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AGC Biologics & Chief Executive Officer Patricio Massera Announce Plans for Him to Step Down

AGC Biologics

AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), today announced that its Chief Executive Officer (CEO), Patricio Massera, will be stepping down from his role effective June 30. Patricio Massera joined the company in 2012, as General Manager of the Copenhagen site at CMC Biologics A/S. He later served as Chief Operating Officer of CMC Biologics at its Seattle headquarters. He held the same role after CMC Biologics was acquired by AGC Inc. and formed AGC Biologics. Mr. Massera was appointed CEO in 2019. He also served as an Executive Officer of the AGC Life Science Company, the Life Science Division of AGC Inc. During his tenure as CEO, Mr. Massera spearheaded several initiatives that elevated AGC Biologics' global business and brand. His work and achievements include key milestones such as navigating the COVID-19 pandemic, acquiring Molecular Medicine S.p.A. (“MolMed”) in Milan to create AGC Biologics’ Global Cell and Gene business, and acquiring facilities in Boulder and Longmont, Colorado to establish new large-scale commercial mammalian capacity and cell and gene services in North America. Mr. Massera also directed the company’s long-standing commitment to investing in single-use technology to ensure AGC Biologics could address the evolving needs of pharmaceutical companies using any platform process to develop new drug candidates. “Over the past 12 years, I have had the privilege of experiencing the most vibrant and remarkable professional position of my life. CMC Biologics, and later AGC Biologics, have provided me with countless opportunities. I have met incredible individuals driven by the desire to build a better world, all sharing the common purpose of enabling our partners to cure life-threatening diseases and bring hope to life.” Massera said. “During this journey, we have managed to grow the business multiple times. However, like all great stories, every book has an end. In this case, it is just a chapter that finishes. AGC Biologics has a long and brilliant journey ahead, but it is time for someone else to write the next chapter.” The new CEO search process is underway. In light of this transition, AGC Biologics is pleased to share Tadashi Murano, President of the AGC Life Science Company, will serve as interim CEO. He brings several decades of experience in global leadership roles within AGC Inc. across various business entities. For more information on AGC Biologics, visit www.agcbio.com. About AGC Biologics: AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 Team Members worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is a part of AGC Inc.’s Life Science Company. The Life Science company runs more than 10 global facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit www.agcbio.com. Contact Details Nick McDonald +1 425-419-3555 nmcdonald@agcbio.com Company Website https://www.agcbio.com/

June 12, 2024 12:00 AM Pacific Daylight Time

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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

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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

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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

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Surging Biotech M&A Reaffirms Massive Opportunity In Rare Disease Drug Development

RazorPitch CRDL NVO AZN SNY

Compared to their non-orphan counterparts, orphan drugs have consistently outpaced growth and have become a major part of pharma’s mainstream business. The U.S. FDA's orphan drug designation, established under the Orphan Drug Act of 1983, encourages the development of treatments for rare diseases affecting fewer than 200,000 people in the U.S. by providing incentives to offset the small market size. Last year, sales from orphan drugs soared to $168 billion, accounting for about 17% of the industry’s total and just shy of the entire oncology therapeutic category at $194 billion. This year, these drugs are on track to generate an impressive $185 billion and are projected to hit around $270 billion by 2028. For such a large cohort of drugs to still be growing at a double-digit pace is impressive and shows that continued investment into the unmet need of rare diseases is warranted. That explains why there has been a surge in M&A activity among orphan drug developers over the past couple of years. For instance, when novel cannabidiol-based drug Epidiolex successfully treated rare forms of child onset epilepsy, GW Pharmaceuticals more than doubled its market value. The 120-patient trial showed patients taking Epidiolex achieved a median reduction in monthly convulsive seizures of 39% compared with a reduction on placebo of 13%. GW Pharmaceuticals went on to be acquired by Jazz Pharmaceuticals for $7.2 billion in 2021, representing a premium of approximately 50% over GW's closing stock price at the time. Clearly, there is a significant opportunity in orphan drug development, which is why these four stocks have been generating substantial investor interest. Cardiol Therapeutics (NASDAQ:CRDL) is a Canadian biotech drug developer focused on developing their novel ultrapure cannabidiol formulation, CardiolRx™, for rare inflammatory heart diseases, specifically recurrent pericarditis and acute myocarditis. Pericarditis is characterized as inflammation of the pericardium, layers of tissue that surround the heart, that affects about 165,000 people in the U.S. annually and has no first-line FDA-approved treatment. Among those treated for acute pericarditis, 15% to 30% may experience recurrent pericarditis. Currently, anti-inflammatory drugs such as colchicine are prescribed for pericarditis treatment in cases of chronic or recurrent pericarditis. If the patient with pericarditis disease does not respond to anti-inflammatory medications, corticosteroids such as prednisone are prescribed. More recently, Kiniksa Pharmaceuticals’ ARCALYST® (rilonacept) became the first and only FDA-approved treatment indicated for the treatment of recurrent pericarditis and the reduction in risk of recurrence in adults and children 12 years and older. ARCALYST is a weekly subcutaneous injection, whereas CardiolRx™ is an oral drug taken twice daily which is a major advantage as the idea of weekly injections could not be as appealing to patients. Cardiol Therapeutics’ (NASDAQ:CRDL) pre-clinical models showed that by inhibiting activation of the NLRP3 inflammasome pathway, cannabidiol may help resolve the symptoms of pericarditis. This approach has already demonstrated incredible potential, as the company was granted Orphan Drug Designation (ODD) by the U.S. FDA for the treatment of pericarditis, which includes recurrent pericarditis. Cardiol Therapeutics followed this major achievement with completing enrollment in its Phase 2, open-label MAvERIC-Pilot study investigating the tolerance, safety, and effect of CardiolRx™ in patients with recurrent pericarditis. The primary endpoint of the trial is the change in patient-reported pericarditis pain using an 11-point numeric rating scale (NRS) from baseline to week 8 with topline results expected in early June. Not only that, Cardiol Therapeutics recently presented its concurrent Phase II ARCHER trial design at the annual congress of the Heart Failure Association of the European Society of Cardiology. This demonstrated the high level of interest from the cardiology community in novel approaches to treat acute myocarditis, for which there are currently no therapies approved by European and US regulatory authorities. The ARCHER trial is expected to enroll 100 patients at pre-eminent cardiovascular research centers in the United States, Canada, France, Brazil, and Israel. Patient recruitment has been accelerating due in large part to the growing global awareness of myocarditis, and ARCHER has already exceeded 85% of target enrollment. Cardiol Therapeutics (NASDAQ:CRDL) expects that results from the ARCHER trial will assist in furthering its understanding of the therapeutic potential of CardiolRx™ and will complement the more advanced MAvERIC-Pilot Phase II study in patients with recurrent pericarditis. Just to put the opportunity here in context, Future Market Insights expects that the worldwide pericarditis treatment market is likely to be worth $ 6 billion by 2032. ARCALYST’s sales further reaffirm this considering that the drug’s 2023 net revenue grew 90% year-over-year to $233.1 million. Several analysts have maintained their positive outlook on the company and have high hopes that the June data will further prove CardiolRx™ efficacy in treating recurrent pericarditis. In fact, Joe Gantoss of Chimera Research Group notes, “I won’t be surprised to see the price breaking out the 3-year high at $4.96 if the recurrent-pericarditis data show a clear success and open the path to move to the next stage with Phase-3 trial,” while analysts at H.C Wainwright & Co. issued a $9 price target for the stock. Novo Nordisk (NYSE:NVO) announced that it was buying Phase II-stage heart failure drug developer Cardior Pharmaceuticals (private) for up to $1.11 billion as it moves to strengthen its pipeline of drugs to treat cardiovascular disease and expand into areas outside of its core diabetes and weight-loss markets. The Denmark-based pharmaceutical giant is enjoying blockbuster success for its Wegovy and Ozempic obesity and diabetes treatments, which aren’t only proving highly effective at regulating blood sugar and helping patients lose weight, but are also yielding extra health benefits such as cutting the risk of stroke and heart attacks and slowing the progression of kidney disease. Based on these findings, the company recently unveiled plans to build a portfolio of therapies in areas like cardiovascular diseases and emerging-therapy areas while strengthening its progress in the rare-disease pipeline. CDR132L, Cardior’s lead compound, is designed to halt and reverse detrimental cardiac remodeling following myocardial infarction (MI) as the first-ever ncRNA-based therapy to enter clinical trials in heart disease. It is currently being investigated in the Phase 2 HF-REVERT clinical trial in 280 post-MI patients with cardiac dysfunction at more than 60 locations across Europe. AstraZeneca (NASDAQ:AZN) also announced that it has entered into a definitive agreement to acquire Amolyt Pharma, a clinical-stage biotechnology company focused on developing novel treatments for rare endocrine diseases for $800 million. The deal also features $250 million in milestones tied to a regulatory event. The proposed acquisition will bolster the Alexion, AstraZeneca Rare Disease late-stage pipeline and expand on its bone metabolism franchise with the notable addition of eneboparatide (AZP-3601), a Phase 3 investigational therapeutic peptide with a novel mechanism of action designed to treat hypoparathyroidism. In patients with hypoparathyroidism, a deficiency in parathyroid hormone (PTH) production results in significant dysregulation of calcium and phosphate, which can lead to life-altering symptoms and complications, including chronic kidney disease. It is one of the largest known rare diseases, affecting an estimated 115,000 people in the US and 107,000 people in the EU, approximately 80% of whom are women. Eneboparatide is designed to produce sustained and stable levels of calcium, which falls to low levels in patients with hypoparathyroidism, while preventing kidney disease and restoring bone turnover. Sanofi (NASDAQ:SNY) earlier this year agreed to buy the U.S. biotech Inhibrx Inc. for as much as $2.2 billion, giving the French drugmaker a potential therapy for a genetic disorder that affects the lungs and liver. Inhibrx shareholders will get $30 per share as part of the deal, along with the right to receive $5 in cash if the experimental drug meets a regulatory milestone. “The addition of INBRX-101 as a high potential asset to our rare disease portfolio reinforces our strategy to commit to differentiated and potential best-in-class products,” said Houman Ashrafian, Sanofi’s head of research and development. “With our expertise in rare diseases and growing presence in immune-mediated respiratory conditions, INBRX-101 will complement our approach to deploy R&D efforts in key areas of focus.” 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 Cardiol Therapeutics to assist in the production and distribution of content related to CRDL. 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 Inc Mark McKelvie +1 585-301-7700 mark@razorpitch.com Company Website http://razorpitch.com

June 11, 2024 06:00 AM Eastern Daylight Time

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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

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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

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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

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

Benzinga

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

June 07, 2024 08:45 AM Eastern Daylight Time

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