Biotechs Zero in on Growing Ovarian Cancer Market as Pivotal Trials Advance Through Regulatory Agencies

Palm Beach, FL – May 3, 2021 Ovarian cancer is the 8th most common cancer among women and ranks 5th in cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system. The three major types of ovarian cancer are epithelial, accounting for 90% of cases, germ cell (3%), and sex cord-stromal (2%). Most of the current information on factors associated with ovarian cancer risk is from studies of epithelial tumors. The strongest risk factor for ovarian cancer is a family history of breast or ovarian cancer. Modifiable factors associated with increased risk include use of menopausal hormone therapy and excess body weight. Although advancing knowledge about ovarian cancer has been hindered by substantial disease heterogeneity and uncertainties about tumor tissues of origin, understanding of the disease has evolved rapidly in recent years, especially for epithelial tumors, the most common subtype.  Because of the R&D activities projections for the market are optimistic… for both the companies’ revenues and the patients need. A report from iHealthcareAnalyst said that the global market for ovarian cancer drugs expected to reach $10.1 billion by 2027, steadily growing at CAGR 17.1% over the forecast period, driven by continued uptake and expected launches of the approved PARP inhibitors, their impressive efficacy, long treatment duration and the large number of treatment opportunities in the first-line advanced setting.   Active biotech companies in the market this week include AstraZeneca Plc’s (NASDAQ: AZN), BioVaxys Technology Corp. (OTCPK: LMNGF) (CSE: BIOV), Citius Pharmaceuticals, Inc. (NASDAQ: CTXR), Bristol Myers Squibb (NYSE: BMY), Roche Holding AG (OTCQX: RHHBY).

Treatment usually includes some combination of surgery, radiation therapy, and chemotherapy. Treatment depends on the stage of the cancer; tumor characteristics and subtype; and the patient’s age, health, and preferences, but typically includes surgery and often chemotherapy (platinum- and taxane-based) and targeted therapy.  The iHealthcareAnalyst report added: “Poly ADP-ribose polymerase (PARP) inhibition remains an attractive target for drugs in this indication with three PARP inhibitors already approved, but developers are also assessing newer immunological pathways… The PARP inhibitors are transforming the ovarian cancer treatment landscape. It is anticipated that the next big wave in ovarian cancer treatment after PARP inhibition monotherapy is combination therapy which is spurring development of other cancer immunotherapies in this space… The continued uptake of the approved PARP inhibitors (olaparib, rucaparib and niraparib) and the launch of two PDL1 inhibitors (avelumab and atezolizumab) will fuel impressive growth of the market in the coming years.”

BioVaxys Technology Corp. (OTCPK: LMNGF) (CSE: BIOV.CNQ) BREAKING NEWS:  BIOVAXYS AND BIOELPIDA SIGN DEFINITIVE EXCLUSIVE AGREEMENT TO BEGIN OVARIAN CANCER VACCINE BIOPRODUCTION – BioVaxys Technology Corp. (“BioVaxys”), announced today that it has signed the definitive exclusive bioproduction agreement (“Agreement”) with BioElpida S.A.S. (“BioElpida”) of Lyon, France, to begin the clinical-grade bioproduction and aseptic packaging for BXV-0918A, BioVaxys’ vaccine candidate for Stage III/Stage IV ovarian cancer.  BioVaxys and BioElpida executed a Term Sheet in February outlining the commercial relationship, with todays definitive Agreement focusing on the GMP facility build-out in Lyon, and technical aspects of the bioproduction protocol such as process design and validation, quality control and quality assurance steps, batch test runs, stability testing, and aseptic fill.  BioVaxys expects to be able to prepare its regulatory submission for a EU Phase I study of BVX-0918A in Stage III/Stage IV ovarian cancer near the end of this year, with vaccine supply for the planned clinical study available early May 2022.

BioElpida is a biotechnology contract development and manufacturing company (“CDMO”) which applies single-use bioprocessing for development and manufacturing of biological and cell-based products.  BioElpida’s expertise extends from R&D to pharmaceutical manufacturing and release of clinical batches, and intermediate steps such as process development, feasibility studies, analytical method validation, as well as aseptic fill & finish and other bioproduction services. BioElpida’s facility is certified for clinical bioproduction by France’s National Security Agency of Medicines and Health Products (ANSM).

“Early on we made the decision to seek a bioproduction partner with the ability to quickly move from smaller-yield GMP-grade clinical study supplies to large-scale manufacturing if our clinical trials prove successful and EU regulatory approval is granted,” said Kenneth Kovan, Co-Founder, President and Chief Operating Officer of BioVaxys.  “BioElpida’s technical experience and previous work on early generations of our cancer vaccine platform will be a significant advantage in our efforts to provide hope to those suffering from advanced ovarian cancer.”

BioVaxys is collaborating on the ovarian cancer vaccine clinical program with Spanish biopharma company ProCare Health Iberia S.A.S., which plans to submit a Clinical Trial Application (“CTA”) for BVX-0918A to the European Medicines Agency (“EMEA”) later this year for a compassionate use approval in Stage III & Stage IV ovarian cancer.    ProCare Health will have marketing rights to BVX-0918A in the EU and UK, whereas BioVaxys will market its ovarian cancer vaccine in North America and Rest of World. CONTINUED… Read this full release and more news for BioVaxys Technology at:  https://www.financialnewsmedia.com/news-biov/    

Other recent developments in the biotech industry include:

Citius Pharmaceuticals, Inc. (NASDAQ: CTXR), a specialty pharmaceutical company dedicated to the development and commercialization of critical care products with a focus on anti-infective products in adjunct cancer care, unique prescription products and stem cell therapy, recently announced updates delivered during its third Mino-Lok^® Phase 3 trial-related webinar. Mino-Lok^®, the Company’s lead product candidate, is an antibiotic lock therapy designed to salvage central venous catheters (CVCs) in patients with catheter related bloodstream infections (CRBSIs) or central line associated blood stream infections (CLABSIs). The webinar, led by Dr. Alan Lader, PhD, Vice President of Clinical Operations at Citius Pharmaceuticals was attended by investigators, clinical trial staff and referring physicians from trial sites participating in the Mino-Lok Phase 3 clinical trial.

“We are encouraged to see strong and growing interest within the clinical community in Mino-Lok as a potential treatment option for patients with CRBSI/CLABSI. There are currently no FDA approved therapies to salvage infected CVCs,” stated Dr. Myron Czuczman, Executive Vice President and Chief Medical Officer of Citius Pharmaceuticals.

Bristol Myers Squibb (NYSE: BMY) recently announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) for the adjuvant treatment of patients with surgically resected, high-risk muscle-invasive urothelial carcinoma, based on results from the CheckMate -274 trial. The FDA granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of September 3, 2021.

“After patients undergo surgery for muscle-invasive urothelial carcinoma, they continue to face uncertainties given the high rate of disease recurrence and the lack of safe and effective treatment options,” said Dana Walker, M.D., M.S.C.E., vice president, development program lead, genitourinary cancers, Bristol Myers Squibb. “Based on the ground-breaking disease-free survival results from CheckMate -274, we believe Opdivo has the potential to change the future of treatment for muscle-invasive urothelial carcinoma. We look forward to working with the FDA towards the goal of bringing the first adjuvant immunotherapy option to these patients in the U.S.”

Roche Holding AG (OTCQX: RHHBY) recently announced the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 10 to 1 in favour of maintaining accelerated approval of Tecentriq® (atezolizumab) for the treatment of adults with locally advanced or metastatic urothelial carcinoma (mUC, bladder cancer) who are not eligible for cisplatin-containing chemotherapy and whose tumours express high levels of PD-L1 (PD-L1–stained tumour-infiltrating immune cells covering ≥5 percent of the tumour area) as determined by an FDA-approved test or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. Today’s ODAC meeting is part of an industry-wide review of accelerated approvals with confirmatory trials that have not met their primary endpoint(s) and have yet to gain regular approvals. The advisory committee provides the FDA with independent opinions and recommendations from outside medical experts though the recommendations are not binding. The FDA has not announced when it will make its final decision for Tecentriq in this indication.

Daniel Simmons, PharmD, MS, AstraZeneca PLC (NASDAQ: AZN), discussed results recently from a study comparing progression-free survival (PFS) and costs per month of PFS between a biomarker-guided approach and non-biomarker guided approach to first-line maintenance therapy for advanced ovarian cancer.

These results were presented at the 2021 Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer.  Read it here

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