On April 28, 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 that the first patient has been dosed in the first-in-human, Phase 1/2a study of GLIX1 for the treatment of recurrent and progressive glioblastoma (GBM) and other high-grade gliomas. The GLIX1 program is being conducted under a collaboration between BioLineRx and Hemispherian announced in September 2025.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The patient was dosed at NYU Langone Health under the supervision of Dr. Alexandra Miller, Chief of Neuro-Oncology & Co-Director of Brain and Spine Tumor Center, Perlmutter Cancer Center. Northwestern University, led by lead investigators Dr. Roger Stupp and Dr. Ditte Primdahl, and Moffit Cancer Center, led by Dr. Patrick Grogan, will also be participating in the study.

GLIX1 is an oral, first-in-class, small molecule with a novel mechanism of action, designed to activate TET2 and drive tumor DNA damage. By restoring TET2 activity, GLIX1 induces DNA damage selectively in cancer cells, representing a differentiated approach to targeting the DNA damage response with potential applicability across a broad range of tumors. Glioblastoma was selected as the initial indication due to its highly suppressed TET2 activity and significant unmet medical need. GBM remains one of the most aggressive and treatment-resistant cancers, and there is an urgent need for breakthrough innovation and more effective treatment options.

In multiple pre-clinical models, including in-vivo GBM models, GLIX1 demonstrated potent anti-tumor activity, excellent blood-brain-barrier penetration, and a favorable safety profile.

"The dosing of the first patient in our Phase 1/2a study of GLIX1 is an important milestone for BioLineRx and, more importantly, for patients battling glioblastoma, a very challenging tumor where there has been very little innovation over the past 20 years," said Philip Serlin, Chief Executive Officer of BioLineRx. "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. We are excited to advance GLIX1 development into this first-in-human clinical trial and look forward to initial data in the first half of 2027."

Zeno Albisser, Chief Executive Officer of Hemispherian, added, "The initiation of patient dosing in this important study represents a watershed event for Hemispherian and GLIX1. This is the culmination of years of focused scientific and operational work, and an important step toward bringing a new therapeutic approach to patients with glioblastoma. We are encouraged by our preclinical data and look forward to generating initial clinical insights as the trial progresses."

Phase 1/2a clinical trial design (NCT07464925)

The Phase 1 part of the trial is a dose escalation part 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 objective is to establish a maximum tolerated dose (MTD) and/or a recommended dose based on safety, PK/PD and preliminary efficacy. Data from the Phase 1 part of the trial are anticipated in H1 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/without standard of care (e.g., 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.

(Press release, BioLineRx, APR 28, 2026, View Source [SID1234664852])

On April 28, 2026 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that ivonescimab, the company’s first-in-class PD-1/VEGF bispecific antibody, has secured multiple authoritative updates and upgrades across first-line and later-line settings in the officially updated 2026 Chinese Society of Clinical Oncology (CSCO) Guideline for the Diagnosis and Treatment of Non-Small Cell Lung Cancer (NSCLC). These strong recommendations further solidify ivonescimab’s breakthrough clinical value and its position as a new standard of care (SOC), highlighting its leadership as a next-generation immunotherapy driving the IO 2.0 era.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Key Highlights

In the Phase III HARMONi-2 study, ivonescimab monotherapy demonstrated superior progression-free survival compared with pembrolizumab in first-line PD-L1-positive (TPS ≥1%) NSCLC. Based on these results, ivonescimab has been upgraded to a Class I recommendation for first-line treatment of both squamous and non-squamous NSCLC with PD-L1 TPS ≥1%. This indication was previously approved in China and included in the National Reimbursement Drug List (NRDL). The upgrade strengthens its position as a preferred first-line option for PD-L1-positive advanced NSCLC.

In the Phase III HARMONi-6 study, ivonescimab plus chemotherapy showed positive results versus PD-1 inhibitor plus chemotherapy in first-line squamous NSCLC. This combination has received a new Class II recommendation for first-line treatment of squamous NSCLC. The supplemental application for this indication is currently under regulatory review.

Latest CSCO Guideline Recommendations for Ivonescimab

Post-resistance treatment in EGFR-mutant NSCLC: Ivonescimab plus chemotherapy maintains a Class I recommendation.
First-line treatment for advanced driver gene-negative squamous NSCLC with PD-L1 TPS ≥1%: Ivonescimab monotherapy upgraded to Class I recommendation.
First-line treatment for advanced driver gene-negative non-squamous NSCLC with PD-L1 TPS ≥1%: Ivonescimab monotherapy upgraded to Class I recommendation.
First-line treatment for advanced driver gene-negative squamous NSCLC: Ivonescimab plus chemotherapy newly added as Class II recommendation.
To date, the breakthrough clinical value of ivonescimab has been demonstrated in dozens of clinical trials and real-world experience involving more than 70,000 patients. It has gained wide acceptance among oncologists and patients, contributing to the ongoing advancement of immuno-oncology treatment paradigms globally.

(Press release, Akeso Biopharma, APR 28, 2026, View Source [SID1234664871])

On April 28, 2026 Remepy, the pioneer of Hybrid Drugs, reported a collaboration with Merck KGaA, Darmstadt Germany, a leading science and technology company, to explore the development of Hybrid Drugs across multiple therapeutic areas.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The collaboration will initially focus on some programs in the US in a rare tumor area, while potentially establishing a broader framework to explore additional Hybrid Drug opportunities across the therapeutic portfolio of Merck KGaA, Darmstadt, Germany, in the future.

Hybrid Drugs are an emerging therapeutic category that combine pharmacological treatments with personalized digital therapeutic protocols delivered through a mobile app. Research increasingly shows that the most effective care is multidisciplinary and integrative, combining medication with behavioral and therapeutic interventions. Hybrid Drugs integrate these evidence-based motor, physical, and cognitive interventions alongside medication to improve clinical outcomes1.

"We are excited about our collaboration with Merck KGaA, Darmstadt, Germany, that is a leading science and technology company," said Dr. Michal Tsur, Co-founder and Co-CEO at Remepy. "Remepy’s Hybrid Drug platform combines traditional drugs with evidence-based AI enabled digital interventions delivering personalized, adaptive integrative treatment. The new advances in regulatory frameworks, supporting the integration of software with drugs, enable the pharma industry to use the power of the digital world to differentiate drugs, enhance their efficacy and amplify their label. We are looking forward to accelerating the delivery of innovative and effective therapies to patients who need them most."

Recent developments, including the introduction of FDA Prescription Drug Use-Related Software (PDURS) guidance, and evolving SaMD-Drug combination pathways are creating clearer regulatory routes for integrating digital therapeutic components directly into pharmaceutical products. Advances in FDA digital health initiatives and guidance on AI for medical devices are opening the door to a new generation of innovative therapeutic solutions.

Hybrid Drugs introduce a new economic model for digital health. By combining a drug and a therapeutic application into a single prescription product, hybrid drugs shift digital health innovation into the established economics of pharmaceutical development, commercialization, and reimbursement.

(Press release, Merck KGaA, APR 28, 2026, View Source [SID1234664872])

On April 28, 2026 Otsuka reported Consolidated Financial Results for the Three-Month Period Ended March 31, 2026.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

(Press release, Otsuka, APR 28, 2026, View Source [SID1234669138])

On April 28, 2026 Sapient, a leader in multi-omics data generation for biomarker discovery and clinical insight delivery, reported the launch of its Tumor Protein Mapping Platform as a suite of mass spectrometry-based discovery proteomics workflows designed to map functional tumor biology across four critical dimensions: the druggable cell surface proteome, phosphorylation-driven signaling pathways, the tumor immune microenvironment, and therapeutic resistance mechanisms. The platform is now available to biopharma sponsors and comprises four purpose-built workflows – SurfaceSeek, SignalingSeek, ImmuneSeek, and ResistanceSeek – each optimized for both fresh-frozen and FFPE human tumor samples.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Central to the platform is SurfaceSeek, which directly measures proteins that are functionally deployed on the tumor cell surface to enable confident identification and validation of druggable targets for ADC, T-cell engager, and radioligand therapies. The workflow combines Sapient’s mass spectrometry-based discovery proteomics with selective enrichment of mature N-linked glycoproteins to preferentially identify proteins that have completed intracellular trafficking and are exposed on the extracellular surface. This enables direct characterization of surface target accessibility, density, and tumor selectivity, and brings peptide-level resolution to identify protein isoforms and post-translationally modified proteoforms bearing extracellular domains compatible with therapeutic binding.

The platform’s additional workflows complement and extend SurfaceSeek findings by mapping functional tumor biology that determines therapeutic outcome. SignalingSeek quantifies tumor signaling pathway activation via the measurement of phosphorylation events across critical oncogenic pathways, enabling direct assessment of on-target pathway modulation as well as identification of adaptive signaling and resistance pathways. ImmuneSeek measures functionally active tumor immune cells and the immune pathways that are driving therapeutic response, immune evasion, or suppression, while ResistanceSeek identifies the coordinated protein networks through which tumors adapt to therapeutic pressure across modalities.

"Building upon our next-generation FFPE Proteomics offering, we have developed specialized workflows that enable precise, multi-dimensional characterization of tumor biology at the protein level – and directly in human tumor tissue," said Jeramie Watrous, PhD, Co-Founder and Head of Analytical R&D at Sapient. "The key technical innovation is that these workflows – including SurfaceSeek’s selective glycoprotein enrichment and SignalingSeek’s deep phosphoproteomics – perform with exceptional concordance in both fresh-frozen and FFPE samples. This means we can apply them retrospectively to the vast biorepositories of archived tissue already collected, unlocking dimensions of functional tumor biology that were previously inaccessible in these samples."

"Tumors are not defined by a single biological dimension. They are complex and changing systems where surface target accessibility, signaling pathway activation, immune function, and resistance mechanisms all interact to determine therapeutic outcome," said Mo Jain, MD, PhD, Founder and Chief Scientific Officer at Sapient. "By mapping each of these dimensions directly at the protein level, we give drug development teams a comprehensive, unified view of what is actually governing drug response – moving oncology development beyond genomic inference alone, adding new layers of insight derived from the direct measurement of dynamic human tumor biology."

"This platform was shaped by many conversations with oncology leaders where we kept hearing the same thing: they were navigating some of the highest-stakes decisions in drug development, such as which targets to pursue, without the ability to directly measure those targets or the mechanisms that influence therapeutic outcome," added Jonathan Usuka, PhD, MBA, Chief Executive Officer at Sapient. "We designed the workflows to interrogate key dimensions of tumor biology that determine whether a drug will succeed, so our clients can advance their programs with direct evidence rather than inference."

All four workflows are available as standalone services or can be delivered in combination to provide integrated, multi-dimensional tumor characterization, and may be supported by Sapient’s DynamiQ Tumor-Tissue virtual biobank which offers streamlined access to annotated FFPE tumors and tissues.

(Press release, Sapient Discovery, APR 28, 2026, View Source [SID1234664873])