Advanced Immunological and Clinical Trials for Treating Ovarian Cancer Accelerating

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Apr 25, 2022, 08:30 ET

PALM BEACH, Fla., April 25, 2022 /PRNewswire/ -- FinancialNewsMedia.com News Commentary - The formation of mutational cells or tissues in female reproductive organs called ovaries leads to ovarian cancer. Cancer remains undetected until the mutation spreads to the stomach and pelvis, a very advanced stage of ovarian cancer, which is fatal. A substantial percentage of women are dying due to ovarian cancer across the world. Ovarian cancer shows pious symptoms in the affected women, but they might experience pain in the abdomen, fatigue, indigestion, bloating, and nausea. A report from Market Data Forecast projected that the size of the global ovarian cancer market is predicted to register a CAGR of 10.1% from 2022 to 2027 and that the increased prevalence of ovarian cancer worldwide are majorly accelerating the growth rate of the global ovarian cancer market. The report said: "The increasing economies of the countries in the developed and developing regions are leading to the expansion of healthcare. As a result, they are contributing to the growth of the global ovarian cancer market. The global ovarian cancer market is further predicted to develop in response to the growing geriatric population of women, the rise in ovarian cancer incidence, the ease of use of new treatments and therapies, and the increase in healthcare expenditure. In addition, increased government financing is also fueling the market's expansion. Active biotech companies in the market this week include BioVaxys Technology Corp. (OTCQB: BVAXF) (CSE: BIOV), CTI BioPharma Corp. (NASDAQ: CTIC), ImmunoGen Inc. (NASDAQ: IMGN), Clovis Oncology, Inc. (NASDAQ: CLVS), Sunshine Biopharma, Inc. (NASDAQ: SBFM).

The article concluded: "Ovarian cancer has become more common in recent years as the female population has aged. Some of the other important reasons driving the growth of the ovarian cancer market are rising ovarian cancer prevalence, the launch of new medications and therapies, increased healthcare expenditure, and increased government funding. Furthermore, growing healthcare awareness is propelling the ovarian cancer market forward. As a result, drugs like Bevacizumab (Avastin) and Pazopanib (Votrient) are expected to enhance the market, now dominated by generics like paclitaxel and carboplatin. In addition, the market is expected to benefit significantly from the development of new medications to treat this form of cancer." It continued: "The global ovarian cancer treatment market is boosted by ongoing research and development to offer effective treatment interventions for various disorders. Several ovarian cancer treatments are now in clinical trials and are likely to hit the market in the near future. In addition, the patent expiration of certain top pharmaceuticals may also help propel the industry by encouraging new companies to enter the market. These altering dynamics are predicted to drive the ovarian cancer market during the forecast period."

BioVaxys Technology Corp. (OTCQB: BVAXF) (CSE: BIOV.CNQ) BREAKING NEWS: BioVaxys Enters Critical Tumor Cell Supply Agreement with Deaconess Research Institute for BVX-0918 Bioproduction - BioVaxys Technology Corp. ("BioVaxys") announced today that it has entered into an agreement with the Deaconess Research Institute ("DRI") to supply BioVaxys with surgically debulked tumors from Stage III/Stage IV ovarian cancer patients undergoing treatment at Deaconess Health System ("Deaconess"). DRI, based in Evansville, Indiana, is the clinical studies arm of Deaconess, a premier regional provider of health care services in the United States. Access to ovarian cancer tumor cells is a critical step enabling BioVaxys to validate the manufacturing process for BVX-0918, the Company's autologous haptenized tumor cell vaccine for late-stage ovarian cancer.

The standard of care for late-stage ovarian cancer often involves surgically debulking of the tumor mass. The debulked tumor cells will be used to test and validate the tumor collection protocol, cryopackaging, cryopreservation, and supply chain logistics for BVX-0918 bioproduction. Following shipment to BioElpida s.a. ("BioElpida"), the Company's bioproduction partner in Lyon, France, the tumor cells will then be used for process testing and manufacturing "dry runs" of BVX-0918, a major step leading to the completion of Good Manufacturing Process ("GMP") production, a requirement for the planned Clinical Trial Application ("CTA") with the European Medicines Agency ("EMA"). BioVaxys, together with its EU partner, ProCare Health of Barcelona, Spain, is preparing to launch a Phase I clinical study for BVX-0918 later this year.

BioElpida developed various tests and validation procedures needed to support GMP manufacturing, such as sterility testing for transport, hapten fixation, and cryopreservation solutions, as well as antibody generation, bioburden screening of the haptens, and endotoxin assays; access to debulked tumor means that BioElpida will begin the final stages of the vaccine production protocol and GMP validation. BioVaxys and BioElpida have also designed and fabricated a specialized shipping package which would cryopreserve the tumor sample while in transit from any hospital site to the BioElpida site.

BioVaxys President & Chief Operating Officer Kenneth Kovan says, "Having complied with the regulatory oversight involved in obtaining waste tumor samples, BioVaxys is now able to provide BioElpida with the materials required for finalizing the vaccine production protocol and performing process validation in the lead up to our planned CTA submission to the European regulator."

BioVaxys' vaccine platform is based on the established immunological concept that modifying surface proteins---whether they are viral or tumor---with haptens makes them more visible to the immune system. This process of haptenization "teaches" a patient's immune system to recognize and make target proteins more "visible" as foreign, thereby stimulating a T-cell mediated immune response. BioVaxys' cancer vaccines are created by extracting a patient's own (autologous) cancer cells, chemically linking with a hapten, and re-injecting them into the patient to induce an immune response to proteins which are otherwise not immunogenic. Haptenization is a well-known and well-studied immunotherapeutic approach to cancer immunotherapy and has been clinically evaluated in both regional and disseminated metastatic tumors. 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:

CTI BioPharma Corp. (NASDAQ: CTIC) recently announced that VONJO™ (pacritinib), its novel oral kinase inhibitor with specificity for JAK2 and IRAK1, without inhibiting JAK1, has been included as a recommended treatment in the latest National Comprehensive Cancer Network^® (NCCN^®) Clinical Practice Guidelines in Oncology for Myeloproliferative Neoplasms.

"We are grateful that NCCN acted quickly to include VONJO with a Category 2A designation in its Clinical Practice Guidelines in Oncology as a first line treatment for high-risk patients with myelofibrosis with platelet counts <50 x 10⁹/L who are not candidates for transplant. This therapeutic option helps address an unmet medical need for patients who previously have no other treatment options. There is no other FDA-approved first line treatment for these patients with a 2A designation within the NCCN guidelines," said Adam R. Craig, M.D., Ph.D., President, and Chief Executive Officer of CTI BioPharma. "Additionally, VONJO was included as a Category 2A designation as second line treatment for lower-risk and higher-risk patients with myelofibrosis with platelet counts ≥50 x 10⁹/L who are not candidates for transplant. This placement provides additional treatment options for patients with myelofibrosis."

ImmunoGen Inc. (NASDAQ: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, recently announced that it has submitted a Biologics License Application (BLA) under the accelerated approval pathway to the US Food and Drug Administration (FDA) for mirvetuximab soravtansine monotherapy in patients with folate receptor alpha (FRα)-high platinum-resistant ovarian cancer who have been previously treated with 1 to 3 prior systemic treatments. The submission is based on results from the pivotal Phase 3 SORAYA trial. Top-line data from SORAYA were announced in November 2021 and full data from the study were presented this month at the Society of Gynecologic Oncology (SGO) 2022 Annual Meeting.

"The BLA submission for mirvetuximab soravtansine is a key inflection point on our journey to delivering a safe and effective treatment option to patients with platinum-resistant ovarian cancer and moves us one step closer to transforming ImmunoGen into a fully-integrated oncology company," said Mark Enyedy, ImmunoGen's President and Chief Executive Officer. "Platinum-resistant ovarian cancer is an area with high unmet need, and we look forward to working with FDA to secure mirvetuximab soravtansine's first approval and bringing this novel therapy to patients as quickly as possible."

Clovis Oncology, Inc. (NASDAQ: CLVS) recently announced positive top-line data from the monotherapy arm of the ATHENA (GOG 3020/ENGOT-ov45) trial (ATHENA-MONO) demonstrating that Rubraca as maintenance treatment successfully achieved the primary endpoint of significantly improved investigator-assessed progression-free survival (PFS) compared with placebo. Benefit was observed in both primary efficacy analyses of newly-diagnosed patients with advanced ovarian cancer following successful treatment with platinum-based chemotherapy: those who had homologous recombination deficiency (HRD-positive), including deleterious BRCA mutations, as well as all patients randomized in the trial (overall intent-to-treat population (ITT)). Benefit in PFS was also seen in the exploratory subgroups of patients with HRD-negative² and BRCA mutant (BRCAm) tumors. The safety of Rubraca observed in the ATHENA-MONO study was consistent with both the US and European labels.

Based on these results, the Company plans to submit a supplemental New Drug Application (sNDA) to the US FDA during the second quarter of 2022 followed by a Type II Variation to the EMA during the third quarter of 2022 for a first-line maintenance treatment indication for women with advanced ovarian cancer regardless of biomarker status who have responded to first-line platinum-based chemotherapy.

Sunshine Biopharma, Inc. (NASDAQ: SBFM), a pharmaceutical company focused on the research, development and commercialization of oncology and antiviral drugs, recently announced that two of its newly designed mRNA molecules are effective at destroying cancer cells grown in culture.

The cytotoxicity tests were performed on a variety of cancer cells including multidrug resistant breast cancer cells (MCF-7/MDR), ovarian adenocarcinoma cells (OVCAR-3), and pancreatic cancer cells (SUIT-2). Toxicity studies using non-transformed (normal) human cells (HMEC cells) showed that these mRNA molecules had little or no cytotoxic effects. These new mRNA molecules are readily adaptable for delivery into patients using the mRNA vaccine technology. The Company anticipates filing a patent application in connection with these results soon.

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