Latest news with #EHA2025Congress
Yahoo
15-05-2025
- Business
- Yahoo
European Hematology Association Accepts Abstract from Telo Genomics for Presentation at The 2025 Congress
Toronto, Ontario--(Newsfile Corp. - May 15, 2025) - Telo Genomics Corp. (TSXV: TELO) (OTCQB: TDSGF) (the "Company" or "Telo") a leader in the development of diagnostic and prognostic tests for human disease through the analysis of chromosomal telomeres, today announced that the European Hematology Association ("EHA") has accepted Telo Genomics' abstract submission for a poster presentation during the upcoming EHA 2025 Congress. The new abstract is titled "Advanced Risk Prediction for Smoldering Multiple Myeloma ("SMM") Patients Through the Combination of Mayo Clinic's 2/20/20 Model with TeloViewSMM Risk Assessment." It reports a synergistic outcome from the co-application of the 2 assessments, for determining the risk of progression from SMM to active multiple myeloma. For the 88 patients examined, the predictive accuracies corresponding to Receiver Operating Characteristic ("ROC") curves were 0.64 for 2/20/20, 0.77 for TeloViewSMM and 0.80 when applied together. The abstract will be presented on June 14th by Dr. Shaji Kumar, Professor of Medicine at Mayo Clinic, Telo's collaborator and Lead Clinical Investigator on the TeloViewSMM validation studies. Dr. Kumar has played a pivotal role in developing the 2/20/20 risk stratification model, which is currently included in the smoldering myeloma prognostic international guidelines. "We are pleased to be presenting our abstract at EHA. The 2/20/20 risk model has found broad implementation in the clinic, and it has been further refined by inclusion of cytogenetic abnormalities with fluorescence in situ hybridization (FISH) testing," said Dr. Sabine Mai, Telo's Co-Founder. "Since TeloViewSMM could also be added to existing FISH laboratory workflows, the co-use of these assessments is now appearing both highly scalable and clinically advantageous." About TeloView-SMM The TeloViewSMM test is for SMM, a precursor to multiple myeloma. The test stratifies patients flagged with the elevated M-protein biomarker, between patients that are high-risk to progress to the full stage of the myeloma disease, and those that are low-risk patients, and confirms the stability of disease in these patients. To date, this has been a critical unmet need in the management of SMM patients. High risk SMM patients may benefit from immediate treatment intervention, with the possibility of a cure, due to recent advancement in treatment regimens. Alternatively, low risk patients can be monitored using TeloViewSMM, without exposing these patients to unnecessary and debilitating treatment. Critically, TeloViewSMM can be used periodically as a non-invasive liquid biopsy test that can be performed using a simple blood sample. About Multiple Myeloma Multiple myeloma is a challenging and potentially deadly blood cancer that involves plasma cells, a type of blood cell that helps to fight infection. It is the second most common blood cancer with an incidence of 35,000 new cases every year in the US, and ~180,000 patients receiving treatment at any given time. The introduction of next-generation therapies (including targeted treatments) has increased the median survival rate to over 5 years, but MM is still considered incurable. Two asymptomatic precursors, Monoclonal Gammopathy of Unknown Significance ("MGUS") and SMM generally precede the progression to classic symptomatic MM. While MGUS carries a steady risk of progression of 1% per year, SMM is more heterogenous with nearly 40% of patients progressing in the first 5 years, 15% in the next 5 years, reaching the same low risk as MGUS after 10 years. To date, identifying patients who will more rapidly progress to MM remains an important clinical need. MM treatment includes various combinations of drugs with a cost as high as $150,000 per year per patient. As most patients will develop resistance to treatment and relapse within a median of 2 years, identifying them proactively remains another important clinical need. Notably, the total addressable market for both MM assays is over 750,000 tests per year in the US. About Telo Genomics Telo Genomics is a biotech company pioneering the most comprehensive telomere platform in the industry with powerful applications and prognostic solutions. These include liquid biopsies and related technologies in oncology and neurological diseases. Liquid biopsy is a rapidly growing field of significant interest to the medical community for being less invasive and more easily replicated than traditional diagnostic approaches. By combining our team's considerable expertise in quantitative analysis of 3D telomeres with molecular biology and artificial intelligence to recognize disease associated genetic instability, Telo Genomics is developing simple and accurate products that improve day-to-day care for patients by serving the needs of pathologists, clinicians, academic researchers and drug developers. The benefits of our proprietary technology have been substantiated in 160+ peer reviewed publications and in30+ clinical studies involving more than 3,000 patients with multiple cancers and Alzheimer's disease. Our lead application, Telo-MM is being developed to provide important, actionable information to medical professionals in the treatment of Multiple Myeloma, a deadly form of blood cancer. For more information, please visit For further information, please contact:Guido BaechlerExecutive Chairman 416-673-8487 info@ MaRS Centre, South Tower101 College Street, Suite 200Toronto, ON, M5G 1L7 Neither the TSX Venture Exchange nor its Regulation Services Provider (as such term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. Cautionary Note Regarding Forward-Looking Statements Certain information contained herein may constitute "forward-looking information" under Canadian securities legislation. Generally, forward-looking information can be identified by the use of forward-looking terminology such as "will", or variations of such words and phrases or statements that certain actions, events or results "will" occur. Certain forward-looking statements, including statements regarding the Company's receipt of TSXV acceptance of the stock option grant are based on the Company's estimates and are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of the Company to be materially different from those expressed or implied by such forward-looking statements or forward-looking information, including capital expenditures and other costs. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements and forward-looking information. The Company will not update any forward-looking statements or forward-looking information that are incorporated by reference herein, except as required by applicable securities laws. To view the source version of this press release, please visit
Yahoo
14-05-2025
- Business
- Yahoo
Arcellx Announces New Positive Data for Its iMMagine-1 Study in Patients with Relapsed and/or Refractory Multiple Myeloma
-- Results from all 117 patients dosed in the pivotal Phase 2 iMMagine-1 study of anito-cel demonstrated 97% ORR and 68% CR/sCR at a median follow-up of 12.6 months -- -- No delayed neurotoxicities including no Parkinsonism, no cranial nerve palsies, and no Guillain-Barré syndrome, and no immune-mediated enterocolitis have been observed to date with anito-cel -- -- iMMagine-1 data to be presented during an oral presentation at EHA2025 on Saturday, June 14, 2025 -- -- Company to host a live webcast event with an expert panel of clinicians during EHA2025 -- REDWOOD CITY, Calif., May 14, 2025--(BUSINESS WIRE)--Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, today announced new positive data from its pivotal Phase 2 iMMagine-1 study of anitocabtagene autoleucel (anito-cel), in patients with relapsed or refractory multiple myeloma (RRMM). These data will be presented during an oral presentation at the EHA2025 Congress in Milan on June 14, 2025. Anito-cel is partnered with Kite, a Gilead Company. The Phase 2 iMMagine-1 data are from a May 1, 2025 data cutoff date, including all 117 patients with a median follow-up of 12.6 months and a minimum follow-up of four months after treatment with anito-cel. All patients received a single infusion of anito-cel (target dose of 115×106 CAR+ viable T cells). 101 of 117 patients (86%) were triple refractory, and 48 of 117 patients (41%) were penta refractory. Patients received a median of three prior lines of therapy, with 60 of 117 patients (51%) having received three prior lines. Overall response rate (ORR) was 97% (114/117) with a complete response/stringent complete response (CR/sCR) rate of 68% (79/117) and a very good partial response or higher (>VGPR) rate of 85% (100/117), per International Myeloma Working Group (IMWG) criteria as investigator-assessed. Of those evaluable for minimal residual disease (MRD) testing at the time of this data cut, 93.3% (70/75) achieved MRD negativity at a minimum of 10-5 sensitivity. Six-month progression-free survival (PFS) and overall survival (OS) rates were 91.9% and 96.6%, respectively, and 12-month PFS and OS rates were 78.8% and 95.2%, respectively. Median PFS and median OS have not been reached. No delayed or non-immune effector cell-associated neurotoxicity syndrome (ICANS) neurotoxicities, including no Parkinsonism, no cranial nerve palsies, and no Guillain-Barré syndrome, and no immune-mediated enterocolitis have been observed to date with anito-cel. No additional treatment- or therapy-related deaths or Grade ≥3 cytokine release syndrome (CRS) or ICANS events have occurred since the previous data presentation in December 2024. Conclusions Preliminary results from the Phase 2 iMMagine-1 study demonstrate deep and durable responses with a predictable and manageable safety profile in a fourth-line or higher (4L+) RRMM population, including triple- and penta-class refractory disease. Notably, no delayed or non-ICANS neurotoxicities, including no Parkinsonism, no cranial nerve palsies, and no Guillain-Barré syndrome, and no immune-mediated enterocolitis have been observed with anito-cel to date. "These clinical data from our registrational study continue to support our belief that anito-cel has the potential to address the needs of myeloma patients and the physicians who serve them," said Rami Elghandour, Arcellx's Chairman and Chief Executive Officer. "There is no cure for multiple myeloma. We believe there remains an unmet medical need for CAR-T therapies that are efficacious, safe, and accessible. Anito-cel has the unique potential to address these needs thanks to our differentiated technology, our incredible and entrepreneurial team, the robust clinical data generated to date, and our strong partnership with Kite. Our 2026 commercial launch plans for anito-cel with our partners at Kite are well underway and we are excited for the opportunity to advance anito-cel in support of the myeloma community. We look forward to sharing these data with the clinical community at EHA and are honored that the iMMagine-1 data will be presented during an oral presentation on Saturday, June 14." EHA2025 Presentation Details Phase 2 Registrational Study of Anitocabtagene Autoleucel for the Treatment of Patients with Relapsed and/or Refractory Multiple Myeloma: Preliminary Results from the iMMagine-1 Trial Speaker: Gurbakhash Kaur, M.D., Assistant Professor of Internal Medicine, Mount Sinai Health SystemSession Title: s431 Treatment of relapsed and/or refractory multiple myeloma (RRMM)Session Date: June 14, 2025Session Time: 17:00-18:15 CESTPublication Number: S201Presentation Title: S201 Phase 2 Registrational Study of Anitocabtagene Autoleucel for Relapsed and/or Refractory Multiple Myeloma (RRMM): Updated Results from iMMagine-1 About Multiple Myeloma Multiple Myeloma (MM) is a type of hematological cancer in which diseased plasma cells proliferate and accumulate in the bone marrow, crowding out healthy blood cells and causing bone lesions, loss of bone density, and bone fractures. These abnormal plasma cells also produce excessive quantities of an abnormal immunoglobulin fragment, called a myeloma protein (M protein), causing kidney damage and impairing the patient's immune function. MM is the third most common hematological malignancy in the United States and Europe, representing approximately 10% of all hematological cancer cases and 20% of deaths due to hematological malignancies. The median age of patients at diagnosis is 69 years with one-third of patients diagnosed at an age of at least 75 years. Because MM tends to afflict patients at an advanced stage of life, patients often have multiple co-morbidities and toxicities that can quickly escalate and become life-endangering. About Anitocabtagene Autoleucel (anito-cel) Anitocabtagene autoleucel (anito-cel, previously ddBCMA) is the first BCMA-directed CAR T-cell therapy to be investigated in multiple myeloma that utilizes Arcellx's novel and compact binder known as the D-Domain. The small, stable D-Domain binder enables high CAR expression without tonic signaling and is designed to quickly release from the BCMA target. This combination may allow for the effective elimination of multiple myeloma cells without severe immunotoxicity. Anito-cel has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy Designations by the U.S. Food and Drug Administration. About Arcellx and Kite Collaboration Arcellx and Kite, a Gilead Company, formed a global strategic collaboration and license agreement to co-develop and co-commercialize anito-cel for patients with multiple myeloma. Anito-cel is currently being developed in a Phase 2 registrational pivotal study and a global Phase 3 randomized controlled study for relapsed and/or refractory multiple myeloma (RRMM). Kite and Arcellx will jointly commercialize the anito-cel asset in the United States, and Kite will commercialize the product outside the United States. About Arcellx, Inc. Arcellx, Inc. is a clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. Arcellx believes that cell therapies are one of the forward pillars of medicine and Arcellx's mission is to advance humanity by developing cell therapies that are safer, more effective, and more broadly accessible. For more information on Arcellx, please visit Follow Arcellx on X @arcellx and LinkedIn. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements in this press release that are not purely historical are forward-looking statements, including, but not limited to, statements regarding the safety and efficacy of anito-cel, the promising clinical profile of anito-cel, the expectation of anito-cel to be a differentiated CAR-T treatment option for RRMM, the potential of anito-cel as an outpatient therapy, and the planned commercial development of anito-cel both inside and outside the United States. The forward-looking statements contained herein are based upon Arcellx's current expectations and involve assumptions that may never materialize or may prove to be incorrect. These forward-looking statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, including those set forth in Part II, Item 1A (Risk Factors) in the Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the Securities and Exchange Commission (SEC) on May 8, 2025, and the other documents that Arcellx may file from time to time with the Securities and Exchange Commission. These forward-looking statements are made as of the date of this press release, and Arcellx assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. View source version on Contacts Investor Contact: Myesha LacyArcellx, 510-418-2412 Media Contact: Andrea CohenSam Brown LLCandreacohen@ 917-209-7163 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
Business Wire
14-05-2025
- Business
- Business Wire
Arcellx Announces New Positive Data for Its iMMagine-1 Study in Patients with Relapsed and/or Refractory Multiple Myeloma
REDWOOD CITY, Calif.--(BUSINESS WIRE)--Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, today announced new positive data from its pivotal Phase 2 iMMagine-1 study of anitocabtagene autoleucel (anito-cel), in patients with relapsed or refractory multiple myeloma (RRMM). These data will be presented during an oral presentation at the EHA2025 Congress in Milan on June 14, 2025. Anito-cel is partnered with Kite, a Gilead Company. The Phase 2 iMMagine-1 data are from a May 1, 2025 data cutoff date, including all 117 patients with a median follow-up of 12.6 months and a minimum follow-up of four months after treatment with anito-cel. All patients received a single infusion of anito-cel (target dose of 115×10 6 CAR+ viable T cells). 101 of 117 patients (86%) were triple refractory, and 48 of 117 patients (41%) were penta refractory. Patients received a median of three prior lines of therapy, with 60 of 117 patients (51%) having received three prior lines. Overall response rate (ORR) was 97% (114/117) with a complete response/stringent complete response (CR/sCR) rate of 68% (79/117) and a very good partial response or higher (>VGPR) rate of 85% (100/117), per International Myeloma Working Group (IMWG) criteria as investigator-assessed. Of those evaluable for minimal residual disease (MRD) testing at the time of this data cut, 93.3% (70/75) achieved MRD negativity at a minimum of 10 -5 sensitivity. Six-month progression-free survival (PFS) and overall survival (OS) rates were 91.9% and 96.6%, respectively, and 12-month PFS and OS rates were 78.8% and 95.2%, respectively. Median PFS and median OS have not been reached. No delayed or non-immune effector cell-associated neurotoxicity syndrome (ICANS) neurotoxicities, including no Parkinsonism, no cranial nerve palsies, and no Guillain-Barré syndrome, and no immune-mediated enterocolitis have been observed to date with anito-cel. No additional treatment- or therapy-related deaths or Grade ≥3 cytokine release syndrome (CRS) or ICANS events have occurred since the previous data presentation in December 2024. Conclusions Preliminary results from the Phase 2 iMMagine-1 study demonstrate deep and durable responses with a predictable and manageable safety profile in a fourth-line or higher (4L+) RRMM population, including triple- and penta-class refractory disease. Notably, no delayed or non-ICANS neurotoxicities, including no Parkinsonism, no cranial nerve palsies, and no Guillain-Barré syndrome, and no immune-mediated enterocolitis have been observed with anito-cel to date. 'These clinical data from our registrational study continue to support our belief that anito-cel has the potential to address the needs of myeloma patients and the physicians who serve them,' said Rami Elghandour, Arcellx's Chairman and Chief Executive Officer. 'There is no cure for multiple myeloma. We believe there remains an unmet medical need for CAR-T therapies that are efficacious, safe, and accessible. Anito-cel has the unique potential to address these needs thanks to our differentiated technology, our incredible and entrepreneurial team, the robust clinical data generated to date, and our strong partnership with Kite. Our 2026 commercial launch plans for anito-cel with our partners at Kite are well underway and we are excited for the opportunity to advance anito-cel in support of the myeloma community. We look forward to sharing these data with the clinical community at EHA and are honored that the iMMagine-1 data will be presented during an oral presentation on Saturday, June 14.' EHA2025 Presentation Details Phase 2 Registrational Study of Anitocabtagene Autoleucel for the Treatment of Patients with Relapsed and/or Refractory Multiple Myeloma: Preliminary Results from the iMMagine-1 Trial Speaker: Gurbakhash Kaur, M.D., Assistant Professor of Internal Medicine, Mount Sinai Health System Session Title: s431 Treatment of relapsed and/or refractory multiple myeloma (RRMM) Session Date: June 14, 2025 Session Time: 17:00-18:15 CEST Publication Number: S201 Presentation Title: S201 Phase 2 Registrational Study of Anitocabtagene Autoleucel for Relapsed and/or Refractory Multiple Myeloma (RRMM): Updated Results from iMMagine-1 About Multiple Myeloma Multiple Myeloma (MM) is a type of hematological cancer in which diseased plasma cells proliferate and accumulate in the bone marrow, crowding out healthy blood cells and causing bone lesions, loss of bone density, and bone fractures. These abnormal plasma cells also produce excessive quantities of an abnormal immunoglobulin fragment, called a myeloma protein (M protein), causing kidney damage and impairing the patient's immune function. MM is the third most common hematological malignancy in the United States and Europe, representing approximately 10% of all hematological cancer cases and 20% of deaths due to hematological malignancies. The median age of patients at diagnosis is 69 years with one-third of patients diagnosed at an age of at least 75 years. Because MM tends to afflict patients at an advanced stage of life, patients often have multiple co-morbidities and toxicities that can quickly escalate and become life-endangering. About Anitocabtagene Autoleucel (anito-cel) Anitocabtagene autoleucel (anito-cel, previously ddBCMA) is the first BCMA-directed CAR T-cell therapy to be investigated in multiple myeloma that utilizes Arcellx's novel and compact binder known as the D-Domain. The small, stable D-Domain binder enables high CAR expression without tonic signaling and is designed to quickly release from the BCMA target. This combination may allow for the effective elimination of multiple myeloma cells without severe immunotoxicity. Anito-cel has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy Designations by the U.S. Food and Drug Administration. About Arcellx and Kite Collaboration Arcellx and Kite, a Gilead Company, formed a global strategic collaboration and license agreement to co-develop and co-commercialize anito-cel for patients with multiple myeloma. Anito-cel is currently being developed in a Phase 2 registrational pivotal study and a global Phase 3 randomized controlled study for relapsed and/or refractory multiple myeloma (RRMM). Kite and Arcellx will jointly commercialize the anito-cel asset in the United States, and Kite will commercialize the product outside the United States. About Arcellx, Inc. Arcellx, Inc. is a clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. Arcellx believes that cell therapies are one of the forward pillars of medicine and Arcellx's mission is to advance humanity by developing cell therapies that are safer, more effective, and more broadly accessible. For more information on Arcellx, please visit Follow Arcellx on X @arcellx and LinkedIn. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements in this press release that are not purely historical are forward-looking statements, including, but not limited to, statements regarding the safety and efficacy of anito-cel, the promising clinical profile of anito-cel, the expectation of anito-cel to be a differentiated CAR-T treatment option for RRMM, the potential of anito-cel as an outpatient therapy, and the planned commercial development of anito-cel both inside and outside the United States. The forward-looking statements contained herein are based upon Arcellx's current expectations and involve assumptions that may never materialize or may prove to be incorrect. These forward-looking statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, including those set forth in Part II, Item 1A (Risk Factors) in the Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the Securities and Exchange Commission (SEC) on May 8, 2025, and the other documents that Arcellx may file from time to time with the Securities and Exchange Commission. These forward-looking statements are made as of the date of this press release, and Arcellx assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.
