Sheba Medical Center

SARASOTA, Fla. and MIAMI, Oct. 24, 2024 (GLOBE NEWSWIRE) -- NAYA Biosciences (“NAYA”) (NASDAQ: NAYA), a life science portfolio company dedicated to bringing breakthrough treatments to patients in oncology, autoimmune diseases, and fertility, today announced an update regarding its clinic trial plans. The Company received regulatory approval from the Israeli Ministry of Health in July 2024 and subsequent institutional review board clearance to initiate patient enrollment in up to 7 academic centers for its clinical trial evaluating the safety and efficacy of NY-303, its GPC3-targeting NK Engager bispecific antibody, as a monotherapy for the treatment of hepatocellular carcinoma in patients not responding to first-line immunotherapy. “With the completion of the recent merger, we can now begin our focus on planning for the initiation of clinical trials with our lead GPC3-targeting NK engager bispecific antibody, which is a significant milestone for NAYA Biosciences,” commented NAYA Biosciences President and NAYA Therapeutics CEO Dr. Daniel Teper. “We are passionate about bringing new options to patients not responding to first line immunotherapy and expect that positive Phase I safety and preliminary efficacy data will support accelerated clinical development in HCC as well as exploration in additional solid and pediatric tumors.” The Phase 1 part of the trial will consist of a dose-escalation where patients responding to treatment will continue weekly administration as long as no disease progression is observed. Key endpoints include safety, pharmacokinetics, activity markers, preliminary clinical efficacy, and time-to-progression. NAYA is planning to start patient recruitment in early 2025 at leading medical centers in Israel including Hadassah Hospital, Sheba Medical Center, and Sourasky Medical Center. The Phase 2a part of the trial is anticipated to be expanded to the United States and Europe subject to additional regulatory approvals and will evaluate NY-303 at two dose levels selected in Phase I. Key efficacy endpoints will include objective response rate and progression-free survival. “Hepatocellular carcinoma is a leading cause of cancer death worldwide with a rapidly increasing global trend,” commented NAYA Therapeutics Chief Medical Officer Dan Chiche, MD. “Currently, less than 30% of patients treated with current standard of care respond to immunotherapy (confirmed objective response) and mean progression-free survival is less than 7 months. NY-303’s dual targeting of NK cells and GPC3 is a unique, novel mechanism of action supported by scientific data showing potential to unlock non-response to checkpoint inhibitors.” About HCC Hepatocellular carcinoma (HCC) is the most common form of primary liver cancer, often developing in individuals with chronic liver conditions like hepatitis B or C, cirrhosis, and Metabolic Dysfunction-Associated SteatoHepatitis (MASH). HCC is a global health challenge, with over 900,000 new cases annually, making it the sixth most common cancer worldwide. The incidence of HCC in the United States has been steadily rising. Survival rates for HCC are often low due to late detection. The five-year survival rate for liver cancer in the United States is around 20%, but this varies widely depending on the stage at diagnosis. For early-stage HCC, where surgical resection or liver transplantation is possible, survival rates can improve dramatically, while advanced stages have far poorer outcomes. Globally, survival rates are similarly low, with wide variation based on healthcare access and screening programs. Recent advances in immunotherapy such as immune checkpoint inhibitors are offering new hope for patients with advanced HCC but new treatment approaches are still critical for improving survival and quality of life for patients. About NY-303 NY-303 is a first-in-class therapeutic candidate that leverages the engagement and activation of natural killer (NK) cells using a bispecific antibody targeting both GPC3, an oncofetal protein uniquely expressed on liver cancer cells, and NKp46, a cell surface receptor on natural killer (NK) cells that plays a central role in NK cell activation and the elimination of target cells. The unique mechanism enables NY-303 to turn the tumor form a “cold” into a ‘hot’ stage making liver cancer cells susceptible against immunotherapy to target and destroy cancer cells. This innovative approach is especially promising for patients with liver cancer, such as hepatocellular carcinoma (HCC), who face limited treatment options and poor survival rates but also for other GPC3-expressing tumors like lung squamous cell carcinoma, ovarian cancer, and pediatric cancer. Currently, liver cancer therapies include surgery, liver transplantation, targeted drugs, and immunotherapies like checkpoint inhibitors, but the prognosis remains grim, especially for advanced-stage disease. With a global five-year survival rate of around 20%, and even lower in more advanced cases, there is a critical need for more effective therapies. NY-303 represents a new opportunity for liver cancer patients by harnessing the body’s immune system to specifically attack tumor cells and engage NK-cells. Unlike traditional treatments, this therapy is designed to offer potent anti-cancer effects with a potentially safer profile, reducing the side effects often associated with chemotherapy and other conventional treatments and overcoming non-responding tumors against immunotherapies. For patients with HCC, NY-303 could significantly improve outcomes by offering a more precise, targeted approach to eradicating cancer, which is critical given the high recurrence rates and challenges in treating advanced liver cancer. As part of the next generation of immunotherapies, NY-303 may redefine treatment possibilities and offer renewed hope to those facing this difficult diagnosis. About NAYA BiosciencesNAYA Biosciences (NASDAQ: NAYA) is a life science portfolio company dedicated to bringing breakthrough treatments to patients in oncology, autoimmune diseases, and fertility. Our hub & spoke model harnesses the shared resources of a parent company and agility of lean strategic franchises, enabling efficient acquisition, development, and partnering of assets and allowing for optimized return on investment by combining scalable, profitable commercial revenues with the upside of innovative clinical-stage therapeutics. NAYA’s expanding portfolio of assets currently includes NY-303, a GPC3 and NKp46 targeting bispecific antibody for the treatment of hepatocellular carcinoma (HCC) with a unique mode of action targeting non-responders to the current immunotherapy standard of care (approximately 70% of the current treatable market) cleared to enroll patients in a Phase 1/2a monotherapy trial in early 2025, NY-338, a CD38 and NKp46 targeting bispecific antibody for the treatment of multiple myeloma and autoimmune diseases with a differentiated safety and efficacy profile, and INVOcell®, an FDA-approved fertility device which has demonstrated comparable success rates to traditional In Vitro Fertilization (IVF). Safe Harbor StatementThis release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The Company invokes the protections of the Private Securities Litigation Reform Act of 1995. All statements regarding our expected future financial position, results of operations, cash flows, financing plans, business strategies, products and services, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as statements that include words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions are forward-looking statements. All forward-looking statements involve risks, uncertainties, and contingencies, many of which are beyond our control, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. Factors that may cause actual results to differ materially from those in the forward-looking statements include those set forth in our filings at www.sec.gov. We are under no obligation to (and expressly disclaim any such obligation to) update or alter our forward-looking statements, whether as a result of new information, future events or otherwise. NAYA Investor & Media ContactAnna Baran-DjokovicSVP, Investor Relations+1-305-615-9162anna@nayabiosciences.com

REHOVOT, Israel, Sept. 16, 2024 /PRNewswire/ -- The Hematology Laboratory, Molecular Hematology Unit, at Sheba Medical Center, Israel's largest medical center, is conducting a joint study utilizing Sequentify's InfiniSeq™ Myeloid Malignancies Panel. This study involves leading clinicians from the Cancer Center Institute, Maccabi Healthcare Services, and Sheba Cancer Research Center, focusing on identifying Clonal Hematopoiesis of Indeterminate Potential (CHIP) in patients previously diagnosed with solid tumors. The results from this study aim to advance personalized medicine in oncology, potentially influencing future patient care protocols. Continue Reading Sequentify Logo (PRNewsfoto/Sequentify) Sequentify's myeloid malignancy panel is a highly effective tool for sequencing patients with myelodysplastic syndromes (MDS), myeloproliferative neoplasms (MPN), acute myeloid leukemia (AML), and chronic myeloid leukemia (CML). The straightforward and efficient InfiniSeq library prep protocol is an ideal choice for laboratories aiming to enhance or expand their sequencing capabilities, whether they are upgrading existing workflows or establishing new ones. Dr. Dan Dominissini, Director of the Diagnostic Division at Sheba Medical Center, commented: "We are thrilled to partner with Sequentify on this study. As one of Israel's leading research institutes and hospitals, ranked #9 among the world's best hospitals by Newsweek, Sheba Medical Center is committed to staying at the forefront of diagnostic innovation. Our ultimate goal is to deliver better, faster, and more cost-effective results to our patients." As part of the study, all patients will undergo sequencing using next-generation sequencing (NGS) technology, with all procedures conducted at the Sheba Medical Center facility to ensure the highest level of accuracy and depth in identifying CHIP. Sequentify's InfiniSeq technology reduces sample preparation time to just 3.15 hours, from DNA extraction to sequencing, using a single-tube reaction. It supports full automation and significantly reduces costs. The patent-pending InfiniSeq technology is compatible with most sequencing machines and seamlessly integrates into any lab workflow. About the Oncology Division at Sheba Medical Center: The Oncology Division at Sheba Medical Center is a leader in cancer treatment and research, offering comprehensive care with advanced technologies. Specializing in hematologic malignancies and solid tumors, the division provides personalized treatment plans, innovative therapies, and access to clinical trials. Its multidisciplinary team of oncologists, hematologists, and researchers collaborates to deliver holistic and compassionate care. Committed to excellence, Sheba's Oncology Division focuses on improving patient outcomes and advancing cancer research globally. About Sequentify: Founded in 2021 as a Weizmann Institute spinoff, Sequentify enables decentralized, population-wide genomic sequencing by providing laboratories with the easiest and quickest solutions available. Their technology facilitates the scaling-up of genomic testing by directly addressing the current pain points in the industry, through sample-prep and software solutions. The company offers panels for oncology and screening applications, and infectious diseases, with a focus on the clinical market. Sequentify is based in Rehovot, Israel. For more information, visit . Logo - Media Contact: Avigayil Simpson [email protected] SOURCE Sequentify WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Published in The American Journal of Managed Care, findings from researchers at major US hospital demonstrate how FeelBetter's AI-powered platform can make accurate recommendations for optimizing medication regimens for older patients with polypharmacy Findings also support benefit of leveraging platform to identify patient cohorts for pharmacy intervention and population health management BOSTON, Sept. 10, 2024 /PRNewswire/ -- FeelBetter, the leading provider of polypharmacy patient management technology and pioneer of Pharmaco-Clinical Intelligence, today announced new peer-reviewed research that evaluated a machine-learning-driven approach to addressing medication risks in senior patients living with multiple comorbidities. The study, which was published in The American Journal of Managed Care (AJMC), demonstrated how FeelBetter's AI-powered platform accurately provided population-level analysis of medically complex senior patients' risk of hospitalization and emergency department visits. Conducted by investigators at Brigham and Women's Hospital in Boston, the retrospective cohort study comprised 108,817 patients and showed that FeelBetter's platform delivered correct medication warnings in 89.2% of cases, and that in 97.3% of cases, the warnings presented would be helpful to clinicians making decisions to optimize medication therapy. The researchers' findings also highlight the potential to leverage the platform for preventing drug-related adverse events and hospitalizations by identifying polypharmacy patient cohorts to target for pharmacy intervention and, more broadly, to support population health management. "Clinician shortages are an ever-evolving problem, and, therefore, technologies that can help clinical team members pinpoint the most meaningful opportunities for medication management optimization are crucial for enhancing the care of elderly patients," said Lisa Rotenstein, MD MBA MSc, the principal investigator of the study. "This study highlights the value and broader potential of using technology-based solutions to aid in identifying patients who are at greatest risk of deterioration and prioritizing and informing clinical pharmacists' efforts to enhance medication management among the highest-risk patients." Every year, suboptimal medication management results in an estimated 275,000 deaths and more than $500 billion in avoidable costs in the US alone. As part of its broader efforts to improve outcomes and quality of life for patients, Brigham and Women's Hospital is testing how AI-based technologies can be used to help providers tackle the growing public health challenges posed by polypharmacy. In the study of FeelBetter's risk stratification capabilities and medication management recommendations, the technology successfully stratified patients into risk groupings with distinct demographic and utilization characteristics. For example, the patients identified by FeelBetter as highest risk, who largely have Medicare and commercial insurance, had the highest rate of emergency department visits and unplanned hospitalizations at one, three, and six months following the algorithm's prediction. For the top 1% of patients identified as at risk by FeelBetter, more than 1/3 were hospitalized within 90 days and the odds of hospitalization were 17.3 times greater over three months than for patients identified as having average risk (with an average of 0.531 events in three months following algorithm prediction for the top 1% high risk patients compared to an average of 0.025 events in the median risk group). These results not only demonstrate that FeelBetter's platform can successfully incorporate disparate data from EHRs to accurately stratify and predict utilization for seniors with multiple comorbidities and complex medication regimens, but they also suggest that the platform could be a key resource to help provider organizations focused on delivering value-based care prioritize resources for the most at-risk patients. Based on these results, the Brigham and Women's Hospital research team is evaluating how FeelBetter can be used to prospectively impact patient outcomes and cost of care trajectories. "Today, AI-based technologies are making it possible to go beyond adherence to more proactively focus on effectiveness, safety, and prevention, identifying patients who may benefit from medication-related interventions and personalized medication regimens," said Dr. Adva Tzuk Onn, FeelBetter's Chief Medical Officer, and a physician with more than 15 years of experience in geriatric and family medicine. "The broad adoption of such solutions, which offer a more holistic view of an individual's health status based on relevant clinical and pharmacology factors, has the potential to be a giant step forward in improving health outcomes and patient safety, easing clinician workload, and mitigating burnout for overburdened clinicians." About FeelBetter FeelBetter is the pioneer of Pharmaco-Clinical Intelligence, changing the polypharmacy paradigm on both an individual and population health level with a comprehensive solution designed to tackle the challenges associated with suboptimal medication management. Powered by AI, FeelBetter's Pharmaco-Clinical Intelligence drives personalized medication management, helping healthcare professionals ensure that their patients' medication regimens are safe, effective, and appropriate. The technology pinpoints patients at high risk of deterioration and preventable hospitalization due to suboptimal medication management, and proactively suggests immediate and actionable interventions to reduce these risks. Provider organizations use FeelBetter to monitor their patients' progress and more proactively deliver the right follow-up care, as well as to efficiently allocate resources and minimize preventable, costly use of healthcare services. Led by an interdisciplinary team of clinicians, clinical pharmacists, and technologists, FeelBetter is headquartered in Boston and Tel Aviv. Investors include Firstime Ventures, Shoni Health Ventures, Triventures, ARC, the innovation hub of Sheba Medical Center, Random Forest VC, The Group Ventures, and GoodCompany Ventures. To learn more, visit feelbetter.healthcare. Contacts: FeelBetter: Nicole Pariser [email protected] SOURCE FeelBetter