Latest news with #Rituximab
Business Upturn
4 days ago
- Business
- Business Upturn
Byondis Announces First Patient Dosed in Phase 1 Clinical Trial of Novel SIRPα-Directed Monoclonal Antibody BYON4228 in Patients With Advanced or Metastatic Solid Tumors
NIJMEGEN, The Netherlands: Byondis B.V., an independent clinical stage biopharmaceutical company creating innovative targeted medicines for patients with cancer, announces the first patient dosed in its Phase 1 dose escalation and expansion BYON4228.002 clinical trial to evaluate the safety, pharmacokinetics, pharmacodynamics and efficacy of novel SIRPα-directed monoclonal antibody (mAb) BYON4228 alone and in combination with pembrolizumab in patients with advanced or metastatic solid tumors. Advertisement This press release features multimedia. View the full release here: Louis Denis, MD, Chief Medical Officer, Byondis BYON4228 is a potential best-in-class novel mAb that targets and blocks the CD47-SIRPα axis, responsible for tumors' ability to escape from recognition and destruction by the immune system. By targeting SIRPα and not CD47, BYON4228 offers selective targeting of myeloid cells and avoids disruption of other biologically meaningful CD47-dependent interactions. In preclinical studies, BYON4228 was found to potentiate the tumor killing capacity of tumor-targeting mAbs tested without the toxicity associated with CD47 agents. 'Building on strong preclinical data, we believe that there is broad potential for BYON4228 alone and in combination with tumor-targeting mAbs, checkpoint inhibitors and antibody drug conjugates and other modalities across hematological and solid tumors,' said Louis Denis, MD, Chief Medical Officer, Byondis. 'We look forward to evaluating the results of this trial to support the clinical development of BYON4228 alone and in combination with other agents and to bring a new therapeutic option to patients with high unmet medical need.' Part 1 of the BYON4228.002 trial will evaluate the safety of BYON4228 alone and in combination to determine the maximum tolerated dose (MTD), or optimal biological dose (OBD) if the MTD is not reached, and recommended combination dose regimen(s) for expansion (RDE(s)). The second part of the trial will evaluate the objective tumor response rate (ORR). The secondary objectives of this trial are safety, pharmacokinetics, immunogenicity and preliminary efficacy. The trial will be conducted at multiple sites across Europe, including the United Kingdom, Belgium and Spain. About BYON4228 BYON4228 is a novel monoclonal antibody (mAb) from Byondis' next generation immuno-oncology (IO) program that targets and blocks the CD47-SIRPα axis, responsible for tumors' ability to escape from recognition and destruction by the immune system. BYON4228 is currently being studied in two Phase 1 Clinical Trials evaluating BYON4228 alone and in combination with Rituximab in patients with Relapsed/Refractory CD20 positive B-cell Non-Hodgkin's Lymphoma (NHL) (NCT05737628) and BYON4228 alone and in combination with pembrolizumab in patients with advanced or metastatic solid tumors (NCT06932952). About Byondis Driven to improve patients' lives, Byondis is an independent clinical stage fully integrated biopharmaceutical research and development company creating innovative targeted medicines for cancer. The company is developing new biological entities (NBEs) with a focus on antibody-drug conjugates and antibody-based therapeutics. Byondis' broad development portfolio comprises preclinical and early-stage clinical programs. The product candidates combine Byondis' expertise in linker-drug (LD) technology, antibody-drug conjugation, targeted cytotoxic therapy, immunology, and monoclonal antibody (mAb) development. Byondis' expertise covers all preclinical R&D from early lead finding to production of clinical batches of the selected product candidates, which are all done in-house. The company's headquarters and state-of-the-art R&D and GMP manufacturing facilities are based in Nijmegen, the Netherlands. For more information visit View source version on Disclaimer: The above press release comes to you under an arrangement with Business Wire. Business Upturn takes no editorial responsibility for the same.
Globe and Mail
21-05-2025
- Business
- Globe and Mail
Marginal Zone Lymphoma Pipeline Appears Robust With 50+ Pharma Companies Actively Working in the Therapeutics Segment
DelveInsight's, ' Marginal Zone Lymphoma Pipeline Insight 2025' report provides comprehensive insights about 50+ companies and 50+ pipeline drugs in Marginal Zone Lymphoma pipeline landscape. It covers the Marginal Zone Lymphoma pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Marginal Zone Lymphoma therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Stay ahead with the latest insights! Download DelveInsight's comprehensive Marginal Zone Lymphoma Pipeline Report to explore emerging therapies, key Marginal Zone Lymphoma Companies, and future Marginal Zone Lymphoma treatment landscapes @ Marginal Zone Lymphoma Pipeline Outlook Report Key Takeaways from the Marginal Zone Lymphoma Pipeline Report In May 2025, BeiGene announced a study is to compare the efficacy of zanubrutinib plus obinutuzumab versus lenalidomide plus rituximab (R^2) in participants with relapsed/refractory (R/R) follicular lymphoma (FL), as measured by progression-free survival as determined by an independent review committee in accordance with the 2014 modification of the International Working Group on non-Hodgkin lymphoma (NHL) Criteria based on n positron emission tomography and computed tomography (PET/CT), and to compare the efficacy of zanubrutinib plus rituximab versus R^2 in participants with R/R marginal zone lymphoma (MZL), as measured by progression free survival (PFS) assessed by IRC in accordance with CT-based Lugano 2014 Criteria. In May 2025, Regeneron Pharmaceuticals conducted a study is researching an experimental drug called odronextamab (referred to as study drug), in combination with lenalidomide. The study is focused on participants who have one of two types of cancer: follicular lymphoma (FL) or marginal zone lymphoma (MZL) that has come back after treatment (called "relapsed"), or did not respond to treatment (called "refractory"). FL and MZL are subtypes of Non-Hodgkin 's lymphoma (NHL). In May 2025, Incyte Corporation organized a study is to evaluate the safety and efficacy of two parsaclisib treatment regimens in participants diagnosed with relapsed or refractory marginal zone lymphoma (MZL) who are naive to or were previously treated with a Bruton's tyrosine kinase (BTK) inhibitor. In May 2025, Genmab conducted a study will require visits to the sites. During the first month, participants must visit every day or every few days, depending on which trial part the participant enters. After that, participants must visit weekly, every other week, once a month, and once every 2 months, as trial participation ends. DelveInsight's Marginal Zone Lymphoma pipeline report depicts a robust space with 50+ active players working to develop 50+ pipeline therapies for Marginal Zone Lymphoma treatment. The leading Marginal Zone Lymphoma Companies such as Incyte Corporation, HUTCHMED, InnoCare Pharma, ENTEROME SA, Beijing Mabworks Biotech Co., Ltd., ADC Therapeutics, MEI Pharma, Inc., Genentech, Inc., Novartis, AstraZeneca, Kite Pharma, Roche, Oncternal Therapeutics, Inc., Celgene, IGM Biosciences, Inc., Loxo Oncology, Genmab, ArQule, Sound Biologics, Adicet Bio, Inc., Celldex Therapeutics, TG Therapeutics, Inc., VelosBio Inc., Newave Pharmaceutical Inc., Boryung Pharmaceutical Co., Ltd., Cellectar Biosciences, Inc., Bio-Path Holdings, Inc., Nurix Therapeutics, Inc. and others. Promising Marginal Zone Lymphoma Therapies such as Pirtobrutinib, Obinutuzumab, Loncastuximab tesirine 150 µg/Kg, Copanlisib, Rituximab, Venetoclax, and others. Discover how the Marginal Zone Lymphoma treatment paradigm is evolving. Access DelveInsight's in-depth Marginal Zone Lymphoma Pipeline Analysis for a closer look at promising breakthroughs @ Marginal Zone Lymphoma Clinical Trials and Studies Marginal Zone Lymphoma Emerging Drugs Tafasitamab: Incyte Corporation Tafasitamab is an investigational humanized Fc-engineered monoclonal antibody directed against CD19. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb® engineered Fc domain, which is intended to lead to a significant potentiation of antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), thus aiming to improve a key mechanism of tumor cell killing. The therapy is currently in Phase III stage of clinical trial evaluation to treat Marginal Zone Lymphoma. Amdizalisib (HMPL-689): HUTCHMED The investigational drug candidate amdizalisib is a novel, selective small molecule inhibitor targeting the isoform phosphoinositide 3'-kinase delta (PI3Kδ), a key component in the B-cell receptor signaling pathway. We have designed amdizalisib with increased PI3Kδ isoform selectivity. Amdizalisib's pharmacokinetic properties have been found to be favorable with good oral absorption, moderate tissue distribution and low clearance in pre-clinical pharmacokinetic studies. Amdizalisib is being investigated in studies in the U.S., Europe, China and Australia in various subtypes of advanced relapsed or refractory non-Hodgkin's lymphoma, including follicular lymphoma and marginal zone lymphoma. Orelabrutinib: InnoCare Pharma Orelabrutinib is a small molecule Bruton's tyrosine kinase inhibitor (BTKi) developed for the treatment of cancer and in development for the potential treatment of autoimmune diseases. In the field of oncology, InnoCare received approval for orelabrutinib from the China National Medical Products Administration (NMPA) in two indications: the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL)/small lymphocytic lymphoma (R/R SLL), and the treatment of patients with relapsed/refractory mantle cell lymphoma (R/R MCL). Currently, it is in Phase II stage of clinical trial evaluation to treat Marginal Zone Lymphoma (MZL). EO2463: Enterome EO2463 is an innovative, off-the-shelf microbiome-peptide based cancer vaccine that combines four microbiome-peptides of B lymphocyte-specific lineage markers. EO2463 is designed to trigger the immune system into recognizing B cells as bacterial (i.e. non-self) and eliciting a targeted cell-killing response. The clinical rationale behind targeting these specific lineage cell markers is to induce the full depletion of malignant B lymphocytes that cause NHL. The Marginal Zone Lymphoma pipeline report provides insights into The report provides detailed insights about companies that are developing therapies for the treatment of Marginal Zone Lymphoma with aggregate therapies developed by each company for the same. It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Marginal Zone Lymphoma Treatment. Marginal Zone Lymphoma Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects. Marginal Zone Lymphoma Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type. Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Marginal Zone Lymphoma market. Get a detailed analysis of the latest innovations in the Marginal Zone Lymphoma pipeline. Explore DelveInsight's expert-driven report today! @ Marginal Zone Lymphoma Unmet Needs Marginal Zone Lymphoma Companies Incyte Corporation, HUTCHMED, InnoCare Pharma, ENTEROME SA, Beijing Mabworks Biotech Co., Ltd., ADC Therapeutics, MEI Pharma, Inc., Genentech, Inc., Novartis, AstraZeneca, Kite Pharma, Roche, Oncternal Therapeutics, Inc., Celgene, IGM Biosciences, Inc., Loxo Oncology, Genmab, ArQule, Sound Biologics, Adicet Bio, Inc., Celldex Therapeutics, TG Therapeutics, Inc., VelosBio Inc., Newave Pharmaceutical Inc., Boryung Pharmaceutical Co., Ltd., Cellectar Biosciences, Inc., Bio-Path Holdings, Inc., Nurix Therapeutics, Inc. and others. Marginal Zone Lymphoma pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Inhalation Inhalation/Intravenous/Oral Intranasal Intravenous Intravenous/ Subcutaneous NA Oral Oral/intranasal/subcutaneous Parenteral Subcutaneous Marginal Zone Lymphoma Products have been categorized under various Molecule types such as Antibody Antisense oligonucleotides Immunotherapy Monoclonal antibody Peptides Protein Recombinant protein Small molecule Stem Cell Vaccine Download DelveInsight's latest report to gain strategic insights into upcoming Marginal Zone Lymphoma Therapies and key Marginal Zone Lymphoma Developments @ Marginal Zone Lymphoma Market Drivers and Barriers, and Future Perspectives Scope of the Marginal Zone Lymphoma Pipeline Report Coverage- Global Marginal Zone Lymphoma Companies- Incyte Corporation, HUTCHMED, InnoCare Pharma, ENTEROME SA, Beijing Mabworks Biotech Co., Ltd., ADC Therapeutics, MEI Pharma, Inc., Genentech, Inc., Novartis, AstraZeneca, Kite Pharma, Roche, Oncternal Therapeutics, Inc., Celgene, IGM Biosciences, Inc., Loxo Oncology, Genmab, ArQule, Sound Biologics, Adicet Bio, Inc., Celldex Therapeutics, TG Therapeutics, Inc., VelosBio Inc., Newave Pharmaceutical Inc., Boryung Pharmaceutical Co., Ltd., Cellectar Biosciences, Inc., Bio-Path Holdings, Inc., Nurix Therapeutics, Inc. and others. Marginal Zone Lymphoma Therapies- Pirtobrutinib, Obinutuzumab, Loncastuximab tesirine 150 µg/Kg, Copanlisib, Rituximab, Venetoclax, and others. Marginal Zone Lymphoma Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination Marginal Zone Lymphoma Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Which companies are leading the race in Marginal Zone Lymphoma drug development? Find out in DelveInsight's exclusive Marginal Zone Lymphoma Pipeline Report—access it now! @ Marginal Zone Lymphoma Emerging Drugs and Major Companies Table of Content Introduction Executive Summary Marginal Zone Lymphoma: Overview Pipeline Therapeutics Therapeutic Assessment Marginal Zone Lymphoma – DelveInsight's Analytical Perspective Late Stage Products (Phase III) Tafasitamab: Incyte Corporation Drug profiles in the detailed report….. Mid Stage Products (Phase II) Orelabrutinib: InnoCare Pharma Drug profiles in the detailed report….. Early Stage Products (Phase I/II) EO2463: Enterome Drug profiles in the detailed report….. Preclinical and Discovery Stage Products Drug name: Company name Drug profiles in the detailed report….. Inactive Products Marginal Zone Lymphoma Key Companies Marginal Zone Lymphoma Key Products Marginal Zone Lymphoma- Unmet Needs Marginal Zone Lymphoma- Market Drivers and Barriers Marginal Zone Lymphoma- Future Perspectives and Conclusion Marginal Zone Lymphoma Analyst Views Marginal Zone Lymphoma Key Companies Appendix About Us DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve. Media Contact Company Name: DelveInsight Business Research LLP Contact Person: Yash Bhardwaj Email: Send Email Phone: 09650213330 Address: 304 S. Jones Blvd #2432 City: Las Vegas State: NV Country: United States Website:
Yahoo
14-05-2025
- Health
- Yahoo
Genmab to Present New and Updated Results from its Robust Epcoritamab (EPKINLY®) Development Program at the 2025 European Hematology Association (EHA) Congress
Media ReleaseCOPENHAGEN, Denmark; May 14, 2025 Data from 14 abstracts highlight the depth, breadth, and strength of Genmab's comprehensive epcoritamab development program across multiple patient populations and treatment settings Genmab A/S (Nasdaq: GMAB) announced today that it will present 14 abstracts evaluating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, as a monotherapy and in combination across disease settings in patients with diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) at the 30th European Hematology Association (EHA) Congress, being held in Milan, Italy, and virtually, June 12-15, 2025. Two oral presentations will feature data from the Phase 1/2 EPCORE® NHL-2 trial evaluating epcoritamab plus rituximab and ifosfamide-carboplatin-etoposide (R-ICE) in patients with relapsed/refractory (R/R) DLBCL eligible for autologous stem cell transplantation, and the Phase 1/2 EPCORE NHL-5 trial evaluating epcoritamab plus polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (pola-R-CHP) in previously-untreated patients with DLBCL. Additionally, results from the Phase 1/2 EPCORE NHL-1 and NHL-3 trials, including three years of follow-up in patients with R/R DLBCL and FL treated with epcoritamab monotherapy, will be presented as a poster. All abstracts accepted for presentation have been published and may be accessed online via the EHA Open Access Library. 'Together with AbbVie, we have made tremendous progress advancing our broad epcoritamab development program and we are pleased to share important results at EHA 2025 evaluating epcoritamab in a variety of treatment settings and patient populations,' said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. 'The data presented at EHA further reinforce our commitment to epcoritamab and its potential to become a core therapy across B-cell malignancies.' Several abstracts evaluating epcoritamab will also be presented at the 18th International Conference on Malignant Lymphoma (ICML), taking place June 17-21, 2025, in Lugano, Switzerland. Abstracts accepted for presentation at EHA include: Abstract Number Abstract Title Type of Presentation Date/Time of Presentation S245 First Disclosure of Epcoritamab + R-ICE in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL) Eligible for Autologous Stem Cell Transplantation (ASCT): EPCORE NHL-2 Oral Sunday, June 1511:00-12:15 CEST S247 Durable Efficacy with Fixed-Duration Epcoritamab + Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (Pola-R-CHP) for 1L Diffuse Large B-cell Lymphoma (EPCORE NHL-5) Oral Sunday, June 1511:00-12:15 CEST PF881 Epcoritamab Monotherapy Demonstrates Deep and Durable Responses at Three-Year follow-up in Patients with Relapsed/Refractory Follicular Lymphoma Poster Friday, June 13 18:30-19:30 CEST PF885 Epcoritamab Plus Lenalidomide and Rituximab Achieves High Response Rates and Survival Benefits Compared with Usual Care in Relapsed/Refractory Follicular Lymphoma: A Comparative Analysis Poster Friday, June 13 18:30-19:30 CEST PF920 Sustained Remission in R/R DLBCL with Epcoritamab Monotherapy: EPCORE NHL-1 3y Results and Novel Subgroup Analyses in Patients with Complete Response at 2y Poster Friday, June 13 18:30-19:30 CEST PS1886 Matching-Adjusted Indirect Comparison of Epcoritamab with Rituximab + Lenalidomide vs Tafasitamab with Rituximab + Lenalidomide in Second-Line+ Follicular Lymphoma Poster Saturday, June 14 18:30-19:30 CEST PS1898 Patient-Reported Outcomes in Patients with Relapsed/Refractory Follicular Lymphoma Treated with Epcoritamab within the Entire Study Cohort and in Patients with Symptoms at Baseline Poster Saturday, June 14 18:30-19:30 CEST PS1968 Match-Adjusted Comparative Analysis of Epcoritamab + R-DHAX/C or R-ICE vs R-DHAX/C or R-ICE In 2L+ Transplant-Eligible Patients with Diffuse Large B-Cell Lymphoma Poster Saturday, June 14 18:30-19:30 CEST PS1942 Match-Adjusted Comparative Analysis of the Efficacy Of Epcoritamab + R-Mini-CHOP vs R-Mini-CHOP in Previously Untreated Diffuse Large B-Cell Lymphoma Poster Saturday, June 14 18:30-19:30 CEST PS1932 Treatment Outcomes in Newly Diagnosed Diffuse Large B-Cell Lymphoma Patients with High Cardiovascular Risk, and Treated with Non-Anthracycline Containing Regimens Poster Saturday, June 14 18:30-19:30 CEST PS1944 Patient Preferences for Attributes of Bispecific Antibodies Indicated for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma in the United States Poster Saturday, June 14 18:30-19:30 CEST PS1912 Circulating Tumour DNA-Directed Intervention with Epcoritamab Alone or in Combination with Lenalidomide and Rituximab is Feasible in the Early Post-CAR-T Population at High Risk of Relapse: Preliminary Data from EpLCART Poster Saturday, June 14 18:30-19:30 CEST PS1979 Epcoritamab with Gemcitabine, Dexamethasone, and Cisplatin (Epco-GDP) in Relapsed, Refractory Large B-cell Lymphoma – An Interim Analysis of Phase II Multicenter Investigator-initiated Trial Poster Saturday, June 1415:30-16:00 CEST PS1892 Phase II Investigator-initiated Trial of Epcoritamab-Lenalidomide in Treatment Naïve Follicular Lymphoma Poster Saturday, June 14 18:30-19:30 CESTAbout Epcoritamab Epcoritamab is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody® technology and administered subcutaneously. Genmab's DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.i Epcoritamab (approved under the brand name EPKINLY® in the U.S. and Japan, and TEPKINLY® in the EU) has received regulatory approval in certain lymphoma indications in several territories. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for the investigational R/R FL indication and additional approvals for the R/R DLBCL indication. Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes five ongoing Phase 3, open-label, randomized trials including a trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL compared to investigators choice chemotherapy (NCT04628494), a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL (NCT05578976), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) in patients with R/R FL (NCT05409066), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) compared to chemoimmunotherapy in patients with previously untreated FL (NCT06191744), and a trial evaluating epcoritamab in combination with lenalidomide compared to chemoimmunotherapy in patients with R/R DLBCL (NCT06508658). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit for more information. About Genmab Genmab is an international biotechnology company with a core purpose of guiding its unstoppable team to strive toward improving the lives of patients with innovative and differentiated antibody therapeutics. For more than 25 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with knock-your-socks-off (KYSO) antibody medicines®. Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. For more information, please visit and follow us on LinkedIn and X. Contact: David Freundel, Senior Director, Product CommunicationsT: +1 609 613 0504; E: dafr@ Andrew Carlsen, Vice President, Head of Investor RelationsT: +45 3377 9558; E: acn@ Media Release contains forward looking statements. The words 'believe,' 'expect,' 'anticipate,' 'intend' and 'plan' and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab's most recent financial reports, which are available on and the risk factors included in Genmab's most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law. Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; HexaBody®; DuoHexaBody®, HexElect® and KYSO®. EPCORE, EPKINLY, TEPKINLY and their designs are trademarks of AbbVie Biotechnology Ltd. i Engelberts PJ, et al. DuoBody-CD3xCD20 Induces Potent T-Cell-Mediated Killing of Malignant B Cells in Preclinical Models and Provides Opportunities for Subcutaneous Dosing. EBioMedicine. 2020;52:102625. doi: 10.1016/ Media Release no. i08CVR no. 2102 3884LEI Code 529900MTJPDPE4MHJ122 Genmab A/SCarl Jacobsens Vej 302500 ValbyDenmark Attachment 140525_MRi08_EHA Curtain Raiser
Yahoo
15-03-2025
- Health
- Yahoo
Sacramento doctor: If not for NIH funding, I wouldn't have survived my leukemia diagnosis
Following a terminal leukemia/lymphoma diagnosis in 2010, my physicians estimated that I would live no more than five to eight years. Today, I am seven years past that expiration date and going strong. I can thank the investments in research made by the National Institutes of Health and other non-profit organizations — notably, the Leukemia & Lymphoma Society — which have allowed me to survive my leukemia. The current administration's threat to dramatically reduce or delay funding for the National Institutes of Health for many of the most talented researchers and clinicians in the best academic institutions in the nation represents a crushing blow not only to the development of future cancer therapies, but to all of medical research. Without previous funding, I would not be alive today. As a family physician, I opened my private practice in Sacramento in 1981, caring for patients from womb to tomb. My practice included obstetrics, pediatrics and adult care. This allowed me to experience the full spectrum of emotions that comes with medical work: the joy that comes with the arrival of a newborn, and the deep sadness of having to give a patient and their families the 'talk' regarding serious or fatal medical conditions. Opinion I self-diagnosed my own lymphoma. I was in shock and denial — as most people in my situation would be. From that day in 2010 until my treatment began in 2013, I continued my medical practice. When chemotherapy made it too risky for me to work in a medical office, I became the executive research director for the Leukemia & Lymphoma Society, blending my previous expertise into building a national database for blood cancer patients to study their outcomes. Since my first treatment in 2013, I have survived ten relapses, surgeries, radiation therapy and a dozen medical treatments, including six experimental therapies by way of clinical trials. Each and every one of the medications I have been given — ranging from conventional chemotherapy to targeted immunotherapy to an allogeneic bone marrow transplant — have been funded (at some point in their development) by the National Institutes of Health. These medications may not be household names, and may not be marketed by direct-to-consumer advertising, but they are lifesaving. My leukemia is not curable because the disease becomes resistant to the therapy given. It can be suppressed: Like playing whack-a-mole, it can be beaten down with the correct cadence of unique treatments by way of new drugs. When I required treatment in 2013, the only U.S. Food and Drug Administration-approved therapies were primarily conventional chemotherapy — a cocktail of drugs called Fludarabine, Cytoxan, Bendamustine and Rituximab, which required months of infusions. At that time, the targeted oral therapies and immunotherapies, which are available today, were only a glimmer in the eyes of doctors who treat the disease. Today, there are over a dozen FDA-approved therapies to treat my flavor of leukemia. Because I needed many of the drugs before they were approved, I opted to participate in clinical trials, where drugs are tested in the experimental phase prior to FDA approval. I am alive today because the National Institutes of Health and the U.S. research community have been able to produce modes of treatment about as quickly as my lymphoma morphed. Five of the clinical trials I entered have become FDA-approved therapies, including two rocket science-like therapies referred to as CAR T-cell therapy (treatments that involved taking my white blood T-cells, re-engineering them with inactive HIV and re-introducing them into my system to act as virtual Pac-Men tracking down and destroying leukemia cells). Research to develop CAR T-cell therapy began in the 1950s with the development of bone marrow transplant technology, taking a leap forward when genetic engineering helped to create the CAR T concept in the 1980s, with the first clinical trials in the 2010s. I am in debt to non-profit foundations that supported me and funded the incredible research that created new therapies for my leukemia. Philanthropic research funding and academic labs are successful because the National Institutes of Health spent billions of dollars for years to make sure that the U.S. research infrastructure supports innovation and progress. This infrastructure includes laboratory buildings and equipment, clinical trial access and expertise and scientists and care teams. I have lived the last 15 years believing that each therapy I was given represented a bridge to the next treatment. The longer the bridge, the better the chance there would be a new therapy waiting in the wings. My survival is based on research. With limited funding for the National Institutes of Health, I fear that my life and the lives of others in similar situations will be left with no hope. Medical research to treat life-threatening diseases has made incredible progress in the past few decades. A reduced investment today means reduced treatment options for far too many future cancer patients. Dr. Larry Saltzman practiced as a family physician in Sacramento and served as the president and CEO of Insurance Benefit Spot Check, Inc, a company he founded to simplify the complexities of healthcare coverage. He joined the Leukemia & Lymphoma Society as its executive research director to search for patterns of care that produce better outcomes with fewer side effects.
