Isatuximab

Press Release: Sarclisa® (isatuximab) plus KRd significantly improved rate of minimal residual disease negativity in transplant-eligible patients with newly diagnosed multiple myeloma versus KRd alone

Retrieved on: 
Monday, December 11, 2023
Isatuximab, ASCT, ITT, Associate, Bone marrow, EMN, MRD, Young, Multiple myeloma, Society, University of Turin, Lenalidomide, Odds ratio, ASH, University, Dexamethasone, NCAA University Division, AOU, Cell, Patient, Carfilzomib

The Phase 3 trial investigating Sarclisa® (isatuximab) in combination with carfilzomib, lenalidomide and dexamethasone (KRd) showed a statistically significant improvement in the rate of minimal residual disease (MRD) negativity, compared with KRd alone, after autologous stem cell transplant (ASCT) consolidation in transplant-eligible patients with newly diagnosed multiple myeloma (MM).

Key Points: 
  • The Phase 3 trial investigating Sarclisa® (isatuximab) in combination with carfilzomib, lenalidomide and dexamethasone (KRd) showed a statistically significant improvement in the rate of minimal residual disease (MRD) negativity, compared with KRd alone, after autologous stem cell transplant (ASCT) consolidation in transplant-eligible patients with newly diagnosed multiple myeloma (MM).
  • The respective rates of MRD negativity at sensitivity of 10-6 were 67% versus 48% (OR 1.93; p=0.006).
  • There was a statistically significant difference in MRD negativity rates after induction with Sarclisa in combination with KRd versus KRd (10-5: 45% versus 26%, p
  • Effective front-line treatment is critical for newly diagnosed patients, because achieving undetectable levels of disease early in the treatment journey may lead to better long-term outcomes.

Adaptive Biotechnologies and Collaborators to Present More than 30 Abstracts Demonstrating the Clinical Utility and Benefit of clonoSEQ® MRD Testing in Blood Cancer Patients at 2022 ASH Annual Meeting

Retrieved on: 
Monday, December 5, 2022
CLEP, Adaptation, Lymphatic system, LCI, VMP, B-ALL, Analysis, Research, Blood, Result, Diagnosis, Genetics, Multiple myeloma, Prednisone, FDA, IVD, CLL, Cancer, Bone marrow, LDT, B-cell lymphoma, Medicare, Drug development, Risk, MRD, Isatuximab, Biology, Autotransplantation, Initial, Skylark Group, ALL, Degenerative disease, DNA, Master, Melphalan, Chronic lymphocytic leukemia, Disease, MM, BCMA, Subgroup analysis, Durable, Physician, Conversation, Financial condition report, Acute lymphoblastic leukemia, Infection, Bortezomib, Vaccine, Medical imaging, Medical device, Dexamethasone, Lenalidomide, Carfilzomib, Patient, DLBCL

clonoSEQ testing for diffuse large B-cell lymphoma (DLBCL) patients is currently available for clinical use as a laboratory-developed test (LDT) performed at Adaptive's CLIA-certified lab in Seattle, WA.

Key Points: 
  • clonoSEQ testing for diffuse large B-cell lymphoma (DLBCL) patients is currently available for clinical use as a laboratory-developed test (LDT) performed at Adaptive's CLIA-certified lab in Seattle, WA.
  • clonoSEQ ctDNA-based MRD testing in DLBCL has also been approved by New York State's Clinical Laboratory Evaluation Program (CLEP).
  • The clonoSEQ Assay leverages Adaptive Biotechnologies’ proprietary immune medicine platform to identify and quantify specific DNA sequences found in malignant cells, allowing clinicians to assess and monitor MRD during and after treatment.
  • Our commercial products and clinical pipeline enable the diagnosis, monitoring, and treatment of diseases such as cancer, autoimmune disorders, and infectious diseases.

Cytovia Therapeutics presents antitumor activity of its CD38-Targeting Flex-NK™ Cell Engager antibody at EHA 2022 Congress

Retrieved on: 
Friday, June 10, 2022
European Hematology Association, Survival, Business, Multiple myeloma, Tripura Merger Agreement, GMP, Multimedia, Sale, Cellectis, HCC, Technology, Isatuximab, Antibody, Cancer, Cytolysis, Name, TALEN, INSERM, Cornerstone, Form, Pharmacokinetics, Ink, Forward-looking statement, Partnership, Laboratory, Securities & Exchange Commission of Pakistan, Communication, Daratumumab, Central Avenue, U.S. Securities and Exchange Commission, CD38, Business architecture, Annual report, Proxy, Glioblastoma, Cell adhesion, Plan, Patient, EHA, FLEX, SEC, MM, Research, LLC, NK, Lymphatic system, UCSF, Therapy, FDA, Prospectus, Myelocyte, NASDAQ, Clinical trial, Person, ADP, Congress, Vaccine, Fine chemical, Security (finance), Ownership, NCR1, Isleworth

AVENTURA, Fla. and NATICK, Mass., June 10, 2022 /PRNewswire/ -- Cytovia Therapeutics, Inc., a biopharmaceutical company empowering natural killer (NK) cells to fight cancer through stem cell engineering and multispecific antibodies, announced today that the novel data it is presenting at the European Hematology Association's annual congress in Vienna, Austria on June 10th, 2022 is now available on both the EHA and Cytovia websites.

Key Points: 
  • CYT-338 showed greater dose dependent NK cell redirected cytolysis, degranulation, and cytokine production against MM1S cells compared to daratumumab.
  • CYT-338 showed minimal immune subset depletion, NK cell fratricide, and cytokine release compared to daratumumab in vitro.
  • Cytovia Therapeutics aims to accelerate patient access to transformational cell therapies and immunotherapies, addressing several of the most challenging unmet medical needs in cancer.
  • Cytovia focuses on harnessing the innate immune system by developing complementary and disruptive NK-cell and NK-engager antibody platforms.

Cytovia Therapeutics to Present In Vivo Multiple Myeloma Data of its CD38-Targeting Flex-NK™ Cell Engager at EHA 2022 Congress

Retrieved on: 
Wednesday, May 18, 2022
Form, CD38, Congress Center, EHA, Cytolysis, UCSF, Tripura Merger Agreement, SEC, LLC, Cancer, Laboratory, Annual report, HCC, Daratumumab, ADP, FLEX, Therapy, Clinical trial, Research, NK, Cellectis, Proxy, Name, Central Avenue, Acquisition, Securities & Exchange Commission of Pakistan, Prospectus, Business, Lymphatic system, Ink, Myelocyte, U.S. Securities and Exchange Commission, TALEN, Multimedia, NCR1, Cornerstone, FDA, Partnership, INSERM, Communication, Isatuximab, Business architecture, Congress, Multiple myeloma, Cell adhesion, Patient, NASDAQ, MM, Antibody, Forward-looking statement, Plan, Technology, Glioblastoma, Sale, Person, Vaccine, Security (finance), Isleworth, Ownership

These results suggest that the CYT-338 engager has a favorable NK cell engager profile for targeting CD38-expressing multiple myeloma distinct from daratumumab.

Key Points: 
  • These results suggest that the CYT-338 engager has a favorable NK cell engager profile for targeting CD38-expressing multiple myeloma distinct from daratumumab.
  • Cytovia Therapeutics is developing novel cell therapies and immunotherapies aimed at addressing solid and hematological tumors with significant unmet medical needs.
  • Cytovia Therapeutics is focusing on harnessing the innate immune system by developing complementary and disruptive NK-cell and NK-engager antibody platforms.
  • Headquartered inAventura, FL, Cytovia Therapeutics has research and development laboratories inNatick, MA, and a cell manufacturing facility inPuerto Rico.

Global NK Cell Therapies 2022: Insights into 80+ Companies and 100+ Pipeline Drugs - ResearchAndMarkets.com

Retrieved on: 
Friday, February 18, 2022
Research, Stem Cells, Other Health, Health, Pharmaceutical, General Health, Other Science, Science, Oncology, Chronic lymphocytic leukemia, ADCC, Cancer, Head, IPH2201, CD8, Merkel-cell carcinoma, Natural killer cell, Myelodysplastic syndrome, Immune system, Acute myeloid leukemia, NK-92, Hepatocellular carcinoma, GMP, Perforin, Therapy, Immortalised cell line, Cell, Glioblastoma, Phase II, ALECSAT, Sanofi, Isatuximab, Breast cancer, Multiple myeloma, TILS, Mergers and acquisitions, Squamous cell carcinoma, Infection, Antibody, CD122, Disease, Karolinska University Hospital, Nature, CD16, Lymphatic system, NK, Natural killer T cell, Hank, ANK, Pharmaceutical industry, Vaccine, Phase

This report provides comprehensive insights about 80+ companies and 100+ pipeline drugs in NK Cell therapy pipeline landscape.

Key Points: 
  • This report provides comprehensive insights about 80+ companies and 100+ pipeline drugs in NK Cell therapy pipeline landscape.
  • The companies and academics are working to assess challenges and seek opportunities that could influence NK Cell therapy R&D.
  • The therapies under development are focused on novel approaches to treat/improve NK Cell therapy.
  • How many emerging drugs are in mid-stage, and late-stage of development for the treatment of NK Cell therapy?

Sorrento Receives FDA Authorization to Start Phase 1 Clinical Trial of Proprietary, "Off-the-Shelf", Allogeneic anti-CD38 DAR-T (Dimeric Antigen Receptor-T) Cell Therapy to Treat Relapsed or Refractory Multiple Myeloma

Retrieved on: 
Monday, August 2, 2021
Life sciences, Branches of biology, Health sciences, Breakthrough therapy, Clusters of differentiation, Biotechnology, Orphan drugs, CD38, Multiple myeloma, Cell therapy, Isatuximab, Daratumumab

First allogeneic, off-the-shelf anti-CD38 DAR-T cell therapy cleared for Phase 1 clinical trial in Relapsed or Refractory Multiple Myeloma.

Key Points: 
  • First allogeneic, off-the-shelf anti-CD38 DAR-T cell therapy cleared for Phase 1 clinical trial in Relapsed or Refractory Multiple Myeloma.
  • CD38 DAR-T is the first allogeneic, off-the-shelf clinical-stage cellular therapy product candidate based on Sorrentos proprietary Dimeric Antigen Receptor (DAR) T cell platform.
  • SAN DIEGO, Aug. 02, 2021 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today announced that the FDA has authorized Sorrentos IND application for the Phase 1 clinical testing of its allogeneic anti-CD38 Dimeric Antigen Receptor (DAR) - T Cell therapy for relapsed or refractory multiple myeloma.
  • RTX has completed a Phase IB trial for intractable pain associated with cancer and a Phase 1B trial in osteoarthritis patients.

Janssen Announces U.S. FDA Approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in Combination with Pomalidomide and Dexamethasone for Patients with Multiple Myeloma After First or Subsequent Relapse

Retrieved on: 
Monday, July 12, 2021
Drugs, Health care, Orphan drugs, Medicine, Daratumumab, Multiple myeloma, CD38, Pomalidomide, Monoclonal antibody, AL amyloidosis, Amyloidosis, Isatuximab

The approval follows the regulatory submission to the FDA in November 2020 and marks the sixth indication for DARZALEX FASPROin the treatment of multiple myeloma.

Key Points: 
  • The approval follows the regulatory submission to the FDA in November 2020 and marks the sixth indication for DARZALEX FASPROin the treatment of multiple myeloma.
  • "Today's approval further distinguishes DARZALEX FASPRO in the treatment of multiple myeloma as the first and only subcutaneously administered anti-CD38 monoclonal antibody approved in combination with the widely used pomalidomide and dexamethasone regimen."
  • DARZALEX FASPRO is the only CD38-directed antibody approved to be given subcutaneously to treat patients with multiple myeloma and now AL amyloidosis.
  • Both systemic administration-related reactions, including severe or life-threatening reactions, and local injection-site reactions can occur with DARZALEX FASPRO.

Janssen Announces Results from Phase 3 MAIA Study Showing Significant Overall Survival Benefits for Treatment with DARZALEX® (daratumumab) in Patients with Newly Diagnosed Multiple Myeloma Who are Transplant Ineligible

Retrieved on: 
Saturday, June 12, 2021
Drugs, Health care, Orphan drugs, Daratumumab, Multiple myeloma, Lenalidomide, Bortezomib, Immunomodulatory imide drug, Dexamethasone, Daratumumab/hyaluronidase, Isatuximab

"These results strongly support the use of daratumumab, lenalidomide and dexamethasoneas a new standard of care to extend survival and improve clinical outcomes in transplant ineligible patients with newly diagnosed multiple myeloma."

Key Points: 
  • "These results strongly support the use of daratumumab, lenalidomide and dexamethasoneas a new standard of care to extend survival and improve clinical outcomes in transplant ineligible patients with newly diagnosed multiple myeloma."
  • Janssen is committed to exploring the potential of DARZALEX (daratumumab) for patients with multiple myeloma across the spectrum of the disease.
  • Overall Survival Results With Daratumumab, Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone in Transplant-ineligible Newly Diagnosed Multiple Myeloma: Phase 3 MAIA Study.
  • Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study.

Updated Data Demonstrate Significant Improvement in Hematologic Complete Response with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in Patients with Newly Diagnosed Light Chain (AL) Amyloidosis

Retrieved on: 
Wednesday, May 26, 2021
Drugs, Amyloidosis, Orphan drugs, Daratumumab/hyaluronidase, Protein folding, AL amyloidosis, Multiple myeloma, Daratumumab, CD38, Cyclophosphamide, Plasma cell dyscrasias, Isatuximab

The study includes 388 patients with newly diagnosed AL amyloidosis with measurable hematologic disease and one or more organs affected.

Key Points: 
  • The study includes 388 patients with newly diagnosed AL amyloidosis with measurable hematologic disease and one or more organs affected.
  • DARZALEX FASPRO is the only CD38-directed antibody approved to be given subcutaneously to treat patients with multiple myeloma and now AL amyloidosis.
  • DARZALEX FASPRO is indicated for the treatment of adult patients with multiple myeloma:
    DARZALEX FASPRO in combination with bortezomib, cyclophosphamide, and dexamethasone is indicated for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.
  • Light chain (AL) amyloidosis is a rare and potentially fatal hematologic disorder that can affect the function of multiple organs.

Genmab Announces that Janssen has Received Positive CHMP Opinion Recommending DARZALEX® (daratumumab) Subcutaneous (SC) Formulation for Patients with Newly Diagnosed Light-chain (AL) Amyloidosis

Retrieved on: 
Friday, May 21, 2021
Drugs, Orphan drugs, Combination drugs, Daratumumab/hyaluronidase, Monoclonal antibodies, Daratumumab, CD38, Hyaluronidase, Multiple myeloma, Genmab, Isatuximab

Janssen Pharmaceutica NV submitted Type II variation applications to the EMA for these indications in November 2020.

Key Points: 
  • Janssen Pharmaceutica NV submitted Type II variation applications to the EMA for these indications in November 2020.
  • Patients were randomized 1:1 to either receive daratumumab in combination with Pd or Pd alone.
  • In the original design of the study, patients in the daratumumab plus Pd arm were treated with the intravenous (IV) formulation of daratumumab.
  • DARZALEX\xc2\xae SC (daratumumab and hyaluronidase-fihj) is the first subcutaneous CD38 antibody approved in the Europe for the treatment of multiple myeloma.