On September 25, 2019 OncoQuest Inc., a privately held, cancer immunotherapy company reported that a Notice of Allowance was received from the U.S. Patent and Trademark Office (USPTO) for patent protection of the schedule of administration of our monoclonal anti-CA-125 antibody, mAb-B43.13, now known as oregovomab, in a specific schedule in combination with carboplatin and paclitaxel in Stage III-IV ovarian cancer patients (Press release, OncoQuest, SEP 25, 2019, View Source [SID1234539791]).

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A Notice of Allowance signifies that the applicant is entitled to receive patent protection of 20 years under the law. The patent claim lays out a specific schedule of administration of oregovomab in combination with carboplatin and paclitaxel, and as a standalone injection 10 to 14 weeks after the third oregovomab administration. This administration protocol generated a statistically significant Progression Free and Overall Survival advantage over chemotherapy alone in a 97-patient randomized controlled Phase 2 study in newly diagnosed Stage III-IV ovarian cancer patients which was completed in 2017 [NCT01616303].

The Company is currently planning to launch a Phase 3 trial in Q1 2020. The planned Phase 3 study is expected to enroll over 500 patients with newly diagnosed, advanced ovarian cancer globally. The primary endpoint will be to evaluate progression-free survival of patients treated with oregovomab plus a standard-of-care chemotherapy combination, carboplatin and paclitaxel, compared to the chemotherapy alone.

"We are very pleased that this additional patent was allowed as it is a significant addition to our oregovomab patent portfolio, providing extended exclusivity protection, in addition to what we are already expecting from the Biologics Price Competition and Innovation Act (BPCIA)," said Dr. Madiyalakan, CEO of OncoQuest. "This marks an important step in our ongoing efforts to optimize the value of our oregovomab product as we embark on our initiation of the Phase III registration study and towards commercialization of oregovomab."