Advanced Clinical Trials Focus on Development of Vaccines to Prevent Ovarian Cancer Progression

Palm Beach, FL – May 18, 2022 – News Commentary – Companies in the Ovarian Cancer market are spending a lot of R&D on vaccine development, therapies and studies. For the past 30 years, researchers have been looking into the potential of vaccines to treat ovarian cancer. Vaccines are a promising future treatment for ovarian cancer. Although they are still at the clinical trial phase, they may someday be used to prevent the progression of ovarian cancer. Ovarian cancer affects the ovaries, a pair of small, almond-shaped organs located on either side of your pelvis. It is one of the most common cancers for women, with more than 20,000Trusted Source new cases each year. It also accounts for more deaths each year than any other female reproductive system cancer.  A recent article in Healthline Media focus on the current state of developments. It said that:  “Ovarian cancer poses treatment challenges. It is difficult to detect and may be at an advanced stage when diagnosed. The overall survival rate after 5 years is less than 50 percent Trusted Source, according to 2019 research. But this varies by stage at diagnosis. Dozens of ovarian cancer vaccines are currently at various stages of development.” Active biotech companies in the market this week include BioVaxys Technology Corp. (OTCQB: BVAXF) (CSE: BIOV), Celsion Corporation (NASDAQ: CLSN), ImmunoGen Inc. (NASDAQ: IMGN), Zentalis Pharmaceuticals, Inc. (NASDAQ: ZNTL), Bristol Myers Squibb (NYSE: BMY).


2020 reviewTrusted Source identified 42 published clinical trials on ovarian cancer vaccines. Some of these are described as follows:  Dendritic cell vaccines: Dendritic cells (DCs) are a critical part of your immune system. They patrol their surroundings to identify threats, known as antigens. When an antigen — for instance, a cancerous cell — is detected, DCs activate a targeted immune system response to eliminate it. Dendritic cell vaccines harness the power of DCs to kill tumor cells. The goal is typically to prevent tumor growth, known as maintenance therapy. Researchers are studying most DC vaccines in combination with other treatments, such as chemotherapy.   CTA vaccines: Cancer-testis antigens (CTAs) are proteins that are active in the testes. Several tumors, including ovarian cancer, also exhibit active CTAs. CTA vaccines help generate an immune response that targets and disables CTAs. The clinical trials published to date have focused on the use of a CTA protein called NY-ESO-1. A 2020 review suggests this protein is present in up to 40 percentTrusted Source of people with ovarian cancer. But as of 2020, only four phase 1 clinical trials on CTA vaccines had been published.


BioVaxys Technology Corp. (OTCQB: BVAXF) (CSE: BIOV.CNQ) BREAKING NEWS:  BioVaxys Confirms First Clinical Site and Principal Investigators for Ovarian Cancer Vaccine Trial and Enters into Second Tumor Cell Supply Agreement  – BioVaxys Technology Corp. (“BioVaxys”) announced today that Hospices Civils de Lyon, France (“HCL”) has agreed to serve as a clinical study site for the Phase I study of BVX-0918, the Company’s autologous haptenized tumor cell vaccine for late-stage ovarian cancer. HCL has further agreed to supply BioVaxys with surgically debulked tumors from Stage III/Stage IV ovarian cancer patients undergoing treatment at the hospital to permit the Company to perform manufacturing tests.


BioVaxys, together with its EU partner, ProCare Health of Barcelona, Spain, is preparing for a Phase I clinical study with BVX-0918 later this year.


HCL is a public hospital and France’s second University Hospital Center, and a premier site for clinical studies in the EU.  Hospices Civils de Lyon is at the heart of the healthcare ecosystem of Greater Lyon, one of the major biotechnology and healthcare markets in Europe.


BioVaxys and Procare personnel will collaborate with Dr Pierre Adrien Bolze, MD, PhD, and Pr. Benoît You, MD, PhD, of HCL who are planned Clinical Investigators for the Phase I study of BVX-0918.


BioVaxys is preparing to file a Clinical Trial Application (“CTA”) with the European Medicines Agency (“EMA”) later in 2022. Access to surgically removed ovarian cancer tumor cells is a critical step enabling BioVaxys to validate the manufacturing process for BVX-0918. BioVaxys recently entered a similar collaboration with Deaconess Research Institute in the United States to provide the Company with surgically debulked tumors from Stage III/Stage IV ovarian cancer patients.   Tumor samples from both hospitals are being used to validate the tumor collection protocol, cryopackaging, cryopreservation, and supply chain logistics for BVX-0918 bioproduction for prospective patients in the US and EU.  Tumor samples from HCL will also 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 CTA with the EMA.


HCL has pre-screened the first patient for tumor collection, with patient enrollment for surgical debulking planned for next week.


Dr. You stated, “There is an unmet medical need for innovative approaches, based on vaccines and immunotherapies drugs, in ovarian cancer, as a way of improving the prognosis of patients. It has been defined as a priority for our institution. This collaboration with Biovaxys is a great opportunity for developing a vaccine that would then be assessed in a first-in-human trial in our early phase trial unit.”   Professor You is a medical oncologist and head of the Phase 1 trial unit oncology group (Centre d’Investigation des Thérapeutiques en Oncologie et Hématologie de Lyon), certified by French National Cancer Institute.  CONTINUED... Read this full release and more news for BioVaxys Technology at:    


Other recent developments in the cancer treatment space include:


Celsion Corporation (NASDAQ: CLSN), a clinical-stage drug-development company focused on DNA-mediated immunotherapy and next-generation vaccines, this week announced financial results for the quarter ended March 31, 2022, and provided an update on its clinical development program of GEN-1, a DNA-based interleukin-12 (IL-12) immunotherapy in Phase II clinical development for the treatment of advanced-stage ovarian cancer, and its preclinical studies of PLACCINE, a proprietary, multivalent DNA plasmid technology utilizing synthetic, non-viral delivery vectors, being evaluated in proof of concept studies for superiority over the current generation of nucleic acid vaccines.


“Patient enrollment in OVATION 2, our randomized Phase II study of advanced ovarian cancer patients, continues to show momentum with 85% of patients enrolled as of May 15, 2022, and full enrollment expected to be completed by the third quarter of 2022. We remain encouraged by surrogate endpoints like surgical resection scores among patients being treated at the 100 mg/m² dose cohort in the study. Early reports from the first thirty-nine patients who have undergone interval debulking surgery showed a 27% improvement in the surgical resection (R0) rate in the GEN-1 treatment arm over the control arm. A complete R0 is a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed,” said Michael H. Tardugno, Celsion’s chairman, president and chief executive officer.


ImmunoGen, Inc. (NASDAQ: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, in March 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.”


Zentalis Pharmaceuticals, Inc. (NASDAQ: ZNTL), a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers, recently announced financial results for the first quarter ended March 31, 2022 and highlighted recent corporate accomplishments.


“In the first quarter of 2022, we achieved multiple clinical milestones and expanded our strategic partnerships with industry leaders,” commented Dr. Anthony Sun, Chairman and Chief Executive Officer of Zentalis. “Most recently at AACR, we shared promising clinical data on ZN-c3 – our potentially best-in-class Wee1 inhibitor – from two ongoing trials, in addition to preclinical data on its potential in settings including AML, PARP-resistant ovarian cancer, and in combination with ZN-d5, our BCL-2 inhibitor. The urgency for novel, tolerable treatments that address cancer patients’ unmet needs remains high, and we have prioritized the development of ZN-c3 and ZN-d5, as we are confident in their ability to fill treatment gaps for a range of solid and liquid tumors. Furthermore, we are thrilled to partner with Pfizer and Caris Life Sciences and are grateful for their support as we work toward delivering differentiated oncology candidates to patients in need.”


Bristol Myers Squibb (NYSE: BMY) this week announced the Phase 3 CheckMate -901 trial, comparing Opdivo (nivolumab) plus Yervoy (ipilimumab) to standard-of-care chemotherapy as a first-line treatment for patients with untreated unresectable or metastatic urothelial carcinoma, did not meet the primary endpoint of overall survival (OS) in patients whose tumor cells express PD-L1 ≥1% at final analysis. The company remains blinded to the data, and an independent Data Monitoring Committee recommended that the trial continue to assess other primary and secondary endpoints. No new safety signals were observed at the time of the analysis.


“Despite some progress in recent years, metastatic urothelial carcinoma remains a difficult disease to address, with a limited number of treatment options that can extend patients’ lives,” said Dana Walker, M.D., M.S.C.E., vice president, development program lead, genitourinary cancers, Bristol Myers Squibb. “Opdivo plus Yervoy has demonstrated durable, long-term survival improvements in several challenging-to-treat advanced cancers, and we are disappointed that the final analysis of CheckMate -901 did not show this same benefit in urothelial carcinoma patients whose tumor cells express PD-L1 ≥1%. We remain committed to advancing research in urothelial carcinoma, we look forward to seeing data from other parts of the CheckMate -901 trial, and we thank all of the patients, investigators and site personnel involved.


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