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Theriva Biologics Receives Fast Track Designation From FDA For VCN-01 For Treating Metastatic Pancreatic Cancer

Benzinga

By Kyle Anthony, Benzinga Theriva™ Biologics (AMEX: TOVX) is an immuno-oncology company developing oncolytic viruses, otherwise known as cancer cell-infecting viruses, to overcome the protective barrier surrounding solid tumors and selectively kill tumor cells. As a company engaged in developing differentiated clinical-stage therapeutics, Theriva’s mission is to change patient outcomes by working to improve the current standard of care and transform the cancer therapy landscape. The firm’s management and scientific advisory board is comprised of determined and experienced leaders who are committed to offering patients with difficult-to-treat cancers the chance of a longer life. The company recently achieved a significant milestone as the U.S. FDA granted Fast Track Designation (FTD) to its candidate VCN-01 to improve progression-free survival and overall survival in patients with metastatic pancreatic adenocarcinoma. Previously, the FDA granted orphan drug designation to VCN-01 for treatment of pancreatic ductal adenocarcinoma (PDAC). Company Background Founded in 2001 and operating as Synthetic Biologics from 2012, the company was previously focused on developing biologic and drug candidates for various indications, including infectious diseases and gastrointestinal disorders. The company rebranded to Theriva Biologics in September 2022 to reflect its evolving focus on oncolytic viruses and cancer therapies. Regarding the impetus behind the firm’s rebranding, Steven A. Shallcross, Chief Executive Officer of Theriva Biologics, said, “The rebranding solidifies our strategic transformation and reflects our sharpened focus on advancing unique, oncolytic viruses optimized for IV administration. We continue to build on the incredible progress made to date and are diligently advancing our oncolytic adenovirus pipeline. This includes lead clinical-stage program VCN-01, designed to break down the tumor stroma, and preclinical-stage program VCN-11, leveraging our proprietary Albumin Shield Technology to protect systemically administered oncolytic viruses from the host immune system. These two differentiated programs are intended to improve the anti-tumor effect of the oncolytic virus, co-administered chemotherapies and/or immuno-oncology therapeutics. Together, VCN-01 and VCN-11 position Theriva at the forefront of oncolytic virus development. We are excited about Theriva’s path towards strategic growth, renewed corporate strategy and remain on track to deliver on upcoming value-driving milestones.” Theriva Biologics Pipeline As Steven A. Shallcross’s preceding quote suggests, Theriva Biologics' leading clinical-stage program, VCN-01, has displayed promise as a treatment solution. Presently, VCN-01 is part of an ongoing phase 2 clinical trial, entitled VIRAGE, where it is being tested in combination with standard-of-care chemotherapy for patients with pancreatic ductal adenocarcinoma (PDAC), the most common form of pancreatic cancer. VCN-01 was also administered with the checkpoint inhibitor durvalumab (an FDA-approved immunotherapy for cancer) in a phase 1 study in patients with head and neck cancers and is currently being evaluated in combination with huCART-meso cells – cells manufactured using a patient’s own white blood cells, which are modified to target cancer cells or cells that help cancer to grow – in an investigator-sponsored study in patients with either pancreatic cancer or ovarian cancer. Beyond VCN-01, Theriva Biologics is also developing SYN-004 (ribaxamase), which is aligned with the company’s oncology focus and seeks to mitigate adverse outcomes for patients who will undergo bone marrow transplant (allogeneic hematopoietic cell transplantation) to treat hematologic cancers. 80% to 90% of these patients will be treated with an intravenous β-lactam antibiotic, and this antibiotic treatment has been strongly associated with increased incidence and severity of acute graft-vs-host disease (aGVHD), vancomycin-resistant Enterococci (VRE) infection and Clostridioides difficile infection (CDI). Preventing one or all of these outcomes by SYN-004 co-administration may significantly improve treatment outcomes and reduce patient mortality. VCN-01 Receives Fast Track Designation By The U.S. FDA Theriva Biologics achieved a significant milestone as the FDA granted Fast Track Designation (FTD) to VCN-01. This designation, in combination with gemcitabine and nab-paclitaxel – standard-of-care chemotherapy drugs – is aimed at improving progression-free survival and overall survival in patients with metastatic pancreatic cancer. This recognition underscores Theriva Biologics' commitment to advancing cancer treatment and the potential of VCN-01 in this field. Pancreatic cancer is one of the leading causes of cancer death globally. The increasing incidence of this cancer across the U.S. and other parts of the world is one of the factors driving the need for drugs used in its treatment. According to research published by Fortune Business Insights, the global pancreatic cancer treatment market size was $2.86 billion in 2023 and is projected to grow from $3.30 billion in 2024 to $10.69 billion by 2032. Attaining FTD is a seminal achievement for pharmaceutical drug companies, as the designation is designed to help treatments reach patients faster by facilitating the development and expediting the review of therapies with the potential to treat serious conditions and fill an unmet medical need. Benefits of FTD to programs include early and frequent interactions with the FDA during the clinical development process, and if relevant criteria are met, the FDA may also review portions of a marketing application before the sponsor submits the complete application. Regarding Theriva Biologics receiving the FTD, Shallcross said, “The FDA’s decision to grant FTD to VCN-01 highlights the urgent need for new treatment options for PDAC, which accounts for the 4 th highest cause of cancer-associated deaths in the US and Europe. VIRAGE, our Phase 2b trial evaluating VCN-01 in metastatic PDAC continues to progress, with enrollment expected to be completed in the third quarter of 2024. FTD is an important step that furthers our ability to expedite the review of and build upon the compelling clinical data that underscores VCN-01’s multiple modes of action and therapeutic potential in combination with chemotherapy or immunotherapy. We will continue to deliver on our mission to advance new therapeutic options for these patients.” Based on the strength of the science and its relevance, VIRAGE was accepted for presentation as a trial-in-progress poster at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, held in Chicago, IL, from May 31-June 4. The Path Forward Theriva Biologics' approach to cancer treatment differentiates it from its peers, potentially placing the company in a unique market position. As incidences of pancreatic cancer continue to rise globally, drug treatment options, such as VCN-01, will likely rise in demand. With VCN-01 receiving FTD from the U.S. FDA, this milestone speaks to the drug's efficacy and long-run potential. As such, the benefit that Theriva Biologics provides and the value proposition the firm espouses could continue to grow and have increased industry resonance. Featured photo by National Cancer Institute on Unsplash. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

June 07, 2024 08:45 AM Eastern Daylight Time

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New Clinical Data Reveals MAIA Biotechnology's THIO Achieves High Efficacy In Advanced Non-Small Cell Lung Cancer Treatment

Benzinga

By Mangeet Kaur Bouns Lung cancer remains the top cause of cancer-related deaths in the U.S., accounting for approximately 20% of all cancer fatalities. The American Cancer Society's projections for 2024 highlight the gravity of this issue, with an estimated 234,580 new lung cancer cases and about 125,070 deaths anticipated in the U.S. Of these, nearly 80% to 85% are non-small cell lung cancer (NSCLC) cases, highlighting the urgent need for effective treatments. MAIA Biotechnology, Inc. (AMEX: MAIA), a clinical-stage biopharmaceutical company focused on developing telomere-targeting immunotherapies for cancer treatment, has unveiled promising new clinical data showcasing the efficacy of its lead product candidate, THIO, in treating NSCLC. This data emerges from a phase 2 clinical trial evaluating THIO in combination with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®), targeting patients with advanced NSCLC who have not responded to at least two standard-of-care therapies. In the context of NSCLC, where traditional treatments often fall short, THIO's potential as a first-in-class telomere-targeting agent raises hope. Its ability to disrupt cancer cell telomeres and stimulate immune responses marks a significant advancement in the fight against this devastating disease. MAIA’s Lead Candidate: THIO THIO is a groundbreaking telomere-targeting agent, currently undergoing phase 2 clinical trials aimed at treating NSCLC with telomerase-positive cancer cells. Telomerase, present in over 85% of human cancers, plays a crucial role in the immortality and proliferation of cancer cells. THIO integrates into telomeres within these cells, disrupting their structure and function – leading to rapid tumor cell death. By inducing telomerase-dependent DNA modification and damage, THIO triggers selective cancer cell death. This process accumulates telomeric damage in cytosolic micronuclei, which then activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. In in vivo cancer models, sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in significant and sustained tumor regression, fostering cancer-specific immune memory. Key Findings From The Phase 2 THIO-101 Clinical Trial The phase 2 THIO-101 trial primarily focuses on assessing the safety and tolerability of THIO both as an anticancer agent and as an immune system activator, alongside evaluating its clinical efficacy through overall response rate (ORR). The trial results are noteworthy. The disease control rate (DCR) for THIO in combination with CPI was 85%, far exceeding the 25-35% DCR typically seen with chemotherapy in third-line treatments. Additionally, 65% of patients surpassed the 5.8-month overall survival (OS) threshold, and 85% exceeded the 2.5-month progression-free survival (PFS) threshold, demonstrating significant clinical benefits. The median survival follow-up time stood at 9.1 months for the cohort of 20 patients. Optimal dose selection yielded even more impressive outcomes. Patients in third-line receiving 180mg of THIO exhibited a median PFS of 5.5 months, a 75% OS rate at six months and an ORR of 38%, compared to the standard 6-10% ORR for chemotherapy. Notably, 75% of these patients crossed the 5.8-month OS threshold and 88% surpassed the 2.5-month PFS threshold, with a median survival follow-up time of 9.1 months among the eight patients assessed. Implications And Future Directions Dr. Vlad Vitoc, chairman and CEO of MAIA, expressed enthusiasm about the trial outcomes, noting, "All exceptional measures of efficacy in our trial to date have exceeded our own expectations and outperformed standard-of-care treatments." He emphasized THIO’s potential as a robust, safe and highly effective alternative for patients who have not benefited from chemotherapy and other treatments. The THIO-101 trial, which completed enrollment ahead of schedule in February, reached its target of 41 patients for the 180 mg dose. This data, which indicates promising disease control and overall response rates, paves the way for further investigation and potential redefinition of cancer treatment protocols. As THIO-101 data continues to demonstrate favorable disease control and response rates, with full efficacy data anticipated in the latter half of this year, MAIA Biotechnology stands poised to redefine cancer treatment. THIO’s promise to transform the standard of care in oncology offers new hope to patients with advanced NSCLC, potentially establishing a new benchmark in cancer therapy. Featured photo by CI Photos at Shutterstock. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

June 07, 2024 08:15 AM Eastern Daylight Time

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This One Company Is Working On A Breakthrough Approach To Revolutionize Pain Management

Autonomix Medical, Inc.

By Austin DeNoce, Benzinga Autonomix Medical (NASDAQ: AMIX) is a medical device company dedicated to transforming the diagnosis and treatment of diseases or disorders related to the nervous system. At the core of Autonomix's innovative approach is a first-in-class technology platform featuring a catheter-based microchip sensing array. This technology boasts an unprecedented ability to detect and differentiate neural signals with up to 3,000 times greater sensitivity than existing technologies. This breakthrough has paved the way for transvascular diagnosis and treatment of nervous system diseases virtually anywhere in the body, offering a new horizon of medical possibilities and market opportunities. Clinical Studies In Pancreatic Cancer Pain Autonomix has initiated its first clinical study targeting pancreatic cancer pain, marking a significant milestone in its ongoing medical innovation. Pancreatic cancer represents a considerable unmet medical need, particularly concerning pain management. Effective solutions in this area are critically needed, as current relief options for pancreatic diseases are limited to drugs like opioids. In light of that, the initiation of these clinical studies represents a crucial step toward addressing this substantial healthcare challenge for suffering patients. Market Opportunities In addition to addressing the pain relief needs of patients, Autonomix’s technology presents significant market opportunities across various medical fields. By accurately targeting the nervous system, Autonomix aims to address unmet needs and improve treatments for a wide range of conditions including but not limited to: Pancreatic Cancer Pain: The successful application of Autonomix's technology in pancreatic cancer pain management would not only help pancreatic cancer patients find relief from pain but also unlocks significant market potential. Pancreatic cancer pain management is part of a $2.2 billion market for pancreatic cancer treatment. Chronic Pain: This market presents a significant opportunity estimated at $75 billion. Conditions such as lower back pain, pelvic pain, urinary tract pain, digestive disorders and other tumor-related pain are prevalent and often inadequately managed with current therapies, particularly opioids. Autonomix's technology offers the potential to significantly reduce or eliminate the dependence on opioids, providing a safer and more effective solution for chronic pain management. Cardiovascular Diseases: With a market opportunity estimated at $23 billion, Autonomix's technology could revolutionize the treatment of conditions like hypertension and cardiovascular disease. By targeting the nervous system's role in these diseases, more precise and effective treatments could be developed. Pulmonary Diseases: Chronic obstructive pulmonary disease (COPD) is another area where Autonomix's technology could have a substantial impact. The market for COPD treatments is estimated to be around $18 billion with considerable growth ahead, driven by the need for more effective and less side-effect-prone therapies. Autonomix's approach could provide a new paradigm in managing this debilitating condition. Meeting Unmet Needs with Innovative Solutions Current drug therapies for many of these conditions often come with significant side effects and do not adequately address the underlying issues. Autonomix's technology offers a promising alternative by providing targeted, nerve-based treatments that could improve patient outcomes and quality of life. This innovative approach aligns with Autonomix's mission to dramatically enhance the lives of millions by enabling precise and effective nerve-targeted treatments. In doing so, Autonomix can both detect and ablate malfunctioning nerves in one simple procedure, effectively opening new treatment options in the field of electrophysiology. The Full Opportunity Autonomix Medical sits at the forefront of a potential revolution in medical treatment for diseases driven by the nervous system. The company’s advanced technology platform not only offers hope for better management of pancreatic cancer pain, but also opens the door to addressing numerous other conditions with significant unmet need. By providing physicians with powerful new tools for diagnosis and treatment, Autonomix is poised to make a profound impact on the future of healthcare. Featured photo by Irwan on Unsplash. Autonomix is a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated. The Company’s first-in-class technology platform includes a catheter-based microchip sensing array that has the ability to detect and differentiate neural signals with approximately 3,000 times greater sensitivity than currently available technologies. We believe this will enable, for the first time ever, transvascular diagnosis and treatment of diseases involving the peripheral nervous system virtually anywhere in the body.We are initially developing our technology for pancreatic cancer pain, a condition that can cause debilitating pain and needs an effective solution. However, our technology constitutes a platform with the potential to address dozens of indications, including in cardiology, renal denervation and chronic pain management across a wide disease spectrum. Some of the statements in this release are “forward-looking statements,” which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the timing of the completion of patient enrollment in the trial and the Company’s ability to successfully meet the milestones set forth in this press release on a timely basis, if at all. Such forward-looking statements can be identified by the use of words such as ‘should,’ ‘may,’ ‘intends,’ ‘anticipates,’ ‘believes,’ ‘estimates,’ ‘projects,’ ‘forecasts,’ ‘expects,’ ‘plans,’ and ‘proposes.’Although Autonomix Medical, Inc. (or Autonomix) believes that the expectations reflected in these forward-looking statements are based on reasonable assumptions, there are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. You are urged to carefully review and consider any cautionary statements and other disclosures, including the statements made under the heading “Risk Factors” and elsewhere in the offering circular filed with the U.S. Securities and Exchange Commission (“SEC”) on January 26, 2024. Forward-looking statements speak only as of the date of the document in which they are contained and Autonomix does not undertake any duty to update any forward-looking statements except as may be required by law. This post contains sponsored content. This content is for informational purposes only and not intended to be investing advice. Contact Details JTC Team, LLC autonomix@jtcir.com Company Website https://autonomix.com/

June 06, 2024 09:00 AM Eastern Daylight Time

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Culturelle® Probiotics and Re:wild Team Up to ‘Protect the Gut Microbiome’

YourUpdateTV

A new campaign from Culturelle® Probiotics and global conservation non-profit, Re:wild, is highlighting the similarities between endangered ecosystems on Earth and the endangered ecosystem within: the human gut microbiome. Recently, Dr. Robin Moore from Re:wild, participated in a nationwide satellite media tour to discuss the new initiative. A video accompanying this announcement is available at: https://youtu.be/JT_Nv2wpwrU Earth’s ecosystems are what sustain us. They are our first line of defense against emerging diseases and climate chaos, and they provide everything from clean air and water to food and medicines. But research shows that the populations of mammals, birds, reptiles, amphibians and fish have declined by nearly 70% since 1970. And a loss of biodiversity can significantly disrupt an ecosystem – lowering its productivity and quality. The gut microbiome – made up of trillions of living, breathing bacterial species – is also facing a loss of biodiversity and is under constant siege from a variety of modern-day stressors, like anxiety, lack of sleep, and poor eating habits, that can put it out of balance and hinder its ability to thrive. This led the Culturelle brand to make a poignant connection between the vulnerable state of our gut microbiome and the other ecosystems of the world. The gut is a critical ecosystem — and it's at risk. Culturelle Probiotics and Re:wild have teamed up to draw attention to the similarities between the endangered ecosystems of our world and the ecosystem within – the human gut microbiome – and raise awareness on the importance of protecting biodiversity in all ecosystems, both inside and out. To learn more about the campaign, visit ProtectTheGut.com. About Dr. Robin Moore Dr. Robin Moore blends his scientific training with his passion for photography and storytelling to connect a broad audience with the urgency and opportunity for saving endangered species and critical ecosystems. Recognizing the importance of communications for challenging perceptions and changing behaviors, Robin has spearheaded innovative campaigns to raise the profile of too-often overlooked species. The Search for Lost Frogs, a global quest to find species missing for decades, attracted significant media attention and inspired the book, In Search of Lost Frogs, which was named one of The Guardian’s best nature books of 2014. Robin is an award-winning photographer and Senior Fellow of the International League of Conservation Photographers. The Search for Lost Species, a signature initiative of Re:wild, builds on this success. About Culturelle® Probiotics For more than 25 years, Culturelle® Probiotics have helped individuals, children and families support their health. Covering digestive, immune, feminine, and pediatric health, Culturelle® product formulations are based on science, utilizing clinically studied probiotics to support the unique benefits of each product. Plus, the ingredients are proven effective and work in harmony with the human body.* About Re:wild Re:wild protects and restores the wild. They have a singular and powerful focus: the wild as the most effective solution to the interconnected climate, biodiversity and human wellbeing crises. Re:wild brings together Indigenous peoples, local communities, influential leaders, nongovernmental organizations, governments, companies and the public to protect and rewild at the scale and speed we need. Learn more at rewild.org. © 2024 dsm-firmenich group, Culturelle® is a trademark of the dsm-firmenich group. * The Food and Drug Administration has not evaluated these statements. This product is not intended to diagnose, treat, cure, or prevent any disease. Contact Details YourUpdateTV +1 212-736-2727 yourupdatetv@gmail.com

June 05, 2024 03:46 PM Eastern Daylight Time

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Mainz Biomed (NASDAQ: MYNZ) Announces Positive Topline Results From Cancer Detection Studies, Including 92% Sensitivity Rate

Benzinga

By James Blacker, Benzinga Mainz Biomed NV (NASDAQ: MYNZ), a company that specializes in the early detection of cancer, recently shared encouraging topline results from a clinical study designed to test the next-generation version of its colorectal cancer screening tool, ColoAlert®. The company recently unveiled compelling findings from its most expansive group to date at the 2024 Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Illinois, as well as virtually. The comprehensive examination consisted of 690 participants from 30 reputable gastroenterology facilities in Europe and the United States, and introduced previously unexplored and unreported specimens. The results underscored the effectiveness of Mainz Biomed's multimodal screening test, marking significant advancements in colorectal cancer detection. Notable figures include a sensitivity of 92.3% for colorectal cancer, a specificity of 90.1%, a sensitivity rate of 82.2% for advanced precancerous lesions, and an impressive high-grade dysplasia detection rate of 95.8%. With the success of this study, Mainz Biomed now plans to move forward with a major clinical trial in the U.S., which will involve up to 15,000 participants. If this next trial produces positive results, the company says its next-generation tool has the potential to disrupt the at-home colorectal cancer screening market by becoming a new gold standard. “The new data read-out demonstrates that our next generation product candidate for early-stage CRC detection utilizing mRNA biomarkers, a FIT test and a proprietary AI algorithm has consistently delivered high sensitivity and specificity for both advanced adenomas and colorectal cancer,” said Guido Baechler, CEO of Mainz Biomed, “These results represent a critical milestone on our path to launching our FDA PMA pivotal study ReconAAsense, which is planned to recruit up to 15,000 patients.” Why Early Detection Matters According to the American Cancer Society’s latest publication, the incidence of colorectal cancer has increased alarmingly since the mid-1990s, continuing to rise between 1% and 2% each year in people under the age of 55. Since the mid-2000s, the mortality rate among young people has increased at a similar rate. Colorectal cancer is the third most common cancer worldwide and the second leading cause of cancer-related deaths worldwide. However, it is also the most preventable, with early detection leading to survival rates above 90 %. About Mainz Biomed Founded in Germany, Mainz Biomed is becoming a leading global provider of easy-to-use diagnostic solutions for patients and healthcare providers everywhere. The company develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. It is involved in the commercializing of its product portfolio in Europe, the United States and the rest of the world, and develops innovative products to quickly and reliably identify the early onset of several leading deadly conditions – such as pancreatic cancer and colorectal cancer. The company reports that its CE-IVD-cleared flagship product, ColoAlert, is the first DNA-based screening test for colorectal cancer in Europe, and that it is developing proprietary genetic testing methods for pancreatic cancer. For 2023, the company earned revenues of $895,479, which compared to revenues of $529,877 in 2022. What Sets ColoAlert Apart In a market with established players such as Cologuard from Exact Sciences Corporation (NASDAQ: EXAS), ColoAlert stands out as an innovative product that addresses the need for a convenient and user-friendly test. Mainz Biomed claims that ColoAlert is not only more effective than traditional blood tests at detecting precancerous polyps early but also detects more cases of colorectal cancer than other stool tests. As Mainz Biomed plans its upcoming major trial in the U.S., the company could be one to watch as a force in the fight against cancer. More information about the company can be found at mainzbiomed.com. Featured photo by Gerd Altmann on Pixabay. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

June 05, 2024 08:30 AM Eastern Daylight Time

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Clarified Precision Medicine and xCures Form Strategic Partnership to Transform Patient Outcomes Through Precision Oncology

Clarified Precision Medicine

Clarified Precision Medicine, the only company that provides oncologists with prioritized therapy options via a combination of expert medical provider review and underlying artificial intelligence (AI) computational algorithms, and xCures, a healthcare technology company that delivers real-time clinical data to power precision medicine support, today announced a strategic partnership to dramatically advance the field of precision oncology. The two companies will come together to enhance cancer-care delivery and personalized patient treatment recommendations through precision medicine and data-driven analysis. The goal of the alliance is to better identify and understand current gaps in providing precision medicine and ultimately improve patient outcomes. Oncology faces an immediate need to improve access to precision medicine. In the United States, there are 18 million patients with a history of cancer and 1.9 million new cancer diagnoses each year. Patients who receive precision therapies have survival rates that are three times greater than those who do not. However, 75 percent of doctors say they need help interpreting the genomic tests that make precision medicine possible — which, in turn, leads to more effective utilization of these powerful 21st-century tools. To that end, Clarified and xCures will collaborate on patient-level data analytics and work together to improve provider support, education, and communication. The two organizations will develop learning systems focused on innovative solutions in precision oncology, such as predictive analytics and treatment optimization. Clarified will contribute its specialized treatment recommendation system, which combines insights from experienced medical professionals with support from its AI-driven treatment algorithm. The company’s team of expert medical reviewers will provide clinical oversight. xCures will provide its AI-driven technology platform, which excels at extracting the critical information needed for care among the complex cancer patient data and enhancing access to medical records. “This partnership unites two of the most innovative leaders in the field of precision oncology,” said Clarified Precision Medicine CEO Rajni Natesan, MD, MBA. “Clarified is the leading expert in closing gaps at the last mile of precision oncology, with an AI platform and the greatest understanding of physician needs and individual patient outcomes. xCures is a leader in data and technology that transforms clinical efficiency and patient care. This powerful alliance enables us to overcome obstacles in cancer care that can only be addressed by an advanced, data-driven understanding of oncology at the patient level.” "We are excited to partner with Clarified Precision Medicine to harness the power of real-time clinical data and advanced analytics,” said xCures CEO Mika Newton. “This collaboration will enable us to deliver highly personalized and effective treatment recommendations, ultimately improving patient outcomes in precision oncology. By combining our strengths, we can address the critical need for better access to precision medicine and support oncologists in making data-driven decisions that enhance patient care." In addition to improving the utilization of precision medicine, the alliance will have significant capabilities in data collection and analytics to drive precision oncology research. The technology integration between Clarified and xCures will facilitate retrospective and prospective data analysis to improve treatment strategies and patient care outcomes. About Clarified Precision Medicine Clarified Precision Medicine is the first scalable molecular tumor board with a combination of ML-based platform plus medical group, offering expert clinical somatic and pharmacogenomics consultations through its ClarifiedSelect™ and OncoGuardian™ solutions. Clarified accelerates the delivery of guidelines-based genomic insights to patients and providers by bringing together nationally recognized experts in medical oncology, oncology pharmacy, data integration, and molecular pathology who have over 100 years of collective experience in the application of precision oncology. For more information, visit clarifiedprecisionmedicine.com About xCures Inc. Launched in 2018, xCures Inc. operates an AI-assisted platform that automatically retrieves and aggregates medical records from any US care site. Data is extracted and structured within 15 minutes, to offer a sophisticated view of a patient’s fully longitudinal health journey that encompasses everything from genomics to social determinants of health. Through a variety of tools and data products, xCures provides clinically actionable, real-time insights that facilitate clinical research and care for patients, providers, and partners. For more information, contact info@xcures.com, or visit www.xcures.com Contact Details For Clarified Precision Medicine info@clarifiedmedicine.com Company Website https://clarifiedprecisionmedicine.com/

June 04, 2024 03:00 PM Eastern Daylight Time

Novus Reports Q1 Results And Key Success Factors Following DEA Rescheduling

Novus Acquisition & Development Corp

Miami, Florida - ( ThriveNewsWire ) - Novus Acquisition & Development Corp d/b/a Novus Cannabis MedPlan (OTC Markets: ( NDEV ) is a leading national supplemental health insurance carrier and pioneer in offering cannabis in health plans for recreational and medicinal users. It released its update on its Q1 2024 results, Rx Dispensing Platform, and Key Elements that fuel its success after the Drug Enforcement Agency (DEA) announced that cannabis will be rescheduled. Novus Cannabis MedPlan (Novus) has been integrating cannabis into health plans since 2015. With a network of over 1,200 agents, brokers, and dispensaries, Novus aims to make cannabis-based treatments more affordable and accessible through insurance plans, benefitting a wider range of consumers. Here are three key highlights that contribute to Novus' success. 1) Financial Snapshot: The company utilizes a receivable-based business model with minimal overhead and no convertible debt, demonstrating consistent organic growth year over year. No Dilution: No common stock has been issued after June 15, 2021. No Sales of Insider Shares: For close to 3 years Gross Revenue Increase: During this reporting period, Gross Revenue increased by 6.8% compared to March 31, 2024 and 2023, respectively, Net Revenue Increase: During this reporting period, EBITDA increased by 19.47% compared to March 31, 2024, and 2023. Profit Margin: During the reporting period, the company experienced a gradual increase in gross profit margins, with margins of 43.14% in 2023 and 45.2% in 2024 Cash and Cash Equivalents: There was an increase of 1.8% compared to the financial reporting periods on March 31, 2024, and December 31, 2023. This is in contrast to the higher increase of 6.84% in the period from March 31, 2023, to 2024. Debt Transparency: Frank Labrozzi, the CEO, is owed $158,061. He has no plans to exercise the call provision, and this debt instrument has no equity conversion provision. Leak Out Vendor Shares: All vendors who received treasury-issued stock must gradually sell their shares. The selling amount is determined based on 15% of the average daily trading volume over the past 30 days. 2) Introducing the Rx Dispensing Platform Novus is strategically positioning its cannabis health plans to become a prominent player in mainstream healthcare insurance by acquiring an Rx Dispensing Platform tech stack. Frank Labrozzi, CEO of Novus, stated, "This advancement will significantly impact cannabis in health plans. By promoting collaboration between brands and dispensaries, we aim to empower policyholders with more choices, enabling them to purchase the brands they prefer at any dispensary. Cannabis brands can use the platform to connect directly with dispensaries and showcase their products at no cost. This will improve product distribution efficiency, increase brand visibility, provide real-time inventory data, and facilitate product research for the policyholder. An added bonus to For Rec Users: This platform serves recreational users who prefer not to disclose personal information like their policyholder status to access plan benefits. Instead, users can discreetly order services for a small subscription or transaction fee. 3) Key Success Factors Midwest Expansion: Novus has partnered with Heya Wellness, a prominent cannabis company in Missouri, to offer MedPlans to 4.3 million potential policyholders in the Midwest. By leveraging Missouri's favorable reciprocity laws, Novus aims to maximize the benefits for our sales hub based in St. Louis. Health Carrier Alliances Integration with Traditional Healthcare: By treating cannabis as a traditional pharmaceutical product and including it in insurance plans, Novus could help normalize cannabis use for medical, recreational, and non-users. Now that there is federal approval, Novus bridges traditional healthcare and the cannabis industry, enhancing major healthcare carriers who have expressed interest in integrating Novus' cannabis-based prescription plans into their benefits packages, establishing a connection between the two industries. Compassionate Care Act (CCA): The CCAs, which the Supreme Court sanctions, typically focus on making medical marijuana accessible to workplace patients with specific conditions. Human Resources departments are revising workplace policies to allow employees to access medical marijuana through employer-sponsored health plans. Novus plans to cover some costs through tax-deductible health savings and health reimbursement accounts. Opioid Settlement Framework: The opioid settlement framework is a legal agreement aimed at resolving litigation against pharmaceutical companies and health carriers accused of contributing to the opioid crisis. It includes $50 billion for prevention, treatment, and recovery programs with the goal of mitigating the crisis' impact and preventing future misuse. Novus is playing a crucial role in reducing opioid use by offering states and private organizations alternative treatment options through our developed health plans that help patients transition from opioids to medical cannabis. Compliance with the Veteran’s Affairs (VA): Veterans are increasingly interested in utilizing cannabis for treatment—over 88% support medical cannabis programs. Novus has developed health plans following VA guidelines to integrate cannabis benefits for veterans. In closing: As Novus adjusts to the positive changes in federal cannabis regulation, we are prepared to utilize our niche approach to cannabis in health plans, which utilizes a receivables-based business model. This approach strategically enables us to organically invest in critical areas such as marketing, improving engagement with policyholders and providers, and establishing a reliable cash flow management system. This positions Novus as a significant player in the fast-evolving cannabis integrated into health insurance plans. Do your research on our company to understand our potential in shaping the future of healthcare. Visit our Investor Relations page to see for yourself. About Novus Further Research: Financial Filings: Click Here Quote: Click Here Website Click Here Investor's Page Click Here Video Of Investment Highlights: Click Here Novus Acquisition & Development Corp. (NDEV) operates through its subsidiary, WCIG Insurance Services, Inc., offering health insurance and related insurance solutions in states with legal medical marijuana programs. With a robust infrastructure covering various insurance lines, including health, life, and fixed annuities, Novus is a leading health insurance carrier, using two key indicators to gauge value and performance. The Benefit Monetization Ratio measures the annual total of monetized policies, offset by the operating cost ratio, a Balance Sheet line item derived from Net Asset Value and calculated to the Price Book Value. Novus' medical cannabis benefits package operates as an outside developer. It does not engage in any activities related to the cultivation, handling, transportation, growth, extraction, dispensing, sale, marketing, vending, delivery, supply, circulation, or trade of cannabis or any substances violating United States law or the Controlled Substances Act. The company adheres strictly to state and federal laws and has no intentions to violate them in the future. It is important to note that statements regarding specific products have not been evaluated by the United States Food and Drug Administration (FDA) and should not be interpreted as intended to diagnose, treat, cure, or prevent disease. The information provided in press releases and product labels is for informational purposes only and should not be considered a substitute for advice from qualified healthcare professionals. Novus respects the individual transactions involving cannabis, which are solely between state-licensed dispensaries and registered patients. However, it's worth noting that state laws may conflict with the federal Controlled Substances Act. The current administration has indicated that federal law enforcement agencies will not prioritize prosecuting those complying with state-designated laws concerning medical marijuana usage and distribution. Nevertheless, changes in government policies and consolidation could impact the provider network, and there is no assurance that future administrations will not alter this stance. While Novus does not engage in the harvest, distribution, or sale of cannabis or cannabis-related products, the company could be affected if there were any shifts in enforcement by federal or state governments concerning existing laws. Such changes could result in significant financial implications for Novus and other industry players. Forward-Looking Statements This release includes forward-looking statements, which are based on certain assumptions and reflect management's current expectations. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results or events to differ materially from current expectations. Some of these factors include general global economic conditions; general industry and market conditions and growth rates; uncertainty as to whether our strategies and business plans will yield the expected benefits; increasing competition; availability and cost of capital; the ability to identify and develop and achieve commercial success; the level of expenditures necessary to maintain and improve the quality of services; changes in the economy; changes in laws and regulations, includes codes and standards, intellectual property rights, and tax matters; or other matters not anticipated; our ability to secure and maintain strategic relationships and distribution agreements. Dilution, if any, would be for the purposes of management taking stock in lieu of cash salary. Novus disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Additionally, this press release that is not statements of historical fact may be considered to be forward-looking statements. Written words such as "may," "will," "expect," "believe," "anticipate," "estimate," "intends," "goal," "objective," "seek," "attempt," or variations of these or similar words, identify forward-looking statements. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the near future. Investor Contact Information Investor Website 855-228-7355 Email: pr@getnovusnow.com Contact Details Novus Acquisition Frank Labrozzi +1 305-467-6699 frank@ndev.biz Company Website https://getnovusnow.com/

June 04, 2024 08:00 AM Eastern Daylight Time

AGC Biologics Completes Copenhagen Campus Expansion, Doubling Single-use Mammalian Bioreactor Capacity at Site

AGC Biologics

AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), today announced at BIO International the completion of its new manufacturing building at the AGC Biologics Copenhagen campus. The completed work doubles the site’s single-use bioreactor capacity for mammalian services and allows it to produce 150 more batches of drug product each year. The expansion adds 19,000 m2 of space in an ultramodern building that houses a large manufacturing floor, expanded quality control and process development lab space, utilities to support all operations and prevent outages caused by natural disasters, and a fully dedicated warehouse to serve the entire AGC Biologics Copenhagen campus. The new AGC Biologics Copenhagen manufacturing building is already in production with its first customer, a phase II/III clinical product. AGC Biologics announced the planned expansion in November 2020, investing roughly $200 million into the work. One-of-a-kind single-use manufacturing offering The new manufacturing area offers 8 x 2,000 L single-use bioreactors with two seed trains, as well as two independent downstream suites – [CW1] more than doubling the existing capacity offered at this site for mammalian-based projects. AGC Biologics Copenhagen is now one of the only sites in the world with multiple single-use bioreactor systems of this magnitude capable of producing batches at high-levels of clinical and commercial production. Further, for developers needing to transfer in an existing process, AGC Biologics Copenhagen’s multiple single-use suites give the site greater flexibility to take on technical transfers and perform like-for-like process and knowledge activities for products entering the facility, eliminating lag time associated with onboarding a new CDMO. AGC Biologics has been a leader in single-use technology over the last decade, and it is one of the largest CDMO networks in the industry offering flexible and scalable single-use bioreactors systems. The news comes after AGC Biologics announced an end-to-end protein biologics drug product partnership with Dutch-based BioConnection in late May. The alliance provides a secure and full-service “gene-to-vial” offering for biopharma developers with drug substance development, manufacturing and aseptic fill and finish capabilities for drug products. “AGC Biologics Copenhagen site continues to be one of the most active in our network with all the necessary commercial approvals – FDA, EMA, HCA, PMDA, ANVISA etc. – and we are more than happy to offer the capacity and capabilities our current and future customers will look for with this completed expansion,” said Christoph Winterhalter, CBO, AGC Biologics. “The expansion, combined with our new drug product alliance, demonstrates AGC Biologics’ agility to meet all the needs developers may have, from pre-clinical through commercial.” AGC Biologics’ Copenhagen site core teams of scientists have more than 25 years of expertise in biopharmaceutical development and manufacturing, including seven commercial products brought to market. The site offers pre-clinical through commercial production for protein biologics services using mammalian and microbial systems. It has a gold EcoVadis Sustainability Rating for its environmental, health and sustainability practices. “I am extremely proud of the work and collaboration of everyone at our site over the last several years, it is truly remarkable to see what we can accomplish by working together. We are eager to offer more of the important capabilities the industry is looking for to support patients in need,” said Andrea C. Porchia, General Manager, AGC Biologics Copenhagen. To learn more about AGC Biologics Copenhagen, visit www.agcbio.com/facilities/copenhagen. For more information about AGC Biologics’ global CDMO services go to www.agcbio.com. About AGC Biologics: AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 Team Members worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is a part of AGC Inc.’s Life Science Company. The Life Science company runs more than 10 global facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit www.agcbio.com. Contact Details Nick McDonald +1 425-419-3555 nmcdonald@agcbio.com Company Website https://www.agcbio.com/

June 04, 2024 12:00 AM Pacific Daylight Time

Mphasis and Classiq Partner to Drive Quantum Innovation

Classiq Technologies

Mphasis, (BSE: 526299; NSE: MPHASIS), an Information Technology (IT) solutions provider specializing in cloud and cognitive services, today announced its strategic partnership with Classiq, a leading quantum software company to demonstrate and commercialize industry solutions powered by Quantum. The strategic partnership aims to accelerate the adoption of quantum solutions for enterprises by integrating them into its operations. The collaboration is committed to fostering innovation and redefining technological boundaries and paving the way for a quantum-powered future. Classiq leads in quantum computing software and has developed a platform for faster and more efficient quantum algorithm design. Mphasis will focus on building industry solutions in sectors such as BFSI, Lifesciences, Healthcare, Supply Chain & Logistics, Chemistry, utilizing these advanced algorithms. By leveraging Classiq’s quantum platform, Mphasis will develop industry-specific intellectual properties (IPs) and will also jointly market and implement customer IPs, execute customer projects, and provide support for the commercialization of Classiq’s platform and IPs. Additionally, Mphasis’ Quantum Initiative, launched in 2020 within the Applied R&D division, NEXT Labs, aims to facilitate our client's transition to the quantum era. The adoption model comprises awareness-building, assessment, and consulting workshops, as well as the development and implementation of quantum solutions in key domains such as optimization, artificial intelligence, simulation, and cybersecurity. Within the realm of quantum computing, the company’s priorities include applied research, the creation of industry-specific solutions and intellectual properties, thought leadership dissemination, building robust partnerships, and leveraging a design thinking approach to drive adoption. “We are thrilled to announce our collaboration with Classiq and leveraging their expertise to unlock the vast potential of quantum computing. This partnership enables us to combine our industry knowledge with cutting-edge quantum technology, to innovative solutions tailored to our clients' needs. Together we hope to lead the way in initiating and implementing state-of-the-art quantum solutions that redefine the boundaries of our field," said Srikumar Ramanathan, Chief Solutions Officer, Mphasis. "Classiq is proud to be partnering with Mphasis to support scalable enterprise quantum computing software development. Together we combine depth of industry domain knowledge and quantum expertise with the technology needed to implement sophisticated optimized quantum computing programs for our clients," said Nir Minerbi, CEO and Co-Founder, Classiq Technologies. By synergizing Mphasis' domain expertise with Classiq's quantum computing acumen, the collaboration is poised to unlock newer possibilities and redefine industry benchmarks. Quantum computing's ability to tackle previously unsolvable problems opens doors for entirely new discoveries and innovations. National Institute of Standards and Technology’s report states that quantum computing could lead to breakthroughs in areas like materials science, drug discovery, and financial modelling. McKinsey & Company estimates a $106B potential quantum technology market size by 2040. The alliance between Mphasis and Classiq represents a fusion of expertise and innovation, with Classiq's cutting-edge quantum development platform complemented by Mphasis' extensive industry knowledge. Together, the companies aim to pioneer groundbreaking quantum solutions that will reshape sectors primed for transformative change. Classiq’s platform enables both beginner and expert designers to rapidly generate, analyze, and execute quantum circuits. The collaboration reflects the shared dedication of Mphasis and Classiq, showcasing a commitment to pioneering quantum computing applications across diverse industry sectors. Apart from this, in June 2021, Mphasis along with the Government of Alberta, and the University of Calgary signed an MoU to announce the launch of the world-leading Quantum City - Canada. The strategic partnerships were to accelerate talent development and the development of a quantum computing ecosystem in Calgary, driving R&D in the technology sector. In June 2022, Mphasis deepened its commitment to Canada by announcing a delivery center in Calgary, opening the center in Alberta for business. The Mphasis business ecosystem was positioned to reinforce the region's reputation as a leading hub for digital transformation, AI, quantum computing, and more, and contribute to Canada's growing digital sector. About Mphasis Mphasis’ purpose is to be the “Driver in Driverless Car” for Global Enterprises by applying next-generation design, architecture, and engineering services, to deliver scalable and sustainable software and technology solutions. Customer centricity is foundational to Mphasis, and is reflected in the Mphasis’ Front2Back ™ Transformation approach. Front2Back™ uses the exponential power of cloud and cognitive to provide hyper-personalized (C= X2C2TM =1) digital experience to clients and their end customers. Mphasis’ Service Transformation approach helps ‘shrink the core’ through the application of digital technologies across legacy environments within an enterprise, enabling businesses to stay ahead in a changing world. Mphasis’ core reference architectures and tools, speed and innovation with domain expertise and specialization, combined with an integrated sustainability and purpose-led approach across its operations and solutions are key to building strong relationships with marquee clients. Click here to know more. ( BSE: 526299; NSE: MPHASIS ) About Classiq Classiq Technologies, the leading quantum software company, provides an all-encompassing software platform (IDE, compiler and OS) with a single point of entry into quantum computing, from algorithm design to execution. Tailored to all levels of developer proficiency, Classiq aims to democratize access to quantum computing with software that equips customers to take full advantage of the quantum computing revolution. A low-code development environment that automates quantum programming ensures that a broader range of talents, including those with backgrounds in AI, ML and linear algebra, can harness quantum computing without requiring deep, specialized knowledge of how to program quantum computer hardware. Classiq also works closely with advanced computation hardware providers providing software for use with quantum computers, HPC and quantum simulators. Backed by powerful investors such as HPE, HSBC, Samsung, Intesa Sanpaolo and NTT, Classiq’s world-class team of scientists and engineers has distilled decades of quantum expertise into its groundbreaking software development platform. Follow Classiq on LinkedIn, X (formerly Twitter) or YouTube, join the Slack community, or try the Classiq platform. Contact Details Rainier Communications Michelle Allard McMahon +1 781-718-3248 classiqPR@rainierco.com Mphasis Corporate Communications Deepa Nagaraj +1 646-424-5160 deepa.nagaraj@mphasis.com Mphasis Corporate Communications Sumana Bhat +91 99029 80980 sumana.bhat@mphasis.com Company Website http://www.classiq.io/

June 04, 2024 02:04 AM Eastern Daylight Time

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