Latest news with #FrontiersinImmunology
Korea Herald
22-04-2025
- Health
- Korea Herald
The Role of Treg Epitopes (Tregitopes) in Antibody Maturation Uncovered in New EpiVax Study: Implications for Therapeutic Antibodies
PROVIDENCE, R.I., April 21, 2025 /PRNewswire/ -- EpiVax, Inc. announces a new study published in Frontiers in Immunology unveiling the impact of peptides known as "Tregitopes" on antibody maturation during immune response. Lymph nodes contain antibodies that undergo changes to their sequence as they adapt to their immune target, such as a flu virus. As this happens, the content of regulatory T cell (Treg) epitope sequences (also called Tregitopes) in the antibodies appears to decrease, which enables the B cells to expand and persist. The study, " Regulatory T Cell Epitope Content in Human Antibodies Decreases During Maturation", was conducted by Andres Gutierrez, PhD and Annie De Groot, MD of EpiVax, using existing antibody sequence data. "This work provides important insights into how antibodies evolve over time, not just in terms of affinity, but in their ability to engage with the immune system." said Dr. Gutierrez. The discovery of Tregitopes in 2008 marked a shift in awareness about the function of natural Tregs in human and animal immunity. Tregitopes may explain, in part, the tolerogenic impact of IV immunoglobulin therapy (IVIG). Tregitope-like peptides have since been found in other self-proteins. A prior analysis of human antibody repertoires demonstrated that T cell epitopes decreased with increasing antibody maturation. However, that study didn't separate regulatory from effector T cell epitope dynamics. In this study, researchers examined antibody repertoires from four healthy human donors. They assessed three subsets of T cell epitopes: previously validated Tregitopes, potentially tolerated T cell epitopes and potential effector T cell epitopes. Findings revealed that as antibodies mature and have higher affinity for their target antigen, Tregitope content systematically decreases, while potential effector T cell epitope content increases. This suggests that Tregitope depletion is a fundamental feature of antibody evolution. The observation was confirmed by testing some of the 'natural' and 'modified' Tregitope sequences in vitro. "This mechanism is likely relevant to immunity from pathogens, to the development of autoantibodies during autoimmune disease, and for the selection of therapeutic antibody candidates", said Dr. De Groot. "We are pleased to contribute this finding to the literature on immune regulation and antibody design." About EpiVax EpiVax is a leader in preclinical immunogenicity assessment and sequence optimization for therapeutics and vaccines. EpiVax collaborates with globally recognized partners to accelerate immunogenicity risk assessment, immune modulation, and rapid vaccine design.
Associated Press
07-04-2025
- Business
- Associated Press
TG Therapeutics Announces Two Publications Highlighting BRIUMVI in Medical Journals
NEW YORK, April 07, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) today announced the publication of two journal articles one describing the evolution of CD20 treatments for multiple sclerosis (MS) and the other detailing the experience of seven individuals with MS who switched to BRIUMVI® (ublituximab-xiiy) from a different anti-CD20 monoclonal antibody therapy due to efficacy or tolerability concerns. Details of the publications are provided below. Michael S. Weiss, the Company's Executive Chairman and Chief Executive Officer stated, 'We are encouraged by these publications, and believe taken together they may provide a rationale for switching patients within the CD20 class prior to leaving the class, as well as the first anecdotal evidence of the success of such a strategy, as highlighted by the seven case reports in Frontiers in Immunology. The findings reinforce the potential of BRIUMVI in improving patient outcomes for those seeking an alternative to their previous anti-CD20 therapy. Furthermore, the article in CNS DRUGS offers an insightful look at the evolution of anti-CD20 treatments and a potential rationale as to why switching within the same class is a viable strategy. We remain committed to the MS community and believe these papers highlight the real-world impact BRIUMVI can have on the those living with MS and we will continue to study this phenomenon through our ongoing ENHANCE and ENABLE studies to assess if these anecdotal accounts can be further supported.' JOURNAL ARTICLES: Title: Switching to Ublituximab from Prior anti-CD20 Monoclonal Antibody Therapy: A Case Report Series The article describes a retrospective case series of seven individuals with multiple sclerosis (MS) treated in private practice or at an MS clinic who switched to ublituximab from a different anti-CD20 monoclonal antibody therapy due to efficacy or tolerability concerns. Details of each case, including clinical and/or radiological outcomes on initial anti-CD20 therapy, reasons for switching, and outcomes after starting ublituximab therapy are provided. This case series was published in Frontiers in Immunology and the online version of the publication can be accessed at Frontiers in Immunology. Title: The Evolution of Anti-CD20 Treatment for Multiple Sclerosis The article focuses on the unique characteristics of the anti-CD20 monoclonal antibodies used to treat MS that may be relevant to differences in therapeutic efficacy, tolerability, and patient experience—namely, scaffold, mechanism of action (eg, complement-dependent cytotoxicity vs antibody-dependent cellular cytotoxicity), and Fc engineering. The discussion of these refinements includes improving the extent of B-cell depletion, reducing infusion-related reactions, and eliminating pharmacogenetic effects of FcγRIIIa polymorphisms. This article was published in CNS DRUGS, a division of Adis International (Spring Nature) and the online version of the article can be accessed at CNS DRUGS. ABOUT THE ULTIMATE I & II PHASE 3 TRIALS ULTIMATE I & II are two randomized, double-blind, double-dummy, parallel group, active comparator-controlled clinical trials of identical design, in patients with RMS treated for 96 weeks. Patients were randomized to receive either BRIUMVI, given as an IV infusion of 150 mg administered in four hours, 450 mg two weeks after the first infusion administered in one hour, and 450 mg every 24 weeks administered in one hour, with oral placebo administered daily; or teriflunomide, the active comparator, given orally as a 14 mg daily dose with IV placebo administered on the same schedule as BRIUMVI. Both studies enrolled patients who had experienced at least one relapse in the previous year, two relapses in the previous two years, or had the presence of a T1 gadolinium (Gd)-enhancing lesion in the previous year. Patients were also required to have an Expanded Disability Status Scale (EDSS) score from 0 to 5.5 at baseline. The ULTIMATE I & II trials enrolled a total of 1,094 patients with RMS across 10 countries. These trials were led by Lawrence Steinman, MD, Zimmermann Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University. Additional information on these clinical trials can be found at (NCT03277261; NCT03277248). ABOUT BRIUMVI® (ublituximab-xiiy) 150 mg/6 mL Injection for IV BRIUMVI is a novel monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of autoimmune disorders, such as RMS. BRIUMVI is uniquely designed to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, allows for efficient B-cell depletion at low doses. BRIUMVI is indicated for the treatment of adults with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing- remitting disease, and active secondary progressive disease. A list of authorized specialty distributors can be found at IMPORTANT SAFETY INFORMATION Active Hepatitis B Virus infection A history of life-threatening infusion reaction to BRIUMVI WARNINGS AND PRECAUTIONS Infusion Reactions: BRIUMVI can cause infusion reactions, which can include pyrexia, chills, headache, influenza-like illness, tachycardia, nausea, throat irritation, erythema, and an anaphylactic reaction. In MS clinical trials, the incidence of infusion reactions in BRIUMVI-treated patients who received infusion reaction-limiting premedication prior to each infusion was 48%, with the highest incidence within 24 hours of the first infusion. 0.6% of BRIUMVI-treated patients experienced infusion reactions that were serious, some requiring hospitalization. Observe treated patients for infusion reactions during the infusion and for at least one hour after the completion of the first two infusions unless infusion reaction and/or hypersensitivity has been observed in association with the current or any prior infusion. Inform patients that infusion reactions can occur up to 24 hours after the infusion. Administer the recommended pre-medication to reduce the frequency and severity of infusion reactions. If life-threatening, stop the infusion immediately, permanently discontinue BRIUMVI, and administer appropriate supportive treatment. Less severe infusion reactions may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment. Infections: Serious, life-threatening or fatal, bacterial and viral infections have been reported in BRIUMVI-treated patients. In MS clinical trials, the overall rate of infections in BRIUMVI-treated patients was 56% compared to 54% in teriflunomide-treated patients. The rate of serious infections was 5% compared to 3% respectively. There were 3 infection-related deaths in BRIUMVI-treated patients. The most common infections in BRIUMVI- treated patients included upper respiratory tract infection (45%) and urinary tract infection (10%). Delay BRIUMVI administration in patients with an active infection until the infection is resolved. Consider the potential for increased immunosuppressive effects when initiating BRIUMVI after immunosuppressive therapy or initiating an immunosuppressive therapy after BRIUMVI. Hepatitis B Virus (HBV) Reactivation: HBV reactivation occurred in an MS patient treated with BRIUMVI in clinical trials. Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with anti-CD20 antibodies. Perform HBV screening in all patients before initiation of treatment with BRIUMVI. Do not start treatment with BRIUMVI in patients with active HBV confirmed by positive results for HB surface antigen (HBsAg) and anti-HB tests. For patients who are negative for HBsAg and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult a liver disease expert before starting and during treatment. Progressive Multifocal Leukoencephalopathy (PML): Although no cases of PML have occurred in BRIUMVI-treated MS patients, JCV infection resulting in PML has been observed in patients treated with other anti-CD20 antibodies and other MS therapies. If PML is suspected, withhold BRIUMVI and perform an appropriate diagnostic evaluation. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. MRI findings may be apparent before clinical signs or symptoms; monitoring for signs consistent with PML may be useful. Further investigate suspicious findings to allow for an early diagnosis of PML, if present. Following discontinuation of another MS medication associated with PML, lower PML-related mortality and morbidity have been reported in patients who were initially asymptomatic at diagnosis compared to patients who had characteristic clinical signs and symptoms at diagnosis. If PML is confirmed, treatment with BRIUMVI should be discontinued. Vaccinations: Administer all immunizations according to immunization guidelines: for live or live-attenuated vaccines at least 4 weeks and, whenever possible at least 2 weeks prior to initiation of BRIUMVI for non-live vaccines. BRIUMVI may interfere with the effectiveness of non-live vaccines. The safety of immunization with live or live-attenuated vaccines during or following administration of BRIUMVI has not been studied. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion. Vaccination of Infants Born to Mothers Treated with BRIUMVI During Pregnancy: In infants of mothers exposed to BRIUMVI during pregnancy, assess B-cell counts prior to administration of live or live-attenuated vaccines as measured by CD19+ B-cells. Depletion of B-cells in these infants may increase the risks from live or live-attenuated vaccines. Inactivated or non-live vaccines may be administered prior to B-cell recovery. Assessment of vaccine immune responses, including consultation with a qualified specialist, should be considered to determine whether a protective immune response was mounted. Fetal Risk: Based on data from animal studies, BRIUMVI may cause fetal harm when administered to a pregnant woman. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 B-cell depleting antibodies during pregnancy. A pregnancy test is recommended in females of reproductive potential prior to each infusion. Advise females of reproductive potential to use effective contraception during BRIUMVI treatment and for 6 months after the last dose. Reduction in Immunoglobulins: As expected with any B-cell depleting therapy, decreased immunoglobulin levels were observed. Decrease in immunoglobulin M (IgM) was reported in 0.6% of BRIUMVI-treated patients compared to none of the patients treated with teriflunomide in RMS clinical trials. Monitor the levels of quantitative serum immunoglobulins during treatment, especially in patients with opportunistic or recurrent infections, and after discontinuation of therapy until B-cell repletion. Consider discontinuing BRIUMVI therapy if a patient with low immunoglobulins develops a serious opportunistic infection or recurrent infections, or if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins. Most Common Adverse Reactions: The most common adverse reactions in RMS trials (incidence of at least 10%) were infusion reactions and upper respiratory tract infections. Physicians, pharmacists, or other healthcare professionals with questions about BRIUMVI should visit ABOUT BRIUMVI PATIENT SUPPORT BRIUMVI Patient Support is a flexible program designed by TG Therapeutics to support U.S. patients through their treatment journey in a way that works best for them. More information about the BRIUMVI Patient Support program can be accessed at ABOUT MULTIPLE SCLEROSIS Relapsing multiple sclerosis (RMS) is a chronic demyelinating disease of the central nervous system (CNS) and includes people with relapsing- remitting multiple sclerosis (RRMS) and people with secondary progressive multiple sclerosis (SPMS) who continue to experience relapses. RRMS is the most common form of multiple sclerosis (MS) and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. It is estimated that nearly 1 million people are living with MS in the United States and approximately 85% are initially diagnosed with RRMS.1,2 The majority of people who are diagnosed with RRMS will eventually transition to SPMS, in which they experience steadily worsening disability over time. Worldwide, more than 2.3 million people have a diagnosis of MS.1 ABOUT TG THERAPEUTICS TG Therapeutics is a fully integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG has received U.S. Food and Drug Administration (FDA) approval for BRIUMVI® (ublituximab-xiiy), for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval by the European Commission (EC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features in Europe and the United Kingdom, respectively. For more information, visit and follow us on X (formerly Twitter) @TGTherapeutics and on LinkedIn. BRIUMVI® is a registered trademark of TG Therapeutics, Inc. Cautionary Statement This press release contains forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward- looking statements contained in this press release. In addition to the risk factors identified from time to time in our reports filed with the U.S. Securities and Exchange Commission (SEC), factors that could cause our actual results to differ materially include the below. Such forward looking statements include but are not limited to statements regarding the results of the ULTIMATE I & II Phase 3 studies, the ENHANCE Phase 3b study, and BRIUMVI as a treatment for relapsing forms of multiple sclerosis (RMS). Additional factors that could cause our actual results to differ materially include the following: the risk that the data from the ULTIMATE I & II or ENHANCE trials that we announce or publish may change, or the product profile of BRIUMVI may be impacted, as more data or additional endpoints are analyzed; the risk that data may emerge from future clinical studies or from adverse event reporting that may affect the safety and tolerability profile and commercial potential of BRIUMVI; the risk that any individual or series of patient's clinical experience in the post-marketing setting, or the aggregate patient experience in the post-marketing setting, may differ from that demonstrated in controlled clinical trials such as ULTIMATE I and II; the risk that BRIUMVI will not be commercially successful; our ability to expand our commercial infrastructure, and successfully market and sell BRIUMVI in RMS; the Company's reliance on third parties for manufacturing, distribution and supply, and a range of other support functions for our commercial and clinical products, including BRIUMVI, and the ability of the Company and its manufacturers and suppliers to produce and deliver BRIUMVI to meet the market demand for BRIUMVI; the failure to obtain and maintain requisite regulatory approvals, including the risk that the Company fails to satisfy post-approval regulatory requirements and general political, economic and business. Further discussion about these and other risks and uncertainties can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in our other filings with the U.S. Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at The information found on our website is not incorporated by reference into this press release and is included for reference purposes only. Investor Relations Media Relations:
Yahoo
07-04-2025
- Business
- Yahoo
TG Therapeutics Announces Two Publications Highlighting BRIUMVI in Medical Journals
NEW YORK, April 07, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) today announced the publication of two journal articles one describing the evolution of CD20 treatments for multiple sclerosis (MS) and the other detailing the experience of seven individuals with MS who switched to BRIUMVI® (ublituximab-xiiy) from a different anti-CD20 monoclonal antibody therapy due to efficacy or tolerability concerns. Details of the publications are provided below. Michael S. Weiss, the Company's Executive Chairman and Chief Executive Officer stated, "We are encouraged by these publications, and believe taken together they may provide a rationale for switching patients within the CD20 class prior to leaving the class, as well as the first anecdotal evidence of the success of such a strategy, as highlighted by the seven case reports in Frontiers in Immunology. The findings reinforce the potential of BRIUMVI in improving patient outcomes for those seeking an alternative to their previous anti-CD20 therapy. Furthermore, the article in CNS DRUGS offers an insightful look at the evolution of anti-CD20 treatments and a potential rationale as to why switching within the same class is a viable strategy. We remain committed to the MS community and believe these papers highlight the real-world impact BRIUMVI can have on the those living with MS and we will continue to study this phenomenon through our ongoing ENHANCE and ENABLE studies to assess if these anecdotal accounts can be further supported.' JOURNAL ARTICLES:Title: Switching to Ublituximab from Prior anti-CD20 Monoclonal Antibody Therapy: A Case Report Series The article describes a retrospective case series of seven individuals with multiple sclerosis (MS) treated in private practice or at an MS clinic who switched to ublituximab from a different anti-CD20 monoclonal antibody therapy due to efficacy or tolerability concerns. Details of each case, including clinical and/or radiological outcomes on initial anti-CD20 therapy, reasons for switching, and outcomes after starting ublituximab therapy are provided. This case series was published in Frontiers in Immunology and the online version of the publication can be accessed at Frontiers in Immunology. Title: The Evolution of Anti-CD20 Treatment for Multiple Sclerosis The article focuses on the unique characteristics of the anti-CD20 monoclonal antibodies used to treat MS that may be relevant to differences in therapeutic efficacy, tolerability, and patient experience—namely, scaffold, mechanism of action (eg, complement-dependent cytotoxicity vs antibody-dependent cellular cytotoxicity), and Fc engineering. The discussion of these refinements includes improving the extent of B-cell depletion, reducing infusion-related reactions, and eliminating pharmacogenetic effects of FcγRIIIa polymorphisms. This article was published in CNS DRUGS, a division of Adis International (Spring Nature) and the online version of the article can be accessed at CNS DRUGS. ABOUT THE ULTIMATE I & II PHASE 3 TRIALSULTIMATE I & II are two randomized, double-blind, double-dummy, parallel group, active comparator-controlled clinical trials of identical design, in patients with RMS treated for 96 weeks. Patients were randomized to receive either BRIUMVI, given as an IV infusion of 150 mg administered in four hours, 450 mg two weeks after the first infusion administered in one hour, and 450 mg every 24 weeks administered in one hour, with oral placebo administered daily; or teriflunomide, the active comparator, given orally as a 14 mg daily dose with IV placebo administered on the same schedule as BRIUMVI. Both studies enrolled patients who had experienced at least one relapse in the previous year, two relapses in the previous two years, or had the presence of a T1 gadolinium (Gd)-enhancing lesion in the previous year. Patients were also required to have an Expanded Disability Status Scale (EDSS) score from 0 to 5.5 at baseline. The ULTIMATE I & II trials enrolled a total of 1,094 patients with RMS across 10 countries. These trials were led by Lawrence Steinman, MD, Zimmermann Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University. Additional information on these clinical trials can be found at (NCT03277261; NCT03277248). ABOUT BRIUMVI® (ublituximab-xiiy) 150 mg/6 mL Injection for IVBRIUMVI is a novel monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of autoimmune disorders, such as RMS. BRIUMVI is uniquely designed to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, allows for efficient B-cell depletion at low doses. BRIUMVI is indicated for the treatment of adults with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing- remitting disease, and active secondary progressive disease. A list of authorized specialty distributors can be found at IMPORTANT SAFETY INFORMATIONContraindications: BRIUMVI is contraindicated in patients with: Active Hepatitis B Virus infection A history of life-threatening infusion reaction to BRIUMVI WARNINGS AND PRECAUTIONS Infusion Reactions: BRIUMVI can cause infusion reactions, which can include pyrexia, chills, headache, influenza-like illness, tachycardia, nausea, throat irritation, erythema, and an anaphylactic reaction. In MS clinical trials, the incidence of infusion reactions in BRIUMVI-treated patients who received infusion reaction-limiting premedication prior to each infusion was 48%, with the highest incidence within 24 hours of the first infusion. 0.6% of BRIUMVI-treated patients experienced infusion reactions that were serious, some requiring hospitalization. Observe treated patients for infusion reactions during the infusion and for at least one hour after the completion of the first two infusions unless infusion reaction and/or hypersensitivity has been observed in association with the current or any prior infusion. Inform patients that infusion reactions can occur up to 24 hours after the infusion. Administer the recommended pre-medication to reduce the frequency and severity of infusion reactions. If life-threatening, stop the infusion immediately, permanently discontinue BRIUMVI, and administer appropriate supportive treatment. Less severe infusion reactions may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment. Infections: Serious, life-threatening or fatal, bacterial and viral infections have been reported in BRIUMVI-treated patients. In MS clinical trials, the overall rate of infections in BRIUMVI-treated patients was 56% compared to 54% in teriflunomide-treated patients. The rate of serious infections was 5% compared to 3% respectively. There were 3 infection-related deaths in BRIUMVI-treated patients. The most common infections in BRIUMVI- treated patients included upper respiratory tract infection (45%) and urinary tract infection (10%). Delay BRIUMVI administration in patients with an active infection until the infection is resolved. Consider the potential for increased immunosuppressive effects when initiating BRIUMVI after immunosuppressive therapy or initiating an immunosuppressive therapy after BRIUMVI. HBV reactivation occurred in an MS patient treated with BRIUMVI in clinical trials. Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with anti-CD20 antibodies. Perform HBV screening in all patients before initiation of treatment with BRIUMVI. Do not start treatment with BRIUMVI in patients with active HBV confirmed by positive results for HB surface antigen (HBsAg) and anti-HB tests. For patients who are negative for HBsAg and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult a liver disease expert before starting and during treatment. Although no cases of PML have occurred in BRIUMVI-treated MS patients, JCV infection resulting in PML has been observed in patients treated with other anti-CD20 antibodies and other MS therapies. If PML is suspected, withhold BRIUMVI and perform an appropriate diagnostic evaluation. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. MRI findings may be apparent before clinical signs or symptoms; monitoring for signs consistent with PML may be useful. Further investigate suspicious findings to allow for an early diagnosis of PML, if present. Following discontinuation of another MS medication associated with PML, lower PML-related mortality and morbidity have been reported in patients who were initially asymptomatic at diagnosis compared to patients who had characteristic clinical signs and symptoms at diagnosis. If PML is confirmed, treatment with BRIUMVI should be discontinued. Administer all immunizations according to immunization guidelines: for live or live-attenuated vaccines at least 4 weeks and, whenever possible at least 2 weeks prior to initiation of BRIUMVI for non-live vaccines. BRIUMVI may interfere with the effectiveness of non-live vaccines. The safety of immunization with live or live-attenuated vaccines during or following administration of BRIUMVI has not been studied. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion. In infants of mothers exposed to BRIUMVI during pregnancy, assess B-cell counts prior to administration of live or live-attenuated vaccines as measured by CD19+ B-cells. Depletion of B-cells in these infants may increase the risks from live or live-attenuated vaccines. Inactivated or non-live vaccines may be administered prior to B-cell recovery. Assessment of vaccine immune responses, including consultation with a qualified specialist, should be considered to determine whether a protective immune response was mounted. Fetal Risk: Based on data from animal studies, BRIUMVI may cause fetal harm when administered to a pregnant woman. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 B-cell depleting antibodies during pregnancy. A pregnancy test is recommended in females of reproductive potential prior to each infusion. Advise females of reproductive potential to use effective contraception during BRIUMVI treatment and for 6 months after the last dose. Reduction in Immunoglobulins: As expected with any B-cell depleting therapy, decreased immunoglobulin levels were observed. Decrease in immunoglobulin M (IgM) was reported in 0.6% of BRIUMVI-treated patients compared to none of the patients treated with teriflunomide in RMS clinical trials. Monitor the levels of quantitative serum immunoglobulins during treatment, especially in patients with opportunistic or recurrent infections, and after discontinuation of therapy until B-cell repletion. Consider discontinuing BRIUMVI therapy if a patient with low immunoglobulins develops a serious opportunistic infection or recurrent infections, or if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins. Most Common Adverse Reactions: The most common adverse reactions in RMS trials (incidence of at least 10%) were infusion reactions and upper respiratory tract infections. Physicians, pharmacists, or other healthcare professionals with questions about BRIUMVI should visit ABOUT BRIUMVI PATIENT SUPPORTBRIUMVI Patient Support is a flexible program designed by TG Therapeutics to support U.S. patients through their treatment journey in a way that works best for them. More information about the BRIUMVI Patient Support program can be accessed at ABOUT MULTIPLE SCLEROSISRelapsing multiple sclerosis (RMS) is a chronic demyelinating disease of the central nervous system (CNS) and includes people with relapsing- remitting multiple sclerosis (RRMS) and people with secondary progressive multiple sclerosis (SPMS) who continue to experience relapses. RRMS is the most common form of multiple sclerosis (MS) and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. It is estimated that nearly 1 million people are living with MS in the United States and approximately 85% are initially diagnosed with RRMS.1,2 The majority of people who are diagnosed with RRMS will eventually transition to SPMS, in which they experience steadily worsening disability over time. Worldwide, more than 2.3 million people have a diagnosis of MS.1 ABOUT TG THERAPEUTICSTG Therapeutics is a fully integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG has received U.S. Food and Drug Administration (FDA) approval for BRIUMVI® (ublituximab-xiiy), for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval by the European Commission (EC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features in Europe and the United Kingdom, respectively. For more information, visit and follow us on X (formerly Twitter) @TGTherapeutics and on LinkedIn. BRIUMVI® is a registered trademark of TG Therapeutics, Inc. Cautionary StatementThis press release contains forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward- looking statements contained in this press release. In addition to the risk factors identified from time to time in our reports filed with the U.S. Securities and Exchange Commission (SEC), factors that could cause our actual results to differ materially include the below. Such forward looking statements include but are not limited to statements regarding the results of the ULTIMATE I & II Phase 3 studies, the ENHANCE Phase 3b study, and BRIUMVI as a treatment for relapsing forms of multiple sclerosis (RMS). Additional factors that could cause our actual results to differ materially include the following: the risk that the data from the ULTIMATE I & II or ENHANCE trials that we announce or publish may change, or the product profile of BRIUMVI may be impacted, as more data or additional endpoints are analyzed; the risk that data may emerge from future clinical studies or from adverse event reporting that may affect the safety and tolerability profile and commercial potential of BRIUMVI; the risk that any individual or series of patient's clinical experience in the post-marketing setting, or the aggregate patient experience in the post-marketing setting, may differ from that demonstrated in controlled clinical trials such as ULTIMATE I and II; the risk that BRIUMVI will not be commercially successful; our ability to expand our commercial infrastructure, and successfully market and sell BRIUMVI in RMS; the Company's reliance on third parties for manufacturing, distribution and supply, and a range of other support functions for our commercial and clinical products, including BRIUMVI, and the ability of the Company and its manufacturers and suppliers to produce and deliver BRIUMVI to meet the market demand for BRIUMVI; the failure to obtain and maintain requisite regulatory approvals, including the risk that the Company fails to satisfy post-approval regulatory requirements and general political, economic and business. Further discussion about these and other risks and uncertainties can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in our other filings with the U.S. Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at The information found on our website is not incorporated by reference into this press release and is included for reference purposes only. CONTACT: Investor RelationsEmail: ir@ (8489), Option 4 Media Relations:Email: media@ (8489), Option 6 1. MS Prevalence. National Multiple Sclerosis Society website: Accessed October 26, 2020. 2. Multiple Sclerosis International Federation, 2013 via Datamonitor in to access your portfolio
Yahoo
17-03-2025
- Health
- Yahoo
Astronauts' Health During Space Missions: Nichi BRITE and Neu REFIX Beta Glucans Could Benefit by Neutrophil-to-Lymphocyte Ratio, IL-6 Control, the Immune Biomarkers of Aging and Longevity
TOKYO, March 17, 2025--(BUSINESS WIRE)--Neutrophil to Lymphocyte ratio (NLR) is a critical biomarker of health of astronauts during space mission, and that of aging related illnesses, inflammaging, longevity and cancer prognosis. Oral consumption of AFO-202 strain of Aureobasidium pullulans produced Nichi BRITE and N-163 strain produced Neu REFIX together in pre-clinical and clinical studies having safely and beneficially modified NLR, are considered holding potential to help maintain astronauts health during space flight and also to bridge the gap between health span and life span by 'Me-Byo' phenomenon as published in Frontiers in Immunology while Neu REFIX standalone yielding enhanced dystrophin, an additional benefit that might help prevent muscle loss during space missions. Astronauts during space travel are exposed to ionizing radiation, circadian rhythm disruption and microgravity leading to stress, inflammation and immune dysfunction which reflects as an increase in NLR. There has been no safe intervention using a food supplement reported yet beneficially modifying NLR, according to the authors. They added that Nichi BRITE reporting immune enhancement and anti-cancer effects, Neu REFIX for its immune modulation and anti-fibrotic effects apart from enhanced gravisensing dystrophin in pre-clinical and clinical studies; when consumed together efficiently enhances butyrate, an indicator of health and longevity through beneficial gut microbiome modulation are worth further research in simulated microgravity and for vulnerable populations, specially immunocompromised and in auto-immune diseases. These potentials may bridge the gap between health span and lifespan. Neu REFIX has been granted ODD and RPD by US FDA for treatment of Duchenne Muscular Dystrophy (DMD). Hastening process of aging & inflammaging during space flight and muscle mass reduction similar to old age reflected by NLR and dystrophin levels, being beneficially modified by these unique exo-polysaccharide beta glucans manufactured in Japan as food supplements open a new area of research which could help space travel and also aging & longevity related health indices. Research could also be of help in the health and resilience of individuals working in harsh environmental conditions such as deep-sea researchers, high-altitude climbers, polar expeditions and workers prone to radiation hazards. *B-1,3-1,6 glucan is a listed food additive in MHLW, Japan; Not a drug or remedy to any illness. Research findings should not be construed as medical advice. Not GRAS, EFSA certified. View source version on Contacts Samuel JK Abrahaminfo@
Associated Press
17-03-2025
- Health
- Associated Press
Astronauts' Health During Space Missions: Nichi BRITE and Neu REFIX Beta Glucans Could Benefit by Neutrophil-to-Lymphocyte Ratio, IL-6 Control, the Immune Biomarkers of Aging and Longevity
Neutrophil to Lymphocyte ratio (NLR) is a critical biomarker of health of astronauts during space mission, and that of aging related illnesses, inflammaging, longevity and cancer prognosis. Oral consumption of AFO-202 strain of Aureobasidium pullulans produced Nichi BRITE and N-163 strain produced Neu REFIX together in pre-clinical and clinical studies having safely and beneficially modified NLR, are considered holding potential to help maintain astronauts health during space flight and also to bridge the gap between health span and life span by ' Me-Byo' phenomenon as published in Frontiers in Immunology while Neu REFIX standalone yielding enhanced dystrophin, an additional benefit that might help prevent muscle loss during space missions. This press release features multimedia. View the full release here: Astronauts during space missions, deep-sea researchers, high-altitude climbers, and workers exposed to radiation hazards, are highly prone to hastened process of aging and inflammaging, reflected by increase in NLR, Interleukin-6, gut dysbiosis and immune dysfunction. Going by earlier pre-clinical & clinical studies where oral consumption of Nichi BRITE and Neu REFIX beta-glucans have shown to safely and beneficially modify those biomarkers including reduction of D-Dimer and Ferritin, besides Neu REFIX standalone reducing skeletal muscle fibrosis are considered holding potentials for benefitting those undertaking expeditions in hostile conditions. Upon validation, they could be included in the guidelines as an ingredient especially for space foods. These exo-polysaccharide beta glucans produced by unique strains of Aureobasidium Pullulans are food supplements and not a drug or remedy for any illness. Research outcomes are not to be construed as medical advice. Astronauts during space travel are exposed to ionizing radiation, circadian rhythm disruption and microgravity leading to stress, inflammation and immune dysfunction which reflects as an increase in NLR. There has been no safe intervention using a food supplement reported yet beneficially modifying NLR, according to the authors. They added that Nichi BRITE reporting immune enhancement and anti-cancer effects, Neu REFIX for its immune modulation and anti-fibrotic effects apart from enhanced gravisensing dystrophin in pre-clinical and clinical studies; when consumed together efficiently enhances butyrate, an indicator of health and longevity through beneficial gut microbiome modulation are worth further research in simulated microgravity and for vulnerable populations, specially immunocompromised and in auto-immune diseases. These potentials may bridge the gap between health span and lifespan. Neu REFIX has been granted ODD and RPD by US FDA for treatment of Duchenne Muscular Dystrophy (DMD). Hastening process of aging & inflammaging during space flight and muscle mass reduction similar to old age reflected by NLR and dystrophin levels, being beneficially modified by these unique exo-polysaccharide beta glucans manufactured in Japan as food supplements open a new area of research which could help space travel and also aging & longevity related health indices. Research could also be of help in the health and resilience of individuals working in harsh environmental conditions such as deep-sea researchers, high-altitude climbers, polar expeditions and workers prone to radiation hazards. *B-1,3-1,6 glucan is a listed food additive in MHLW, Japan; Not a drug or remedy to any illness. Research findings should not be construed as medical advice. Not GRAS, EFSA certified. SOURCE: GN Corporation Co Ltd Copyright Business Wire 2025. PUB: 03/17/2025 05:22 AM/DISC: 03/17/2025 05:21 AM
