Ovarian Cancer

Study Results Position Company to Target Segments of $270B+ Multi-Billion Dollar Drug Delivery Systems Market1 VANCOUVER, BC, Oct. 31, 2024 /PRNewswire/ -- BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) ("BioVaxys" or the "Company") highlights studies showing that its novel immune educating delivery platform, DPX™, recruits and activates unique subsets of antigen presenting cells ("APCs") to drive immunogenicity of antigens, and exhibits superior immune activation compared to aqueous and emulsion-based antigen delivery systems. With cancer vaccines, the successful eradication of tumors relies on the persistent delivery of antigenic APCs to prime potent, antigen specific, cytotoxic T cells. Current peptide antigen delivery methods include using either water-based formulations which provide short exposure of peptides to immune cells, or oil-in-water emulsions that provide longer peptide exposure but that can elicit dysfunctional T cell phenotypes. In contrast, BioVaxys' DPX technology is a non-aqueous, lipid-in-oil, immune-educating therapeutic delivery platform that keeps the antigen cargo at the site of injection, ensuring that uptake of the DPX-encapsulated cargo is an active process driven by the APCs across time. In a study done in collaboration with Dalhousie University of Halifax, Nova Scotia, DPX was compared to aqueous and emulsion-based formulations to evaluate the dynamics of immune cell recruitment to the site of injection, antigen consumption, and trafficking by immune cells. Immune cell composition and antigen uptake at the injection site were assessed by multi-parameter flow cytometry and confocal microscopy using model peptide antigens administered in mice. Antigen-specific immune responses were assessed by interferon-gamma (IFN-γ)-based Enzyme-Linked Immunospot (ELISpot) assay to measure IFN-γ, the presence of which plays a crucial role in activating the immune system. The ELISpot assay is a sensitive method for measuring the number of cells that produce cytokines or antibodies in response to an antigen. "BioVaxys is at the forefront of a significant shift in the drug delivery landscape," James Passin, CEO of BioVaxys, stated, "These groundbreaking study results validate our strategic position in an important segment of the multi-billion drug delivery market. DPX not only outperforms current antigen delivery solutions but also demonstrate inherent immune-activating properties, opening up significant revenue potential across multiple market segments." The study results showed that aqueous formulations were poorly able to retain lymphocytes at the injection site and consequently did not elicit a detectable IFN-γ ELISpot response. Both DPX and the oil emulsion were superior in recruiting APCs to the injection site and inducing antigen-specific immune responses, and with significant increases in immune cell infiltration detected as early as 2 days post DPX injection. However, a significant difference between DPX and oil emulsion was that antigen presentation driven by the DPX platform resulted in activation of more critical markers of T cell subsets than emulsion. An additional and highly significant finding is that recruitment and activation of these T cell subsets by DPX was evident regardless of whether an antigen was contained as cargo in DPX, indicating that DPX on its own has immune system activating properties. Kenneth Kovan, President and Chief Operating Officer at BioVaxys, stated "We know that compared to DPX remaining at the injection site, emulsion-based and aqueous formulations leach cargo into surrounding tissues. These findings further highlight the quantitative, qualitative, and temporal differences in immune cell recruitment by DPX and two common delivery platforms and show the character of the immune response triggered by the DPX platform via activation of T cell subsets with intrinsically higher capacity for antigen uptake, presentation, and activation." BioVaxys is planning to present additional data in early December on the unique characteristics of DPX 1Drug Delivery Devices Market Size, Share & Trends Analysis Report By Application (Oncology, Infectious Diseases), By Route Of Administration (Oral, Transdermal, Injectable), By End-use, By Region, And Segment Forecasts, 2024 – 2030, Grand View Research About BioVaxys Technology Corp. BioVaxys Technology Corp. () is a clinical-stage biopharmaceutical company dedicated to improving patient lives with novel immunotherapies based on its DPX™ immune-educating technology platform and its HapTenix© "neoantigen" tumor cell construct platform, for treating cancers, infectious disease, antigen desensitization for food allergy, and other immunological diseases. Through a differentiated mechanism of action, the DPX™ platform delivers instruction to the immune system to generate a specific, robust, and persistent immune response. The Company's clinical stage pipeline includes maveropepimut-S (MVP-S), based on the DPX™ platform, and is in Phase IIB clinical development for advanced Relapsed-Refractory Diffuse Large B Cell Lymphoma (DLBCL) and platinum resistant Ovarian Cancer. MVP-S delivers antigenic peptides from survivin, a well-recognized cancer antigen commonly overexpressed in advanced cancers, and also delivers an innate immune activator and a universal CD4 T cell helper peptide. MVP-S has been well tolerated and has demonstrated defined clinical benefit in multiple cancer indications as well as the activation of a targeted and sustained, survivin-specific anti-tumor immune response. BioVaxys is also developing DPX™+SurMAGE, a dual-targeted immunotherapy combining antigenic peptides for both the survivin and MAGE-A9 cancer proteins to elicit immune responses to these two distinct cancer antigens simultaneously, DPX™-RSV for Respiratory Syncytial Virus, DPX+rPA for peanut allergy prophylaxis, and BVX-0918, a personalized immunotherapeutic vaccine using its proprietary HapTenix© "neoantigen" tumor cell construct platform for refractive late-stage ovarian cancer. BioVaxys common shares are listed on the CSE under the stock symbol "BIOV" and trade on the Frankfurt Bourse (FRA: 5LB) and in the US (OTCQB: BVAXF). For more information, visit and connect with us on X and LinkedIn. ON BEHALF OF THE BOARD Signed "James Passin" James Passin, Chief Executive Officer Phone: +740 358 0555 Email: [email protected] Cautionary Statements Regarding Forward Looking Information This press release includes certain "forward-looking information" and "forward-looking statements" (collectively "forward-looking statements") within the meaning of applicable Canadian and United States securities legislation including the United States Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, included herein, without limitation, statements relating the future operating or financial performance of the Company, are forward looking statements. Forward-looking statements are frequently, but not always, identified by words such as "expects", "anticipates", "believes", "intends", "estimates", "potential", "possible", and similar expressions, or statements that events, conditions, or results "will", "may", "could", or "should" occur or be achieved. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those expressed or implied in such forward-looking statements. These forward-looking statements reflect the beliefs, opinions and projections on the date the statements are made and are based upon a number of assumptions and estimates, primarily the assumption that BioVaxys will be successful in developing and testing vaccines, that, while considered reasonable by the Company, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies including, primarily but without limitation, the risk that BioVaxys' vaccines will not prove to be effective and/ or will not receive the required regulatory approvals. With regards to BioVaxys' business, there are a number of risks that could affect the development of its biotechnology products, including, without limitation, the need for additional capital to fund clinical trials, its lack of operating history, uncertainty about whether its products will complete the long, complex and expensive clinical trial and regulatory approval process for approval of new drugs necessary for marketing approval, uncertainty about whether its autologous cell vaccine immunotherapy can be developed to produce safe and effective products and, if so, whether its vaccine products will be commercially accepted and profitable, the expenses, delays and uncertainties and complications typically encountered by development stage biopharmaceutical businesses, financial and development obligations under license arrangements in order to protect its rights to its products and technologies, obtaining and protecting new intellectual property rights and avoiding infringement to third parties and their dependence on manufacturing by third parties. The Company does not assume any obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law. Logo - SOURCE BioVaxys Technology Corp. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Collaborative, Multiomics, Patient-first Approach to Transform Cancer Care, Treatment SEATTLE, Oct. 30, 2024 /PRNewswire/ -- Providence Swedish today announced the official opening of the Paul G. Allen Research Center at Providence Swedish Cancer Institute (PSCI). The new center takes a highly collaborative, sophisticated approach to improving the experience and outcome for every cancer patient by advancing modern oncology research to transform clinical care and treatment. "We are thrilled to officially open the Paul G. Allen Research Center, a focused extension of our long-standing, robust clinical trials program, to enhance resources available to our researchers and collaborators. The model convenes a broad range of problem solvers by inviting competitive proposals from physicians across our institution, stewarding the best research ideas and creating an optimal environment for them to collaborate with academic and industry partners," said Elizabeth Wako, M.D., Swedish Health Services president and CEO. "The center provides advanced analytics for specimens and data, while bringing together a broad range of clinical, biologic and computer scientists at the forefront of their respective fields. In effect, creating a nimble, responsive environment to drive innovation, united behind a mission to improve care. Our physician researchers are the secret sauce. They know firsthand existing gaps, develop ideas and evaluate promising treatments to identify care improvement opportunities." The center's research portfolio is divided among three independent, but complimentary, research pillars focused on prevention, exploration and treatment. The Initiative for Prevention and Early Detection – led by Charles Drescher, M.D. – investigates the genesis of cancer, focused on ways to prevent cancers before they start and ways to detect them as early as possible. The Initiative for Molecular and Genomic Evaluation of Cancer – led by Henry Kaplan, M.D. – uses genetic and molecular testing, combined with patients' disease and treatment history, to examine cancer progression and how it evolves to evade therapies. Lastly, the Center for Immuno-oncology – led by Kelly Paulson, M.D., Ph.D. – focuses on developing and testing leading-edge immunotherapies to improve cancer treatment. "By combining multiomics data through these synergistic research pillars – transcending the cancer continuum from genesis to recurrence or cure – we've created an opportunity to discover new approaches to prevent, detect and fight cancer," said Douglas Kieper, director of the new First Hill Campus-based center. "This is a mission far beyond the lab benches and computer workstations. With this gift, Paul challenged us to improve the experience and outcome of every patient. That simple, aspirational charge is a natural extension of our role as a nonprofit health system, with patient care at the center of all we do." Unlike traditional research models, where a lab is established for one major researcher who guides the work, Paul G. Allen Research Center is investigator agnostic, using a competitive review model to select and mentor the most promising research ideas from all Providence Swedish researchers. The center currently supports 42 studies from 16 Providence Swedish physician investigators which, collectively, involve more than 27 academic and commercial partner organizations. "We can make a meaningful difference in people's lives by expanding access to a broad range of clinical trials and the most contemporary treatment options," said Providence Swedish Cancer Institute Executive Medical Director Ashwani Rajput, M.D. "Paul G. Allen Research Center's novel resource combinations, personalized and data-backed approaches will help foster a new wave of cancer care." Early successes from Paul G. Allen Research Center team members include: Its first clinical trial opened in February 2023 to examine the role of Tarlatamab in lung cancer as part of a multicenter study. The therapy received FDA clearance in May 2024 as the first approved immunotherapeutic in its class. On May 7, 2024, the center was part of a first-in-man allogeneic CAR-T therapy for lupus. Charles Drescher, M.D., is preparing a manuscript for Nature Genetics – funded, in part, by Paul G. Allen Research Center – that supports his efforts to launch an ovarian cancer precancer atlas project with a team of national researchers. Center history, resources Paul G. Allen Research Center was made possible through a generous $20 million donation from the late philanthropist, Paul G. Allen, co-founder of Microsoft. It remains the largest ever donation made to Swedish Health Services. "Paul believed Swedish and its leadership would create lasting impact, with patients at the center, and built on years of innovation, research, and compassionate care," said Jody Allen, Allen's sister and executor of his estate. "As a cancer patient himself, Paul knew too well the toll that cancer takes on so many people and their families, but also the many opportunities there are to create a better future." The center, which is located in the First Hill Medical Pavilion, is a translational research lab with both biospecimen (wet) and data (dry) laboratory spaces. The wet lab is staffed and equipped to quickly collect tissue for individual clinical research projects. The dry lab provides infrastructure needed to seamlessly, swiftly analyze bioinformatics output of internal and external labs, and amplify the value of these specimens and data by placing them into the context of disease and treatment history. About Providence Swedish Providence Swedish has served the Puget Sound region since the first Providence hospital opened in Seattle in 1877 and the first Swedish hospital opened in 1910. The two organizations affiliated in 2012 and today comprise the largest health care delivery system in Western Washington, with 22,000 caregivers, eight hospitals and 244 clinics throughout Western Washington – from Everett to Centralia. A not-for-profit family of organizations, Providence Swedish provides more than $545 million in community benefit in the Puget Sound region each year. The health system offers a comprehensive range of services and specialty and subspecialty care in a number of clinical areas, including cancer, cardiovascular health, neurosciences, orthopedics, digestive health and women's and children's care. For more information, visit providence.org/swedish. About Swedish Cancer Institute Swedish Cancer Institute has been a Seattle-area leader in innovative cancer diagnosis, treatment and recovery since 1932. It utilizes a multidisciplinary team of providers focused exclusively on cancer care, from diagnosis to treatment to survivorship. The institute's specialists – who practice at the First Hill, Ballard, Edmonds and Issaquah campuses – have helped develop screening tests, technologies and therapies that are helping cancer patients around the world. Swedish Cancer Institute is a longtime member of SWOG Cancer Research Network, which is a major part of the cancer research infrastructure in the U.S. and around the world. It has members in 45 states and nine other countries as part of the NCI's National Clinical Trials Network. The Commission on Cancer (CoC) is a group of organizations dedicated to improving survival and quality of life for patients with cancer by setting – and raising – standards. The CoC promotes cancer prevention, research, education, and monitoring of comprehensive quality care. Providence is designated as an integrated network cancer program by the American College of Surgeons, the overseeing organization of the CoC. For more information, visit swedish.org/cancer. About Paul G. Allen Research Center at Swedish Cancer Institute Founded with a cornerstone gift from the late Paul G. Allen in 2018, this translational research center drives innovation in care and provides resources to physician researchers and their collaborators. For more information, visit paulgallenresearchcenter.org. 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HONG KONG, Oct. 30, 2024 /PRNewswire/ -- Even with the ever-changing situation, technological innovation is still the most critical component for biopharmaceutical companies' long-term development. This continuous innovation keeps companies up to date and promotes the evolution of R&D and the success of commercialization. Recently, Viva Biotech's portfolio companies have new updates. Keep reading for more details. Seraxis Announces FDA IND Allowance for Clinical Study of SR-02 Replacement Islets for Type 1 Diabetes October 15, 2024, Germantown, MD. Seraxis Inc., a clinical stage regenerative medicine company invested by Viva BioInnovator (VBI), has received FDA's allowance of an Investigational New Drug (IND) application for a Phase I/II clinical study of its novel islet replacement therapy SR-02. SR-02 is the first reprogrammed stem cell-derived pancreatic product candidate allowed by FDA for testing in humans as a potential functional cure for insulin-requiring diabetes. Arthrosi Therapeutics and ApicHope Pharmaceutical Co-developed Gout Treatment AR882 Achieves Promising Phase II Clinical Results in China and Granted Fast Track Designation by the FDA According to ApicHope Pharmaceutical, Arthrosi Therapeutics, Inc. ("Arthrosi"), a portfolio company incubated by Viva Biotech, has achieved outstanding results in a Phase II clinical trial for the investigational gout treatment AR882. Developed in collaboration with ApicHope Pharmaceutical, this Class I novel drug showed promising outcomes for treating primary gout with hyperuricemia and has now entered Phase II clinical trials in China. The Phase II clinical trial primarily aimed to explore the optimal dosing of AR882 capsules for treating primary gout with hyperuricemia and to preliminarily assess the drug's efficacy and safety. The primary endpoint was the percentage of patients with serum uric acid levels below 360 μmol/L after eight weeks of treatment. By week six, AR882 demonstrated significant efficacy, with the 75mg dose of AR882 showing superiority over Febuxostat (P<0.001). AR882 exhibited an excellent safety profile, with no severe adverse events reported. Mild to moderate side effects observed included diarrhea, headache, and upper respiratory infections. Importantly, AR882 did not interfere with the management of patients' comorbidities, which remained stable throughout the trial. On August 19, Arthrosi Therapeutics announced that it received FDA Fast Track Designation for AR882 in Tophaceous Gout. Antag Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for Lead Molecule, AT-7687 Copenhagen, Denmark – October 9, 2024 – Antag Therapeutics, a leading biopharmaceutical company focused on targeting the Glucose-Dependent Insulinotropic Polypeptide (GIP) receptor to pioneer novel treatments for obesity and invested and incubated by Viva BioInnovator (VBI), announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for its lead molecule, AT-7687. This milestone enables Antag Therapeutics to initiate its Phase I clinical trial, which will evaluate the safety, tolerability, and pharmacokinetics of AT-7687 in both healthy lean and healthy obese subjects. The study will also explore AT-7687 as a monotherapy and in combination with semaglutide, a GLP-1 receptor agonist, in healthy obese individuals. Cybrexa Therapeutics Announces First Patient Dosed with First-in-Class Peptide-Drug Conjugate CBX-12 in Phase 2 Trial in Ovarian Cancer NEW HAVEN, Conn. – October 7, 2024 – Cybrexa Therapeutics, invested and incubated by Viva BioInnovator (VBI), a clinical-stage oncology biotechnology company developing a novel class of tumor-targeting peptide-drug conjugate (PDC) therapeutics, announced that the first patient has been dosed in a Phase 2 clinical trial evaluating CBX-12 in patients with platinum-resistant or refractory ovarian cancer. CBX-12 is a first-in-class PDC that uses Cybrexa's proprietary alphalex™ technology to enhance the delivery of exatecan, a potent, established topoisomerase 1 (TOP1) inhibitor, directly to tumor cells while sparing healthy tissue. This trial initiation follows promising Phase 1 results, which demonstrated CBX-12's broad activity across ovarian, breast, non-small cell lung cancer (NSCLC), thymic, gallbladder, and colorectal cancers, along with a manageable safety profile. Basking Biosciences Doses First Patients in Phase 2 Clinical Trial of Reversible Thrombolytic BB-031 for Acute Ischemic Stroke Columbus, Ohio – Sept. 10, 2024 – Basking Biosciences (Basking), invested and incubated by Viva BioInnovator (VBI), a clinical-stage biopharmaceutical company developing a novel acute thrombolytic therapy, announced that the first patients have been dosed in RAISE, a Phase 2 clinical trial evaluating BB-031 in patients presenting with acute ischemic stroke (AIS). HAYA Therapeutics Announces Collaboration with Lilly to Discover Novel Regulatory Genome Targets for Obesity and Related Metabolic Conditions Using Proprietary RNA Platform LAUSANNE, Switzerland & SAN DIEGO, HAYA Therapeutics, SA, invested and incubated by Viva BioInnovator (VBI), a biotechnology company pioneering precision RNA-guided regulatory genome targeting therapeutics for chronic diseases, announced a multi-year agreement with Eli Lilly and Company to apply HAYA's advanced RNA-guided regulatory genome platform to support preclinical drug discovery efforts in obesity and related metabolic conditions. The partners will identify multiple regulatory genome derived RNA-based drug targets to address these chronic conditions. Under the terms of the collaboration, HAYA will receive an upfront payment, including an equity investment, and is eligible to receive up to an aggregate $1 billion in pre-clinical, clinical and commercial milestone payments, as well as royalties on product sales. About Seraxis Seraxis is bringing transformative therapies to the millions of people worldwide struggling with the management of insulin-requiring diabetes and the associated life-threatening complications. Seraxis' lead program, SR-02, is a novel islet replacement therapy for patients of insulin-requiring diabetes with concurrent immunosuppression therapy. This therapy is the foundation of Seraxis follow-on therapies for patients without immune suppression. Frazier Life Sciences, Polaris Partners, Eli Lilly and Company, the T1D Fund and others are investors in Seraxis. Visit . About Arthrosi Arthrosi Therapeutics, Inc., headquartered in San Diego, CA, is focused on developing AR882, a potentially best-in-class, highly potent and selective next generation URAT1 inhibitor to reduce serum urate levels, flares and tophi in patients with gout. In the U.S., an estimated 13 million individuals are diagnosed with gout and approximately 2 million of those patients have visible tophi. In Phase II studies, AR882 demonstrated encouraging efficacy and safety compared to standard of care (SOC), while Phase IIb results showed impressive success in the complete elimination of tophi. Arthrosi is currently advancing AR882 into Phase III clinical trials. About Antag Therapeutics Antag Therapeutics is a clinical-stage biopharmaceutical company committed to discovering and developing novel therapies for obesity and cardiometabolic diseases through GIP receptor antagonism. As a pioneer in exploring the potential of GIP receptor antagonists, the company is dedicated to advancing science and improving patient outcomes by delivering groundbreaking solutions that address unmet medical needs. For more information, please visit . About Cybrexa Therapeutics Cybrexa is a privately held clinical-stage biotechnology company pioneering novel antigen-independent, tumor-targeting peptide-drug conjugate (PDC) therapeutics. The company is led by a dynamic team of highly successful life science entrepreneurs and veteran drug development scientists. Cybrexa is on a mission to create therapeutics that revolutionize the standard of care in oncology, and its robust pipeline aims to combat breast, ovarian, non-small cell lung cancer, and a range of other tumors. Its assets are built on Cybrexa's alphalex™ technology platform, which enables intracellular delivery of highly potent anti-cancer treatments. Cybrexa is based in New Haven, Connecticut and was founded in 2017. For more information, please visit or follow us on LinkedIn and X. About Basking Biosciences Basking Biosciences, a clinical-stage biopharmaceutical company, was founded to solve the biggest need in acute thrombosis – for a rapid-onset, short-acting thrombolytic drug capable of reopening blocked arteries, and whose activity can be quickly reversed in the event of a bleeding complication. Leveraging RNA aptamer technology, our lead drug candidate, BB-031, targets von Willebrand Factor (vWF), an important structural component of blood clots and driver of the clotting process, and is designed to be safer, more effective, and able to significantly expand the population receiving acute revascularization therapy. About HAYA Therapeutics HAYA Therapeutics is a precision medicines company developing programmable therapeutics targeting regulatory RNAs derived from the dark genome, a cell information processing unit, to reprogram pathological cell states for a broad range of diseases, including cardiovascular and metabolic diseases and cancer. The company is using its innovative platform to gain novel insights into the biology of disease cell states and the long non-coding RNAs (lncRNAs) that regulate them. HAYA's lead therapeutic candidate is HTX-001, in development for the treatment of heart failure. HAYA is also developing a pipeline of lncRNA-targeting precision therapies for the cell-specific treatment of diseases in other tissues. SOURCE Viva Biotech WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED