Norwegian Biotech Secures FDA IND Clearance for Novel Mechanism in Brain Cancer

Norwegian biotech Hemispherian brings a distinctive approach to glioblastoma treatment with GLIX1, a first-in-class small-molecule TET2 agonist that recently cleared an IND with the U.S. FDA. CEO Zeno Albisser outlines how the company translated academic discoveries in DNA repair into a therapeutic targeting one of oncology’s most challenging indications, building from Oslo to Phase 1/2a trials in just four years.

From Academic Discovery to Clinical Reality

Hemispherian emerged from cutting-edge academic research in DNA repair conducted by co-founders Adam Robertson and Terezia Prikrylova. Founded in Oslo in 2020, the company assembled a cross-disciplinary team combining scientific expertise with drug discovery capabilities. Albisser, whose background spans computer science, entrepreneurship, and finance, secured support from world-class clinicians to advance the program through preclinical development and regulatory milestones.

The company raised approximately €6.5 million in equity financing and secured a highly competitive grant and equity package from the European Innovation Council Accelerator. This funding enabled Hemispherian to complete preclinical development and obtain Orphan Drug Designations in both the U.S. and EU before achieving FDA IND clearance.

A Novel Mechanism in Oncology

Hemispherian’s approach diverges fundamentally from conventional cancer therapeutics. “Instead of targeting traditional oncogenic drivers, we harness the TET2 enzyme to induce profound DNA demethylation, which selectively kills cancer cells while sparing healthy tissue,” Albisser explains. “This represents a completely novel mechanism of action in oncology.”

Unlike conventional cytotoxics or targeted therapies, GLIX1 works by reactivating a natural mechanism that is otherwise inhibited in cancer. The company targets glioblastoma, one of the most aggressive and deadly cancers, where standard therapies have not changed meaningfully in two decades. The first-in-human Phase 1 clinical trial will evaluate safety, tolerability, pharmacokinetics, and preliminary efficacy in patients with recurrent glioblastoma.

Strategic Partnership Accelerates Clinical Development

Very recently, Hemispherian entered a joint venture with BioLineRx, a strategic move that addresses a critical challenge for small biotechs entering clinical trials. “We are only about to embark on the real journey through clinical development,” Albisser notes. “I think that the support of leading clinicians in the field will be crucial for success in this phase.”

The partnership with BioLineRx provides complementary capabilities that Hemispherian will rely upon heavily for clinical execution. This collaboration enables the company to access specialized expertise while maintaining focus on their core scientific platform.

Manufacturing Strategy: CDMO Partnership with Internal Oversight

Hemispherian opted for a CDMO-based manufacturing strategy rather than building internal capabilities at this early stage. The company works with a leading global CDMO to handle manufacturing and scale-up, accessing world-class expertise and infrastructure without capital-intensive overhead.

However, Albisser emphasizes that outsourcing does not mean relinquishing control. The company maintains tight internal oversight to ensure quality and regulatory compliance. The primary challenges centered on partner selection—finding the right organization to develop and scale the manufacturing route within the constraints facing a small biotech.

“For a small company with limited financial resources, it is absolutely crucial to have a partner that delivers within budget, on time, and according to specification,” Albisser stresses. His advice for other biotechs navigating CMC scale-up is unequivocal: “You need to have a person in-house who has managed CMC scale-up projects before, and is intimately familiar with these processes. Only with such a person in place is it possible to stay in control of manufacturing.”

This dual approach—external manufacturing capabilities paired with internal CMC expertise—allows Hemispherian to leverage CDMO strengths while maintaining the oversight necessary to manage timelines, budgets, and specifications effectively.

Building a Global Support Network

Hemispherian benefited from strong ties to both North American and European biotech ecosystems. Organizations including the European Innovation Council, Innovation Norway, and SMB Norge provided support, alongside collaborations with academic institutions in Norway and internationally. Building this global network helped the company access funding, expertise, and visibility across geographies.

Over the next 12 to 18 months, Hemispherian’s primary focus is the initiation and successful execution of the Phase 1/2a trial for GLIX1 through the joint venture with BioLineRx. Operationally, the company aims to deliver early clinical data while strengthening strategic partnerships and continuing pipeline development.

Strategic Advice for Fellow Founders

As Albisser emphasized: “My advice to other biotech founders is to build a team and network you can truly rely on, engage early with regulators and partners, and never underestimate the value of clear, transparent communication with investors and stakeholders.”