PCNSL

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.

Curis Announces Initial Combination Study Data from its TakeAim Lymphoma Study

Retrieved on: 
Tuesday, December 12, 2023
CNS, Stomatitis, BTK, History, Patient, PCNSL, BID, Symantec Endpoint Protection, Non-Hodgkin lymphoma, Infrared spectroscopy correlation table, NHL, Syncope, Pharmaceutical industry, Curie Institute (Paris)

LEXINGTON, Mass., Dec. 12, 2023 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 inhibitor, today announced initial combination study data from its TakeAim Lymphoma trial including 5 primary CNS lymphoma (PCNSL) patients.

Key Points: 
  • LEXINGTON, Mass., Dec. 12, 2023 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 inhibitor, today announced initial combination study data from its TakeAim Lymphoma trial including 5 primary CNS lymphoma (PCNSL) patients.
  • "We are very pleased with the initial emavusertib/ibrutinib combination data from the TakeAim Lymphoma study.
  • As of October 12th, the TakeAim Lymphoma trial has enrolled and treated 19 Non-Hodgkin Lymphoma (NHL) patients, with a combination of emavusertib and ibrutinib; with emavusertib doses ranging from 100 mg to 300 mg BID.
  • These data underscore the potential of emavusertib to re-sensitize patients to BTKi therapy, marking a significant advancement in Non-Hodgkin Lymphoma treatment.

Data of InnoCare’s Robust Pipelines Presented at the European Hematology Association (EHA) 2023 Hybrid Congress

Retrieved on: 
Monday, June 12, 2023
Science, Other Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Clinical Trials, Abstract, Rituximab, PCNSL, European Hematology Association, DLBCL, Glucocorticoid, Platelet, Lymphoma, Sequence, ITP, Trae Waynes, SSE, Clinical research associate, HKEX, Patient, Randomness, EHA, IVIG, GC, Primary central nervous system lymphoma, ORR, Safety, Medical imaging

Data of InnoCare’s (HKEX: 09969; SSE: 688428) robust pipelines were presented at the European Hematology Association (EHA) 2023 Hybrid Congress.

Key Points: 
  • Data of InnoCare’s (HKEX: 09969; SSE: 688428) robust pipelines were presented at the European Hematology Association (EHA) 2023 Hybrid Congress.
  • As of cut-off date on 6 Feb 2023, 33 patients were enrolled.
  • Both 50mg QD and 30mg QD of orelabrutinib were safe in the treatment of patients with ITP.
  • Among the 22 patients with previous response to GC or IVIG, 75.0% at the 50mg arm achieved the primary endpoint.

ONO PHARMA USA's Tirabrutinib Receives Orphan Drug Designation from the FDA for the Treatment of Primary Central Nervous System Lymphoma

Retrieved on: 
Thursday, March 23, 2023
Lymphoma, Seizure, PCNSL, Spinal cord, Eye, Brain, Trial of the century, ONO, Vomiting, Incidence, Patient, Nausea, Orphan, Diagnosis, Neoplasm, Rare, FDA, Headache, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Primary central nervous system lymphoma, Food, Pharmaceutical industry

CAMBRIDGE, Mass., March 23, 2023 /PRNewswire/ -- ONO PHARMA USA, INC., announced that its candidate, tirabrutinib (ONO-4059), a Bruton's tyrosine kinase inhibitor, was granted Orphan Drug Designation on March 21, 2023 by the U.S. Food and Drug Administration (FDA) for the treatment of patients with primary central nervous system lymphoma (PCNSL).

Key Points: 
  • CAMBRIDGE, Mass., March 23, 2023 /PRNewswire/ -- ONO PHARMA USA, INC., announced that its candidate, tirabrutinib (ONO-4059), a Bruton's tyrosine kinase inhibitor, was granted Orphan Drug Designation on March 21, 2023 by the U.S. Food and Drug Administration (FDA) for the treatment of patients with primary central nervous system lymphoma (PCNSL).
  • The FDA's Orphan Drug Designation program supports the development and evaluation of investigational drugs and biologics that show promise for the diagnosis, treatment, or prevention of rare diseases or disorders, affecting fewer than 200,000 people in the United States (U.S.).
  • ONO is currently recruiting newly diagnosed and relapsed or refractory adult PCNSL patients in the U.S. for the PROSPECT clinical study ( www.theprospectstudy.com ; NCT04947319).
  • "We are extremely pleased that tirabrutinib has been granted orphan drug status for the treatment of PCNSL," said Kunihiko Ito, President and CEO of ONO PHARMA USA.

Cellectar Biosciences Reports Complete Response in a Relapsed/Refractory CNS Lymphoma Patient

Retrieved on: 
Tuesday, February 28, 2023
Female, BCL6, PCNSL, Cancer, Lymphoma, Survival, Primary central nervous system lymphoma, Pharmacotherapy, Patient, CT, CNS, Neoplasm, Recombinant DNA, Medical imaging

She had BCL6 gene rearrangement which predicts worse outcomes and reduced survival.

Key Points: 
  • She had BCL6 gene rearrangement which predicts worse outcomes and reduced survival.
  • 50 days post cycle 1 day 1 infusion, a CT scan showed a very good partial response (VGPR) with a 93% reduction in tumor volume.
  • “Complete resolution of this patient’s primary CNS lymphoma, which had been relapsed or refractory to four lines of therapy, is extraordinary and provides further evidence of iopofosine’s ability to cross the blood/brain barrier and target cancer.
  • Importantly, these patients currently have very poor prognoses and there is no approved therapy for CNS lymphoma,” said Dr. Andrei Shustov, senior vice president, medical of Cellectar.

10 Studies on Orelabrutinib Selected at the Upcoming 64th Annual Meeting of ASH

Retrieved on: 
Tuesday, November 8, 2022
Oncology, Health, FDA, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Food, Dexamethasone, MCD, MCL, FDA, CLL, BTK, SSE, NMPA, Cancer, Primary central nervous system lymphoma, Society, National Medical Products Administration, Lymphoma, Methotrexate, New Drug Application, Food and Drug Administration, Multiple sclerosis, DLBCL, Degenerative disease, PCNSL, B-cell lymphoma, HKEX, ASH, SLL, Neuromyelitis optica spectrum disorder, ITP, SLE, NMOSD, Breakthrough therapy, Fine chemical, Medical imaging, Pharmaceutical industry, Safety, Lenalidomide, Newly industrialized country, Patient, Rituximab

InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that 10 studies on the BTK inhibitor orelabrutinib developed by InnoCare were selected at the 64th American Society of Hematology (ASH) Annual Meeting on December 10-13, 2022, which will be held online and offline in New Orleans, United States.

Key Points: 
  • InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that 10 studies on the BTK inhibitor orelabrutinib developed by InnoCare were selected at the 64th American Society of Hematology (ASH) Annual Meeting on December 10-13, 2022, which will be held online and offline in New Orleans, United States.
  • At the end of 2021, orelabrutinib was included into National Reimbursement Drug list to benefit more lymphoma patients.
  • The supplemental New Drug Applications of orelabrutinib for the treatment of R/R WM and R/R Marginal Zone Lymphoma were accepted in China.
  • Orelabrutinib was granted as Breakthrough Therapy Designation for the treatment of r/r MCL by U.S. Food and Drug Administration (FDA).

Gossamer Bio Announces Third Quarter 2022 Financial Results and Provides Business Update

Retrieved on: 
Thursday, November 3, 2022
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Annual report, G&A, Company, BTK, Private Securities Litigation Reform Act, Research, Administration, Therapy, European Committee on Antimicrobial Susceptibility Testing, Industry, Congress, Security (finance), U.S. Securities and Exchange Commission, STAR, COVID-19, Patient, Nasdaq, Multiple sclerosis, Immunotherapy, CEO, Program, CNS, Research and development, PCNSL, Clinical trial, Entrepreneurship, PAH, Bio, R, Inflammation, Disease, Public expenditure, SEC, Society, Treatment, SITC, Gossamer, GOSS, Pharmaceutical industry, Air cargo, Cancer

Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, today announced its financial results for the third quarter ended September 30, 2022 and provided a business update.

Key Points: 
  • Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, today announced its financial results for the third quarter ended September 30, 2022 and provided a business update.
  • It has been a productive quarter as we eagerly await topline results from the Phase 2 TORREY Study, said Faheem Hasnain, Chairman, Co-Founder and CEO of Gossamer Bio.
  • Ongoing TORREY Study is a Phase 2 clinical trial in patients with PAH whose disease has progressed despite standard-of-care therapy.
  • Gossamer cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements.

Gossamer Bio Announces Second Quarter 2022 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, August 9, 2022
Oncology, Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, U.S. Securities and Exchange Commission, Inflammation, Industry, CEO, CNS, R, Private Securities Litigation Reform Act, SEC, Clinical trial, Security (finance), Disease, GOSS, Caregiver, Research, Research and development, Public expenditure, Patient, COVID-19, Company, Therapy, G&A, STAR, Pathology, PAH, Nasdaq, Annual report, Bio, PCNSL, Administration, Entrepreneurship, Fine chemical, Pharmaceutical industry, Tutoring, Gossamer

Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, today announced its financial results for the second quarter ended June 30, 2022 and provided a business update.

Key Points: 
  • Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, today announced its financial results for the second quarter ended June 30, 2022 and provided a business update.
  • Ongoing TORREY Study is a Phase 2 clinical trial in patients with PAH whose disease has progressed despite standard-of-care therapy.
  • Topline data from the Phase 2 TORREY Study are expected in the second half of November or first half of December.
  • Financial Results for Quarter Ended June 30, 2022
    Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of June 30, 2022, were $222.2 million.

Nurix Therapeutics Reports Dosing of First Patient in Phase 1 Clinical Trial of NX-5948, a Selective BTK Degrader, in Development for B-cell Leukemias and Lymphomas

Retrieved on: 
Tuesday, May 17, 2022
BTK, Lymphoid leukemia, Primary central nervous system lymphoma, Private Securities Litigation Reform Act, Enzyme, Nasdaq, Microglia, Patient, Goal, Solution, Therapy, Clinical trial, Society, COVID-19, United Kingdom, SAN, CNS, Intention, PCNSL, Forward-looking statement, Central nervous system, Safety, ASH, Protein, SEC, Cancer, Annual report, GLOBE, Pharmaceutical industry, Vaccine

Nurix is conducting the open-label, dose escalation and expansion trial at multiple centers in the United Kingdom.

Key Points: 
  • Nurix is conducting the open-label, dose escalation and expansion trial at multiple centers in the United Kingdom.
  • The trial is designed to evaluate the safety and tolerability of NX-5948 in adults with relapsed or refractory B-cell malignancies.
  • Brown, M.D., executive vice president of clinical development of Nurix.
  • NX-5948 has the potential to offer a differentiated clinical profile for patients with relapsed or refractory B cell malignancies.

Gossamer Bio Announces First Quarter 2022 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, May 10, 2022
Oncology, Health, Other Health, General Health, Clinical Trials, Pharmaceutical, Biotechnology, COVID-19, U.S. Securities and Exchange Commission, Private Securities Litigation Reform Act, STAR, Nasdaq, Bio, CNS, Security (finance), Company, Public expenditure, Annual report, Research, PAH, Patient, Gossamer, Enrollment, Clinical trial, PCNSL, Administration, Inflammation, Therapy, Industry, Research and development, R, Disease, SEC, G&A, Entrepreneurship, GOSS, Pharmaceutical industry

Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, today announced its financial results for the first quarter ended March 31, 2022 and provided a business update.

Key Points: 
  • Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, today announced its financial results for the first quarter ended March 31, 2022 and provided a business update.
  • As part of this reprioritization, we now anticipate moving GB7208 into the clinic in the first half of 2023, pending the TORREY Study results.
  • We expect to initiate the Phase 1b/2 STAR CNS Study in relapsed / refractory PCNSL and other rare CNS malignancies in the second quarter of 2022.
  • Financial Results for Quarter Ended March 31, 2022
    Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of March 31, 2022, were $271.6 million.