Quest Pharma Tech Inc. (QPT.V) specializes in cancer and pharmaceutical therapies. We initiated coverage on May 2017, with notes on April 2018 and September 2018 and April 2019. As a reminder, QPT.V operates six subsidiaries with different ownership stakes:
OncoQuest and OncoVent are joint ventures with Shenzhen Hepalink Pharmaceutical Co. Ltd, a global company based in China. Below is an update.
Sept. 25 - OncoQuest Receives "Notice of Allowance" for Patent Protection of the Administration Schedule of Oregovomab and Chemotherapy for Stage III-IV Ovarian Cancer Patients. 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.
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.
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.
Indeed, only one release was issued in the last seven months but it is nonetheless significant and comes eights months after the original announcement. As per the last MD&A, the Phase 3 trial is an evolution on the US-Italian phase 2 trials that was completed (December 2017).
A multi-centre Italian and U.S. cooperative trial to establish evidence for the clinical benefit associated with enhanced specific T cell immunity achievable by combining Oregovomab with carboplatin and paclitaxel in the initial treatment of advanced ovarian cancer (frontline). In November 2016, OncoQuest announced positive interim clinical results from this 97-patient clinical trial and presented those findings at the American Society of Clinical Oncology meeting in June 2017. This trial was completed in December 2017.
Other than the U.S. Patent and Trademark Office (USPTO) patent protection for this specific schedule of administration for Oregovomab for 20 years, the announcement of the beginning of Phase 3 critical trials is an acknowledgement that there is merit to this compound. According to the FDA, 33% of the drugs tested in phase 2 move to phase 3 trials and 25 to 30% of those in tested in Phase 3 move to Phase 4 trials.
As a reminder, Oregovomab has three other phase 2 trials which are ongoing which can add to the merit of the compound in different modalities.
1. A Phase 2 clinical trial in the US to evaluate the ability of an immuno-adjuvant (TLR3 agonist, Hiltonol®) to enhance the strength of the Oregovomab immune response with ovarian cancer patients in the recurrent setting.
2. Another Phase 1/2 clinical trial to evaluate the safety and bioactivity of oregovomab and Nivolumab, a checkpoint inhibitor, as a combinatorial immunotherapy strategy in patients with recurrent ovarian cancer. This trial is being conducted at the National Cancer Centre in Singapore.
2. A Phase 2 U.S. physician sponsored clinical trial is also currently ongoing evaluating Neoadjuvant Chemotherapy with the use of gemcitabine, another cytotoxic agent, and immunotherapy to CA125 (Oregovomab) followed by radiotherapy in a cohort of patients with CA125 associated partially resectable pancreatic cancer.
Results from these other trials (interim, final) are also expected in the future. Otherwise, QPT.V trade sporadically even as Oregovomab enters Phase 3.
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