On September 22, 2026 Beactica Therapeutics AB, a Swedish precision medicine company, reported the initiation of IND-enabling studies for BEA-17, the Company’s wholly owned, first-in-class oral degrader of the epigenetic regulators LSD1 and CoREST, being developed as a precision immunotherapy for glioblastoma (GBM). The studies advance BEA-17 from preclinical proof-of-concept into the formal safety, manufacturing and regulatory programme required to support a Clinical Trial Application (CTA) in the EU and/or an Investigational New Drug (IND) application in the US, and the start of first-in-human clinical trials.
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Glioblastoma is the most common and most aggressive primary brain tumour, with a median overall survival of around 15 months and a standard of care that has remained essentially unchanged for more than two decades. Immunotherapies that have transformed other cancers have repeatedly failed in GBM, largely because the tumour maintains a profoundly immunosuppressive, immune-"cold" microenvironment. BEA-17 is designed to overcome this barrier: by degrading LSD1 and its scaffolding partner CoREST, BEA-17 enhances antigen presentation, induces viral mimicry and reprogrammes macrophages towards a pro-inflammatory state. In preclinical models of glioblastoma, BEA-17 in combination with standard of care substantially improved survival and produced durable tumour regression not observed with standard of care alone. BEA-17 has also potentiated anti-PD-1 checkpoint blockade in a preclinical model of colon cancer – effects not seen with catalytic LSD1 inhibitors. BEA-17 is orally bioavailable, brain-penetrant, and has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of glioblastoma.
"Initiating IND-enabling studies is a defining milestone for Beactica and for the BEA-17 programme," said Dr Per Källblad, Chief Executive Officer of Beactica Therapeutics. "With a first-in-class mechanism and compelling preclinical efficacy in combination with standard of care, we are now executing the rigorous safety and manufacturing programme that will carry BEA-17 into first-in-human trials."
The IND-enabling programme comprises GLP-compliant repeat-dose toxicology in rodent and non-rodent species, safety pharmacology, pharmacokinetic studies, and manufacture of a traceable, fully documented batch of BEA-17 drug substance suitable for a Clinical Trial Application and a finalised oral clinical trial formulation.
The work is conducted under GLIOBREAK, a 30-month project supported by a EUR 2.5 million EIC Transition grant under Horizon Europe, announced in February 2026. Beactica expects to complete the IND-enabling programme and submit a Clinical Trial Application in the EU and/or an Investigational New Drug application to the US FDA in 2027.
(Press release, Beactica, SEP 22, 2026, View Source [SID1234671007])