Primary central nervous system lymphoma

Cellectar Biosciences Highlights Promising Interim Data from Its Ongoing Study of Iopofosine I 131 in Multiple Myeloma in an Oral Presentation at the SNMMI Annual Meeting

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Wednesday, June 28, 2023

FLORHAM PARK, N.J., June 28, 2023 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of targeted drugs for the treatment of cancer, today announced it presented data at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting from 64 evaluable, relapsed, or refractory multiple myeloma (MM) patients in which iopofosine I 131 demonstrated an overall response rate (ORR) of 28%, a clinical benefit rate (CBR) of 70% and a disease control rate (DCR) of 92%.

Key Points: 
  • “Our first-in-class targeted radiotherapy, iopofosine I 131, continues to deliver impressive results in patients with hematologic cancers.
  • Currently, there is a significant unmet need for patients with refractory multiple myeloma, who essentially have no treatment options once previous therapies stop working,” said Andrei Shustov, MD, senior vice president, medical.
  • The oral presentation highlighted data demonstrating the outcomes from two dose levels (60 mCi total administered dose) across these highly refractory patients.
  • A copy of the poster is available on the Posters and Publications section of the company’s website.

BTG Pharmaceuticals Statement on NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Recommendation for Use of Glucarpidase (Voraxaze®) and MTXPK.org

Retrieved on: 
Thursday, June 22, 2023

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Key Points: 
  • i-iv
    Describe the currently accepted approach in the event a patient receiving high-dose methotrexate (HDMTX) experiences delayed elimination due to renal impairment.
  • Explain that optimal administration of glucarpidase is within 48 to 60 hours from the start of MTX infusion.
  • However, since leucovorin is a substrate for glucarpidase, it should not be administered within two 2 hours prior to or following glucarpidase.
  • Acute kidney injury due to high-dose methotrexate is a serious, life-threatening toxicity that can occur in pediatric and adult patients.

Nurix Therapeutics Presents Data from Studies of Its Targeted Protein Degraders in B Cell Malignancies and Initiates Expansion of NX-2127 Phase 1b Trial in Diffuse Large B Cell Lymphoma and Mantle Cell Lymphoma Indications

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Wednesday, June 14, 2023

SAN FRANCISCO, June 14, 2023 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with hematologic malignancies and solid tumors, today announced the presentation of clinical and preclinical data from its targeted protein degradation programs, NX-5948 and NX-2127, which are being evaluated in ongoing Phase 1 clinical trials in patients with relapsed/refractory B cell malignancies. These data are being presented at the 17th International Conference on Malignant Lymphoma (ICML) which is being held June 13-17, in Lugano, Switzerland.

Key Points: 
  • These data are being presented at the 17th International Conference on Malignant Lymphoma (ICML) which is being held June 13-17, in Lugano, Switzerland.
  • Limitations of current covalent and non-covalent BTK inhibitors include the susceptibility to mutational escape as a basis for resistance.
  • Nurix’s BTK degraders have the potential to address these limitations of BTK inhibitors and provide a new therapeutic option for patients.
  • Nurix is announcing plans to initiate two new Phase 1b dose expansion cohorts in the ongoing Phase 1a/1b clinical trial of NX-2127 in patients with relapsed or refractory B-cell malignancies.

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

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Monday, June 12, 2023

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.

FORE Biotherapeutics to Present Promising New Data from Phase 1/2a Trial Evaluating Plixorafenib (FORE8394) in Patients With BRAF-Altered Advanced Solid and Central Nervous System Tumors at ASCO 2023

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Friday, May 26, 2023

The results demonstrate promising single-agent activity against BRAF-altered tumors, including primary central nervous system (CNS) tumors, and will be featured in presentations at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, being held June 2-6, 2023, in Chicago, IL.

Key Points: 
  • The results demonstrate promising single-agent activity against BRAF-altered tumors, including primary central nervous system (CNS) tumors, and will be featured in presentations at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, being held June 2-6, 2023, in Chicago, IL.
  • “The updated data from our Phase 1/2a study further reinforces plixorafenib’s differentiated clinical profile,” said Stacie Shepherd, MD, PhD, and Chief Medical Officer of FORE.
  • “Plixorafenib has demonstrated both promising antitumor activity with durable responses and favorable tolerability as a single agent in patients with advanced BRAF-altered tumors.
  • Details for the ASCO 2023 presentations are as follows:
    Title: Safety and efficacy of the novel BRAF inhibitor FORE8394 in patients with advanced solid and CNS tumors: Results from a phase 1/2a study

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

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 Reports Financial Results for Year Ended 2022 and Provides a Corporate Update

Retrieved on: 
Thursday, March 9, 2023

FLORHAM PARK, N.J., March 09, 2023 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted treatments for cancer, today announced financial results for the year ended December 31, 2022 and provided a corporate update.

Key Points: 
  • FLORHAM PARK, N.J., March 09, 2023 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted treatments for cancer, today announced financial results for the year ended December 31, 2022 and provided a corporate update.
  • Presented preclinical data on the CLR 12120 series of targeted alpha therapies (TATs) at the 13th Annual World ADC Conference.
  • Net cash used in operating activities during the year ended December 31, 2022 was approximately $25.2 million.
  • Research and Development Expense: R&D expense for the year ended December 31, 2022 was approximately $19.2 million, compared to approximately $17.6 million for the year ended December 31, 2021.

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

Retrieved on: 
Tuesday, February 28, 2023

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.

Global CAR T Cell Therapy Competitive Landscape 2022: Featuring Innovent Biologics, Sorrento Therapeutics, Cartesian Therapeutics and Novartis Among Others - ResearchAndMarkets.com

Retrieved on: 
Wednesday, January 11, 2023

This report provides comprehensive insights about 193+ companies and 450+ drugs in CAR T - Cell Therapy Competitive landscape.

Key Points: 
  • This report provides comprehensive insights about 193+ companies and 450+ drugs in CAR T - Cell Therapy Competitive landscape.
  • Abecma is the first cell-based CAR T - Cell Therapy approved by the FDA for the treatment of multiple myeloma.
  • How many emerging drugs are in mid-stage, and late-stage of development for the treatment of CAR T - Cell Therapy?
  • What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the CAR T - Cell Therapy therapeutics?

Kite and Daiichi Sankyo Announce Changes to YESCARTA® CAR T-Cell Therapy Licensing Agreement in Japan

Retrieved on: 
Thursday, December 8, 2022

Kite Pharma, Inc., a Gilead Company, (hereafter Kite) and Daiichi Sankyo Co., Ltd. (hereafter, Daiichi Sankyo) today jointly announced the revision of their 2017 partnership agreement, which gave Daiichi Sankyo exclusive rights to develop, manufacture and commercialize Yescarta (axicabtagene ciloleucel) in Japan.

Key Points: 
  • Kite Pharma, Inc., a Gilead Company, (hereafter Kite) and Daiichi Sankyo Co., Ltd. (hereafter, Daiichi Sankyo) today jointly announced the revision of their 2017 partnership agreement, which gave Daiichi Sankyo exclusive rights to develop, manufacture and commercialize Yescarta (axicabtagene ciloleucel) in Japan.
  • Kite was acquired by Gilead Sciences, Inc. later in 2017 after the Daiichi Sankyo partnership agreement.
  • Daiichi Sankyo and Kite have now agreed that the Marketing Authorization for Yescarta will be transferred to Gilead Sciences K.K., the Japan subsidiary of Gilead Sciences, Inc., in 2023.
  • As the global leader in cell therapy, we are pleased that our partnership with Daiichi Sankyo has brought this innovative therapy to patients in Japan.