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2024 DEC 23 (NewsRx) -- By a News Reporter-Staff News Editor at Hematology Week -- New study results on B-cell lymphoma have been published. According to news reporting out of [...]

Charles River generated best-in-class data with Kytopen's Flowfect(TM) technology in comparative study. The study using CRISPR/Cas9 TRAC gene knockout experiments in primary T cells revealed that the Flowfect Tx(TM) platform [...]

2024 OCT 23 (NewsRx) -- By a News Reporter-Staff News Editor at Vaccine Weekly -- Investigators publish new report on influenza A virus. According to news reporting originating from the [...]

2024 SEP 27 (NewsRx) -- By a News Reporter-Staff News Editor at Health & Medicine Week -- According to news reporting based on a preprint abstract, our journalists obtained the [...]

2024 AUG 30 (NewsRx) -- By a News Reporter-Staff News Editor at Health & Medicine Week -- Researchers detail new data in human T-lymphotropic virus. According to news originating from [...]

HyBryte(TM) demonstrates more rapid and robust treatment response compared to Valchlor during 12-week treatment course PRINCETON, N.J., June 25, 2024 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), [...]

2024 JUN 24 (NewsRx) -- By a News Reporter-Staff News Editor at Hematology Week -- Fresh data on leukemia are presented in a new report. According to news originating from [...]

2024 JUN 21 (NewsRx) -- By a News Reporter-Staff News Editor at Health & Medicine Week -- Investigators publish new report on multiple myeloma. According to news reporting from the [...]

2024 JUN 10 (NewsRx) -- By a News Reporter-Staff News Editor at AIDS Weekly -- Research findings on Immune System Diseases and Conditions - HIV/AIDS are discussed in a new [...]

2024 MAY 20 (NewsRx) -- By a News Reporter-Staff News Editor at Hematology Week -- Investigators discuss new findings in B-cell lymphoma. According to news reporting out of Inha University [...]

Bristol Myers Squibb and 2seventy bio Inc announced on 11 Dec 2023 results from the preplanned final progression-free survival (PFS) analysis of KarMMa-3, the pivotal Phase 3, open-label, global, randomized controlled study evaluating Abecma (idecabtagene vicleucel) compared with standard combination regimens in adults with relapsed and refractory multiple myeloma after two to four prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody (triple-class exposed), who were refractory to their last regimen. At a median follow-up of 30.9 months, representing the longest follow-up for a randomized Phase 3 CAR T cell therapy trial in this patient population, significantly improved PFS was maintained with Abecma compared to standard regimens, with a 51% reduction in the risk of disease progression or death. These data are being presented on 11 Dec 2023 in an oral presentation at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition. With extended follow-up, treatment with Abecma (n=254) continued to demonstrate higher overall response rates (ORR) and a deepening of responses versus standard regimens. The ORR with Abecma was 71% with a complete response (CR) rate of 44%, which increased by 5% from the interim analysis. In comparison, the ORR for standard regimens was 41%, with a CR rate of 5%, which remained unchanged from the time of interim analysis. The PFS, ORR and CR rates observed in the KarMMa-3 trial in the standard regimens arm are consistent with those that have historically been observed in this heavily pre-treated triple-class exposed patient population, in which PFS is approximately four months and deep and durable responses are limited. With these data, Abecma is the first and only anti-BCMA CAR T cell therapy to demonstrate superiority over standard regimens in a randomized, controlled Phase 3 trial designed to evaluate patients with triple-class exposed relapsed and refractory multiple myeloma. In the study, which included a patient-centric design that allowed for crossover from standard regimens to Abecma upon confirmed disease progression, overall survival (OS) was a key secondary endpoint. Due to the median PFS observed with standard regimens, more than half (56%) of patients in the standard regimens arm crossed over to receive Abecma as a subsequent therapy. The median OS was 41.4 months with Abecma and 37.9 months with standard regimens. However, the prespecified sensitivity analyses adjusting for crossover showed a median OS of 41.4 months for Abecma and 23.4 months for standard regimens, suggesting a positive trend in OS benefit for Abecma compared with standard regimens. Historically, based on real-world evidence, median OS for patients with triple-class exposed relapsed and refractory multiple myeloma is approximately 13 months. In the KarMMa-3 study, Abecma continued to exhibit a well-established and generally predictable safety profile, including no new safety signals, with mostly low-grade occurrences of cytokine release syndrome (CRS) and neurotoxicity. Original source: Bristol-Myers Squibb, website: http://www.bms.com/, Copyright Bristol-Myers Squibb 2023., research and development; Abecma; anticancer drugs; cell therapies; idecabtagene vicleucel; 2seventy bio; Bristol Myers [...]

2024 JAN 26 (NewsRx) -- By a News Reporter-Staff News Editor at Health & Medicine Week -- Data detailed on chronic fatigue syndrome have been presented. According to news reporting [...]

2024 JAN 8 (NewsRx) -- By a News Reporter-Staff News Editor at Hematology Week -- Current study results on Bone Marrow Diseases and Conditions - Aplastic Anemia have been published. [...]

Kite, a Gilead Company, announces on 6 Jun 2023 findings from the largest real-world analysis to date of Tecartus (brexucabtagene autoleucel) in patients with relapsed or refractory mantle cell lymphoma (R/R MCL), which show that outcomes of Tecartus therapy had consistent high complete response (CR) and overall response rates (ORR), regardless of type of prior treatment, including: Bruton's tyrosine kinase inhibitor (BTKi), bendamustine or autologous hematopoietic cell transplant (autoHCT). Higher CR was seen when Tecartus was given as second-and-third-line compared to later lines of treatment. The data are being presented orally on 6 Jun 2023 at the 2023 American Society of Clinical Oncology Annual Meeting (ASCO) (Abstract no 7507). With median follow-up of 12 months, ORR was 90%, which was similar to ZUMA-2 results, and high CR (78%) was seen in patients who received Tecartus. Additionally, at 12 months, duration of response (DOR) (since earliest CR/partial response), progression-free survival (PFS) and overall survival (OS) rates were 64%, 61% and 74% respectively. Grade 3 or higher cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) (based on American Society for Transplantation and Cellular Therapy (ASTCT) criteria) incidence were 10% and 28% respectively. In a multivariate analysis of patients who received Tecartus in earlier lines of therapy (1-2 vs above or equal to 3 prior lines of therapy), the data showed an ORR of 94% and a CR of 88%. The multivariate analysis assessed outcomes based on prior therapy; findings show that real-world effectiveness and safety outcomes with Tecartus in patients with R/R MCL are consistent regardless of prior treatment. In BTKi-naive patients, effectiveness (ORR 92%, CR 83%) and safety outcomes are consistent when compared with prior BTKi-treated patients. In patients with prior bendamustine use, effectiveness remained consistent and prior bendamustine use was associated with a reduced risk of grade above or equal to 3 immune effector cell-associated neurotoxicity syndrome {ICANS [odds ratio (OR) 0.50; 95% confidence interval (CI), 0.30-0.84]} and increased risk of prolonged thrombocytopenia (OR 1.98; 95% CI, 1.11-3.53). Within the multivariate analysis, PFS was improved in patients with prior autoHCT compared to those without prior autoHCT [hazard ratio (HR) 0.56; 95% CI, 0.35-0.88]. Original source: Gilead, website: http://www.gilead.com/, Copyright Gilead 2023., research and development; anticancer drugs; bendamustine; brexucabtagene autoleucel; cell therapies; enzyme inhibitors; Tecartus; Gilead; [...]

Kite, a Gilead Company, announces on 6 Jun 2023 findings from the largest real-world analysis to date of Tecartus (brexucabtagene autoleucel) in patients with relapsed or refractory mantle cell lymphoma (R/R MCL), which show that outcomes of Tecartus therapy had consistent high complete response (CR) and overall response rates (ORR), regardless of type of prior treatment, including: Bruton's tyrosine kinase inhibitor (BTKi), bendamustine or autologous hematopoietic cell transplant (autoHCT). Higher CR was seen when Tecartus was given as second-and-third-line compared to later lines of treatment. The data are being presented orally on 6 Jun 2023 at the 2023 American Society of Clinical Oncology Annual Meeting (ASCO) (Abstract no 7507). Prospective data from 380 patients registered in the Center for International Blood and Marrow Transplant Research (CIBMTR) observational database receiving Tecartus for R/R MCL from 73 US treatment centres were included in this analysis; these data from standard-of-care practice were collected for the post-authorization safety study (PASS) for Tecartus in the US, which completed enrolment in Dec 2022. Patients had a median of four lines of prior therapy; prior to infusion, 87% were BTKi-exposed, 56% received bendamustine, and 30% received autoHCT. Median time from leukapheresis to infusion (also referred to as vein-to-vein time) was 28 days, during which time 46% received bridging therapy. With median follow-up of 12 months, ORR was 90%, which was similar to ZUMA-2 results, and high CR (78%) was seen in patients who received Tecartus. Additionally, at 12 months, duration of response (DOR) (since earliest CR/partial response), progression-free survival (PFS) and overall survival (OS) rates were 64%, 61% and 74% respectively. Grade 3 or higher cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) [based on American Society for Transplantation and Cellular Therapy (ASTCT) criteria] incidence were 10% and 28% respectively. In a multivariate analysis of patients who received Tecartus in earlier lines of therapy (1-2 vs above or equal to 3 prior lines of therapy), the data showed an ORR of 94% and a CR of 88%. The multivariate analysis assessed outcomes based on prior therapy; findings show that real-world effectiveness and safety outcomes with Tecartus in patients with R/R MCL are consistent regardless of prior treatment. In BTKi-naive patients, effectiveness (ORR 92%, CR 83%) and safety outcomes are consistent when compared with prior BTKi-treated patients. In patients with prior bendamustine use, effectiveness remained consistent and prior bendamustine use was associated with a reduced risk of grade above or equal to 3 immune effector cell-associated neurotoxicity syndrome (ICANS [odds ratio (OR) 0.50; 95% confidence interval (CI), 0.30-0.84] and increased risk of prolonged thrombocytopenia (OR 1.98; 95% CI, 1.11-3.53). Within the multivariate analysis, PFS was improved in patients with prior autoHCT compared to those without prior autoHCT [hazard ratio (HR) 0.56; 95% CI, 0.35-0.88]. Original source: Gilead, website: http://www.gilead.com/, Copyright Gilead 2023., research and development; anticancer drugs; bendamustine; brexucabtagene autoleucel; cell therapies; Tecartus; Gilead; [...]

Kite, a Gilead Company, announces detailed results from the overall survival (OS) analysis of the landmark Phase 3 ZUMA-7 study of Yescarta [axicabtagene ciloleucel (axi-cel)] CAR T-cell therapy compared with historical standard of care (SOC) as initial treatment in the curative setting for patients with relapsed or refractory large B-cell lymphoma (R/R LBCL). Yescarta is the first treatment in nearly 30 years to demonstrate a significant improvement in survival in this patient population. The late-breaking data are being presented orally at the 2023 American Society of Clinical Oncology Annual Meeting (Abstract no LBA107) and published simultaneously in the New England Journal of Medicine. Yescarta's safety profile remains consistent with prior studies, and no new treatment-related deaths occurred since the primary EFS analysis. The primary EFS analysis showed that Grade 3 or higher adverse events (AEs) occurred in 91% of patients treated with axi-cel compared with 83% of those treated with SOC. The most common grade 3 or higher AEs were neutropenia (69% vs 41%, respectively), anaemia (30% vs 39%), and leukopenia (29% vs 22%). Original source: Gilead, website: http://www.gilead.com/, Copyright Gilead 2023., research and development; anticancer drugs; axicabtagene ciloleucel; cell therapies; Yescarta; Gilead; [...]

2023 OCT 22 (NewsRx) -- By a News Reporter-Staff News Editor at Medical Letter on the CDC & FDA -- Data detailed on COVID-19 have been presented. According to news [...]

Bristol Myers Squibb and 2seventy bio Inc announced on 10 Feb 2023 the first publication and presentation of positive results from KarMMa-3, a pivotal Phase 3, open-label, global, randomized, controlled study evaluating Abecma (idecabtagene vicleucel) compared with standard combination regimens in adults with relapsed and refractory multiple myeloma after two to four prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody, and who were refractory to their last regimen. Data from KarMMa-3 are being published in The New England Journal of Medicine and simultaneously presented at the EBMT and the European Hematology Association's (EHA) 5th European CAR T-cell Meeting on 10 Feb 2023 in an oral presentation during the Best Abstract Session. At a median follow up of 18.6 months, treatment with Abecma (n=254) demonstrated a clinically meaningful and statistically significant improvement in the primary endpoint of progression-free survival (PFS) compared with standard regimens (n=132), with a median PFS of 13.3 months vs 4.4 months, respectively. This represents a 51% reduction in risk of disease progression or death with Abecma. Based on results from KarMMa-3, Abecma is the first and only chimeric antigen receptor (CAR) T cell therapy to demonstrate superiority over standard regimens in triple-class exposed relapsed and refractory multiple myeloma in a randomized, controlled Phase 3 trial. Results for the key secondary endpoint of overall response rate also met statistical significance with the majority of patients (71%) treated with Abecma achieving a response, and 39% achieving a complete response or stringent complete response. In comparison, less than half of patients (41%) who received standard regimens achieved a response, with 5% experiencing a complete response or stringent complete response. Responses with Abecma were durable with a median duration of 14.8 months compared with 9.7 months for standard regimens. Clinical benefit with Abecma was consistently observed across difficult-to-treat subgroups. Abecma exhibited a consistent and generally predictable safety profile, including no new safety signals, with mostly low-grade occurrences of cytokine release syndrome (CRS) and neurotoxicity. In patients treated with Abecma, 88% experienced any grade CRS, with Grade 3/4 events occurring in 4% of patients. Two patients (1%) experienced a Grade 5 CRS event. Median time to onset of CRS was 1 day and median duration of CRS was 3.5 days (range: 1-51). Any grade neurotoxicity occurred in 15% of patients, with Grade 3/4 neurotoxicity occurring in 3% of patients, and no Grade 5 events reported. Median time to onset of neurotoxicity was 3 days (range: 1-317) and median duration of neurotoxicity was 2 days (range: 1-37). Bristol Myers Squibb and 2seventy bio intend to include these data in a planned supplemental biologics licence application submission to the US Food and Drug Administration (FDA) in 2023. Abecma is the first-in-class B-cell maturation antigen (BCMA)-directed CAR T cell immunotherapy approved by the FDA for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. Original source: Bristol-Myers Squibb, website: http://www.bms.com/, Copyright Bristol-Myers Squibb 2023., joint venture; regulations and rulings; research and development; Abecma; anticancer drugs; cell therapies; idecabtagene vicleucel; 2seventy; Bristol Myers [...]

2023 JUN 6 (NewsRx) -- By a News Reporter-Staff News Editor at Cancer Weekly -- According to news reporting based on a preprint abstract, our journalists obtained the following quote [...]

Kite, a Gilead Company, announced on 12 Dec 2022 findings from follow-up analyses of two pivotal studies (ZUMA-2 and ZUMA-3) of the CAR T-cell therapy Tecartus (brexucabtagene autoleucel). A comparison of two-year follow-up from ZUMA-3 and SCHOLAR-3, a retrospective historical control study, evaluating Tecartus versus standard of care (SOC) in adult patients with relapsed/refractory (R/R) B-cell acute lymphoblastic leukaemia (B-ALL), was presented in a poster session at the 2022 American Society of Hematology (ASH) Annual Meeting & Exposition on 10 Dec 2022 (Abstract no 1368) and simultaneously published in the Journal of Hematology & Oncology. An additional exploratory analysis on patient and product characteristics associated with long-term response from the three-year follow-up of the Phase 2 ZUMA-2 study of Tecartus in patients with R/R mantle cell lymphoma (MCL) was also presented in a poster session on 12 Dec 2022 (Abstract no 4199). Finally, a comparison analysis of ZUMA-2 and SCHOLAR-2, a retrospective historical control study, evaluating Tecartus vs. SOC in adult patients with R/R MCL, was presented in a poster session on 12 Dec 2022 (Abstract no 4627). Original source: Gilead, website: http://www.gilead.com/, Copyright Gilead 2022., research and development; anticancer drugs; brexucabtagene autoleucel; cell therapies; Tecartus; Gilead; [...]

2023 MAR 5 (NewsRx) -- By a News Reporter-Staff News Editor at Medical Letter on the CDC & FDA -- Data detailed on COVID-19 have been presented. According to news [...]

2023 MAR 3 (NewsRx) -- By a News Reporter-Staff News Editor at Health & Medicine Week -- According to news reporting based on a preprint abstract, our journalists obtained the [...]

2022 NOV 23 (NewsRx) -- By a News Reporter-Staff News Editor at Vaccine Weekly -- Fresh data on hepatitis B virus are presented in a new report. According to news [...]

2022 NOV 11 (NewsRx) -- By a News Reporter-Staff News Editor at Health & Medicine Week -- New research on Autoimmune Diseases and Conditions - Lupus is the subject of [...]

2022 NOV 2 (NewsRx) -- By a News Reporter-Staff News Editor at Vaccine Weekly -- Investigators publish new report on Immunization - Vaccines. According to news reporting originating from Seoul, [...]

Chinese pharma companies are continuously focusing on the research and development of new innovative oncology therapies. Recently, Innovent Biologics and Gracell Biotechnologies have initiated Phase I trials for their innovative chimeric-antigen receptor T (CAR-T) therapies. It could further address remaining unmet needs, says GlobalData, a leading data and analytics company. Gracell Biotechnologies' GC012F is developed using the proprietary FasTCAR platform for next-day manufacturing. Similarly, Innovent Biologics developed IBI345 leveraging technology licensed from Roche. IBI345 has two components: anti-Claudin18.2 antibodies and 'modular' CAR-T cells leading to a precisely targeted approach compared to conventional CAR-T therapy that directly detects and destroys tumour cells. According to GlobalData's Pharma Intelligence Center, considering the Phase I, Phase II and Phase III candidates based on their highest development stage, 130 CAR-T therapies are in development in China as of 24 Feb 2022. CAR-T therapies for haematological cancers are well-established. The US has approved five CAR-T therapies and China has approved two CAR-T therapies to treat haematological cancers. However, the CAR-T therapies landscape in solid tumours is still evolving and finding a molecule with efficacy against solid tumours has been challenging. Notably, IBI345 is in development to treat advanced Claudin18.2-positive solid tumours. Original source: Global Data, website: http://www.energy.globaldata.com, Copyright Global Data 2022., patents and technical know-how; regulations and rulings; research and development; anticancer drugs; cell therapies; therapeutic antibodies; Gracell Biotechnologies; Innovent Biologics; [...]

2022 OCT 2 (NewsRx) -- By a News Reporter-Staff News Editor at Medical Letter on the CDC & FDA -- According to news reporting based on a preprint abstract, our [...]

2022 AUG 8 (NewsRx) -- By a News Reporter-Staff News Editor at AIDS Vaccine Week -- Investigators discuss new findings in HIV/AIDS. According to news reporting out of Frederick, Maryland, [...]

Bristol Myers Squibb announced on 11 Dec 2021 the first disclosure of results from a prespecified interim analysis of the pivotal TRANSFORM study, a global, randomized, multicentre, Phase 3 study evaluating Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, as a second-line treatment in adults with relapsed or refractory large B-cell lymphoma (LBCL) compared to the standard of care consisting of salvage chemotherapy followed by high-dose chemotherapy plus autologous hematopoietic stem cell transplant (HSCT). Results show, at a median follow up of 6.2 months, Breyanzi significantly improved event-free survival (EFS) compared to standard of care, the study's primary endpoint, with a median EFS of 10.1 months for Breyanzi and 2.3 months for standard of care, representing a 65% reduction in risk of EFS events with Breyanzi. The data will be presented in an oral session during the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition and has been selected for inclusion in the ASH Annual Meeting Press Program. In the TRANSFORM study, 184 patients with primary refractory LBCL or relapsed disease within less than or equal to 12 months after first-line therapy who were eligible for autologous HSCT were randomized to receive Breyanzi (n=92) or salvage chemotherapy followed by high-dose chemotherapy and autologous HSCT (n=92), which is considered the current standard of care for these patients. In the trial, which allowed for crossover, 50 patients switched from the standard of care arm to receive Breyanzi following failure to achieve a response by nine weeks post-randomization (after three cycles of salvage chemotherapy) or after disease progression at any time. The majority of patients (86%) treated with Breyanzi achieved a complete or partial response, with 66% of patients achieving a complete response. In comparison, less than half (48%) of patients who received the standard of care achieved a response, and only 39% of these patients achieved a complete response. Median progression-free survival was significantly longer with Breyanzi compared to standard of care (14.8 months vs 5.7 months). Although overall survival data were not yet mature, the prespecified interim analysis showed a trend favouring Breyanzi compared with the standard of care. Breyanzi exhibited a manageable safety profile with very low rates of severe cytokine release syndrome (CRS) and neurologic events, and no new safety signals were observed in this second-line setting. In the trial, no Grade 4/5 CRS or neurologic events were reported. Any-grade CRS was reported in 49% of patients, with Grade 3 CRS reported in only one patient. Any-grade neurologic events were reported in 12% of patients treated with Breyanzi, with Grade 3 neurologic events reported in four patients (4%). Results from the long-term follow-up of treatment with Breyanzi in the TRANSCEND NHL 001 study, the largest pivotal trial in third-line plus relapsed or refractory LBCL, reinforcing durable remissions demonstrated with Breyanzi, will also be presented at the meeting during a poster presentation on 12 Dec 2021. Original source: Bristol-Myers Squibb, website: http://www.bms.com/, Copyright Bristol-Myers Squibb 2021., research and development; anticancer drugs; Breyanzi; cell therapies; lisocabtagene maraleucel; stem cell therapies; Bristol Myers [...]

HOLON: Compugen Ltd., a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, announced the presentation of new translational preliminary data detailing the differentiated profile of PVRIG compared [...]

- Data presented further support Compugen's earlier findings that PVRIG plays a distinct role within the DNAM axis, with the potential to trigger robust immune responses in the tumor microenvironment [...]