Similar to the microcap biotech sector as a whole, during the last several months BIOV shares have been forming a bottoming pattern. This is notable because BioVaxys is on track to begin an important clinical trial for its ovarian cancer vaccine in Europe. Considering BIOV's continued fundamental progress in advancing its vaccine pipeline, the risk/reward proposition at the current valuation appears to be particularly attractive
MedicalGold sat down with Dr. David Berd, Founder and Chief Medical Officer of BioVaxys. The company is preparing for their Phase 1 clinical trial for an ovarian cancer vaccine. We asked Dr. Berd to give us insight into the clinical study design and schedule. He provided some highly technical insight, and a tremendous amount of transparency into the upcoming study. This type of information is usually kept tight to the chest, so we were pleasantly surprised by Dr. Berd's willingness to divulge so much information.
Based in Vancouver, BioVaxys Technology Corp. (CNSX: BIOV) is a British Columbia registered, clinical-stage biotechnology company that is developing anti-viral and oncology vaccines based on its proprietary haptenized protein platform technology. The Company is currently advancing an ovarian cancer vaccine candidate into Phase 1 clinical trials. This vaccine leveraged the company's proprietary, haptenized autologous cell therapy used in combination with anti-PD1 and anti-PDL-1 checkpoint inhibitors to treat advanced ovarian cancer. BioVaxys has licensed two issued US patents, applied for two wholly-owned patent applications related to its cancer vaccine, and has a patent application pending for its antiviral vaccine platform which includes use in SARS-CoV-2 (Covid-19).
Where do we stand with the GMP manufacturing of the ovarian cancer vaccine? And what has been done so far?
The design of dedicated GMP facility completed. and the construction ongoing.
The technology transfer from BIOV to BioElpida is complete and we are establishing the control methods and manufacturing process development.
We have completed development of quality control (QC) assays, which are necessary to characterize the drug.
We have completed the creation of multiple OVCAR-3 cell banks as the next step in the GMP manufacturing process (The OVCAR-3 cell lineis mandatory for creating the identity assays that will have to be performed one very GMP batch of ovarian cancer vaccine. This assay is required by regulatory bodies in the EU and United States. The cell line is derived from a human ovarian adenocarcinoma, established from a patient refractory to cisplatin, a chemotherapeutic agent used in late-stage ovarian cancer).
We have entered into agreements with Hospices Civils de Lyon, France ("HCL") and Deaconess Institute (“Deaconess”) in the US to provide surgically excised ovarian cancer tumor cells.
These tumor cells (to date, 3/10) have been sent by HCL to BioElpida. Having this source of tumor cells is critical, as it permits our manufacturing partner, BioElpida, to validate the manufacturing process. The tumor excision and supply agreements also establish and validate the steps needed to be taken by each Phase I clinical site to determine patient inclusion and exclusion criteria (i.e. HIV 1/2 positive by ELISA, confirmed by Western blot, Hepatitis B surface antigen or hepatitis C antibody positive, blood chemistry panel results, tumor profile, patient history), guidelines for tumor acquisition, pathology, cell counts, cold storage containers/shipping logistics, patient consent documentation, IRB and regulatory approvals for tumor. Etc.
What are the upcoming hurdles?
The major hurdles are obtaining a sufficient number of “waste” ovarian cancer specimens (from HCL and Deaconess) to adequately evaluate the manufacturing and quality control processes.
The next milestone is recruiting clinical sites in Spain that have sufficient numbers of eligible ovarian cancer subjects.
We are also obtaining approval of the CTA by Spanish regulatory authorities.
What characterization needs to be done for the CMC (Chemistry, Manufacturing, and Controls) section of the IND (Investigational New Drug) application?
Currently being done w/ the excised tumors from our partner, HCL:
Specific experiments that go into characterization.
What characterization has been completed so far, and how were the results?
Flow cytometric analysis of the expression of ovarian cancer antigens and DNP on ovarian cancer cells after vaccine manufacturing. These results were positive.
How much of the IND has been written, and has an independent reviewer been selected?
The clinical protocol has been prepared (the BIOV protocol is based on the previous clinical study in the US with single hapten (i.e. “first generation”) vaccine performed by Dr. Berd. The IND/CTA requires CMC and QC/QA section, which will be added by BioElpida when GMP validation is complete
How many Phase 1 study sites and number of participants?
30 subjects in a multicenter study. Hospices Civils de Lyon, France ("HCL") has agreed to serve as a clinical study site for the Phase I or Phase II study of BVX-0918. HCL is a public hospital and France's second University Hospital Center, and premier site for clinical studies in the EU. Study centers are being selected for Spain.
Phase I study parameters as follows:
Protocol Title: Phase I Study of a Bihaptenized Autologous Ovarian Tumor Cell Vaccine in Ovarian Cancer Patients After Relapse
Study Population: Patients with advanced and/or recurrent epithelial ovarian cancer whose therapeutic tumor surgery provides a mass which yields adequate tumor cells for vaccine preparation
Study Design: A Phase I single-arm, multi-center study
Investigational Product: Bihaptenized autologous ovarian tumor cell vaccine
Dosage Form: Cell suspension
Route of Administration: Intradermal
Schedule: Weekly doses of bihaptenized autologous ovarian tumor cells vaccine for 6 weeks, with 3-month post vaccine follow-up
Endpoints: Treatment-emergent and related adverse events, serious adverse events, and Grade 3 and 4 laboratory abnormalities
When can we expect the IND to be submitted?
This is dependent on when BioElpida completes all GMP Q/C validation. It is possible that the CTA could be submitted as early as end of 2022, but more likely January 2023.
How long will patient recruiting take?
Patient recruiting will not be difficult given the availability of Stage III/Stage IV ovarian cancer patients in Spain and France. The oncologists being recruited have large OC patient populations.
An upcoming step for September/October is a meeting being organized by ProCare with The Spainsh Ovarian Cancer Research Group (GEICO). This is a non-profit Scientific Association that is a leader in clinical and translational research on gynecological cancer in general, with special attention to ovarian cancer. AT this meeting we will be presenting the clinical protocol and scientific basis of BVX-0918 so as to gain the support of GEICO.
When should we expect Phase 1 to start/finish?
First patient to be dosed in 1Q23. Subject accrual is expected to be completed in 6 months. The time on-study for each subject is 9 months (actual dosing w/ vaccine + safety follow-up).
Thank you very much for this highly detailed, technical insight. Our readers will definitely appreciate this transparency into your clinical studies.
Author owns BIOV.CA shares at the time of publishing and may choose to buy or sell at any time without notice. Author has been compensated for marketing services by BioVaxys Technology Corp.
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