Latest news with #IgG4
Yahoo
5 days ago
- Business
- Yahoo
IgG4-Related Disease Market Insights, Epidemiology, and Forecast to 2034: UPLIZNA and Obexelimab Expected to Compete Strongly
Dublin, June 03, 2025 (GLOBE NEWSWIRE) -- The "IgG4-Related Disease - Market Insight, Epidemiology, and Market Forecast - 2034" report has been added to offering. This report delivers an in-depth understanding of historical and forecasted epidemiology as well as market trends in the United States, EU4 (Germany, France, Italy, Spain) and the United Kingdom, and Japan. The report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM market size from 2020 to 2034. The report also covers current treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential. Key Highlights from the Report There were nearly 148,970 diagnosed prevalent cases of IgG4-RD in 7MM in 2024. Among these, the US accounted for the highest number of diagnosed prevalent cases of IgG4-RD. Contrary to the scenario in the US and EU4, and the UK, there have been multiple studies conducted in Japan stating the diagnosed prevalence; therefore, based on 10-year cumulative diagnosed prevalence estimates from the National Database in Japan, along with evidence around drastic increase in the diagnosis of IgG4 related disease from 2015-2018, there were ~38,690 diagnosed cases in 2024 in Japan. Almost 20-30% of the diagnosed IgG4 patients do not undergo any treatment by systemic therapies, as they opt for either surgery or are under a watchful waiting strategy. There are no specific drugs to cure IgG4-RD due to unclear pathophysiology completely, and no approved therapies are available. The main treatment is corticosteroids like prednisone to manage inflammation and symptoms. If the disease relapses or doesn't respond, immunosuppressants like azathioprine or methotrexate may be used to reduce steroid dependence. Rituximab, an anti-CD20 monoclonal antibody, has also shown effectiveness in controlling inflammation and slowing disease progression. Glucocorticoids remain the first-line therapy. The current constrained pipeline features three emerging therapies: UPLIZNA (Amgen), obexelimab (Zenas BioPharma and Bristol Myers Squibb), and rilzabrutinib (Sanofi). Among these emerging therapies, UPLIZNA and obexelimab are expected to compete with each other strongly. The anticipated April 2025 approval of UPZILNA will transform the IgG4-RD market, marking the first-ever approved therapy for this underserved condition. It will redefine the treatment landscape, drive higher diagnosis rates, and shape commercial dynamics through pricing and physician adoption. However, market education, real-world validation, and future competition will influence its long-term impact. Rilzabrutinib, a Phase II therapy, represents a promising oral therapy targeting B-cell signaling pathways. If approved, it could disrupt the IV/SC biologic market by offering a more convenient, self-administered alternative. In 2024, the total market size of IgG4-RD in 7MM was nearly USD 170 million. The market size is expected to observe significant growth after the approval of potential emerging therapies in the pipeline. IgG4-RD EpidemiologyAs the market is derived using a patient-based model, the IgG4-RD epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total diagnosed prevalent cases of IgG4-RD, gender-specific diagnosed prevalent cases of IgG4-RD, and age-specific diagnosed prevalent cases of IgG4-RD in the 7MM covering the United States, EU4 countries (Germany, France, Italy, Spain) and the United Kingdom, and Japan from 2020 to 2034. In 2024, the total diagnosed prevalent cases of IgG4-RD in the United States were approximately 56,800 cases, projected to increase during the forecast period (2025-2034). In 2024, gender-specific diagnosed prevalent cases accounted for approximately 39,100 and 17,700 cases for males and females, respectively, in the US. The total diagnosed prevalent cases of IgG4-RD in EU4 and the UK were approximately 53,550 in 2024. Males accounted for approximately 38,850 cases, and 14,750 cases in females. We have considered six age groups for the categorization of age groups, i.e., 0-17 years, 18-29 years, 30-44 years, 45-64 years, 65-74 years, and =75 years. As per our analysis, a higher percentage of diagnosed prevalent cases was observed in the age group =75 years in Japan. In 2024, the age-specific diagnosed prevalent cases of IgG4-RD in Japan were approximately 12,800 cases in the age group =75 years. The cases will increase during the forecast period (2025-2034). Drug ChaptersThe drug chapter segment of the IgG4-RD report encloses a detailed analysis of IgG4-RD marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also helps understand the IgG4-RD clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press Drugs Obexelimab (XmAb5871): Zenas BioPharma and Bristol Myers SquibbObexelimab (XmAb5871) is a bifunctional monoclonal antibody designed to bind both CD19 and Fc?RIIb, which are broadly present across B-cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. This unique mechanism of action and self-administered SC injection regimen may broadly and effectively address the pathogenic role of B-cell lineage in chronic autoimmune Zenas is conducting multiple Phase II and Phase III trials of obexelimab in several autoimmune diseases, including IgG4-RD, multiple sclerosis, systemic lupus erythematosus, and warm autoimmune hemolytic anemia. In August 2023, The Lancet Rheumatology published findings from a Phase II study evaluating obexelimab for the treatment of patients with IgG4-RD. Based on these results, a Phase III study in patients with IgG4-RD is ongoing to investigate further the efficacy and safety of obexelimab administered as an SC (inebilizumab): AmgenUPLIZNA is a humanized monoclonal antibody that causes targeted and sustained depletion of key cells that contribute to the underlying disease process (autoantibody-producing CD19+ B cells, including plasmablasts and some plasma cells). After two initial infusions, patients need one dose of UPLIZNA every 6 months. UPLIZNA is currently approved for the treatment of Neuromyelitis Optica. Currently, the drug has completed its Phase III results, and the FDA has granted a PDUFA action date of April 3, is anticipated to be the first approved cornerstone therapy for managing this complex and often debilitating condition, providing significant benefits to patients while addressing a critical gap in current treatment options for IgG4-RD. In the future, the drug could face competition with the approval of obexelimab, which operates through a bifunctional targeting mechanism of Class InsightsThe current IgG4-RD emerging landscape has only three drugs. Among them, obexelimab (bifunctionally) and UPLIZNA target CD-19. Targeting CD19, a protein found in B cells, shows promise as a treatment for IgG4-RD by depleting B cells, which are thought to play a role in the disease's pathogenesis. Specifically, UPLIZNA, a CD19-targeted antibody, has demonstrated efficacy in reducing flares and achieving remission in IgG4-RD OutlookAs the etiology of IgG4-RD is unclear and still being studied, no particular medications can cure the disease. For people with IgG4-RD, there are no approved treatments on the market at this time. The criteria for identifying the disease caused by IgG4 levels and patient treatment recommendations were recently detailed in the guidelines released by the "International Consensus Guidance Statement on the Management and Treatment of IgG4-RD."Patients with IgG4-RD that are active or untreated typically get glucocorticoids as their first line of therapy. Depending on the severity of the condition and the urgency of the situation, remission induction is frequently started with 30-40 mg/day of prednisone or a weight-adjusted dosage of 0.6 mg/kg of body weight each certain instances, conventional "Disease-Modifying Anti-Rheumatic Drugs" (DMARDs) are utilized to treat IgG4-RD. Plasmablasts are the first cell in any rheumatologic disorder to serve as an effective biomarker, and tailored therapy in B-cell employs total plasmablast concentration to track disease numerous potential therapies are being investigated to manage IgG4-RD, it is safe to predict that the treatment space will experience significant reconstitution during the forecast period. However, the challenges of pricing and reimbursement accompanied by will decide the fate of all these pipeline therapies and the impact they will have on overall revenue players such as Zenas Biopharma, Amgen, and Sanofi are evaluating their lead candidates in different stages of clinical development, respectively. They aim to investigate their products to treat IgG4-RD. In 2024, the US captured the highest market share, i.e., nearly USD 90 million out of all the 7MM countries. EU4 and the UK accounted for nearly USD 80 million of the market share, and Germany accounted for the highest share in Europe in 2024. In Japan, the IgG4-RD market size accounted for nearly USD 6 million and is expected to increase at a significant CAGR during the forecast period (2025-2034). The lack of an established regulatory precedent and standardized endpoints for IgG4-RD trials poses approval risks. Additionally, payer resistance to high-cost biologics may slow adoption, especially if off-label rituximab remains a cost-effective alternative. However this will not be an issue in Japan as rituximab is not yet permitted for use to treat IgG4-RD in Japan due to Japanese medical insurance reasons. Key Updates In November 2024, Zenas BioPharma announced the completion of its targeted enrollment for the Phase III INDIGO trial of its lead product candidate, obexelimab, for the treatment of patients with IgG4-RD. In November 2024, Zenas BioPharma announced that the company anticipates reporting topline results for the INDIGO trial by the end of 2025. In August 2024, Amgen announced that the US FDA had granted Breakthrough Therapy Designation (BTD) to UPLIZNA for the treatment of IgG4-RD based on data from the MITIGATE study. In February 2025, Amgen announced that the FDA had accepted the regulatory submission for the Phase III MITIGATE study under priority review, with a PDUFA action date of April 3, 2025. IgG4-RD Drugs UptakeThis section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020-2034. The landscape of IgG4-RD treatment has experienced a profound transformation with the uptake of novel drugs. These innovative therapies are redefining standards of care. Furthermore, the increased uptake of these transformative drugs is a testament to the unwavering dedication of physicians, oncology professionals, and the entire healthcare community in their tireless pursuit of advancing cancer care. This momentous shift in treatment paradigms is a testament to the power of research, collaboration, and human ActivitiesThe report provides insights into different therapeutic candidates in Phase III, Phase II/III, Phase II, Phase I/II, and Phase I. It also analyzes key players involved in developing targeted ActivitiesThe report covers detailed information on collaborations, acquisitions and mergers, licensing, and patent details for IgG4-RD emerging ViewsTo keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Some of the leaders like MD, PhD, Research Project Manager, Director, and others. Their opinion helps to understand and validate current and emerging therapies and treatment patterns or IgG4-RD market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as the Massachusetts General Hospital, Hopital La Timone, Harvard Medical School, Hospital Universitari Vall d'Hebron, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, etc., were contacted. Their opinion helps understand and validate IgG4-RD epidemiology and market trends. Reasons to Buy The report will help in developing business strategies by understanding trends shaping and driving IgG4-RD. To understand the future market competition in the IgG4-RD market and an Insightful review of the SWOT analysis of IgG4-RD. Organize sales and marketing efforts by identifying the best opportunities for IgG4-RD in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan. Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors. Organize sales and marketing efforts by identifying the best opportunities for the IgG4-RD market. To understand the future market competition in the IgG4-RD market. For more information about this report visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
28-05-2025
- Business
- Yahoo
GlycoEra secures $130m to progress IgG4-targeted protein degrader
Biotechnology company GlycoEra has closed an oversubscribed Series B financing round, raising $130m, to support the progression of its lead immunoglobulin G4 (IgG4)-targeted protein degrader through clinical proof-of-concept. The investment will help in developing the company's pipeline of precision extracellular degraders for immunology and other indications. Spearheaded by Novo Holdings, the financing round also saw contributions from new investors, including Catalio Capital Management, QIA and LifeArc Ventures. Current investors Sofinnova Partners, Roche Ventures, Bristol Myers Squibb, and 5AM Ventures also participated in the round. Joining the syndicate were Sixty Degree Capital, Agent Capital, and MP Healthcare Venture Management, Mitsubishi Tanabe Pharma's subsidiary. GlycoEra noted that its platform is capable of targeting a wide range of extracellular proteins, and the company's bispecific degraders utilise a natural process to degrade proteins, offering a sustained removal of disease-causing proteins rapidly while eliminating systemic off-target effects. This method is said to contrast with traditional approaches, as the production of the company's degraders takes place via a single-step recombinant process, providing scalability and modularity. The company's lead programme, GE8820, aims to degrade pathogenic IgG4 autoantibodies selectively, without causing immunosuppression. GlycoEra CEO and president Ganesh Kaundinya said: 'Our lead programme, which has demonstrated deep and rapid IgG4 degradation preclinically, presents an opportunity to deliver transformative therapies to patients suffering from multiple autoimmune diseases. With this financing, we plan to initiate first-in-human clinical trials for our lead programme later this year. 'This financing is a strong validation of our science and platform, allowing us to accelerate our lead program into clinical development while advancing our robust pipeline of precision immunology medicines.' Furthermore, the company has added three new members to its board of directors: Max Klement, Matthew Hobson, Catalio Capital Management principal, and LifeArc Ventures partner Sohaib Mir, Partner. GlycoEra is based in Switzerland and operates additional offices and labs in the US. "GlycoEra secures $130m to progress IgG4-targeted protein degrader " was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Yahoo
27-05-2025
- Business
- Yahoo
GlycoEra raises $130M, riding interest in protein degraders
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. A biotechnology startup developing drugs designed to eliminate troublesome proteins found outside of cells has raised $130 million to start its first clinical trial. The startup, GlycoEra, will use the Series B funds to generate initial clinical data for its lead program, an immune disease treatment dubbed GE8820. It intends to bring a second immune drug into human testing as well. GlycoEra views GE8820 as having the type of broad potential that could make it a 'pipeline in a product,' said company president and CEO Ganesh Kaundinya. The drug targets IgG4, a circulating antibody that can be protective against allergies, but malfunctions and attacks the body's own tissues in many autoimmune conditions, among them the skin disorder pemphigus and the kidney condition primary membranous nephropathy. GE8820 is a dual-acting drug that coaxes the body into destroying this defective IgG4. One part of the molecule binds to the antibody and drags it to the liver. The other part then latches onto a receptor that absorbs IgG4 into cells, where it's trashed by an internal protein-disposal system. According to GlycoEra, preclinical testing has shown the approach can remove malfunctioning IgG4 antibodies with the type of precision not seen with other approaches. By doing so, GE8820 may avoid the broadly immunosuppressive effects of other autoimmune medicines. It may also ease the 'burden on the healthcare system,' Kaundinya said. Patients typically 'get treated, they get better, they are fine, and then they come back to that relapse,' Kaundinya said. 'Our approach not only enables the patients to live better lives, it also overall contributes to better healthcare economics across the board.' GlycoEra has publicly disclosed three other programs behind GE8820, but hasn't specified which diseases they're targeting. The company could submit a request to begin trials for its second drug in 2026, according to its website. Novo Holdings led GlycoEra's Series B round, which involved the venture arms of Roche and Bristol Myers Squibb, Sofinnova Partners and several other firms. 'What really stood out with GlycoEra is that you had a use case here where, in autoimmune disease, there's limited competition, a high amount of medical need and the biological rationale is really strong,' said Novo Holdings partner Max Klement. 'As we see the autoimmune disease space evolve, precision medicine makers such as GlycoEra are going to come to the forefront.' GlycoEra is named after glycosylation, the process by which sugar chains are attached to proteins. The company is headquartered in Wädenswil, Switzerland and has a U.S. footprint in Newton, Massachusetts. It was spun out of Swiss biotech LimmaTech Biologics in January 2021, and raised approximately $49 million in Series A funding that November. The company's latest round is further evidence of continued interest in so-called protein degraders, which offer a way of getting to proteins traditional drugmaking methods can't reach. Research into protein degradation has taken off since the turn of the century, yielding an array of companies using different methods to destroy harmful proteins. Many of these companies are focused on protein targets inside of cells. GlycoEra is among those zeroing in on so-called extracellular proteins outside of cells or on their membranes. Fellow startups EpiBiologics and Lycia Therapeutics are as well. Sign in to access your portfolio
Business Wire
15-05-2025
- Business
- Business Wire
Agenus Announces New Data from Expanded MSS Metastatic Colorectal Cancer Cohort to be Presented at ESMO GI 2025
LEXINGTON, Mass.--(BUSINESS WIRE)-- Agenus Inc. ('Agenus' or the Company') (NASDAQ: AGEN), a leader in immuno-oncology, today announced new data from its ongoing Phase 1 trial evaluating botensilimab and balstilimab (BOT/BAL) in patients with microsatellite stable (MSS) metastatic colorectal cancer (mCRC) at the 2025 European Society for Medical Oncology (ESMO) Gastrointestinal Cancers Congress in Barcelona, Spain. A poster presentation will feature updated findings from an expanded cohort of 123 patients, incorporating additional participants and extended follow-up to further assess clinical activity of the combination, including durability of response and overall survival (NCT03860272). Presentation Details: Presentation: Botensilimab plus balstilimab in an expanded cohort of 123 patients with metastatic microsatellite stable colorectal cancer and no active liver metastases Presenting Author: Dr. Benjamin Schlechter, Dana Farber Cancer Institute Poster Number: 8P About Botensilimab (BOT) Botensilimab is a human Fc enhanced CTLA-4 blocking antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to 'cold' tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses. Approximately 1,100 patients have been treated with botensilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus' investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit About Balstilimab (BAL) Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. It has been evaluated in >900 patients to date and has demonstrated clinical activity and a favorable tolerability profile in several tumor types. About Agenus Agenus is a leading immuno-oncology company targeting cancer with a comprehensive pipeline of immunological agents. The company was founded in 1994 with a mission to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants (through SaponiQx). Agenus has robust end-to-end development capabilities, across commercial and clinical cGMP manufacturing facilities, research and discovery, and a global clinical operations footprint. Agenus is headquartered in Lexington, MA. For more information, visit or @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels. Forward-Looking Statements This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding its botensilimab and balstilimab programs, expected regulatory timelines and filings, and any other statements containing the words "may," "believes," "expects," "anticipates," "hopes," "intends," "plans," "forecasts," "estimates," "will," 'establish,' 'potential,' 'superiority,' 'best in class,' and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Annual Report on Form 10-K for 2024, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.
Yahoo
02-04-2025
- Health
- Yahoo
Desentum to advance pollen allergy vaccine after positive Phase I trial
A vaccine designed to ward against allergic reactions brought on by birch pollen has proven to be safe and well-tolerated while showing early and sustained signs of efficacy. Finnish biopharma Desentum Oy is advancing the vaccine, dubbed DM-101PX, to Phase II studies after it announced positive results from a randomised, double-blind, placebo-controlled Phase I trial (NCT04266028). The trial investigated the short-course treatment in patients allergic to birch pollen. According to the company, nearly all patients reached their targeted maximum dose whilst demonstrating a strong Immunoglobulin G4 (IgG4) response. The company has said that results from the Phase I trial saw DM-101PX able to induce an allergen-specific IgG4 response, which was found to be effective at blocking immunoglobulin E (IgE). Desentum CEO Pekka Mattila said: 'We are very excited to see that a short treatment with DM-101PX is safe and able to induce a very strong protective immune response, which exceeds that of marketed Allergen immunotherapy products. 'The results endorse Desentum's approach to designing highly efficient allergy vaccines. Based on the positive data from Phase I, we have decided to advance the product into Phase II clinical trials in which the clinical effects of treatment with DM-101PX will be investigated.' The trial recruited 30 adult patients from a single site in Finland who were randomised into three dose escalation cohorts and a placebo group. Each cohort received ten subcutaneous injections over ten weeks. Doses escalated from ten nanograms (ng) of DM-101PX on day one, up to 100ng on days 28, 42, and 56 in the lower multiple-ascending dose (MAD) group, and up to 300ng by day 56 in the highest dose group. According to Desentum, the active ingredient in DM-101PX is a genetically engineered version of the recombinant variant of major birch pollen, Bet v 1. Research by GlobalData estimates that the global market for pollen allergy medications brought in $84m in 2024 alone. GlobalData is the parent company of Clinical Trials Arena. Elsewhere in the world of allergy therapies, ALK's Itulatek (birch pollen allergen extract) has met its primary endpoint in the Phase III paediatric clinical trial for treating tree-pollen-induced allergic rhinoconjunctivitis. Meanwhile, Stallergenes Greer has initiated a Phase III clinical study of Staloral Birch to treat children and adolescents with birch pollen-induced allergic rhino-conjunctivitis. "Desentum to advance pollen allergy vaccine after positive Phase I trial" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
