B-cell lymphoma

Viracta Therapeutics to Host R&D Day Highlighting Nana-val in Epstein-Barr Virus (EBV)-Associated Cancers

Retrieved on: 
Wednesday, October 4, 2023

SAN DIEGO, Oct. 04, 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 that it plans to highlight new preliminary clinical and preclinical data from studies of nanatinostat and valganciclovir (Nana-val), its all-oral investigational therapy targeting Epstein-Barr virus (EBV)-associated cancers, during an R&D Day today, Wednesday, October 4, 2023, at 8:00 a.m. EDT.

Key Points: 
  • “The clinical responses and favorable safety profile observed in multiple relapsed or refractory EBV-positive lymphoma patient populations continue to be encouraging.
  • In addition, the R&D Day will feature presentations by expert key opinion leaders who will discuss the high unmet medical needs of EBV-associated lymphomas.
  • Enrollment completed through the fifth dose level of the Phase 1b dose escalation portion of the trial without any dose-limiting toxicities reported.
  • A live video webcast of the presentation will be available here and on the Investors section of the Viracta website under " Events and Webcasts ".

Genmab Announces European Commission Approval of TEPKINLY® (epcoritamab) for Adults with Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL)

Retrieved on: 
Monday, September 25, 2023

DLBCL is the most common type of B-cell non-Hodgkin’s lymphoma worldwide.

Key Points: 
  • DLBCL is the most common type of B-cell non-Hodgkin’s lymphoma worldwide.
  • “Today’s approval underscores our commitment to bringing our bispecific antibody to more patients worldwide.
  • “Relapsed or refractory DLBCL is an aggressive cancer and patients can face a difficult and emotional treatment journey.
  • AbbVie will continue to pursue regulatory submissions for epcoritamab across international markets throughout the year.

EPKINLY™ (epcoritamab) Approved by Japan Ministry of Health, Labour and Welfare as the First Bispecific Antibody to Treat Adults Patients with Certain Types of Relapsed or Refractory (R/R) Large B-Cell Lymphoma (LBCL)

Retrieved on: 
Monday, September 25, 2023

Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration.

Key Points: 
  • Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration.
  • Of 157 patients treated with EPKINLY, 130 (82.8 percent) experienced treatment related side effects.
  • The most common side effects (>15 percent) included cytokine release syndrome (49.7 percent), injection site reactions (19.7 percent), and neutropenia (17.8 percent).
  • Of 36 patients treated with EPKINLY, 36 (100 percent) experienced treatment related side effects.

Genmab Announces European Commission Approval of TEPKINLY® (epcoritamab) for Adults with Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL)

Retrieved on: 
Monday, September 25, 2023

DLBCL is the most common type of B-cell non-Hodgkin’s lymphoma worldwide.

Key Points: 
  • DLBCL is the most common type of B-cell non-Hodgkin’s lymphoma worldwide.
  • “Today’s approval underscores our commitment to bringing our bispecific antibody to more patients worldwide.
  • “Relapsed or refractory DLBCL is an aggressive cancer and patients can face a difficult and emotional treatment journey.
  • AbbVie will continue to pursue regulatory submissions for epcoritamab across international markets throughout the year.

Cellectar Biosciences Receives European Medicines Agency Priority Medicines (PRIME) Designation for Iopofosine for Waldenstrom’s Macroglobulinemia

Retrieved on: 
Monday, September 18, 2023

The PRIME program aims to optimize development plans and speed up evaluation of medicines that may offer a major therapeutic advantage over existing treatments or benefit patients without treatment options.

Key Points: 
  • The PRIME program aims to optimize development plans and speed up evaluation of medicines that may offer a major therapeutic advantage over existing treatments or benefit patients without treatment options.
  • These medicines are considered priority medicines by the EMA and are intended to reach patients earlier.
  • To be accepted for PRIME, new therapies must demonstrate the potential to significantly address an unmet medical need in clinical trials.
  • “PRIME designation from the EMA further underscores our confidence in iopofosine I 131 to provide a differentiated and highly needed new treatment option for patients with WM,” said James Caruso, president and CEO of Cellectar.

Kite’s Car T-cell Therapy Yescarta® Demonstrates High Response Rate and Durable Remission in ALYCANTE Study as Initial Treatment for Transplant Ineligible Patients With Relapsed/Refractory Large B-cell Lymphoma

Retrieved on: 
Monday, September 18, 2023

The ALYCANTE study, a multicenter, open-label Phase 2 LYSA study, evaluated for the first time the efficacy and safety of Yescarta as a second-line therapy in 62 patients with R/R LBCL who were deemed ineligible for HDCT and ASCT.

Key Points: 
  • The ALYCANTE study, a multicenter, open-label Phase 2 LYSA study, evaluated for the first time the efficacy and safety of Yescarta as a second-line therapy in 62 patients with R/R LBCL who were deemed ineligible for HDCT and ASCT.
  • “Transplant ineligible patients with aggressive relapsed or refractory B-cell lymphomas face poor prognosis,” said Prof. Roch Houot, Head of Haematology Department, University Hospital of Rennes, France and coordinator of the ALYCANTE study.
  • The ALYCANTE study included patients deemed ineligible for HDCT/ASCT because of age ≥65 years (88.7%), high hematopoietic cell transplantation-specific comorbidity index score ≥3 (32.3%), and/or prior ASCT (3.2%).
  • “The data generation for Yescarta continues to reaffirm its potential to bring hope to patients suffering from a variety of sub-types of large B-cell lymphoma and follicular lymphoma.”

EQS-News: MorphoSys Receives U.S. FDA Fast Track Designation for Tulmimetostat in Endometrial Cancer

Retrieved on: 
Saturday, September 16, 2023

The FDA grants Fast Track designation to facilitate the development and expedite the review of medicines intended to treat serious conditions and potentially address an unmet medical need, with the goal of getting these important, new therapies to patients earlier.

Key Points: 
  • The FDA grants Fast Track designation to facilitate the development and expedite the review of medicines intended to treat serious conditions and potentially address an unmet medical need, with the goal of getting these important, new therapies to patients earlier.
  • The Fast Track designation in endometrial cancer was granted based on preclinical results and preliminary clinical data from an ongoing Phase 1/2 study.
  • “Receiving Fast Track designation from the FDA for tulmimetostat in ARID1A-mutated endometrial cancer underscores this investigational therapy’s potential in a patient population with limited treatment options,” said Tim Demuth, M.D., Ph.D., MorphoSys Chief Research and Development Officer.
  • Pelabresib, an investigational BET inhibitor, received Fast Track designation for myelofibrosis in 2018, and tafasitamab, a CD19-targeting immunotherapy, received this designation for relapsed or refractory diffuse large B-cell lymphoma in 2014.

CARGO Therapeutics Announces Appointment of Michael Ports, PhD, as Chief Scientific Officer

Retrieved on: 
Tuesday, September 12, 2023

SAN MATEO, Calif., Sept. 12, 2023 (GLOBE NEWSWIRE) -- CARGO Therapeutics, Inc. (CARGO), a clinical-stage biotechnology company uniquely positioned to advance next generation, potentially curative cell therapies for cancer patients, today announced the appointment of Michael Ports, PhD, as Chief Scientific Officer. Dr. Ports will be responsible for advancing CARGO's proprietary platform technologies and discovery-stage programs.

Key Points: 
  • SAN MATEO, Calif., Sept. 12, 2023 (GLOBE NEWSWIRE) -- CARGO Therapeutics, Inc. (CARGO), a clinical-stage biotechnology company uniquely positioned to advance next generation, potentially curative cell therapies for cancer patients, today announced the appointment of Michael Ports, PhD, as Chief Scientific Officer.
  • “I am delighted to welcome Michael, an experienced leader in cell therapy, to CARGO as our Chief Scientific Officer.
  • Michael brings strong scientific leadership and a deep understanding of cell therapy to this role and will be an inspiring thought partner to our research and development teams,” said Gina Chapman, CARGO's President and Chief Executive Officer.
  • Throughout my career, I have sought opportunities to develop differentiated therapeutics and treatment strategies to significantly improve outcomes for patients,” said Michael Ports, Chief Scientific Officer, CARGO Therapeutics.

Marker Therapeutics Announces Complete Response in First Lymphoma Patient Treated with MT-601 after CAR T Relapse

Retrieved on: 
Monday, September 11, 2023

HOUSTON, Sept. 11, 2023 (GLOBE NEWSWIRE) -- Marker Therapeutics, Inc. (Nasdaq: MRKR) is a clinical-stage immuno-oncology company focusing on developing next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications. Today Marker is announcing the preliminary results of the first participant treated with MT-601, its multi-tumor associated antigen (multiTAA)-specific T cell product targeting 6 TAAs, in the Phase 1 multicenter APOLLO clinical trial. The APOLLO trial is investigating the safety and efficacy of MT-601 for the treatment of patients with lymphoma who have either failed or are ineligible to receive anti-CD19 CAR T cell therapy.

Key Points: 
  • After relapse following anti-CD19 CAR T cell therapy, the participant was treated with 2 doses of MT-601 at the 200 million cell dose level without prior lymphodepletion.
  • Eight weeks after the 2nd infusion of MT-601, the participant demonstrated complete metabolic response based on PET-CT scans.
  • “We are delighted to announce that the first study participant treated in the APOLLO trial achieved a complete response after treatment with MT-601,” said Monic Stuart, M.D., Chief Medical Officer of Marker Therapeutics.
  • “Our APOLLO trial is an important area for MT-601 assessment, as up to 60% of patients treated with anti-CD19 CAR T therapies relapse within one year.

Cellectar Biosciences Announces Closing of up to Approximately $103 Million Private Placement Financing

Retrieved on: 
Monday, September 11, 2023

The financing was led by Rosalind Advisors with participation from AIGH Capital, ADAR1, Second Line, Nantahala Capital, AuGC, and other new and existing institutional investors.

Key Points: 
  • The financing was led by Rosalind Advisors with participation from AIGH Capital, ADAR1, Second Line, Nantahala Capital, AuGC, and other new and existing institutional investors.
  • Conversion of the Series E Preferred Stock into shares of common stock of the Company is subject to approval by the Company's stockholders.
  • Oppenheimer & Co. Inc. acted as the sole placement agent for the private placement.
  • Cellectar has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of common stock underlying the Series E Preferred Stock.