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Atossa Therapeutics backing Endoxifen in the fight against breast cancer

Atossa Therapeutics Inc

Atossa Therapeutics (NASDAQ:ATOS) President & CEO Dr. Steven Quay joins Thomas Warner from Proactive to speak about the latest developments in his and the clinical-stage biopharma company's fight against breast cancer. Dr. Quay gives an overview of ongoing clinical trials centered around their innovative drug, oral Endoxifen. The drug combines oestrogen receptor degradation, suppression, and PKC beta inhibition to combat breast cancer. The trials are conducted at different stages of breast cancer management. One focus is on breast cancer prevention, specifically targeting high mammographic breast density, a significant risk factor. Dr. Quay emphasises the link between density and cancer risk, noting the potential for changing mammograms' readability and reducing future risk. He goes on to talk about a trial of Endoxifen during what is known as the neoadjuvant window, the period between diagnosis and initial treatment, which is aimed at rapidly reducing tumour activity after diagnosis. These trials, held at Mayo Clinic and UCSF, test the drug's impact on oestrogen-driven cancers, where current treatments often fall short. Additionally, the CEO discussed Atossa's broader motivations, underscoring breast cancer's prevalence and the immense impact it has on individuals and society. He goes on to discuss the company's financial position. with approximately $99.4 million on the balance sheet as of Q2, enabling continued research and development. Dr. Quay also reveals research collaborations at Weill Cornell Medical Centre targeting triple-negative breast cancer, a particularly aggressive form. These efforts seek to transform it into a more treatable type, potentially revolutionising treatment options. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

August 23, 2023 08:00 AM Eastern Daylight Time

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BiVictriX Therapeutics passes "exciting milestone" with US patent for BVX001

BiVictriX Therapeutics PLC

BiVictriX Therapeutics PLC (AIM:BVX, OTC:BVTXF) founder and CEO Tiffany Thorn speaks to Thomas Warner from Proactive after announcing that the UK-based drug discovery and development company has been granted a patent for its primary cancer treatment BVX001 by the United States Patent and Trademark Office (USPTO). Thorn describes the granting of the US patent as an "exciting milestone" for the business and explains that the patent marks a significant achievement for the company as it encompasses broad claims, unlike the typical narrow specifications for antibody therapeutics. She highlights that BiVictriX's approach allows for more extensive intellectual property protection. The company's global focus is evident, with patent prosecution spanning eight jurisdictions, including Japan, a pivotal market. A Notice of Allowance has been received from the Japanese patent office that showcases even broader protection than the US grant. Thorn also discusses a recent £2.1mln fundraise and an intensification of business development efforts, including participation in an upcoming partnering conference. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

August 23, 2023 06:43 AM Eastern Daylight Time

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NAVEX Enhances Communication with AI-Driven Translations

NAVEX Global

NAVEX, the leader in integrated risk and compliance management software, announces the launch of a new NAVEX One platform shared service: dynamic machine translations. This first-to-market addition in the governance, risk and compliance (GRC) space will empower organizations operating across different countries to overcome language barriers, enabling accurate risk and compliance-related communication between employees, third parties and program administrators. NAVEX understands the challenges organizations face in maintaining accurate communication when dealing with sensitive data arising from risk and compliance tasks. Many organizations struggle with language barriers, hindering effective collaboration. With varying language skills among responders, the potential for misunderstandings and misinterpretations can be detrimental to decision-making and compliance efforts – especially in time-sensitive cases. "NAVEX is pioneering the future of machine translations within the GRC space, directly tackling the complexities of multilingual communication," stated A.G. Lambert, chief product officer at NAVEX. "The integration of secure machine translation into NAVEX One makes it simple for GRC professionals to translate disclosures, assessments, and responses, leading to better communication and faster resolution." The introduction of dynamic machine translations addresses these issues and improves communication efficiency. With advanced artificial intelligence technology, this shared service allows end users to translate directly from the NAVEX One user interface. How machine translations work In the past, administrators encountered the repetitive task of manually copying text, relying on external translation tools, and then painstakingly inputting the translations to proceed with their workflow. However, with the introduction of the machine translations shared service built on Amazon Web Services (AWS), administrators are now equipped to address important matters promptly and efficiently, leading to quicker resolution rates. Moreover, administrators can assess third-party entities proficiently, regardless of the languages they speak or the answers they provide. The user-friendly NAVEX One interface makes translating disclosures, evaluations, and responses easy, promoting smooth communication and understanding. "By relying on the broadest and deepest set of cloud services on AWS, including Amazon Translate, NAVEX is able to use machine translations within the governance, risk and compliance space, directly tackling the complexities of multilingual communication,” stated Venky Nagapudi, Senior Product Management Leader, Amazon Translate, AWS. “The work between NAVEX and AWS makes it easy to translate disclosures, assessments, and responses, leading to better communication and faster resolution." Key benefits of NAVEX One machine translations include: Multilingual support: The system supports 75 languages, facilitating seamless communication with stakeholders worldwide. Accurate and reliable: Powered by advanced neural network technology, the feature ensures precise translation of critical information. Streamlined workflow: The translation functionality integrates seamlessly into existing GRC workflows, saving time and effort for administrators and responders. Cost-effective translations: Organizations can deliver faster results and decrease operational costs by reducing the need for external translation services. Data privacy: Advanced technical and physical measures, including encryption at rest and in transit, are used to prevent unauthorized access or sharing of content. Incorporating a dynamic machine translation service highlights NAVEX's continued commitment to fostering innovative solutions throughout the NAVEX One platform. By seamlessly integrating artificial intelligence and machine learning capabilities, NAVEX continues to empower companies to overcome language obstacles, promoting cross-cultural teamwork and elevating the effectiveness of GRC processes. As NAVEX continues to leverage AI and ML, it cements its position as a leader in cutting-edge technology within the GRC space. The NAVEX One GRC – Information System Multilingual Machine Translation marks a bold stride in NAVEX’s innovative journey following the recent launch of the NAVEX Compliance Assistant. NAVEX's unwavering commitment to AI/ML innovation propels the governance, risk, and compliance landscape into a new era. By harnessing the power of AI, NAVEX is reshaping the compliance landscape, streamlining intricate processes, and automating tasks. This first-to-market shared service accelerates and enhances compliance initiatives while fostering clarity across your organization. Navigate the future of compliance with your AI-powered ally, simplifying employee compliance in ways that redefine ease and efficiency. For more information, visit the NAVEX One Platform. And read our blog. NAVEX is trusted by thousands of customers worldwide to help them achieve the business outcomes that matter most. As the global leader in integrated risk and compliance management software and services, we deliver solutions through the NAVEX One platform, the industry’s most comprehensive governance, risk and compliance (GRC) information system. For more information, visit NAVEX.com and our blog. Follow us on Twitter and LinkedIn. Contact Details Scott Levesque +1 617-388-5773 scott.levesque@navex.com Company Website https://www.navex.com

August 22, 2023 08:00 AM Eastern Daylight Time

Navigating the ADC Frontier: Kognitic's Swift Adaptation Empowers Drug Developers in Payload Tracking

Kognitic

Kognitic, a premier entity in advanced AI-driven clinical and commercial intelligence, today launches a comprehensive one-stop solution for dynamically tracking and staying informed about ADCs, ADC payloads, and their MoAs. ADC, a rapidly growing therapeutic field in oncology, holds immense promise. Despite its potential, challenges such as toxicity and resistance persist. To address these issues, improving ADC design becomes crucial. For a comprehensive understanding of ADC targets, payloads, and their MoAs, Kognitic offers a powerful solution. Users can quickly access vital information, aiding in overcoming challenges and advancing ADC research. The ADCs fuse a monoclonal antibody with a cytotoxic payload, offering a potential solution for various cancers, including breast, lung, and lymphomas. The augmented ADC filtering now provide pivotal information about the payload type, target, and mechanism of action, facilitating a precise identification of clinical trials. "This advancement serves as a powerful tool for researchers and drug developers managing oncology clinical trials, assisting them to identify potential candidate ADCs for their pipeline," said Aqil Ahsan, CEO of Kognitic, expressing confidence that this new feature will accelerate the development and commercialization trajectories of ADC trials in the cancer treatment landscape. About Kognitic Headquartered in Somerville, New Jersey, Kognitic stands alone as a leading provider of advanced AI-driven clinical and commercial intelligence. Offering access to a comprehensive database of visualized clinical trial reporting, along with powerful tools for effective management and commercialization of drug pipelines. Kognitic has received awards for being a top resource in biopharma informatics by Life Science Review and Health Care Tech Outlook, as well for its stunning visualizations and is regarded for the freshness of their data. Contact Details Rob Staats VP Marketing +1 973-727-9890 Rob.Staats@kognitic.com

August 21, 2023 02:51 PM Eastern Daylight Time

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News Release

Cybin Inc protects IP with granting of 2nd US Patent for its deuterated analog programs

Cybin Inc.

Cybin Inc CEO Doug Drysdale joined Steve Darling from Proactive to share news the US Patent and Trademark Office has granted another patent to a deuterated psilocybin analog within the company's CYB003 investigational drug program. This patent is expected to provide exclusivity until 2041 and encompasses composition of matter claims for deuterated tryptamines. These claims support various programs within Cybin, including CYB003, a deuterated psilocybin analog, and CYB004, a deuterated dimethyltryptamine. The patent also covers methods of treating major depressive disorder and treatment-resistant depression. Drysdale explained that CYB003 is a proprietary deuterated psilocybin analog developed for the potential treatment of major depressive disorder. The deuterated structure of CYB003 aims to optimize its therapeutic profile, including rapid onset of effect, shorter treatment duration, and efficacy at lower doses. Currently, CYB003 is undergoing Phase 2 clinical trials involving participants with moderate to severe MDD. Additionally, Drysdale mentioned CYB004, an investigational deuterated dimethyltryptamine program targeted for the potential treatment of Generalized Anxiety Disorder. This program is in Phase 1, with dosing underway as part of the CYB004-E clinical trial evaluating intravenous DMT and CYB004 in healthy volunteers. Cybin Inc anticipates releasing topline Phase 2 efficacy data for CYB003 in MDD and Phase 1 data from the CYB004-E study in the third or fourth quarter of 2023. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

August 21, 2023 01:40 PM Eastern Daylight Time

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News Release

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Coya Therapeutics

Coya Therapeutics CEO Dr Howard Berman joined Steve Darling from Proactive to share news regarding the company's recent financial results and developments. Notably, Coya Therapeutics presented positive outcomes from a proof-of-concept clinical study involving low-dose interleukin-2 (ld IL-2) in patients with Amyotrophic Lateral Sclerosis (ALS) during the second quarter. The study revealed several encouraging findings, including enhanced Treg (T-regulatory cell) function during treatment, a halt in disease progression at the 24-week mark, and minimal decline at 48 weeks. Additionally, the treatment appeared to be well-tolerated by the patients. These promising results were presented at the 2023 Muscular Dystrophy Association Conference. Coya Therapeutics also shared the results from an open-label clinical study involving ld IL-2 in patients with mild to moderate Alzheimer's Disease. During the four-month treatment period, the therapy enhanced Treg function and numbers, showed good tolerability, and resulted in a statistically significant improvement in mean MMSE scores compared to baseline. These findings are significant for potential Alzheimer's Disease treatments. Dr Berman expressed the company's belief in the potential of their proof-of-concept clinical data and revealed plans for a pre-IND (Investigational New Drug) meeting with the FDA in the upcoming fall of 2023. The company aims to have its IND application for a phase 2 trial accepted by the FDA in early 2023, with the optimism of commencing the trial soon after acceptance. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

August 21, 2023 01:31 PM Eastern Daylight Time

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News Release

Tonix Pharmaceuticals begins Phase 1 trial of TNX-1500 in healthy participants

Tonix Pharmaceuticals

Tonix Pharmaceuticals CEO Dr Seth Lederman joined Steve Darling from Proactive to announce the company has initiated a Phase 1 clinical study involving TNX-1500 in healthy volunteers, focusing on single ascending dose escalation. The primary objectives of this study are to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous TNX-1500. TNX-1500 is a pharmaceutical product under development for the prevention of kidney transplant rejection, as well as other potential indications related to transplantation and autoimmune disorders. Lederman highlighted that recent animal studies have shown promising results, indicating that TNX-1500 has the potential to prevent organ rejection and maintain graft function, either as a standalone treatment or when combined with other drugs. The Phase 1 study will involve the evaluation of eligible participants over a 120-day period after dosing, with a target enrollment of 36 participants. The initiation of this Phase 1 study is a crucial step towards supporting the dosing regimen for an upcoming Phase 2 trial involving kidney transplant recipients. Tonix Pharmaceuticals is optimistic about TNX-1500's potential to improve long-term graft survival with reduced toxicity compared to current immunosuppressive treatments. Additionally, the company believes that TNX-1500 could address various indications, including autoimmune diseases beyond transplantation. Contact Details Proactive Studio +1 604-688-8158 na-editorial@proactiveinvestors.com

August 21, 2023 01:18 PM Eastern Daylight Time

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Immunic CEO hails "great day" after completing IMU-838 phase 2 trial enrolment

Immunic Inc

Immunic Inc (NASDAQ:IMUX) President and CEO Dr Daniel Vitt speaks to Thomas Warner from Proactive after the biotechnology company announced the completion of the enrolment of its phase 2 CALLIPER trial of lead asset vidofludimus calcium (IMU-838), in patients with progressive multiple sclerosis (PMS). Dr Vitt explains that 467 patients have been enrolled across various sub-indications including primary progressive, secondary active, and non-active secondary progressive MS. He calls it a "great day for the programme." The trial aims to assess the efficacy of IMU-838 and Dr. Vitt highlights the focus on biomarkers, particularly the neurofilament light chain (NFL), a protein indicative of active disease. Anticipated next steps include an interim analysis set for release this fall, which will examine biomarker benefits for different sub-indications. Dr. Vitt also reflects on what he considers a successful 2023 so far, with positive data emerging from Immunic's colitis maintenance and IMU-856 celiac disease programs. Contact Details Proactive United States +1 347-449-0879 action@proactiveinvestors.com

August 21, 2023 08:00 AM Eastern Daylight Time

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Nearly 2 In 5 American Workers Are Now Freelance – Here’s How They’re Keeping Dental Costs Down Even Without Employer-Sponsored Dental Insurance

DentalPlans.com

By Rachael Green, Benzinga In the first year of the pandemic, approximately 2 million Americans switched from traditional employment to freelance or contract jobs bringing the total percentage of the U.S. workforce that freelances from 28% in 2019 to 36% in 2020. By 2022, that percentage had grown to 39% — or 60 million Americans — suggesting that the trend is here to stay even as other parts of the economy return to their pre-pandemic norm. While freelance or contract work brings flexibility and more control over work/life balance to American workers, it also often places the costly burden of paying for insurance entirely out of pocket. The average monthly premium contribution employees pay for employer-sponsored plans is $110 for single coverage. Meanwhile, self-employed workers pay an average of $560 for the same coverage. That’s not even counting dental insurance, which can add another $46 to the monthly insurance bill for a self-employed person – more if they need to provide coverage for a family. Dental Savings Plans Are An Easy, Low-Cost Alternative To Dental Insurance According to survey research by the USDA, self-employed workers were twice as likely as employees to be completely uninsured, with approximately one in five self-employed workers going without health insurance. Approximately 84% of people without health insurance also don’t have dental coverage. Another 50% of self-employed workers were covered by a family member’s employer-sponsored plan or by taking on a second job from an employer who offered health insurance to avoid paying the high premiums for an individual plan. Though a potentially steep financial burden has pushed many freelance and contract workers to the risky decision to skip or scale back insurance coverage, it’s important to know that insurance and no insurance are not your only options. One way to keep those costs under control is with a dental savings plan. Regardless of your insurance status, signing up for a dental savings plan on DentalPlans.com can save you an average of 50%* on your dental care. After signing up, simply show your membership card to any participating dentist, and you’ll be charged the discounted rates included in your plan. Dental savings plans provide savings on virtually all dental procedures, have no annual limits, no restrictions on who can sign up or when and activate in as little as one to three days. Visit DentalPlans.com to find tools that help you choose the best plan for your unique needs. Filter plans by dentist, location and procedures and get a personalized dental plan recommendation right away. DentalPlans.com, founded in 1999, is a leading online marketplace for dental savings plans in the U.S., helping more than a million people to affordably access quality healthcare services. Our mission is to empower consumers with the tools, information, and services that they need to live happier, healthier lives. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. *Discount Health Program consumer & provider surveys indicate average savings of 50%. Savings may vary by provider, location, and plan. Contact Details Matthew Wong matthew.wong@wpromote.com Company Website https://www.dentalplans.com/

August 18, 2023 09:00 AM Eastern Daylight Time

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