OvaRex (oregovomab)

The safety and compatibility of combining oregovomab with Hiltonol® have been demonstrated in this study. The potential to enhance activity of chemotherapy using oregovomab indirect immunization and Hiltonol® stimulation is proposed.

This study suggests that simultaneous administration of oregovomab on alternate cycles during front-line carboplatin and paclitaxel could enhance progression-free survival and long-term overall survival. This increase in median overall survival after 9 years of follow-up is meaningful in patients with optimally debulked epithelial ovarian cancer.

P2, N=88, Active, not recruiting, CanariaBio Inc. | Recruiting --> Active, not recruiting | Trial completion date: May 2026 --> Sep 2027 | Trial primary completion date: Sep 2024 --> Jan 2026

P2, N=10, Active, not recruiting, CanariaBio Inc. | Trial completion date: Dec 2024 --> Jul 2025 | Trial primary completion date: Mar 2024 --> Mar 2025

P3, N=615, Active, not recruiting, CanariaBio Inc. | Trial completion date: Aug 2027 --> Aug 2028 | Trial primary completion date: Sep 2025 --> Mar 2026

In the 97 EOC patients after optimal debulking surgery (residual tumor <1 cm or no gross residual tumor), patients treated with CIT had a dramatical and statistically significant improvement of both progression-free survival (PFS) and overall survival (OS) compared to those treated with chemotherapy alone with a median PFS of 41.8 months versus 12.2 months (hazard ratio &lsqb;HR] 0.46, 95 % confidence interval &lsqb;CI] 0.28-0.7) and OS not yet been reached (NE) versus 42.3 months (HR 0.35, 95 % CI 0.16-0.74), respectively. The current review as Part II will explore the possibility of using CIT as front-line therapy in the management of advanced-stage EOC patients after maximal cytoreductive surgery based on the evidence by many phase 2 studies.

The current standard therapy of epithelial ovarian cancer (EOC) is the combination of surgery (primary cytoreductive surgery or interval cytoreductive surgery) and platinum-based chemotherapy (mainly using paclitaxel and carboplatin either by neoadjuvant chemotherapy and/or by postoperative adjuvant chemotherapy) with/without adding targeted therapy (mainly using anti-angiogenesis agent- bevacizumab)...It is well-known that overexpression of CA125 has been associated with attenuated cellular apoptosis, platinum chemotherapy resistance, tumor proliferation and disease progression, suggesting that anti-CA125 may play a role in the management of patients with EOC. The current review is a Part I which will focus on development of anti-CA125 monoclonal antibody, hoping that alternation of the front-line therapy by chemo-immunotherapy will be beneficial for prolonged survival of patients with EOC.

The primary objective is PFS determined by RECIST 1.1 criteria. Current Trial Status: At the time of abstract submission, 618 patients were enrolled and target enrolment Cohort 1 (378) and Cohort 2 (240) was achieved.

P1b/2, N=54, Recruiting, CanariaBio Inc. | Trial primary completion date: Apr 2023 --> Apr 2024

P2, N=10, Active, not recruiting, CanariaBio Inc. | Trial completion date: May 2024 --> Oct 2024 | Trial primary completion date: Sep 2023 --> Jan 2024

P2, N=10, Active, not recruiting, CanariaBio Inc. | Recruiting --> Active, not recruiting | Trial completion date: May 2023 --> May 2024 | Trial primary completion date: May 2023 --> Sep 2023

P3, N=615, Active, not recruiting, CanariaBio Inc. | Recruiting --> Active, not recruiting | Trial primary completion date: Jun 2024 --> Sep 2025