‘s-Hertogenbosch, 1 July 2019.
ORCA Therapeutics B.V., a clinical stage company developing oncolytic viruses, announced today they have a received a No Objection Letter (NOL) from the regulatory authorities in Canada. With this NOL, Health Canada approves the initiation of a Phase I/IIa study evaluating the safety and tolerability of intratumoral administration of ORCA-010 in treatment-naïve patients with localized prostate cancer. The clinical trial application was submitted in May 2019.
The company will initiate the clinical testing with CMX Research, a urology-focused CRO in Oakville, Canada, with the first patient expected to be included in the study in August 2019, and top-line safety, tolerability and biomarker results of the first part of the study to be available in the second quarter of 2020.
ORCA-010 is being developed as a first-line treatment for patients with solid tumors. Treatment should require maximally three treatment cycles with 2-4 weeks interval.
The approval to initiate this clinical study is a key milestone in the development of ORCA-010. “We are excited to receive this approval and look forward to the outcome of this very important study with ORCA-010” says Kees Groen, CEO of ORCA Therapeutics. “We anticipate the study will confirm that ORCA-010 is safe and tolerable. The secondary endpoint is to evaluate the biological activity and anti-tumor efficacy of the intervention.”
ORCA Therapeutics has successfully designed a virus, ORCA-010, that kills cancer cells, while leaving normal cells unharmed. ORCA-010 is up to ten thousand-fold more effective at killing a wide variety of cancer cells than competitor oncolytic viruses. Extensive laboratory and animal experiments have demonstrated that ORCA-010 can attack different cancer types. ORCA has developed a scalable process for the production of ORCA-010, and the product is protected by patents.
ORCA-010 is aimed to be used in solid tumors, as first-line treatment, with intratumoral or intravenous injection. Maximally three treatment cycles with 2-4 weeks interval are anticipated, either given alone or in combination with other cancer therapies.
About ORCA Therapeutics
ORCA Therapeutics is a Dutch biopharmaceutical company developing innovative oncolytic immunotherapies for the treatment of cancer. The company has a strong platform of technologies to engineer highly potent oncolytic adenoviruses. ORCA’s lead product ORCA-010 is a powerful oncolytic adenovirus that exhibits strong oncolytic potency in different cancer types in vitro and in vivo.
For more information please contact:
Kees Groen, PhD, CEO
(O) +31 6 53648230