PTLD

Hornet Therapeutics emerges from stealth with data published in Science demonstrating the first potential drug intervention for Epstein-Barr Virus (EBV) driven disease

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Giovedì, Maggio 23, 2024
Human services, EBV, Patient, Infection, Survival, University, GSK plc, Kyowa Kirin, Risk, Malignancy, Infectious mononucleosis, Pathology, Autoimmunity, Therapy, PTLD, Disease, Transplant, Medical research, Lymphoma, DRS, Multiple sclerosis, NAD, Pharmaceutical industry

Targeting this pathway with an IDO-1 inhibitor hinders B cell transformation and EBV-driven pathogenesis in vitro and in animal models in vivo.

Key Points: 
  • Targeting this pathway with an IDO-1 inhibitor hinders B cell transformation and EBV-driven pathogenesis in vitro and in animal models in vivo.
  • The groundbraking findings reported in Science point at IDO-1 inhibition as a potential treatment mechanism for pathologies related to EBV latency.
  • Professor Christoph Hess, founder and Chief Scientific Officer at Hornet Therapeutics added: “In a landmark paper published 60 years ago, Drs.
  • Our data demonstrate that HTX-201 has the potential to hinder EBV latency in its primary host cells, the B cells.

Atara Biotherapeutics Submits Tabelecleucel (Tab-cel®) Biologics License Application for Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease with U.S. FDA

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Lunedì, Maggio 20, 2024
Surgery, FDA, Genetics, Clinical Trials, Stem Cells, Practice Management, Biotechnology, Health, Pharmaceutical, EBV, Patient, Epstein–Barr virus, Food, Lymphoproliferative disorders, PTLD, ATRA, Cancer, Biologics license application, BLA, Physician, Pharmaceutical industry

There are no FDA approved therapies in this treatment setting.

Key Points: 
  • There are no FDA approved therapies in this treatment setting.
  • Tab-cel has been granted Breakthrough Therapy Designation for the treatment of rituximab-refractory EBV-associated lymphoproliferative disease by the U.S. FDA and has orphan drug designation.
  • In addition, Pierre Fabre is reimbursing Atara for expected tab-cel global development costs through the BLA transfer and purchasing tab-cel inventory through the manufacturing transfer date.
  • Atara is also eligible to receive double-digit tiered royalties on net sales of tab-cel in the U.S. and remaining global commercial markets referenced above.

Viracta Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Update

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Giovedì, Maggio 9, 2024
FDA, CRR, DLBCL, Investment, Safety, Food, Nausea, Research, PTCL, Peripheral T-cell lymphoma, Thrombocytopenia, Insurance, Weight loss, Appetite, PTLD, Data, Dor, Patient, Fatigue, Diarrhea, SDD, Therapy, PMDA, Valganciclovir, Food and Drug Administration, SAN, Anemia, Pharmaceutical industry

We look forward to sharing additional data from Stage 1, which continue to mature, as well as initial results from Stage 2 in the third quarter of 2024.

Key Points: 
  • We look forward to sharing additional data from Stage 1, which continue to mature, as well as initial results from Stage 2 in the third quarter of 2024.
  • As of the February 7, 2024 data cutoff date, Nana-val demonstrated greater efficacy than nanatinostat alone and was generally well-tolerated.
  • 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.
  • Initiate a dose-optimization cohort to confirm the RP2D as part of the study’s Phase 2 expansion by year-end 2024.

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

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Giovedì, Marzo 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

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Giovedì, Marzo 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

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Giovedì, Gennaio 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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Martedì, Gennaio 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

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Mercoledì, Dicembre 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

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Mercoledì, Novembre 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

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Giovedì, Novembre 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.