Indicate by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F:
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.
Exhibit 1
For Immediate
Release
BioLineRx
and Hemispherian Present Preclinical Data Demonstrating Synergy of GLIX1 with
PARP
Inhibitors in HR-Proficient Ovarian Cancer at ESMO 2026
GLIX1
demonstrated reproducible synergy across different PARP inhibitors and multiple HR-
proficient ovarian cancer cell lines, with high ZIP
synergy scores, highlighting
GLIX1’s
potential to expand the efficacy of PARP inhibitors
In
an HR-proficient ovarian cancer patient-derived xenograft model, low-doses of GLIX1 plus
olaparib demonstrated statistically significant
tumor growth inhibition versus vehicle control,
and tumor growth inhibition comparable to cisplatin
TEL
AVIV, Israel, and OSLO, Norway, October 23, 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, announced today that the companies presented data at the 2026 European Society for Medical Oncology Annual
Congress (ESMO 2026) demonstrating synergy between GLIX1 and multiple PARP inhibitors (PARPi) in homologous recombination (HR)-proficient
ovarian cancer cell lines and in an in vivo patient-derived xenograft (PDX) model.
“These
preclinical findings extend the rationale for GLIX1 beyond glioblastoma, where we have already enrolled three dose-level patient cohorts
in our Phase 1/2a clinical trial,” said Philip Serlin, Chief Executive Officer of BioLineRx. “Importantly, the in vivo
results further strengthen the rationale for combining GLIX1 with PARP inhibitors, demonstrating meaningful anti-tumor activity in an
HR-proficient ovarian cancer model even at reduced doses of both agents. We are very encouraged by these findings and look forward to
further exploring GLIX1/PARP inhibitor combinations, including the planned addition of an ovarian cancer arm in the expansion phase of
our ongoing clinical trial.”
“GLIX1
is designed to restore TET2 activity and drive tumor-selective DNA damage,” said Dr. Adam Robertson, Ph.D., Chief Scientific Officer
of Hemispherian AS and presenting author of the abstract. “These findings suggest GLIX1 could remove the HR-deficiency requirement
for PARPi activity, thereby both improving and broadening the use of PARP inhibitors in ovarian cancers, and we look forward to building
on this work.”
Presentation
Details:
Title:
GLIX1, a TET2 Activator Targeting the DNA Damage Response, Synergizes with PARP Inhibitors in Ovarian Cancer Cell Lines
Category:
Gynecological Cancers
Presentation
#: 1435eP
Presentation
type: e-Poster
Location:
e-Poster Area, Hall 25
Summary:
Ovarian
cancer remains difficult to treat, particularly in HR-proficient tumors, where PARP inhibitors have shown limited activity. GLIX1 is
a first-in-class small molecule that activates TET2, an enzyme that is suppressed in cancer and normally drives DNA demethylation. By
restoring TET2 activity, GLIX1 is designed to induce tumor-selective single-stranded DNA breaks through base excision repair, which could
overcome the PARP inhibitor requirement for HR deficiency.
GLIX1
was combined with three PARP inhibitors (olaparib, veliparib and niraparib) across a panel of HR-proficient ovarian cancer cell lines,
supporting a mechanism-driven class effect. The combination produced reproducible synergy with all three agents, with ZIP synergy scores
ranging from 10.9 to 43.2 (olaparib: 15.4–43.0; veliparib: 10.9–43.2; niraparib: 12.2–39.8). Cells treated with the
combination also showed upregulation of p21, consistent with activation of the DNA damage response.
The
poster also presents results from a 28-day study in an HR-proficient ovarian cancer patient-derived xenograft (PDX) model (OV0250). The
low-dose combination of GLIX1 (50 mg/kg daily) and olaparib (10 mg/kg daily) demonstrated statistically significant tumor growth inhibition
versus vehicle control, and greater antitumor activity than either GLIX1 (250 mg/kg daily) or olaparib (50 mg/kg daily) administered
alone at their respective optimal doses. The combination also demonstrated tumor growth inhibition comparable to cisplatin.
Additional
tumor-exposure measurements demonstrated GLIX1 penetration into ovarian tumor tissue following oral administration, with tumor-to-plasma
concentration ratios of approximately 50%. Plasma and tumor GLIX1 concentrations were measured one hour after dosing in a representative
animal from each of the two GLIX1 monotherapy groups.
These
data support synthetic lethality between GLIX1 and PARP inhibition and indicate that GLIX1 may remove the HR-deficiency requirement for
PARP inhibitor activity. Such a combination, when applied clinically, may improve and broaden the use of PARPi in ovarian cancers. GLIX1
is currently being evaluated in a Phase 1/2a clinical trial in glioblastoma, with plans to include an ovarian cancer arm in the expansion
phase (NCT07464925).
About
GLIX1
GLIX1
is a first-in-class, orally administered, brain-penetrant small molecule activator of the Ten-Eleven Translocation 2 (TET2) pathway,
which is commonly suppressed in cancer. Activating TET2 with GLIX1 is designed to overwhelm the DNA repair capacity of cancer cells,
resulting in tumor-selective cell death. GLIX1 is being developed by BioLineRx and Hemispherian AS for the treatment of glioblastoma
and other solid tumors.
About
Ovarian Cancer
Ovarian
cancer is the deadliest gynecologic malignancy in the United States, with an estimated 21,000 new cases and over 12,000 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
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 clinical-stage 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 was 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 Auspex 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, the
therapeutic potential of GLIX1, the potential benefits and clinical applicability of GLIX1 in combination with PARP inhibitors, the ability
of GLIX1 to improve or broaden the use of PARP inhibitors in ovarian cancer and other solid tumors, the significance and implications
of the preclinical data presented at ESMO 2026, expectations regarding BioLineRx's ongoing Phase 1/2a GLIX1 clinical trial, including
the planned addition of an ovarian cancer arm in the expansion phase, and BioLineRx's business strategy. 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 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