Hadassah University Hospital

Innovative platform can identify breast, lung, prostate and colorectal cancers with a single, non-invasive test ENGLEWOOD, N.J., Dec. 4, 2024 /PRNewswire/ -- SpotitEarly, a biotech startup focused on transforming cancer screening by harnessing the power of artificial intelligence and canines to detect cancer early in breath samples, is proud to announce the results of a successful new study for the early detection of cancer using its pioneering bio-AI hybrid cancer screening approach. The research – known as the Rainbow Study – was published in Scientific Reports, a Nature publishing group journal. It demonstrated that SpotitEarly has remarkably high sensitivity and specificity detecting early stage disease in multiple common cancers, including breast, lung, prostate and colorectal cancers, with its unique, single, breath-based test. In the largest clinical trial to date for cancer detection using a fusion of AI and trained canines, SpotitEarly analyzed breath samples from over 1,400 individuals ages 22-94. Participants in the study provided a breath sample using a breath collection mask, a process designed to be quick and non-invasive. The samples were then sent to the SpotitEarly lab where it was screened by the AI-canine hybrid system. The test demonstrated exceptional accuracy, achieving a sensitivity of 93.9 percent and a specificity of 94.3 percent across the four targeted cancer types. Notably, the sensitivity for early-stage cancer detection (stages 0-2) was an impressive 95 percent. "Taken together, these results are a very encouraging step toward improving cancer survival rates, especially given the ease of obtaining the breath samples used to perform the test," said Len Lichtenfeld, MD, chief medical officer of SpotitEarly and former deputy chief medical officer for the American Cancer Society. "Discovering cancer early is critical to recovery. I am pleased to see these promising results and that this new research supports and validates our non-invasive, self-administered cancer screening method. In combining the unique, scent-based biometrics of dogs and the power of AI, we have successfully unlocked the technology to detect different common cancers, in its early stages, with a single test. I expect that these results will pave the way for the development of a new generation cancer screening test to enhance cancer screening capabilities." The test demonstrated high early-stage sensitivity across all tested cancer types: Breast cancer: 94 percent Lung cancer: 97 percent Prostate cancer: 97 percent Colorectal cancer: 86 percent The test has also shown efficacy in identifying other cancers as well. The test is based on the detection of 'cancer odor signatures,' which are unique patterns of volatile organic compounds (VOCs) secreted into the respiratory system during the early stages of cancer. SpotitEarly's innovative bio-AI hybrid platform builds on the well-documented ability of trained sniffer dogs to detect cancer. By combining sniffer dogs—an integral part of the company's laboratory team—with dynamic sensors, AI-based models, and machine learning algorithms, the system can mark the presence or absence of cancer odor signatures within breath samples in just fractions of a second. This technology decodes hundreds of real-time signals from the dogs' physical and behavioral responses, integrating it with medical data to deliver an accurate, non-invasive and scalable cancer screening solution. "SpotitEarly's solution demonstrates effectiveness in the early detection of cancer," said Prof. Nadir Arber, principal investigator and director of the Integrated Cancer Prevention Center (ICPC) at Sourasky Medical Center, who led the research. "After rigorously reviewing the clinical validation, I am deeply impressed by its potential to revolutionize cancer screening and set a new standard in early detection. SpotitEarly is on its way to becoming a game-changer in this field." The study was conducted in conjunction with three leading medical centers in Israel, where the company operates an R&D center, including the Sourasky Medical Center, Hadassah University Medical Center and the Rambam Health Care Campus. Following the success of the Rainbow study, the company plans to collaborate with leading US medical centers on two upcoming clinical trials. These trials aim to strengthen the evidence for its breath-based screening test for breast and lung cancers. For more information about SpotitEarly, visit . About SpotitEarly SpotitEarly aims to revolutionize cancer screening with its breath-based early detection test for multiple types of cancer. Powered by a proprietary bio-AI hybrid platform, the test integrates advanced artificial intelligence with nature's unparalleled detection abilities to identify cancer-associated volatile organic compounds (VOCs) at early stages. By combining AI with the scent-based biometrics of trained canines, SpotitEarly utilizes a simple breath collection process involving a face mask kit. A diverse, multidisciplinary team of medical professionals, scientists, and technology experts collaborate seamlessly to bring this innovative solution to life. Subject to regulatory approval, SpotitEarly aims to improve access to cancer screening, enhance early detection rates, and significantly boost survival outcomes. For more information, visit our website or follow SpotitEarly on LinkedIn. 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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

PALO ALTO, Calif., July 30, 2024 (GLOBE NEWSWIRE) -- PALO ALTO, Calif., July 30, 2024 (GLOBE NEWSWIRE) -- 180 Life Sciences Corp. (NASDAQ: ATNF) (“180 Life Sciences” or the “Company”), today announced topline results from a clinical pharmacology study (the “Study”), that evaluated the uptake of cannabidiol (CBD) in a solid formulation which can be delivered as a pill orally. The clinical trial in humans, performed with Prof. Avi Domb of the Hebrew University, School of Pharmacy, and with Prof. Elyad Davidson, of Hadassah Hospital, compared two solid formulations of CBD with a U.S. Food and Drug Administration (FDA) approved drug for epilepsy, Epidiolex. The purpose of the Study was to compare the pharmokinetic (PK) profile of a generic approved CBD product, Epidiolex®, with two solid formulations. We believe this type of trial has yet to be examined in a clinical setting. For the Company’s trial, twelve volunteers received all three formulations in a crossover randomized trial. Epidiolex is a CBD dissolved in 8% ethanol and 80% sesame seed oil, plus flavoring agents, that is given as a liquid solution via syringe in the mouth. Results of the clinical trial indicate that one of the two solid forms was absorbed faster and exhibited higher maximal levels compared to Epidiolex. Both of the solid formulations were well tolerated. CBD is a purified product that is not psychoactive, which we believe has potential benefits for treatment of inflammatory processes and pain. A major problem in working with CBD is its low, unpredictable and variable uptake following the most convenient delivery form, by mouth, as a liquid CBD in oil like the approved pharmaceutical Epidiolex, given for epilepsy. To help try to solve this problem, Prof. Domb and colleagues developed “ProNanoLipospheres” (PNL), a mixture of components available over-the-counter, which form little droplets and have been shown to be absorbed from the gastrointestinal tract into blood. The results of the clinical trial performed on 12 adult males at the Hadassah Hospital, shows that capsules composed of one of the PNL formulations performed better statistically than Epidiolex in terms of the speed of absorption and achievement of maximal levels. The other PNL formulation, also given as a capsule, was statistically equivalent to Epidiolex in terms of speed of absorption and achievement of maximal levels. We believe that a solid formulation for testing in clinical trials will advance testing CBD in other indications. CBD has shown promise in studies on treatment of pain, post-traumatic stress disorder (PTSD), head trauma, and other indications, yet an oral liquid formulation is undesirable.1 The new formulations tested by 180 Life Sciences and its collaborators open a potential path for testing solid CBD given by mouth in a capsule. According to Prof. Avi Domb, “If shown via further clinical testing, 180 Life Sciences’ proprietary solid formulation for the delivery of CBD may provide medical professionals with greatly expanded options to prescribe and deliver CBD in a precisely dosed, high uptake pill format rather than the current liquid format. This may have potentially significant commercial market potential by avoiding the complexity associated with unpredictable liquid formulation delivery. Both physicians and patients may have broader acceptance of a solid oral pill format.” Full study results are not yet available. The trial results are planned to be submitted for scientific publication at a later date. We do not anticipate the outcome of this trial to have any effect on our financial results for the year ended December 31, 2024. About 180 Life Sciences Corp. 180 Life Sciences Corp. is a clinical stage biotechnology company focused on the development of therapeutics for unmet medical needs in chronic pain, inflammation and fibrosis by employing innovative research, and, where appropriate, combination therapy. Forward-Looking Statements This press release includes “forward-looking statements”, including information about management’s view of the Company’s future expectations, plans and prospects, within the safe harbor provisions provided under federal securities laws, including under The Private Securities Litigation Reform Act of 1995 (the “Act”). Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believes,” “predicts,” “potential,” “continue” and similar expressions are intended to identify such forward-looking statements. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results and, consequently, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements and factors that may cause such differences include, without limitation, statements expressed or implied relating to the properties or potential benefits of PNL; our ability to commercialize PNL and our other drug candidates, if proven successful for treatment in trials; risks regarding whether the administrative processes required for the issuance of patents will be completed in a timely manner or at all; the Company’s ability to meet Nasdaq’s conditions for continued listing on Nasdaq, and the timing relating thereto; the ability of the Company to maintain the continued listing of the Company’s securities on The Nasdaq Stock Market, including that the Company is not currently in compliance with Nasdaq’s continued listing standards; the review and evaluation of strategic transactions and their impact on shareholder value; the process by which the Company engages in evaluation of strategic transactions; the outcome of potential future strategic transactions and the terms thereof; the ability of the Company to raise funding, the terms of such funding, and dilution caused thereby; risks regarding the outcome of pharmaceutical studies, the timing and costs thereof, and the ability to obtain sufficient participants; the timing of, outcome of, and results of, clinical trials statements regarding the timing of marketing authorization application (MAA) submissions to the UK Medicines and Healthcare products Regulatory Agency (MHRA) and New Drug Application submissions (NDA) to the U.S. Food and Drug Administration (FDA), our ability to obtain approval and acceptance thereof, the willingness of MHRA to review such MAA and the FDA to review such NDA, and our ability to address outstanding comments and questions from the MHRA and FDA; statements about the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results; the uncertainties associated with the clinical development and regulatory approval of 180 Life Sciences’ drug candidates, including potential delays in the enrollment and completion of clinical trials, the costs thereof, closures of such trials prior to enrolling sufficient participants in connection therewith, issues raised by the FDA, the MHRA and the European Medicines Agency (EMA); the ability of the Company to persuade regulators that chosen endpoints do not require further validation; timing and costs to complete required studies and trials, and timing to obtain governmental approvals; the accuracy of simulations and the ability to reproduce the outcome of such simulations in real world trials; 180 Life Sciences’ reliance on third parties to conduct its clinical trials, enroll patients, and manufacture its preclinical and clinical drug supplies; the ability to come to mutually agreeable terms with such third parties and partners, and the terms of such agreements; estimates of patient populations for 180 Life Sciences planned products; 180 Life Sciences’ ability to fully comply with numerous federal, state and local laws and regulatory requirements, as well as rules and regulations outside the United States, that apply to its product development activities; current negative operating cash flows and a need for additional funding to finance our operating plans; the terms of any further financing, which may be highly dilutive and may include onerous terms, increases in interest rates which may make borrowing more expensive and increased inflation which may negatively affect costs, expenses and returns; statements relating to expectations regarding future agreements relating to the supply of materials and license and commercialization of products; the availability and cost of materials required for trials; the risk that initial drug trials and results are not predictive of future results or will not be able to be replicated in clinical trials or that such drugs selected for clinical development will not be successful; challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; the inherent risks in early stage drug development including demonstrating efficacy; development time/cost and the regulatory approval process; the progress of our clinical trials; our ability to find and enter into agreements with potential partners; our ability to attract and retain key personnel; changing market and economic conditions; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes to applicable laws and regulations, including global health care reforms; expectations with respect to future performance, growth and anticipated acquisitions; expectations regarding the capitalization, resources and ownership structure of the Company; the ability of the Company to execute its plans to develop and market new drug products and the timing and costs of these development programs; estimates of the size of the markets for the Company’s potential drug products; the outcome of current litigation involving the Company; potential future litigation involving the Company or the validity or enforceability of the intellectual property of the Company or lawsuits alleging that we have violated the intellectual property of others; global economic conditions; geopolitical events and regulatory changes; the expectations, development plans and anticipated timelines for the Company’s drug candidates, pipeline and programs, including collaborations with third parties; and the effect of changing interest rates and inflation, economic downturns and recessions, declines in economic activity or global conflicts. These risk factors and others are included from time to time in documents the Company files with the Securities and Exchange Commission, including, but not limited to, its Form 10-Ks, Form 10-Qs and Form 8-Ks, and including the Annual Report on Form 10-K for the year ended December 31, 2023, and Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, and future SEC filings. These reports and filings are available at www.sec.gov and are available for download, free of charge, soon after such reports are filed with or furnished to the SEC, on the “Investors”, “SEC Filings”, “All SEC Filings” page of our website at www.180lifesciences.com. All subsequent written and oral forward-looking statements concerning the Company, the results of the Company’s clinical trial results and studies or other matters and attributable to the Company or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements above. Readers are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made, including the forward-looking statements included in this press release, which are made only as of the date hereof. The Company cannot guarantee future results, levels of activity, performance or achievements. Accordingly, you should not place undue reliance on these forward-looking statements. The Company does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statement to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as otherwise provided by law. Investors: Please contact Blair Jordan, Interim CEO – bjordan@180lifesciences.com 1 See, for example: Izzo, A. A., Borrelli, F., Capasso, R., Di Marzo, V. & Mechoulam, R. Non-psychotropic plant cannabinoids: new therapeutic opportunities from an ancient herb. Trends Pharmacol. Sci. 30, 515–527 (2009).Hayakawa, K. et al. Therapeutic time window of cannabidiol treatment on delayed ischemic damage via high-mobility group box1-inhibiting mechanism. Biol. Pharm. Bull. 32, 1538–44 (2009).Chagas, M. H. N. et al. Cannabidiol can improve complex sleep-related behaviours associated with rapid eye movement sleep behaviour disorder in Parkinson’s disease patients: a case series. J. Clin. Pharm. Ther. 39, 564–566 (2014).Giacoppo, S. et al. A new formulation of cannabidiol in cream shows therapeutic effects in a mouse model of experimental autoimmune encephalomyelitis. DARU J. Pharm. Sci. 23, 48 (2015).Pertwee, R. G. Cannabinoids and multiple sclerosis. Mol. Neurobiol. 36, 45–59 (2007).Parker, L. A., Mechoulam, R. & Schlievert, C. Cannabidiol, a non-psychoactive component of cannabis and its synthetic dimethylheptyl homolog suppress nausea in an experimental model with rats. Neuroreport 13, 567–570 (2002).Ribeiro, A. et al. Cannabidiol, a non-psychotropic plant-derived cannabinoid, decreases inflammation in a murine model of acute lung injury: Role for the adenosine A2A receptor. Eur. J. Pharmacol. 678, 78–85 (2012).WHO, W. H. O. Cannabidiol (CBD): pre-review report. Expert Committee on Drug Dependence 39, (2017).