Healthcare

Addiction Biotech Cannabis Genetics Healthcare Medical Devices Pharmaceutical Science Veterinary
News Release Digital Asset Direct

News Release

Lava Cake is the top cannabis strain on the market, new poll finds

NuggMD

Lava Cake is the cannabis strain whose effects are most popular with consumers, according to new consumer polling and analysis conducted by NuggMD, the leading telehealth platform for cannabis. The poll asked cannabis users their main goal for using cannabis, desired flavor/aroma, and desired effect. More than 6,500 randomized cannabis users responded. As a representative sample of all U.S. cannabis consumers, the poll’s margin of error is 1.2%. The top preferences respondents cited were: the goal of pain relief (25%), anxiety relief (23%), and stress relief (18%); a flavor profile of fruit (27%), sweetness (19%), and earthiness (18%); and the effects of relaxation (30%) and euphoria (24%). The full poll results are available here. The company then used its database of cannabis strains to identify popular strains that fit those preferences. While strains like Georgia Pie, Cheetah Piss, Mendo Breath, and GMO Cookies rank highly, Lava Cake is the only strain that meets all of those preferences, suggesting it is both the most durable strain on the market and the one that offers the most effects that consumers want. The poll also finds nearly half of all cannabis users hit it whenever they feel like it—the poll asked respondents when they prefer to consume cannabis, with a plurality, 48 percent, saying “anytime.” “Since the onset of the Covid-19 pandemic, Americans have become much more stressed out and anxious than previous generations, and I don’t think it’s a coincidence to see everyday Americans doing whatever they can to manage it all,” said Deb Tharp, head of legal and policy research at NuggMD. “Our polling data suggests that more Americans are using cannabis to mentally and emotionally handle the world around them than to escape from it.” NuggMD.com used first-party data to conduct this poll. It was a questionnaire sent via email to a random list of opt-in respondents, all of whom consume cannabis regularly. The poll was conducted in May 2024. The sample contained no NuggMD customers. 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 1,300,000 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 potential 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

June 11, 2024 03:47 PM Eastern Daylight Time

Busting the Myths Around Weight Loss Medication

YourUpdateTV

Obesity is one of the most common chronic health issues in the U.S. today, and can lead to or exacerbate many other significant physical and mental health challenges, including type 2 diabetes, heart disease and depression. But GLP-1 injections are an impactful new tool that can help people on their weight loss journey. Recently, Dr. Craig Primack, the Senior Vice President of Weight Loss at Hims and Hers, participated in a nationwide satellite media tour to discuss the impact of obesity, common myths surrounding weight loss medications, and personalized options that can help. A video accompanying this announcement is available at: https://youtu.be/NGNz92bi7nY Research shows that even just 5-10% of body weight loss can improve blood pressure, blood sugar, cholesterol, joint pain, sleep apnea, and other weight-related conditions. Weight loss drugs like GLP-1 medication are not only an exciting tool in the weight loss tool belt but can help to address the challenges associated with obesity. GLP-1 injections can support healthy weight loss along with a reduced calorie diet and increased exercise. Some common myths regarding weight loss medications, include: ● Many people assume that weight loss medications are magic. Weight loss drugs can be excellent tools for decreasing hunger and therefore reducing overall calorie intake, but their effects are not instant and should be combined with a healthy lifestyle approach, including a balanced diet and regular exercise. ● People also assume that the injections are painful. The injection is a very small needle that goes just under the skin. It feels like a small pinch, and is quite painless. For the most part, people do great with self-administering GLP-1 injections. ● Lastly, many people think that weight loss drugs come with dangerous side effects. Like all medications, there is a risk of side effects, but there are really only three common side effects associated with GLP-1’s, and they are generally mild: nausea, heartburn, and constipation. The benefits of these drugs far outweigh the risks for many, especially when compared to the health risks associated with being overweight. Hims & Hers’ personalized approach means custom treatment for individual needs to minimize these side effects. Known for its holistic, personalized approach to health and wellness, Hims & Hers is now offering access to GLP-1 injections designed for affordability and effectiveness. These are the four things you should know. ● Hims & Hers’ weight loss program is tailored to an individual’s needs and includes customized medication kits or GLP-1 medication, as determined appropriate by the healthcare provider. ● The science-backed and doctor-developed program is available 100% online for as little as $199 a month. ● Through the app, a licensed healthcare provider will work with you to decide the recommended treatment, plus provide realistic nutritional tips with easy to follow snack and meal ideas. ● Hims & Hers takes the safety of each customer very seriously. The pharmacies the brand works with provide sterile, single-use syringes with each GLP-1 shipment, and products are made with active ingredients from FDA regulated suppliers. And, injection medications are shipped in cold packs for temperature control in transit in the summer weather. For more information, visit hims.com/glp1 or forhers.com/glp1 About Dr. Craig Primack MD, FACP, FAAP, MFOMA Dr. Craig Primack is the Senior Vice President of Weight Loss at Hims & Hers. He completed his undergraduate studies at the University of Illinois and subsequently attended medical school at Loyola University — The Stritch School of Medicine. He completed a combined residency in Internal Medicine and in Pediatrics at Banner University- Phoenix, and Phoenix Children's Hospital. He received post-residency training in Obesity Medicine and is one of about 7,000 physicians in the U.S. certified by the American Board of Obesity Medicine. In 2006, Dr. Primack co-founded Scottdale Weight Loss Center in Scottsdale, Arizona, where he began practicing full-time obesity medicine. Scottsdale Weight Loss Center has grown since then to six obesity medicine clinicians in four locations around the greater Phoenix Metropolitan area.From 2019–2021, he served as president of the Obesity Medicine Association (OMA), a society of over 5,400 clinicians dedicated to clinical obesity medicine. He proudly served on the OMA board from 2010-2024, most recently as ex-officio trustee. Dr. Primack routinely does media interviews regarding weight loss and regularly speaks around the country educating medical professionals about weight loss and obesity care. He is co-author of the book, “Chasing Diets.” Contact Details YourUpdateTV +1 212-736-2727 yourupdatetv@gmail.com

June 11, 2024 11:37 AM Eastern Daylight Time

Video

NOVUS INK Advisors and Solidus Capital Group Team-up to Serve Growing Transatlantic Commercial Interests of Mid-Market Enterprises

NOVUS INK Advisors

NOVUS INK Advisors and Solidus Capital Group signed a services agreement today to provide integrated senior advisory and execution services to small-and mid-market enterprises amid thriving commercial interests between the United States and Europe. The two firms aim to accelerate client services by combining expertise and resources to support growth into new markets, encompassing management counsel, valuation, performance tracking, board advisory, marketing, communication, public and government affairs. The collaboration will enable NOVUS INK Advisors and Solidus Capital Group to meet the unique needs of global small-and mid-market enterprise clients operating across business-to-consumer, business-to-business, and business-to-government segments. The transatlantic economy is proving remarkably robust in the face of global economic and geopolitical disruptions. No two other regions in the world are as deeply integrated as the United States and Europe, according to the 2024 Transatlantic Economy Report from the U.S. Chamber of Commerce, AmCham EU, Johns Hopkins SAIS and the Transatlantic Leadership Network. The report states: "the $8.7 trillion transatlantic economy employs more than 16 million workers in mutually onshored jobs on both sides of the Atlantic. It is the largest and wealthiest market in the world, accounting for half of total global personal consumption and close to one-third of world GDP in purchasing power. Ties are solid in foreign direct investment, portfolio investment, banking claims, trade and affiliate sales in goods and services, digital links, energy, mutual R&D investment, patent cooperation, technology flows, and sales of knowledge-intensive services." The services agreement will be overseen by a committee chaired by Pia De Lima and Daniel Diaz, NOVUS INK Advisors' Managing Partners, and Andreas Dal Santo, Solidus Capital Group's Managing Director. NOVUS INK Advisors is based in Miami. Solidus Capital Group, affiliated with Atlantic Business Labs, is based in New York. NOVUS INK Advisors is a communication, public and government affairs lobbying firm. NOVUS INK Advisors' practice areas include Corporate, Band and Product Reputation, Business Strategy, Crisis and Reputation Risk, Financial Services, Investor Relations, Mergers & Acquisitions, Brand and Product Marketing Communications Strategy, and Public and Government Affairs. NOVUS INK Advisors is a registered lobbying firm. To learn more, visit: www.NovusInk.com. Solidus Capital Group specializes in management consulting, business valuation, and board advisory services for firms expanding into North America, Latin America, and Europe. It is spearheading an ecosystem of companies, consultants, and subject matter experts with experience from different industries and regions to support corporate and institutional clients' global strategies and growth into new markets. To learn more, visit www.solidus-capital.com. CONTACTS: NOVUS INK Advisors: client.services@NovusInk.com Solidus Capital Group: client.services@Solidus-Capital.com Contact Details NOVUS INK Advisors Client Services client.services@NovusInk.com Company Website https://www.novusink.com/about

June 11, 2024 09:30 AM Eastern Daylight Time

NEWPORT NEWS SPINE SURGEON PERFORMS FIRST TWO INTRACEPT® BASIVERTEBRAL NERVE ABLATIONS IN HAMPTON ROADS

Orthopaedic & Spine Center

Mark McFarland, DO, Performs Outpatient Procedure for Vertebrogenic Back Pain NEWPORT NEWS, VIRGINA / ThriveNewsWire / June 10, 2024 / On Thursday, Spine Surgeon Mark W. McFarland, DO, performed the first two Intraosseus Basivertebral Nerve Ablation procedures, using the Intracept® device by Relievant Medsystems, Inc., a subsidiary of Boston Scientific. The outpatient procedures were performed at Mercy Bon Secours Mary Immaculate Hospital in Newport News, Virginia and were a first for this region. The first procedure was performed on a 91year-old man with a history of chronic vertebrogenic back pain, on levels L3-S1. The second procedure was performed on a 53-year-old man who also had a long-standing history of vertebrogenic back pain, on levels L3-5. Both patients did very well during their procedures and were discharged to go home after spending a few hours in recovery. “With the Intracept Procedure, we are embarking on a paradigm shift in the treatment and diagnosis of vertebrogenic pain,” said Dr. McFarland, who practices at Orthopaedic and Spine Center in Newport News, Virginia. “Not only is the procedure proven to be safe and durable, but it also provides patients with the opportunity to get back to living without the burden of chronic low back pain.” Mark W. McFarland, DO, is a spine specialist who provides the most advanced treatments available for spinal deformities, disease and disorders, as well as arthritis. He is also known for his pioneering work as a consultant and innovator in developing new surgical techniques and instruments to improve spine surgery and the resulting outcomes for patients. Orthopaedic & Spine Center offers specialized Orthopaedic and Interventional Pain Management services, including spine care, sports medicine, arthroscopic surgery, total joint replacement, pain management and Workers’ Compensation Injury Management. They serve patients throughout the Hampton Roads area. Their physicians have full staff privileges at Coastal Virginia Surgery Center and Mercy Bon Secours Mary Immaculate Hospital. Orthopaedic & Spine Center is located at 250 Nat Turner Boulevard in Newport News, VA. For an appointment, call (757) 596-1900, and for more information on the practice and its physicians, visit www.osc-ortho.com. Contact Details Orthopaedic & Spine Center Shannon Bednarova – Director of Marketing 757-596-1900 sbednarova@osc-ortho.com Company Website https://www.osc-ortho.com/ Contact Details Orthopaedic & Spine Center Shannon Bednarova – Director of Marketing +1 757-596-1900 sbednarova@osc-ortho.com

June 10, 2024 03:25 PM Eastern Daylight Time

Elicio Therapeutics Unveils Promising Phase 1a Data For ELI-002 7P In mKRAS Tumors

Benzinga

By Kyle Anthony, Benzinga Elicio Therapeutics (NASDAQ: ELTX) has announced that preliminary data from their AMPLIFY-7P Phase 1a Study of ELI-002 7P in patients with mKRAS-driven solid tumors was well tolerated with T cell responses correlating with a reduction in tumor biomarkers at the recommended Phase 2 dose (“RP2D”). Elicio Therapeutics is a clinical-stage biotechnology company focused on developing innovative lymph node-targeted immunotherapies to treat aggressive cancers. Given the firm’s expertise in materials science, immunology and oncology, it plans to forge a new path forward for cancer treatment by utilizing its diverse capabilities to fulfill its mission of amplifying the potential of immunotherapies, empowering patients to fight cancer with full force. The initial findings from its study are encouraging, given that KRAS mutated cancers are difficult to target in part due to the number of diverse mutations and bypass resistance mechanisms. “We are encouraged by the first data from the ongoing AMPLIFY-7P trial, which demonstrate ELI-002 7P has a favorable safety profile and early antitumor effects that correlate with induction of T cells specific for multiple KRAS mutations potentially providing broader coverage for patients, said Craig E. Devoe, M.D., MHCM., chief of the Division of Medical Oncology & Hematology and the R.J. Zuckerberg Cancer Center, and scientific investigator at Northwell Health. Elicio Therapeutics Pipeline Elicio Therapeutics’ lead product candidate, ELI-002, is a structurally novel investigational Amphiphile (AMP) cancer vaccine that targets cancers that are driven by mutations in the mKRAS-gene — a prevalent driver of many human cancers. ELI-002 is comprised of two powerful components that are built with Elicio Therapeutics’ AMP technology, consisting of AMP-modified mutant KRAS peptide antigens and an AMP-modified CpG adjuvant that is available as an off-the-shelf subcutaneous administration. ELI-002 2P (2 peptide formulation) is currently being studied in an ongoing Phase 1 (AMPLIFY-201) trial in patients with high relapse risk mKRAS-driven solid tumors following surgery and chemotherapy. ELI-002 7P (7 peptide formulation) is being studied in a Phase 1/2 (AMPLIFY-7P) trial in patients with mKRAS-driven pancreatic cancer. The ELI-002 7P formulation is designed to provide immune response coverage against seven of the most common KRAS mutations(G12D, G12R, G12V, G12A, G12C, G12S and G13D) present in 25% of all solid tumors, thereby increasing the potential patient population for ELI-002. Compelling Results From The Ongoing AMPLIFY-7P Phase 1a Study The company reports that the efficacy of ELI-002 7P as a treatment solution was successful in several instances, demonstrating the versatility of the drug and its ability to provide a strong T cell response. The preliminary data findings from the ongoing AMPLIFY-7P Phase 1a Study of ELI-002 7P include: ELI-002 7P administered as a monotherapy was well tolerated and able to generate a ~100x mKRAS-specific expanded T cell response relative to baseline levels ELI-002 7P generated an mKRAS-specific T cell response in 100% of patients including responses targeting all mKRAS mutations enrolled (G12D, V, R and G13D) mKRAS-specific T cells were polyfunctional with 66.7% (4/6) of evaluable patients having both CD8+ and CD4+ responses at the 4.9 mg Phase 2 dose level Tumor biomarker reductions were observed in 5/7 (71%) of evaluable patients at the 4.9 mg Phase 2 dose level ELI-002 7P was shown to induce antigen-spreading with increased T cell responses targeting non-immunizing, personalized tumor neoantigens in 6/6 (100%) of evaluable patients at the 4.9 mg Phase 2 dose level In speaking about these findings, Christopher Haqq, MD, PhD, executive vice president, head of Research and Development and chief medical officer at Elicio Therapeutics, stated, “These early immunogenicity and biomarker response data from ELI-002 7P continue to provide encouraging results showing that our lymph node-targeted approach generates a robust and differentiated T cell response that strongly correlates with tumor biomarker reductions.” “Across two trials, ELI-002 has demonstrated an ability to generate a robust T cell response against all mKRAS mutations of enrolled patients as well as T cell responses against non-immunizing personalized tumor neoantigens. ELI-002’s broader KRAS mutation coverage and higher T cell responses with the 7-peptide vaccine at the Phase 2 dose holds promise for the high unmet need of patients with KRAS-mutated tumors,” Haqq said. The AMPLIFY-7P Phase 1a Study data findings of ELI-002 7P were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, held from May 31 to June 4, 2024, in Chicago, IL. The ASCO Annual Meeting is considered the premier international forum for presenting scientific research and state-of-the-art education in clinical oncology. The five-day event attracts 30,000 attendees from around the world. An Immunotherapeutics Company Founded as a spin-out from the Massachusetts Institute of Technology (MIT), Elicio Therapeutics leverages the research of Professor Darrell Irvine, a Howard Hughes Investigator and expert in biomedical engineering and immunology. The company's main innovation, the Amphiphile (AMP) platform, delivers immunotherapeutics directly to the body’s lymph nodes to enhance the immune system's cancer-fighting mechanisms. By delivering cancer immunotherapies to the center of the immune response, Elicio Therapeutics intends to optimize the natural ability of the lymph nodes to educate, activate, and amplify cancer-specific T cells. Elicio Therapeutics' mission is to give patients battling cancer the best possible outcome. The firm’s leadership and scientific advisory board are composed of determined and experienced individuals who are committed to engineering lymph node–targeted immunomodulators, adjuvants, and vaccines for an array of aggressive cancers. The Path Forward Elicio Therapeutics’ recent findings are encouraging news and a tailwind for the firm’s innovation activities. Given the applicability of ELI-002 7P in treating patients with differing cancers, this is a milestone moment for Elicio Therapeutics and an encouraging step forward in the firm’s research and development and eventual commercialization of its treatment offering. As such, the benefit that Elicio Therapeutics provides and the value proposition the firm espouses could continue to grow and have increased industry resonance. 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

June 10, 2024 08:30 AM Eastern Daylight Time

Image

Room to Roam: ‎The Elephant’s Path to Climate Resilience

News Media Group, Inc.

Contact Details Karl Wayne +1 334-440-6397 karl@newsmg.com Company Website https://newsmg.com/

June 10, 2024 07:00 AM Eastern Daylight Time

Video

Loneliness Crisis Being Faced by Older Americans: AmeriCorps Seniors Believes Volunteering Fosters Connections and Conquers Loneliness

YourUpdateTV

A video accompanying this announcement is available at: https://youtu.be/dcH7-VsQaYQ Older adults are especially vulnerable to loneliness and social isolation, which can have a serious effect on health, according to a recent report issued by the U.S. Surgeon General. Chronic loneliness (persistent feelings of isolation and/or a lack of companionship) can adversely affect mental, cognitive, and physical health, general well-being and even longevity. However, there are ways to overcome loneliness and volunteering might be the answer. AmeriCorps Seniors is helping older adults form connections in their community, provide purpose and improve their lives through volunteering. After two years of volunteering with AmeriCorps Seniors, 78% of those who reported more than five symptoms of depression at the beginning of the study said that they felt less depressed two years later. Of those who first described a lack of companionship, 88% said they felt less isolated after two years. AmeriCorps is the federal agency for national service and volunteerism. AmeriCorps Seniors focuses on engaging adults ages 55 and up in service in their local communities. Through three signature programs, RSVP, the Foster Grandparent Program and the Senior Companion Program, AmeriCorps Seniors provides a space for older adults to take charge of this moment in life and use their time in impactful ways. Each year, AmeriCorps Seniors matches more than 140,000 Americans with service opportunities. For example, Shelley Brosnan, a volunteer with AmeriCorps Seniors RSVP through Volunteer Fairfax, Fairfax, Va., said, “Giving back is so very important. I’ve been volunteering for most of my adult life. Volunteering allows me to connect with my community and make it a better place. I also love the social aspects and meeting people who share my interests. We have a chance to help others and form new relationships, which has grown my social circle.” RSVP offers flexible scheduling and a diverse mix of opportunities. The Foster Grandparent Program pairs volunteers with children and youth in mentoring and tutoring relationships. Lastly, the Senior Companion Program provides a helping hand to other older adults and those with disabilities. They also support caregivers through respite services. For more information and to find volunteer opportunities near you, visit AMERICORPS.GOV/YOURMOMENT. Contact Details YourUpdateTV +1 212-736-2727 yourupdatetv@gmail.com

June 07, 2024 12:06 PM Eastern Daylight Time

Video

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

Benzinga

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

June 07, 2024 08:45 AM Eastern Daylight Time

Image

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

Benzinga

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

June 07, 2024 08:15 AM Eastern Daylight Time

Image

1 2 3 4 5 ... 270