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符合「Clinical Trials/Medical Discoveries」新聞搜尋結果, 共 745 篇 ,以下為 1 - 24 篇 訂閱此列表,掌握最新動態
Mezzion Pharmaceuticals Announces Dr. Rahul Rathod of Boston Children's Hospital and Harvard Medical School as the Global Principal Investigator for the Confirmatory Pivotal Phase 3 Trial FUEL-2

FORT LEE, N.J., March 2, 2024 /PRNewswire/ -- Mezzion Pharmaceuticals is a rare disease company conducting the confirmatory pivotal phase 3 clinical trial in Fontan subjects: The Fontan Udenafil Exercise Longitudinal Assessment Trial- 2, or FUEL-2 trial. The company is pleased to announce Dr. Rahul Rathod, a pediatric cardiology specialist and leader with over 20 years of experience at Boston Children's Hospital, as the Global Principal Investigator of FUEL-2. Dr. Rathod currently serves as the Associate Chair of Cardiology, Director of the Single Ventricle Program, and Director of the Fontan Clinic at Boston Children's Hospital as well as Associate Professor of Pediatrics at Harvard Medical School. He is an internationally recognized medical expert, researcher, and key opinion leader in the single ventricle heart disease space and Fontan circulation—with more than 80 peer-reviewed publications. Dr. Rathod is the Founder and Executive Director of the Fontan Outcomes Registry Using CMR Examinations (FORCE). The FORCE Registry is a tech-enabled research platform dedicated to improving the quality and longevity of life for single ventricle patients by aggregating global Fontan data, advancing cardiac imaging through big data and analytics, and utilizing machine learning to improve workflows and patient outcomes. FORCE is the largest Fontan dataset in the world. As the Global Principal Investigator for FUEL-2, Dr. Rathod will lead the clinical trial, overseeing clinical protocol, conduct, and operations at all study sites. He will also lead the study analysis and contribute to reporting the results to the Food and Drug Administration (FDA). "FUEL-2 represents a pivotal moment in Fontan research pioneering advancements for our patients. This landmark study delves into the potential of udenafil to empower individuals to reclaim vitality in their daily lives," said Dr. Rathod about the trial. "The Fontan population is one with significant medical complexities and unmet needs; this trial offers the promise of tangible solutions and a powerful tool that can redefine the treatment landscape for Fontan patients." "Dr. Rathod is a preeminent expert in Fontan physiology and the ideal clinical leader to serve as the Global Principal Investigator of FUEL-2. Mezzion is very proud and encouraged to have him as our partner as this pivotal clinical trial progresses," said Dr. John Hariadi, Chief Medical Officer and Senior Vice President of Global Regulatory Affairs at Mezzion. Dr. Hariadi recently joined Mezzion from Johnson & Johnson, where he was senior director for global regulatory affairs. He previously served in several senior medical leadership roles at the FDA and the United States Department of Homeland Security. He will serve as Mezzion's primary liaison to the FUEL-2 clinical research organization, study sites, and investigators. FUEL-2 is a Mezzion Pharmaceuticals-sponsored clinical trial investigating the clinical efficacy and safety of udenafil in teenagers 12-18 years of age who have undergone the Fontan procedure. It is poised to be the world's largest Fontan clinical trial and is set to enroll 438 patients globally. Currently, 22 sites in the U.S. are enrolling or will begin enrolling in the coming weeks. The latest site information for FUEL-2 can be found here.  Udenafil is a selective phosphodiesterase type 5 (PDE5) inhibitor and was previously studied in some adolescents with Fontan physiology. PDE5 inhibitors relax the blood vessels and may increase the blood flow to the lungs. This may mean higher blood oxygen levels; if so, individuals may be less tired when exercising or during everyday activities. For more information about the study, please visit FUEL2study.com.  About Mezzion Pharma Co., Ltd. Mezzion Pharma Co., Ltd. is headquartered in Korea. Mezzion and its wholly owned subsidiary, Mezzion Pharmaceuticals, Inc., has an administrative office in Fort Lee, New Jersey. Mezzion Pharma is an innovation-driven pharmaceutical company that is focused on discovering, developing, and commercializing novel therapeutics in the field of rare pediatric diseases. Mezzion Pharma is a publicly listed pharmaceutical company in Korea on the Korean stock exchange under (140410:KOSDAQ). Forward-Looking StatementsStatements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: Mezzion Pharma's expectations regarding the potential benefits of udenafil; Mezzion Pharma's expectations regarding the anticipated timing of any future clinical trials; Mezzion Pharma's expectations on regulatory submissions for marketing approval of udenafil for the treatment of patients that have undergone the Fontan operation, to improve exercise capacity in the United States, including the timing of these submissions; and Mezzion Pharma's expectations regarding the potential commercial launch of udenafil, including the timing of a potential approval of udenafil. Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include: the expectation that Mezzion Pharma will need additional funds to finance its operations; Mezzion Pharma's or any of its collaborative partners' ability to initiate and/or complete clinical trials; the unpredictability of the regulatory process; the possibility that Mezzion Pharma's or any of its clinical trials will not be successful; Mezzion Pharma's dependence on the success of udenafil; Mezzion Pharma's reliance on third parties for the manufacture of Mezzion Pharma's udenafil and udenafil tablets; possible regulatory developments in the United States and foreign countries; and Mezzion Pharma's ability to attract and retain senior management personnel. These and other risks and uncertainties are described more fully in Mezzion Pharma's most recent filings with the Statements under the Private Securities Litigation Reform Act: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risk and uncertainties that may individually or mutually impact the matters herein described, including but not limited to FDA review and approval, product development and acceptance, manufacturing, competition, and/or other factors, which are outside the control of Mezzion Pharma. All forward-looking statements contained in this press release speak only as of the date on which they were made. Mezzion undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Media Contacts: PR Contact –Philicia Thompson, Philicia.thompson@curastrategies.com, 7047749643 Medical Contact –John Hariadi, John.Hariadi@mezzion.com, (443) 699-6746 Mezzion Pharma Co. Ltd. Contact –S.I. Noh,  09428lgtokyo@mezzion.co.kr,  +82 2 560 8000 Logo - https://mma.prnasia.com/media2/2352797/Mezzion_Logo.jpg?p=medium600Logo - https://mma.prnasia.com/media2/2352786/FUEL_2_Logo.jpg?p=medium600

文章來源 : PR Newswire 美通社 發表時間 : 瀏覽次數 : 319 加入收藏 :
NMPA Approves the NDA for CARsgen's BCMA CAR-T Therapy Zevorcabtagene Autoleucel for Relapsed or Refractory Multiple Myeloma

SHANGHAI, March 1, 2024 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces that today the National Medical Products Administration ("NMPA") of China has approved the New Drug Application ("NDA") for zevorcabtagene autoleucel (R&D code: CT053, an autologous CAR-T product candidate against BCMA), for the treatment of adult patients with relapsed or refractory multiple myeloma who have previously progressed after at least 3 lines of therapy (including a proteasome inhibitor and immunomodulator agent). Zevorcabtagene autoleucel is an autologous BCMA-targeted CAR T-cell product, generated by transducing T cells with a lentivirus encoding a CAR comprising a fully human BCMA-specific single chain variable fragment ("scFv"), the human CD8α hinge domain, CD8α transmembrane domain, 4-1 BB co-stimulatory domain and CD3ζ activation domain. The proprietary novel fully-human scFv has high binding affinity and stability. The approval of zevorcabtagene autoleucel is based on an open-label, single arm, multi-center Phase II clinical trial (LUMMICAR STUDY 1, NCT03975907) conducted in China. The trial results were released at the 2022 Annual Meeting of the American Society of Hematology ("ASH"), and zevorcabtagene autoleucel demonstrated encouraging efficacy and a favorable safety profile. Multiple myeloma is an incurable malignant plasma cell disorder that accounts for approximately 10% of all hematological cancers.[1] With China's ageing population coupled with an increase in life expectancy, the number of patients with multiple myeloma is expected to expand. Frost & Sullivan forecasts that the prevalence of multiple myeloma in China in 2023 is approximately 153,000 per annum, and the number of new cases would be 23,200 per annum. It is estimated that the prevalence of multiple myeloma in China is expected to grow to 266,300 by 2030.[2] Prof. Wenming Chen, the principal investigator of the LUMMICAR STUDY 1, Director of Hematology Department, Beijing Chao-Yang Hospital, Capital Medical University, said, "In the realm of traditional treatments, the prognosis for patients dealing with relapsed or refractory multiple myeloma remains notably grim, given the limitations of available therapeutic alternatives. These individuals confront substantial unmet clinical needs, necessitating an expeditious adoption of an effective, safe, and convenient treatment modalities. The approval of zevorcabtagene autoleucel not only expands the array of choices available to clinical practitioners but also brings new hope to patients." Prof. Chengcheng Fu, the principal investigator of the LUMMICAR STUDY 1, Director of Hematology Department, the First Affiliated Hospital of Soochow University, said, "Based on the published results of the LUMMICAR-1 study, zevorcabtagene autoleucel has demonstrated profound and enduring therapeutic efficacy in patients with relapsed or refractory multiple myeloma, exhibiting overall favorable tolerability. We are pleased to witness the regulatory approval and market launch of zevorcabtagene autoleucel. We look forward to its potential to benefit a larger number of individuals, aiding them in achieving high-quality, long-term survival." Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics, said, "This year marks the tenth anniversary of CARsgen, and I am delighted to announce the NDA approval of zevorcabtagene autoleucel. This achievement stands as a significant milestone in the company's development and serves as a testament to the unwavering dedication of our team. I would like to express heartfelt gratitude to our team members, investigators, patients, and the broader community for their support and trust. We look forward to zevorcabtagene autoleucel bringing renewed hope to adult patients with relapsed or refractory multiple myeloma, thereby improving their survival. Guided by the vision of 'Making Cancer Curable,' we remain committed to exploring new technologies, expanding our product pipeline with global rights to address the major challenges of CAR T-cell therapies, and bringing innovative and differentiated cell therapies to cancer patients worldwide." About Zevorcabtagene Autoleucel Zevorcabtagene autoleucel is a fully human, autologous BCMA CAR T-cell product for the treatment of R/R MM. As informed by the NMPA on March 1, 2024, zevorcabtagene autoleucel was approved on February 23, 2024, for the treatment of adult patients with relapsed or refractory multiple myeloma who have previously progressed after at least 3 lines of therapy (at least one proteasome inhibitor and immunomodulator). CARsgen is conducting a separate Phase 1b/2 LUMMICAR STUDY 2 clinical trial in North America to evaluate the safety and efficacy of zevorcabtagene autoleucel in R/R MM. Zevorcabtagene autoleucel received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug designations from the U.S. FDA in 2019, as well as Priority Medicines (PRIME) and Orphan Medicinal Product designations from the European Medicines Agency (EMA) in 2019 and 2020, respectively. Zevorcabtagene autoleucel also received Breakthrough Therapy designation from the NMPA in 2020. In January 2023, CARsgen and Huadong Medicine announced a collaboration for the commercialization of zevorcabtagene autoleucel in mainland China. Huadong Medicine was granted the exclusive right to commercialize zevorcabtagene autoleucel in mainland China. About CARsgen Therapeutics Holdings Limited CARsgen is a biopharmaceutical company with operations in China and the U.S. and is focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors. CARsgen has established a comprehensive CAR T-cell research and development platform, encompassing target discovery, innovative CAR T-cell development, clinical trials, and commercial-scale production. CARsgen has internally developed novel technologies and a product pipeline with global rights to address major challenges of CAR T-cell therapies, such as improving the safety profile, enhancing the efficacy in treating solid tumors, and reducing treatment costs. CARsgen's vision is to become a global biopharmaceutical leader that brings innovative and differentiated cell therapies to cancer patients worldwide and makes cancer curable. Forward-looking Statements All statements in this press release that are not historical fact or that do not relate to present facts or current conditions are forward-looking statements. Such forward-looking statements express the Group's current views, projections, beliefs and expectations with respect to future events as of the date of this press release. Such forward-looking statements are based on a number of assumptions and factors beyond the Group's control. As a result, they are subject to significant risks and uncertainties, and actual events or results may differ materially from these forward-looking statements and the forward-looking events discussed in this press release might not occur. Such risks and uncertainties include, but are not limited to, those detailed under the heading "Principal Risks and Uncertainties" in our most recent annual report and interim report and other announcements and reports made available on our corporate website, https://www.carsgen.com. No representation or warranty is given as to the achievement or reasonableness of, and no reliance should be placed on, any projections, targets, estimates or forecasts contained in this press release. References 1.    Kyle RA, Rajkumar SV. Multiple myeloma. N Engl J Med. 2004;351:1860-1873. 2.    Frost and Sullivan. Cellular Immunotherapy Market. Independent Market Research version March, 2021. Data on file.   Contact CARsgen For more information, please visit https://www.carsgen.com/Public Relations: PR@carsgen.comInvestor Relations: IR@carsgen.com 

文章來源 : PR Newswire 美通社 發表時間 : 瀏覽次數 : 370 加入收藏 :
Kinnate Biopharma Inc. Sells Its Investigational Pan-RAF Inhibitor, exarafenib, to Pierre Fabre Laboratories

Kinnate has entered into an Asset Purchase Agreement (the "APA") with Pierre Fabre Laboratories for global rights to exarafenib and other pan-RAF program assets. The transaction is in furtherance of Kinnate's previously announced pursuit of strategic alternatives. This acquisition is intended to enable Pierre Fabre Laboratories to pursue its efforts in the field of precision oncology and provide it the opportunity to broaden its reach to patients in need for targeted therapies in RAF and RAS solid tumors.   CASTRES, France and SAN FRANCISCO, March 1, 2024 /PRNewswire/ -- Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate" or the "Company"), a clinical-stage precision oncology company, and Pierre Fabre Médicament, SAS ("Pierre Fabre Laboratories"), a global player in oncology, today announced their agreement to the sale of the Company's investigational pan-RAF inhibitor, exarafenib, and other pan-RAF program assets pursuant to the APA entered into by the parties. The sale of global rights is in furtherance of the Company's previously announced exploration of strategic alternatives. "We are delighted to partner with Pierre Fabre Laboratories, a company that brings significant expertise in the global development and commercialization of targeted therapies in RAF and RAS driven solid tumors," said Nima Farzan, Chief Executive Officer of Kinnate. "The sale of exarafenib and our pan-RAF program assets to Pierre Fabre will expand the reach of these programs globally, allowing the promise of targeted therapies for patients with NRAS driven melanoma and BRAF driven solid tumors to further develop." "Based on the clinical and preclinical data generated to date, we believe exarafenib may present a best-in-class product profile as a pan-RAF inhibitor targeting solid tumors such as NRAS mutant melanoma, for which there are currently no approved targeted therapies. The addition of exarafenib and other pan-RAF program assets from Kinnate is complementary to our existing BRAF and MEK inhibitors portfolio with encorafenib and binimetinib. This acquisition continues to expand our efforts in precision oncology and provide us with the opportunity to broaden our reach to patients in need for targeted therapies in RAF and RAS solid tumors," added Francesco Hofmann, Head of Research and Development for Medical Care at Pierre Fabre Laboratories.  Under the terms of the APA, Pierre Fabre Laboratories has purchased exarafenib and other pan-RAF assets and will assume 100% of the ongoing program and costs associated with these assets. In consideration, Kinnate will receive a total consideration of up to $31 million, consisting of $500,000 at closing, and a $30.5 million payment, contingent upon the earlier of the dosing of the first patient in the first pivotal trial for exarafenib or any other acquired asset, or the application for an accelerated approval pursuant to the FDA's Accelerated Approval Program for exarafenib or any other acquired asset, or the submission of a marketing application for regulatory approval for exarafenib or any other acquired asset. In addition, Pierre Fabre Laboratories will assume up to $5 million of trade payables for the transferred assets. The transaction is not subject to closing conditions and closed upon signing. As previously announced in connection with Kinnate's transaction with XOMA Corporation ("XOMA"), Kinnate stockholders will receive 100% of the net proceeds (after deducting appliable costs, expenses, taxes or other deductions pursuant to the Contingent Value Rights Agreement to be entered into in connection with the proposed transaction with XOMA (the "CVR Agreement")) payable from the $30.5 million contingent payment, assuming the closing of the proposed transaction with XOMA occurs and such proceeds are received within five years from the closing date thereof, pursuant to the CVR Agreement. There will be no net proceeds from the $500,000 closing payment, as such payment will only cover transaction expenses. Lazard served as financial advisor to Kinnate, and Wilson Sonsini Goodrich & Rosati served as legal counsel. About Kinnate Biopharma Inc. For more information, visit Kinnate.com and follow the company on LinkedIn to learn about its most recent initiatives.  About Pierre Fabre Laboratories  Further information about Pierre Fabre Laboratories can be found at http://www.pierre-fabre.com and on X (formerly Twitter) at @PierreFabre.  Important Additional Information and Where to Find It In connection with the proposed acquisition of Kinnate, XOMA or its affiliates will commence a tender offer for all of the outstanding shares of Kinnate (the "Offer") pursuant to the terms of an Agreement and Plan of Merger, dated as of February 16, 2024 (the "Merger Agreement"), by and among Kinnate, XOMA, and XRA 1 Corp., a Delaware corporation and a wholly owned subsidiary of XOMA. The Offer has not yet commenced, and this communication is neither a recommendation, nor an offer to purchase nor a solicitation of an offer to sell any shares of the common stock of the Company or any other securities. On the commencement date of the Offer, a tender offer statement on Schedule TO, including an offer to purchase, a letter of transmittal and related documents, will be filed with the Securities and Exchange Commission (the "SEC") by XOMA and its acquisition subsidiary, and a Solicitation/Recommendation Statement on Schedule 14D-9 will be filed with the SEC by the Company. The Offer to purchase the outstanding shares of Common Stock will only be made pursuant to the offer to purchase, the letter of transmittal and related documents filed as a part of the Schedule TO. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE TENDER OFFER MATERIALS (INCLUDING THE OFFER TO PURCHASE, A LETTER OF TRANSMITTAL AND RELATED DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT ON SCHEDULE 14D-9 REGARDING THE OFFER, AS THEY MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO TIME, WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION THAT INVESTORS AND SECURITY HOLDERS SHOULD CONSIDER BEFORE MAKING ANY DECISION REGARDING TENDERING THEIR SHARES, INCLUDING THE TERMS AND CONDITIONS OF THE OFFER. Investors and security holders may obtain a free copy of these statements (when available) and other documents filed with the SEC at the website maintained by the SEC at www.sec.gov or by directing such requests to the information agent for the Offer, which will be named in the tender offer statement. Investors and security holders may also obtain, at no charge, the documents filed or furnished to the SEC by the Company under the "SEC Filings" subsection of the "Financial Information" section of the Company's website at https://investors.kinnate.com/. Cautionary Note Regarding Forward-Looking Statements This communication contains forward-looking statements, including, but not limited to, statements regarding the intended effect of the transaction on Pierre Fabre Laboratories' future activities; statements by the Company's Chief Executive Officer and Pierre Fabre Laboratories' Head of Research and Development for Medical Care; the consideration to be received by the Company under the APA; the liabilities to be assumed by Pierre Fabre Laboratories under the APA; the Company's beliefs and expectations and statements about the CVR Agreement; and the potential payment of proceeds to the Company's stockholders, if any, pursuant to the APA and the CVR Agreement, including with respect to any net proceeds or contingent payments related to exarafenib or any other pan-RAF asset under the APA. These statements may be identified by their use of forward-looking terminology including, but not limited to, "anticipate," "believe," "continue," "could," "estimate," "expect," "goal," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "will," and "would," and similar words expressions are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance and involve risks and uncertainties that could cause actual results to differ materially from those projected, expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the possibility that various closing conditions set forth in the Merger Agreement may not be satisfied or waived, including uncertainties as to the percentage of the Company's stockholders tendering their shares in the Offer; the possibility that competing offers will be made; the Company's ability to retain key personnel; the risk that the Offer, the merger of Merger Sub with and into the Company and the other transactions contemplated by the Merger Agreement and the CVR Agreement  (collectively, the "Transactions") may not be completed in a timely manner, or at all, which may adversely affect the Company's business and the price of its common stock; significant costs associated with the proposed Transactions; the risk that any stockholder litigation in connection with the Transactions may result in significant costs of defense, indemnification and liability; the risk that activities related to the CVR Agreement may not result in any value to the Company's stockholders; and other risks and uncertainties discussed in the Company's most recent annual and quarterly reports filed with the SEC as well as in the Company's subsequent filings with the SEC. As a result of such risks and uncertainties, the Company's actual results may differ materially from any future results, performance or achievements discussed in or implied by the forward-looking statements contained herein. There can be no assurance that the proposed Transactions will in fact be consummated. The Company cautions investors not to unduly rely on any forward-looking statements. The forward-looking statements contained in this communication are made as of the date hereof, and the Company undertakes no obligation to update any forward-looking statements, whether as a result of future events, new information or otherwise, except as expressly required by law. All forward-looking statements in this document are qualified in their entirety by this cautionary statement. Kinnate Contact:  Investors@kinnate.com   Pierre Fabre Laboratories Media Contact:  Laurence Marchallaurence.marchal@pierre-fabre.com   

文章來源 : PR Newswire 美通社 發表時間 : 瀏覽次數 : 447 加入收藏 :
Jacobio Pharma Receives IND Approval for P53 Y220C Activator JAB-30300 in the U.S.

BEIJING, SHANGHAI and BOSTON, March 1, 2024 /PRNewswire/ -- Jacobio Pharma (1167.HK), a clinical-stage oncology company drugging the undruggable targets, today announced it received IND (Investigational New Drug) approval of its self-developed drug JAB-30300 (P53 Y220C activator) from the FDA of the U.S. Jacobio plans to initiate a Phase I/IIa advanced solid tumors clinical trial in the U.S., to evaluate safety and efficacy of JAB-30300. Jacobio also plans to submit IND in China, and will conduct clinical studies once receives the IND approval. P53 is the single most frequently altered gene in human cancers, with mutations being present in approximately 50% of all invasive tumors. JAB-30300 is an orally bioavailable small molecule activator for the treatment of patients with solid tumors harboring P53 Y220C mutation. Studies shows that, JAB-30300 has shown very high binding affinity to P53 Y220C mutant proteins. Tumor regression was achieved in multiple cancer models covering various tumor types, such as gastric cancer, ovarian cancer, breast cancer and lung cancer. The synergistic effect was found when combined with chemo or oncogenic protein inhibitors which indicates a widely combo potential of JAB-30300. There is only one P53 Y220C activator program in the Phase I clinical stage globally. JAB-30300 is expected to be one of the first P53 Y220C activator to be approved. About Jacobio Jacobio Pharma (1167.HK) is committed to developing and providing new and innovative products and solutions to improve people's health. Our pipeline revolves around novel molecular targets on six major signalling pathways: KRAS, immune checkpoints, tumor metabolism, P53, RB and MYC. We aim for our key projects to be among the top three in the world. Our vision is to become a global leader recognized for our impact in drug R&D together with our partners. Jacobio has R&D centers in Beijing, Shanghai and Boston with our Induced Allosteric Drug Discovery Platform (IADDP) and our iADC Platform.

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Innovent Announces First Participant Dosed in a Phase I Study of IBI3002 (an anti-IL-4Rα/TSLP bispecific antibody) in Australia

ROCKVILLE, Md. and SUZHOU, China, March 1, 2024 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, announces that the first participant has been dosed in Australia in a first-in-human (FIH) phase 1 clinical trial of IBI3002, a global first-in-class bispecific antibody targeting Interleukin 4 receptor α (IL-4Rα) and thymic stromal lymphopoietin (TSLP). This FIH study (NCT06213844) is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) (only in participants with asthma) of IBI3002 in healthy participants and participants with mild to moderate asthma, and to support further global clinical development of IBI3002. IBI3002 is a humanized bispecific antibody targeting cell surface IL-4Rα and the alarmin cytokine TSLP, discovered and developed by Innovent for the treatment of inflammatory diseases, including asthma. IL-4 receptors mediate the IL-4 signaling (both type 1 and type 2) and the IL-13 signaling (type 2). Both cytokine signaling pathways play key roles in the pathophysiology of type 2 (T2) inflammatory disorders1. TSLP is an epithelial cell-derived alarmin cytokine and triggers both T2 and non-T2 inflammation in asthma2. IBI3002 has high-efficient dual-blocking function on both IL-4Rα and TSLP. In-vitro assays have shown superiority over the marketed monoclonal antibodies to respective target. By targeting both IL-4Rα and TSLP, IBI3002 is hypothesized to have potential effect in suppressing T2 and non-T2 inflammation. The potential synergistic effect in suppressing T2 inflammation is believed to be the basis of its superior efficacy in the treatment of T2 inflammatory disorders. Dr. Lei Qian, Vice President of Clinical Development at Innovent, stated, "In the last few decades, knowledge about both pathophysiological mechanisms, clinical phenotypes and therapeutic options for asthma have significantly increased. In particular, the introduction of biologics for severe asthma paved the way to a true revolution in the field of asthma management, by potentially allowing a precision medicine approach. Targeting specific steps of the immune-inflammatory cascade through highly selective drugs represents a true revolution in the field of severe asthma management, and brings with it the potential of achieving optimal disease control in different severe asthma inflammatory phenotypes. We are looking forward to the development of this molecule in asthma and other inflammatory diseases." About Asthma Asthma is a heterogeneous disease driven by multiple immune cells, cytokines and inflammatory mediators, affecting all age groups. Characterized by variable symptoms of wheeze, shortness of breath, cough, and chest tightness, asthma is associated with chronic airway inflammation, reversible airflow limitation, and airway hyperresponsiveness3. According to the 2015 Global Burden of Disease (GBD) study, about 358 million people are suffering from asthma4. Asthma can be broadly classified as eosinophilic or non-eosinophilic on the basis of airway or peripheral blood cellular profiles. Eosinophilic inflammation is driven predominantly by T2 inflammation, including T-helper cells type 2 and group 2 innate lymphoid cells5. Compared with eosinophilic asthma, non-eosinophilic asthma is poorly understood6. Up to 10% of adults and 2.5% of children with asthma have severe asthma7. Patients with severe asthma have persistent symptoms or frequent exacerbations that require repetitive systemic glucocorticoid bursts or maintenance, despite adequate treatment with high-dose inhaled treatments8. In these patients, add-on treatment, which may include biologic therapies, is needed to reduce the disease burden2,3. About IBI3002 IBI3002 is a global first-in-class bispecific antibody targeting cell surface IL-4Rα and the alarmin cytokine TSLP. It has high-efficient dual-blocking function on both IL-4Rα and TSLP. In-vitro assays have shown superiority over the marketed monoclonal antibodies to respective targets. By simultaneously targeting IL-4Rα and TSLP, IBI3002 has the potential of treating several inflammatory disorders, including asthma. IL-4 is a central mediator of type 2 lymphocyte cell differentiation; it induces the production of type 2 associated cytokines such as IL-5, IL-9, IL-13, and/or type 2 related chemokines as thymus and activation-regulated chemokine (TARC/CCL17) and eotaxins-3. IL-4 involved in B cells regulated isotype class switching to produce serum IgE, and the eosinophils recruitment through IL-5 releasement. Although IL-13 displays some redundancies in these pro-inflammatory processes, it has additional roles in mediating goblet cell hyperplasia, mucus production, smooth muscle contractility, and airway hyperresponsiveness. Together, IL-4 and IL-13 play critical roles in T2 inflammation1. TSLP is an epithelial cell-derived alarmin cytokine that occupies an upstream position in the T2 inflammation induction and Th2 cells differentiation and maturation via IL-4, IL-5 and IL-13 production. TSLP is also believed to be a trigger of non-T2 inflammation in asthma 2. About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to provide high-quality biologics that are affordable to all. The company discovers, develops, manufactures and commercializes innovative medicines that treat some of the most intractable illnesses. Its pioneering therapies to treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has 10 products in the market, 3 new drug applications under the NMPA review, 4 assets in Phase III or pivotal clinical trials and 20 more molecules in early clinical stage. Innovent partners with over 30 global healthcare leaders, including Eli Lilly, Roche, Sanofi, Adimab, Incyte and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn. Statement: Innovent does not recommend the use of any unapproved drug (s)/indication (s). Forward-looking statement This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent Biologics ("Innovent"), are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions. The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialise or turn out to be incorrect. References:  1.        Zhu J. T helper 2 (Th2) cell differentiation, type 2 innate lymphoid cell (ILC2) development and regulation of interleukin-4 (IL-4) and IL-13 production[J]. Cytokine, 2015, 75(1): 14-24. 2.        Brusselle G G, Koppelman G H. Biologic therapies for severe asthma[J]. New England Journal of Medicine, 2022, 386(2): 157-171. 3.        Global Initiative for Asthma. 2023 GINA Report, Global Strategy for Asthma Management and Prevention. 2023. 4.        GBD 2015 Chronic Respiratory Disease Collaborators. Global, regional, and national deaths, prevalence, disability-adjusted life years, and years lived with disability for chronic obstructive pulmonary disease and asthma, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015 [published correction appears in Lancet Respir Med. 2017 Oct;5(10 ):e30]. Lancet Respir Med. 2017;5(9):691-706. 5.        Gans MD, Gavrilova T. Understanding the immunology of asthma: Pathophysiology, biomarkers, and treatments for asthma endotypes. Paediatr Respir Rev. 2020;36:118-127. 6.        Israel E, Reddel H K. Severe and difficult-to-treat asthma in adults[J]. New England Journal of Medicine, 2017, 377(10): 965-976. 7.        Settipane RA, Kreindler JL, Chung Y, Tkacz J. Evaluating direct costs and productivity losses of patients with asthma receiving GINA 4/5 therapy in the United States. Ann Allergy Asthma Immunol 2019; 123(6): 564-572.e3. 8.        Caminati M, Vaia R, Furci F, Guarnieri G, Senna G. Uncontrolled Asthma: Unmet Needs in the Management of Patients. J Asthma Allergy. 2021;14:457-466.

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FDA Grants Fast Track Designation to 9MW2821

SHANGHAI, Feb. 27, 2024 /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announces that its self-developed novel ADC drug targeting Nectin-4 (R&D Code: 9MW2821) has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of advanced, recurrent, or metastatic esophageal squamous cell carcinoma (hereinafter referred to as "ESCC"). As of February 20, 2024, for the indication of esophageal cancer (EC), 9MW2821 has shown an ORR and DCR of 30% and 73.3%, respectively, in a Phase II clinical study at a dose of 1.25 mg/kg in 30 patients with advanced EC who have received monotherapy and completed at least one tumor assessment. Of those, 28 patients have undergone chemotherapy and immunotherapy. The study is still ongoing with further enrollment and evaluation. 9MW2821 is the world's first Nectin-4-targeting drug to disclose clinical efficacy data for the indication of EC. 9MW2821 is a site-specific conjugated novel Nectin-4-targeting ADC developed by Mabwell's ADC platform and automated high-throughput hybridoma antibody molecular discovery platform, and is the first clinical stage Nectin-4-targeting ADC developed by Chinese company. The drug achieves site-specific modification of antibody through proprietary conjugate technology linkers and optimized ADC conjugation process. After injection, 9MW2821 can specifically bind to Nectin-4 on the cell membrane surface, be internalized and release cytotoxic drug, and induce the apoptosis of tumor cells. In addition to EC, Mabwell is conducting clinical studies for multiple indications such as urothelial cancer (UC), Cervical Cancer (CC), with monotherapy for UC entering Phase III clinical study, combination therapy with PD-1 entering Phase I/II clinical study, and monotherapy for CC entering Phase II clinical study. As of now, more than 280 patients have been enrolled. 9MW2821 is also the first to disclose preliminary clinical efficacy data for the indication of CC among drugs with the same target in the world. About EC According to the global cancer burden data released by the International Agency for Research on Cancer (IRAC), there were 604 thousand new cases of EC worldwide in 2020, with 544 thousand deaths. In 2024, the National Cancer Center published the Cancer Burden Data in China in 2022 on JNCC, showing that there were 224 thousand new cases of EC in China (167.5 thousand in men, 56.5 thousand in women), with 187.5 thousand deaths (140.4 thousand in men, 47.1 thousand in women), ranking 7th and 5th, respectively, in terms of new cases and deaths. According to the statistics from the American Cancer Society, it is estimated that there will be 22,370 new cases of EC (17,690 in men, 4,680 in women), and 16,130 deaths (12,880 in men, 3,250 in women) in the United States in 2024. In China, ESCC is the most common histological type, accounting for about 85.79% of EC cases, while esophageal adenocarcinoma (EAC) and other types account for 11.00% and 3.21%, respectively. In the United States, EAC is the most common type of EC among White population, accounting for about 70% of EC cases, with ESCC accounting for about 30%, and ESCC is more common among African Americans. Furthermore, according to IQVIA's report, in 2022, the number of prevalent patients with EC in China was 742 thousand, with approximately 70% being cases of advanced metastatic EC, of which about 80% (approximately 416,000 cases) were eligible for systemic treatment. The guidelines of the Chinese Society of Clinical Oncology (CSCO) recommends that PD-1 monoclonal antibody combined with platinum-based chemotherapy is the standard first-line treatment, and PD-1 or monotherapy chemotherapy is an optional second-line treatment. In actual clinical practice, there is a significant unmet clinical need after first-line treatment failure, since no preferred options are available. About MabwellMabwell (688062.SH) is an innovation-driven biopharmaceutical company with the entire value chain of the pharmaceutical industry. We provide more effective and accessible therapy and innovative medicines to fulfill global medical needs. Since 2017, an advanced R&D system which covers target discovery, early discovery, druggability, preclinical, clinical research and manufacturing transformation was established. Mabwell has 14 pipeline products in different R&D stages based on a world-class and state-of-the-art R&D engine, including 10 novel drug candidates and 4 biosimilars. We focus on the therapeutic areas of oncology, auto-immune diseases, metabolic disorders, ophthalmologic diseases and infectious diseases, etc. Of these, 2 products have been approved and commercialized, 2 products have been filed for MA approval, 3 products are in pivotal trials. We have also undertaken 1 national major scientific and technological special project for "Significant New Drugs Development", 2 projects for National Key R&D Programmes, and several provincial and municipal science and technological innovation projects. Mabwell's Taizhou factory possesses robust in-house manufacturing capability compliant with international GMP standards regulated by the NMPA, FDA and EMA, and has passed the EU QP Audit. The large-scale manufacturing base located in Shanghai is under construction. Our mission is "Explore Life, Benefit Health" and our vision is "Innovation, from ideas to reality". For more information, please visit www.mabwell.com/en.  Forward-Looking Statements This press release contains forward-looking statements including, but not limited to, the potential safety, efficacy, regulatory review or approval and commercial success of our product candidates and those relating to the Company's product development, clinical studies, clinical and regulatory milestones and timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. "Forward-looking statements" are statements that are not historical facts and involve a number of risks and uncertainties, which may cause actual results to be materially different from any future results expressed or implied in the forward-looking statements. These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential," "predict," "project," "should," "would," and similar expressions and the negatives of those terms. Forward-looking statements are based on the Company's current expectations and assumptions. Forward-looking statements are subject to a number of risks, uncertainties, and other factors, many of which are beyond the Company's control, including, but not limited to: environment; politic; economy; society; legislation; our dependence on our product candidates, most of which are still in preclinical or various stages of clinical development; our reliance on third-party vendors, such as contract research organizations and contract manufacturing organizations; the uncertainties inherent in clinical testing; our ability to complete required clinical trials for our product candidates and obtain approval from regulatory authorities for our product candidates; our ability to protect our intellectual property; the potential impact of COVID-19; the loss of any executive officers or key personnel. In case one or more of these risks or uncertainties deteriorate, or any assumptions are incorrect, the actual results may be seriously inconsistent with the stated results. The Company cautions all the persons not to place undue reliance on any such forward-looking statements, which speaks only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the applicable Stock authority to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. All forward-looking descriptions, figures and assumptions in this press release are applicable to this statement.  

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