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BioLineRx (NASDAQ: BLRX) reports GLIX1-PARP synergy in ovarian cancer model

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Rhea-AI Filing Summary

BioLineRx and Hemispherian report new preclinical data showing strong synergy between GLIX1 and the PARP inhibitor olaparib in a patient-derived ovarian cancer xenograft model. Low-dose combination therapy delivered substantially better efficacy than controls and than each drug alone at its optimal dose, and showed efficacy comparable to cisplatin.

The data support synthetic lethality between GLIX1 and PARP inhibitors in homologous recombination-proficient ovarian cancer, a large group that responds poorly to current PARP inhibitor therapy. Based on these results, BioLineRx plans to add an ovarian cancer arm to the expansion part of its ongoing Phase 1/2a GLIX1 trial.

GLIX1 is a first-in-class, oral small molecule that activates the TET2 pathway to overwhelm cancer DNA repair and induce cell death. It is already in a Phase 1/2a trial in glioblastoma and other high-grade gliomas, with updates expected in H2 2026 and full dose-escalation results anticipated in 2027.

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Insights

Preclinical GLIX1-PARP synergy is promising but still early-stage.

The update highlights strong synergy between GLIX1 and PARP inhibitor olaparib in an ovarian cancer xenograft model, with efficacy exceeding monotherapy arms and comparable to cisplatin. It reinforces the synthetic lethality mechanism in homologous recombination-proficient tumors, a group poorly served by current PARP inhibitors.

Clinically, GLIX1 is in an open-label Phase 1/2a trial in glioblastoma and other high-grade gliomas, with dose escalation enrolling up to 30 patients to determine a recommended dose based on safety, PK/PD and preliminary efficacy. The expansion phase is planned to include newly diagnosed GBM and select cancers, now including an ovarian cancer cohort.

For investors, these data extend GLIX1’s potential addressable indications, but they remain preclinical and subject to the usual risks of translation to humans. Milestones mentioned include Phase 1/2a trial updates during H2 2026 and full dose-escalation results expected in 2027, which will better define GLIX1’s clinical profile.

New ovarian cancer cases approximately 21,000 cases Projected in the United States in 2026
Ovarian cancer deaths 12,450 deaths Projected in the United States in 2026
HR-proficient tumor share approximately 50% Share of high-grade serous ovarian cancers that are HR-proficient
Dose-escalation enrollment target up to 30 patients Phase 1/2a GLIX1 trial in recurrent/progressive GBM and other high-grade gliomas
Trial update timing H2 2026 Planned timing for Phase 1/2a GLIX1 trial updates
Full dose-escalation results 2027 Expected timing for full results from Phase 1/2a dose escalation
Clinical trial identifier NCT07464925 Identifier for the Phase 1/2a GLIX1 clinical trial
synthetic lethality medical
"GLIX1 in combination with PARPi is expected to result in synthetic lethality, a mechanism in which GLIX1-induced single-stranded DNA breaks overcome PARP inhibitors’ requirement for HR-deficiency"
Synthetic lethality occurs when two separate weaknesses in a cell—each harmless alone—combine to cause the cell to die; targeting the partner weakness lets a drug kill diseased cells while sparing healthy ones. Think of it like removing the second support of a wobbly chair: a targeted nudge collapses only the defective ones. For investors, therapies based on this idea can offer more precise drugs, clearer patient selection tests, and potentially faster, less risky development paths.
PARP inhibitors medical
"Ovarian cancer remains a major therapeutic challenge, particularly in homologous recombination (HR)-proficient disease where PARP inhibitors (PARPi) presently have limited efficacy"
PARP inhibitors are a class of cancer drugs that block an enzyme cells use to repair damaged DNA, effectively preventing cancer cells from fixing themselves and causing them to die. Investors watch them because their clinical approvals, safety profiles, patent status, and tests that identify which patients will benefit determine market size and revenue potential—much like backing a tool that only works on certain problems but can be very valuable when it does.
homologous recombination (HR)-proficient medical
"Ovarian cancer remains a major therapeutic challenge, particularly in homologous recombination (HR)-proficient disease where PARP inhibitors (PARPi) presently have limited efficacy"
Phase 1/2a trial medical
"The Phase 1/2a trial is an open-label, multicenter trial. Part 1 of the trial is a dose escalation study where patients receive GLIX1 daily as monotherapy."
A phase 1/2a trial is an early-stage clinical study that first checks how a new drug or therapy behaves in people (safety and appropriate dose) and then expands to see if it shows initial signs of benefit in a small group. For investors, these results are an early proof point similar to a prototype demo: positive findings can sharply increase a program’s value and reduce uncertainty, while problems can indicate higher risk or delays.
patient-derived xenograft (PDX) model medical
"new preclinical data demonstrating strong synergy between GLIX1 and PARP inhibitors in a patient-derived xenograft (PDX) model of ovarian cancer."
Ten-Eleven Translocation 2 (TET2) pathway medical
"GLIX1 is a first-in-class, orally administered, brain penetrating, small molecule activator of the Ten-Eleven Translocation 2 (TET2) pathway that is commonly inhibited in cancer."
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FAQ

What new data did BioLineRx (BLRX) report on GLIX1 and PARP inhibitors?

BioLineRx and Hemispherian reported preclinical data showing strong synergy between GLIX1 and the PARP inhibitor olaparib in a patient-derived ovarian cancer xenograft model, with better efficacy than either drug alone and comparable efficacy to cisplatin.

How could GLIX1 benefit homologous recombination-proficient ovarian cancer patients?

GLIX1 activates the TET2 pathway, causing single-stranded DNA breaks that can induce synthetic lethality when combined with PARP inhibitors. This mechanism may enable PARP inhibitors to work in homologous recombination-proficient ovarian cancers, where PARP inhibitors currently have limited benefit.

How will the new GLIX1 data affect BioLineRx’s clinical plans?

Based on the new preclinical synergy data, BioLineRx plans to add an ovarian cancer arm to the expansion part of its ongoing Phase 1/2a GLIX1 trial. This expansion aims to generate preliminary efficacy and dose optimization data in additional tumor types.

What is the design of the Phase 1/2a trial evaluating GLIX1?

The Phase 1/2a trial is open-label and multicenter. Part 1 is a dose-escalation study of daily GLIX1 monotherapy in up to 30 patients with recurrent and progressive glioblastoma and other high-grade gliomas, aiming to define a maximum tolerated or recommended dose.

When are key GLIX1 clinical milestones expected for BioLineRx (BLRX)?

Updates from the GLIX1 Phase 1/2a trial are anticipated during H2 2026, with full results from the dose-escalation part expected in 2027. These milestones should clarify GLIX1’s safety, pharmacology and initial efficacy before broader development decisions.

What other products and programs does BioLineRx currently have?

BioLineRx’s first approved product is APHEXDA (motixafortide) for stem cell mobilization in multiple myeloma. It also retains motixafortide rights in solid tumors, including an ongoing Phase 2b trial in metastatic pancreatic cancer under a collaboration with Columbia University.

 

  

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16 OF

THE SECURITIES EXCHANGE ACT OF 1934

 

For the month of July 2026

 

Commission file number: 001-35223

 

BioLineRx Ltd.

(Translation of registrant’s name into English)

 

2 HaMa’ayan Street

Modi’in 7177871, Israel

(Address of Principal Executive Offices)

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:

 

Form 20-F ☒     Form 40-F

 

 

On July 8, 2026, the registrant issued the press release which is filed as Exhibit 1 to this Report on Form 6-K.

 

The first five paragraphs of the press release attached as Exhibit 1 to this Form 6-K, other than the fourth paragraph, are hereby incorporated by reference into all effective registration statements filed by the registrant under the Securities Act of 1933.

 

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

  BioLineRx Ltd.  
       
  By: /s/ Philip A. Serlin  
    Philip A. Serlin  
    Chief Executive Officer  

Dated: July 8, 2026

 

 

 

Exhibit 99.1

 

   

For Immediate Release

 

BioLineRx and Hemispherian Announce New Preclinical Data Demonstrating Strong

Synergistic Effect between GLIX1 and PARP Inhibitor in a Patient-Derived

Ovarian Cancer Xenograft Model

 

- Synergy was demonstrated in a combination arm of GLIX1 and the PARP inhibitor olaparib at

low doses, with substantially better efficacy compared to the control arm and compared to

each drug individually at its optimal dose -

 

- GLIX1 in combination with olaparib also showed comparable efficacy to that seen with the

chemotherapy drug cisplatin -

 

- Results reinforce synthetic lethality between GLIX1 and PARP inhibitors, indicating that GLIX1

can broaden the use of PARPi in ovarian cancer -

 

TEL AVIV, Israel and OSLO, Norway – July 8, 2026 – BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, and Hemispherian AS, a clinical-stage oncology company developing novel small molecule therapeutics, today announced highly encouraging new preclinical data demonstrating strong synergy between GLIX1 and PARP inhibitors in a patient-derived xenograft (PDX) model of ovarian cancer.

 

Ovarian cancer remains a major therapeutic challenge, particularly in homologous recombination (HR)-proficient disease where PARP inhibitors (PARPi) presently have limited efficacy, as well as for patients with platinum-resistance.

 

GLIX1 in combination with PARPi is expected to result in synthetic lethality, a mechanism in which GLIX1-induced single-stranded DNA breaks overcome PARP inhibitors’ requirement for HR-deficiency, enabling synergistic activity in HR-proficient cancers. This effect was first observed in vitro, where GLIX1 showed reproducible synergy across different PARP inhibitors and multiple HR-proficient ovarian cancer cell lines, with very high ZIP synergy scores.

 

“We are very excited to observe, in a patient-derived ovarian cancer model, the synergistic effect as we anticipated based on the mechanistic rationale and as demonstrated by in vitro data” said Philip Serlin, Chief Executive Officer of BioLineRx. “GLIX1 has the potential to sensitize patients to PARP inhibitors as well as to potentially address the huge unmet need for patients with platinum-resistance. Based on these highly encouraging data, we plan to include an ovarian cancer arm in the expansion part of our ongoing Phase 1/2a study.”

 

Today’s results represent a compelling in vivo confirmation of GLIX1 and PARPi synergy from an HR-proficient ovarian cancer PDX model.

 

·The study included six arms: cisplatin, GLIX1 monotherapy and olaparib monotherapy (all at doses expected to be optimal), low-dose GLIX1, a low-dose GLIX1/olaparib combination arm, and a control arm

 

·Results show substantially better efficacy in the combination arm versus the control arm and versus the monotherapy arms, despite using lower doses in the combination arm

 

·The low-dose GLIX1/olaparib combination tumor reduction was similar to cisplatin, the current chemotherapy benchmark

 

BioLineRx and Hemispherian plan to present the data from this study at one or more future medical conferences.

 

 

About Ovarian Cancer

 

Ovarian cancer is the deadliest gynecologic malignancy in the United States, with an estimated approximately 21,000 new cases and 12,450 deaths projected in 2026. Standard first-line treatment consists of cytoreductive surgery and platinum-based chemotherapy, with PARP inhibitors used as maintenance therapy in selected patients, particularly those with BRCA-mutated or homologous recombination (HR)-deficient disease. However, PARP inhibitors are markedly less effective in patients with HR-proficient tumors, which account for approximately 50% of high-grade serous ovarian cancers and are associated with primary platinum resistance and shorter survival. This leaves a substantial and currently underserved patient population in need of new treatment strategies capable of extending the benefits of PARP inhibitors.

 

About GLIX1

 

GLIX1 is a first-in-class, orally administered, brain penetrating, small molecule activator of the Ten-Eleven Translocation 2 (TET2) pathway that is commonly inhibited in cancer. Activating the novel TET2 pathway by GLIX1 overwhelms the DNA repair capacity of cancer cells, resulting in apoptotic cancer cell death.

 

About the Phase 1/2a Trial with GLIX1

 

The Phase 1/2a trial is an open-label, multicenter trial. Part 1 of the trial is a dose escalation study where patients receive GLIX1 daily as monotherapy. This part is expected to recruit up to 30 patients with recurrent and progressive GBM and other high-grade gliomas. The primary objective is to establish a maximum tolerated dose (MTD) and/or a recommended dose based on safety, PK/PD and preliminary efficacy. Updates to the Phase 1/2a trial are anticipated during H2 2026, with full results on the dose escalation part expected in 2027.

 

The Phase 2a expansion part of the trial is planned to include additional indications, including newly diagnosed GBM, as well as select cancers, with GLIX1 as monotherapy or in combination with standard of care (including in combination with PARP inhibitors). These cohorts are expected to identify preliminary efficacy, PD assessments and dose optimization data, serving as the basis for a rapid and effective advanced clinical development plan.

 

For more information on the Phase 1/2a trial, please visit NCT07464925.

 

About Hemispherian

 

Hemispherian AS is a clinical-stage pharmaceutical company developing first-in-class small-molecule cancer therapies. Its lead program, GLIX1, is being advanced in partnership with BioLineRx for the treatment of glioblastoma and a broad range of solid tumors.

 

The company is headquartered in Oslo, Norway, and collaborates with leading academic and clinical institutions worldwide.

 

Learn more at www.hemispherian.com or on LinkedIn.

 

 

About BioLineRx

 

BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases. The Company’s lead development asset is GLIX1, a first-in-class, oral, small molecule targeting DNA damage response in glioblastoma and other solid tumors, for which a Phase 1/2a clinical trial has been initiated in the first quarter of 2026. GLIX1 is being developed under a collaboration with Hemispherian AS.

 

The Company's first approved product, APHEXDA® (motixafortide), is indicated in the U.S. for stem cell mobilization for autologous transplantation in multiple myeloma, and is being commercialized by Ayrmid Ltd. (globally, except Asia) and Gloria Biosciences (in Asia). BioLineRx has retained the rights to develop motixafortide in solid tumors, including metastatic pancreatic cancer (PDAC), and has a Phase 2b PDAC trial currently ongoing under a collaboration with Columbia University.

 

Learn more about who we are, what we do, and how we do it at www.biolinerx.com, or on LinkedIn.

 

Forward Looking Statement

 

Various statements in this release concerning BioLineRx's future expectations constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," and "would," and describe opinions about future events. These include statements regarding management's expectations, beliefs and intentions regarding, among other things, GLIX1’s potential to sensitize patients to PARP inhibitors as well as the potential to address the need for patients with platinum-resistance. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Factors that could cause BioLineRx's actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: the clinical development, commercialization and market acceptance of GLIX1 and motixafortide including the degree and pace of market uptake of APHEXDA for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients; the initiation, timing, progress and results of BioLineRx’s preclinical studies, clinical trials and other therapeutic candidate development efforts; BioLineRx’s ability to advance GLIX1 and motixafortide into clinical trials or to successfully complete its preclinical studies or clinical trials; whether the clinical trial results for GLIX1 and motixafortide will be predictive of real-world results; BioLineRx’s receipt of regulatory approvals for GLIX1 and motixafortide and the timing of other regulatory filings and approvals; whether access to GLIX1 and motixafortide is achieved in a commercially viable manner and whether GLIX1 and motixafortide receives adequate reimbursement from third-party payors; BioLineRx’s ability to establish, manage, and maintain corporate collaborations, as well as the ability of BioLineRx’s collaborators to execute on their development and commercialization plans; BioLineRx’s ability to integrate new therapeutic candidates and new personnel, as well as new collaborations; the interpretation of the properties and characteristics of BioLineRx’s therapeutic candidates and of the results obtained with its therapeutic candidates in preclinical studies or clinical trials; the implementation of BioLineRx’s business model and strategic plans for its business and therapeutic candidates; the scope of protection that BioLineRx’s is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; estimates of BioLineRx’s expenses, future revenues, capital requirements and its need for and ability to access sufficient additional financing; risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere; competitive companies, technologies and BioLineRx’s industry; BioLineRx’s ability to maintain the listing of its ADSs on Nasdaq; statements as to the impact of the political and security situation in Israel on BioLineRx’s business which may exacerbate the magnitude of the factors discussed above. These and other factors are more fully discussed in the "Risk Factors" section of BioLineRx's most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 23, 2026. In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.

 

Contacts:

 

For BioLineRx:

United States

Chuck Padala

LifeSci Advisors, LLC

IR@biolinerx.com

 

Israel

Moran Meir

LifeSci Advisors, LLC

moran@lifesciadvisors.com

 

For Hemispherian AS:

Zeno Albisser, CEO

zeno@hemispherian.com

 

 

 

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