GLIX1 / Hemispherian - LARVOL DELTA

Clinical Updates (PRNewswire) - "Continued to advance preparations for initiation of a Phase 1/2a clinical trial of GLIX1 in recurrent and newly diagnosed glioblastoma in the first quarter of 2026....Enrollment continues in the CheMo4METPANC Phase 2b clinical trial, which is being led by Columbia University, and supported by both Regeneron and BioLineRx. The CheMo4METPANC trial is evaluating motixafortide in combination with the PD-1 inhibitor cemiplimab and standard chemotherapy (gemcitabine and nab-paclitaxel)."

Enrollment status • New P1/2 trial • Glioblastoma • Pancreatic Ductal Adenocarcinoma

BioLineRx Announces Receipt of USPTO Notice of Allowance for Key Patent Covering GLIX1 for Treating a Broad Range of Cancer Types (PRNewswire) - "Patent covers the use of GLIX1 for treating cancers in which cytidine deaminase (CDA) is not over-expressed (representing over 90% of cancers). Patent further broadens and strengthens GLIX1 patent protection until 2040, with a possible patent-term extension of up to five years."

Patent • Solid Tumor

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 (StockTitan.net) - "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%...With data expected in H1 2027, this represents a mid-term catalyst for BioLineRx..."

Commercial • P1/2 data • Glioblastoma

Hemispherian Receives FDA IND Clearance for First-in-Class Glioblastoma Therapeutic, GLIX1 (PRNewswire) - "Hemispherian AS...announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application for GLIX1, a first-in-class small molecule targeting DNA repair vulnerabilities in glioblastoma and other solid tumors. The IND clearance allows Hemispherian to proceed with a first-in-human Phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of GLIX1 in patients with recurrent glioblastoma....The Phase 1 study will be conducted at leading neuro-oncology centers across the United States, starting at Northwestern University in Chicago."

IND • New P1 trial • Glioblastoma

Hemispherian Receives U.S. FDA Orphan Drug Designation for GLIX1 for the Treatment of Malignant Glioma (PRNewswire) - "Hemispherian AS...announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for GLIX1 for the treatment of malignant glioma, a category of devastating brain cancers that includes glioblastoma....The designation marks a major regulatory milestone for Hemispherian, recognizing both the urgent unmet medical need in glioma and the potential of GLIX1 to offer significant clinical benefit beyond current therapies....The designation is based on GLIX1's potential to treat a rare and life-threatening disease affecting fewer than 200,000 people in the United States. GLIX1 demonstrated substantial preclinical efficacy, including tumor regression and survival benefit in validated models of glioma."

Orphan drug • Glioblastoma • Glioma

Hemispherian receives positive opinion for Orphan Medicinal Product Designation in the EU for GLIX1 in glioma (Yahoo Finance) - "Hemispherian AS...announced today that the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP) has issued a positive opinion recommending Orphan Drug Designation (ODD) for GLIX1, the company's lead molecule, for the treatment of glioma, one of the most devastating and lethal brain cancers."

Orphan drug • Glioma

Hemispherian awarded NOK 16M grant from the Research Council of Norway (PRNewswire) - "Hemispherian AS...has been granted NOK 16 million by the Research Council of Norway. Hemispherian's proprietary GLIX compounds target a novel mechanism that is common to all cancers. The company's lead drug candidate, GLIX1, is in late-stage preclinical development for the treatment of glioblastoma, a highly aggressive and most common primary brain cancer, which continues to be one of the highest unmet needs in oncology. The funding awarded is earmarked for the development of Hemispherian's promising drug candidates aimed at treating platinum-resistant ovarian cancers, one of the most challenging gynecological malignancies."

Financing • Brain Cancer • CNS Tumor • Glioblastoma • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

First-in-class cancer therapeutics targeting the DNA Damage Response (SNO 2023) - "Hemispherian’s lead GLIX molecules, GLIX1 and GLIX5, show excellent efficacy in vivo in xenograft models, have a superior safety profile, are orally bioavailable and are blood brain barrier penetrant. GLIX efficacy against a panel of patient-derived cell lines representing a broad spectrum of pediatric and adult brain tumor diagnoses will be discussed. Taken together, these molecules have an exceptional profile for treating a broad range of cancers including cancers of the brain."

Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Pediatrics • Solid Tumor • TET2

Hemispherian raises the first tranche of a Series A to fund the development of its novel cancer therapeutics (PRNewswire) - "Hemispherian AS...is delighted to announce the closure of the first tranche of its series A1 financing round. The round raised NOK 30M (USD 2.9M). The proceeds will support the company's drug development activities, expand its preclinical pipeline and advance its lead therapeutic compounds towards clinical development.'This funding will support preclinical development of GLIX1 and GLIX5, the company's lead assets'."

Financing • Oncology

Hemispherian Secures EUR 10M in Financing from the European Innovation Council (EIC) Accelerator Program (PRNewswire) - "Hemispherian AS...announce a successful European Innovation Council (EIC) Accelerator grant application. This grant will provide EUR 2.5M in grant funding and the jury recommends an additional EUR 7.5M in equity financing from the EIC fund. Financing from the EIC accelerator will be used to advance GLIX1, one of Hemispherian's lead assets, through a phase I and phase II clinical trial."

Financing • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor