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Theriva Biologics Advances Its Product Pipeline To Improve Survival Rates For Many Difficult-To-Treat Cancers

Benzinga

By Anthony Termini, Benzinga According to Cancer Research UK, "Cancer survival has doubled in the last 40 years, but progress hasn’t been equal across all types of the disease." Their research shows that survival rates of some forms of brain tumors and pancreatic cancers have barely improved in that time. One company has made it its mission to change that. Theriva TM Biologics Has A Novel Approach To Address Difficult-To-Treat Cancers Theriva Biologics (AMEX: TOVX) is headquartered in Rockville, Maryland, and its clinical research efforts span the Atlantic. Theriva is a leader in the development of oncolytic virus therapies – treating cancer with viruses that target tumors. The company recently announced positive results from one of its several ongoing clinical trials. Theriva’s oncolytic viruses are designed to address a wide range of difficult-to-treat tumor types. “Solid tumors are complex organ-like structures consisting of cancer cells, vasculature, and tumor matrix,” said Steven A. Shallcross, CEO of Theriva. He added that “this dense extracellular matrix, also known as stroma, hampers the intratumoral accessibility of chemotherapy, making them hard to treat.” And these are the challenges that Theriva seeks to address in a number of clinical trials. How Theriva Focuses Specific Oncolytic Viruses To Treat Various Cancers Theriva says its viruses have the potential to treat a broad range of difficult-to-treat tumor types. Their leading candidate, VCN-01, is a stroma-degrading oncolytic virus. It is intended to break down the tumor’s protective barrier and improve tumor access by co-administered cancer therapies and the patient’s immune system. It may be combined with other types of cancer therapies to treat a number of tumor types. Theriva has reported encouraging results from clinical trials in pancreatic cancer (PDAC), retinoblastoma and head and neck squamous cell carcinomas (HNSCC). Ongoing clinical trials conducted in collaboration with the School of Medicine at the University of Leeds in England and the University of Pennsylvania's Perelman School of Medicine are evaluating VCN-01 in other difficult to treat cancers.. Theriva’s additional next generation oncolytic viruses such as VCN-11, which incorporates the novel Albumin Shield technology, are in preclinical development in collaboration with researchers from at the Institut d’Investigació Biomèdica de Bellvitge ( I DIBELL) and the Catalan Institute of Oncology ( ICO ). These studies are being conducted to determine safe dosage protocols and assess potential toxicity issues. The data from the tests will help inform clinical trial plans and other important aspects of product development programs. In conjunction with Washington University in St. Louis, Theriva is also investigating an approach to prevent acute graft-versus-host disease (aGVHD), a common and serious immune complication in allogeneic hematopoietic cell transplantation (allo-HCT). Allo-HCT, commonly known as bone marrow transplantation, is used to treat hematologic cancers, which begin in blood-forming tissue or immune system cells. Theriva’s oral β-lactamase (SYN-004), is an antibiotic-degrading enzyme being evaluated as a way to prevent aGVHD and other serious side effects caused by extensive use of antibiotics in these high-risk patients.. Addressing Difficult-To-Treat Cancers Represents Significant Commercial Opportunity The various types of solid tumors that Theriva’s oncolytic virus therapies treat represent a global commercial opportunity that could be as large as $532 billion by 2032, according to Precedence Research. Other analysts estimate the global market will be over $885 billion by 2033. Grand View Research estimates the global retinoblastoma treatment market will reach more than $3.3 billion by 2030. In its estimate of the growing market for treating the disease, Grand View attributes growing advancements in medical technology and the rising incidence of retinoblastoma. Theriva Has High Hopes For Its Therapies In a poster presented at the 2024 meeting of the American Society of Clinical Oncology, the principal investigator and country coordinator of Theriva’s main clinical site in Spain, Dr. Rocio Garcia-Carbonero detailed the clinical trial design for the VIRAGE Phase 2b clinical trial of VCN-01 when administered to PDAC patients in combination with standard of care chemotherapy. In a recent interview, Garcia-Carbonero noted that metastatic PDAC has a high fatality rate despite recent treatment advancements. While the field has seen minimal improvement in standard care for decades, she said that she has “high hopes for VCN-01 due to its unique mechanism of action, which differs from traditional chemotherapy. VCN-01 aims to induce a robust immune response against the cancer.” More information about Theriva’s oncolytic virus therapies is available on the company’s website. Featured photo by Prawny from Pixabay. 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 01, 2024 08:35 AM Eastern Daylight Time

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Zynex Inc. CEO Thomas Sandgaard Discusses Significant Company Growth and Future Innovations

Zynex Medical

Zynex Inc CEO Thomas Sandgaard joined Steve Darling from Proactive to announce the company's financial and operational results for the second quarter ending June 30, 2024, in an interview with Proactive. The company achieved a remarkable 20% year-over-year increase in orders, marking the ninth consecutive quarter of record-breaking order numbers. Zynex reported an 11% year-over-year increase in second-quarter revenue, totaling $49.9 million, and a 20% increase in year-to-date cash flow from operations, reaching $3.2 million. Sandgaard emphasized the company's ongoing efforts to secure FDA approvals for next-generation devices and expand its product line in pain management. The pain management division saw a significant 20% improvement in orders compared to the previous year, highlighting strong market demand. Looking ahead, Zynex has provided guidance for the third quarter, with revenue expected to reach at least $50.0 million. Zynex's pain management devices are prescribed for various conditions, from post-surgical recovery to general pain management, by a diverse group of medical professionals, including surgeons, general practitioners, and chiropractors..In terms of innovation, Zynex is developing new monitoring devices, including a pulse oximeter based on laser technology for more accurate blood measurements, which could also detect sepsis. This product, along with others in development, positions Zynex to potentially capture significant market share. The company aims to diversify its product portfolio. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

July 31, 2024 09:42 AM Eastern Daylight Time

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Syra Health Wins Contract Valued At Nearly $6M To Train Indiana Health Workers

Syra Health

By Kyle Anthony, Benzinga Syra Health Corp. (NASDAQ: SYRA), has been awarded a $5.8 million contract to train professionals who deliver healthcare to Indiana residents at home or in a community-based setting under the purview of the Indiana Family and Social Services Administration (FSSA). Headquartered in Carmel, Indiana, Syra Health was founded in 2020 and is focused on improving healthcare through innovative services and technology solutions. At its core, the company is a healthcare technology company powering better health in challenging areas such as behavioral and mental health, digital health, and population health. Syra Health's offerings are centered on prevention, improved access, and affordable care. In securing this new contract, Syra Health says it will deliver curriculum development, competency assessments, a sophisticated learning management system (LMS), a comprehensive training registry, and a dynamic quality improvement plan, all to fulfill FSSA's vision of "ensuring all home and community support professionals serving any population under a home and community-based settings waiver have the same competencies and training." In speaking about being selected for this new contract, Dr. Deepika Vuppalanchi, CEO of Syra Health, stated, “We are proud to have been selected to implement statewide home and community support professionals training as part of this important program administered by FSSA. In recent months, we have seen a surge in demand for our off-the-shelf training services, and we look forward to providing additional health training services across the country.” Syra Health’s curriculum reflects important gold-standard learning models and over 200 years of experience. It has module-specific learning objectives and interactive activities across the foundational, fundamentals, medication administration, and micro-credentials curricula. These areas, aligned with state-defined core competencies, integrate health equity and cultural competency principles aimed at supporting home and community support professionals of all backgrounds. Syra Health’s training registry will track the utilization of the training materials and will be integrated into the LMS. As such, it will be able to provide a snapshot of workforce capacity and competency at any given moment in time. Effective monitoring and reporting will also be a critical aspect of this project. Syra Health says it will be providing regular comprehensive reports to the FSSA and modifying the process to meet any evolving monitoring or reporting needs. Featured photo by Ani Kolleshi on Unsplash. Syra Health is a healthcare technology company addressing some of healthcare's most significant challenges in areas such as behavioral and mental health, digital health, and population health, by providing innovative services and technology solutions. Syra Health’s products and services are centered on prevention, improved access, and affordable care. Syra Health supplies its solutions to payers, providers, life sciences organizations, academic institutions, and government. For more information, please visit www.syrahealth.com. Statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements." These statements include, but are not limited to, statements relating to the expected use of proceeds, the Company’s operations and business strategy and the Company’s expected financial results. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The forward-looking statements contained in this press release are based on management's current expectations and are subject to substantial risks, uncertainty and changes in circumstances. Investors should read the risk factors set forth in our registration statement on Form S-1 and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Christine Drury +1 463-345-8950 Christined@syrahealth.com Company Website https://www.syrahealth.com/

July 31, 2024 08:55 AM Eastern Daylight Time

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Acarix announces shares are now being traded on the OTCQB under the ticker ACIXF

Acarix AB

Acarix CEO Aamir Mahmood joined Steve Darling from Proactive to share news the company has begun trading on the OTCQB Market in the United States, under the ticker symbol ACIXF. This listing complements its existing presence on the Nasdaq First North Growth Market in Stockholm. Mahmood expressed that with the US being Acarix's most important commercial market, this development allows for a broader investor base to participate in the company’s growth journey. Acarix specializes in medical devices aimed at rapid assessment of coronary artery disease (CAD) at the point of care. The company's flagship product, the CADScor System, is CE-approved and FDA DeNovo-cleared, offering a non-invasive solution to help healthcare providers rule out CAD in patients experiencing chest pain, potentially reducing the need for costly and invasive diagnostic procedures. The company recently announced a significant reorder of single-use patches for the CADScor System by a primary care clinic in the New Orleans, Louisiana metropolitan area. These patches are integral to the system's operation in evaluating patients suspected of having coronary artery disease. Additionally, Acarix has received a multi-order for the CADScor System from Saving Grace Concierge, which will use it as a diagnostic aid for symptomatic patients in the Oklahoma City and Tulsa metro areas. Looking ahead, Mahmood outlined the company's focus on top-line growth, reimbursement efforts with CMS and private payers, and initiating clinical trials. He emphasized the device's potential to save significant healthcare costs and drive commercial success in the US market. Contact Details Proactive North America +1 604-688-8158 na-editorial@proactiveinvestors.com

July 30, 2024 10:58 AM Eastern Daylight Time

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LeadStar and LeadingResponse Announce Strategic Partnership to Enhance Lead Generation with In-Person Seminar Programming

AmeriLife

LeadStar, the proprietary, private leads platform created with and exclusively for AmeriLife -affiliated agents, announced today that it has partnered with LeadingResponse to launch LeadStar Seminars Powered by LeadingResponse to strengthen its spectrum of lead options and provide AmeriLife agents with a comprehensive seminars services platform to offer face-to-face educational opportunities for health and life insurance and financial services customers. LeadStar Seminars Powered by LeadingResponse is the newest addition to the LeadStar platform, which now provides a comprehensive set of lead delivery options. LeadingResponse’s dynamic seminar programming will provide agents with a seamless experience from lead acquisition to conversion, with services that include real-time lead delivery, comprehensive campaign management, and expertly crafted seminar content designed to engage and convert. “This partnership is a game-changer for AmeriLife’s Health and Wealth professionals looking to drive growth and enhance live engagement with their target audiences,” said Chief Lead Officer for AmeriLife William DeCourcy. "We recognize that there is no ‘one size fits all’ approach to delivering compliant, high-performance leads to AmeriLife agents. Partnering with LeadingResponse expands the lead options available to AmeriLife agents, allowing health and wealth product sales professionals to scale efficiently and effectively in multiple channels – including the key channel of face-to-face educational seminars.” LeadingResponse, with decades of experience in targeted seminar marketing, brings unparalleled expertise in engaging affluent consumers through in-person seminars, webinars, and multichannel marketing approaches. Their proven conversion strategies in educational workshops and seminar solutions have filled countless events with qualified consumers, perfectly complementing LeadStar's capabilities in lead generation. “We are excited about our partnership with AmeriLife and LeadStar,” said Matthew Kearney, Chief Executive Officer for LeadingResponse. “We look for partners that share in our mission to connect health and wealth experts to consumers exactly when help is needed, and AmeriLife and LeadStar are a perfect fit. By leveraging our expertise, concierge service, and advanced technology, AmeriLife sales professionals can grow their businesses through our highly effective solution suite.” The LeadingResponse platform includes targeted audience reach specifically designed to target affluent consumers aged 50 and above; a robust client portal, Hub, which allows for 24/7 review of ongoing campaigns while integrating with your CRM and marketing automation workflows; and high conversion rates through seminar attendance, with attendee rates over twice the industry average. “LeadStar Seminars Powered by LeadingResponse represent a significant step forward in our ongoing efforts to provide AmeriLife’s distribution partners with the tools and strategies they need to succeed in a competitive marketplace,” added DeCourcy. “We are confident that LeadStar Seminars Powered by LeadingResponse can drive client growth with data-driven insights and marketing solutions that optimize LeadStar’s lead generation suite of services to achieve strong outcomes.” AmeriLife-affiliated licensed health agents and financial professionals interested in leveraging LeadStar Seminars Powered by LeadingResponse are encouraged to inquire with their marketers or uplines about access to these integrated services, promising a boost in both the quantity and quality of leads and conversions. For more information about the partnership and to request access, please visit the LeadStar Seminars Powered by LeadingResponse page on the LeadStar website. ### About LeadStar LeadStar is an industry-leading enterprise leads program that delivers the compliant, reliable, and performative leads that today’s health and life insurance agents need to grow their books of business and maximize their success. Powered by AmeriLife and exclusively for the company’s affiliated agents, LeadStar’s suite of solutions includes LeadStar Marketplace, LeadStar Connect, LeadStar Direct, and LeadStar Seminars Powered by LeadingResponse. For more information, contact an AmeriLife-affiliated marketing company or visit LeadStarHub.com. About LeadingResponse Founded in 1996 with headquarters in Tampa, LeadingResponse is a trusted and proven leader in customer acquisition for health and wealth organizations across the United States. LeadingResponse’s solution suite enables clients to connect with consumers in the medium they want to engage and at the point in the consumer journey clients wish to target. Whether consumers need Preneed, legal defense, financial advice, a senior living community, Estate Planning, or a Medicare procedure, LeadingResponse connects our client experts to provide the needed consultation. With our teams of marketers, designers, and developers, LeadingResponse is the easiest way for organizations to grow their business and increase revenue. For more information, visit the LeadingResponse website. About AmeriLife AmeriLife’s strength is its mission: to provide insurance and retirement solutions to help people live longer, healthier lives. In doing so, AmeriLife has become recognized as the leader in developing, marketing, and distributing life and health insurance, annuities, and retirement planning solutions to enhance the lives of pre-retirees and retirees across the United States. For over 50 years, AmeriLife has partnered with top insurance carriers to provide value and quality to customers through a distribution network of over 300,000 insurance agents and advisors and 120 marketing organizations and insurance agency locations nationwide. For more information, visit AmeriLife.com and follow AmeriLife on Facebook and LinkedIn. Contact Details Jeff Maldonado media@amerilife.com LeadingResponse Pamela Girardin pamela.girardin@leadingresponse.com Partnership Inquiries Patrick Nichols corporatedevelopment@amerilife.com Company Website https://amerilife.com/

July 30, 2024 09:00 AM Eastern Daylight Time

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Citius Pharmaceuticals Nears Market Breakthrough With Two Leading Products

Benzinga

By Meg Flippin, Benzinga From fighting cancer to treating bloodstream infections, Citius Pharmaceuticals Inc. (NASDAQ: CTXR) is busy trying to solve some of the world’s ills. That’s picking up steam with two of its lead products close to commercialization. Take Mino-Lok (MLT), Citius Pharmaceuticals ' novel antibiotic lock solution that combines minocycline, ethanol and edetate disodium to treat patients with catheter-related blood stream infections. Mino-Lok offers hospitals an alternative to removing and replacing a central venous catheter (CVC), and that could reduce the number of serious adverse events like air embolism and bleeding. It could also save hospitals money. Bringing It To The Market Citius Pharmaceuticals CEO and co-founder Leonard Mazur told Benzinga that his company has “extremely positive” topline data from a Phase 3 Trial of Mino-Lok. Now Citius is meeting with the U.S. Food and Drug Administration (FDA) to move ahead with Mino-Lok, he said. Once Mino-Lok is approved, the company says it will be the only FDA-backed product for infected catheters in the market, presenting a big opportunity for the company. “The market potential is about $2 billion,” said Mazur. “Positive announcements will come out of the meeting but I can’t predict that moment.” Then there is LYMPHIR, a recombinant fusion protein designed to treat T-cell lymphomas. The drug agent combines the interleukin-2 (IL-2) receptor binding domain with diphtheria toxin fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. In 2011 and 2013, the FDA granted orphan drug designation to LYMPHIR for the treatment of peripheral T-cell lymphoma (PTCL) and Cutaneous T-cell lymphoma (CTCL). In 2021, Citius acquired an exclusive license with rights to develop and commercialize LYMPHIR in all markets except for Japan and certain other parts of Asia. In March this year, the FDA accepted Citius’s Biologics License Application (BLA) for LYMPHIR with a decision expected on August 13, the FDA's assigned Prescription Drug User Fee Act (PDUFA) action date. If approved, Citius is preparing for LYMPHIR commercialization later this year. “We’re very excited about this launching during the fourth quarter,” said Mazur. “We go from no revenue to revenues.” The executive pegged the market opportunity at $300 to $400 million, telling Benzinga LYMPHIR is an additive and won’t take market share from anyone. Shoring Up Shareholder Value Bringing two drug products to market isn't the only way Citius is enhancing shareholder value. The company is also spinning out its wholly-owned oncology unit to form Citius Oncology, a stand-alone publicly traded entity. It is doing it via a SPAC deal with TenX Keane (NASDAQ: TENK). Citius Pharma is getting 67.5 million shares in Citius Oncology at $10 per share, valuing the stake at $675 million and will retain majority ownership of approximately 90%. This transaction is expected to unlock significant value for Citius shareholders by separating the oncology business, potentially leading to increased access to capital markets and further development of new applications and additional intellectual property, reports Citius. It also underscores Citius’s strategy to purchase assets, develop them and bring them to market and then unlock shareholder value. Citius Oncology will serve as a platform to develop and commercialize novel targeted oncology therapies, with LYMPHIR the first to go to market. The company said the deal is expected to provide Citius Oncology with improved access to the public equity markets and thereby facilitate the commercialization of LYMPHIR and position the company to explore additional value-creating opportunities more fully. “The reason we are doing it is we get a Nasdaq listing by having the SPAC acquire the assets and at the same time it enables us to do something to prevent dilution for shareholders,” said Mazur. The CEO counts himself as one of them; he has invested $22.5 million of his own money in the business. “During the first year on the market we will be profitable. All that benefits Citius shareholders.” Featured photo by Nataliya Smirnova 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

July 30, 2024 08:45 AM Eastern Daylight Time

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Pancreatic Cancer Could Overtake Colorectal Cancer To Become Second Leading Cause Of Cancer Death – Oncolytics Is Working On A Promising Treatment

Benzinga

By Meg Flippin, Benzinga Pancreatic cancer isn’t something that only happens to those who smoke, are overweight, have a family history of the condition, or are older than 55. Increasingly, women and younger adults are getting diagnosed with this deadly form of cancer. It’s alarming, given one study found that in the U.S., the incidence of pancreatic cancer among those under the age of 55 is increasingly more rapidly than in those 55+. While pancreatic cancer is now the third leading cause of cancer deaths, by 2030, it is expected to morph into second place, surpassing colorectal cancer deaths. This year alone, about 66,440 Americans will be diagnosed with pancreatic cancer, a record for this deadly form of cancer. What’s more, about 51,750 Americans are expected to die from the disease this year. Among cancers, pancreatic is a tough one to treat. It’s a highly aggressive form of cancer that attacks the pancreas, an organ needed for digestion. With limited treatment options, the five-year survival rate is just 13%. It doesn’t help that most people are diagnosed with pancreatic cancer in a late stage when it has already spread to other parts of the body. That’s particularly true with pancreatic ductal adenocarcinoma (PDAC), which is a type of pancreatic cancer that’s created from the cells that line the ducts of the pancreas. It's one of the most lethal forms of pancreatic cancer. A person’s health, lifestyle, diet, age and family history all play a role in whether they will get this lethal disease, and changing lifestyles may be a factor in the rise in the condition’s prevalence. Given the difficulty of treating pancreatic cancer and its increasing incidence, much medical research is directed toward earlier detection and better treatments. As a result, the global pancreatic cancer market is projected to reach $7.4 billion by 2032, growing at a CAGR of 13.7% during the forecast period. Your Immune System Fired Up One area of treatment that holds promise is immunotherapies. Administered as a pill, injection, or intravenously, immunotherapies help the body’s immune system attack cancer cells. On its own, the immune system has difficulty finding and attacking cancer cells but with these therapies, it can be an avid hunter. That’s exactly what Oncolytics Biotech Inc. (NASDAQ: ONCY), the clinical-stage biopharmaceutical company specializing in immunotherapeutics for oncology, is betting will happen with pelareorep, its leading agent to fight pancreatic cancer that has demonstrated promising results in phase 1 and 2 studies. It 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. Testing Under Way Pelareorep is being tested in the GOBLET study, a phase 1/2 multiple-indication study in advanced or metastatic gastrointestinal cancers conducted at 17 centers in Germany. The aim of the study, which kicked off in fall 2021, is to investigate the safety of the drug combination and improvements in tumor size. The GOBLET study was recently expanded to include a new cohort to test pelareorep and modified FOLFIRINOX (mFOLFIRINOX) with or without atezolizumab (Tecentriq®) in newly diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC) patients. mFOLFIRINOX is a chemotherapy treatment for pancreatic cancer that combines several drugs. The new cohort, which is testing the objective response rate (ORR) and safety, is supported by the $5 million Pancreatic Cancer Action Network (PanCAN) Therapeutic Accelerator Award. The grant was established to accelerate the development of new treatments for pancreatic cancer patients. Hitting Milestones Oncolytics Biotech recently dosed the first patient in that expanded cohort, marking a major milestone for the company. “We’re excited to begin evaluating another pelareorep combination therapy that could result in a second pancreatic cancer registration program for the company,” said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. “The combination of pelareorep, atezolizumab, gemcitabine and nab-paclitaxel in pancreatic cancer patients more than doubled tumor response rates compared to earlier trials of chemotherapy alone. That combination received Fast Track Designation from the FDA and is expected to be evaluated in an adaptive registration-enabling trial through the Global Coalition for Adaptive Research (GCAR). If the combination of pelareorep and mFOLFIRINOX also demonstrates a promising efficacy signal, we could have two pancreatic cancer treatment regimens on the path to registration.” The trial is being closely watched because of the promise the treatment holds if it proves successful. mFOLFIRINOX is currently considered one of two primary treatment options for many pancreatic cancer patients. If pelareorep is effective, it could broaden the population of metastatic pancreatic cancer patients who could benefit from pelareorep-based therapies, the company reports. “Oncolytics is in a favorable position as we prepare to advance multiple pelareorep programs toward registration track studies and continue to expand pelareorep’s potential as a backbone immunotherapy that can impact various tumor types,” said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. “The ability to improve the lives of cancer patients is something that motivates everyone at Oncolytics, and beginning to treat pancreatic cancer patients in the mFOLFIRINOX cohort of GOBLET is hopefully yet another step towards that goal.” 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

July 30, 2024 08:35 AM Eastern Daylight Time

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MIRA Pharmaceuticals (NASDAQ: MIRA) Reports Promising Pre-Clinical Trial Results For Mental Health Treatment, To Submit Investigational New Drug Application By End Of Year

MIRA Pharmaceuticals, Inc.

By Meg Flippin, Benzinga From cognitive impairments to depression-related illnesses, the current treatments aren’t doing enough. Sure, some may bring relief to the millions of people worldwide affected by neurological and neuropsychiatric disorders, but they come with a lot of side effects and accessibility challenges that can render them less than ideal. That leaves a gap in effective, safe and affordable solutions. MIRA Pharmaceuticals (NASDAQ: MIRA) may have the answer. This preclinical-stage pharmaceutical company is focused on transforming the treatment of mental health disorders through scientific research and technological advancements. It's betting that its two compounds, MIRA-55 and Ketamir-2, will revolutionize mental health care. Take MIRA-55 for starters. The novel compound aims to deliver the therapeutic benefits of THC and CBD without their associated side effects, such as increased appetite, paranoia and cognitive decline. It’s currently under investigation for treating neuropathic pain, anxiety and cognitive enhancements without the impurities of marijuana. In preclinical studies, MIRA-55 has shown the ability to double the memory of mice, in contrast to THC, which is known to impair memory, reports MIRA. MIRA-55 could be particularly beneficial for patients seeking cognitive enhancements and anxiety relief without the downside of impaired memory or other side effects. Meanwhile, Ketamir-2, an oral ketamine analog designed to be taken as a pill, is being investigated for its potential antidepressant effects, particularly for treatment-resistant depression (TRD) and major depressive disorder with suicidal ideation. Unlike traditional ketamine, which requires intravenous administration – posing accessibility and safety challenges – Ketamir-2 aims to simplify and improve the treatment experience. The Science Behind Ketamir-2 Recent preclinical data reveals that Ketamir-2 selectively inhibits the NMDA receptor at the PCP-binding site, avoiding interactions with opioid receptors, dopamine, serotonin transporters, and acetylcholine receptors. This unique selectivity may reduce side effects typically associated with traditional ketamine. Ketamir-2 has a 30- to 50-fold lower affinity to the PCP site compared to ketamine, which itself has about 10-fold lower affinity than PCP (Phencyclidine, Angel Dust). This is significant because ketamine was developed to be similar to PCP but with lower affinity, thereby reducing the risk of psychoactive side effects. In this respect, advocates consider Ketamir-2 a third-generation drug. Moreover, Ketamir-2 is optimized for brain delivery. It is not a substrate for P-glycoprotein (P-gp), a membrane protein that pumps drugs out of cells, including those in the brain. This characteristic could allow Ketamir-2 to have better oral absorption and penetrate the blood-brain barrier more effectively than traditional ketamine, enhancing its therapeutic potential and bioavailability. Ketamir-2's oral bioavailability is predicted to be around 80%, which is significantly higher than traditional ketamine's 30%. Preclinical studies have shown that oral Ketamir-2 is safe at high doses and effective in several antidepressant and anxiolytic models. It does not appear to induce hyper-locomotor activity – a common side effect of traditional ketamine – and has shown no interaction with the mu-opioid receptor. MIRA says this could potentially mean a reduced risk of opioid-related side effects and dependency. Recent studies further highlight Ketamir-2's anti-depressive and anxiolytic effects in a mouse model, with significant improvements in behavioral tests compared to traditional ketamine. A Step Toward Improved Patient Care If MIRA is right about Ketamir-2, it has the potential to significantly positively impact mental health care, potentially helping millions of people through improved access and affordability. Traditional ketamine treatment for depression requires a Risk Evaluation and Mitigation Strategy (REMS) protocol due to its potential for abuse and severe side effects. This involves strict regulations, including the need for intravenous administration under medical supervision, making it less accessible and more costly for patients. In contrast, Ketamir-2, as an oral formulation, aims to provide a more convenient and less intimidating treatment option, with the ease of taking a pill at home potentially leading to better adherence to treatment regimens compared to frequent hospital visits for IV infusions. By reducing the need for medical supervision and hospital visits, Ketamir-2 could enhance patient compliance and decrease overall treatment costs. Furthermore, MIRA reports that the U.S. Drug Enforcement Administration (DEA) has conducted a scientific review of both MIRA-55 and Ketamir-2 and determined that neither compound is classified as a controlled substance – significantly easing their regulatory pathway. Exploring New Frontiers: Orphan Drug Indications MIRA's journey doesn't stop at common mental health disorders. The company is exploring Ketamir-2's potential efficacy in treating chemotherapy-induced depression and cancer-related neuropathic pain. These conditions often have limited treatment options and significant patient populations in need of effective therapies. Moreover, due to its novel chemical profile, MIRA is investigating options for orphan drug indications such as multiple sclerosis-induced depression and Huntington's disease-induced depression. The company believes these rare conditions could benefit from innovative treatments like Ketamir-2. Market Potential And Patient Population The market potential for MIRA Pharmaceuticals' compounds is substantial. Cognitive impairments, including conditions like Alzheimer's disease and dementia, affect millions of individuals. Close to seven million Americans are currently living with Alzheimer's, a number expected to rise to nearly 13 million by 2050, according to the Alzheimer’s Association. Meanwhile, anxiety disorders affect over 40 million adults in the United States, according to the National Alliance on Mental Illness. For depression, particularly treatment-resistant depression, the numbers are equally staggering. Approximately 17.6 million Americans are diagnosed with major depressive disorder, with 5.5 million reporting suicidal ideation and about 2 million having suicidal ideation with intent. The annual burden of medication-treated major depressive disorder in the United States is estimated at $92.7 billion, with $43.8 billion attributable to treatment-resistant depression. Looking Ahead: The Path To Regulatory Approval MIRA Pharmaceuticals reports that it is on track to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) by the end of this year. If granted, this would pave the way for human clinical trials, bringing Ketamir-2 closer to becoming a new standard of care for neurological and neuropsychiatric disorders. The company's commitment to advancing these compounds underscores its mission to address the unmet needs of patients suffering from debilitating conditions like depression, TRD and PTSD. For more information about MIRA Pharmaceuticals and its novel compounds, visit MIRA Pharmaceuticals. Featured photo by Yuris Alhumaydy on Unsplash. MIRA Pharmaceuticals, Inc., is a pre-clinical-stage pharmaceutical development company with two neuroscience programs targeting a broad range of neurologic and neuropsychiatric disorders. We hold exclusive license rights in the U.S., Canada and Mexico for Ketamir-2, a novel, patent pending oral ketamine analog under pre-clinical investigation to potentially deliver ultra-rapid antidepressant effects, providing hope for individuals battling treatment-resistant depression (“TRD”), major depressive disorder with suicidal ideation (MDSI), and potentially post-traumatic stress disorder (“PTSD”). The statements of the Company's management related thereto contains "forward-looking statements," which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any statements that are not historical facts may be deemed forward-looking. These forward-looking statements include, without limitation, statements regarding the anticipated benefits of the study results described herein as well as the timing for the Company's other preclinical studies and the filing of an IND for Ketamir-2 and MIRA-55. Any forward-looking statements are based on the Company's current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties (many of which are beyond the Company's control) that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These and other risks concerning the Company's programs and operations are described in additional detail in Annual Report on Form 10-K for the year ended December 31, 2023 and other SEC filings, which are on file with the SEC at www.sec.gov and the Company's website at https://www.mirapharmaceuticals.com/investors/sec-filings. The Company explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Michelle Yanez Myanez@mirapharma.com Company Website http://www.mirapharmaceuticals.com/

July 29, 2024 11:30 AM Eastern Daylight Time

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AGC Biologics’ Seattle Site Achieves Successful Multi-Product Inspection by U.S. Food and Drug Administration for Biologics License Applications

AGC Biologics

AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), announced today that its Seattle Campus completed a new commercial milestone for regulatory compliance in 2024. The site supported a multi-product inspection in March 2024 with the Food and Drug Administration (FDA) to support Biologics License Applications (BLA) for new products seeking commercial approval in the U.S., two of which are now approved for commercial production at the facility. The two approved products include a fusion protein-based drug for treating bladder cancer and a monoclonal antibody (mAb) for treating macular degeneration. AGC Biologics Seattle predicts delivering multiple batches per year for the biopharma partners that received the approvals and accommodating increases in future demand. “This achievement is significant for this site, our team members and our partners in the pharmaceutical industry seeking to bring products from clinical stages to commercial approval,” notes Michael Tranmer, General Manager of AGC Biologics Seattle. “Inspections for multiple products at one time is not easy. This accomplishment is a true testament to our commitment to quality and regulatory compliance and helping developers reach their goals as fast and efficiently as possible.” This is the latest achievement for the Seattle-based CDMO manufacturing site, which has produced six commercial products for AGC Biologics. This includes three commercial approvals in the last two years. AGC Biologics Seattle is active in helping clients navigate clinical milestones, as well. The site team is working with several clinical-stage companies and predicts more commercial license application submissions in the coming 18 to 24 months. AGC Biologics runs multiple mammalian cGMP manufacturing lines and a variety of scales at its Seattle site. The campus serves as a center of excellence for formulation and employs the latest fed-batch and perfusion manufacturing processes. Over the last year, AGC Biologics Seattle has also expanded. This work includes a new microbial-based manufacturing line system and a state-of-the-art 67,000 sq. ft. GMP-compliant warehouse to further enhance the quality, efficiency and operational excellence of the site. To learn more about AGC Biologics’ protein biologics manufacturing site in Seattle, visit www.agcbio.com/facilities/seattle. For more information on the company’s end-to-end global CDMO services in the U.S., Europe, and Japan visit www.agcbio.com. About AGC Biologics: AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 Team Members worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is a part of AGC Inc.’s Life Science Company. The Life Science company runs more than 10 global facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit www.agcbio.com. Contact Details Nick McDonald +1 425-419-3555 nmcdonald@agcbio.com Company Website https://www.agcbio.com/

July 29, 2024 05:30 AM Pacific Daylight Time

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