ORCA Therapeutics Achieves Major Regulatory Milestone for Oncolytic Virus Therapy in the Netherlands

Amsterdam, The Netherlands – August 2024

ORCA Therapeutics, a biotechnology company developing innovative oncolytic virus therapies, announces a significant step forward in its regulatory process for a planned clinical trial in The Netherlands. The company has received a positive review and approval from the Office for Genetically Modified Organisms (GMO Office) for the use of ORCA-010 in patients.

This positive assessment from the GMO Office, operating under the Ministry of Infrastructure and Water Management (IenW), represents an important milestone in ORCA Therapeutics’ journey towards initiating its clinical trial for esophageal cancer treatment. The review focused on evaluating potential environmental risks associated with the use of genetically modified organisms in the proposed therapy.

Dr. Wenliang Dong, CEO of ORCA Therapeutics, stated: “We are extremely pleased with this positive outcome from the GMO Office. This approval is a critical step in our regulatory pathway and reflects the careful considerations regarding environmental safety factors in developing our oncolytic virus therapy, ORCA-010. What’s particularly encouraging is the GMO Office’s assessment that our planned activities, under the proposed conditions, do not pose unacceptable risks to the environment. This not only brings us closer to our goal of initiating our clinical trial for esophageal cancer patients but also reinforces our commitment to responsible and safe development of innovative cancer therapies.”

ORCA-010, the company’s lead oncolytic virus therapy, is being developed to address the significant unmet medical need in esophageal cancer treatment. Esophageal cancer is a serious and often life-threatening condition, with limited effective treatment options currently available.

ORCA Therapeutics remains committed to advancing its innovative approach to cancer treatment and looks forward to the potential of bringing new therapeutic options to patients with esophageal cancer. The company anticipates initiating the clinical trial in 2024, subject to final regulatory approvals.

For more information about ORCA Therapeutics and its development programs, please visit www.orca-therapeutics.com.

For further information and media inquiries, please contact:

Dr. Wenliang Dong, Ph.D. MBA
CEO, ORCA Therapeutics
Email: wen.dong@orca-therapeutics.com
Website: www.orca-therapeutics.com

About ORCA Therapeutics BV: ORCA Therapeutics BV is a clinical stage biopharmaceutical company dedicated to developing oncolytic immunotherapies for cancer treatment. With a focus on innovative gene therapies, ORCA Therapeutics is committed to improving patient outcomes and addressing unmet medical needs. Learn more at www.orca-therapeutics.com.