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NuggMD is Providing Free Medical Cannabis Evaluations to Veterans on Veterans Day

NuggMD

NuggMD, the nation's leading telemedicine platform for cannabis, today announced that it is providing free online medical marijuana evaluations to veterans from Nov. 7 to Nov. 11. Rates of PTSD range from 10% to 30% among war-time vets and 31% struggle with chronic pain. Additionally, according to the U.S. Department of Veterans Affairs, fewer than 50% of veterans in need of mental health treatment end up receiving it. While cannabis remains illegal federally, 38 states and several U.S. territories have legalized cannabis used to treat qualifying medical conditions, among them PTSD and chronic pain. “Every adult deserves the freedom to use cannabis. That is what we stand for,” said Bobby Brock, vice president of marketing at NuggMD. “We urge our peers in the cannabis industry to use their resources to help veterans, because serving in the armed forces is one of the most selfless, patriotic things an American can do. We also invite policymakers to take seriously the potential that cannabis may have to improve the quality of life of those who choose to enlist, both as they serve and after they return home.” The free evaluations will be offered to all veterans who reside in the 28 markets that NuggMD serves, and who provide valid proof of service and their state-issued identification. The applicable states are listed on NuggMD’s website, and veterans can secure their appointment using NuggMD’s on-demand platform from 8 AM to 10 PM in their local time zone. In addition to providing free evaluations to veterans, the company is also offering a 25% discount to the spouses of veterans, under the same conditions. Since its launch in 2016, NuggMD's affiliated medical cannabis practitioners have helped over two million patients connect with qualified medical cannabis doctors. About NuggMD NuggMD is the nation's leading medical marijuana technology platform, serving patients in Arizona, California, Connecticut, Delaware, Florida, Georgia, Illinois, Iowa, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nevada, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Texas, Vermont, Virginia, Washington, and West Virginia. They've connected over 2,000,000 patients face-to-face with their new medical marijuana doctors via their state-of-the-art telemedicine platform. They believe every human being has the right to explore the benefits of medical cannabis and are fully committed to helping each patient explore every option in their journey to wellness. For further information, visit https://www.nuggmd.com. Contact Details Andrew Graham +1 646-385-0189 andrew.g@getnugg.com Company Website http://www.nuggmd.com

October 29, 2024 02:50 PM Eastern Daylight Time

AGC Biologics Appoints Alberto Santagostino as new Chief Executive Officer

AGC Biologics

AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), today announced the appointment of Alberto Santagostino to Chief Executive Officer and President of AGC Biologics, effective November 1 st. Alberto has had a distinguished career in biotech, pharma and managing large-scale global CDMO operations. His expertise and knowledge will lead AGC Biologics’ next chapter as the company reemphasizes delivering reliable services to biopharmaceutical developers without unnecessary complications. AGC Biologics will have a friendly business approach with customers and provide them with expert CDMO services to become an increasingly preferred service provider. AGC Biologics intends to be valued as collaborative, reliable and stable: it will be a safe harbor for those customers seeking to minimize geopolitical risks, intellectual property concerns, steep price expectations and transactional or confrontational supplier relationships. This direction builds on the company’s 30 years of biopharma CDMO experience, including serving more than 250 customers across over 400 different projects, with more than 90 successful regulatory inspections and 25 commercial products launched. Alberto joins AGC Biologics after most recently serving as the Head of Cell and Gene Technology (CGT) at Lonza for six years. While there, his business unit grew four-fold in size by enabling clients to advance four new CGT therapies to commercial production and many more to late-stage clinical milestones, with now thousands of patients being cured annually. During his tenure, Alberto led the industrialization of CGT therapeutics manufacturing: from a “science workshop” into “industrial scale compliant operations” with several positive Pre-Approval Inspections (PAI) from the U.S. FDA and EMA that led to three CGT biomanufacturing sites becoming licensed for commercial supply. Before Lonza, Alberto was a Partner in the Pharmaceutical & Medical Product practice at McKinsey & Co., serving more than 70 clients with over 200 projects. While there, Alberto developed a proprietary operational benchmark that analyzed the performance of more than 30 biomanufacturing sites and published books and articles about Biopharma operations. Alberto currently serves as a board member for the Alliance for Regenerative Medicine (ARM) and holds a degree in Industrial Biotechnology from the University of Milano-Bicocca and a Master of Business Administration from Politecnico di Milano. “I am excited to announce Alberto is joining us to lead AGC Biologics and to set the tone for the coming years. We share the common vision of service, delivery and quality that is at the core of AGC Group’s business philosophy,” said Murano Tadashi, President of AGC Life Science Company. “I am confident Alberto will bring both a wide knowledge of the biopharma industry and the experience of successfully leading growth at scale. He will enhance AGC Biologics’ reputation as an increasingly preferable CDMO in the industry.” “I am grateful for the opportunity to serve AGC Biologics and its team members and customers. We will have customers at the heart of our action and our technical talent as the enabler of our CDMO’s aspiration of friendly & expert services to the biopharma industry,” said Alberto Santagostino, new Chief Executive Officer at AGC Biologics. “Over the last several years our industry has faced more complexity. Chemistry Manufacturing Control (CMC), technical development and manufacturing have been a headache for the biopharma industry, also, and sometimes especially, when dealing with CDMOs. AGC Biologics aspires to become an easy choice. We will be a friendly CDMO to work with, expert and reliable in our technical role. We will leverage our technical talent, established centers of excellence, commercial track record, growing capacity at our global sites and the solidity of the parent company, to offer reliability while staying uncomplicated to work with. Ultimately, ‘#YourfriendlyCDMOexpert.’ ” For more information on AGC Biologics’ end-to-end global CDMO services in the U.S., Europe and Japan visit 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, to provide friendly and expert services. We provide world-class development and manufacturing 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, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 Team Members worldwide. AGC Biologics is a part of AGC Inc.’s Life Science Business. The Life Science Business runs 10+ facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit www.agcbio.com. Contact Details AGC Biologics Nick McDonald +1 425-419-3555 nmcdonald@agcbio.com Company Website https://www.agcbio.com/

October 28, 2024 06:03 AM Eastern Daylight Time

PathAI Unveils New Features on AISight Image Management System: Introducing Guided Algorithm Review and Z-Stack Image Support

PathAI

PathAI, a global leader in AI-powered digital pathology, today announced the launch of two new features on its AISight® 1 Image Management System (IMS): Guided Algorithm Review and Z-Stack Image Support. These enhancements reflect PathAI’s ongoing commitment to empowering pathologists with innovative tools that enhance pathology interpretation, optimize laboratory operations, and lay the foundation for broader adoption of AI tools in the field of pathology. The Guided Algorithm Review feature is designed to help pathologists streamline and enhance case evaluations by highlighting potential Fields of Interest (FOIs) identified by algorithms. TumorDetect 2, PathAI’s AI product, will be the first to incorporate this functionality, highlighting key areas of interest. By automatically pinpointing these critical areas, the feature allows pathologists to focus their initial review on the regions that require the most attention. Key Features of the Guided Algorithm Review: Gallery of FOIs: A visual gallery of algorithm-detected fields of interest provides an intuitive way for pathologists to navigate to key tissue areas requiring further analysis. Click-Through Review: Enables systematic, step-by-step navigation through regions highlighted by the AI’s predictions, such as areas with high tumor concentration or biomarker quantification, potentially streamlining the review process and enhancing thoroughness. Enhanced Interpretability: Overlays and side-by-side comparisons improve the clarity of AI predictions, allowing pathologists to better interpret and verify the results. Third-Party AI Integration: Allows for seamless integration with third-party AI algorithms, enabling pathologists to work with various AI solutions in a unified platform, enhancing flexibility and adaptability across different AI tools and workflows. In addition to the Guided Algorithm Review, PathAI’s Z-Stack Image Support introduces a multi-layer imaging capability that enables pathologists to examine all layers of a multi-layered Whole Slide Image (WSI), producing a 3D-like representation of slides. This feature is particularly beneficial in cytology, where three-dimensional cell clusters often require a more nuanced, layered analysis. Key Benefits of the Z-Stack Image Support: Multi-Layer Viewing: Pathologists can view all layers of a multi-layered Whole Slide Image (WSI), providing an experience similar to a microscope fine focus, particularly useful for cytology cases. Efficient Navigation: Features such as Focus Control and keyboard shortcuts allow for smooth transitions between image layers. Customizable Workflow: Pathologists can personalize their review process with adjustable zoom, pan, and annotation features, and track their progress through visual indicators. PathAI has also upgraded its ArtifactDetect 3 algorithm, broadening its support for additional file types, such as.mrxs format files and stains, including Masson’s Trichrome and other special stains. These improvements allow laboratories to apply quality control measures across a wider range of specimens and staining protocols, further optimizing laboratory efficiency. Additional AISight Enhancements: Refreshed User Interface: Includes categorized tables for clearer quantitative results, such as tissue areas and cell counts, facilitating easier interpretation. Custom Slide Panning: Enhanced control features like Snap to Zoom and adjustable animation durations for more precise slide navigation. Automatic Specimen Orientation: Automatically rotates skin specimens based on metadata, ensuring consistency and accuracy in evaluations. “We are thrilled to introduce these new capabilities to the AISight IMS platform,” said Eric Walk, M.D., FCAP, chief medical officer at PathAI. “The Guided Algorithm Review and Z-Stack Image Support are significant advancements that help pathologists conduct high-quality assessments with efficiency and precision. These tools help enhance and streamline case management supporting the needs of modern pathology labs.” Footnotes AISight is for research use only in the US and is not for use in diagnostic procedures. TumorDetect is a workflow optimization algorithm available on AISight for research use only. ArtifactDetect is a quality control algorithm available on AISight for research use only. About PathAI PathAI is a global leader in AI-powered digital pathology solutions, dedicated to advancing diagnostic accuracy and operational efficiency in pathology laboratories worldwide. Through the integration of cutting-edge technology and strategic partnerships, PathAI empowers pathologists to be leaders in precision pathology and shape the future of medical diagnostics. Contact Details SVM Public Relations and Marketing Communications Maggie Naples +1 401-490-9700 pathai@svmpr.com Company Website https://www.pathai.com/

October 23, 2024 10:00 AM Eastern Daylight Time

NeuroSense Advances Plans For Early Commercialization Of Potentially Groundbreaking ALS Treatment In Canada, Targeting A $100M+ Market

Benzinga

By Kyle Anthony, Benzinga NeuroSense Therapeutics Ltd. (NASDAQ: NRSN), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases – such as amyotrophic lateral sclerosis (ALS), Alzheimer's disease and Parkinson's disease – recently announced its plans to file for early commercialization approval for PrimeC, the firm’s leading drug candidate designed to synergistically target several biological mechanisms of ALS, under Health Canada’s Notice of Compliance with Conditions (NOC/c) policy. This submission is backed by promising results from the company’s phase 2b ALS PARADIGM clinical trial and supplementary clinical and preclinical data. ALS Explained ALS is a nervous system disease that affects nerve cells in the brain and spinal cord. The disease causes loss of muscle control, and gradually worsens over time. Often called Lou Gehrig's disease after the baseball player who was diagnosed with it, the exact cause of the disease is still not known. ALS often begins with muscle twitching and weakness in the arm or leg, trouble swallowing or slurred speech. Eventually, ALS affects the control of the muscles needed to move, speak, eat and breathe. There is no cure for this fatal disease. Every year, more than 5,000 people are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of people living with ALS is expected to grow by 24% by 2040 in the U.S. and European Union. The Efficacy Of NeuroSense’s PrimeC Treatment PrimeC, NeuroSense's lead drug candidate, is a novel extended-release oral formulation with a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to synergistically target several biological mechanisms of ALS that contribute to motor neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid (RNA) regulation. The goal is to inhibit the progression of ALS. NeuroSense reports that PARADIGM, a prospective, multinational, randomized, double-blind, placebo-controlled phase 2b clinical trial of PrimeC in ALS, has demonstrated the drug's efficacy. The trial d emonstrated that PrimeC significantly reduced disease progression (p=0.009) and improved survival rates by 43% compared to placebo, highlighting its potential as a breakthrough therapy for ALS. The trial included 68 participants living with ALS in Canada, Italy and Israel. 96% of the trial participants who completed the 6-month double-blind portion of the trial chose to receive treatment with PrimeC through a 12-month open-label extension. As of June 2024, all participants who completed the 18-month trial treatment duration requested to continue PrimeC, which is provided to them in an Investigator Initiated Trial, not limited to time. The PARADIGM clinical study observed a statistically significant slowing of disease progression in patients who used PrimeC versus placebo, based on the ALS Functional Rating Scale-Revised (ALSFRS-R). The Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS) is the gold standard instrument for evaluating the functional status of patients with ALS. It is used to monitor functional change in a patient over time. NeuroSense reports that most patients enrolled in both the active and placebo arms of the trial were concurrently treated with Riluzole, the ALS standard of care medication, indicating PrimeC slowed disease progression well beyond the level afforded by the FDA-approved ALS drug. The FDA and the European Medicines Agency have granted PrimeC Orphan Drug Designation. Commercialization Of PrimeC In Canada And Worldwide Health Canada’s Notice of Compliance with Conditions (NOC/c) is authorization to market a drug, with the condition that the sponsor undertake additional studies to verify the clinical benefit. As such, this speeds up the time to market for the drug, enabling earlier commercialization. In advancing PrimeC's commercialization potential, NeuroSense plans to submit its regulatory dossier to Health Canada in Q2 2025, with a regulatory decision anticipated by Q1 2026, and NeuroSense estimates the market opportunity for PrimeC in Canada alone to be approximately $100 million to $150 million in annual revenue, reflecting the unmet need for effective ALS treatments. Beyond Canada, NeuroSense plans to pursue regulatory approval in additional global markets as part of its broader strategy to make PrimeC accessible to ALS patients worldwide. Alon Ben-Noon, CEO of NeuroSense, stated, “The Canadian market presents a significant near-term opportunity, with the addressable market for PrimeC valued above $100 million in annual revenue. Securing early commercialization approval in Canada would represent an important milestone, not only to address the unmet need for ALS treatments but also as part of our strategy to drive sustainable growth. With additional markets on our radar, this marks the beginning of what we anticipate will be a long-term revenue-generating opportunity." Looking Forward NeuroSense’s PrimeC has the potential to reshape the landscape for ALS treatment, enhancing the quality of life for individuals around the globe afflicted by this debilitating disease. The promising results from the PARADIGM clinical trial and NeuroSense's commercial advancement plans for the drug indicate that PrimeC may soon be able to benefit ALS patients around the world and potentially position the company to be a leader in treating the disease. Featured photo courtesy of NeuroSense Therapeutics. 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

October 17, 2024 02:00 PM Eastern Daylight Time

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Minerva Surgical Signs Agreement with Blackmaple Group (BMG) and WHAAPA

Minerva Surgical, Inc.

Minerva Surgical, a manufacturer and distributor of minimally invasive gynecologic technologies, today announced a new strategic partnership with Blackmaple Group, designed to provide access to office-based solutions for its Women’s Health Administrative and Purchasing Alliance (WHAAPA) physician members for the detection and treatment of uterine conditions. The Medical Endoscopy Image Processing System and the Minerva ES Ablation System – both of which will be available to BMG WHAAPA members under this new agreement – are designed to quickly and effectively address causes of Abnormal Uterine Bleeding (AUB) a set of debilitating conditions affecting one in three women. Left untreated, AUB may drive women to withdraw or become absent from family, social, and work activities. Some of these conditions can be life threatening, if not detected early. According to Darin Hammers, CEO of Minerva Surgical, “Integrating hysteroscopy into the office setting enables gynecologists to detect uterine cavity disease earlier and more accurately than using other, less sensitive methods. The Minerva ES endometrial ablation can be performed in the comfort of the office setting, while reducing the cost to the patient. Effectiveness of the Minerva ES has been proven in clinical trials demonstrating procedure safety and long-term avoidance of hysterectomy in over 99% of the patients.” Additionally, Minerva ES is a one-time, non-hormonal, incisionless treatment with the recovery time of 1-2 days. “The agreement with Minerva Surgical is important to Blackmaple Group because it provides WHAAPA members with more options to safely and effectively treat patients in the office setting”, said Dr. Jeff Gold, CEO of BMG. About Minerva Surgical: Minerva Surgical is a Women’s Health company committed to improving women's health and quality of life by providing access to minimally invasive, technologically advanced, and innovative solutions for early detection, treatment, and management of uterine conditions. About Blackmaple Group: founded in 2008 as a consulting firm focused on bringing business rigor to provider group management, the Blackmaple Group (BMG) has grown to become an industry leader in procurement, medical group management and healthcare economics. Under the leadership of its founder Dr. Jeff Gold and COO Marc Cooper, BMG has grown to over 16,000 physician members across the United States and continues to add new clients every day. Contact Details Kevin Tracey +1 855-646-7874 info@minervasurgical.com Company Website https://minervasurgical.com/

October 17, 2024 10:00 AM Eastern Daylight Time

AGC Biologics Seattle Achieves Approval for all 2024 Biologics License Applications from U.S. Food and Drug Administration, Concluding Pre-License Inspection

AGC Biologics

AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), announced the U.S. Food and Drug Administration (FDA)’s approval of a third Biologics License Applications (BLA) from the March 2024 inspection of the company’s Seattle facility. The closure of this inspection and final BLA approval resulted in each of the three commercial products evaluated being approved for commercial production – a regulatory compliance and quality milestone for the site. The Seattle CDMO facility welcomed the FDA in March 2024 for an intensive week of three product inspections. The approved products include two FC-fusion proteins and a monoclonal antibody (mAb). One of the FC-fusion proteins is focused on treating non-muscle invasive bladder cancer; the other is designed to treat age-related neovascular Macular Degeneration (nAMD) and other serious retinal diseases. The mAb product targets chronic-versus-host disease (GVHD). The series of 2024 BLA approvals continues a trend of successful regulatory milestones for the AGC Biologics Seattle site. The FDA has approved four biologics products manufactured at this facility in the last two years. AGC Biologics received commercial approval at the end of 2022 for a mAb product targeting type 1 diabetes (T1D), the first and only treatment of its type at the time of approval. “Performing an agency inspection for three products simultaneously is not easy and I am extremely proud of this result. We took on the challenge and helped ensure every product evaluated achieved commercial approval this year,” said Jose Gonzalez, General Manager, AGC Biologics Seattle. “This is a tremendous achievement for our site. For our partners bringing lifesaving treatments to patients, it is pivotal for their manufacturing partner to maintain regulatory compliance and a high level of product quality to help them reach commercial success. This is a shining example of AGC Biologics’ Seattle ability to do that.” AGC Biologics operates multiple mammalian cGMP manufacturing lines of various scales at its Seattle site, which serves as a center of excellence for formulation and employs the latest fed-batch and perfusion manufacturing processes. In the past year, AGC Biologics Seattle has also expanded to include a new microbial-based manufacturing line system and a state-of-the-art 67,000 sq. ft. GMP-compliant warehouse to further enhance the quality, efficiency and operational excellence of the site. To learn more about AGC Biologics’ protein biologics manufacturing site in Seattle, visit www.agcbio.com/facilities/seattle. For more information on the company’s end-to-end global CDMO services in the U.S., Europe and Japan visit 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 AGC Biologics Nick McDonald +1 425-419-3555 nmcdonald@agcbio.com Company Website https://www.agcbio.com/

October 17, 2024 05:57 AM Eastern Daylight Time

Symphion® Technology to Help Gynecologists Mitigate Nationwide Saline Shortage

Minerva Surgical, Inc.

As the nationwide saline shortage impacts healthcare facilities across the country and the number of elective procedures is being reduced or halted, The Symphion technology from Minerva Surgical offers a solution to help gynecologists mitigate the rationing of saline for operative hysteroscopy procedures. A key feature of the Symphion Operative Hysteroscopy System is the fluid recirculation system. Unlike many uterine tissue removal products that use multiple bags of saline for operative hysteroscopy procedures, Symphion is designed to use one bag of saline during the uterine polyp or uterine fibroid removal. Symphion is the only operative hysteroscopy system with the capability to filter and recirculate saline for continuous use during each procedure. In addition to conserving saline with the fluid recirculation feature, Symphion may improve procedural efficiency by eliminating a workflow disruption or stoppage to replace a depleted bag of saline. This is a common occurrence with open-loop, weight-based fluid management systems. Other features of the Symphion Operative Hysteroscopy System include. • Volumetrically limit patient exposure to saline fluid absorption below the maximum AAGL guidelines of 2500mL • One bipolar RF tissue resecting device to remove uterine polyps and fibroids • Control persistent bleeding with optional coagulation function, which ACOG recognized as an advantage for a tissue removal device • Maintain visibility with independent on-demand aspiration to flush the uterine cavity • Optional digital fluid deficit readout device Darin Hammers, Minerva Surgical Chief Executive Officer said, “Symphion was engineered to address the needs of operative hysteroscopy. We are proud to support our physician and health system partners with a solution to help navigate this critical saline supply shortage and help them continue to provide relief to patients that suffer from Abnormal Uterine Bleeding (AUB).” About Minerva Surgical: Minerva Surgical is a Women’s Health company committed to improving women’s health and quality of life by providing access to minimally invasive, technologically advanced, and innovative solutions for early detection, treatment, and management of uterine conditions. Contact Details Kevin Tracey +1 855-646-7874 info@minervasurgical.com Company Website https://minervasurgical.com/

October 16, 2024 11:00 AM Eastern Daylight Time

RedHill Biopharma Secures U.S. Government Funding Through BARDA To Advance Opaganib For Ebola Treatment

Benzinga

By Meg Flippin, Benzinga A decade after a deadly ebola outbreak that left more than 11,000 people dead and only six years after another outbreak killed over 2,000, more needs to be done to find an effective treatment for this infectious disease. That’s what RedHill Biopharma Ltd. (NASDAQ: RDHL), a specialty biopharmaceutical company, is seeking to do with its novel, potentially broad-acting, host-directed therapy, opaganib, a first-in-class new chemical entity with anti-inflammatory, anti-cancer and antiviral activity. The U.S. government’s Biomedical Advanced Research and Development Authority (BARDA), a center of the Department of Health and Human Services’ (HHS) Administration for Strategic Preparedness and Response (ASPR), just selected opaganib for further development to treat exposure to Ebola virus disease (EBOV). To date, RedHill Biopharma said opaganib has made positive progress on the expected Animal Rule pathway towards potential approval as a treatment for EBOV. The Animal Rule allows for the use of pivotal animal model efficacy studies to support the U.S. Food and Drug Administration’s (FDA) approval of new drugs when human clinical trials are not ethical or feasible. New Treatments Needed Ebola is a rare and often deadly virus caused by infection by one of a group of four viruses known as ebolaviruses. Transmission of the disease is mostly through contact with an infected animal (bat or nonhuman primate) or a sick or dead person infected with an ebolavirus. Currently, only Inmazeb, a combination of three monoclonal antibodies and Ebanga, a single monoclonal antibody, are FDA-approved to treat EBOV. Both are intravenously administered. According to RedHill Biopharma, there is an urgent need for host-directed small molecule therapies that may be effective against multiple strains of ebolavirus, are less likely to be impacted by viral mutation and are easy to store, distribute and administer, especially in areas where healthcare services and infrastructures may be sub-optimal. With ebola cases predicted to grow in the years to come, driven by a lack of effective treatment, so is the market size for vaccines and treatments. According to one forecast, the ebola drug and vaccine market is poised to reach $223.7 million by 2027, growing at a CAGR of 12.8% from 2022 to 2027. Opaganib, which is orally administered, is thought to work through the inhibition of multiple pathways, the induction of autophagy and apoptosis and the disruption of viral replication, through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SPHK2, DES1 and GCS). BARDA To Provide Funding Under the cost-sharing agreement with BARDA, BARDA will provide funding to further advance opaganib to mitigate infections and contain EBOV outbreaks. In an in vivo EBOV study with the United States Army Medical Research Institute of Infectious Diseases, RedHill Biopharma said opaganib delivered a statistically significant increase in survival time when given at 150 mg/kg twice a day. RedHill Biopharma said it’s the first host-directed molecule to show activity in EBOV. What’s more, RedHill said opaganib also recently demonstrated a distinct synergistic effect when combined individually with the COVID-19 antiviral treatment remdesivir, significantly improving potency while maintaining cell viability. “EBOV is deadly, killing, on average, half of all those who contract it. This year marks ten years since the West Africa Ebola epidemic in which 11,000 people died, and yet there are still no host-directed, small molecule therapies approved to provide effective and usable treatment strategies,” said Guy Goldberg, RedHill’s Chief Business Officer. “There are also enormous geopolitical and logistical challenges to overcome in managing outbreaks such as EBOV, and others like Mpox, and so new host-directed, small-molecule therapeutic options for biodefense and global health preparedness could prove to be major life-saving advances – this is especially true if they are capable of viral mutation-resistance, have extended shelf-lives for long-term storage, are relatively straightforward to transport to hard-to-reach territories and are easy to administer without the need for cold-storage or injections.” Fighting More Than EBOV In addition to EBOV, RedHill said opaganib has demonstrated antiviral activity against SARS-CoV-2, multiple variants and several other viruses, including Influenza A. Opaganib is currently also in development for multiple oncology, viral, inflammatory and diabetes and obesity-related indications, including COVID-19, acute respiratory distress syndrome (ARDS) and radiological and chemical protection or mitigation. RedHill Biopharma’s novel drug has also been selected for evaluation by other NIH-funded U.S. government countermeasure programs including the Radiation and Nuclear Countermeasures Program (RNCP) for development as a potential treatment for Acute Radiation Syndrome (ARS) and by the BARDA Chemical Medical Countermeasures (Chem MCM) Program and the NIH/NIAID Chemical Countermeasures Research Program (CCRP), in addition to several other U.S. government and non-government collaborations. Ebola is a fast-spreading and often deadly disease that needs better solutions. RedHill Biopharma and BARDA are betting on opaganib to potentially provide another easier-to-mobilize option to fight outbreaks. To learn more about RedHill Biopharma’s novel drug, click here. Featured photo by CDC 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

October 15, 2024 09:00 AM Eastern Daylight Time

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News Release

Kairos Pharma (NYSEAmerican: KAPA): Advancing New Strategies to Overcome Cancer Treatment Challenges

KAPA

The global oncology landscape is on the brink of transformation, with cancer cases expected to rise sharply, particularly in lower-income countries, where the number of new cases could soar to 32 million annually by 2050. This growing demand for cancer treatments has driven global spending on oncology medicines to $223 billion in 2023, with a projected increase to $409 billion by 2028. The launch of 25 novel oncology drugs in 2023, along with over 2,000 new clinical trials, highlights a dynamic period of innovation in the sector. Breakthrough therapies, including cell and gene therapies, antibody-drug conjugates, and radioligand treatments, show significant promise but remain unevenly accessible. As oncology treatments continue to evolve at a rapid pace, this environment presents a unique window of opportunity for investors to explore emerging biopharma companies, which are positioned to lead the charge in addressing unmet medical needs in cancer care. Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company based in Los Angeles, is steadily building a presence in the oncology space. Focusing on therapies aimed at overcoming cancer drug resistance and immune suppression, Kairos has developed a promising pipeline that could attract attention. Among its most notable candidates is ENV105, a therapy designed to target the mechanisms that allow tumors to evade treatment. With ongoing clinical trials and a recent IPO, Kairos Pharma (KAPA) shows potential as an emerging player in biotechnology, particularly as it continues to develop personalized cancer treatments. Exploring New Avenues in Cancer Treatment with ENV105 At the forefront of Kairos Pharma's mission is ENV105, a groundbreaking therapy aimed at reversing drug resistance in cancer patients. This drug distinguishes itself from traditional treatments by targeting the mechanisms that allow tumors to evade existing therapies. Mechanism of Action: ENV105 works by inhibiting the CD105 protein, which plays a critical role in the Bone Morphogenetic Protein (BMP) pathway. Unlike many cancer treatments that focus on blocking Tumor Necrosis Factor (TNF), ENV105 addresses the BMP pathway, which can contribute to increased tumor resistance. By disrupting this pathway, ENV105 enhances the effectiveness of existing cancer treatments. Biomarker Advantage: A significant aspect of ENV105 is its associated biomarker, which can predict patient responses before treatment begins. This capability allows for a more personalized approach, ensuring that patients who are most likely to benefit from the therapy are identified upfront, potentially increasing treatment success rates. Clinical Trial Successes The results from recent clinical trials are promising. In studies involving ENV105, 62% of patients experienced disease stabilization or regression after just two months of treatment—a remarkable outcome compared to the typical response rates seen in similar populations. Additionally, ENV105 has shown efficacy in enhancing the effects of existing therapies for both prostate and lung cancers, two of the most prevalent cancer types. Recent Developments and Partnerships Kairos Pharma is making significant strides in its clinical trials. The company recently dosed its first patients in a Phase 1 trial combining ENV105 with osimertinib for non-small cell lung cancer. This trial aims to evaluate the safety and tolerability of the combination, while a concurrent Phase 2 trial tests ENV105 alongside apalutamide for treating castrate-resistant prostate cancer. John Yu, CEO of Kairos Pharma, emphasizes the company’s commitment to addressing urgent medical needs: “The initiation of these trials speaks to the dedication of the Kairos team to develop therapies for today’s unmet medical needs.” Further enhancing its prospects, Kairos Pharma has partnered with PreCheck Health Services to develop companion biomarkers that will identify which patients are most likely to benefit from ENV105. This collaboration aims to incorporate advanced molecular diagnostics into clinical practice, allowing for better patient selection and monitoring. On September 16, 2024, Kairos Pharma made its debut on the NYSE American under the ticker symbol “KAPA,” successfully raising $6.2 million through its initial public offering. The proceeds will be vital for funding ongoing clinical trials and advancing its diverse pipeline, which includes ENV105 and other innovative candidates like KROS 101. Conclusion With its focus on reversing cancer drug resistance and improving immune response, KAPA is poised to make an impact in oncology. As Kairos Pharma continues to advance its trials and develop personalized cancer therapies, it stands on the brink of potentially revolutionizing cancer treatment. For those looking to invest in a company with a bright future in biotechnology, Kairos Pharma is one for the watchlist. Disclaimers: RazorPitch Inc. "RazorPitch" is not operated by a licensed broker, a dealer, or a registered investment adviser. This content is for informational purposes only and is not intended to be investment advice. The Private Securities Litigation Reform Act of 1995 provides investors a safe harbor in regard to forward-looking statements. 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October 14, 2024 06:00 AM Eastern Daylight Time

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