Rheumatoid Arthritis

FN Media Group Presents GlobalInvestmentDaily.com Market Commentary LONDON , March 19, 2024 /PRNewswire/ -- The U.S. Federal Drug Administration (FDA) has now designated psilocybin, a classical compound found in "magic mushrooms," as a "breakthrough therapy" for the treatment of major depressive disorder three times. And the world's largest clinical trial ever into the use of psilocybin for treating depression at London hospital in what scientists are hailing as a "milestone" in mental health research. Mentioned in today's commentary includes: Johnson & Johnson (NYSE: JNJ), COMPASS Pathways plc (NASDAQ: CMPS), Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), Atai Life Sciences N.V. (NASDAQ: ATAI), AbbVie Inc. (NYSE: ABBV). This new frontier in treatment has kickstarted a multi-trillion-dollar industry geared at fixing the brain through therapy. Johnson and Johnson has gone all in on its fastest-growing drug for depression, SPRAVATO, which is the only FDA-approved psychedelic medicine on the market. In its Q4 2023 earnings released in January, JNJ reported a 74.1% increase in sales of SPRAVATO worldwide and views the drug as its next billion-plus product. And some of the core team members behind the development of the SPRAVATO have now joined a small, but emerging NYSEAmerican-listed company, CYBIN (CYBN, CYBN.NE). CYBIN has now been granted "Breakthrough Therapy Designation", and is the first adjunctive psychedelic-based therapy for Major Depressive Disorder (MDD) ever to receive this FDA designation. Oppenheimer initiated coverage on CYBN last year, saying it was encouraged by the results so far and believed the stock would have room to run further with new results. It has a price target of $4. H.C.Wainwright & Co. took it further, with a price target of US $10.00 per share, after the recent Small Pharma acquisition. But with impressive Phase 2 results showing remission after only two doses and a coveted FDA designation, this small company is now poised for much greater attention from investors. Phase 2: Behind the Breakthrough Therapy Designation CYBIN is developing differentiated, next-generation therapeutics that hope to offer fast, sustained therapeutic effects that are safe and tolerable, with efficacy in only 1-2 doses and short in-clinic times. The company is on the leading edge of transformational psychedelic therapeutics, developing novel and proprietary therapeutics to improve clinical outcomes and patients' mental health and well-being. The emerging biopharmaceutical company already has clinical validation of the novel, proprietary CYB003 molecule, which demonstrates a rapid-acting and robust psychedelic profile at a low dose. And it's been pounding the patent pavement, too. In August, CYBIN agreed to acquire Small Pharma Inc in an all-share transaction that creates an international clinical-stage leader in novel psychedelic therapeutics. The companies' combined portfolios, at closing, will include two proprietary, advanced clinical programs in development for depression and anxiety disorders with demonstrated safety and efficacy. The combined portfolio creates the industry's largest, most advanced, well protected DMT program. The combined company has the intellectual property strength of 29 patents granted and 158 patents pending in the psychedelic drug development sector. That is the largest portfolio in the industry. Phase 2 topline efficacy data for the company's CYBOO3 was one of the biggest drivers of value for CYBIN in the near-term, and the results were even better than expected. Now that it's been granted "Breakthrough Therapy Designation", CYBIN is targeting the potential for its CYB003 to achieve "Best-in-Class Status", and it's confident it has a solid shot at this. In targeting depression, CYBIN's CYB003 is hoping to offer a lifeline to a chronic illness that victimizes some 280 million people around the world. They are also targeting what is now recognized as the leading cause of disability in the world, which costs the global economy an estimated $1 trillion in lost productivity annually. Nowhere But Up: The Next Near-Term Catalysts CYBIN plans to initiate its Phase 3 study of CYBOO3 in MDD in the middle of this year, with the Phase 2 study of CYB004 in Generalized Anxiety Disorder (GAD) launched on March 15. For the Phase 2 proof-of-concept study of CYB004, CYBIN is using its proprietary DMT molecule, which was developed for the treatment of GAD, following the FDA's clearance of its new drug application in January. "We are building on foundational investigative work from our Phase 2a trial of intravenous SPL026 (DMT) which showed preliminary evidence of effectiveness treating anxiety with rapid onset of antidepressant effects and reduction in anxiety scores," Drysdale said in a press release. "The molecular structure of psilocybin, a naturally occurring psychedelic compound found in 'magic mushrooms,' allows it to penetrate the central nervous system and the scientific and medical experts are just beginning to understand its effects on the brain and mind and its potential as therapeutics for mental illnesses," according to Johns Hopkins Center for Psychedelic and Consciousness Research. This is a space where proprietary IP is absolutely essential, and Cybin now has 29 patents granted and 158 patents pending. CYBIN (CYBN, CYBN.NE) is a clear leader in the biotech race for an alternative to the antidepressant empire, and now it has breakthrough therapy status, and is the first adjunctive therapy known to achieve this for massive depressive disorder. Big Pharma is Racing for a Piece of the Pie Johnson & Johnson (JNJ) is a global leader in healthcare, with a diverse portfolio that spans pharmaceuticals, medical devices, and consumer health products. Within this vast array, Janssen, its pharmaceutical branch, has made significant strides in mental health with esketamine, marketed as Spravato. This nasal spray, a derivative of the anesthetic ketamine, represents a significant breakthrough, gaining FDA approval for use in treatment-resistant depression. The approval of Spravato underscores J&J's commitment to addressing complex mental health challenges. AbbVie (ABBV) emerged as a standalone biopharmaceutical entity following its split from Abbott Laboratories in 2013. Focused on discovering treatments for a wide range of diseases, including rheumatoid arthritis and various cancers, AbbVie's acquisition of Allergan expanded its reach into the burgeoning field of psychedelics for mental health. Allergan, known for its pioneering work in this area, has enriched AbbVie's pipeline with potential psychedelic-based therapies. Atai Life Sciences (ATAI) is at the forefront of transforming mental health care, prioritizing the development of treatments for mental health disorders. Atai's innovative strategy encompasses a wide array of compounds, including psychedelics. The company's collaborative approach, partnering with leading firms to accelerate the development of groundbreaking therapies, exemplifies its commitment to pioneering advancements in mental health treatment. Compass Pathways (CMPS) is pioneering the therapeutic use of psilocybin, focusing its research efforts on addressing treatment-resistant depression. The company's clinical trials and research initiatives are part of a larger mission to establish psilocybin therapy as a validated treatment option, highlighting the potential of psychedelics to offer profound therapeutic benefits. Compass's dedication to rigorous scientific inquiry and ethical research practices positions it as a leader in the psychedelic research community, contributing valuable insights that could reshape mental health care. MindMed (MNMD) tands as an innovator in the neuro-pharmaceutical industry, delving into the therapeutic potential of psychedelics for treating a range of mental health conditions. MindMed's exploratory work with substances such as LSD, MDMA, DMT, and psilocybin is driven by a vision to unlock new treatment pathways for conditions like anxiety, depression, and addiction. Recent advancements in MindMed's research highlight the company's role in pioneering the use of psychedelics as therapeutic agents, underscoring the potential of these substances to revolutionize mental health care. ** IMPORTANT NOTICE AND DISCLAIMER -- PLEASE READ CAREFULLY! ** PAID ADVERTISEMENT. This article is a paid advertisement. GlobalInvestmentDaily.com and its owners, managers, employees, and assigns (collectively "the Publisher") is often paid by one or more of the profiled companies or a third party to disseminate these types of communications. In this case, the Publisher has been compensated by Cybin, Inc. ("Cybin" or "Company") to conduct investor awareness advertising and marketing. Cybin paid the Publisher two hundred and fifty thousand US dollars to produce and disseminate one article profiling the Company over a period of one week. This compensation should be viewed as a major conflict with our ability to be unbiased. 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CEL-4000 may deliver safe and effective therapy for RA by rebalancing the inflammatory response, without weakening important immune defense mechanisms, risking infections or cancer, as current treatments may VIENNA, Va.--(BUSINESS WIRE)-- CEL-SCI Corporation (NYSE American: CVM) today announced the peer reviewed scientific journal Frontiers in Immunology published an article regarding CEL-SCI’s Ligand Epitope Antigen Presentation System (LEAPS) technology in the treatment of rheumatoid arthritis (RA) titled: “Current status of immunological therapies for rheumatoid arthritis with a focus on antigen-specific therapeutic vaccines”. CEL-SCI’s LEAPS team, along with outside collaborators from U.S. and Europe, reviewed published/presented results from pre-clinical animal model of antigen-specific LEAPS therapeutic vaccines, such as CEL-4000 and CEL-5000, made specific for the treatment of RA, and compared these findings with published results of other RA-therapies that either suppress or alter the immune response in order to treat RA. In the article, the authors note that the currently available therapeutic arsenal for the treatment of RA consists mainly of immunosuppressive or ablative drugs, which may carry the potential risk of facilitating recurrent or primary infectious diseases or cancer. They also underscore that a therapeutic vaccine that can rebalance the inflammatory disease process, promoting antigen-specific disease-directed T cell immune responses, is highly desirable. CEL-4000, an antigen specific immunomodulating vaccine, is provided as a new treatment paradigm that should deliver therapy for RA without weakening important immune defense mechanisms against microbial infections or cancer. The authors also emphasized that the most appropriate way to advance the LEAPS vaccines to the clinic would be an adaptive study design for clinical trials, enrollment of patients with early-stage RA, and using the Bayesian optimal design model, currently used in oncology studies, as well as the use of disease-related biomarkers to ascertain responsiveness to treatment and introduce additional tools to assess outcome at the disease level. “At CEL-SCI, we focus on utilizing a healthy immune system to overcome disease safely and with minimal side effects. Our LEAPS platform, and CEL-4000 specifically approaches the treatment of auto immune diseases like rheumatoid arthritis in a completely different way. By rebalancing the immune system to its original healthy state, CEL-4000 could protect patients from the risk of cancer and infection,” stated CEL-SCI CEO, Geert Kersten. “The growing body of preclinical data on LEAPS supports the advancement of this asset into human studies.” About CEL-SCI Corporation CEL-SCI believes that boosting a patient’s immune system while it is still intact should provide the greatest possible impact on survival. Multikine* (Leukocyte Interleukin, Injection) is designed to help the immune system "target" the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor. In a Phase 3 study, CEL-SCI studied patients who were newly diagnosed with locally advanced primary squamous cell carcinoma of the head and neck (oral cavity and soft-palate) with the investigational product Multikine administered first, before they received the standard of care, which involved surgery followed by either radiation or chemoradiation. The Phase 3 study enrolled 928 patients. Our approach is unique because most other cancer immunotherapies are administered only after conventional therapies have been tried and/or failed. After analyzing data from the Phase 3 study, we have better defined the target head and neck cancer population for Multikine, which is advanced primary head and neck cancer patients with no lymph node involvement and with low PD-L1 tumor expression. In the Phase 3 study, we observed statistically significant survival data in the final target population, showing that Multikine cut the risk of death in half at five years vs control. We plan to submit the proposed study protocol to the FDA in Q1 2024, with the goal to get FDA buy-in for a confirmatory clinical trial, and also to discuss potential accelerated approval pathways. Multikine (Leukocyte Interleukin, Injection) received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Such statements include, but are not limited to, statements about the terms, expected proceeds, use of proceeds and closing of the offering. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2023. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. * Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy. This proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use.

Second biotechnology company to potentially out-license novel compounds from Enveric’s portfolio of assets with possible significant milestone payments and royalties CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of depression, anxiety, and addiction disorders, is pleased to announce that it has signed two non-binding term sheets with an undisclosed biotechnology company to pursue the out-licensing of cannabinoid-COX-2 conjugate compounds for both pharmaceutical and non-pharmaceutical applications for treatment of joint diseases. The term sheets contemplate that, for all human and animal joint pathology, such as osteoarthritis, rheumatoid arthritis, and other joint pathology applications, the undisclosed licensee would assume responsibility for all future product development efforts and in return would receive exclusive, royalty-bearing global licenses to develop, market and sublicense the compounds. The compounds are new chemical entities that include cannabinoids in conjugate form with COX-2 inhibitors and cannabinoids in conjugate form with selected steroids. The pharmaceutical application term sheet provides that Enveric could be eligible to receive future development and sales milestone payments that in total could add up to approximately $61 million, assuming certain conditions are met, including receiving approval for the investigational new drug (IND) application and completing Phases I through III testing of the licensed product. Royalty rates could range from 2.5% up to 10% on future sales, depending on meeting certain sales criteria. The non-pharmaceutical application term sheet provides that Enveric could be eligible to receive future development and sales milestone payments, which in total could add up to approximately $21 million and with royalty rates ranging from 0.25% up to 7%, assuming certain conditions are met, including successful product development and commercial launch and on meeting certain sales criteria. Together, through the out-licensing of the two assets and meeting various development and sales milestones, Enveric could potentially receive milestone payments that total up to approximately $82 million. “We are pleased to announce that a second biotechnology company has stepped forward looking to join Enveric in moving some of the Company’s promising assets forward,” said Joseph Tucker, Ph.D., Director and CEO of Enveric. “We look forward to working with our partner, and we are confident in their leadership and capabilities to continue the development of these compounds for both pharmaceutical and non-pharmaceutical applications to advance joint disease treatment options for patients. Ultimately, we believe the definitive licensing agreements, once negotiated and finalized, could represent an excellent potential source of revenue for Enveric, and continue to demonstrate the value of Enveric’s extensive portfolio of assets.” About Enveric Biosciences Enveric Biosciences (NASDAQ: ENVB) is a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of depression, anxiety, and addiction disorders. Leveraging its unique discovery and development platform, Psybrary™, Enveric has created a robust intellectual property portfolio of new chemical entities for specific mental health indications. Enveric’s lead program, EB-003, is a first-in-class approach to the treatment of difficult-to-address mental health disorders designed to promote neuroplasticity without inducing hallucinations in the patient. Enveric is also developing EB-002, formerly EB-373, a next generation synthetic prodrug of the active metabolite, psilocin, being studied as a treatment of psychiatric disorders. Enveric is headquartered in Naples, FL with offices in Cambridge, MA and Calgary, AB Canada. For more information, please visit . Forward-Looking Statements This press release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward-looking statements or information. Generally, forward-looking statements and information may be identified by the use of forward-looking terminology such as “plans,” “expects” or “does not expect,” “proposed,” “is expected,” “budgets,” “scheduled,” “estimates,” “forecasts,” “intends,” “anticipates” or “does not anticipate,” or “believes,” or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, should, would, or might occur or be achieved. Forward-looking statements may include historical statements and statements regarding beliefs, plans, expectations, or intentions regarding the future and are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to, the ability of Enveric to: negotiate and finalize definitive agreements based on the any of its out-licensing term sheets, including the two identified herein, and perform pursuant to the terms thereof; carry out successful clinical programs in Australia; achieve the value creation contemplated by technical developments; avoid delays in planned clinical trials; establish that potential products are efficacious or safe in preclinical or clinical trials; establish or maintain collaborations for the development of therapeutic candidates; obtain appropriate or necessary governmental approvals to market potential products; obtain future funding for product development and working capital on commercially reasonable terms; scale-up manufacture of product candidates; respond to changes in the size and nature of competitors; hire and retain key executives and scientists; secure and enforce legal rights related to Enveric’s products, including patent protection; identify and pursue alternative routes to capture value from its research and development pipeline assets; continue as a going concern; and manage its future growth effectively. The two out-licensing term sheets identified herein are non-binding and may not result in definitive agreements or attainment of the licensing fees referenced therein. A discussion of these and other factors, including risks and uncertainties with respect to Enveric, is set forth in Enveric’s filings with the Securities and Exchange Commission, including Enveric’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Enveric disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. View source version on businesswire.com: Contacts Investor Relations Tiberend Strategic Advisors, Inc. Daniel Kontoh-Boateng (862) 213-1398 dboateng@tiberend.com Media Relations Tiberend Strategic Advisors, Inc. Casey McDonald (646) 577-8520 cmcdonald@tiberend.com Source: Enveric Biosciences View this news release online at: