•  First ovarian cancer therapy for ST oncology portfolio
• .. Phase 2 study demonstrated oregovomab in combination with chemotherapy improved progression free survival by ~30 months compared to chemotherapy alone ¹
• .. Phase 3 results expected in 2025
• .. Exclusive license for AU, NZ, Singapore, Malaysia, Brunei, Thailand and Vietnam

The therapy, known as oregovomab, is currently in a pivotal phase III international clinical trial known as the FLORA-5 study.² This investigation is examining oregovomab in combination with chemotherapy agents carboplatin and paclitaxel for patients with advanced ovarian cancer.

Under the terms of the arrangement, ST will be responsible for all commercial, medical, regulatory and distribution activities for oregovomab in its key territoriesof Australia, NewZealand, Singapore, Thailand, Vietnam, Brunei and Malaysia. CanariaBio will be responsible for the manufacture and supply of oregovomab to ST.

Announcing the partnership, ST Chief Executive Officer Carlo Montagner said he was pleased CanariaBio had selected ST as a partner for this highly promising therapy.

"ST has a portfolio of anti-cancer therapies targeting multiple solid tumours with the exception of ovarian cancer, and now oregovomab becomes our first ovarian cancer agent," Mr Montagner said.

"Despite great advances in recent years, there remains a high unmet need in all our regions to treat this patient population. We look forward to working closely with our new partners at CanariaBio and pending the results of the pivotal Phase III registration study, making oregovomab available to eligible patients."

CanariaBio Chairman and CEO Michael Na said the company had selected ST for its regional expertise and strong track record commercialising oncology products.

"Formalising this agreement is a pivotal moment for our program. This collaboration is more than just a deal – it's a shared commitment as we develop novel therapies to address unmet medical needs. At CanariaBio, we've always believed in the transformative power of partnerships, and teaming up with ST reinforces this belief."

Oregovomab works by targeting and binding specifically to a surface protein known as CA-125 found on the surface of ovarian cancer cells, then activating the patient's own immune system to respond.³

In the Phase 2 study, the addition of oregovomab to chemotherapy yielded a median progression-free survival of 41.8 months compared with 12.2 months with standard chemotherapy alone (HR, 0.46, P=0.0027). The overall survival hazard ratio was 0.35.¹

The Phase 3 FLORA-5 study is fully enrolled and ongoing. Final results are expected in 2025.