Rituximab

Nurix Therapeutics Reports First Clinical Evidence of CNS Activity of NX-5948, a Brain-Penetrant, Orally Available, BTK Degrader in Development for B Cell Malignancies

Retrieved on: 
Tuesday, April 9, 2024
Histology, Brain, Rituximab, Chronic lymphocytic leukemia, CLL, Lymphoma, Disease, CSF, Central nervous system, SAN, CNS, Patient, PCNSL, BCL2, Cancer, Leukemia, Inflammation, Cerebrospinal fluid, NHL, Lymph, AACR, Proteolysis targeting chimera, Neoplasm, Therapy, MYC, BTK, Myenteric plexus, Lymphoid leukemia, Spleen, Medical imaging

SAN FRANCISCO, April 09, 2024 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with cancer and inflammatory diseases, today announced the presentation of the first findings of clinical responses in the brain for NX-5948, an orally available, selective degrader of Bruton’s tyrosine kinase (BTK). The presentation included case studies for two patients, one with CLL with CNS involvement and the other with PCNSL, each demonstrating clinically meaningful responses. The presentation also provided evidence of measurable drug levels in the CNS of multiple patients in the ongoing Phase 1 trial who had CNS tumor involvement. These data were presented by Gwenn M. Hansen, Ph.D., chief scientific officer of Nurix, as part of the Major Symposium session Molecular Glues, PROTACs, and Next-Gen Degraders: Discovery and Early Preclinical Advances at the AACR 2024 Annual Meeting, which is being held from April 5-10, 2024, in San Diego, CA.

Key Points: 
  • The presentation included case studies for two patients, one with CLL with CNS involvement and the other with PCNSL, each demonstrating clinically meaningful responses.
  • The presentation also provided evidence of measurable drug levels in the CNS of multiple patients in the ongoing Phase 1 trial who had CNS tumor involvement.
  • “These data are the first demonstration of clinical activity in the brain of a targeted protein degrader, opening the door for new therapeutic strategies to treat leukemias and lymphomas with CNS involvement,” said Dr. Hansen.
  • “The CLL patient with CNS involvement showed an impressive durable response with NX-5948 as single agent therapy in this setting.

ALX Oncology Reports Encouraging Clinical Data of Evorpacept in Combination with Standard-of-Care in an Ongoing Phase 1/2 Clinical Trial in Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (“R/R B-NHL”)

Retrieved on: 
Tuesday, April 9, 2024
Drug design, Rituximab, R2, ALT, Assistant, Patient, SAN, CRR, University, CD47, MD Anderson Cancer Center, Clinical trial, Anemia, Fatigue, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., April 09, 2024 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., (“ALX Oncology” or “the Company”) (Nasdaq: ALXO), an immuno-oncology company developing therapies that block the CD47 immune checkpoint pathway, today reported encouraging clinical data from the ongoing Phase 1/2 investigator-sponsored trial (“IST”) of evorpacept in combination with R2 in patients with indolent and aggressive R/R B-NHL. The new data were presented in an oral presentation at the 2024 American Association for Cancer Research (“AACR”) Annual Meeting.

Key Points: 
  • The new data were presented in an oral presentation at the 2024 American Association for Cancer Research (“AACR”) Annual Meeting.
  • Patients received evorpacept 30 mg/kg Q2W (n=3) or 60 mg/kg Q4W (n=17) in combination with standard R2 treatment.
  • “We are pleased evorpacept in combination with R2 demonstrated a favorable safety profile and encouraging response in this patient population.
  • We look forward to applying these and other clinical trial data to inform new evorpacept combinations in our expanding pipeline.

PolTREG identifies promising efficacy biomarker for Type-1 diabetes in patients treated with its Treg therapy in combination with rituximab

Retrieved on: 
Thursday, April 4, 2024
Rituximab, Multiple sclerosis, ALS, Insulin, Patient, Warsaw Stock Exchange, GMP, PTG, Therapy, Marketing, Autoimmune disease, PD-1, Pharmaceutical industry

This three-arm trial had earlier shown that 50% of PTG-007-treated patients in combination with rituximab were still in remission after 24 months.

Key Points: 
  • This three-arm trial had earlier shown that 50% of PTG-007-treated patients in combination with rituximab were still in remission after 24 months.
  • PolTREG CEO Piotr Trzonkowski, who co-authored the peer-reviewed study, said: “This peer-reviewed scientific publication adds to our growing excitement about the potential of polyclonal Treg therapies.
  • We have treated over 100 patients with our cell therapy at our facility over the last 17 years.
  • Having a biomarker of efficacy, like PD-1+ T-cells, could facilitate doctors’ ability to monitor their patients’ responses to therapy.

Mustang Bio Announces Vision for CAR T-Cell Therapy Platform Expansion into Autoimmune Diseases

Retrieved on: 
Thursday, March 28, 2024
Mustang, Rheumatoid arthritis, Rituximab, Chronic lymphocytic leukemia, Patient, DSM-IV codes, CD20, Cancer, Translation, NHL, B cell, Clinical trial, Society, Waldenström macroglobulinemia, Hematology, Health, Lymphoma, Waldenström, Autoimmune disease, Pharmaceutical industry

WORCESTER, Mass., March 28, 2024 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (“Mustang”) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers and rare genetic diseases, today announced its expansion into autoimmune diseases with MB-106, a personalized CD20-targeted, 3rd-generation autologous CAR T-cell therapy. MB-106 is being developed in a collaboration between Mustang and Fred Hutchinson Cancer Center (“Fred Hutch”). Mustang and Fred Hutch are in preliminary discussions to explore a potential Phase 1 investigator-sponsored clinical trial to evaluate MB-106 for the treatment of autoimmune diseases.

Key Points: 
  • MB-106 is being developed in a collaboration between Mustang and Fred Hutchinson Cancer Center (“Fred Hutch”).
  • Mustang and Fred Hutch are in preliminary discussions to explore a potential Phase 1 investigator-sponsored clinical trial to evaluate MB-106 for the treatment of autoimmune diseases.
  • “MB-106’s observed safety profile, encouraging efficacy data, and our robust manufacturing capabilities have the potential to translate to improved outcomes for patients with autoimmune diseases.
  • Several antibody therapies targeting CD20 on B-cells have successfully transitioned from cancer to autoimmune diseases, such as rituximab for both lymphoma and rheumatoid arthritis.

Gamida Cell Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Company Update

Retrieved on: 
Wednesday, March 27, 2024
Capacity utilization, Diagnosis, Research, RSA, Bone marrow, TCT, Rituximab, Cell, General counsel, Health, Patient, EAP, Highbridge Capital Management, Society, Ronald Reagan, ATM, Depreciation, ID, Transplant, Therapy, Medicare, NK, CMS, Marketing, UCLA Health, Dentistry

BOSTON, March 27, 2024 (GLOBE NEWSWIRE) -- Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today provided a business update and reported financial results for the fourth quarter and full year ended December 31, 2023.

Key Points: 
  • (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today provided a business update and reported financial results for the fourth quarter and full year ended December 31, 2023.
  • Gamida Cell will become a private company, wholly owned by Highbridge, and the company’s outstanding ordinary shares are expected to be canceled.
  • The company has confirmed coverage with payers who cover more than 90% of commercial lives, exceeding the 2023 goal of 70%.
  • The full year Net Revenue included $1.1 million of net review for the fourth quarter of 2023.

argenx Announces Approval of VYVGART (efgartigimod alfa) in Japan for Adults with Primary Immune Thrombocytopenia

Retrieved on: 
Tuesday, March 26, 2024
Diagnosis, Blood pressure, Efgartigimod alfa, System, Urination, Urinary tract infection, MHLW, Chest pain, Rituximab, Allergy, Disease, Infection, Risk, Headache, Patient, Sore throat, IWG, History, ITP, Chills, Quality of life, Cough, Euronext, Rash, Respiratory tract infection, Splenectomy, Medicine, Skin, Fever, Antibody, Wheeze, Back pain, Shivering, Safety, Pain, Fatigue, Phlegm, Swelling, Food, Autoimmune disease, Nursing

“argenx is on a mission to deliver transformative medicines for people living with severe autoimmune disease,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx.

Key Points: 
  • “argenx is on a mission to deliver transformative medicines for people living with severe autoimmune disease,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx.
  • By reducing circulating autoantibodies, VYVGART is uniquely designed to serve as a precision intervention that targets the underlying disease biology of ITP.
  • ADVANCE successfully met its primary endpoint, demonstrating that a higher proportion of chronic ITP patients receiving VYVGART achieved a sustained platelet count response compared to placebo.
  • Do not use VYVGART if you have a serious allergy to efgartigimod alfa or any of the other ingredients in VYVGART.

Astria Therapeutics Appoints Sunil Agarwal to Its Board of Directors

Retrieved on: 
Tuesday, April 9, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, Neuroscience, Juno Therapeutics, Genentech, Cornell University, Heredity, Patient, Carmustine, Acquisition, Allergy, Senior, Research and development, Therapy, Drug development, Rituximab, Management

Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company focused on developing life-changing therapies for allergic and immunological diseases, today announced the appointment of Sunil Agarwal, M.D., to its Board of Directors.

Key Points: 
  • Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company focused on developing life-changing therapies for allergic and immunological diseases, today announced the appointment of Sunil Agarwal, M.D., to its Board of Directors.
  • Dr. Agarwal has more than 20 years of biotechnology research, development, and commercialization experience.
  • “It is a pleasure to welcome Sunil to our Board of Directors,” said Jill C. Milne, Ph.D., Chief Executive Officer at Astria Therapeutics.
  • “STAR-0215 has the potential to significantly improve the lives of patients and I look forward to contributing to its progress at this exciting time.”
    Dr. Agarwal currently serves on the Board of Directors of Arvinas and was previously a Board member of Calithera Biosciences, MyoKardia, and Vitrisa Therapeutics.

ADC Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Updates

Retrieved on: 
Wednesday, March 13, 2024
AXL, PIN, Neutropenia, Growth, Rituximab, Sarcoma, ALT, NSCLC, ASH, FY, Progression-free survival, Skin infection, Patient, Follicular lymphoma, S&M, Research, EDT, Aes, Periodic breathing, G&A, University, Lung cancer, Insurance, AACR, DLT, Pancreatic cancer, Hyperglycemia, Society, Therapy, Clinical trial, Diffuse large B-cell lymphoma, PFS, CD22, ADC, Data, Fatigue, MD Anderson Cancer Center, FDA, DLBCL, Marketing, PSMA, IDMC, Pharmaceutical industry

LAUSANNE, Switzerland, March 13, 2024 (GLOBE NEWSWIRE) -- ADC Therapeutics SA (NYSE: ADCT) today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided business updates.

Key Points: 
  • “In the fourth quarter we saw results of our strategy in action across a number of key areas.
  • A return to sequential quarter-over-quarter growth in the fourth quarter of 2023 followed the restructuring of the commercial model, with sales volume increasing in both community and academic settings.
  • R&D expenses were $30.3 million for the fourth quarter and $127.1 million for full year 2023, compared to $48.1 million and $186.5 million, respectively, for the fourth quarter and full year 2022.
  • ADC Therapeutics management will host a conference call and live audio webcast to discuss fourth quarter and full year 2023 financial results and provide a company update today at 8:30 a.m. Eastern Time.

Pfizer Announces Positive Overall Survival in Phase 3 Trial of ADCETRIS® Regimen in Patients with Relapsed/​Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Retrieved on: 
Tuesday, March 12, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Rituximab, Survival, Lymphoma, Inc., Disease, Patient, PFE, Brentuximab vedotin, Lenalidomide, Safety, CD30, PFS, Food, FDA, DLBCL, Pharmaceutical industry

Positive outcomes were also observed in key secondary endpoints, including progression free survival (PFS) and overall response rate (ORR).

Key Points: 
  • Positive outcomes were also observed in key secondary endpoints, including progression free survival (PFS) and overall response rate (ORR).
  • The safety and tolerability of ADCETRIS in the ECHELON-3 trial were consistent with what has been previously presented for patients with relapsed/refractory DLBCL treated with ADCETRIS in clinical trials.
  • “This is the third Phase 3 study in a type of lymphoma to demonstrate an overall survival benefit for an ADCETRIS combination.
  • Pfizer plans to share the ECHELON-3 data with the U.S. Food and Drug Administration (FDA) to potentially support regulatory filing in the U.S.

Navrogen Presents Its Anti-CD20 Antibody NAV-006 and ICAM-1 Refractory Antibody-Drug Conjugate Platform at the 2024 American Association for Cancer Research Annual Meeting

Retrieved on: 
Thursday, April 4, 2024
Conference, Rituximab, B-cell lymphoma, Serum, HIO, Patient, CD20, Humoral immunity, Cancer, BRITE, NHL, AACR, CA125, ADC, Lymphoma, CD19, Vaccine

Recent clinical evidence suggests that high serum levels of the tumor-produced MUC16/CA125 protein has a negative impact on the efficacy of rituximab.

Key Points: 
  • Recent clinical evidence suggests that high serum levels of the tumor-produced MUC16/CA125 protein has a negative impact on the efficacy of rituximab.
  • Navrogen will present data showing NAV-006's superior efficacy over rituximab in animal models of human NHL.
  • "We have engineered a trastuzumab-drug conjugate variant with superior cytotoxicity against ICAM-1 positive cancer cells.
  • We are now building a portfolio of enhanced ADCs using this platform to advance internal as well as partnered ADC programs".