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ORCA Therapeutics Announces Treatment of First Patient in Phase I/IIa study

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‘s-Hertogenbosch, the Netherlands, December 23, 2019.

ORCA Therapeutics BV, a privately held clinical-stage biopharmaceutical company developing oncolytic viruses, today announced that the first patient has been dosed in a Phase I/IIa study with ORCA-010 in treatment-naïve patients with localized prostate cancer. ORCA-010 is a genetically modified adenovirus being developed to treat cancer. This Phase I/IIa study is considered the proof-of-concept study to assess the safety, tolerability and antitumor activity upon administration of this oncolytic virus. The initiation of the study follows Health Canada approval of the company’s clinical trial application.

The study entitled, “A Phase I/IIa Study Evaluating the Safety and Tolerability of Intratumoral Administration of ORCA-010 in Treatment-Naïve Patients with Localized Prostate Cancer”, is composed of two parts. The first part comprises a doseescalation to assess the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of ORCA-010. It is used to define the recommended dose for the second part of the study comprising of a repeat-dose cohort of patients. The principal investigator of the study is Dr. Richard Casey of The Fe/Male Health Centre in Oakville, Canada.

Based on the 14-day safety and tolerability data, the Data Safety Monitoring Board (DSMB) positively advised on dosing of the other patients in the cohort with ORCA-010.

“We expect that this study will generate important insights about the utility of ORCA010 in patients with a properly functioning immune system,” said Dr. Kees Groen, CEO of the company. “This research furthers the adequate application of oncolytic viruses.”

About Orca Therapeutics BV ORCA Therapeutics B.V. is developing a pipeline of innovative anticancer immunotherapies based on the highly promising approach of oncolytic viruses. ORCA’s lead product ORCA-010 is a new oncolytic adenovirus based on the Company’s proprietary T1 technology. ORCA-010 has up to ten thousand fold higher oncolytic potency as compared to current state of the art oncolytic adenoviruses in a broad panel of cancer cell lines.

ORCA Therapeutics receives approval from Health Canada to initiate a Phase I/IIa study with its oncolytic adenovirus ORCA-010 in treatment-naïve prostate cancer patients.

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‘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.”

About ORCA-010

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

(E)          kees.groen@orca-therapeutics.com

(W)        www.orca-therapeutics.nl