SLL

U.S. FDA Approves Bristol Myers Squibb’s Breyanzi® as the First and Only CAR T Cell Therapy for Adults with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

Retrieved on: 
Friday, March 15, 2024
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, SLL, BMY, B-cell lymphoma, Chronic lymphocytic leukemia, CLL, Bone marrow, Caregiver, Patient, Lymphocytosis, City, CRS, Commercial, Bristol Myers Squibb, BTK, MRD, Cytokine release syndrome, Division, Drug resistance, Multimedia, Blood, Associate professor, Food, Pharmaceutical industry

Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Key Points: 
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
  • Please see the Important Safety Information section below, including Boxed WARNINGS for Breyanzi regarding Cytokine Release Syndrome (CRS), Neurologic Toxicities, and Secondary Hematological Malignancies.
  • “For years, attempts to bring other CAR T cell therapies to patients with relapsed or refractory CLL or SLL met challenges and found little success.
  • After relapsing or becoming refractory to these therapies, patients have few options and poor outcomes, including lack of durable complete responses.

InnoCare Announces Approval of Clinical Trial of BCL2 Inhibitor ICP-248 in Combination with Orelabrutinib as First-Line Therapy for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma in China

Retrieved on: 
Wednesday, March 13, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, SLL, CLL, Hematology, E-3, Incidence, Patient, Malignancy, BCL2, Cancer, Leukemia, Death, IND, Clinical trial, Investigational New Drug, HKEX, BTK, Safety, Marketing, NRDL, Lymphoma, CD19, Pharmaceutical industry

This multicenter, randomized-controlled, open-label clinical study is designed to evaluate the efficacy and safety of ICP-248 combined with orelabrutinib versus immunochemotherapy in treatment-naive patients with CLL/SLL.

Key Points: 
  • This multicenter, randomized-controlled, open-label clinical study is designed to evaluate the efficacy and safety of ICP-248 combined with orelabrutinib versus immunochemotherapy in treatment-naive patients with CLL/SLL.
  • ICP-248 is a novel, orally bioavailable BCL2-selective inhibitor, which aims to treat hematologic malignancies as a monotherapy or in combination with other therapies.
  • BCL2 is an important regulatory protein of apoptosis pathway, and its abnormal expression is related to the development of various hematologic malignancies.
  • ICP-248 has an anti-tumor effect by selectively inhibiting BCL2 and restoring the mechanism of programmed cell death.

Memorial Sloan Kettering Cancer Center Now Enrolling Patients in Phase 1/2 Clinical Trial of IMUNON’s IMNN-001 in Combination with Bevacizumab in Advanced Ovarian Cancer

Retrieved on: 
Tuesday, February 27, 2024
Progression-free survival, PFS, Woman, Research, Break, Reproductive medicine, Immunotherapy, University, Ovarian cancer, Cancer, DNA repair, Koch Institute, Bevacizumab, Gynecologic Oncology (journal), MD Anderson Cancer Center, Patient, MRD, SLL, Survival, Medical imaging

LAWRENCEVILLE, N.J., Feb. 27, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development company focused on developing non-viral DNA-mediated immunotherapy and next-generation vaccines, announces that Memorial Sloan Kettering Cancer Center has joined MD Anderson Cancer Center in enrolling patients in a Phase 1/2 clinical trial evaluating IMUNON’s IMNN-001 in combination with bevacizumab in patients with advanced ovarian cancer. IMNN-001 is a DNA-based interleukin-12 (IL-12) immunotherapy currently in the Phase 2 OVATION 2 Study for the localized treatment of advanced ovarian cancer.

Key Points: 
  • LAWRENCEVILLE, N.J., Feb. 27, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development company focused on developing non-viral DNA-mediated immunotherapy and next-generation vaccines, announces that Memorial Sloan Kettering Cancer Center has joined MD Anderson Cancer Center in enrolling patients in a Phase 1/2 clinical trial evaluating IMUNON’s IMNN-001 in combination with bevacizumab in patients with advanced ovarian cancer.
  • IMNN-001 is a DNA-based interleukin-12 (IL-12) immunotherapy currently in the Phase 2 OVATION 2 Study for the localized treatment of advanced ovarian cancer.
  • We believe this combination therapy holds promise based on our preclinical animal studies, which showed strong synergies between IMNN-001 and bevacizumab.
  • Patients undergoing frontline neoadjuvant therapy will be randomized 1:1 to receive standard chemotherapy plus bevacizumab vs. chemotherapy plus bevacizumab and IMNN-001.

Merck Announces Phase 3 Trial Initiations for Four Investigational Candidates From its Promising Hematology and Oncology Pipeline

Retrieved on: 
Friday, January 5, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, MSD, LSD1, Lung cancer, Science, Lymphocytosis, Bone marrow, Research, Malignancy, Orion, Chronic lymphocytic leukemia, CLL, Merck & Co., BTK, Cancer, Patient, SLL, MRK, ADC, Therapy, NSCLC, CYP11A1, Pharmaceutical industry

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the initiation of pivotal Phase 3 trials for four of its investigational candidates from its diverse pipeline in hematologic malignancies and solid tumors.

Key Points: 
  • Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the initiation of pivotal Phase 3 trials for four of its investigational candidates from its diverse pipeline in hematologic malignancies and solid tumors.
  • Global Phase 3 studies have been initiated and are actively enrolling for the following investigational candidates:
    Bomedemstat, an investigational orally available lysine-specific demethylase 1 (LSD1) inhibitor, being evaluated for the treatment of certain patients with essential thrombocythemia (ET);
    Nemtabrutinib, an investigational oral, reversible, non-covalent Bruton’s tyrosine kinase (BTK) inhibitor, being evaluated for the treatment of certain patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL);
    MK-2870, an investigational trophoblast cell-surface antigen 2 (TROP2)-directed antibody drug conjugate (ADC) being developed in collaboration with Kelun-Biotech, which is being evaluated for certain patients with non-small cell lung cancer (NSCLC) and certain patients with previously treated endometrial carcinoma;
    and MK-5684, an investigational CYP11A1 inhibitor being developed in collaboration with Orion, which is being evaluated for the treatment of certain patients with metastatic castration-resistant prostate cancer (mCRPC).
  • “These Phase 3 trial initiations for four of our investigational candidates represent a critical step forward in our efforts to advance potential treatment options for people with solid tumors and hematologic neoplasms and malignancies,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories.
  • “We have a proud legacy of turning breakthrough science into medicines that save and improve lives around the world, and we are dedicated to continuing research to expand our broad portfolio of oncology therapeutics to continue to address unmet needs in cancer care.”

Bristol Myers Squibb Presents New Data at ASH 2023 Demonstrating Clinical Benefit Across B-cell Malignancies with Breyanzi as a Second-Line Treatment in High-Risk Follicular Lymphoma and in Relapsed or Refractory Chronic Lymphocytic Leukemia

Retrieved on: 
Monday, December 11, 2023
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Genetics, Clinical Trials, City, ASH, CRS, Pros, Patient, Probability, Conference, Bristol Myers Squibb, Prognosis, ORR, Quality of life, Disclosure, Safety, Food, SLL, Jungian cognitive functions, DOR, Trial of the century, Blood, Lymphoma, Society, Bone marrow, Neuropsychological test, Haematopoietic system, BMY, Pain, Journal of Clinical Oncology, NYSE, BTK, MCL, Clinical trial, Fatigue, Follicular lymphoma, PRO, Chronic lymphocytic leukemia, BMS, NHL, CLL, HIV disease progression rates, Pharmaceutical industry, Veterinary medicine, Lisocabtagene maraleucel, Hematology

TRANSCEND FL is the largest clinical trial to date to evaluate a CAR T cell therapy in patients with relapsed or refractory indolent non-Hodgkin lymphoma, including FL.

Key Points: 
  • TRANSCEND FL is the largest clinical trial to date to evaluate a CAR T cell therapy in patients with relapsed or refractory indolent non-Hodgkin lymphoma, including FL.
  • Additionally, the company presented long-term data from the TRANSCEND CLL 004 study evaluating Breyanzi in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) with 24-month follow-up ( Oral Presentation #330 ).
  • Bristol Myers Squibb (BMS) has the broadest ongoing cell therapy development program in CD19-positive malignancies with Breyanzi, which also includes trials investigating its use in patients with relapsed/refractory mantle cell lymphoma (MCL).
  • In the TRANSCEND FL clinical trial, 130 patients with relapsed or refractory follicular lymphoma (FL) were enrolled and treated with Breyanzi in the second-line and third-line plus settings.

CDB Aviation Enters Into Inaugural Sustainability Linked Loan for $625 Million

Retrieved on: 
Thursday, December 7, 2023
Environmental, Social and Governance (ESG), Aerospace, Green Technology, Manufacturing, Sustainability, Socially Responsible Investing, Finance, Professional Services, Other Transport, Environment, Air, Transport, Other Manufacturing, Machinery, DEI (Diversity, Equity and Inclusion), Party, Aviation, Carbon, Social, China Construction Bank, Workforce, MLA, CDB, China Minsheng Bank, KPI-driven code analysis, MPEG transport stream, SLL, Agent, BNP Paribas, Investment banking, Aircraft, Biophysical environment, Natixis, ESG, Jet fuel, Security (finance), PRC, Hong Kong

CDB Aviation, a wholly owned Irish subsidiary of China Development Bank Financial Leasing Co., Ltd. (“CDB Leasing”), announced today that the lessor entered into its inaugural Sustainability Linked Loan (“SLL”) on December 1, 2023, anchored with a $625 million syndicated term loan facility.

Key Points: 
  • CDB Aviation, a wholly owned Irish subsidiary of China Development Bank Financial Leasing Co., Ltd. (“CDB Leasing”), announced today that the lessor entered into its inaugural Sustainability Linked Loan (“SLL”) on December 1, 2023, anchored with a $625 million syndicated term loan facility.
  • “This innovative facility marks a landmark transaction for the aviation finance space,” underscored Jie Chen, CDB Aviation’s Chief Executive Officer.
  • Moody’s Investors provided the Second Party Opinion as to the appropriateness of the KPIs and SPTs, confirming the conformity of the facility with the Sustainability Linked Loan Principles (“SLLPs”), with a best-in-class SQS2 rating.
  • Crédit Agricole Corporate and Investment Bank acted as Sole Sustainability Agent, as well as Lead Sustainability Structuring Advisor jointly with BNP Paribas and the Hong Kong and Shanghai Banking Corporation.

Florida Cancer Specialists & Research Institute Contributing to Cutting-Edge Advancements in Hematology Science

Retrieved on: 
Wednesday, December 13, 2023
Annual Reviews (publisher), ASH, BTK, Research, Bortezomib, Omicron, Conference, Bangladesh Technical Education Board, Poster, Mantle cell lymphoma, SLL, Risk, Science, Abstract, Drug development, Tyrosine kinase, Society, B-cell lymphoma, FACP, Rituximab, Reversibility, Delta, Phase, Nivolumab, Hospital, Safety, DRD, MCL, FCS, FDA, Lymphocytosis, Pivotal trial, Chronic lymphocytic leukemia, Meta-analysis, Artery, Bias, Coronary thrombosis, NHL, CLL, Pharmaceutical industry, Dietary supplement, Vaccine, Birth control, Incidence, Patient, Dexamethasone, Lenalidomide, Hematology, Relapse, Dacarbazine, MD, Doxorubicin

FORT MYERS, Fla., Dec. 13, 2023 /PRNewswire/ -- Research conducted at Florida Cancer Specialists & Research Institute, LLC (FCS) was presented in the cutting-edge advancements being shared at the American Society of Hematology (ASH) 65th Annual Meeting and Exposition in San Diego on Dec. 9 - 12, 2023. Scientific abstracts submitted by FCS hematologists and medical oncologists were among the 7,000 accepted submissions selected through an extensive peer review process.

Key Points: 
  • FORT MYERS, Fla., Dec. 13, 2023 /PRNewswire/ -- Research conducted at Florida Cancer Specialists & Research Institute, LLC (FCS) was presented in the cutting-edge advancements being shared at the American Society of Hematology (ASH) 65th Annual Meeting and Exposition in San Diego on Dec. 9 - 12, 2023.
  • Scientific abstracts submitted by FCS hematologists and medical oncologists were among the 7,000 accepted submissions selected through an extensive peer review process.
  • Pirtobrutinib has also been approved for patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
  • Once again, FCS is proud to have a strong presence, sharing the latest and most promising research and science that is moving the field forward."

Updated Data from the BRUIN Phase 1/2 Study of Pirtobrutinib in Chronic Lymphocytic Leukemia and Mantle Cell Lymphoma Presented at the 2023 ASH Annual Meeting

Retrieved on: 
Tuesday, December 12, 2023
Medicine, Drug, Safety, NYSE, Arrhythmia, BTK, CTCAE, MCL, Lymphoid leukemia, Progression-free survival, ASH, Cytopenia, Dana–Farber Cancer Institute, Lymphocytosis, Bleeding, Clinical trial, Fatigue, Non-Hodgkin lymphoma, Rituximab, Patient, Abstract, Mantle cell lymphoma, PFS, SLL, Lymphoma, Infection, FDA, DOR, LLY, Exposition, Neutropenia, PVR, ORR, Lilly, Eli Lilly and Company, Chronic lymphocytic leukemia, Nausea, Diarrhea, Pulmonary toxicity, IRC, Chills, Society, OS, NHL, PV, HIV disease progression rates, Venetoclax, Pharmaceutical industry, Dietary supplement, CLL

These data, which were presented in oral and poster presentations at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition, continue to support the role of pirtobrutinib in the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) and mantle cell lymphoma (MCL).

Key Points: 
  • These data, which were presented in oral and poster presentations at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition, continue to support the role of pirtobrutinib in the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) and mantle cell lymphoma (MCL).
  • The labeling for pirtobrutinib contains warnings and precautions for infections, hemorrhage, cytopenias, cardiac arrhythmias, second primary malignancies, and embryo-fetal toxicity.
  • The BRUIN Phase 1/2 clinical trial is evaluating pirtobrutinib in patients previously treated for MCL, CLL/SLL, or other non-Hodgkin lymphomas (NHL).
  • All presentations of safety and efficacy data from the BRUIN Phase 1/2 trial utilized a cutoff date of May 5, 2023.

Jaypirca® (pirtobrutinib) Now Approved by U.S. FDA for the Treatment of Adult Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Who Have Received at Least Two Lines of Therapy, Including a BTK Inhibitor and a BCL-2 Inhibitor

Retrieved on: 
Friday, December 1, 2023
CNS, NYSE, Food, Arrhythmia, Toxicity, BTK, MCL, HSCT, University, Cytopenia, Disease, Tablet, Bleeding, Patient, SLL, Infection, Hematopoietic stem cell transplantation, FDA, DOR, Acalabrutinib, Lymphocytosis, LLY, Chronic lymphocytic leukemia, Eli Lilly and Company, ORR, IRC, Accelerated approval (FDA), CLL, HIV disease progression rates, Lymphoma, Pharmaceutical industry, Pirtobrutinib

INDIANAPOLIS, Dec. 1, 2023 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) approved Jaypirca® (pirtobrutinib, 100 mg & 50 mg tablets) for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a Bruton's tyrosine kinase (BTK) inhibitor and a BCL-2 inhibitor. Jaypirca was approved under the FDA's Accelerated Approval pathway based on overall response rate (ORR) and duration of response (DOR) from the open-label, single-arm, multicohort, international, Phase 1/2 BRUIN trial.1 Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.1

Key Points: 
  • The labeling for Jaypirca contains warnings and precautions for infections, hemorrhage, cytopenias, cardiac arrhythmias, second primary malignancies, and embryo-fetal toxicity.
  • "The treatment landscape for CLL has been dramatically improved by the introduction of covalent BTK inhibitors and BCL-2 inhibitors.
  • Patients with active central nervous system (CNS) involvement by lymphoma or allogeneic hematopoietic stem cell transplantation (HSCT) within 60 days were excluded.
  • Patients in the efficacy-eligible population had received a median of five prior lines of therapy (range: 2 to 11).

Netrality Data Centers Secures $380M Sustainability-Linked Loan to Support Energy-Efficiency

Retrieved on: 
Tuesday, November 28, 2023
UPS, Carbon, Sustainability, TD Securities, ESG Solutions, LLP, White, White & Case, Public expenditure, SLL, Goldman Sachs, Artificial intelligence, MIAMI, Huntington Bancshares, Société Générale, Societe Generale bank Montenegro, Morgan, Lewis & Bockius, Water, Sustainable finance, ESG, Security (finance), Renewable energy

The SLL will fuel data center expansion projects that embody sustainable designs and implement infrastructural measures to support the reduction of power usage effectiveness ("PUE") levels across Netrality's portfolio.

Key Points: 
  • The SLL will fuel data center expansion projects that embody sustainable designs and implement infrastructural measures to support the reduction of power usage effectiveness ("PUE") levels across Netrality's portfolio.
  • The SLL is comprised of a $125 million initial term loan, a $145 million revolving credit facility, and a $110 million delayed draw term loan.
  • "TD Securities was pleased to support Netrality as a Sustainability Structuring Agent on the sustainability-linked credit facility.
  • Andrew Weisberg, Kerrick Seay, and Chiara Eramo of White & Case LLP, represented Netrality Data Centers in the transaction.