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BioLineRx and Hemispherian Announce New GLIX1 Data Demonstrating Potent Anti-Tumor Effect in Glioblastoma (GBM) Across Multiple In-Vivo Studies, Including a Temozolomide (TMZ)-Resistant Model with Patient-Derived Xenografts

On May 19, 2026 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical development 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, reported highly encouraging new preclinical data that further support the recently initiated Phase 1/2a clinical trial evaluating GLIX1 for the treatment of recurrent and progressive GBM and other high-grade gliomas.

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GBM remains one of the most aggressive and treatment-resistant cancers, urgently in need of breakthrough innovations and more effective treatment.

In a comprehensive pre-clinical program, orally administered GLIX1 demonstrated robust anti-tumor activity in orthotopic cell-derived xenograft (CDX) GBM models, as well as in a newly completed subcutaneous TMZ-resistant patient-derived xenograft (PDX) GBM model. In the three orthotopic CDX studies, significant tumor growth inhibition and survival benefit were observed following treatment with GLIX1 across all doses tested, with greater benefit at higher dose levels. In these models, mice treated with TMZ also showed significantly decreased tumor volume and survival benefit. Most notably, in the subcutaneous PDX model, GLIX1 demonstrated a robust anti-tumor effect while TMZ showed no effect.

"The compelling results from these studies, including the recently completed TMZ-resistant PDX model, are very exciting as they suggest that GLIX1 may bring hope to a broad range of patients with GBM," said Philip Serlin, Chief Executive Officer of BioLineRx. "In addition, the pre-clinical dose-response characterization adds important information for dose optimization in the Phase 2 part of the ongoing clinical study. We believe GLIX1 has the potential to offer a novel therapeutic approach in this cancer indication, as well as in multiple other cancer indications where DNA damage repair is critical for cancer survival."

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

About Glioblastoma
Glioblastoma is the most common primary brain tumor and remains one of the most aggressive and treatment-resistant cancers, urgently in need of breakthrough innovations and more effective treatment. The standard of care for newly diagnosed GBM established since 2005 consists of surgery, followed by radiotherapy and treatment with temozolomide (TMZ), with no established standard of care for recurrent GBM. However, patients with unmethylated MGMT[1] promoter status (who represent more than half of all GBM patients) have demonstrated a limited response to TMZ.

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.

[1] MGMT stands for O6-methylguanine-DNA methyltransferase, a DNA repair enzyme.

(Press release, BioLineRx, MAY 19, 2026, View Source [SID1234665855])

IPAX-2 Study of TLX101-Tx in First-line Glioblastoma Completes Enrolment and Confirms Dosing

On May 19, 2026 Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") reported that the IPAX-2 study1 of TLX101-Tx (¹³¹I-iodofalan) in patients with newly diagnosed glioblastoma has completed patient enrolment. No dose-limiting toxicities (DLTs) have been observed to date, including with two doses of 5GBq (total administered activity of 10GBq), the maximum administered dose in the study.

IPAX-2 is an international, multicenter, open-label Phase 1 dose finding study to evaluate the safety and tolerability of TLX101-Tx in combination with post-surgical standard-of-care treatment (external beam radiation therapy and temozolomide) in primary glioblastoma. Twelve patients were enrolled into three dose escalating cohorts across four sites in Australia, Austria and the Netherlands to assess the safety and tolerability, and to assess the maximum tolerated dose (MTD) for further development. Patients remain on standard-of-care treatment until study completion, after which the MTD primary endpoint will be confirmed.

Dr. David N. Cade, Group Chief Medical Officer, Telix, commented, "We are pleased to have completed enrolment in IPAX-2, an important milestone in the development of TLX101-Tx as a potential treatment for first-line glioblastoma. The tolerability amongst patients, and the absence of dose-limiting toxicities observed on this study strongly support the continued development of this targeted radiopharmaceutical candidate. We thank the principal investigators, their clinical teams, and the patients who have participated in this important research."

TLX101-Tx is currently also under evaluation in the pivotal IPAX BrIGHT2 trial to assess the safety and efficacy of TLX101-Tx in combination with chemotherapy (lomustine), compared to chemotherapy alone in patients with recurrent glioblastoma (last line). IPAX BrIGHT is actively enrolling and dosing patients in Australia and the Netherlands and is also approved in Austria and Belgium with enrollment to begin soon. This marks the first radiopharmaceutical therapy to enter Phase 3 development for glioblastoma.

Telix’s PET imaging candidate TLX101-Px (floretyrosine F 18) has been used across the IPAX series of trials to identify participants with overexpressed LAT1 as suitable candidates for TLX101-Tx therapy, and to provide baseline and follow-up information on tumor response and progression.

About TLX101-Tx

TLX101-Tx (¹³¹I-iodofalan) is a systemically administered radiopharmaceutical therapy that targets L-type amino acid transporter 1 (LAT1), which is typically over-expressed in glioblastoma. TLX101-Tx utilizes a small molecule approach due to the need to cross the blood brain barrier, the normal protective barrier that prevents many potential drug candidates entering the brain. In addition to IPAX-2, TLX101-Tx was also the subject of the IPAX-1 study3 in recurrent glioblastoma, which reported a median overall survival (OS) of 13 months from the initiation of treatment with TLX101-Tx, or 23 months from initial diagnosis4. Preliminary results from the IPAX-Linz investigator-initiated trial of TLX101-Tx in the recurrent setting were consistent and confirmatory to IPAX-1, with a median OS of 11.9 months from the relapse prior to trial enrollment and 32.2 months from initial diagnosis5. Beyond the clinical trial setting, an early access program for TLX101-Tx in Europe has dosed 18 patients at first recurrence or later, further establishing the clinical utility of TLX101-Tx.

TLX101-Tx has received orphan drug designation in the U.S. and Europe for the treatment of glioma. TLX101-Tx and TLX101-Px have not received a marketing authorization in any jurisdiction and are for investigational use only.

About glioblastoma

Glioblastoma (GBM), is a high-grade glioma and the most common and aggressive form of primary brain cancer, with approximately 22,000 new cases diagnosed annually in the U.S.6. The mainstay of treatment for GBM comprises surgical resection, followed by combined radiotherapy and chemotherapy. Despite such treatment, recurrence occurs in almost all patients7, with an expected survival duration of 12-15 months from diagnosis

(Press release, Telix Pharmaceuticals, MAY 19, 2026, View Source [SID1234665846])

Roche to present new data at ASCO 2026, reinforcing giredestrant’s potential to transform the treatment paradigm in early breast cancer

On May 19, 2026 Roche (SIX: RO, ROP; OTCQX: RHHBY) reported it will present new data from nine approved and investigational medicines across more than 15 indications at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, held 29 May to 2 June in Chicago.

"Roche’s ASCO (Free ASCO Whitepaper) data reflect our commitment to addressing those cancers that impose the highest burden on patients and society," said Levi Garraway, MD, PhD, Roche’s chief medical officer and head of Global Product Development. "In particular, our ASCO (Free ASCO Whitepaper) data highlight significant advances in breast cancer, including the latest results for giredestrant and our evolving approach to HER2-positive metastatic disease."

Redefining the standard of care in breast cancer
Roche’s ASCO (Free ASCO Whitepaper) 2026 focus is on giredestrant, an investigational, oral, selective oestrogen receptor degrader (SERD) being studied in early and advanced oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer.

This subtype accounts for approximately 70% of breast cancer cases, and the majority are diagnosed in the early stage.1,2 Data from three phase III trials demonstrate giredestrant’s potential as a future standard of care endocrine therapy across multiple disease stages:

lidERA Breast Cancer: Building on the transformational results shared in December 2025, which demonstrated a 30% reduction in the risk of invasive disease recurrence or death,3 new data will indicate whether the efficacy and safety of giredestrant remain consistent across pre- and post-menopausal patients with early breast cancer. The lidERA data have been submitted to the U.S. Food and Drug Administration (FDA).
persevERA Breast Cancer: Primary results investigating giredestrant in combination with palbociclib as a first-line therapy in locally advanced or metastatic cancer will be presented. These data will provide context following the announcement that while the study did not meet its primary endpoint, the giredestrant combination showed a numerical improvement in this distinct patient population, suggesting that giredestrant is active in the first-line setting.
evERA Breast Cancer: New post-progression treatment analyses will be shared exploring the sustained clinical benefit for people treated with giredestrant plus everolimus in the post-cyclin-dependent kinase 4/6 inhibitor setting. The U.S. FDA recently accepted the New Drug Application for giredestrant based on the positive evERA data.
Our ASCO (Free ASCO Whitepaper) data also highlight progress in HER2-positive breast cancer, an area Roche has led for over 30 years:

RG6596/ZN-A-1041 in HER2-positive breast cancer: Preliminary results from a phase Ic expansion trial will provide early information on the safety and efficacy of ZN-A-1041, a highly blood-brain barrier-permeable, HER2-selective tyrosine kinase inhibitor, in combination with other HER2-targeted therapies, for patients with pre-treated HER2-positive metastatic breast cancer. Designed for enhanced brain penetration, ZN-A-1041 may improve the ability to prevent and treat brain metastases, a major challenge in metastatic breast cancers.
Advancing precision medicine and novel combinations
Roche is also presenting data from its diverse pipeline targeting specific genetic drivers and difficult-to-treat cancers, including:

Divarasib in non-small cell lung cancer (NSCLC): Roche will present results from the Krascendo 170 phase Ib/II study evaluating the next-generation oral KRAS G12C inhibitor divarasib combined with pembrolizumab in treatment-naive patients with KRAS G12C+ advanced NSCLC. These data informed the phase III Krascendo 2 study, which investigates this combination as a first-line therapy regardless of PD-L1 status. Divarasib is currently being evaluated in three pivotal phase III studies as a monotherapy or in chemotherapy-free combinations.
Lunsumio (mosunetuzumab) plus Polivy (polatuzumab vedotin) in diffuse large B-cell lymphoma (DLBCL): Roche will present updated data from the phase III SUNMO trial to further establish the efficacy and safety of Lunsumio plus Polivy compared to chemotherapy (R-GemOx) particularly in second-line patients with relapsed/refractory DLBCL who are not eligible for transplant. This first combination of a bispecific antibody and antibody-drug conjugate could potentially provide patients who often face poor prognoses and significant treatment burdens with an effective, fixed-duration, chemotherapy-free regimen.

Overview of key presentations featuring Roche medicines and molecules:

Medicine or molecule Abstract title Abstract number/ presentation details
Breast cancer
Giredestrant Giredestrant (GIRE) + palbociclib (PALBO) vs letrozole (LET) + PALBO as first-line (1L) therapy in patients (pts) with estrogen receptor-positive, HER2-negative locally advanced or metastatic breast cancer (ER+, HER2– LA/mBC): Primary analysis of the phase III persevERA Breast Cancer (BC) trial #LBA1006 oral

Breast Cancer — Metastatic

Tuesday 02 June 2026
11:45 – 11:57 AM CDT
Giredestrant Efficacy and safety of giredestrant (GIRE) in patients (pts) with estrogen receptor-positive, HER2-negative early breast cancer (ER+, HER2– eBC) in the phase III lidERA BC clinical trial: Results by menopausal status #502 oral

Breast Cancer —Local/Regional/Adjuvant

Saturday 30 May 2026
1:39 – 1:51 PM CDT
Giredestrant Post-progression treatment (tx) analyses of evERA Breast Cancer (BC): A phase III trial of giredestrant (GIRE) + everolimus (E) in patients (pts) with estrogen receptor-positive, HER2-negative advanced BC (ER+, HER2– aBC) previously treated with a CDK4/6 inhibitor (i) #1016 rapid oral

Breast Cancer — Metastatic

Sunday 31 May 2026
12:00 – 12:06 PM CDT
RG6596/ ZN-A-1041 Safety and efficacy of ZN-A-1041, a highly blood–brain barrier (BBB)-permeable HER2 tyrosine kinase inhibitor (TKI), + trastuzumab deruxtecan (T-DXd) or pertuzumab-trastuzumab (PH) in HER2-positive metastatic breast cancer (HER2+ mBC): Phase Ic expansion results from the ZN-A-1041-101-US trial #1055 poster

Breast Cancer — Metastatic

Monday 01 June 2026
1:30 – 4:30 PM CDT
Itovebi (inavolisib) Outcomes by lobular (lob) histology status at initial diagnosis in patients (pts) in the INAVO120 phase 3 trial with PIK3CA-mutated (mut), hormone receptor-positive (HR+), HER2-negative (HER2–), endocrine-resistant advanced breast cancer (aBC) treated with inavolisib (INAVO)/placebo (PBO) + palbociclib (PALBO) + fulvestrant (FULV) #1079 poster

Breast Cancer — Metastatic

Monday 01 June 2026
1:30 – 4:30 PM CDT
Kadcyla (trastuzumab emtansine) Adjuvant antibody–drug conjugate (ADC) eligibility and corresponding prognosis in HER2+ early breast cancer (eBC): A US-based real-world comparison of KATHERINE and DESTINY-Breast05 populations #535 poster

Breast Cancer —Local/Regional/Adjuvant

Monday 01 June 2026
1:30 – 4:30 PM CDT
Blood cancer
Lunsumio (mosunetuzumab) and Polivy (polatuzumab vedotin) Mosunetuzumab plus polatuzumab vedotin (Mosun-Pola) versus rituximab, gemcitabine and oxaliplatin (R-GemOx) in patients with relapsed/refractory large B-cell lymphoma (R/R LBCL): Updated efficacy and safety from the phase 3 SUNMO study including in second-line (2L) versus third-line plus (3L+) patient subgroups #7007 oral

Hematologic Malignancies —Lymphoma and Chronic Lymphocytic Leukemia

Saturday 30 May 2026
5:12 – 5:24 PM CDT
Columvi (glofitamab) Fixed-duration glofitamab monotherapy in relapsed/refractory (R/R) mantle cell lymphoma (MCL) with/without prior Bruton’s tyrosine kinase inhibitor (BTKi) exposure: updated data after a 3.5-year follow-up #7006 oral

Hematologic Malignancies —Lymphoma and Chronic Lymphocytic Leukemia

Saturday 30 May 2026
5:00 – 5:12 PM CDT
Polivy Outcomes by LymphoMAP archetypes in untreated diffuse large B-cell lymphoma from the POLARIX trial #7017 rapid oral

Hematologic Malignancies —Lymphoma and Chronic Lymphocytic Leukemia

Friday 29 May 2026
2:12 – 2:18 PM CDT
Columvi, Lunsumio and Polivy Multivariable analyses (MVAs) of overall survival (OS) in the phase 3 SUNMO, STARGLO and POLARGO trials in relapsed/refractory large B-cell lymphoma (LBCL) #7093 poster

Hematologic Malignancies —Lymphoma and Chronic Lymphocytic Leukemia

Monday 01 June 2026
9:00 – 12:00 PM CDT
Lung cancer
Divarasib First-line (1L) divarasib plus pembrolizumab (pembro) in advanced or metastatic KRAS G12C+ non-small cell lung cancer (NSCLC): results from the Krascendo-170 study #8510 clinical science symposium

Lung Cancer — Non-Small Cell Metastatic

Saturday 30 May 2026
8:36 – 8:48 AM CDT
Tecentriq (atezolizumab) Transcriptomic analyses of molecular subsets and correlations with clinical outcomes from the phase 3 IMforte study of lurbinectedin (lurbi) + atezolizumab (atezo) maintenance treatment (Tx) in extensive-stage small-cell lung cancer (ES-SCLC) #8014 rapid oral

Lung Cancer — Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

Sunday 31 May 2026
5:12 – 5:18 PM CDT
Tecentriq IMforte: Quality-adjusted time without symptoms or toxicity (Q-TWiST) analysis of first-line maintenance (1Lm) treatment (Tx) with lurbinectedin (lurbi) + atezolizumab (atezo) vs atezo in extensive-stage small cell lung cancer (ES-SCLC) #8086 poster

Lung Cancer — Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

Sunday 31 May 2026
9:00 – 12:00 PM CDT
Gastrointestinal cancer
Tecentriq IMbrave251: Final analysis of atezolizumab (atezo) plus lenvatinib (lenva) or sorafenib (sora) vs lenva or sora alone in locally advanced or metastatic hepatocellular carcinoma (LA/mHCC) previously treated with atezo and bevacizumab (bev) #4002 oral

Gastrointestinal Cancer —Gastroesophageal, Pancreatic, and Hepatobiliary

Monday 01 June 2026
10:09 – 10:21 AM CDT
Tecentriq Health-related quality of life (HRQOL) in the phase 3 trial of standard chemotherapy alone or combined with atezolizumab as adjuvant therapy for patients with stage III deficient DNA mismatch repair (dMMR) colon cancer (Alliance A021502, ATOMIC)* #3626 poster

Gastrointestinal Cancer —Colorectal and Anal

Saturday 30 May 2026
9:00 – 12:00 PM CDT
Bladder cancer
Tecentriq Patient-reported outcomes from IMvigor011: A phase 3 study of circulating tumor (ct)DNA-guided adjuvant atezolizumab vs placebo in muscle-invasive bladder cancer (MIBC) #4627 poster

Genitourinary Cancer — Kidney and Bladder

Sunday 31 May 2026
9:00 – 12:00 PM CDT
*Study led by the Alliance for Clinical Trials in Oncology and supported by Roche

(Press release, Hoffmann-La Roche, MAY 19, 2026, View Source [SID1234665845])

Mestag Therapeutics Announces the First Patient Dosed with MST-0312 in the Phase I STARLYS Trial

On May 19, 2026 Mestag Therapeutics, a clinical-stage biotech company harnessing fibroblast immunology for the benefit of patients with inflammatory disease and cancer, reported the dosing of the first patient in a Phase 1 clinical trial evaluating MST-0312 in patients with selected advanced solid tumors. The first in human trial, named the STARLYS trial, is an adaptive, modular multi-part, multi-arm open-label study designed to evaluate the safety, tolerability, pharmacodynamics, pharmacokinetics and anti-tumor activity of MST-0312 alone and in combination with pembrolizumab.

MST-0312 is a bispecific antibody designed to activate lymphotoxin-beta receptor (LTBR) in the tumor microenvironment to induce the formation of tertiary lymphoid structures (TLS) and associated high endothelial venules (HEV) in tumor tissue. TLS are a hallmark of effective anti-tumor immunity consisting of aggregates of T, B and dendritic cells, associated with the recruitment, education, and activation of immune cells to drive anti-tumor immune responsesi,ii. Patients with TLS and HEV in their tumors show significantly improved response to treatment and extended survival outcomes compared to patients whose tumors lack these structuresiii,iv,v,vi. The STARLYS trial will initially evaluate MST-0312 in tumors formed in barrier organs (lung, gut, bladder, breast and skin), which are believed to be particularly sensitive to TLS formation.

"Dosing the first patient with MST-0312 is a significant milestone in developing this potential new therapeutic class," said Dr. Lindsey Rolfe, MBChB, Chief Medical Officer of Mestag. "Our carefully designed study evaluates monotherapy and combination therapy in immunologically ‘cold’ and ‘warm’ tumors, generating multiple mechanistic and clinical insights to inform future development. This important step reflects the scientific rigor and dedication of the Mestag team, as we advance novel therapies for patients."

Dr. Emiliano Calvo MD PhD, a Principal Investigator of the study and Director of Clinical Research at START Madrid-CIOCC (Centro Integral Oncológico Clara Campal) Hospital in Madrid, Spain where the first patient was dosed, said "MST-0312 is an exciting new investigative approach for the treatment of solid tumors and we are thrilled to have dosed the first patient in the STARLYS trial."

Dr. Elena Garralda MD PhD, Co-Director of the Clinical Research Program and Head of Early Drug Development at Vall d’Hebron Institute of Oncology in Barcelona, Spain, and coordinating Principal Investigator of the STARLYS trial, added, "Published data show that the presence of TLS is associated with significantly improved outcomes for patients. Despite recent therapeutic advances, many patients with solid tumors derive limited benefit from current therapies. MST-0312 is designed to address this unmet need by inducing TLS and reshaping anti-tumor immunity. I look forward to working with the STARLYS investigators to evaluate MST-0312 in the clinic."

(Press release, Mestag Therapeutics, MAY 19, 2026, View Source [SID1234665844])

Amplia Launches First Stage of Pivotal Narmafotinib Trial

On May 19, 2026 Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF), ("Amplia" or the "Company"), reported that it is initiating a Phase 2b study of narmafotinib in pancreatic cancer exploring a new dosing regimen. Designed in alignment with FDA feedback, the study will form the basis – and first stage – of a registrational study in this indication given the high existing unmet need for innovative treatments. Narmafotinib is a best-in-class FAK inhibitor that has received orphan drug designation and fast track designation from the U.S. FDA as a potential treatment in pancreatic cancer.

To-date narmafotinib has shown no significant tolerability burden over chemotherapy alone, and we have observed a range of compelling efficacy signals across responses and survival. This has been achieved with only an intermittent dosing schedule, giving us confidence that moving into daily dosing may further enhance the therapeutic potential of narmafotinib", said Dr Chris Burns, CEO and Managing Director of Amplia. "We have been able to accelerate this phase of the narmafotinib program with redeployed resources, including drug product, following the wind-down of recruitment in the AMPLICITY trial. We believe our registrational study submission to the FDA will be stronger for the inclusion of this portion of the Phase 2b study and we look forward to further engagement with regulators."

The study will investigate, for the first time, a daily dosing schedule for narmafotinib, at two dosing levels, with the chemotherapies gemcitabine and Abraxane in newly diagnosed advanced pancreatic cancer patients. In this first stage, each dosing cohort will have 6 patients (12 patients in total), which will be combined with gemcitabine and Abraxane given on their conventional schedule. In addition to safety and tolerability, pharmacokinetics (PK) and efficacy will be assessed. Exploratory endpoints will include effects on disease biomarkers as well as effects on fibrosis, a key indicator of FAK activity. The study will enrol patients across 3-4 sites in Australia. The Company anticipates patient enrolment will begin by the fourth quarter of this year with the safety, tolerability and PK assessment for the 12 patients completed in the second quarter of 2027.

(Press release, Amplia Therapeutics, MAY 19, 2026, View Source [SID1234665832])