Latest news with #Telitacicept
Business Insider
4 days ago
- Business
- Business Insider
Vor Bio enters into license pact witht RemeGen for late-stage autoimmune asset
Vor Bio (VOR) and RemeGen announced entry into an exclusive license agreement granting Vor Bio global rights to develop and commercialize telitacicept, a novel dual-target fusion protein approved in China for generalized myasthenia gravis, systemic lupus erythematosus, and rheumatoid arthritis. Under the terms of the agreement, Vor Bio will pay RemeGen an initial payment of $125M consisting of an upfront payment of $45M as well as $80M of warrants to purchase common stock with an exercise price of $0.0001 per share. The agreement also provides for potential regulatory and commercial milestones exceeding $4B, in addition to tiered royalties. Telitacicept is a novel, investigational fusion protein that targets key immune pathways involved in autoimmune disease. By selectively inhibiting BlyS and APRIL – cytokines critical to B cell survival – telitacicept reduces autoreactive B cells and autoantibody production. RemeGen is conducting a global Phase 3 clinical trial which is now enrolling in the United States, Europe, and South America, with initial results expected in the first half of 2027. Confident Investing Starts Here:
Business Upturn
4 days ago
- Business
- Business Upturn
Vor Bio Enters into Exclusive Global License Agreement with RemeGen for Late-Stage Autoimmune Asset
– Vor Bio receives ex-Greater China rights to develop and commercialize telitacicept, a novel, dual-target recombinant fusion protein in global Phase 3 development for generalized myasthenia gravis -RemeGen receives initial payment of $125 million consisting of an upfront payment of $45 million plus $80 million of warrants, potential regulatory and commercial milestones exceeding $4 billion, as well as tiered royalties -Seasoned biopharma leader, Jean-Paul Kress, MD, appointed as Chief Executive Officer and Chairman of the Board, bringing proven track record in clinical development, commercialization, and strategic growth CAMBRIDGE, Mass., June 25, 2025 (GLOBE NEWSWIRE) — Vor Bio, Inc. (Nasdaq: VOR) and RemeGen Co., Ltd. (HKEX: 9995, SHA: 688331) today announced entry into an exclusive license agreement granting Vor Bio global rights (excluding China, Hong Kong, Macau and Taiwan) to develop and commercialize telitacicept, a novel dual-target fusion protein approved in China for generalized myasthenia gravis (gMG), systemic lupus erythematosus (SLE), and rheumatoid arthritis (RA). Under the terms of the agreement, Vor Bio will pay RemeGen an initial payment of $125 million consisting of an upfront payment of $45 million as well as $80 million of warrants to purchase common stock with an exercise price of $0.0001 per share. The agreement also provides for potential regulatory and commercial milestones exceeding $4 billion, in addition to tiered royalties. Telitacicept is a novel, investigational fusion protein that targets key immune pathways involved in autoimmune disease. By selectively inhibiting BlyS (also known as BAFF) and APRIL – cytokines critical to B cell survival – telitacicept reduces autoreactive B cells and autoantibody production. RemeGen is conducting a global Phase 3 clinical trial which is now enrolling in the United States, Europe, and South America, with initial results expected in the first half of 2027. Vor Bio also announced that its Board of Directors (the 'Board') has appointed Jean-Paul Kress, M.D., as Chief Executive Officer and Chairman of the Board, effective today. This follows Dr. Robert Ang's resignation from the positions of Chief Executive Officer and director earlier today. Dr. Ang will continue with Vor Bio as a strategic advisor to assist in the transition through October 2025. Dr. Kress's strategic vision and track record of transformative leadership position him to guide the company into its next phase of growth. 'I am absolutely thrilled to be leading Vor Bio as we transform the company to become a major player in autoimmune disease treatment,' said Dr. Kress, Chairman and Chief Executive Officer, Vor Bio. 'Targeting BAFF/APRIL signaling with telitacicept represents a significant advancement in addressing autoantibody driven diseases, which is highly differentiated from other modalities in this space. With a clinically advanced asset, we are uniquely positioned to develop this innovative therapy, with the goal of making a meaningful impact for patients living with autoimmune diseases around the world.' Dr. Kress brings decades of executive leadership experience in the pharmaceutical and biotech industries. He most recently served as Chief Executive Officer of MorphoSys, where he led the development, approval and commercialization of Monjuvi®️ (tafasitamab), and advanced the company's pipeline through the landmark acquisition of Constellation Pharmaceuticals in 2021, strengthening MorphoSys' position in oncology innovation and ultimately leading to its subsequent acquisition by Novartis in 2024. Prior to that, he was CEO of Syntimmune, guiding its lead immunology program through to acquisition by Alexion Pharmaceuticals. He currently serves on the Board of Sanofi S.A. and has held senior roles across leading biopharma companies. 'Today marks a transformative milestone for RemeGen and the global development of telitacicept,' said Dr. Jianmin Fang, CEO of RemeGen. 'The strategic out-licensing of telitacicept's ex-China rights accelerates our mission to deliver this innovative therapy to patients worldwide and will help maximize telitacicept's clinical and commercial potential on the global scale.' About Telitacicept Telitacicept is a novel, investigational recombinant fusion protein designed to treat autoimmune diseases by selectively inhibiting BLyS (BAFF) and APRIL – two cytokines essential to B cell and plasma cell survival. This dual-target mechanism reduces autoreactive B cells and autoantibody production, key drivers of autoimmune pathology. In a Phase 3 clinical trial in generalized myasthenia gravis in China, telitacicept demonstrated a 4.8-point improvement in MG-ADL (Myasthenia Gravis Activities of Daily Living scale) vs. placebo at 24 weeks, the primary endpoint of the trial. Telitacicept is approved in China for systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and generalized myasthenia gravis (gMG). A global Phase 3 clinical trial in gMG is currently underway across the United States, Europe, and South America to support potential approval in the United States and Europe. About Vor Bio Vor Bio is a clinical-stage biotechnology company transforming the treatment of autoimmune diseases. The company is focused on rapidly advancing telitacicept, a novel dual-target fusion protein, through Phase 3 clinical development and commercialization to address serious autoantibody-driven conditions worldwide. For more information visit About RemeGen Co. Ltd. Founded in 2008, RemeGen is a leading biopharmaceutical company in China committed to providing solutions to the unmet clinical needs of patients suffering from life-threatening illnesses. RemeGen has research laboratories and offices in China and the United States. The company is committed to discovering, developing, and commercializing innovative and differentiated biologic drugs of significant clinical value in the key therapeutic areas of autoimmune, oncology, and ophthalmic diseases. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The words 'aim,' 'anticipate,' 'can,' 'continue,' 'could,' 'design,' 'enable,' 'expect,' 'initiate,' 'intend,' 'may,' 'on-track,' 'ongoing,' 'plan,' 'potential,' 'should,' 'target,' 'update,' 'will,' 'would,' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements in this press release include Vor Bio's statements regarding its plans for development and commercialization of telitacicept, the potential of telitacicept in various indications, the timing and pace of patient enrollment and dosing in clinical trials and the availability of data therefrom, the expected safety profile of telitacicept, the market opportunities for telitacicept and the ability of telitacicept to transform patient lives. Vor Bio may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: uncertainties inherent in the initiation and completion of preclinical studies and clinical trials and clinical development of Vor Bio's product candidates; availability and timing of results from preclinical studies and clinical trials; whether interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; uncertainties regarding regulatory approvals to conduct trials or to market products; and availability of funding sufficient for its foreseeable and unforeseeable operating expenses and capital expenditure requirements and Vor Bio's ability to continue as a going concern. These and other risks are described in greater detail under the caption 'Risk Factors' included in Vor Bio's most recent annual or quarterly report and in other reports it has filed or may file with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Vor Bio expressly disclaims any obligation to update any forward-looking statements, whether because of new information, future events or otherwise, except as may be required by law. Contact:Investors & MediaSarah Spencer +1 857-242-6076 [email protected]
Yahoo
4 days ago
- Business
- Yahoo
Vor Bio Enters into Exclusive Global License Agreement with RemeGen for Late-Stage Autoimmune Asset
-Vor Bio receives ex-Greater China rights to develop and commercialize telitacicept, a novel, dual-target recombinant fusion protein in global Phase 3 development for generalized myasthenia gravis -RemeGen receives initial payment of $125 million consisting of an upfront payment of $45 million plus $80 million of warrants, potential regulatory and commercial milestones exceeding $4 billion, as well as tiered royalties -Seasoned biopharma leader, Jean-Paul Kress, MD, appointed as Chief Executive Officer and Chairman of the Board, bringing proven track record in clinical development, commercialization, and strategic growth CAMBRIDGE, Mass., June 25, 2025 (GLOBE NEWSWIRE) -- Vor Bio, Inc. (Nasdaq: VOR) and RemeGen Co., Ltd. (HKEX: 9995, SHA: 688331) today announced entry into an exclusive license agreement granting Vor Bio global rights (excluding China, Hong Kong, Macau and Taiwan) to develop and commercialize telitacicept, a novel dual-target fusion protein approved in China for generalized myasthenia gravis (gMG), systemic lupus erythematosus (SLE), and rheumatoid arthritis (RA). Under the terms of the agreement, Vor Bio will pay RemeGen an initial payment of $125 million consisting of an upfront payment of $45 million as well as $80 million of warrants to purchase common stock with an exercise price of $0.0001 per share. The agreement also provides for potential regulatory and commercial milestones exceeding $4 billion, in addition to tiered royalties. Telitacicept is a novel, investigational fusion protein that targets key immune pathways involved in autoimmune disease. By selectively inhibiting BlyS (also known as BAFF) and APRIL - cytokines critical to B cell survival - telitacicept reduces autoreactive B cells and autoantibody production. RemeGen is conducting a global Phase 3 clinical trial which is now enrolling in the United States, Europe, and South America, with initial results expected in the first half of 2027. Vor Bio also announced that its Board of Directors (the 'Board') has appointed Jean-Paul Kress, M.D., as Chief Executive Officer and Chairman of the Board, effective today. This follows Dr. Robert Ang's resignation from the positions of Chief Executive Officer and director earlier today. Dr. Ang will continue with Vor Bio as a strategic advisor to assist in the transition through October 2025. Dr. Kress's strategic vision and track record of transformative leadership position him to guide the company into its next phase of growth. "I am absolutely thrilled to be leading Vor Bio as we transform the company to become a major player in autoimmune disease treatment," said Dr. Kress, Chairman and Chief Executive Officer, Vor Bio. "Targeting BAFF/APRIL signaling with telitacicept represents a significant advancement in addressing autoantibody driven diseases, which is highly differentiated from other modalities in this space. With a clinically advanced asset, we are uniquely positioned to develop this innovative therapy, with the goal of making a meaningful impact for patients living with autoimmune diseases around the world." Dr. Kress brings decades of executive leadership experience in the pharmaceutical and biotech industries. He most recently served as Chief Executive Officer of MorphoSys, where he led the development, approval and commercialization of Monjuvi®️ (tafasitamab), and advanced the company's pipeline through the landmark acquisition of Constellation Pharmaceuticals in 2021, strengthening MorphoSys' position in oncology innovation and ultimately leading to its subsequent acquisition by Novartis in 2024. Prior to that, he was CEO of Syntimmune, guiding its lead immunology program through to acquisition by Alexion Pharmaceuticals. He currently serves on the Board of Sanofi S.A. and has held senior roles across leading biopharma companies. 'Today marks a transformative milestone for RemeGen and the global development of telitacicept,' said Dr. Jianmin Fang, CEO of RemeGen. 'The strategic out-licensing of telitacicept's ex-China rights accelerates our mission to deliver this innovative therapy to patients worldwide and will help maximize telitacicept's clinical and commercial potential on the global scale.' About TelitaciceptTelitacicept is a novel, investigational recombinant fusion protein designed to treat autoimmune diseases by selectively inhibiting BLyS (BAFF) and APRIL - two cytokines essential to B cell and plasma cell survival. This dual-target mechanism reduces autoreactive B cells and autoantibody production, key drivers of autoimmune pathology. In a Phase 3 clinical trial in generalized myasthenia gravis in China, telitacicept demonstrated a 4.8-point improvement in MG-ADL (Myasthenia Gravis Activities of Daily Living scale) vs. placebo at 24 weeks, the primary endpoint of the trial. Telitacicept is approved in China for systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and generalized myasthenia gravis (gMG). A global Phase 3 clinical trial in gMG is currently underway across the United States, Europe, and South America to support potential approval in the United States and Europe. About Vor BioVor Bio is a clinical-stage biotechnology company transforming the treatment of autoimmune diseases. The company is focused on rapidly advancing telitacicept, a novel dual-target fusion protein, through Phase 3 clinical development and commercialization to address serious autoantibody-driven conditions worldwide. For more information visit About RemeGen Co. Ltd. Founded in 2008, RemeGen is a leading biopharmaceutical company in China committed to providing solutions to the unmet clinical needs of patients suffering from life-threatening illnesses. RemeGen has research laboratories and offices in China and the United States. The company is committed to discovering, developing, and commercializing innovative and differentiated biologic drugs of significant clinical value in the key therapeutic areas of autoimmune, oncology, and ophthalmic diseases. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The words 'aim,' 'anticipate,' 'can,' 'continue,' 'could,' 'design,' 'enable,' 'expect,' 'initiate,' 'intend,' 'may,' 'on-track,' 'ongoing,' 'plan,' 'potential,' 'should,' 'target,' 'update,' 'will,' 'would,' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements in this press release include Vor Bio's statements regarding its plans for development and commercialization of telitacicept, the potential of telitacicept in various indications, the timing and pace of patient enrollment and dosing in clinical trials and the availability of data therefrom, the expected safety profile of telitacicept, the market opportunities for telitacicept and the ability of telitacicept to transform patient lives. Vor Bio may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: uncertainties inherent in the initiation and completion of preclinical studies and clinical trials and clinical development of Vor Bio's product candidates; availability and timing of results from preclinical studies and clinical trials; whether interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; uncertainties regarding regulatory approvals to conduct trials or to market products; and availability of funding sufficient for its foreseeable and unforeseeable operating expenses and capital expenditure requirements and Vor Bio's ability to continue as a going concern. These and other risks are described in greater detail under the caption 'Risk Factors' included in Vor Bio's most recent annual or quarterly report and in other reports it has filed or may file with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Vor Bio expressly disclaims any obligation to update any forward-looking statements, whether because of new information, future events or otherwise, except as may be required by law. Contact:Investors & MediaSarah Spencer +1 857-242-6076sspencer@
Yahoo
17-06-2025
- Business
- Yahoo
RemeGen's Telitacicept (RC18) Received Orphan Drug Designation from EMA for Myasthenia Gravis
YANTAI, China, June 17, 2025 /PRNewswire/ -- On June 16, 2025, RemeGen Co., Ltd. ("RemeGen", stock symbols: announced that telitacicept (RC18; brand name: 泰爱®) has received Orphan Drug Designation (ODD) from European Medicines Agency (EMA) for the treatment of Myasthenia Gravis (MG), marking a key milestone achieved in its global development. Telitacicept now is the first dual-target biologic drug for MG with ODD from both FDA and EMA worldwide. The designation, granted based on telitacicept's significant benefits in treating the life-threatening rare disease of MG, will provide advantages to this novel agent on protocol assistance, regulatory fee reductions/waivers and up to 10 years of market exclusivity, thereby accelerating the clinical development, registration and drug approval process in Europe and its availability among MG patients. MG is an acquired antibody-mediated rare autoimmune disorder affecting the neuromuscular junction. According to the Myasthenia Gravis Foundation of America (MGFA) and various studies, its global prevalence is estimated to be 15-25 per 100,000, meeting EMA's definition of the rare disease (the prevalence of less than 5 in 10,000 in the EU). Though the current treatment options (including cholinesterase inhibitors, glucocorticoids, immunosuppressants, intravenous immunoglobulins, plasma exchange, and targeted biological agents) may help to manage symptoms, many patients still suffer from poor response, drug intolerance and disease relapse, highlighting a significant unmet clinical need. Telitacicept is the world's first approved innovative BLyS/APRIL dual-targeting fusion protein drug for MG. The pathology of MG is characterized by the autoantibodies produced by pathological B cells attacking the neuromuscular junction protein (such as acetylcholine receptor, muscle-specific tyrosine kinase). Telitacicept can block both BLyS and APRIL signaling pathways, effectively inhibiting abnormally activated B cells and reducing the production of pathogenic autoantibodies, which is expected to interfere with the source of disease progress of MG. Telitacicept was approved for marketing in China in May this year. Its phase III clinical trial boasts excellent results: after treatment with telitacicept for 24 weeks, improvement ≥ 3 points in myasthenia gravis-activities of daily living (MG-ADL) was observed in 98.1% of participants (12.0% in the placebo group) and improvements ≥ 5 points in quantitative myasthenia gravis (QMG) score was observed in 87% of participants (16.0% in the placebo group), with statistically significant difference in efficacy from the placebo group and manageable safety profile. The ODD granted by EMA represents the recognition of telitacicept's innovative mechanism of action and potential in treating MG. RemeGen is proceeding the global multi-center phase III clinical trial of telitacicept in patients with MG to bring the breakthrough treatment option to more patients globally. View original content to download multimedia: SOURCE RemeGen Co., Ltd Error 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
27-05-2025
- Business
- Yahoo
RemeGen: Telitacicept for the Treatment of Generalized Myasthenia Gravis Approved in China
YANTAI, China, May 27, 2025 /PRNewswire/ -- On May 27, RemeGen Co., Ltd.( / announced that Telitacicept has officially been approved for marketing in China by the National Medical Products Administration (NMPA) for the treatment of adult patients with anti-acetylcholine receptor (AChR) antibody-positive generalized myasthenia gravis (gMG) in combination with conventional therapies. As the world's first innovative biologic drug targeting both BLyS and APRIL for the treatment of myasthenia gravis (MG), Telitacicept's approval not only brings new treatment options to patients, but also fills the gap of domestic innovative drugs in the field of MG treatment in China. It is expected to reshape the treatment landscape in this field. Previously, the indication of Telitacicept for MG was included in the breakthrough therapy category and priority review by the NMPA of China, and was granted orphan drug qualification and fast track designation by the FDA. Myasthenia gravis is an autoimmune disease caused by neuromuscular junction transmission disorders. It is characterized by fluctuating muscle weakness and fatigue in symptoms, long treatment cycles and high recurrence rate. Approximately 80%-85% of patients with MG patients are AChR antibody positive, and more than 85% of patients develop to gMG within 24 months of onset. According to Frost & Sullivan report, there are about 1.2 million MG patients worldwide, including approximately 220,000 patients in China. At present, there is a great unmet medical need. Telitacicept is constructed with the extracellular domain of the human transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI) receptor and the fragment crystallizable (Fc) domain of human immunoglobulin G(IgG). It simultaneously targets B-cell lymphocyte stimulator (also known as BLyS) and a proliferation-inducing ligand (APRIL), and directly attack the source of pathenogenic antibody production – B cells and plasma cells. According to the phase III data presented at the annual meeting of the American Academy of Neurology (AAN) on April 9, 2025, Telitacicept demonstrated a clinically meaningful efficacy and safety profile in patients with gMG. According to the data, after 24 weeks of treatment, 98.1% of patients in the Telitacicept group demonstrated a ≥ 3-point improvement in Myasthenia Gravis Activities of Daily Living ("MG-ADL") score, far exceeding that of the placebo group which was 12.0%. The MG-ADL score decreased by 5.74 points from baseline in the Telitacicept group, compared to a decrease of 0.91 point in the placebo group. 87.0% of the patients in the Telitacicept group demonstrated a ≥ 5-point improvement in Quantitative Myasthenia Gravis ("QMG") score, far exceeding that of the placebo group which was 16.0%. The QMG score decreased by 8.66 points from baseline in the Telitacicept, compared to a decrease of 2.27 points in the placebo group, thereby proving significant treatment benefit. In terms of safety, the overall adverse event (AE) rate in the Telitacicept group was comparable to that in the placebo group, indicating a good overall safety profile. Among the drugs for gMG that have completed phase III clinical studies, Telitacicept had the highest MG-ADL response rate. The approval of Telitacicept in China will benefit more patients with MG in the country, thereby allowing more ambitious treatment goals to be achieved in terms of long-term disease management. Currently, the Company is advancing the global multi-center phase III trial of Telitacicept in patients with MG, aiming to validate the efficacy and safety of Telitacicept in a wider patient population. The principal researcher, Professor Yin Jian from Beijing Hospital, said: "We sincerely congratulate the approval of the therapeutic indication of Telitacicept for MG! Telitacicept demonstrated rapid and significant clinical improvements in the Phase III trial with good tolerability. This is a major breakthrough and key progress for Chinese innovative drugs in the field of neuro-immune diseases. It provides a high profile basis for evidence-based clinical application of Telitacicept in the treatment of MG, and has also opened up a new paradigm of precise treatment in this field. We believe that with the inclusion of this indication in the medical insurance, Telitacicept will bring new and more effective treatment options to more patients." Dr. Fang Jianmin, the CEO of RemeGen, said: "The approval of the MG indication for Telitacicept in China is of great significance. It provides clinicians with a new and more powerful 'weapon' to treat patients more effectively and precisely. We look forward to the inclusion of this indication in the medical insurance system to help patients and their families reduce the burden of treatment and further improve their quality of life. RemeGen is advancing the global Phase III clinical study of Telitacicept for MG. We are looking forward to working closely with global experts and scholars to contribute to the continuous advancement of treating autoimmune diseases." Aside from Myasthenia Gravis, Telitacicept has been approved in China for the treatment of two other major indications, systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA). View original content to download multimedia: SOURCE RemeGen Co., Ltd Error 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
