CanaryBio Strengthens Clinical Development Team to Achieve 100% Market Share

[Asia Economy Reporter Jang Hyowon] Canaria Bio (CEO Nahanik) announced on the 4th that it has recruited Dr. Yoon Byung-hak, who led global clinical trials at HLB last year, as Chief Development Officer, and clinical expert Choi Seung-young, who managed clinical trials at global CRO Parexel and HLB, as Head of Clinical Division.

This time, they hired team leaders Victoria Kim (USA) and Raj Teja (India), and added two team members.

Canaria Bio started Phase 2 clinical trials of combined administration of oregovomab and Zejula with GSK in the United States last year, and Phase 2 clinical trials of oregovomab as neoadjuvant chemotherapy in India.

The company expects that if safety is confirmed in combination with GSK’s PARP inhibitor Zejula, oregovomab could be applied to BRCA mutation patients as well, significantly increasing market share. Also, although cases of neoadjuvant chemotherapy in ovarian cancer have been steadily increasing recently, there are no approved treatments for neoadjuvant chemotherapy.

Neoadjuvant chemotherapy is already included as a second cohort in the ongoing global Phase 3 clinical trial, but after discussions with medical advisory committees, the company plans to develop a next-generation regimen by adding oregovomab to chemotherapy administered before surgery, believing this method can further enhance efficacy.

CEO Nahanik stated, “Market research firm Evaluate Pharma projected peak sales (base case) of oregovomab at 8 trillion KRW with a 46% market share. Beyond the ongoing combination therapies with PARP inhibitors and Avastin (active ingredient bevacizumab), we aim to conduct additional clinical trials for recurrent patients to achieve 100% market share not only among new patients but also in the recurrent patient group. To this end, strengthening the clinical development organization will continue,” outlining the organizational management direction.

According to the company, oregovomab is administered at 2 mg per dose, with only four doses required, resulting in very minimal toxicity. Its mechanism of action is completely different from existing treatments, allowing combination with all chemotherapy agents used in ovarian cancer.

CEO Nahanik said, “Avastin is administered at 900 mg per dose. Compared to that, oregovomab’s 2 mg dose inevitably results in very minimal toxicity. Minimal toxicity means it can be a drug that all ovarian cancer patients must use,” arguing that achieving 100% market share is not an unrealistic goal.