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Communication Service for the Deaf, Inc. Receives $250,000 Engagement Award from PCORI

Communication Service for the Deaf

Communication Service for the Deaf, Inc. (CSD) has been awarded $250,000 through the Eugene Washington PCORI Engagement Award Program, an initiative of the Patient-Centered Outcomes Research Institute (PCORI). The funding will support a two-year project titled "Building Capacity for Deaf American Sign Language Users in Virtual Healthcare PCOR/CER," running from November 1, 2024 through October 31, 2026. The COVID-19 pandemic has significantly accelerated the adoption of telemedicine in healthcare yet little is known about best practices for the Deaf community. Deaf individuals who use American Sign Language (ASL) face communication and health literacy challenges, making virtual healthcare services potentially inaccessible and inequitable. CSD’s health and patient advocacy division, DeafHealth, will recruit a diverse group of stakeholders to form a national Deaf Patient Coalition. This coalition will identify and capture diverse Deaf patient experiences with virtual healthcare platforms to help shape future patient-centered outcomes research (PCOR) and comparative clinical effectiveness research (CER) focused on healthcare virtual platforms for the Deaf community. By collaborating with academic institutions, researchers, and patient communities, this groundbreaking project aims to advance equitable care and decision-making among Deaf patients that aligns with patient-centric outcomes and preferences. The project will be directed by project lead Allysa Dittmar, MHS, Vice President of DeafHealth. Rochester Institute of Technology (RIT), under the leadership of Dr. Tiffany Panko, executive director of the Deaf Health Care & Biomedical Science Hub and director of the Deaf Health Laboratory at RIT’s National Technical Institute for the Deaf will support the project. “Deaf people comprise approximately 13% or 30 million of the American population, yet they are often overlooked in research. We are grateful to PCORI for this opportunity to promote equitable participation and engagement for both Deaf patients and researchers alike," said Dittmar. "The lack of opportunities for our community has hindered the ability to identify effective interventions to improve the health and wellbeing of Deaf people who use ASL. As healthcare increasingly shifts to virtual platforms for care and treatment, it is crucial to include the Deaf population, researchers, and stakeholders to ensure that future PCOR/CER research is patient-centered and equitable.” By incorporating diverse lived Deaf patient experiences, this project empowers this historically marginalized community with the resources and PCOR/CER knowledge necessary to drive community-centered change for improved health outcomes, aligning with PCORI’s mission to empower patients and others. In the long term, the project provides an opportunity to propose future PCOR/CER studies that align with the community’s identified priorities regarding virtual healthcare platforms for the Deaf community. PCORI is an independent, nonprofit organization authorized by Congress with a mission to fund patient-centered comparative clinical effectiveness research that provides patients, their caregivers, and clinicians with the evidence-based information they need to make better informed health and healthcare decisions. For more information on the PCORI Engagement Award and CSD's funded project, visit here. Projects approved for funding by PCORI’s Engagement Award Program were selected through a rigorous and highly competitive review process, assessing their ability to meet PCORI's engagement goals and objectives, as well as program criteria. About Communication Service for the Deaf, Inc. Communication Service for the Deaf (CSD) is the largest Deaf-led social impact organization in the world. For more than four decades, CSD has been a leader in creating and providing accessible and innovative solutions for the Deaf community. Through CSD's patient and health advocacy division, DeafHealth focuses on improving health outcomes for deaf and hard-of-hearing patients through state-wide initiatives by providing culturally and linguistically accessible health information, resources, and services. For more information, please visit CSD and follow CSD on Facebook, Twitter, Instagram, and LinkedIn. About Rochester Institute of Technology’s National Technical Institute for the Deaf Established by the U.S. Congress in 1965, the National Technical Institute for the Deaf is the first and largest technological college in the world for deaf and hard-of-hearing students. NTID offers associate degree programs for deaf and hard-of-hearing students and provides support and access services for deaf and hard-of-hearing students who study in the other eight colleges of Rochester Institute of Technology. NTID also offers certificate programs in educational, deaf, healthcare, trilingual, and signed language translation interpretation, as well as bachelor’s degree programs in sign language interpreting and community development and leadership, and master’s degrees in secondary education and healthcare interpretation. Deaf and hard-of-hearing students come from all over the United States and around the world to take advantage of the opportunities available to them at RIT/NTID. Visit RIT/NTID and follow on Facebook, Twitter, Instagram, and LinkedIn. Contact Details Allysa Dittmar adittmar@csd.org Company Website https://www.csd.org/

August 15, 2024 08:00 AM Eastern Daylight Time

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Morning Brief: Actelis Networks (ASNS) Achieves Positive EBITDA and Major Revenue Growth Q2 2024

Global Markets News Network

Actelis Networks (NASDAQ: ASNS) recently announced its Q2 2024 results, marking a significant achievement with a positive EBITDA, a first for the company since 2022. This milestone, coupled with robust revenue growth and a reduction in operating expenses, reflects Actelis’ strong execution and strategic focus on growth within the IoT and cybersecurity sectors. The company reported a remarkable 372% sequential revenue growth from Q1 2024, bringing in $3.43 million in Q2 2024. This represents an 81% year-over-year increase, highlighting the growing demand for Actelis’ innovative solutions. The company’s gross margin saw a significant improvement, soaring to 57% in Q2 2024, up from 30% in the prior quarter. This increase in profitability was driven by strong revenue growth and effective cost management. Actelis has also successfully reduced operating expenses by 20% in Q2 2024 compared to the previous year, highlighting the effectiveness of its ongoing cost reduction initiatives. The company reported a net loss of just $78,000 in Q2 2024, a substantial improvement from the $1.59 million net loss in Q2 2023. Additionally, Actelis achieved positive Non-GAAP adjusted EBITDA of $11,000 in the quarter, marking its first positive quarter since 2022. The company's strong financial performance is complemented by its recent business achievements. Actelis has secured and delivered a $2.3 million order from Washington D.C.’s Department of Transportation, further establishing its position in the intelligent transportation space. The company has also successfully deployed its hybrid-fiber, cyber-hardened solution in Bakersfield, CA, demonstrating its technology's ability to enhance urban infrastructure and security. Moreover, Actelis' newly launched GigaLine 800 and GigaLine 900 Multi-Dwelling Unit (MDU) solutions are generating significant market interest, with a growing list of customer trials underway. A first order for the GigaLine 800 worth $160,000 from a contractor to a major military carrier was received, marking a major milestone in executing on the new products’ potential. In addition to these business wins, Actelis has strengthened its liquidity position by raising nearly $5 million in June 2024. As of June 30, 2024, shareholders’ equity stood at $1.06 million, and on a pro forma basis, including this fundraise, shareholders' equity was $3.0 million—above Nasdaq's continued listing requirement of $2.5 million. “We are extremely proud of our progress in the second quarter of 2024,” said Tuvia Barlev, Chairman and CEO of Actelis. “Our team's relentless efforts have translated into significant customer successes and the successful execution for key customers. We are delivering on the commitments we made to drive growth and innovation, and the results speak to the impact of our strategic initiatives.” As Actelis continues to build on this momentum, the company remains focused on scaling these successes, expanding its SaaS offerings through strategic partnerships, and continuing to reduce operational costs while maintaining high margins. The significant order from Washington D.C.’s Department of Transportation and the successful deployments in cities like Bakersfield demonstrate not only the strength of Actelis' technology but also the trust that major urban centers place in the company to modernize and secure their infrastructure. Looking ahead, Actelis could be well-positioned to capitalize on the expanding IoT market, particularly in sectors like intelligent transportation and critical infrastructure. With its strong financial performance, recent business achievements, and ongoing strategic initiatives, Actelis eyes significant growth potential. ### This article is for informational purposes only and is not intended to serve as financial, investment or any form of professional advice, reccomendation or endorsement. Please review the full documentation detailing financial compensation disclosures and disclaimers the article is subject to. https://justpaste.it/ecto7/pdf. Global Markets News Network is a compensated to publish and syndicate commentary and exploration into innovative companies and industries and it is subject to conflicts of interest. Contact Details Global Markets News Network Covearge Desk robert@futuremarketsresearch.org Company Website https://www.futuremarketsresearch.com/global-markets-news

August 15, 2024 04:11 AM Eastern Daylight Time

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Nuestro Studios’ Dark Fantasy ‘El Clavito’ Goes into Production Starring Ruben Rabasa, Vivian Lamolli, and Alexander Arias

Brilla Media

Nuestro Studios, a division of Nuestro Stories, announced today that Ruben Rabasa (“I Think You Should Leave with Tim Robinson”), Vivian Lamolli (“Say a Little Prayer”), and comedy influencer Alexander Arias ( Mr. Red ) will star in their dark fantasy short, “El Clavito”. The bilingual film, the first in a slate of three planned films by Nuestro Studios, begins production in Miami this month and is being co-produced in partnership with CSP Media Group. “El Clavito” is the haunting story of a young couple who in the midst of a major home buying crisis are able to purchase a house from a mysterious elderly man for just $1 – and a strange condition that just might haunt them. “This story is an adaptation of a powerful sermon I first heard 30 years ago from my late pastor so I’m extremely honored this great cast and crew are joining me to produce a truly special, awesome story,” said Manuel Ruiz-Barrera, who will direct the film, and wrote the adapted screenplay. The film is being produced with a talented cast and production team that includes Mexican Americans, Puerto Ricans, Cubans, Colombians, Ecuadorians, and an Afro Latina lead actress. Nuestro Studios collaborated with Chicano Hollywood to find some of the actors who are joining the production. “El Clavito” will be ready for film festival season as of November, and will become the second major production completed by Nuestro Studios this year after the recent launch of this summer’s podcast series hit, “ Bistec ”. About Nuestro Stories Headquartered in Miami, Nuestro Stories is the flagship media brand of Brilla Media Ventures, and was founded with the premise of celebrating Latino heritage, history and origins every day. We provide engaging cultural content for multicultural marketers through our owned and operated platforms, Nuestro Stories, Nuestro Studios, and Brilla Latina. Our offerings also include programmatic advertising technology services for scalable media delivery, influencer marketing, creative studio services, and activations. Nuestro Stories is led by Angela Sustaita-Ruiz and Manuel Ruiz-Barrera, creators of Hispanicize, and trailblazers in the Hispanic media, social and influencer marketing industries, the Latino press release wire industry, and the first network of Hispanic print media companies online. Contact Details Rameh Echeverri +1 305-303-2322 Rameh@brillamedia.com

August 14, 2024 03:32 PM Eastern Daylight Time

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Betterauds Celebrates 3000 Blog Posts with a Milestone Achievement in Entertainment and Inspirational Blogging

Rev Up Marketers

Betterauds.com is a forefront voice in the industry of entertainment and inspirational content. In the latest development, the company has proudly announced a momentous achievement: the publication of its 3000th blog post. Since its inception in 2019, this esteemed platform has become a cornerstone for compelling storytelling, offering readers an inside look into the lives of Celebrities, Musicians, Authors, Entrepreneurs, and other influential figures across the globe. This significant milestone underscores Betterauds.com's dedication to delivering a rich tapestry of content that resonates with diverse audiences. From in-depth profiles of notable personalities to exclusive interviews, the blog has cemented its reputation as a go-to source for captivating and inspiring content. With more than 1000 exclusive interviews, Betterauds.com has provided its audience with unparalleled insights into the personal and professional journeys of people who have made a substantial impact in their fields. Swati Sukhija Khattar, Co-Founder of Betterauds.com, expressed her excitement about the achievement, stating, "Our 3000th blog post is not just a testament to the tireless efforts of our team but also a celebration of the unwavering support from our readers. We are delighted to continue our mission of informing and inspiring our global audience with content that truly resonates." The blog's unique approach shines through in its focus on uplifting stories from individuals of varied backgrounds, including disabled persons, abuse survivors, U.S. veterans, and emerging entrepreneurs. By highlighting these narratives, Betterauds.com has established itself as a beacon of motivation and resilience, showcasing the human spirit in its most powerful form. In addition to its inspirational content, Betterauds.com offers a rich array of features for pop culture enthusiasts. Its extensive collection of articles on Celebrities, including detailed biographies and career highlights, allows fans to connect more deeply with their favorite stars. This personal touch adds a unique dimension to the blog's celebrity coverage, enhancing the reader's engagement with the content. Among its many achievements, Betterauds.com proudly boasts over 1000 interviews, reflecting its commitment to presenting diverse perspectives and valuable insights from around the world. These interviews not only highlight personal success stories but also offer a platform for voices that may otherwise remain unheard. The impact and quality of Betterauds.com's content have been recognized by major news outlets, further affirming the blog's influence in the entertainment and inspirational spheres. As it celebrates this landmark achievement, Betterauds.com remains committed to its mission of producing high-quality, engaging, and informative content. About the Company - Betterauds.com Founded in 2019, Betterauds.com is a premier entertainment blog dedicated to sharing the stories of Celebrities, Musicians, Authors, Entrepreneurs, YouTubers, and more. The blog focuses on illuminating the successes and inspirational journeys of individuals, making it a leading source for engaging and motivational content. Potential clients can visit the Betterauds.com for the latest updates and to explore the wealth of stories that Betterauds.com has to offer. Contact Details Betterauds Rajiv Khattar editor@betterauds.com Company Website https://betterauds.com/

August 14, 2024 11:29 AM Eastern Daylight Time

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FitFast Develops Intermittent Fasting App Changing the Narratives of Health and Wellness Industry

Rev Up Marketers

FitFast is the pioneering force in health technology. In the recent development, the company has launched its groundbreaking app, designed to transform the world of intermittent fasting (IF). This innovative application harnesses the power of artificial intelligence (AI) to provide users with a highly personalized and adaptive approach to intermittent fasting, addressing the unique challenges and needs of individuals seeking to improve their health and well-being. Conceived by George Anderson, the visionary founder and CEO of FitFast, this advanced app marks a significant milestone in the intersection of technology and health. The development of FitFast reflects Anderson’s personal struggles with intermittent fasting, which highlighted a gap in the market for a tool that could offer more tailored and effective solutions. Intermittent fasting has garnered widespread acclaim over the past decade for its potential benefits, including weight loss, enhanced metabolic health, and increased longevity. However, many individuals encounter difficulties in successfully implementing fasting regimes. Challenges such as choosing the right fasting schedule, maintaining consistency, and monitoring progress often hinder the effectiveness of these plans. Traditional approaches to intermittent fasting frequently adopt a one-size-fits-all model, which fails to consider the diverse physiological and lifestyle factors of each individual. Enter FitFast is an app designed to overcome these limitations through its use of cutting-edge AI technology. The core of FitFast’s innovation lies in its ability to provide personalized fasting plans that adapt to users’ evolving needs. The app’s AI-driven algorithms analyze user data in real-time to offer customized recommendations and adjustments, ensuring that each fasting plan is uniquely suited to the individual’s progress and challenges. The FitFast experience begins with a comprehensive onboarding quiz that gathers crucial information about users’ lifestyles, preferences, and health goals. This initial assessment allows the app to craft a fasting plan that is not only effective but also sustainable over the long term. By addressing the specific needs and circumstances of each user, FitFast ensures a more engaging and achievable path to better health. Central to FitFast’s user experience is its AI-powered "Coach" feature, which offers real-time, personalized guidance through an intuitive conversational interface. This interactive element helps users stay on track with their fasting schedules, make informed decisions, and overcome obstacles. Additionally, FitFast includes a suite of tracking tools that monitor various health metrics such as weight, energy levels, and sleep patterns, providing users with valuable insights into their progress and allowing for timely adjustments. The integration of AI technology in FitFast represents a significant advancement in the wellness app market. The app’s AI system is designed to be both responsive and adaptive, learning from user interactions and continuously refining its recommendations. This dynamic interaction ensures that FitFast remains relevant and effective as users’ needs evolve over time, making intermittent fasting a viable and rewarding option for a broader audience. FitFast’s commitment to excellence is also reflected in its approach to user feedback. Prior to its official launch, the app underwent a closed beta testing phase, where a select group of users provided detailed feedback on their experiences. This beta testing phase was instrumental in refining the app’s features and functionality, ensuring a polished and effective final product. The development team remains dedicated to actively seeking user input, using this feedback to guide future updates and enhancements. Consequently, FitFast represents a new chapter in health and wellness, combining advanced technology with a personalized approach to intermittent fasting. With its innovative features and user-focused design, FitFast is set to redefine how individuals integrate fasting into their lives and achieve their health goals. About the Company - FitFast FitFast was founded by George Anderson, inspired by his own challenges with intermittent fasting and a vision to create a more effective and adaptable solution. The app brings together a team of experts dedicated to leveraging technology to improve health outcomes and simplify the fasting process. FitFast is committed to offering a transformative experience for users, making intermittent fasting a practical and rewarding endeavor. Intending users can visit the following link: https://www.fitfast.com/ for further details. Contact Details Fit Fast George Anderson +1 305-452-6789 press@fitfast.com Company Website https://www.fitfast.com/

August 14, 2024 11:18 AM Eastern Daylight Time

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Notable Live Announces Partnership with NFL and Tennessee Titans Great, Chris “CJ2K” Johnson

Notable Live

Notable Live, a digital platform that facilitates exceptional fan experiences is today announcing that former NFL and Tennessee Titans running back Chris “CJ2K” Johnson has joined its team as a brand ambassador focused on athlete relations and outreach. Johnson joins the Notable Live team to introduce athletes to the platform and encourage current and former athletes to extend the fan experience beyond the playing field through in-person and virtual events, e-commerce offerings, and curated fan experiences. “Over the past year I’ve developed a meaningful relationship with the Notable Live team to connect with my fans, build a community, and help my legacy live on by sharing items from my playing days with my fans,” said Johnson. “I look forward to growing my relationship with Notable Live and sharing with some of my former teammates and colleagues the unique opportunity the platform provides.” “This is an exciting day for Notable Live. From day one, Chris utilized the Notable Live platform to create unique activation opportunities for his fans and quickly became an asset to our company,” said Mike Antonucci, co-founder and CEO of Notable Live. “We are thrilled to expand our relationship with Chris as a former player and now power user of the platform,” said Antonucci. “We look forward to what we can accomplish together and remain focused on bringing new and unique opportunities to the Notable Live community.” Fans can browse and bid on current inventory from Johnson and other NFL legends in the Notable Live on eBay Store ( https://www.ebay.com/str/notablelive ). About Notable Live Notable Live was co-founded in 2018 by fan Mike Antonucci and NFL Hall of Fame player Emmitt Smith to create a unique platform providing fans with unparalleled access to their favorite notables via virtual interactive events, in-person experiences, and curated e-commerce offerings. Notable Live has a mobile app available on the App Store and Google Play that puts fans “in the room” with their favorite notables for memorable virtual experiences. Connect with Notable Live at www.notable.live or on Instagram, Facebook or Twitter. Contact Details Notable Live Shannon Gross +1 318-537-2967 shannon.gross@notable.live Company Website https://www.notable.live/

August 14, 2024 09:00 AM Eastern Daylight Time

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News Direct's Ongoing Marketing Campaign Turns Its Focus to the Benefits of Its Unique In-platform Stakeholder Collaboration Tool

News Direct

Contact Details News Direct Media at News Direct sales@newsdirect.com Company Website http://www.newsdirect.com

August 14, 2024 09:00 AM Eastern Daylight Time

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Panther Minerals Inc. (CSE: PURR) (OTC: GLIOF) Gears Up for Growth in the Uranium Revival

GLIOF

The uranium market is experiencing a remarkable resurgence as global energy strategies shift toward cleaner, more sustainable sources. Projected to reach $11.38 billion by 2030, the uranium sector is set to grow at an annual rate of over 5%, driven by increased reliance on nuclear energy and heightened climate goals. The rise in demand is fueled by major economies expanding their nuclear power capacities to cut carbon emissions and secure energy independence. In North America, this growth is evident as both established and new players in the uranium mining sector seek to meet the increasing global demand. This dynamic environment presents numerous opportunities for companies to explore and develop new uranium resources. As the market evolves, the focus now turns to how emerging companies are positioning themselves to take advantage of this booming industry. A Force in Uranium Exploration Panther Minerals Inc. (CSE: PURR) (OTC: GLIOF) is at the forefront of a revitalized uranium sector, poised to leverage the market’s impressive growth. The company is actively expanding its presence in North America with a focus on high-quality uranium projects, including its key assets: the Boulder Creek and Fireweed prospects. Fireweed Prospect: A Promising Uranium Discovery Panther Minerals has been particularly enthusiastic about its Fireweed Prospect, an exploration target located approximately 28 kilometers northwest of the Boulder Creek deposit. Discovered in 2006 by Triex Minerals Inc., the Fireweed Prospect has shown promising results, including a sample that returned 0.82% U3O8, indicating significant mineralization potential. Recent advancements include the use of advanced satellite imagery and hyperspectral analysis conducted by DIRT Exploration. This technology has provided valuable insights into mineral distribution and highlighted new exploration targets. The application of long-wave infrared (LWIR) and AI in mineral exploration is enhancing the company’s ability to pinpoint high-potential areas and refine their exploration strategies. “We are very positive about the satellite imagery attained from the DIRT Report, which gives us a more visual overview of the prospective Fireweed target on our Boulder Creek project. With ongoing historical compilation of data from the projects previous operators, adding updated materials through new technology will provide us crucial information as we advance future work programs,” stated Rob Birmingham, Chief Executive Officer of Panther Minerals. Boulder Creek Property: Building on Historical Data The Boulder Creek property, located in Alaska’s Seward Peninsula, continues to be a cornerstone of Panther Minerals' strategy. Historical drilling by previous operators has outlined a substantial uranium deposit, though the resource estimate is considered historical and not compliant with current NI 43-101 standards. The company is actively reviewing and analyzing existing data, with plans for comprehensive exploration including diamond drilling and geophysical surveys. Panther Minerals has made significant progress in securing permits for a five-year exploration program at Boulder Creek. The company has filed applications with both State and Federal authorities, including the US Bureau of Land Management (BLM) and the Alaska Department of Natural Resources (DNR). These permits will enable Panther to undertake a broad range of exploration activities and advance its development plans for the property. Strategic Expansion and Financial Position In addition to its current projects, Panther Minerals is expanding its portfolio through strategic acquisitions. The recent non-binding letter of intent to acquire the Huber Heights Uranium Property in Nevada demonstrates the company’s commitment to exploring underexplored regions with significant uranium potential. The property’s known prospects and historical production provide a solid foundation for future exploration. Financially, Panther Minerals has successfully closed a $2 million private placement, positioning itself well to fund exploration activities and advance its projects. The funds from this placement are earmarked for exploration and working capital, reinforcing the company’s ability to execute its growth strategy. Panther Minerals Inc. (CSE: PURR) (OTC: GLIOF) is well-positioned to capitalize on the growing uranium market. With a strong focus on high-potential properties, strategic acquisitions, and advanced exploration technologies, investors may want to take notice of the potential role Panther Minerals can play in the uranium resurgence. 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. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions, or future events or performance are not statements of historical fact may be forward looking statements. Forward looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. Forward looking statements in this action may be identified through use of words such as projects, foresee, expects, will, anticipates, estimates, believes, understands, or that by statements indicating certain actions & quote; may, could, or might occur. Understand there is no guarantee past performance will be indicative of future results. Investing in micro-cap and growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investors investment may be lost or impaired due to the speculative nature of the companies profiled. RazorPitch has been retained and compensated by Awareness Consulting to assist in the production and distribution of this content. RazorPitch is responsible for the production and distribution of this content. It should be expressly understood that under no circumstances does any information published herein represent a recommendation to buy or sell a security. This content is for informational purposes only, you should not construe any such information or other material as legal, tax, investment, financial, or other advice. Nothing contained in this article constitutes a solicitation, recommendation, endorsement, or offer by RazorPitch or any third party service provider to buy or sell any securities or other financial instruments. All content in this article is information of a general nature and does not address the circumstances of any particular individual or entity. Nothing in this article constitutes professional and/or financial advice, nor does any information in the article constitute a comprehensive or complete statement of the matters discussed or the law relating thereto. RazorPitch is not a fiduciary by virtue of any persons use of or access to this content. Contact Details RazorPitch Mark McKelvie +1 585-301-7700 mark@razorpitch.com Company Website http://razorpitch.com

August 14, 2024 08:51 AM Eastern Daylight Time

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Extending Survival: Oncolytics Biotech's Pelareorep Shows Promise In Fighting Metastatic Breast Cancer

Benzinga

By Meg Flippin, Benzinga One in eight women will face a breast cancer diagnosis in the U.S. Of those, one in three will become metastatic. When breast cancer metastases, it often spreads to the bones, lungs or liver. Unfortunately, these tumors eventually become resistant to endocrine-blocking therapies and can reoccur in approximately 50% of patients. Depending on how much and far the cancer spreads, the five-year survival for distant metastatic breast cancer rate is 29%. The metastatic breast cancer treatment market is forecast to grow at a CAGR of 10.4% from 2021 to 2030, reaching $41.74 billion. With no direct cure in sight, keeping the cancer under control and increasing survival rates are the focus areas of biopharmaceutical companies, big and small, including Oncolytics Biotech Inc. (NASDAQ: ONCY). The clinical-stage biopharmaceutical company specializing in immunotherapeutics for oncology and their leading agent pelareorep, has demonstrated promising results in Phase 1 and 2 studies to fight challenging cancers. When pelareorep was added to standard metastatic breast cancer treatment, overall survival rates nearly doubled in a randomized study of patients with HR+/HER2- breast cancer, reports Oncolytics. Pelareorep is an intravenously delivered immunotherapeutic agent that induces anti-cancer immune responses and promotes an inflamed tumor phenotype — turning “cold” tumors “hot.” Pelareorep works by generating, recruiting and training immune cells to recognize and kill cancer while remodeling the tumor microenvironment to enable immune cell access. When added to existing treatment regimens such as chemotherapy, pelareorep demonstrates the potential to extend survival times in addition to expanding existing and new T cell clones in the blood, the company reports. Proving Its Mettle In Oncolytics’ randomized Phase 2 trials, known as BRACELET-1, pelareorep demonstrated meaningful improvements in overall response rate and progression-free survival. Overall survival from this trial continues to mature. A previous randomized phase 2 trial also showed positive results, including a statistically significant near doubling of median overall survival observed. Data from BRACELET-1 and AWARE-1 studies consistently show that pelareorep produces an expansion of T cell clones and/or an increase in CelTIL scores and peripheral tumor-infiltrating lymphocyte counts, reports the company. The trials also demonstrated a manageable safety profile which is consistent with prior studies. Positive data from BRACELET-1 and IND-213 randomized trials showed meaningful clinical improvements in the pelareorep/paclitaxel combination arms compared to paclitaxel monotherapy, says Oncolytics. Multiple patients in the pelareorep/paclitaxel arm continue to be followed for survival, with overall survival results expected in the second half of the year. “We believe this data will further bolster our compelling data package and underscores the therapeutic potential of pelareorep,” said Wayne Pisano, interim CEO and chair of the board of Oncolytics. “We remain committed to improving the standard of care and addressing the high unmet medical needs of these patients.” Working Hand-In-Hand With The FDA Pelareorep has fast track designation from the Food and Drug Administration, which allows for the expedited review of drugs for serious conditions that need novel treatments. Oncolytics was also recently part of a productive Type C meeting with the FDA to support the planned potential registration-enabling trial for pelareorep in HR+/HER2- metastatic breast cancer (mBC). Oncolytics said the FDA supports progression-free survival as the primary endpoint of the study, with overall survival as a key secondary endpoint. The company’s proposed study will enroll patients for whom hormonal therapy hasn’t worked and who have received no more than one line of antibody-drug conjugate (ADC) therapy. “Aligning with the FDA on key design elements and objectives of our planned registrational trial for pelareorep marks a critical step towards bringing this innovative treatment to patients,” said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. “Our de-risked program builds on compelling data and key learnings from two randomized studies, BRACELET-1 and IND-213, which demonstrated clinically meaningful benefit in patients receiving pelareorep and paclitaxel compared to paclitaxel alone. Additionally, translational data from the AWARE-1 study highlights pelareorep’s immune-mediated mechanism of action in breast cancer patients. We are now well-positioned to deliver on our mission of making pelareorep available to breast cancer patients in need of better treatment options,” he said. Breast cancer is common, and while many cases are treatable, metastatic breast cancer is a different story. At stage 4, the tumors have spread to other parts of the body and recurrence is frequent. Extending the survival rate is the name of the game, and Oncolytics thinks it has a winner with pelareorep. With clinical trials demonstrating pelareorep’s potential under its belt and a big one in the works, Oncolytics may be right. Featured photo by Susan G. Komen 3-Day 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

August 14, 2024 08:45 AM Eastern Daylight Time

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