Immunex Corp.

BALTIMORE--( BUSINESS WIRE )--TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) (“TNFA” or the “Company”), a clinical stage biopharmaceutical company committed to developing novel therapies for age-related diseases, and autoimmune and inflammatory conditions, today announced that it is preparing to advance its lead program, MYMD-1®, through fully funded mid-stage clinical trials. MYMD-1 is a small molecule shown to block excessive activity of TNF-alpha (TNF-α) in the blood to regulate the immuno-metabolic system. The next clinical studies of MYMD-1 will further explore the drug’s efficacy in sarcopenia/frailty following statistically significant positive results from an earlier Phase 2 clinical study. “In our view, MYMD-1, if approved, could be the first orally administered TNF-alpha inhibitor drug and the first and only therapy for sarcopenia, a common age-related disorder that causes a prolonged decline in physical function. The success of our clinical strategy and regulatory pathway to date supports MYMD-1’s potential to disrupt the TNF-alpha inhibitor market,” said Mitchell Glass, M.D., President and Chief Medical Officer of TNF Pharmaceuticals. “As we prepare for our next fully funded clinical studies in sarcopenia/frailty, we also have open INDs for Phase 2 trials of MYMD-1 in two additional chronic inflammatory conditions, rheumatoid arthritis (RA) and Hashimoto’s thyroiditis, which we could pursue with the support of non-dilutive domestic and/or international development partnerships. A partner outside of the U.S. could potentially help us accelerate the timeline to commercialization of our lead asset. “Each of MYMD-1’s indications provide solid measures of Company value,” Dr. Glass continued. “We are excited about the positive data we have gathered so far for our lead asset. Our next steps, to be revealed soon, will extend our reach toward significant and sustainable value creation, and long-term Company growth.” MYMD-1 Phase 2 Clinical Development MYMD-1 targets TNF-alpha (TNF-alpha tumor necrosis factor-alpha, or TNF-α), a protein in the body that plays a key role in inflammation and autoimmunity. Sarcopenia. A small Phase 2 study, completed in 2023, investigated the efficacy, tolerability and pharmacokinetics of MYMD-1 in the treatment of participants with chronic inflammation associated with sarcopenia/frailty. The study met its primary endpoints for significantly reducing chronic inflammatory markers with statistically significant results. MYMD-1 significantly reduced serum levels of chronic inflammatory markers and met all primary pharmacokinetic and secondary safety and tolerability endpoints. MYMD-1 demonstrated statistical significance across three biomarkers: TNF-α (P=0.008), sTNFR1 (P=0.02), and IL-6 (P=0.03). No treatment-related adverse events (AEs) or serious adverse events (SAEs) occurred over the course of the study. Sarcopenia, the aging-related progressive loss of muscle mass and strength in older people and in a growing population of younger people, is a condition which leads to greater risk of hospitalization, disability, and death. With no FDA-approved treatments for sarcopenia, the estimated $40+ billion in related hospitalization costs is a considerable economic burden on the U.S. healthcare system. 1 Rheumatoid arthritis (RA) . An Investigational New Drug (IND) application for a Phase 2 study of MYMD-1 in RA was reviewed and approved by the FDA in August 2023. MYMD-1’s small molecule design enables the drug to cross the blood brain barrier for entry into the central nervous system. In a preclinical trial, MYMD-1 was shown to significantly reduce swelling and other clinical arthritis measures compared to the widely used RA therapy Enbrel® (etanercept). 2 Disease severity (total composite score) was reduced by 47% with MYMD-1 (450 mg/kg/day orally) versus a 37% reduction with etanercept (10 mg/kg by subcutaneous injection). RA is a chronic, systemic inflammatory disorder that causes chronic inflammation of the joints and affects approximately 1.5 million Americans. RA’s cost to society, including healthcare costs; loss of employment; costs to employers, government, and caregivers; and costs associated with a deterioration of quality of life, is estimated to be over $40 billion annually. 3 Hashimoto’s thyroiditis. MYMD holds an FDA-cleared IND for a Phase 2 pilot study of MYMD-1 for Hashimoto’s thyroiditis, a condition in which the immune system stops recognizing the thyroid as part of the body and begins attacking it. Hashimoto’s thyroiditis is the most common cause of hypothyroidism in the United States. 4 According to an American Thyroid Association report, approximately 12% of the U.S. population will develop a thyroid condition during their lifetime and an approximate amount of 20 million Americans are diagnosed with some form of thyroid disease during their lifetime. 5 The global thyroid gland disorder market was valued at $2.1 billion in 2017, and is estimated to reach $2.7 billion by 2025 at a CAGR of 3.8% from 2018 to 2025. 6 Secondary Drug Platform — Supera-CBD ™ TNFA’s secondary drug platform, Supera-CBD ™ , is a synthetic, non-toxic cannabidiol (CBD) analog that is an 8000-times more potent CB2 agonist than plant-based CBD. 7 Supera-CBD is targeted for the treatment of epilepsy, pain and anxiety/depression. Based on an in vitro binding analysis of Supera-CBD with three types of opioid receptors, the profile suggests that Supera-CBD could play a role in treating opioid addiction. About TNF Pharmaceuticals, Inc. TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) (formerly known as MyMD Pharmaceuticals, Inc.), a clinical stage pharmaceutical company committed to extending healthy lifespan, is focused on developing two novel therapeutic platforms that treat the causes of disease rather than only addressing the symptoms. MYMD-1® is a drug platform based on a clinical stage small molecule that regulates the immune system to control TNF-α, which drives chronic inflammation, and other pro-inflammatory cell signaling cytokines. MYMD-1 is being developed to treat diseases and disorders marked by acute or chronic inflammation. The Company’s second drug platform, Supera-CBD, is being developed to treat chronic pain, addiction and epilepsy. Supera-CBD is a novel synthetic derivative of cannabidiol (CBD) and is being developed to address and improve upon the rapidly growing CBD market, which includes both FDA approved drugs and CBD products not currently regulated as drugs. For more information, visit www.tnfpharma.com . Cautionary Statement Regarding Forward-Looking Statements This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and neither the Company nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and other similar expressions are intended to identify these forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the Company’s ability to maintain compliance with the Nasdaq Stock Market’s listing standards; the timing of, and the Company’s ability to, obtain and maintain regulatory approvals for clinical trials of the Company’s pharmaceutical candidates; the timing and results of the Company’s planned clinical trials for its pharmaceutical candidates; the amount of funds the Company requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which the Company operates; the Company’s ability to retain and attract senior management and other key employees; the Company’s ability to quickly and effectively respond to new technological developments; and the Company’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on the Company’s proprietary rights. A discussion of these and other factors with respect to the Company is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed by the Company on April 1, 2024, and subsequent reports that the Company files with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and the Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise. 1 Journal of Frailty & Aging, Economic Impact of Hospitalizations in US Adults with Sarcopenia (2019) 2 ENBREL ETANERCEPT is a registered trademark of Immunex Corporation 3 https://reporter.nih.gov/project-details/10080141 4 Taylor N Peter et al. Global epidemiology of hyperthyroidism and hypothyroidism. Nature: Endocrinology. 2018 May; 14:301-316. 5 American Thyroid Association. General Information/Press Room. Available in: https://www.thyroid.org/media-main/press-room/ 6 KUNSEL, Tenzin. Thyroid Gland Disorder Treatment Market. Allied Market Search, 2018. Available in: < https://www.alliedmarketresearch.com/thyroid-gland-disorder-treatment-market > 7 Company reports ; study conducted by Eurofins Discovery , a Eurofins Scientific (EUFI.PA) company

The new prices will go into effect on Jan. 1, 2026. CMS estimates that Medicare beneficiaries will see aggregate savings of $1.5 billion in their personal out-of-pocket costs in 2026. The Centers for Medicare & Medicaid Services offered the first look at the potential savings generated by the first crop of Medicare drug price negotiations.On Thursday morning, the agency released data that show if the negotiated prices for the first 10 drugs in the program had been available last year, it would have generated an estimated $6 billion in savings for Medicare. That's savings of about 22% on those 10 products.CMS will offer additional details on negotiations down the line, officials said on a call with reporters on Thursday, but they said the program led to price reductions of between 38% and 79% on the initial list of drugs.On the highest end, negotiations led to a price decrease for Merck's Januvia, a diabetes drug, from $527 for a 30-day supply to $113, down 79%. CMS said 843,000 Medicare beneficiaries took Januvia in 2023, with the drug accounting for nearly $4.1 billion in spending. “Americans pay too much for their prescription drugs. That makes today’s announcement historic. For the first time ever, Medicare negotiated directly with drug companies and the American people are better off for it,” said U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra.Here's a look at savings for other drugs included in the program:Fiasp and NovoLog insulins (Novo Nordisk): Reduced the cost of a 30-day supply from $495 to $119, a decrease of 76%.Farxiga (AstraZeneca): List price for a 30-day supply decreased from $556 to $178.50, or 68%.Enbrel (Immunex Corporation): Cut the list price for a 30-day supply by 67% from $7,106 to $2,355.Jardiance (Boehringer Ingelheim): Reduced the cost of a 30-day supply by 66%, or from $573 to $197.Stelara (Janssen): The list price for a 30-day supply dropped from $13,836 to $4,695 or by 66%.Xarelto (Janssen): Lowered the cost for a 30-day supply by 62%, or from $517 to $197.Eliquis (Bristol Myers Squibb): The cost for a 30-day supply decreased from $521 to $231, or by 56%.Entresto (Novartis): Reduced the list price for a 30-day supply by 53%, or from $628 to $295.Imbruvica (Pharmacyclics): Decreased the cost for a 30-day supply from $14,934 to $9,319, or by 28%.CMS sent the initial offers for the 10 drugs to the manufacturers on Feb. 1, and the companies had until March 2 to respond with a counteroffer. Then throughout the summer, the agency held meetings with the drugmakers to continue negotiations, before sending final offers on July 15.The negotiation period ended on Aug. 1 with a deal in place for all 10 drugs, CMS said.The new prices will go into effect on Jan. 1, 2026. CMS estimates that Medicare beneficiaries will see aggregate savings of $1.5 billion in their personal out-of-pocket costs in 2026.Final cost savings can vary based on the enrollee's specific plan, the agency said.CMS said it will select up to 15 additional drugs for negotiation in 2027, and the list will be announced by Feb. 1, 2025.Reaction rolls inMultiple lawmakers praised CMS and the efforts to reduce drug prices in statements Thursday.Sen. Ron Wyden, D-Ore., who chairs the Finance Committee, said that Medicare used "the bargaining power of tens of millions of American seniors to fight Big Pharma for lower drug prices.""These new, lower prices for prescription drugs in Medicare means seniors save money at the pharmacy counter and marks the first step in a seismic shift in the relationship between Big Pharma, taxpayers, and seniors who need affordable prescription drugs," Wyden said.Rep. Frank Pallone, D-N.J., who is the ranking Democrat on the House Energy & Commerce Committee, said that the negotiations will lead to $101 million in savings for seniors living in the Garden State.Pallone also helped to co-write the Inflation Reduction Act, which gave Medicare the power to negotiate with drug companies."This is a historic day for New Jersey and the nation. After more than two decades of fighting, we have finally empowered Medicare to negotiate lower prescription drug prices for our seniors," said Pallone. "This milestone is especially meaningful for New Jersey, where many seniors rely on Medicare for their life-saving medications."Reactions, however, were not universally positive. Pharmaceutical Research and Manufacturers of America (PhRMA) CEO Steve Ubl said in a statement Wednesday that regulators won't be able to achieve their ultimate goal as the negotiation program does not take aim at pharmacy benefit managers. Ubl also said that the IRA "fundamentally alters" the incentives drugmakers have in researching and developing new products and therapies. He said companies are already making changes to their R&D programs in response.“The administration is using the IRA’s price-setting scheme to drive political headlines, but patients will be disappointed when they find out what it means for them," Ubl said. "There are no assurances patients will see lower out-of-pocket costs because the law did nothing to rein in abuses by insurance companies and PBMs who ultimately decide what medicines are covered and what patients pay at the pharmacy."“As a result of the IRA, there are fewer Part D plans to choose from and premiums are going up," he continued." Meanwhile, insurers and PBMs are covering fewer medicines and say they intend to impose further coverage restrictions as the price-setting scheme is implemented."The Pharmaceutical Care Management Association, which represents PBMs, meanwhile, said that its analyses show that PBM negotiations have driven more significant discounts on six of the 10 drugs included in the program.“While we share the Administration’s goal to reduce prescription drug costs for America’s seniors and to push back against the high prices set by drug manufacturers, the Administration has missed the mark by choosing several prescription drugs for which PBMs are already actively negotiating steep discounts that significantly lower costs for beneficiaries and taxpayers," PCMA said.“The key to reducing drug costs is to increase competition among manufacturers," the organization said. "We encourage the Administration to focus on those drugs where a lack of competition is driving higher prices and higher costs, and to allow PBM negotiations to continue to deliver value and savings for Medicare.”While the negotiation program takes more direct aim at drugmakers, PBMs are also under the microscope on the Hill. Lawmakers are mulling a slew of potential reforms to the industry, which critics argue is too concentrated, too opaque and too profit-driven at the expense of patients.

HENDERSON, Nev.--(BUSINESS WIRE)-- Zura Bio Limited (Nasdaq: ZURA) (“Zura Bio”), a clinical-stage immunology company developing novel dual-pathway antibodies for autoimmune and inflammatory diseases, today announced the formation of a Scientific Advisory Board (SAB) with leading experts from rheumatology, dermatology, and immunology. The five distinguished founding members of the SAB are Johann Gudjonsson, M.D, Ph.D., Dinesh Khanna, M.D., M.Sc., Ajay Nirula, M.D., Ph.D., Michael Weinblatt, M.D. and Steven Ziegler, Ph.D. “With the launch of the SAB, we are strengthening our commitment to advancing solutions in translational and clinical science across our portfolio,” stated Michael Howell, Ph.D., Chief Scientific Officer and Head of Translational Medicine. “We welcome these esteemed advisors whose expertise will enhance our understanding of targeted pathways and their pivotal role in disease pathogenesis. This understanding will be impactful across our portfolio, particularly in directing our efforts towards supporting Phase 2 clinical development in systemic sclerosis and hidradenitis suppurativa, as well as elucidating the roles of BAFF and IL-17A across autoimmune and inflammatory diseases.” Johann Gudjonsson, M.D., Ph.D., is a Professor of Molecular Skin Immunology and Dermatology at the University of Michigan Dermatology Department and a foremost expert in dermatological science. He leads a National Institutes of Health - funded research group examining the immunological and genetic drivers of inflammatory skin disease, with projects directed at improving the diagnosis and treatment of disorders such as atopic dermatitis, cutaneous lupus, hidradenitis suppurativa, lichen planus, psoriasis, and psoriatic arthritis. Since 2008, Dr. Gudjonsson has provided dermatology patient care at the University of Michigan Taubman Center. He is a graduate of the University of Iceland Medical School and completed his internship and dermatology residency training at the University of Michigan. Dinesh Khanna, M.D., M.Sc., is a Professor of Medicine and serves as the Director of the University of Michigan Scleroderma Program. Guiding a multidisciplinary team of caregivers, scientists, and clinical researchers, Dr. Khanna is dedicated to advancing knowledge about scleroderma and related conditions. His research interests include developing new patient-reported outcome measures in patients with scleroderma and leading clinical trials evaluating new treatments for scleroderma. Dr. Khanna received an M.D. from University College of Medical Sciences and completed a clinical and research rheumatology fellowship and an M.Sc. in Clinical Research from UCLA. Ajay Nirula, M.D., Ph.D., is the Executive Vice President and Head of Research and Development at Recludix Pharma. He was previously a Senior Vice President and the Immunology Therapeutic Area Head for Eli Lilly & Co, which he joined in 2015. He was responsible for the company’s research and early clinical development work in immunology. Before his tenure at Lilly, Dr. Nirula held leadership roles at Amgen and Biogen Idec, contributing to various research programs and regulatory filings across diseases such as rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, psoriasis, and vasculitis. Dr. Nirula received his undergraduate degree in molecular biology from UC Berkeley, followed by a medical degree from the University of California, Los Angeles (UCLA) School of Medicine, and a Ph.D. from the University of Texas Southwestern Medical School. Michael Weinblatt, M.D., is the Co-Director of Clinical Rheumatology at Brigham and Women’s Hospital and a Professor of Medicine at Harvard Medical School. As a recognized authority in rheumatology with 40 years of experience, his clinical interests have been focused on innovations in rheumatoid arthritis (RA) treatment. Dr. Weinblatt leads the Brigham and Women’s clinical trial program in rheumatology and was involved in the development of methotrexate for the treatment of RA. Dr. Weinblatt earned an M.D. from the University of Maryland School of Medicine and has been board certified in rheumatology since 1980. Steven Ziegler, Ph.D., is a Director of External Collaborations and a Member of the Center for Fundamental Immunology at Benaroya Research Institute (BRI). He is also an Affiliate Professor in the Immunology Department at the University of Washington School of Medicine. Dr. Ziegler graduated with honors from the University of Michigan in 1979, and in 1984 received his Ph.D. in molecular biology from UCLA. Following post-doctoral training at the University of Washington, Dr. Ziegler spent five years as a staff scientist at Immunex, followed by three years as the Director of Immunology/Molecular Biology at Darwin Molecular. He joined BRI as an Associate Member in 1997. ABOUT ZURA BIO Zura Bio is a clinical-stage, multi-asset immunology company developing novel dual-pathway antibodies for autoimmune and inflammatory diseases. Currently, Zura Bio is developing three assets which have completed Phase 1/1b studies and are Phase 2 ready. The company is developing a portfolio of therapeutic indications for tibulizumab (ZB-106), ZB-168, and torudokimab (ZB-880), with a goal of demonstrating their efficacy, safety, and dosing convenience in autoimmune and inflammatory diseases, including systemic sclerosis and other novel indications with unmet needs. FORWARD-LOOKING STATEMENTS This communication includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believe,” “predict,” “potential,” “continue,” “strategy,” “future,” “opportunity,” “would,” “seem,” “seek,” “outlook” and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties that could cause the actual results to differ materially from the expected results. These statements are based on various assumptions, whether or not identified in this communication. These forward-looking statements in this release include, but are not limited to, statements regarding Zura Bio’s anticipated proceeds to be received in the proposed Private Placement, expected timing of closing of the proposed Private Placement and the size, completion and use of proceeds of the proposed Private Placement, the forecast of cash runway and the Company’s expectations regarding funding, operating and working capital expenditures, business strategies and objectives, statements related to Zura Bio’s abilities to achieve anticipated internal readouts and achieve them in expected time periods, Zura Bio’s product candidates, clinical trials and the design and timing thereof, statements with respect to expected therapeutic potential and statements regarding Zura Bio’s product candidates ability to proceed into Phase 2 clinical trials. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and the ability to consummate the proposed Private Placement and the timing and proceeds thereof; are difficult or impossible to predict and could differ materially from those expressed or implied in such forward-looking statements. You should carefully consider the risks and uncertainties described in the “Risk Factors” sections of Zura Bio's 10-K for the year ended December 31, 2023 and other filings with the SEC, including: Zura Bio’s expectations regarding product candidates and their related benefits; Zura Bio’s beliefs regarding potential benefits or limitations of competing products both in development and approved; information regarding Zura Bio’s vision and strategy; anticipated timing of key events and initiation of Zura Bio’s studies and release of clinical data; Zura Bio’s expectations regarding the general acceptability and maintenance of our products by regulatory authorities, payors, physicians, and patients; Zura Bio’s ability to attract and retain key personnel; the accuracy of Zura Bio’s future operating expenses, capital requirements and needs for additional financing; Zura Bio’s ability to obtain funding for operations, including funds that may be necessary to complete development of our product candidates; the fact that Zura Bio has not completed any clinical trials and has no products approved for commercial sale; the fact that Zura Bio has incurred significant losses since inception, and it expects to incur significant losses for the foreseeable future and may not be able to achieve or sustain profitability in the future; Zura Bio’s ability to renew existing contracts; Zura Bio’s reliance on third-party contract development manufacturing organizations for the manufacture of clinical materials; Zura Bio’s ability to obtain regulatory approval for our products, and any related restrictions or limitations of any approved products; Zura Bio’s ability to effectively manage growth and competitive pressures from other companies worldwide in the therapies in which Zura Bio competes; and litigation and Zura Bio’s ability to adequately protect intellectual property rights. These risks and uncertainties may be amplified by health epidemics or other unanticipated global disruption events, which may continue to cause economic uncertainty. Zura Bio cautions that the foregoing list of factors is not exclusive or exhaustive and not to place undue reliance upon any forward-looking statements, including projections, which speak only as of the date made. Zura Bio gives no assurance that it will achieve its expectations. Zura Bio does not undertake or accept any obligation to publicly provide revisions or updates to any forward-looking statements, whether as a result of new information, future developments or otherwise, or should circumstances change, except as otherwise required by securities and other applicable laws. View source version on businesswire.com: Contacts Megan K. Weinshank Head of Investor Relations ir@zurabio.com Source: Zura Bio Limited View this news release online at: