Increasing R&D Studies to Develop Cancer Vaccines Attributed to Spike in Number of Cancer Patients

PALM BEACH, Fla., Feb. 18, 2021 /PRNewswire/ -- Ovarian cancer and its rising incidence rate is a growing concern worldwide and the rising incidence of ovarian cancer will be driving the ovarian cancer drugs market for years to come. Ovarian cancer is regarded as one of the most common types of cancer among women. It accounts for more deaths than any other cancer of the female reproductive system, while it ranks 5th in overall women deaths due to cancer. This type of cancer is rarely diagnosed at an early stage, making treatment at an advanced stage difficult. According to American Cancer Society estimates, risk of any woman acquiring ovarian cancer in her lifetime is 1 in 75, while her chance of death due to ovarian cancer is 1 in 100. Ovarian cancer is more prevalent among elderly women, making women over 55 a high-risk population. A report from Allied Market Research projected that the global cancer vaccines market was valued at $4,188 million in 2019, and is projected to reach $7,303 million by 2027, registering a CAGR of 12.6% from 2020 to 2027.  The report said that: "(The) growth of the cancer vaccines market is attributed to rise in number of cancer patients across the globe. Furthermore, rise in public awareness toward benefits of cancer vaccines, surge in demand for cancer vaccines, and rise in adoption rate of preventive and therapeutic vaccines are other factors that contribute toward growth of the market."    Active biotech companies in the market this week include Ziopharm Oncology,Inc. (NASDAQ: ZIOP), BioVaxys Technology Corp. (OTCPK: LMNGF) (CSE: BIOV), Evofem Biosciences, Inc., (NASDAQ: EVFM), Onconova Therapeutics, Inc. (NASDAQ: ONTX), Nektar Therapeutics (NASDAQ: NKTR).

Allied Market Research continued: "The cancer vaccines market is expected to experience a significant growth during the forecast period, owing to rise in demand for novel cancer vaccine products, increase in prevalence of HPV infections, surge in public awareness toward cancer diseases, and rise in investments by government & private organizations for production of new cancer vaccines. Moreover, rise in adoption rates of preventive and therapeutic vaccines, technological advancements in cancer vaccines, increase in number of cancer cases, and launch of novel cancer vaccines further boost the cancer vaccines market growth… Furthermore, growth in transition from prophylactic to therapeutic cancer vaccines is expected to offer lucrative opportunities in the near future."

BioVaxys Technology Corp. (OTCPK: LMNGF) (CSE: BIOV.CNQ) BREAKING NEWS:  BioVaxys and BioElpida Sign Term Sheet for Clinical Grade BVX-0918a Bio-Production - Significant Advancement Towards Launch of Phase 1 Ovarian Cancer Vaccine Trial - BioVaxys Technology Corp. ("BioVaxys") announced today that it has signed a Term Sheet ("Term Sheet") with BioElpida S.A.S. ("BioElpida") of Lyon, France, to collaborate on the build-out for the clinical-grade manufacturing process and aseptic packaging for BXV-0918A, BioVaxys' vaccine for Stage III/Stage IV ovarian cancer.  Completion of the GMP-grade bioproduction process development is planned for later this year, with the EU Phase I/II clinical trial slated for early 2022, pending European Medicines Agency ("EMEA") approval.

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).

The two companies are working towards the execution of a definitive agreement by the end of this March.  Completion of the GMP-grade bioproduction process development is planned for later this year, with the EU Phase I/II clinical trial slated for early 2022, pending European Medicines Agency ("EMEA") approval.

Kenneth Kovan, President and Chief Operating Officer of BioVaxys, stated that "In addition to its bioproduction expertise, the BioElpida team is intimately familiar with our haptenized protein approach, having previously been involved in the process development for the clinical supply of the 'first generation' haptenized tumor cell vaccines."

BioVaxys recently announced that it 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.

Globally, there remain significant unmet therapeutic needs for ovarian cancer treatment. Worldwide, over 300,000 women are diagnosed with ovarian cancer each year (World Cancer Research Fund, 2020), with ovarian cancer the leading cause of death from gynecologic malignancy in the United States (American Cancer Society Facts & Figures 2020). An estimated 21,750 new cases of ovarian cancer were expected in the US in 2020 with 13,940 deaths (National Cancer Institute, Surveillance and Epidemiology Program, 2020). The majority of women with Stage III or Stage IV cancer will ultimately have recurrent disease resistant to chemotherapy. Patients who have relapsed after platinum-based chemotherapy have limited life expectancy even with multiple salvage regimens. This large group of non-responders to, or those who relapse after, first line therapy is the initial target market for BioVaxys. 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:

Onconova Therapeutics, Inc. (NASDAQ: ONTX), a biopharmaceutical company focused on discovering and developing novel products to treat cancer, recently announced receipt of U.S. Food and Drug Administration (FDA) permission for a Phase 1 study to proceed under the Company's Investigational New Drug application (IND) for ON 123300, a proprietary, differentiated, first-in-class multi-kinase inhibitor.

"We are grateful to receive this timely, favorable response from the FDA to initiate a Phase 1 trial with ON 123300," said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova. "We are advancing the process to secure Institutional Review Board approval, and affirm our expectation that the first patient will be enrolled during the first half of 2021."

Ziopharm Oncology,Inc. (NASDAQ: ZIOP), recently announced that the Taiwan Food and Drug Administration has cleared an investigational new drug application (IND) from Eden BioCell, a joint venture between Ziopharm and cell therapy company TriArm Therapeutics, for its phase 1 clinical trial to evaluate patient-derived CD19-specific CAR-T, using Ziopharm's Rapid Personalized Manufacturing (RPM) technology. This is an investigational treatment for patients with relapsed CD19⁺leukemias and lymphomas and the first clinical study of autologous non-viral CD19-specific CAR-T in Taiwan.

This trial will utilize Ziopharm's non-viral Sleeping Beauty cell engineering technology to infuse autologous CAR-T the day after T cells have been genetically modified. Ziopharm's RPM CD19-specific CAR-T therapy results from the stable, non-viral insertion of DNA into the genome of resting T cells to co-express the chimeric antigen receptor (CAR), membrane-bound IL-15 (mbIL15) and a safety switch. The trial is being conducted at National Taiwan University Hospital.

Evofem Biosciences, Inc., (NASDAQ: EVFM) recently announced the launch of "Get Phexxi", a national direct-to-consumer (DTC) campaign aimed at broadening awareness of its non-hormonal, use-it-only-when-you-need-it birth control method, Phexxi ® (lactic acid, citric acid and potassium bitartrate).

Approved by the U.S. Food and Drug Administration (FDA) in May 2020, Phexxi is an innovative non-hormonal contraceptive method created for women. With 21 million women in the U.S. at risk for pregnancy who are NOT using hormonal contraception, the time is right for the "Get Phexxi" campaign to educate women about this innovative birth control option.

The campaign highlights some of the struggles women face when choosing among the many available methods of contraception, whether it's the lack of control with condoms, constant daily use of the pill, or abstinence required for cycle tracking. The women featured in the commercial represent the real-life drawbacks that Phexxi may help eliminate as a hormone-free, on-demand birth control method.

Nektar Therapeutics (NASDAQ: NKTR) recently announced that it has entered into a clinical trial collaboration and supply agreement with Merck (known as MSD outside the United States and Canada) for a Phase 2/3 study of bempegaldesleukin (NKTR-214, BEMPEG), Nektar's investigational IL-2 pathway agent, in combination with Merck's KEYTRUDA^® (pembrolizumab) for first-line treatment of patients with metastatic or unresectable recurrent squamous cell carcinoma of the head and neck (SCCHN) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1). The study is planned to start in the second half of 2021.

"We are excited to advance the combination of BEMPEG plus KEYTRUDA to a Phase 2/3 study in first-line squamous cell carcinoma of the head and neck," said Jonathan Zalevsky, PhD, Chief R&D Officer at Nektar. "Earlier studies of BEMPEG in combination with immune checkpoint inhibitors, also known as ICIs, evaluated in patients with immune-sensitive cancers have shown the potential to increase and deepen treatment responses as compared to historical rates for ICIs alone. This collaboration with Merck will enable us to further explore the combination of BEMPEG with the leading checkpoint inhibitor therapy in the setting of advanced head and neck cancer."

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