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Medscape
2 days ago
- Health
- Medscape
Can New Combo Fill ‘Unmet Need' in R/R Hodgkin Lymphoma?
Acimtamig, a first-in-class CD30/CD16A bispecific innate cell engager (ICE), combined with an off-the-shelf cord-blood derived natural killer cell product (AlloNK), shows safety and efficacy in the treatment of patients with relapsed or refractory (R/R) classical Hodgkin lymphoma, who otherwise have poor prognoses. 'Acimtamig in combination with AlloNK shows promising efficacy with a well-managed safety profile with the potential to address an unmet need in patients with R/R Hodgkin lymphoma who have exhausted standard-of-care treatment options,' said first author Joseph Maakaron, MD, of the Division of Hematology, Oncology and Transplantation, Department of Medicine, Masonic Cancer Center, University of Minnesota, Minneapolis, in presenting the findings at the American Society of Clinical Oncology (ASCO) 2025 annual meeting in Chicago. Patients with classical Hodgkin lymphoma who relapse after standard-of-care treatments, including chemotherapy, brentuximab vedotin, and checkpoint inhibitors, have few remaining treatment options. Acimtamig has previously shown some efficacy as monotherapy in the treatment of Hodgkin lymphoma, and when further combined with an allogenic cord blood derived natural killer cell product, encouraging objective response rates were observed in a proof-of-concept study. To test the approach in a more rigorous multicenter trial, Maakaron and colleagues conducted the current open-label phase 2 LuminICE-203 trial, enrolling 24 patients with R/R Hodgkin lymphoma. For the study, the patients were treated in one of four cohorts investigating two doses of acimtamig (200 mg or 300 mg weekly flat dosing for 6 weeks) in combination with two dose levels of AlloNK after standard lymphodepletion of up to three cycles and followed by a randomized part using the Simon two-stage design. While the patients had a median age of 42.5 years, the range was wide, ranging from age 23 to 80 years, and 16 (67%) were men. About two thirds of patients (66.7%) had extranodal disease, and they had all been heavily pre-treated with brentuximab vedotin and programmed cell death protein 1 inhibitors, with a median of 4.5 prior lines of treatment, including previous stem cell transplant and CAR T cell therapy among 14 (58%) patients. 'The patients had essentially exhausted all standard-of-care therapy options,' Maakaron emphasized. As of the latest cut-off, the study achieved its primary end point of an objective response rate, with a rate of 88% among the patients, with 14 (58%) achieving complete responses. Across all four dose cohorts, clinically meaningful deep responses were seen, with 10 ongoing responses. A progression-free survival estimate of 61% was observed at 6 months. More robust maximum peaks were observed after the third infusion, which was presumed to be due to a steady state that had been achieved at that time, he added. The safety profile was consistent with previous reports, with the therapy combination being well tolerated. The most common treatment-related side effects were mild to moderate infusion-related reactions, occurring in 50% of patients. There were no cases of graft vs host disease or immune effector cell-associated neurotoxicity syndrome, and cytokine release syndrome (CRS) was reported in six patients shortly after infusion. All treatment-emergent adverse events including infusion-related reactions and CRS events were controlled with standard-of-care interventions and quickly resolved. There were no fatal treatment-emergent adverse events. 'Acimtamig with AlloNK may provide a safe, effective, and durable new therapeutic option for patients with R/R Hodgkin lymphoma, with a progression-free survival estimate of 61% at 6 months,' Maakaron said. 'These early results support the co-administration approach of acimtamig with an off-the-shelf, commercially scalable, allogenic, cryopreserved natural killer cell product in a multicenter setting,' he said. Study Shows Best Response Rates to Date Commenting on the findings at the meeting, Sarah C. Rutherford, MD, associate professor of clinical medicine at Weill Cornell Medicine in New York City, said the need for better treatment options for those who have relapsed after standard therapies is pressing. 'This is really an unmet need in the field,' she underscored. 'Novel treatments in R/R classic Hodgkin lymphoma after brentuximab vedotin, checkpoint inhibitors, and autologous transplant are limited, and most don't really work that well.' 'We tend to use single-agent chemotherapies, repeat checkpoint inhibitors, and radiation, but these patients really suffer because of that, and clinical trial options have been lacking.' Rutherford noted that, with the innovative combination, safety and tolerability were important concerns. 'I was really struck by the tolerability of this regimen, with only five patients having grade 3 and one [having] grade 4 treatment-emergent adverse events.' Furthermore, the response rates were impressive, she noted. 'These are the best response rates observed to date in the post-brentuximab vedotin and checkpoint inhibitor setting, and the toxicities appear manageable,' she said. 'I think it's going to be unlikely to be as widely adopted as checkpoint inhibitors because of the nature of the cellular therapy approach, but I do think this is a very promising agent,' Rutherford said. 'I think it's the current best available trial option, and in the future, some version of this could become a third-line therapy in this disease.'
Yahoo
28-05-2025
- Business
- Yahoo
Artiva Biotherapeutics to Participate in the Jefferies Global Healthcare Conference
SAN DIEGO, May 28, 2025 (GLOBE NEWSWIRE) -- Artiva Biotherapeutics, Inc. (Nasdaq: ARTV), a clinical-stage biotechnology company whose mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases and cancers, announced today that management will participate in a fireside chat at the Jefferies Global Healthcare Conference on Wednesday, June 4, 2025, at 9:20 a.m. EDT. Members of the Artiva management team will also be available to participate in investor meetings with investors who are registered to attend the conference. Investors and the general public are invited to listen to a live webcast of the presentation through the "Investors" section on A webcast replay will be made available following the event for 90 days. About Artiva Biotherapeutics Artiva is a clinical-stage biotechnology company whose mission is to develop effective, safe and accessible cell therapies for patients with devastating autoimmune diseases and cancers. Artiva's lead program, AlloNK® (also known as AB-101), is an allogeneic, off-the-shelf, non-genetically modified, cryopreserved NK cell therapy candidate designed to enhance the antibody-dependent cellular cytotoxicity effect of monoclonal antibodies to drive B-cell depletion. AlloNK is currently being evaluated in three ongoing clinical trials for the treatment of B-cell driven autoimmune diseases. This includes two company-sponsored trials, one in systemic lupus erythematosus for patients with or without lupus nephritis, and a basket trial across autoimmune diseases including rheumatoid arthritis and Sjögren's disease, as well as an investigator-initiated basket trial in B-cell driven autoimmune diseases. Artiva's pipeline also includes CAR-NK candidates targeting both solid and hematologic cancers. Artiva was founded in 2019 as a spin out of GC Cell, formerly GC Lab Cell Corporation, a leading healthcare company in the Republic of Korea, pursuant to a strategic partnership granting Artiva exclusive worldwide rights (excluding Asia, Australia and New Zealand) to GC Cell's NK cell manufacturing technology and programs. Artiva is headquartered in San Diego, California. For more information, please visit Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this press release that are not statements of historical fact are forward-looking statements. Such forward-looking statements include, without limitation, statements regarding upcoming events or Artiva Biotherapeutics, Inc.'s (the 'Company') participation at such events. These forward-looking statements are based on the beliefs of the management of the Company as well as assumptions made by and information currently available to the Company. Such statements reflect the current views of the Company with respect to future events and are subject to known and unknown risks and uncertainties. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. These and other factors that may cause the Company's actual results to differ from current expectations are discussed in the Company's filings with the Securities and Exchange Commission (the 'SEC'), including the section titled 'Risk Factors' in the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date this press release is given. Except as required by law, the Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. ContactsInvestors: Neha Krishnamohan, Artiva Biotherapeutics, ir@ Jessica Yingling, Ph.D., Little Dog Communications Inc., jessica@ +1.858.344.8091 Source: Artiva Biotherapeutics, in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
28-04-2025
- Business
- Yahoo
Artiva Biotherapeutics to Present Longer-term Phase 1/2 Data for AlloNK® in Combination with Rituximab in Patients with B-cell-Non-Hodgkin Lymphoma at the ASGCT 28th Annual Meeting
Prolonged duration of response, deep B-cell depletion, and well-tolerated safety profile support the potential of AlloNK® + rituximab for the treatment of B-cell driven diseases in a community setting Additional poster presentation to feature scalability and consistency of AlloNK manufacturing process SAN DIEGO, April 28, 2025 (GLOBE NEWSWIRE) -- Artiva Biotherapeutics, Inc. (Nasdaq: ARTV), a clinical-stage biotechnology company whose mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases and cancers, announced today that the Company will have a poster presentation on new longer-term Phase 1/2 data for AlloNK® (also known as AB-101) in patients with relapsed/refractory B-cell non-Hodgkin lymphoma at the upcoming American Society of Gene & Cell Therapy (ASGCT) 28th Annual Meeting taking place May 13-17, 2025, in New Orleans, Louisiana. These results demonstrate prolonged duration of response, deep B-cell depletion and a well-tolerated safety profile of AlloNK in combination with rituximab. In addition, the Company will have a poster presentation featuring the scalability and consistency of the AlloNK manufacturing process. Details of the presentations are as follows: Abstract 858 – AlloNK® Cell Therapy ± Rituximab in Patients with Relapsed or Refractory Non-Hodgkin Lymphoma Date/Time: May 13, 2025, 6:00 p.m. – 7:30 p.m. CT Session Title: Poster Reception Location: Poster Hall I2 Abstract 1765 – AlloNK: A Scalable and Consistent NK Cell Therapy in Development for Treatment of Oncology and Autoimmune Diseases Date/Time: May 15, 2025, 5:30 p.m. – 7:00 p.m. CT Session Title: Poster Reception Location: Poster Hall I2 Abstracts are currently available on the ASGCT website. Following the presentations, copies will be available on the "Scientific Posters & Publications" section of the 'Events & Presentation' page on the Company's website. About Artiva Biotherapeutics Artiva is a clinical-stage biotechnology company whose mission is to develop effective, safe and accessible cell therapies for patients with devastating autoimmune diseases and cancers. Artiva's lead program, AlloNK®, is an allogeneic, off-the-shelf, non-genetically modified, cryopreserved NK cell therapy candidate designed to enhance the antibody-dependent cellular cytotoxicity effect of monoclonal antibodies to drive B-cell depletion. AlloNK® is currently in clinical trials for treatment of systemic lupus erythematosus, for patients with or without lupus nephritis, and in an investigator-initiated basket trial in multiple autoimmune indications. Artiva's pipeline also includes CAR-NK candidates targeting both solid and hematologic cancers. Artiva was founded in 2019 as a spin out of GC Cell, formerly GC Lab Cell Corporation, a leading healthcare company in the Republic of Korea, pursuant to a strategic partnership granting Artiva exclusive worldwide rights (excluding Asia, Australia and New Zealand) to GC Cell's NK cell manufacturing technology and programs. Artiva is headquartered in San Diego, California. For more information, please visit Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this press release that are not statements of historical fact are forward-looking statements. Such forward-looking statements include, without limitation, statements regarding Artiva Biotherapeutics, Inc.'s (the 'Company') participation in the ASGCT 28th Annual Meeting; the content of the Company's presentations; the potential benefits, accessibility, effectiveness and safety of AlloNK® + rituximab for the treatment of B-cell driven diseases; and the Company's expectations regarding timing and availability of data from the Company's clinical trials. These forward-looking statements are based on the beliefs of the management of the Company as well as assumptions made by and information currently available to the Company. Such statements reflect the current views of the Company with respect to future events and are subject to known and unknown risks and uncertainties. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. These and other factors that may cause the Company's actual results to differ from current expectations are discussed in the Company's filings with the Securities and Exchange Commission (the 'SEC'), including the section titled 'Risk Factors' in the Company's Annual Report on Form 10-K for the year ended December 31, 2024. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date this press release is given. Except as required by law, the Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. ContactsInvestors: Neha Krishnamohan, Artiva Biotherapeutics, ir@ Jessica Yingling, Ph.D., Little Dog Communications Inc., jessica@ +1.858.344.8091 Source: Artiva Biotherapeutics, in to access your portfolio
