PTCL

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.

SELLAS Life Sciences Reports Full Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, March 28, 2024
Ovarian cancer, SLS, Survival, Lymphoma, Fast track (FDA), PTCL, National Cancer Institute, CMC, Clinical trial, Committee, Research, NCI, European School, Bone marrow, AML, GPS, Pembrolizumab, Doctor of Science, Nivolumab, Safety, MRD, CDK9, BLA, Food, CR2, Zanubrutinib, Mesothelioma, BIW, MD, Completeness, WT1, FDA, DLBCL, IDMC, Therapeutic index, Type, Fast Track, Biomarker, BTK, Pharmaceutical industry

The SLS009 aza-ven treatment was well-tolerated and evoked anti-leukemic effects in 67% of patients across all levels dosed.

Key Points: 
  • The SLS009 aza-ven treatment was well-tolerated and evoked anti-leukemic effects in 67% of patients across all levels dosed.
  • The first patient who achieved a complete response continues on the study and remains leukemia-free 9 months post-enrollment.
  • The net proceeds from the offering strengthen the Company’s financial position and will be used for research and development activities, working capital, and general corporate purposes.
  • Cash Position: As of December 31, 2023, cash and cash equivalents totaled approximately $2.5 million.

Corvus Pharmaceuticals Provides Business Update and Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Tuesday, March 19, 2024
Atopic dermatitis, Head, T helper cell, HNSCC, Patient, PTCL, Lung cancer, Ipilimumab, Asthma, CTCL, ALCL, Fungal infection, Pulmonary fibrosis, Lymphocyte, RCC, Clinical trial, CRS, Marketing, B-cell lymphoma, Research, PR, PTCL-NOS, Psoriasis, T-cell lymphoma, ASH, Webcast, Immunomodulation, Pembrolizumab, PRS, Exposition, Cancer, Nivolumab, Safety, Scleroderma, Food, NSCLC, Teva Pharmaceuticals, Modified, Lymphoma, Knowledge, Allergy, Immunodeficiency, Time management, Peripheral, Poster, FDA, ITK, Conference call, Kidney cancer, T helper 17 cell, Society, Preprint, BioRxiv, Autoimmunity, Physician, Total, Pharmaceutical industry

BURLINGAME, Calif., March 19, 2024 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS) (GLOBAL NEWSWIRE), a clinical-stage biopharmaceutical company, today provided a business update and reported financial results for the fourth quarter and year ended December 31, 2023.

Key Points: 
  • ET / 1:30 p.m. PT
    BURLINGAME, Calif., March 19, 2024 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS) (GLOBAL NEWSWIRE), a clinical-stage biopharmaceutical company, today provided a business update and reported financial results for the fourth quarter and year ended December 31, 2023.
  • We have several exciting opportunities in immunology, including plans for a randomized, placebo controlled clinical trial of soquelitinib in atopic dermatitis.
  • Mr. Arcara previously served as senior vice president, head global marketing & portfolio and strategy for the innovative medicines and biosimilars business at Teva Pharmaceuticals.
  • ET (1:30 p.m. PT), during which time management will provide a business update and discuss the fourth quarter and full year 2023 financial results.

SIRPant Immunotherapeutics Announces First Patient Dosed in Phase 1 Clinical Trial Evaluating SIRPant-M in Patients with Relapsed/Refractory Non-Hodgkin Lymphoma

Retrieved on: 
Tuesday, March 12, 2024
XRT, ASH, Patient, PTCL, City, Tumor microenvironment, NHL, CTCL, Society, Safety, Bone marrow, Poster

“The culmination of years of development work, initially in Academia, and later taken forward by SIRPant, we are pleased to announce the dosing of the first patient in this Phase 1 study evaluating SIRPant-M™, last week at the City of Hope Cancer Center.”, said Jelle Kijlstra, M.D., Chief Medical Officer of SIRPant.

Key Points: 
  • “The culmination of years of development work, initially in Academia, and later taken forward by SIRPant, we are pleased to announce the dosing of the first patient in this Phase 1 study evaluating SIRPant-M™, last week at the City of Hope Cancer Center.”, said Jelle Kijlstra, M.D., Chief Medical Officer of SIRPant.
  • The interaction of immune cells in the tumor microenvironment influences progression of cutaneous T cell lymphoma,” said Christiane Querfeld, M.D., Ph.D., Director of the Multidisciplinary Cutaneous Lymphoma Program, and one of the principal investigators of the study.
  • Both B-cell and certain T-cell NHL (select PTCL; CTCL) are eligible.
  • The primary objective of the study is to assess the safety and tolerability of autologous SIRPant-M™.

CASI PHARMACEUTICALS ANNOUNCES FOURTH QUARTER AND FULL-YEAR 2023 BUSINESS AND FINANCIAL RESULTS

Retrieved on: 
Thursday, March 28, 2024
Agreement, Transplant, CASI Pharmaceuticals, CASI, Patient, Travel, PTCL, Immunoglobulin G, CMC, Depreciation, Bone marrow, Therapy, VCP, Marketing, Research, Cleave, Pralatrexate, MCL, Rituximab, AML, Pembrolizumab, Trial of the century, Myelodysplastic syndrome, Melphalan, MDS, Clinical trial, Follicular lymphoma, Republic, Multiple myeloma, Acute myeloid leukemia, Annual report, National Medical Products Administration, Haematopoietic system, FDA, Cayman, CD19, NMPA, COVID-19, CTA, HKIAC, NHL, Non-Hodgkin lymphoma, MICL, Pharmaceutical industry

BEIJING, March 28, 2024 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a Cayman incorporated biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today reported business and financial results for the year ended December 31, 2023, and provided an update on key highlights for 2023.

Key Points: 
  • BEIJING, March 28, 2024 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a Cayman incorporated biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today reported business and financial results for the year ended December 31, 2023, and provided an update on key highlights for 2023.
  • CASI reported fourth quarter 2023 revenue of $6.9 million for EVOMELA®, 33% lower than the same period in 2022.
  • 2023 marks a major milestone for CASI and our partner Juventas; Inaticabtagene Autoleucel (CNCT-19 CAR-T cell therapy) was approved by National Medical Products Administration (NMPA) in November 2023.
  • As of December 31, 2023, CASI had cash, cash equivalents and short term investment of $29.1 million compared to $48.6 million as of December 31, 2022.

Withdrawn application: Adcetris, 23/02/2024

Retrieved on: 
Wednesday, April 3, 2024
PTCL-NOS, Lymphoma, B-cell lymphoma, CHOP, Patient, PTCL, Doxorubicin, Vincristine, CHP, Cancer, Vinblastine, European Medicines Agency, CTCL, Prednisone, Lymphocyte, Agency, Clinical trial, Skin, Dacarbazine, CD30, Cyclophosphamide, Medicine

Adcetris was designated an ‘orphan medicine’ (a medicine used in rare diseases) for peripheral T cell lymphoma 21 August 2019.

Key Points: 
  • Adcetris was designated an ‘orphan medicine’ (a medicine used in rare diseases) for peripheral T cell lymphoma 21 August 2019.
  • The cytotoxic molecule then enters the cancer cells and prevents them from dividing, causing the cancer cells to die.
  • The application was withdrawn after the European Medicines Agency had evaluated the initial information from the company and had prepared questions for the company.
  • If you are in a clinical trial and need more information about your treatment, speak with your clinical trial doctor.

SELLAS Announces Executive Leadership Reorganization and Prioritization of Commercialization Partnerships

Retrieved on: 
Friday, March 8, 2024
Senior, AML, MD, Stifel, PTCL, General counsel, GPS, Associate, Doctor of Science, SLS, Corporation

As part of this effort, Senior Vice President, Chief Commercial Officer, Robert Francomano and Executive Vice President, General Counsel and Corporate Secretary, Barbara Wood, will be departing the Company.

Key Points: 
  • As part of this effort, Senior Vice President, Chief Commercial Officer, Robert Francomano and Executive Vice President, General Counsel and Corporate Secretary, Barbara Wood, will be departing the Company.
  • “As part of our efforts to rapidly advance our clinical pipeline, we continue to streamline our operations to effectively and efficiently deliver on our key business objectives,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS.
  • “As I mentioned on the January shareholder call, our focus remains on shareholder value through the development of our assets and tight financial stewardship and exploration of commercial partnerships with the assistance of Stifel Financial Corp.
  • Stacy Yeung, recently promoted to Vice President, Associate General Counsel, and Head of Compliance, with 20 years of relevant experience will lead the Company’s legal and compliance functions.

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 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.