ORCA Therapeutics Announces Collaboration with Erasmus MC to Conduct Phase I/IIA Clinical Study of ORCA-010 in Glioblastoma
Amsterdam, The Netherlands – August 2025
ORCA Therapeutics B.V., a Dutch biopharmaceutical company pioneering innovative oncolytic neo-adjuvant immunotherapies for cancer treatment, today announced a strategic collaboration with Erasmus MC Rotterdam to conduct a Phase I/IIA clinical study evaluating ORCA-010 in patients with glioblastoma. The study will be led by Dr. Clemens Dirven, Professor of Neurosurgery at Erasmus MC.
This collaboration represents a significant expansion of ORCA-010’s clinical development program beyond prostate cancer, targeting one of the most challenging and aggressive forms of cancer. Glioblastoma remains one of the most difficult cancers to treat, with limited therapeutic options and poor prognosis for patients.
“We are honored to partner with Erasmus MC and Prof. Dr. Dirven, whose extensive experience with oncolytic adenovirus therapy in glioblastoma makes him an ideal collaborator for this important study,” said Dr. Wenliang Dong, CEO of ORCA Therapeutics. “This collaboration allows us to leverage Prof. Dirven’s pioneering work in the field while advancing ORCA-010’s potential to transform treatment outcomes for glioblastoma patients through our innovative oncolytic immunotherapy approach.”
Building on Proven Oncolytic Virus Experience
Prof. Dr. Dirven brings extensive expertise in oncolytic virus therapy for brain tumors, having previously conducted groundbreaking research with Ad5-D24RGD, another earlier generation oncolytic adenovirus. In his and other previous studies, injection of oncolytic adenovirus in the tumor and in surrounding brain was safe, induces a local inflammatory reaction, and shows promising clinical responses. Furthermore, these clinical studies supported the notion that activation of the immune system is a crucial mechanism of action for oncolytic therapies in glioblastoma.
“The encouraging results from previous work with oncolytic adenoviruses in glioblastoma, particularly the observation of a long-lasting tumor response and correlation with clinical benefit in a subset of patients, provide a strong foundation for this new collaboration with ORCA Therapeutics,” said Prof. Dr. Clemens Dirven. “ORCA-010’s enhanced design and expected ability to induce anti-tumor immune responses make it a promising candidate for glioblastoma treatment. We are excited to explore how this next-generation oncolytic immunotherapy can potentially improve outcomes for our patients facing this devastating disease.” This clinical trial will be performed in the context of the EU Cancer Mission sponsored Gliomatch consortium (www.gliomatch.eu) , in which immunotherapy strategies for treatment of glioblastoma will be explored, providing unique opportunities for in depth genetic and immunological evaluation of treated patients.
About ORCA-010
ORCA-010 is a clinical stage oncolytic immunotherapy. Its dual mechanism of action, selective tumor cell destruction combined with robust long term immune system activation, addresses key challenges in treatment of cancer with poor immune infiltration and activation. The therapy’s demonstrated ability to convert “cold” tumors into “hot” immunologically active environments positions it as a promising therapeutic approach for cancer. The upcoming Phase I/IIA study will evaluate the safety, tolerability, and preliminary efficacy of ORCA-010 in glioblastoma patients, building on the successful clinical experience gained from previous trials.
Prof. Dr. Victor W. van Beusechem, CSO of ORCA Therapeutics, commented: “This collaboration with Erasmus MC represents an important milestone in demonstrating the versatility of our oncolytic immunotherapy platform. With ORCA-010’s proven ability to generate long-term anti-tumor immunity we strive to make a difference in treating multiple cancer indications with a high unmet medical need, such as glioblastoma.”
About Glioblastoma
Glioblastoma is the most common and aggressive form of primary brain tumor in adults. Despite current standard-of-care treatments including surgery, radiation, and chemotherapy, the prognosis remains poor with median survival of approximately 12 months from time of diagnosis. Poor survival is associated with lack of intratumoral T cell infiltrates and a highly immunosuppressive tumor microenvironment. There is a critical need for innovative therapeutic approaches that can improve outcomes for patients with this devastating disease.
About Erasmus MC
Erasmus MC is one of the largest university medical centers in Europe, combining world-class research with outstanding patient care. The Department of Neurosurgery at Erasmus MC is recognized internationally for its expertise in brain tumor treatment and research, including pioneering work in oncolytic virus therapy.
About ORCA Therapeutics BV
ORCA Therapeutics BV is a leader in potent neo-adjuvant immuno-oncology therapeutics, specializing in oncolytic viruses and innovative gene therapy approaches. The company is dedicated to translating cutting-edge scientific discoveries into effective therapeutic solutions, addressing unmet medical needs and improving patient outcomes globally.
For more information about our mission and ongoing projects, visit www.orca-therapeutics.com
Media Contact
Dr. Wenliang Dong, Ph.D., MBA
CEO, ORCA Therapeutics BV
Email: info@orca-therapeutics.com
Website: www.orca-therapeutics.com