inhabitants present process autologous HSCT, together with older sufferers and those that obtained lenalidomide-containing induction therapies – components related to impaired HSPC mobilization –
– Motixafortide plus G-CSF preferentially mobilized primitive stem and early progenitor cells with distinctive transcriptional profiles related to enhanced self-renewal and regeneration –
TEL AVIV, Israel, April 17, 2023 /PRNewswire/ — BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a pre-commercial-stage biopharmaceutical firm centered on oncology, as we speak introduced the publication of knowledge from the Firm’s GENESIS Part 3 medical trial within the peer-reviewed journal Nature Drugs. The worldwide GENESIS trial evaluated the security and efficacy of the Firm’s lead investigational candidate motixafortide plus granulocyte colony-stimulating issue (G-CSF) versus placebo plus G-CSF for the mobilization of hematopoietic stem cells in sufferers with a number of myeloma previous to autologous stem cell transplantation (ASCT).
A number of myeloma is the second most typical hematologic malignancy and ASCT has been proven to enhance survival and performs a central position within the remedy of those sufferers. A significant variety of sufferers, nonetheless, are unable to gather a desired variety of peripheral blood CD34+ hematopoietic stem and progenitor cells (HSPC) with present remedy modalities.
The first goal of the examine was to exhibit that one dose of motixafortide with G-CSF, in comparison with placebo with G-CSF, allowed extra sufferers to mobilize ≥ 6 million CD34+ cells per kilogram of body weight, in as much as two apheresis classes. A secondary goal of the examine was to exhibit that one dose of motixafortide with G-CSF was superior to placebo with G-CSF in its skill to mobilize ≥ 6 million CD34+ cells per kilogram of body weight in only one apheresis session. The medical trial discovered that every one major and secondary endpoints had been achieved with a statistical significance of p<0.0001.
“Regardless of enhancements in survival that ASCT provides sufferers with a number of myeloma, there has not been important innovation in stem cell mobilization remedies in over a decade,” stated John DiPersio, MD, PhD, Professor of Drugs and Director of the Heart for Gene and Mobile Immunotherapy at Washington College College of Drugs in St. Louis, and principal investigator of the GENESIS examine. “With as we speak’s elevated use of a number of drug induction therapies and transplants in more and more older sufferers, there’s a corresponding elevated want for brand new remedy choices. These knowledge spotlight the potential of motixafortide plus G-CSF, if authorized, to boost the remedy choices for clinicians and sufferers with a number of myeloma present process ASCT.”
“This primary peer-reviewed publication of outcomes from the Part 3 GENESIS trial is a crucial validation of the potential of motixafortide to deal with important medical challenges and the evolving wants of as we speak’s ASCT remedy panorama in applicable a number of myeloma sufferers,” stated Tami Rachmilewitz, MD, Chief Medical Officer at BioLineRx. “We sit up for persevering with the event of motixafortide with the purpose of advancing take care of sufferers with a number of myeloma.”
Further GENESIS medical trial aims included time to engraftment of neutrophils and platelets and sturdiness of engraftment. The motixafortide-plus-G-CSF routine resulted in speedy and sturdy engraftment[i] of HSPCs following transplantation, and the routine was additionally proven to have a good safety-profile and that it was typically well-tolerated, with the commonest treatment-emergent hostile occasions noticed being transient, grade 1/2 injection web site reactions.[ii]
The examine included sufferers which can be consultant of the everyday a number of myeloma inhabitants present process ASCT, with a median age of 63 years and with ~70% of sufferers in each arms of the trial receiving lenalidomide-containing induction remedy. Elevated age, in addition to elevated publicity to lenalidomide-containing induction regimens, together with four-drug mixture regimens, have been related to impaired HSPC mobilization.[iii]
The examine authors additionally carried out parallel comparative FACS and single-cell transcriptional profile analyses, utilizing GENESIS knowledge and knowledge from trial cohorts with different mobilization regimens, to raised perceive the kinds of cells mobilized.
The FACS evaluation, as described by the examine authors in Nature, discovered that motixafortide plus G-CSF resulted in a ten.5-fold enhance in primitive HSPCs collected versus placebo plus G-CSF (p<0.0001); and considerably larger numbers of early stem and progenitor cells versus each placebo plus G-CSF (p<0.0001) and plerixafor plus G-CSF (p=0.0327). Primitive HSPCs and early stem and progenitor cells could also be related to enhanced self-renewal and regeneration.[iv] “The cohort analyses weren’t designed to grasp potential medical outcomes; nonetheless, we consider the findings are of curiosity and a compelling space for additional analysis,” stated Dr. DiPersio.
A New Drug Utility (NDA) for motixafortide in stem cell mobilization for autologous transplantation in a number of myeloma sufferers is presently beneath overview with the U.S. Meals and Drug Administration (FDA), with an assigned PDUFA date of September 9, 2023.
Concerning the GENESIS Trial
The GENESIS trial (NCT03246529) was initiated in December 2017. GENESIS was a world, randomized, double-blind, placebo-controlled, multicenter examine, evaluating the security and efficacy of motixafortide and G-CSF, in comparison with placebo and G-CSF, for the mobilization of hematopoietic stem-cells for autologous transplantation in a number of myeloma sufferers. The first goal of the examine was to exhibit that one dose of motixafortide with G-CSF, in comparison with placebo with G-CSF, allowed extra sufferers to mobilize ≥ 6 million CD34+ cells per kilogram of body weight, in as much as two apheresis classes. A secondary goal of the examine was to exhibit that one dose of motixafortide with G-CSF was superior to placebo with G-CSF in its skill to mobilize ≥ 6 million CD34+ cells per kilogram of body weight in only one apheresis session. Further aims included time to engraftment of neutrophils and platelets and sturdiness of engraftment, in addition to different efficacy and security parameters.
CD34+ cells within the GENESIS trial had been assessed utilizing each central lab and native lab knowledge, each of which achieved statistical significance (p<0.0001) throughout all major and secondary endpoints. The Nature Drugs publication centered on the examine’s native lab knowledge, because it was used for all medical choices within the examine.
About A number of Myeloma
A number of myeloma is an incurable blood most cancers that impacts some white blood cells referred to as plasma cells, that are discovered within the bone marrow. When broken, these plasma cells quickly unfold and change regular cells within the bone marrow with tumors. In response to the American Most cancers Society, in 2023, it’s estimated that greater than 35,000 folks might be identified with a number of myeloma, and practically 13,000 folks will die from the illness within the U.S. Whereas some folks identified with a number of myeloma initially haven’t any signs, most sufferers are identified resulting from signs that may embody bone fracture or ache, low purple blood cell counts, tiredness, excessive calcium ranges, kidney issues or infections.
About Autologous Stem Cell Transplantation
Autologous stem cell transplantation (ASCT) is a part of the usual remedy paradigm for a lot of blood cancers, together with a number of myeloma. Within the U.S., practically 15,000 ASCTs are carried out every year with the bulk in sufferers with a number of myeloma. The present commonplace of care consists of the administration of 5-8 each day doses of granulocyte colony stimulating issue (G-CSF), with or with out 1-4 doses of plerixafor, and the efficiency of 1-4 apheresis classes. For sufferers unable to mobilize enough numbers of cells for harvesting throughout this major mobilization section, rescue remedy is carried out, consisting of 1-4 extra doses of plerixafor on prime of G-CSF, and the efficiency of a further variety of apheresis classes as essential.
BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a pre-commercial-stage biopharmaceutical firm centered on oncology. The Firm’s lead growth program, motixafortide, a novel selective inhibitor of the CXCR4 chemokine receptor, might help various therapeutic approaches in oncology and different ailments. Motixafortide was efficiently evaluated in a Part 3 examine in stem cell mobilization for autologous transplantation for a number of myeloma sufferers and has had its NDA submission accepted by the FDA with an assigned PDUFA date of September 9, 2023. Motixafortide was additionally efficiently evaluated in a Part 2a examine for the remedy of metastatic pancreatic most cancers (mPDAC) together with the PD-1 inhibitor pembrolizumab and chemotherapy and is presently being studied together with the PD-1 inhibitor cemiplimab and chemotherapy as a primary line mPDAC remedy. As well as, a randomized section 2b examine with 200 sufferers assessing motixafortide together with a PD-1 inhibitor and chemotherapy as a primary line mPDAC remedy is predicted to provoke in 2023. BioLineRx can also be creating a second oncology program, AGI-134, an immunotherapy remedy for a number of strong tumors. A primary-in-human Part 1/2a examine of AGI-134 met its major endpoint for security and tolerability and demonstrated immune exercise throughout a number of biomarkers. For extra info on BioLineRx, please go to the Firm’s web site at www.biolinerx.com, the place you may overview the Firm’s SEC filings, press releases, bulletins and occasions.
Ahead Trying Assertion
Numerous statements on this launch regarding BioLineRx’s future expectations represent “forward-looking statements” inside the that means of the Non-public Securities Litigation Reform Act of 1995. These statements embody phrases reminiscent of “anticipates,” “believes,” “might,” “estimates,” “expects,” “intends,” “might,” “plans,” “potential,” “predicts,” “tasks,” “ought to,” “will,” and “would,” and describe opinions about future occasions. These embody statements relating to administration’s expectations, beliefs and intentions relating to, amongst different issues, the GENESIS trial, together with the plans and aims of administration for future operations and expectations and business potential of motixafortide. These forward-looking statements contain identified and unknown dangers, uncertainties and different components which will trigger the precise outcomes, efficiency or achievements of BioLineRx to be materially totally different from any future outcomes, efficiency or achievements expressed or implied by such forward-looking statements. Elements that might trigger BioLineRx’s precise outcomes to vary materially from these expressed or implied in such forward-looking statements embody, however aren’t restricted to: the initiation, timing, progress and outcomes of BioLineRx’s preclinical research, medical trials and different therapeutic candidate growth efforts; BioLineRx’s skill to advance its therapeutic candidates into medical trials or to efficiently full its preclinical research or medical trials; BioLineRx’s receipt of regulatory approvals for its therapeutic candidates, and the timing of different regulatory filings and approvals, together with BioLineRx’s skill to safe ample and viable pricing and reimbursement protection of any marketed product; the medical growth, commercialization and market acceptance of BioLineRx’s therapeutic candidates; BioLineRx’s skill to ascertain and preserve company collaborations; BioLineRx’s skill to combine new therapeutic candidates and new personnel; the interpretation of the properties and traits of BioLineRx’s therapeutic candidates and of the outcomes obtained with its therapeutic candidates in preclinical research or medical trials; the implementation of BioLineRx’s enterprise mannequin and strategic plans for its enterprise and therapeutic candidates; the scope of safety BioLineRx is ready to set up and preserve for mental property rights masking its therapeutic candidates and its skill to function its enterprise with out infringing the mental property rights of others; estimates of BioLineRx’s bills, future revenues, capital necessities and its wants for and skill to entry enough extra financing; dangers associated to modifications in healthcare legal guidelines, guidelines and rules in america or elsewhere; aggressive corporations, applied sciences and BioLineRx’s trade; dangers associated to unfavorable financial and market circumstances and hostile developments with respect to monetary establishments and related liquidity threat; and statements as to the affect of the political and safety state of affairs in Israel on BioLineRx’s enterprise. These and different components are extra absolutely mentioned within the “Threat Elements” part of BioLineRx’s most up-to-date annual report on Kind 20-F filed with the Securities and Change Fee on March 22, 2023. As well as, any forward-looking statements symbolize BioLineRx’s views solely as of the date of this launch and shouldn’t be relied upon as representing its views as of any subsequent date. BioLineRx doesn’t assume any obligation to replace any forward-looking statements until required by regulation.
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[i] Z.D. Crees, J.F. DiPersio, A randomized, placebo-controlled, Part III trial evaluating motixafortide and G-CSF to mobilize hematopoietic stem cells for autologous transplantation in a number of myeloma – the Genesis Trial. Nature Drugs, Quantity 29, Concern 4 (2023)
[ii] Ibid. p18
[iii] Ibid. p35-36
[iv] Ibid. p2
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