Erythema Induratum

STAFFORD, Texas, April 02, 2025 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced the following update on FLAMINGO-01 open label immune response data. FLAMINGO-01 Immune Response Data Summary The Company has analyzed the preliminary immune response data from FLAMINGO-01. Immune response data in both the HLA-A*02 treated and placebo arms and the third open label arm with all other HLA types (non- HLA-A*02), show that GLSI-100 is creating an immune response over time as the frequency of patients exhibiting an injection site reaction or GP2 Delayed-Type Hypersensitivity (DTH) skin test reaction as measured by induration or erythema is increasing with increased vaccinations. The number of patients experiencing an immune response increased over time from baseline through the 4th to 6th month vaccinations in both HLA-A*02 and non-HLA-A*02 arms.In addition, a baseline immune response to GP2 is being observed before any treatment with GP2 in both HLA-A*02 and non-HLA-A*02 arms. This result suggests that GP2 is a natural antigen, that may have been part of an immune response in the patient during prior trastuzumab or other treatments.These two general immune response findings, immune response at baseline and increasing immune response over time, were also observed in the Phase IIb clinical trial for HLA-A*02 only patients. These results confirm that the HLA prevalence, safety, and immune response in FLAMINGO-01 patients is trending as expected in both HLA arms.The Company recently filed patent claims for non-HLA-A*02 patients which may be solely owned by the Company separate from any prior license. These claims are also supported by binding prediction algorithms and in vitro binding experiments conducted by the Company. This represents an invention that was originated by the Company which could double the number of patients eligible for GP2 treatment to approximately 88,000 new patients per year in the US and Europe. The market potential using the drug prices per year of Kadcyla or Enhertu could be in the range of $8-10 billion per year.As mentioned in a prior press release, the non-HLA-A02 types that are most commonly being enrolled in FLAMINGO-01 include HLA-A*03, HLA-A*24, HLA-A*01, HLA-A*11, HLA-A*68, HLA-A*29, HLA-A*30, HLA-A*23, and HLA-A*33. Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label immune response data is based on the patients enrolled to date in FLAMINGO-01 and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results and the results at the end of the study may differ. CEO Snehal Patel commented, "We are very encouraged to see that the preliminary results from FLAMINGO-01 show immune responses in both HLA-A*02 and non-HLA-A*02 patients. We are now considering the merits of adding a randomized placebo arm for non-HLA-A*02 patients, transforming this current open label third arm into effectively a second pivotal and blinded Phase III trial. If successful, the Company could pursue approval for both HLA-A*02 and non-HLA-A*02 patients in similar time frames using independent or combined analysis of the two patient groups with the potential to double the market for GP2 to up to $10 billion in revenue per year." Mr. Patel added, "The Company may choose to expand its immune response analysis of GP2 specific T cells by sequencing the DNA of the T cells at baseline and after treatment with GP2. The T cell sequences can be compared to the immune response increases over time. Expansion into GP2 specific CAR-T cells could potentially become another platform technology to complement GP2 peptide treatment for non-responding higher risk patients. Blood samples have been collected at multiple timepoints for future T cell and immune response analysis." Previously Published Phase IIb Immune Response Data In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb results can be summarized as follows: 80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up compared to 20-50% reduction in recurrence rate by other approved productsPeak immune response at 6 months No reported serious adverse events attributable to treatmentWell-tolerated safety profile Full immunization was received in the Primary Immunization Series (PIS), which included the first 6 GLSI-100 injections over the first 6 months. The PIS elicited a potent immune response as measured by local skin tests and immunological assays. Further, booster injections given every 6 months prolonged the immune response, thereby providing longer-term protection. In the Phase IIb and three Phase I clinical trials, where 146 patients were treated, the GP2 immunotherapy was well tolerated, and there were no reported serious adverse events related to GLSI-100. The Phase IIb immune response data in HLA-A*02 only patients was published at AACR in 2021 with the following findings: GP2 immunotherapy generated GP2-specific immune responses leading to promising clinical benefit, thus supporting GP2’s mechanism of action.Immune responses to GP2 were measured over time using a CD8 T cell dimer binding assay (Dimer Binding Assay) and GP2 DTH skin tests. GP2 immunity peaked at 6 months in HER2 3+ patients after they completed their first 6 immunizations, as measured by the Dimer Binding Assay. The data also shows that for the 2.5 years that the immune response was measured, the immunity was sustained and remained above baseline, resulting in a reduction in metastatic breast cancer recurrences.Broad based immune response suggests that GP2 immunotherapy and Herceptin based products may also have the potential to treat low HER2 and other HER2 1-3+ expressing cancers in combination with trastuzumab or trastuzumab antibody drug conjugates. About FLAMINGO-01 and GLSI-100 FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US clinical sites from university-based hospitals and cooperative networks with plans to expand into Europe and to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types will be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater. For more information on FLAMINGO-01, please visit the Company's website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the "Contacts and Locations" section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: flamingo-01@greenwichlifesciences.com About Breast Cancer and HER2/neu Positivity One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. About Greenwich LifeSciences, Inc. Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2 protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences has commenced a Phase III clinical trial, FLAMINGO-01. For more information on Greenwich LifeSciences, please visit the Company's website at www.greenwichlifesciences.com and follow the Company's Twitter at https://twitter.com/GreenwichLS. Forward-Looking Statement Disclaimer Statements in this press release contain "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will," "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.'s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including statements regarding the intended use of net proceeds from the public offering; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section entitled "Risk Factors" in Greenwich LifeSciences' Annual Report on Form 10-K for the year ended December 31, 2023 and other periodic reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. undertakes no duty to update such information except as required under applicable law. Company ContactSnehal PatelInvestor RelationsOffice: (832) 819-3232Email: info@greenwichlifesciences.com Investor & Public Relations Contact for Greenwich LifeSciencesDave GentryRedChip Companies Inc.Office: 1-800-RED CHIP (733 2447)Email: dave@redchip.com

COPENHAGEN, Denmark I March 31, 2025 I Bavarian Nordic A/S (OMX: BAVA) today announced that the U.S. Food and Drug Administration (FDA) has approved the freeze-dried formulation of JYNNEOS ® (Smallpox and Mpox Vaccine, Live, Non-replicating) for prevention of smallpox and mpox disease in adults 18 years of age and older. This approval will provide additional flexibility for stockpiling against a smallpox event or mpox outbreak. The approval follows a standard review with the FDA of a supplemental Biologics License Application (sBLA) submitted in May 2024. The sBLA was primarily based on clinical data that showed comparability in terms of the immune responses and safety between the freeze-dried and liquid-frozen formulations, as well as other non-clinical and manufacturing data. The current liquid-frozen formulation of JYNNEOS, approved by the FDA in September 2019, has specific cold-chain requirements, while the freeze-dried formulation provides advantages in terms of transportation, storage conditions and shelf life, all of which are important factors for long-term stockpiling. “ Today’s FDA approval represents a significant milestone in our development of this next generation of JYNNEOS and in our collaborative efforts with the U.S. government to strengthen public health security. ” said Paul Chaplin, President and CEO of Bavarian Nordic . “ As a long-term supplier of JYNNEOS to the U.S. biological preparedness, we are committed to continue supporting the government’s efforts to protect its citizens against current and future public health threats.” About our contracts with the U.S. government Since 2003, Bavarian Nordic has worked with the U.S. government on the development, manufacturing and supply of a non-replicating smallpox vaccine to ensure all populations can be protected from smallpox and mpox, including people with weakened immune systems who are at high risk of adverse reactions to traditional smallpox vaccines, which are based on replicating vaccinia virus strains. Approved by the FDA in 2019, JYNNEOS was the first smallpox vaccine successfully developed under Project BioShield, a program created by the U.S. Congress in 2004 to accelerate the research, development, procurement, and availability of medical countermeasures against biological, chemical, radiological, and nuclear (CBRN) agents through public-private partnerships. Bavarian Nordic has supplied a liquid-frozen version of JYNNEOS to the U.S. government for stockpiling since 2010 and in response to the mpox outbreak in 2022-2023. The Company has been contracted by the U.S Biomedical Advanced Research and Development Authority (BARDA) to develop and supply a freeze-dried version of JYNNEOS for stockpiling. Manufacturing under this contract was initiated in 2024, and the first vaccines will be delivered later in 2025. Federal funding acknowledgements This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number HHSO100201700019C. About JYNNEOS ® JYNNEOS (Smallpox and Mpox Vaccine, Live, Non-replicating) is approved for the prevention of smallpox and mpox disease in adults 18 years of age and older determined to be at high risk for smallpox and monkeypox infection. The vaccine was developed in collaboration with the U.S. government originally to ensure supply of a smallpox vaccine for the entire population, including immunocompromised individuals who are not recommended vaccination with traditional replicating smallpox vaccines. JYNNEOS was approved by the U.S. Food and Drug Administration (FDA) in 2019 and in 2021, the Advisory Committee on Immunization Practices (ACIP) under the Centers for Disease Control and Prevention (CDC) voted to recommend JYNNEOS for pre-exposure vaccination of people at occupational risk for orthopoxvirus exposures. In 2022, the CDC issued interim guidance, enabling pre- and post-exposure use of JYNNEOS during the mpox outbreak and an Emergency Use Authorization (EUA) was issued by the FDA allowing the use of JYNNEOS in people under 18 years. In October 2023, the CDC updated its guidance for use of JYNNEOS and now recommends routine use of the vaccine for at risk individuals 18 years and older. Important Safety Information Appropriate medical treatment must be available to manage possible anaphylactic reactions following administration of JYNNEOS. Anyone who has experienced a severe allergic reaction following a previous dose of JYNNEOS or following exposure to any component of JYNNEOS may be at increased risk for severe allergic reactions. Syncope (fainting) has been reported following vaccination with JYNNEOS. Procedures should be in place to avoid injury from fainting. Immunocompromised persons, including those receiving immunosuppressive therapy, may have a diminished immune response to JYNNEOS. Vaccination with JYNNEOS may not protect all recipients. In smallpox vaccine-naïve healthy adults, the most common (>10%) solicited injection site reactions were pain (84.9%), redness (60.8%), swelling (51.6%), induration (45.4%), and itching (43.1%); the most common solicited systemic adverse reactions were muscle pain (42.8%), headache (34.8%), fatigue (30.4%), nausea (17.3%) and chills (10.4%). In healthy adults previously vaccinated with a smallpox vaccine, the most common (>10%) solicited injection site reactions were redness (80.9%), pain (79.5%), induration (70.4%), swelling (67.2%), and itching (32.0%); the most common solicited systemic adverse reactions were fatigue (33.5%), headache (27.6%), and muscle pain (21.5%). The frequencies of solicited local and systemic adverse reactions among adults with HIV infection and adults with atopic dermatitis were generally similar to those observed in healthy adults. Across all studies, a causal relationship to JYNNEOS could not be excluded for 5 serious adverse events (SAEs), all non-fatal, which included Crohn’s disease, sarcoidosis, extraocular muscle paresis, throat tightness, and hemolytic anemia. Cardiac adverse events of special interest (AESIs) considered causally related to study vaccination were reported in <0.1% of subjects who received JYNNEOS and included tachycardia, electrocardiogram T wave inversion, electrocardiogram abnormal, electrocardiogram ST segment elevation, electrocardiogram T wave abnormal, and palpitations. None of the cardiac AESIs considered causally related to study vaccination were considered serious. To report SUSPECTED ADVERSE REACTIONS, contact Bavarian Nordic at 1-833-365-9596 or the US Department of Health and Human Services by either visiting www.vaers.hhs.gov/reportevent.html or calling 1-800-822-7967. Please see full Prescribing Information . About Bavarian Nordic Bavarian Nordic is a global vaccine company with a mission to improve health and save lives through innovative vaccines. We are a preferred supplier of mpox and smallpox vaccines to governments to enhance public health preparedness and have a leading portfolio of travel vaccines. For more information, visit www.bavarian-nordic.com SOURCE: Bavarian Nordic

TAKHZYRO Solution for Injection in 2 mL Pre-Filled Pen is Now Approved to Facilitate Subcutaneous Administration in Adolescent (Aged 12 Years and Above) and Adult Patients with HAE.1 The Pre-Filled Pen Option is Designed to Allow for An Individualized Treatment Approach for Adolescent and Adult HAE Patients. In the EU, TAKHZYRO is Approved for Routine Prevention of Recurrent HAE Attacks in Patients Aged 2 Years and Older.1 ZURICH, Feb. 24, 2025 /PRNewswire/ -- Takeda (TSE: 4502) (NYSE: TAK) announced today that the EMA has approved an additional 2 mL pre-filled pen option for TAKHZYRO® (lanadelumab) for subcutaneous administration in adolescents (aged 12 years and above) and adult patients with Hereditary Angioedema (HAE).1 The additional subcutaneous administration option expands Takeda's offering in this space, showing dedication to the HAE community while providing individualized treatment options to support patients with a life-threatening disease, by helping to reduce HAE burden and improving their Quality of Life. "HAE affects an estimated 1 in 50,000 people worldwide and is often under recognised, under diagnosed and under treated.3 We welcome the swift approval by the EMA on this additional subcutaneous administration option," said Irmgard Andresen, Global Medical Lead HAE at Takeda. "HAE patients 12 years and older now have an additional individualized treatment option available to them." TAKHZYRO® (lanadelumab) is currently approved as 150 mg solution for injection in pre-filled syringe, 300 mg solution for injection in pre-filled syringe, and 300 mg solution for injection in vial.1 This approval for an additional subcutaneous administration option, TAKHZYRO® 300 mg solution for injection in pre-filled pen, containing 300 mg of lanadelumab in 2 mL of solution, was supported by a clinical study.2 Takeda is dedicated to providing innovative treatment options to support patients, particularly those from underserved communities, and continues its leadership in HAE treatment, supported by a noteworthy data pool from historical engagement in this area. Notes to editors: About HAE Hereditary angioedema (HAE) is a rare genetic disorder that results in recurring attacks of oedema – swelling – in various parts of the body, including the abdomen, face, feet, genitals, hands and throat. The swelling can be debilitating and painful.4 Attacks that obstruct the airways can cause asphyxiation and are potentially life threatening.5 HAE affects an estimated 1 in 50,000 people worldwide.3 It is often under recognised, under diagnosed and under treated.3 HAE, like so many other rare diseases, is highly complex, and patients, their families and caregivers often undergo years of strain trying to understand their disease, get a definitive diagnosis and gain access to the medicines they need. At Takeda we are a committed champion for the patients we serve. Every individual living with HAE is unique and by listening and reacting to their needs, we translate the insights we gain into innovative solutions – from diagnosis to ongoing management. Advancing the science is crucial to the way we operate and we are bold in our mission to accelerate diagnosis and develop treatments that will make a difference to the lives of HAE patients, their support networks and those medical professionals who care for them. About Lanadelumab (TAKHZYRO®)1 Lanadelumab is a fully human monoclonal antibody that specifically binds and decreases plasma kallikrein and is indicated for routine prevention of recurrent attacks of HAE in patients aged 2 years and older.1 It was studied in one of the largest prevention studies in HAE with the longest active treatment duration, and Lanadelumab consistently demonstrated HAE attack reduction. Lanadelumab is formulated for subcutaneous administration and has a half-life of approximately two weeks.1 Lanadelumab is intended for self-administration or administration by a caregiver once trained by a healthcare professional.1 About Takeda Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit . Guidance for use TAKHZYRO treatment should be initiated under the supervision of a physician experienced in the management of patients with hereditary angioedema (HAE). For adults and adolescents (12 to less than 18 years of age), TAKHZYRO may be self-administered or administered by a caregiver only after training on subcutaneous injection technique by a healthcare professional. For children (2 to less than 12 years of age), TAKHZYRO should only be administered by a caregiver after training on SC subcutaneous injection technique by a healthcare professional. Contraindication Hypersensitivity to the active substance or to any of the excipients. Hypersensitivity reactions have been observed. In case of a severe hypersensitivity reaction, administration of TAKHZYRO must be stopped immediately and appropriate treatment must be initiated. The most commonly observed adverse reaction (52.4%) associated with TAKHZYRO was injection site reactions (ISR) including injection site pain, injection site erythema and injection site bruising. Of these ISRs, 97% were of mild intensity, 90% resolved within 1 day after onset with a median duration of 6 minutes. Hypersensitivity reaction (mild and moderate pruritus, discomfort and tingling of tongue) was observed (1.2%) Very common adverse reactions (frequency ≥1/10) were injection site reactions including: pain, erythema, bruising, discomfort, haematoma, haemorrhage, pruritus, swelling, induration, paraesthesia, reaction, warmth, oedema and rash. Please consult the EMA TAKHZYRO® Summary of Product Characteristics before prescribing.1 Important Notice For the purposes of this notice, "press release" means this document, any oral presentation, any question-and-answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited ("Takeda") regarding this release. This press release (including any oral briefings and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. 1 . Relevant documents to be published here as soon as publicly available. 2 . Last accessed: February 2025. 3 Longhurst, H. J., & Bork, K. (2019). Hereditary angioedema: an update on causes, manifestations and treatment. British Journal of Hospital Medicine, 80(7), 391-398. 4 Maurer, M., et al. (2022). The international WAO/EAACI guideline for the management of hereditary angioedema—The 2021 revision and update. Allergy, 77(7), 1961–1990. . 5 Banerji, A., Davis, K. H., Brown, T. M., Hollis, K., Hunter, S. M., Long, J., ... & Devercelli, G. (2020). Patient-reported burden of hereditary angioedema: findings from a patient survey in the United States. Annals of Allergy, Asthma & Immunology, 124(6), 600-607. Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED