BioLineRx Ltd. and Hemispherian AS Establish Joint Venture to Develop GLIX1, a First-in-Class, Oral, Small Molecule Targeting DNA Damage Response in Glioblastoma and Other Cancers
BioLineRx (NASDAQ:BLRX) and Hemispherian AS have formed a joint venture to develop GLIX1, a first-in-class oral drug targeting DNA damage response in glioblastoma and other cancers. The FDA has cleared the IND application for GLIX1, with a Phase 1/2a study set to begin in Q1 2026.
Under the agreement, Hemispherian contributes GLIX1's global rights and will initially hold 60% of the JV, while BioLineRx will manage and fund development activities with a 40% initial stake, potentially increasing to 70%. The glioblastoma market opportunity is projected to reach $3.8 billion annually across the US and EU5 by 2030.
GLIX1 has shown promising results in preclinical studies, including potent anti-tumor activity, blood-brain barrier penetration, and a favorable safety profile. The drug has received Orphan Drug Designation from both FDA and EMA.
BioLineRx (NASDAQ:BLRX) e Hemispherian AS hanno formato una joint venture per sviluppare GLIX1, un farmaco orale di prima classe che punta alla risposta al danno al DNA nel glioblastoma e in altri tumori. La FDA ha autorizzato l'IND per GLIX1, con uno studio di Fase 1/2a che inizierà nel Q1 2026.
Secondo l'accordo, Hemispherian conferisce i diritti globali su GLIX1 e deterrà inizialmente il 60% della JV, mentre BioLineRx gestirà e finanzierà le attività di sviluppo con una partecipazione iniziale del 40%, che potrebbe crescere fino al 70%. L'opportunità di mercato per il glioblastoma è prevista in 3,8 miliardi di dollari all'anno negli Stati Uniti e nell'UE5 entro il 2030.
GLIX1 ha mostrato risultati promettenti in studi preclinici, tra cui significativa attività antitumorale, penetrazione della barriera emato-encefalica e un profilo di sicurezza favorevole. Il farmaco ha ricevuto la Designazione di Farmaco Orfano sia dalla FDA che dall'EMA.
BioLineRx (NASDAQ:BLRX) y Hemispherian AS han formado una empresa conjunta para desarrollar GLIX1, un fármaco oral de primera clase que apunta a la respuesta ante el daño en el ADN en glioblastoma y otros cánceres. La FDA ha autorizado la IND para GLIX1, con un estudio de Fase 1/2a que comenzará en el Q1 de 2026.
Según el acuerdo, Hemispherian aporta los derechos globales de GLIX1 y tendrá inicialmente el 60% de la JV, mientras que BioLineRx gestionará y financiará las actividades de desarrollo con una participación inicial del 40%, que podría aumentar hasta el 70%. Se proyecta que la oportunidad de mercado para el glioblastoma alcance 3,8 mil millones de dólares anuales en EE. UU. y la UE5 para 2030.
GLIX1 ha mostrado resultados prometedores en estudios preclínicos, incluyendo fuerte actividad antitumoral, penetración de la barrera hematoencefálica y un perfil de seguridad favorable. El fármaco ha recibido Designación de Fármaco Huérfano por parte de la FDA y de la EMA.
BioLineRx (NASDAQ:BLRX) 와 Hemispherian AS 는 GLIX1 을 개발하기 위한 공동 벤처를 형성했습니다. GLIX1 은 뇌종양인 교모세포종 및 기타 암에서 DNA 손상 반응을 표적으로 하는 1세대 경구 약물입니다. FDA 는 GLIX1 의 IND 를 승인했으며 1상/2상 통합 연구 는 2026년 1분기에 시작될 예정입니다.
계약에 따르면 Hemispherian 은 GLIX1 의 글로벌 권리를 제공하고 초기에는 JV 의 60% 를 보유하며, BioLineRx 는 개발 활동을 관리하고 자금을 조달하며 초기 지분 40% 을 가지며, 향후 70% 로 증가할 수 있습니다. 다발성 뇌종양 중 글리오블라스트종 시장 기회는 2030년까지 미국과 EU5에서 연간 38亿美元에 이를 것으로 예상됩니다.
GLIX1 은 전임상 연구에서 강력한 항종양 활성, 혈뇌장벽 통과 능력, 우수한 안전성을 보였으며, 이 약물은 FDA 와 EMA 로부터 외래 약물(Orphan Drug) 지정을 받았습니다.
BioLineRx (NASDAQ:BLRX) et Hemispherian AS ont formé une coentreprise pour développer GLIX1, un médicament oral de nouvelle classe ciblant la réponse à l’endommagement de l’ADN dans le glioblastome et d’autres cancers. La FDA a approuvé l’IND pour GLIX1, avec une étude Phase 1/2a qui doit débuter au T1 2026.
Selon l’accord, Hemispherian apporte les droits mondiaux sur GLIX1 et détiendra initialement 60% de la JV, tandis que BioLineRx gérera et financera les activités de développement avec une participation initiale de 40%, pouvant augmenter jusqu’à 70%. L’opportunité de marché du glioblastome est estimée à 3,8 milliards de dollars par an aux États‑Unis et dans l’UE5 d’ici 2030.
GLIX1 a montré des résultats prometteurs dans les études précliniques, incluant une forte activité antitumorale, la pénétration de la barrière hémato‑encéphalique et un profil de sécurité favorable. Le médicament a reçu la Désignation de Médicament Orphelin de la FDA et de l’EMA.
BioLineRx (NASDAQ:BLRX) und Hemispherian AS haben eine Joint Venture zur Entwicklung von GLIX1 gegründet, einem ersten in seiner Klasse stehenden oralen Medikament, das die DNA-Damage-Response bei Glioblastom und anderen Krebsarten adressiert. Die FDA hat den IND-Antrag für GLIX1 freigegeben, mit einer Phase-1/2a-Studie, die im Q1 2026 beginnen soll.
Nach der Vereinbarung überträgt Hemispherian die globalen Rechte an GLIX1 und wird anfänglich 60% des JV halten, während BioLineRx Entwicklungsaktivitäten steuert und finanziert und anfänglich eine 40%-Beteiligung hält, die sich möglicherweise auf 70% erhöhen könnte. Das Marktpotenzial für Glioblastom wird bis 2030 auf 3,8 Milliarden USD pro Jahr in den USA und der EU5 geschätzt.
GLIX1 zeigte in präklinischen Studien vielversprechende Ergebnisse, darunter starke antitumorale Aktivität, Durchlässigkeit der Blut-Hirn-Schranke und ein vorteilhaftes Sicherheitsprofil. Das Medikament hat die Orphan-Drug-Designation sowohl von der FDA als auch von der EMA erhalten.
BioLineRx (NASDAQ:BLRX) وHemispherean AS قد شكلتا مشروعاً مشتركاً لتطوير GLIX1، وهو دواء فموي من فئة أولى يستهدف استجابة تلف الحمض النووي في الورم الأرومي الدبقي الدبقي (glioblastoma) وغيره من السرطانات. صادقت FDA على طلب IND الخاص بـ GLIX1، مع دراسة المرحلة 1/2a من المقرر أن تبدأ في الربع الأول من 2026.
وفقاً للاتفاق، تساهم Hemispherian بحقوق GLIX1 العالمية وستمتلك في البداية 60% من المشروع المشترك، بينما ستدير BioLineRx وتموّل أنشطة التطوير بحصة ابتدائية 40%، قد ترتفع إلى 70%. من المتوقع أن يصل سوق الورم الأرومي الدبقي إلى 3.8 مليار دولار سنوياً في الولايات المتحدة والـ EU5 بحلول 2030.
أظهر GLIX1 نتائج واعدة في الدراسات قبل السريرية، بما في ذلك نشاط مضاد للورم قوي، اختراق الحاجز الدموي الدماغي، وملف أمان إيجابي. كما حصل الدواء علىDesignation دواءٍ يتيم من FDA وEMA.
BioLineRx (NASDAQ:BLRX) 与 Hemispherian AS 已成立合资企业以开发 GLIX1，这是一种针对 glioblastoma 及其它癌症的第一类口服药物，针对DNA损伤应答。FDA 已批准 GLIX1 的 IND 申请，计划在 2026 年第一季度启动 1/2 期联合研究。
根据协议，Hemispherian 将GLIX1 的全球权利移交给合资企业，初始持有 60% 的股权，而 BioLineRx 将管理并资助开发活动，初始持股为 40%，未来可能增至 70%。到 2030 年，在美国和 EU5 市场，胶质母细胞瘤的市场机会预计达 每年 38 亿美元。
GLIX1 在前瞻性研究中显示出令人鼓舞的结果，包括强大的抗肿瘤活性、穿透血脑屏障能力以及有利的安全性特征。该药物已获得 FDA 与 EMA 的孤儿药（Orphan Drug） designation。
- FDA IND clearance received for GLIX1, with Phase 1/2a trial starting Q1 2026
- Large market opportunity of $3.8 billion annually by 2030 in US and EU5
- Orphan Drug Designation granted by both FDA and EMA
- BioLineRx confirms cash runway into first half of 2027
- GLIX1 demonstrates strong preclinical results with blood-brain barrier penetration
- Potential synergy with PARP inhibitors for additional cancer applications
- Early-stage drug development with significant clinical trial risks ahead
- Complex joint venture structure with evolving ownership stakes
- Highly competitive and challenging glioblastoma treatment landscape
- Phase 1 trial data not expected until H1 2027
Insights
BioLineRx's joint venture to develop GLIX1 for glioblastoma represents significant potential in an area with minimal treatment advances since 2005.
This joint venture between BioLineRx and Hemispherian represents a significant development in glioblastoma (GBM) treatment, an area with minimal advances since 2005. GLIX1's mechanism of action is particularly noteworthy – it agonizes TET2 activity in cancer cells specifically, causing double-stranded DNA breaks that lead to cancer cell death while sparing healthy tissue. This selectivity could potentially overcome the toxicity limitations of current GBM treatments.
The preclinical data package appears compelling: GLIX1 has demonstrated efficacy in multiple GBM models with favorable blood-brain barrier penetration – a critical hurdle for CNS therapeutics. The FDA's IND clearance validates the preclinical safety profile and enables progression to human trials, scheduled for Q1 2026. Securing Orphan Drug Designation from both FDA and EMA provides regulatory advantages and acknowledges the unmet need in GBM.
What's particularly interesting is GLIX1's potential beyond GBM. Early data suggesting synergy with PARP inhibitors in homologous recombination proficient cancers could significantly expand its application. PARP inhibitors currently work best in HR-deficient cancers (like BRCA-mutated tumors); expanding efficacy to HR-proficient cancers would address a substantial patient population currently lacking targeted options.
The development team appears strong, with Dr. Roger Stupp involved – notable as the developer of the current GBM standard-of-care regimen (the "Stupp protocol"). His involvement lends considerable credibility to this program. With data expected in H1 2027, this represents a mid-term catalyst for BioLineRx, whose 40% initial stake could increase to 70% based on continued investment, providing significant upside exposure if GLIX1 proves successful.
BioLineRx's strategic joint venture targets a $3.8B glioblastoma market with a novel TET2-targeting compound that already has FDA IND clearance.
This joint venture represents a strategic pipeline expansion for BioLineRx into the high-value oncology space through an asset with multiple competitive advantages. GLIX1 targets the DNA damage response pathway through a novel mechanism – TET2 agonism – which differentiates it from other DDR-targeting agents like PARP inhibitors. The structure of the deal is particularly noteworthy: BioLineRx starts with a 40% stake that can increase to 70% based on continued investment, creating a favorable risk/reward profile with significant upside exposure.
The market opportunity is substantial, with projected $3.8 billion annual addressable market across US and EU5 by 2030. Glioblastoma represents an area of extremely high unmet need with no major treatment advances in nearly two decades, creating favorable regulatory pathways and pricing potential for effective therapies.
The deal structure appears efficiently designed – BioLineRx provides development funding and expertise while Hemispherian contributes the asset and scientific know-how. BioLineRx's commitment to directing all funding toward asset development (rather than corporate overhead) demonstrates fiscal discipline. Additionally, the company's confirmation of cash runway into H1 2027 indicates sufficient resources to reach initial clinical data readouts without immediate dilutive financing.
While early stage, GLIX1 has cleared significant development hurdles with both FDA IND clearance and Orphan Drug Designations. The planned clinical development strategy is well-designed, with a traditional dose-finding Phase 1 followed by three strategic expansion cohorts targeting different markets: recurrent GBM as monotherapy, newly diagnosed GBM in combination with standard care, and other solid tumors in combination with PARP inhibitors – maximizing shots on goal from a single compound.
- GLIX1 restores TET2 activity in cancer, resulting in double stranded DNA breaks in cancer cells only -
- FDA IND clearance received for Phase 1/2a study, expected to initiate in Q1 2026 -
- Glioblastoma market opportunity estimated to be in excess of
- BioLineRx affirms its cash runway into the first half of 2027 -
- Management to host conference call today, September 29th, at 8:30 am EDT -
GLIX1, Hemispherian's lead drug candidate, is being developed as a potential treatment for newly diagnosed and recurrent GBM. GLIX1 has demonstrated potent anti-tumor activity in multiple glioblastoma models, excellent blood-brain barrier penetration and a favorable safety profile in preclinical toxicology studies. An Investigational New Drug (IND) application was cleared by the
"This joint venture combines our expertise in DNA damage response research and discovery, with BioLineRx's proven track record of clinical and regulatory success," stated Zeno Albisser, Chief Executive Officer of Hemispherian. "Glioblastoma is a notoriously challenging tumor type in urgent need of new treatment options. GLIX1 is a small molecule that crosses the blood-brain-barrier, has a novel mechanism of action targeting a DNA repair mechanism in cancer cells, and has demonstrated impressive efficacy and a favorable safety profile in pre-clinical models. We are eager to initiate the Phase 1/2a study as expeditiously as possible, and are working with leading neuro-oncology centers and the BioLineRx team to bring this promising asset to patients."
"Following a comprehensive review of pipeline expansion opportunities in oncology and rare diseases, we are thrilled to have identified a highly innovative asset such as GLIX1, with the potential to become an effective and safe treatment option for cancer patients with high unmet needs. I could not be more excited to work alongside the Hemispherian team," said Philip Serlin, Chief Executive Officer of BioLineRx. "This JV brings together highly complementary capabilities in DNA repair research, alongside clinical development and regulatory expertise, to create an entity that I believe is well positioned to bring much-needed innovation to the most challenging cancer types while creating shareholder value. The JV also has a first look at other molecules in Hemispherian's pipeline, but will initially focus on GLIX1."
Terms of the Joint Venture
Pursuant to the terms of the JV agreement, Hemispherian will contribute the global rights of GLIX1 to the JV, and BioLineRx will be responsible for managing, performing and funding all JV development activities. In consideration for their respective contributions, as of the JV's inception, Hemispherian will hold
Urgent Unmet Need and Significant Commercial Opportunity in Glioblastoma
GBM is the most common and aggressive form of primary brain cancer. The current standard of care (SoC) treatment was established in 2005, with only limited further advancements since. Treatment includes surgical resection, followed by radiotherapy, and concomitant and adjuvant chemotherapy (Temozolomide), yet most patients will succumb to their disease within less than 18 months (median OS of 12-18 months).
GBM occurs at all ages, but peaks in the fifth and sixth decades of life, with an increasing incidence in light of the aging global population. New and better treatments are desperately needed aiming at improving survival, maintaining quality of life and delaying tumor progression and symptoms.
The annual incidence of GBM is expected to be approximately 18,500 patients in the
Phase 1/2a Study to be Conducted by World Leading Investigators in Glioblastoma
Dr. Roger Stupp and Dr. Ditte Primdahl of the Malnati Brain Tumor Institute of the Lurie Comprehensive Cancer Center at Northwestern University will serve as principal investigators for the study.
The Phase 1 part of the trial is expected to recruit up to 30 patients with recurrent GBM. The objective of this part 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 is anticipated in H1 2027.
The Phase 2a expansion part of the trial is planned to include three population cohorts: (1) GLIX1 as monotherapy in recurrent GBM, (2) GLIX1 in combination with standard of care in newly diagnosed GBM patients (likely a "window of opportunity" study), and (3) GLIX1 in combination with PARP inhibitors in other solid tumors.
Conference Call and Webcast Information
To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company's website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until October 1, 2025; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.
About Hemispherian AS
Hemispherian AS is a pioneering biotech company developing next-generation therapeutics for aggressive cancers. The company is focused on developing a novel class of small molecule drugs targeting the TET2 enzyme.
The company's lead compound, GLIX1, has a unique mechanism of action that selectively targets DNA repair pathways in tumor cells while sparing healthy tissue. Hemispherian has received IND clearance from the FDA to start clinical development for GLIX1. Hemispherian is based in
About BioLineRx
BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases. 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
In addition, BioLineRx has established a joint venture with Hemispherian AS to develop 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 will be initiated in the first quarter of 2026.
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 potential success of the joint venture with Hemispherian, expectations with regard to the therapeutic potential of GLIX1 and the addressable market, expectations regarding the timeline for initiation of a Phase 1/2a study, the expected cash runway of BioLineRx, 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 BioLineRx's therapeutic candidates, 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 its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials, whether the clinical trial results for APHEXDA will be predictive of real-world results; BioLineRx's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings and approvals; whether access to APHEXDA is achieved in a commercially viable manner and whether APHEXDA 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 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 needs for and ability to access sufficient additional financing; risks related to changes in healthcare laws, rules and regulations in
Contacts:
BioLineRx
Irina Koffler
LifeSci Advisors, LLC
IR@biolinerx.com
Moran Meir
LifeSci Advisors, LLC
moran@lifesciadvisors.com
Hemispherian
Zeno Albisser
info@hemispherian.com
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