Peripheral T-cell lymphoma

Viracta Therapeutics to Present Topline Nana-val Results from Stage 1 of the NAVAL-1 Trial at the 2024 Annual Congress of The Hematology Society of Taiwan

Retrieved on: 
Monday, April 1, 2024
UMass Memorial Health, Patient, SAN, Peripheral T-cell lymphoma, PTCL, Therapy

SAN DIEGO, April 01, 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 announced that topline results from Stage 1 of the NAVAL-1 trial of Nana-val (nanatinostat in combination with valganciclovir) in patients with relapsed or refractory (R/R) Epstein-Barr virus-positive (EBV+) peripheral T-cell lymphoma (PTCL) will be featured in an oral presentation during the 2024 Joint Annual Congress of Taiwan Society of Blood and Marrow Transplantation and The Hematology Society of Taiwan.

Key Points: 
  • SAN DIEGO, April 01, 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 announced that topline results from Stage 1 of the NAVAL-1 trial of Nana-val (nanatinostat in combination with valganciclovir) in patients with relapsed or refractory (R/R) Epstein-Barr virus-positive (EBV+) peripheral T-cell lymphoma (PTCL) will be featured in an oral presentation during the 2024 Joint Annual Congress of Taiwan Society of Blood and Marrow Transplantation and The Hematology Society of Taiwan.
  • Details of the presentation are as follows:
    Presenting Author: Professor Hung Chang, M.D., principal investigator in the NAVAL-1 trial, Chief of the Hematology Division, Linkou Chang Gung Memorial Hospital and Visiting Scholar at UMass Memorial Health Care

Vincerx Pharma Reports Fourth Quarter and Full Year 2023 Financial Results and Corporate Update

Retrieved on: 
Friday, March 29, 2024
Patient, PTCL, G&A, IND, Prednisone, Neoplasm, Therapy, SMDC, Medicinal chemistry, Lymphoma, Research, Frontiers Media, RNA polymerase II, Body modification, Primate, RNA, NIH, CPT, Potential, Safety, CDK9, ADC, MCL1, Solubility, Oncogene, RNA polymerase, Venetoclax, Journal, Manuscript, Cancer, Peripheral T-cell lymphoma, AACR, Antibody, MYC, Downregulation and upregulation, DLBCL, Annual general meeting, HER2, European Hematology Association, EHA, Spacecraft, PDX, Bangladesh Technical Education Board, Journal of Medicinal Chemistry, Blood, Pharmaceutical industry

PALO ALTO, Calif., March 29, 2024 (GLOBE NEWSWIRE) --  Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a corporate update.

Key Points: 
  • Vincerx presented preclinical data at the 2023 AACR Annual Meeting demonstrating significant activity in patient-derived xenograft (PDX) lymphoma mouse models.
  • Vincerx shared preclinical data at the 2023 ASH Annual Meeting showing superior activity and safety compared with commercially available B-cell targeted ADCs.
  • For the fourth quarter and full year 2023, Vincerx reported a net loss of $4.9 million, or $0.23 per share, and a net loss of $40.2 million, or $1.89 per share, respectively.
  • For the fourth quarter and full year 2022, Vincerx reported a net loss of $13.8 million, or $0.65 per share, and a net loss of $63.0 million, or $3.00 per share, respectively.

GenFleet and BeiGene Enter into Trial Collaboration for a Potentially First-in-class Combination Therapy to Initiate Phase Ib/II Study of GFH009 (CDK9 inhibitor) and BRUKINSA® (zanubrutinib) Treating Diffuse Large B Cell Lymphoma

Retrieved on: 
Thursday, March 28, 2024
B-cell lymphoma, Plasma, Shanghai Cancer Center, Rituximab, Apoptosis, Leukemia, International Journal of Hematology, Patient, Hospital, Doxorubicin, Vincristine, Fudan University, CC3, Standard of care, Acute myeloid leukemia, Epidemiology, Biomedical Chromatography, Prednisone, Peripheral T-cell lymphoma, PARP, National Cancer Center, Therapy, MYC, BTK, Safety, BeiGene, CDK9, Cyclophosphamide, DLBCL, Canadian International Council, MCL1, Follicular lymphoma, Pharmaceutical industry

The first patient was dosed in the trial led by prominent Henan Cancer Hospital and Fudan University Shanghai Cancer Center.

Key Points: 
  • The first patient was dosed in the trial led by prominent Henan Cancer Hospital and Fudan University Shanghai Cancer Center.
  • This study will be the first combination trial conducted by a Chinese biotech to combine CDK9 inhibitor and BTK inhibitor targeting DLBCL.
  • The trials of GFH009 treating peripheral T-cell lymphoma and acute myeloid leukemia have entered into phase II stage in China and the U.S. respectively.
  • Epidemiology of diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) in the United States and Western Europe: population-level projections for 2020–2025, Leukemia & Lymphoma, 2021
    3.

Viracta Therapeutics Announces Completion of Second-Stage Enrollment into the Peripheral T-Cell Lymphoma Cohort of the NAVAL-1 Trial

Retrieved on: 
Thursday, February 29, 2024
SAN, FDA, Food, Stage 2, PTCL, Epstein–Barr virus, Valganciclovir, EBV, Therapy, Patient, Peripheral T-cell lymphoma, Pharmaceutical industry

SAN DIEGO, Feb. 29, 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 announced that its lead development program, Nana-val (nanatinostat in combination with valganciclovir), a first-in-class, all-oral investigational therapy targeting Epstein-Barr virus (EBV)-associated cancers, has completed Stage 2 enrollment into the relapsed or refractory (R/R) Epstein-Barr virus-positive (EBV+) peripheral T-cell lymphoma (PTCL) cohort of the NAVAL-1 trial.

Key Points: 
  • “The completion of Stage 2 enrollment of the PTCL cohort in NAVAL-1 is a major milestone for the Nana-val clinical development program.
  • We would like to acknowledge the dedication of our study execution team and the commitment of our investigators for this achievement.
  • Present Stage 1 + Stage 2 data (n=21) from the R/R EBV+ PTCL cohort in patients treated with Nana-val in the third quarter of 2024.
  • Engage with the U.S. Food and Drug Administration (FDA) in mid-2024, to align on requirements for accelerated approval.

Orphan designation: Autologous T lymphocytes containing a T-cell receptor against Epstein–Barr virus Treatment of peripheral T-cell lymphoma, 13/12/2023 Positive

Retrieved on: 
Sunday, February 4, 2024
COMP, IRIS, EMA, European Commission, Patient, Peripheral T-cell lymphoma, Committee, Pharmaceutical industry

Key facts

Key Points: 
  • Key facts
    - Active substance
    - Autologous T lymphocytes containing a T-cell receptor against Epstein–Barr virus
    - Intended use
    - Treatment of peripheral T-cell lymphoma
    - Orphan designation status
    - Positive
    - EU designation number
    - EU/3/23/2868
    - Date of designation
    - Sponsor
    Carthagenetics Iberica S.L.
  • Patients' organisations
    For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
    European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
  • EU register of orphan medicines
    The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:
    EMA list of opinions on orphan medicinal product designation
    EMA publishes information on orphan medicinal product designation adopted by the Committee for Orphan Medicinal Products (COMP) on the IRIS online platform:

Vincerx Pharma Announces Compelling Clinical Efficacy of Enitociclib in Combination with Venetoclax and Prednisone in Lymphoma

Retrieved on: 
Sunday, January 7, 2024
Lead, Spacecraft, CDK9, Prednisone, Progression-free survival, Cancer, B-cell lymphoma, PALO, Venetoclax, Peripheral T-cell lymphoma, NIH, Patient, Safety, PTCL, ADC, Therapy, Pharmaceutical industry

PALO ALTO, Calif., Jan. 07, 2024 (GLOBE NEWSWIRE) -- Vincerx Pharma, Inc. (Nasdaq: VINC) (“Vincerx”), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, today announced promising clinical results from a Phase 1 NIH-sponsored study of enitociclib in combination with venetoclax and prednisone for the treatment of relapsed/refractory lymphoma.

Key Points: 
  • “Enitociclib continues to differentiate itself in the CDK9 inhibitor field,” said Ahmed Hamdy, M.D., Chief Executive Officer of Vincerx.
  • “Enitociclib is well tolerated, making it ‘the partner of choice’ for novel combinations.
  • We are pleased to see the high response rate and tolerability of enitociclib in combination with venetoclax and prednisone in patients with hard-to-treat types of non-Hodgkin’s lymphoma such as peripheral T-cell lymphoma (PTCL) and double-hit diffuse large B-cell lymphoma (DH-DLBCL).
  • ADCs and bi-specifics have been limited by numerous safety and efficacy challenges, so the profile we are observing in these initial dose levels is exciting.”

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.

Kymera Therapeutics Presents Interim Results from STAT3 Degrader Phase 1 Clinical Trial at American Society of Hematology Annual Meeting

Retrieved on: 
Monday, December 11, 2023
Patient, STAT3, Montefiore Medical Center, Cholangiocarcinoma, Stomatitis, Neoplasm, Constipation, Tumor microenvironment, PRS, SOCS3, Relapse, Leukemia, Anemia, Fatigue, Nausea, Blood, Carcinoma, Society, Therapy, CTCL, Infrared spectroscopy correlation table, PD, Head, ASH, T-PLL, Cancer, Biomarker, Poster, Peripheral T-cell lymphoma, TPD, Safety, Arthralgia, Cutaneous T-cell lymphoma, PTCL, T-cell prolymphocytic leukemia, Lymphoma, Bone marrow, Pharmaceutical industry

WATERTOWN, Mass., Dec. 10, 2023 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of small molecule medicines using targeted protein degradation (TPD), today shared new data from its ongoing KT-333 Phase 1 trial. KT-333, a first-in-class, potent, highly selective, heterobifunctional small molecule degrader of STAT3, demonstrated early signs of antitumor activity at doses that were generally well-tolerated and associated with substantial STAT3 knockdown in blood and tumor. The data were presented at the American Society of Hematology (ASH) 65th Annual Meeting and Exposition taking place from December 9-12, 2023, in San Diego, California.

Key Points: 
  • The data were presented at the American Society of Hematology (ASH) 65th Annual Meeting and Exposition taking place from December 9-12, 2023, in San Diego, California.
  • The poster provides an interim update with a data cut-off as of October 18, 2023.
  • Dr. Aditi Shastri from Montefiore Medical Center and Albert Einstein College of Medicine, a lead investigator in the study, presented the interim Phase 1 findings.
  • Preclinical data demonstrating the potential of STAT3 protein degraders as a therapeutic approach in venetoclax-resistant Acute Myeloid Leukemia was also presented at the meeting.

Vincerx Pharma Reports Third Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, November 14, 2023
ASH, ADC, EMA, Patient, Camptothecin, Research, Therapy, Cancer, Oncogene, Poster, Multiple myeloma, Hematology, PALO, Safety, Therapeutic index, IND, DLBCL, Prednisone, Mantle cell lymphoma, Tumor microenvironment, SMDC, Society, RNA, Venetoclax, Corporation, Spacecraft, SME, Salivary gland tumour, MCL1, Cohort, European Medicines Agency, PDX, B-cell lymphoma, University, HER2, Acute lymphoblastic leukemia, Myelodysplastic syndrome, PTCL, MYC, MCL, Neoplasm, CPT, Peripheral T-cell lymphoma, Small and medium-sized enterprises, CDK9, FDA, RNA polymerase II, NIH, Toxicity, Vaccine, Pharmaceutical industry, Fine chemical, Medical imaging, Rare-earth element, Cryptocurrency

PALO ALTO, Calif., Nov. 14, 2023 (GLOBE NEWSWIRE) -- Vincerx Pharma, Inc. (Nasdaq: VINC)(“Vincerx”), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, today reported financial results for the third quarter ended September 30, 2023 and provided a corporate update.

Key Points: 
  • “We continue to take a very disciplined approach to our portfolio, focusing our resources on our two lead programs, VIP943 and VIP236.
  • We will present new data on robust preclinical activity at the 65th American Society for Hematology Meeting (ASH 2023) in December.
  • Collaborators from the University of Calgary will present a poster at ASH 2023 showing preclinical activity in pediatric leukemia.
  • For the quarter ended September 30, 2023, Vincerx reported a net loss of approximately $9.7 million, or $0.46 per share, compared to a net loss of approximately $16.9 million, or $0.80 per share, for the quarter ended September 30, 2022.

Electra Therapeutics presents first clinical data from ongoing Phase 1b study of ELA026 for treatment of secondary hemophagocytic lymphohistiocytosis (sHLH)

Retrieved on: 
Monday, December 11, 2023
Biotechnology, Health, Oncology, Clinical Trials, Assistant, IL2RA, CRP, Safety, C-reactive protein, Therapy, University, ASH, Disease, Patient, Peripheral T-cell lymphoma, Monoclonal antibody, Trial of the century, Prognosis, ORR, MD, HLH, Cancer, SIRP, Doctor of Philosophy, Biomarker, MD Anderson Cancer Center, Society, Pharmaceutical industry, Vaccine, Nursing

Data from ten sHLH patients in the ongoing Phase 1b clinical study showed favorable safety results and overall response rate (ORR) of 70% in all patients dosed with ELA026.

Key Points: 
  • Data from ten sHLH patients in the ongoing Phase 1b clinical study showed favorable safety results and overall response rate (ORR) of 70% in all patients dosed with ELA026.
  • The majority of enrolled patients were difficult-to-treat, malignancy-associated HLH and displayed poor prognostic clinical and biomarker features at baseline.
  • The Phase 1b study is an ongoing open-label, multi-dose, single-arm, multicenter study designed to evaluate the safety and efficacy of ELA026, assess biomarkers and identify a dose for Phase 2/3 testing (ClinicalTrials.gov identifier: NCT05416307 ).
  • “We are extremely encouraged by the data from the first two cohorts, and we look forward to continuing enrollment for this study as we advance the ELA026 clinical program.”