Uppsala, Sweden, September 22, 2026
Beactica Therapeutics AB has announced the initiation of IND-enabling studies for BEA-17, its wholly owned, first-in-class oral degrader targeting the LSD1–CoREST epigenetic regulatory complex for the treatment of glioblastoma (GBM). The program marks the transition of BEA-17 from preclinical proof-of-concept toward the formal safety, manufacturing and regulatory activities required to support a Clinical Trial Application (CTA) in Europe and/or an Investigational New Drug (IND) application in the United States. Beactica is developing BEA-17 as a potential precision immunotherapy designed to address the highly immunosuppressive tumor environment associated with glioblastoma. The company expects to complete the IND-enabling program and submit regulatory applications in 2027, with the ultimate goal of beginning first-in-human clinical studies.
BEA-17 Targets LSD1 and CoREST in Glioblastoma
Glioblastoma is an aggressive primary brain tumor with substantial unmet medical need. Beactica notes that the disease has a median overall survival of approximately 15 months, while standard treatment approaches have remained broadly unchanged for more than two decades. The company is developing BEA-17 to address one of the key challenges in glioblastoma research: the tumor’s profoundly immunosuppressive and immune-cold microenvironment, which has limited the effectiveness of immunotherapies that have demonstrated activity in other cancers. BEA-17 is designed to simultaneously degrade LSD1 and its scaffolding partner CoREST, rather than simply inhibiting LSD1’s catalytic activity. According to Beactica, this mechanism is intended to produce several changes within the tumor environment, including enhanced antigen presentation, induction of viral mimicry and reprogramming of macrophages toward a pro-inflammatory state. In preclinical glioblastoma models, the company reported that BEA-17 combined with standard-of-care treatment substantially improved survival and generated durable tumor regression that was not observed with standard treatment alone. These findings remain preclinical and will require validation in human clinical trials.
IND-Enabling Program Moves BEA-17 Toward the Clinic
The newly initiated IND-enabling program includes a comprehensive package of studies intended to establish the safety, pharmacology and manufacturing information required before human testing. Beactica said the program includes GLP-compliant repeat-dose toxicology studies in both rodent and non-rodent species, safety pharmacology and pharmacokinetic assessments. The company is also manufacturing a traceable and fully documented batch of BEA-17 drug substance suitable for regulatory submissions and finalizing an oral clinical trial formulation.
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The company describes BEA-17 as orally bioavailable and brain-penetrant, characteristics that are particularly relevant for a therapeutic being developed against a primary brain tumor. Beactica has also reported preclinical evidence suggesting that BEA-17 could enhance the activity of anti-PD-1 checkpoint blockade. In a preclinical colon cancer model, the company reported potentiation of anti-PD-1 therapy, with effects that were not observed with catalytic LSD1 inhibitors. The findings provide additional rationale for investigating the degrader mechanism, although the potential combination strategy remains experimental.
Beactica Plans Regulatory Submission in 2027
BEA-17 has received Orphan Drug Designation from the U.S. Food and Drug Administration for glioblastoma, adding regulatory recognition to the program as it progresses through preclinical development. The IND-enabling work is being conducted through GLIOBREAK, a 30-month project supported by a €2.5 million EIC Transition grant under Horizon Europe. Beactica expects the program to support submission of a CTA in the European Union and/or an IND application to the U.S. FDA in 2027.
The advancement of BEA-17 represents an important development milestone for Beactica’s precision medicine pipeline and its Eclipsor™ platform, which supports the development of allosteric modulators and targeted protein degraders. If the planned regulatory submissions proceed successfully, BEA-17 could enter first-in-human testing and provide an opportunity to evaluate whether its LSD1–CoREST degradation mechanism can translate the company’s preclinical findings into clinical benefit for patients with glioblastoma. Until clinical trials are completed, however, the safety and efficacy of BEA-17 in humans remain unestablished.
Source: Beactica Therapeutics press release
