ORCA Therapeutics welcomes Industry Veteran Joern Skibsted Jakobsen to its Scientific Advisory Board

Amsterdam, The Netherlands – August 2026

ORCA Therapeutics B.V., a Dutch biopharmaceutical company pioneering innovative oncolytic immunotherapies for cancer treatment, today announced that the Central Committee on Research Involving Human Subjects (CCMO) in the Netherlands has approved the initiation of a clinical trial evaluating ORCA-010 in patients with recurrent glioblastoma.

The trial will be led by Erasmus MC in Rotterdam and will be conducted in collaboration with the Amsterdam UMC and supported by the EU Cancer Mission-sponsored Gliomatch consortium.

Advancing Innovative Immunotherapy for Aggressive Brain Tumors

Glioblastoma is the most common and aggressive form of primary brain tumours in adults. Effective treatment options are unavailable, resulting in unavoidable recurrence and a very poor prognosis with a median overall survival of only one year from first diagnosis.

Building on the strategic collaboration between ORCA Therapeutics and Erasmus University Medical Center, this trial marks a crucial step in expanding ORCA-010’s clinical development program into high-unmet-need indications beyond prostate cancer. The trial will be conducted at two leading Dutch medical centers, Erasmus MC and Amsterdam UMC, under the direction of leading brain cancer clinical investigators.

“Receiving CCMO approval is a monumental milestone for ORCA Therapeutics,” said Dr. Dong, CEO of ORCA Therapeutics. “It validates the robust preclinical and safety profile of ORCA-010 and paves the way for us to bring our next-generation oncolytic immunotherapy to patients facing recurrent glioblastoma. With ORCA-010’s proven safety and ability to generate long-term local and systemic anti-tumor immunity, we strive to make a profound difference in treating challenging oncology indications like glioblastoma. We look forward to supporting our clinical partners as they lead this important trial.”

Prof. Dr. Dirven, Professor of Neurosurgery at Erasmus MC, welcomed the regulatory clearance as a significant step forward for the neuro-oncology field. Securing regulatory approval from the CCMO is a vital step that brings many years of pre-clinical research to this clinical trial in which patients will be treated with a new paradigm; repeated exposure of the tumor to ORCA-010. With this we hope to alter the “cold” and immunosuppressive tumor microenvironment enabling the patient’s own immune system to attack the tumor cells. This trial builds directly on our previous clinical trial experience with an earlier generation oncolytic adenovirus. Given the severe limitations of current standard-of-care options and positive results of previous oncolytic virus trials, innovative approaches like ORCA-010 hold strong promise. We are eager to begin this trial and evaluate how this therapy can meaningfully alter the disease trajectory for our patients.”

Prof. Dr. van Beusechem, Chief Scientific Officer of ORCA Therapeutics and Professor of Applied Molecular Oncology at Amsterdam UMC, pointed to the trial’s broader significance for the company’s platform. “The planned clinical trial builds on our previous biological observations where ORCA-010 induced anti-tumor immunity in patients with prostate cancer. Evaluation of ORCA-010 in glioblastoma, which has a similarly immunosuppressive tumor microenvironment as prostate cancer, but a much more aggressive course, should allow a meaningful assessment of the potential of ORCA-010 to make a clinical difference in a cancer with a very poor prognosis.”

About ORCA-010 and the Clinical Study

ORCA-010 is an advanced, clinical-stage oncolytic immunotherapy designed with a dual mechanism of action: selective tumor cell lysis coupled with potent, systemic immune activation. Local administration of ORCA -010 in the tumor will convert immunologically “cold” tumors into “hot,” and create an inflamed microenvironment. With this, ORCA-010 aims to overcome the primary barriers that render brain tumors resistant to conventional therapies.

The approved clinical trial will assess repeat administrations of ORCA-010 in patients with recurrent glioblastoma, leveraging insights from the EU Cancer Mission-sponsored Gliomatch consortium (www.gliomatch.eu) to conduct in-depth genetic and immunological evaluations.

About Erasmus MC and Amsterdam UMC

Erasmus MC

One of the largest and most respected university medical centers in Europe, Erasmus MC combines world-class scientific research with exceptional patient care. Its Department of Neurosurgery and the Brain Tumor Center are internationally recognized for brain tumor treatment and research, pioneering oncolytic virus therapies. .

Amsterdam UMC

A leading academic medical center formed by the merger of VU University Medical Center and Academic Medical Center, Amsterdam UMC is renowned for advanced neurological research and clinical excellence in oncology.

About ORCA Therapeutics BV

Contact

Dr. W. Dong, Ph.D., MBA
CEO, ORCA Therapeutics BV
Email: info@orca-therapeutics.com
Website: www.orca-therapeutics.com