CanaryBio Registers First Patient in India Phase 2 Trial of Neoadjuvant Anticancer Therapy

[Asia Economy Reporter Jang Hyowon] Canaria Bio (CEO Hanik Na) announced on the 13th that the first patient has been enrolled in the Phase 2 clinical trial (Flora-6) in India for the neoadjuvant chemotherapy of the immuno-oncology drug ‘Oregovomab’.

Currently, angiogenesis inhibitor Avastin (bevacizumab) and PARP inhibitors used for newly diagnosed ovarian cancer patients have not been approved for neoadjuvant chemotherapy.

Canaria Bio is already conducting a global Phase 3 trial for neoadjuvant chemotherapy, but has initiated an additional clinical trial to secure the currently unoccupied neoadjuvant chemotherapy market for ovarian cancer.

After discussions with medical advisory board members, the company decided to proceed with the additional trial, judging that administering the drug additionally when CA125 levels are high before surgery could further enhance efficacy.

In this trial, Oregovomab is administered both before and after surgery. This differs from the Phase 3 protocol where Oregovomab is administered only after surgery.

Hanik Na, CEO of Canaria Bio, stated, “There are no targeted therapies or immuno-oncology drugs approved in combination with neoadjuvant chemotherapy. While it is important to be the first to secure a position as cases of neoadjuvant chemotherapy increase, it is equally important to defend that position, so developing a more advanced next-generation regimen is very important.”

Canaria Bio is conducting combination therapy clinical trials of Oregovomab with Avastin, PARP inhibitors, PLD, and Weekly Taxol for recurrent patients in addition to the global Phase 3 trial to apply Oregovomab to all ovarian cancer patients. The strategy is to continuously expand the scope of Oregovomab’s application to make it available to all patients.

The Phase 2 trial, which has started enrolling the first patient, will divide 88 newly diagnosed advanced ovarian cancer patients into two groups. Both groups will receive chemotherapy; the control group will receive a placebo, and the experimental group will receive Oregovomab. Clinical efficacy will be evaluated by observing progression-free survival (PFS) and overall response rate (ORR).

Neoadjuvant chemotherapy is known to create conditions that facilitate optimal tumor reduction surgery, increase the cure rate after surgery, and be effective in treating cancer tissues where surgery is difficult.

In particular, considering the mechanism of action of the immuno-oncology drug Oregovomab, the company explained that administering Oregovomab before surgery, when the blood concentration of the ovarian cancer antigen CA-125 is highest, could further enhance its anticancer efficacy.

Dr. Byunghak Yoon, President of Drug Development at Canaria Bio, said, “The first patient was enrolled smoothly, and since the follow-up period is only 12 months, we expect to see results relatively quickly. This trial will be an important opportunity to expand the application of Oregovomab to all ovarian cancer patients regardless of specific causes such as genetic or environmental factors.”

This content was produced with the assistance of AI translation services.