Cancer is one of the leading causes of death worldwide. There is a great need for new treatment options with more efficacy and less side effects.

ORCA Therapeutics B.V. (ORCA) 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, and is being prepared for its first clinical study in prostate cancer patients.

Technology

Oncolytic viruses represent a promising new therapeutic approach for treatment of cancer. Oncolytic viruses selectively destroy cancer cells without affecting normal cells, thereby minimizing side effects. Owing to their ability to self-replicate within the cancer cell, ORCA’s oncolytic viruses have unique pharmacokinetic properties that set them apart from conventional small molecule or monoclonal antibody-based therapeutics. ORCA’s approach entails magnifying the cell-killing potential of the underlying oncolytic virus while maintaining strong safety. Another course of action of ORCA’s oncolytic viruses consists of the induction of anti-tumor immune responses. Since the mode of action of these viruses is different from currently available therapies such as chemotherapy, radiation, monoclonal antibodies, and other immunotherapies our approach offers the potential for novel and powerful combination therapies to treat cancer.

Strategy

ORCA’s strategy is to initiate clinical development of its lead product ORCA-010 in cancer indications with a high need for loco-regional control and a substantial risk of damage associated with removal of the tumor.

The first clinical study will be performed in treatment naive prostate cancer patients. The objective is to obtain safety and efficacy data with ORCA-010 in prostate cancer by the first half of 2017. Yearly, approximately 50,000-80,000 patients are diagnosed with prostate cancer in the world’s more developed regions. For these patients, no adequate standard treatment options are available, resulting in a fatal outcome in the majority of cases. ORCA-010 is well positioned to fill this treatment gap in prostate cancer.

Pipeline

In addition to the ORCA-010 product, ORCA has developed other patent-protected technologies thus improving the applicability of its oncolytic viruses. The tumor-restricted replication of ORCA’s oncolytic adenoviruses provides an opportunity to express proteins and nucleic acids of interest specifically in tumor cells. This allows ORCA to expand its product pipeline by developing new oncolytic adenoviruses that suppress tumor growth, increase immunogenicity and improve cytotoxicity.
Positive data from the Phase I/II clinical study with ORCA-010 in prostate cancer will put the Company in a strong position to progress to phase II/III clinical studies, to extend clinical development of ORCA-010 in other cancer indications and to take ORCA’s next generation products into clinical development.