PTLD

Atara Biotherapeutics Announces Fourth Quarter and Full Year 2023 Financial Results and Operational Progress

Retrieved on: 
Thursday, March 28, 2024
Oncology, Health, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, The Lancet, Research, Graft-versus-host disease, LD, ASH, International Society, Partnership, Central nervous system, ATRA, Epstein–Barr virus, Patient, Follicular lymphoma, CNS, Biomarker, PTLD, Cancer, Lymphoproliferative disorders, SLE, EBV, NHL, Lymphoma, Mantle cell lymphoma, Investment, ATM, Safety, Pharmacokinetics, Depreciation, File, Workforce, Cell, FDA, BLA, Lupus nephritis, CD19, Food, Autoimmune disease, Pharmaceutical industry

“We are expanding Atara’s proven EBV T-cell platform into allogeneic CAR T therapy for both oncology and autoimmune disease,” said Pascal Touchon, President and Chief Executive Officer of Atara.

Key Points: 
  • “We are expanding Atara’s proven EBV T-cell platform into allogeneic CAR T therapy for both oncology and autoimmune disease,” said Pascal Touchon, President and Chief Executive Officer of Atara.
  • “This includes strong momentum for our lead CAR T program, ATA3219, which is positioned to deliver near-term clinical data for both non-Hodgkin’s lymphoma and lupus nephritis.
  • Subjects will receive lymphodepletion (LD) treatment followed by ATA3219 at a dose of 40, 80, or 160 x 106 CAR+ T cells.
  • Subjects will receive LD treatment followed by ATA3219 at a dose of 40, 80, 240, or 480 x 106 CAR+ T cells.

Viracta Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, March 7, 2024
SAN, Research, Investment, FDA, Food, PTCL, SDD, ODD, Valganciclovir, Completeness, Therapy, Food and Drug Administration, NPC, Patient, PTLD, G&A, DLBCL, Pharmaceutical industry

SAN DIEGO, March 07, 2024 (GLOBE NEWSWIRE) -- Viracta Therapeutics, Inc. (Nasdaq: VIRX), a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, today reported financial results for the fourth quarter and full-year of 2023 and provided a business update.

Key Points: 
  • “Nana-val is a first-in-class, all-oral combination treatment regimen that has entered late-stage development to target and treat EBV-associated cancers.
  • Completed enrollment of Stage 2 in the R/R EBV+ PTCL cohort of patients treated with Nana-val (n=21, Stage 1 + Stage 2 patients) in the first quarter of 2024.
  • Amended protocol to additionally enable enrollment of second-line R/R EBV+ DLBCL patients and R/R EBV+ PTLD patients, including pediatric EBV+ PTLD patients ≥ 12 years of age.
  • Present Stage 1 + Stage 2 data (n=21) in the R/R EBV+ PTCL cohort in patients treated with Nana-val in the third quarter of 2024.

Viracta Therapeutics Provides Clinical Update and Outlook for 2024

Retrieved on: 
Thursday, January 4, 2024
SDD, NPC, Food, Stage 2, Nasopharyngeal carcinoma, Lymphoma, DLBCL, FDA, PTLD, ODD, SAN, Therapy, Peripheral T-cell lymphoma, Patient, PTCL, Pharmaceutical industry

SAN DIEGO, Jan. 04, 2024 (GLOBE NEWSWIRE) -- Viracta Therapeutics, Inc. (Nasdaq: VIRX), a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, today provided a clinical update, including its roadmap for advancing Nana-val’s clinical development in 2024. Nana-val (nanatinostat in combination with valganciclovir), is the company’s all-oral investigational therapy targeting Epstein-Barr virus-associated cancers.

Key Points: 
  • Complete enrollment of Stage 2 in the R/R EBV+ peripheral T-cell lymphoma (PTCL) cohort of patients treated with Nana-val (n=11) in the first quarter of 2024.
  • Present Stage 2 data from patients with R/R EBV+ PTCL in the second half of 2024.
  • Report Stage 1 data from patients with R/R EBV+ diffuse large B-cell lymphoma (DLBCL) and R/R EBV+ post-transplant lymphoproliferative disorder (PTLD) by year-end 2024.
  • Best responses through the fifth dose cohort included two confirmed partial responses and five stable diseases out of 17 patients.

Human medicines European public assessment report (EPAR): Ebvallo, tabelecleucel, Date of authorisation: 16/12/2022, Revision: 3, Status: Authorised

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Tuesday, January 2, 2024
Medical Subject Headings, Diarrhea, Marketing, Agency, INN, Fever, Immune system, Fatigue, Constipation, Infection, Lymph, Hypotension, Virus, Bone marrow, Graft-versus-host disease, International, PTLD, Nasal congestion, Disease, Bone pain, Nausea, Language, Lymphoproliferative disorders, Cancer, Liver, Hyponatremia, Rash, Neutrophil, Appetite, Observation, European Medicines Agency, Transplant, Hypoxia, Select, Cell, Patient, Human, Safety, Dehydration, Anemia, Alkaline phosphatase, IIA, Epstein–Barr virus, Medical device

Human medicines European public assessment report (EPAR): Ebvallo, tabelecleucel, Date of authorisation: 16/12/2022, Revision: 3, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Ebvallo, tabelecleucel, Date of authorisation: 16/12/2022, Revision: 3, Status: Authorised

Atara Biotherapeutics Announces Closing of Expanded Global Tab-cel® Partnership with Pierre Fabre Laboratories

Retrieved on: 
Wednesday, December 20, 2023
Oncology, Health, Stem Cells, Clinical Trials, Research, Science, Biotechnology, Partnership, Food, FDA, PTLD, Trial of the century, Lymphoproliferative disorders, Biologics license application, Cancer, ATRA, USD, EBV, Patient, CD19, Epstein–Barr virus, BLA, Pharmaceutical industry

Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today announced the closing of the expanded global partnership with Pierre Fabre Laboratories for tabelecleucel (tab-cel® or EBVALLOTM).

Key Points: 
  • Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today announced the closing of the expanded global partnership with Pierre Fabre Laboratories for tabelecleucel (tab-cel® or EBVALLOTM).
  • Building on the earlier partnership announced in October 2021 to commercialize tab-cel in Europe, this transaction provides Pierre Fabre Laboratories with the development, manufacturing, and commercialization rights for tab-cel in the United States and all remaining markets.
  • In addition, Pierre Fabre Laboratories will reimburse Atara for expected tab-cel global development costs through the Biologics License Application (BLA) transfer, and purchase future tab-cel inventory through the manufacturing transfer date.
  • Substantially all tab-cel manufacturing, clinical, and regulatory activities are planned to transition from Atara to Pierre Fabre Laboratories at the time of BLA transfer.

Atara Biotherapeutics To Present Positive New Tab-cel® Clinical Data During Oral Session at ESMO Immuno-Oncology Annual Congress 2023

Retrieved on: 
Wednesday, November 29, 2023
Oncology, Health, Stem Cells, Clinical Trials, Research, Science, Biotechnology, CNS, ATRA, Epstein–Barr virus, Safety, Partial-response maximum-likelihood, PST, Disease, Northwest Biotherapeutics, ESMO, HCT, Patient, CET, ORR, SOT, Cancer, Symantec Endpoint Protection, PTLD, Neurotoxicity, Congress, Central nervous system, EBV, TTR, OS, PR, Vaccine, Pharmaceutical industry

These results will be presented as an oral session at the European Society for Medical Oncology Immuno-Oncology (ESMO I‑O) Annual Congress taking place December 6-8, 2023, in Geneva, Switzerland.

Key Points: 
  • These results will be presented as an oral session at the European Society for Medical Oncology Immuno-Oncology (ESMO I‑O) Annual Congress taking place December 6-8, 2023, in Geneva, Switzerland.
  • “We’re pleased to share new multicenter data, including the first results from our ongoing multicohort EBVision trial and first clinical trial report of treatment with tab-cel in the first line setting.
  • The estimated one-year overall survival (OS) rate was 70.6% (95% CI: 43.0, 86.6) for all patients.
  • Date & Time: December 7, 2023, at 2:15 - 3:45 p.m. CET / 5:15 - 6:45 a.m. PST

Viracta Therapeutics Reports Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, November 9, 2023
CR, DLBCL, FDA, Research, CRR, Food, PTCL, G&A, B-cell lymphoma, R, Post-transplant lymphoproliferative disorder, SDD, Dor, PTLD, ORR, Safety, Therapy, Investment, Patient, Food and Drug Administration, SAN, Pharmaceutical industry, Fine chemical, Computer data storage, Nursing, Medical device

SAN DIEGO, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Viracta Therapeutics, Inc. (Nasdaq: VIRX), a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, today provided a business update and reported financial results for the third quarter of 2023.

Key Points: 
  • SAN DIEGO, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Viracta Therapeutics, Inc. (Nasdaq: VIRX), a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, today provided a business update and reported financial results for the third quarter of 2023.
  • Completion of enrollment into the nanatinostat monotherapy arm (n=10) and Nana-val combination arm (n=10) of the NAVAL-1 R/R EBV+ PTCL cohort is anticipated by year-end 2023.
  • U.S. Food and Drug Administration (FDA) meeting to discuss additional requirements for accelerated approval for the treatment of patients with R/R EBV+ PTCL.
  • On October 4, 2023, Viracta hosted an R&D Day highlighting Nana-val clinical programs in EBV-associated cancers.

QIAGEN launches QuantiFERON-EBV RUO assay, facilitating research of cell-mediated immune response to Epstein-Barr virus

Retrieved on: 
Wednesday, October 4, 2023
Vaccine, IGRA, DNA, QIAGEN, QGEN, Central nervous system, Senior, EBV, SARS-CoV-2, COVID-19, Nonpathogenic organisms, Cytomegalovirus, Research, Post-transplant lymphoproliferative disorder, Multiple sclerosis, Antibody, Lyme, MS, DiaSorin, Infectious mononucleosis, QuantiFERON, RUO, HIV disease progression rates, Patient, Risk, Blood, PTLD, Immune system, Gamma ray, Lymphocyte, Health, Virus, NYSE, Epstein–Barr virus infection, Autoimmunity, Conditional sentence, Dentistry

Venlo, the Netherlands, Oct. 04, 2023 (GLOBE NEWSWIRE) -- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the launch of its QuantiFERON-EBV RUO (Research Use Only) assay.

Key Points: 
  • Venlo, the Netherlands, Oct. 04, 2023 (GLOBE NEWSWIRE) -- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the launch of its QuantiFERON-EBV RUO (Research Use Only) assay.
  • In organ transplant recipients, EBV is associated with post-transplant lymphoproliferative disorder (PTLD), a potentially fatal complication after solid organ transplantation.
  • Measuring the T-cell response to EBV can help researchers better understand immune responses to the virus.
  • This approach is different from but complementary to traditional tests, which focus on detecting viral DNA or antibodies produced in response to the virus.

Viracta Therapeutics Announces Publication in Blood Advances Demonstrating Promising and Durable Signal of Nana-val Efficacy in Patients with Relapsed or Refractory (R/R) Epstein-Barr Virus-Positive (EBV+) Lymphoma

Retrieved on: 
Tuesday, August 8, 2023
Lymphoma, PTCL, Peripheral T-cell lymphoma, Hematopoietic stem cell transplantation, ASH, Angioimmunoblastic T-cell lymphoma, Lymphoproliferative disorders, Creatinine, DLBCL, Thomas Jefferson University, Aes, Valganciclovir, Constipation, Oncology, Histone deacetylase inhibitor, B-cell lymphoma, Bone marrow, Patient, Division, American Society of Hematology, Data, SAN, PTLD, PTCL-NOS, Cytopenia, Nausea, Paper, CRS, Therapy, Society, ORR, Disease, Vaccine, Pharmaceutical industry, Hematology

SAN DIEGO, Aug. 08, 2023 (GLOBE NEWSWIRE) -- Viracta Therapeutics, Inc. (Nasdaq: VIRX), a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, today announced the publication of clinical data from an open-label, multicenter, Phase 1b/2 study of Nana-val in 55 patients with R/R EBV+ lymphoma in Blood Advances. Results showed complete responses (CRs) achieved and ongoing durable responses observed out to approximately 36 months across multiple EBV+ lymphoma subtypes, including some of the most aggressive cancers: peripheral T-cell lymphoma (PTCL), diffuse large B-cell lymphoma (DLBCL), and post-transplant lymphoproliferative disease (PTLD). This paper titled, “Targeted therapy with nanatinostat and valganciclovir in recurrent Epstein-Barr virus-positive lymphoid malignancies: a Phase 1b/2 study,” can be found here.

Key Points: 
  • This paper titled, “Targeted therapy with nanatinostat and valganciclovir in recurrent Epstein-Barr virus-positive lymphoid malignancies: a Phase 1b/2 study,” can be found here .
  • The published paper includes an additional 10-month follow-up period, which demonstrated durable response durations across multiple EBV+ lymphoma subtypes.
  • Overall, trial participants received a median of two prior therapies before entering the trial, with 75% (41/55) being refractory to their last therapy.
  • Initial data from the Nana-val Phase 1b/2 clinical trial were previously presented at the 2021 American Society of Hematology (ASH) Annual Meeting .

Atara Biotherapeutics Presents Updated Tab-cel® Clinical Effectiveness Data at ASCO 2023

Retrieved on: 
Monday, June 5, 2023
Science, Biotechnology, Research, Pharmaceutical, Oncology, General Health, Health, Clinical Trials, Lymphoma, Northwest Biotherapeutics, EAP, Epstein–Barr virus, PRS, Symantec Endpoint Protection, EBV, PCNS, Cancer, HCT, SOT, ASCO, TTR, American Society of Clinical Oncology, MD, Patient, Microsoft Access, PTLD, Annual general meeting, ATRA, CR, Partial-response maximum-likelihood, Safety, Society, ORR, Disease, PR, Vaccine, Pharmaceutical industry

The results will be featured in a poster presentation at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting taking place June 2-6 in Chicago.

Key Points: 
  • The results will be featured in a poster presentation at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting taking place June 2-6 in Chicago.
  • Atara supported 27 EAP requests in Europe for patients with relapsed or refractory (r/r) Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD) following solid organ transplant (SOT) or hematopoietic cell transplant (HCT).
  • “These data provide important insights on the effectiveness of EBVALLO™ in the real-world treatment setting,” said Dr. Sylvain Choquet, Head of the Clinical Hematology Department at Pitié-Salpêtrière, Paris, France.
  • Detailed results on baseline demographics and disease characteristics, and additional safety data including tab-cel exposure details, will be shared at the conference.