Lenalidomide

Beactica Therapeutics appoints Jarl Ulf Jungnelius M.D. to its Board of Directors as it advances towards clinical-stage activities

Retrieved on: 
Monday, June 19, 2023
Bachelor of Science in Human Biology, Sweden, Takeda, Sunitinib, Lenalidomide, Research, Development, Eli Lilly and Company, Karolinska Institute, Therapy, Pfizer, Pharmaceutical industry, Celgene

STOCKHOLM, June 19, 2023 /PRNewswire/ -- Beactica Therapeutics AB, the Swedish precision oncology company, today announced the appointment of Jarl Ulf Jungnelius M.D.

Key Points: 
  • STOCKHOLM, June 19, 2023 /PRNewswire/ -- Beactica Therapeutics AB, the Swedish precision oncology company, today announced the appointment of Jarl Ulf Jungnelius M.D.
  • The appointment marks another step in Beactica's strategic plan to become a clinical-stage company.
  • "We are delighted to welcome Jarl Ulf Jungnelius to the Board of Beactica Therapeutics," said Dr Per Källblad, CEO of Beactica Therapeutics.
  • "His extensive experience in the corporate clinical development of life-changing oncology drugs will be valuable as Beactica accelerates its strategic plan to become a clinical-stage company."

Latest Data of InnoCare’s Orelabrutinib Presented at the 17th International Conference on Malignant Lymphoma (ICML)

Retrieved on: 
Friday, June 16, 2023
Oncology, Health, Other Science, Clinical Trials, Science, Pharmaceutical, Biotechnology, Rituximab, IRC, Independent Review Committee, POLARIS, Classification, Progression-free survival, ICML, Lymphoma, Lenalidomide, BTK, PFS, SSE, HKEX, International Conference on Population and Development, Dor, Patient, MCL, Hospital, Abstract, Conference, ORR, Safety, Fine chemical, Pharmaceutical industry

InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company, today announced the latest clinical data of its Bruton Tyrosine Kinase (BTK) inhibitor orelabrutinib at the 17th International Conference on Malignant Lymphoma (ICML).

Key Points: 
  • InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company, today announced the latest clinical data of its Bruton Tyrosine Kinase (BTK) inhibitor orelabrutinib at the 17th International Conference on Malignant Lymphoma (ICML).
  • Among the enrolled Chinese patients, the majority had late-stage diseases, with the stage IV accounting for 75.9%.
  • The 12-month PFS rate was 84.3% and the rate of overall survival (OS) was 91.5% at 12 months.
  • The preliminary data indicated that the orelabrutinib plus lenalidomide and rituximab exerted synergistic antitumor activity, with a good safety profile in the treatment of MCL.

BeiGene Highlights Significant BRUKINSA® (zanubrutinib) Data at the 17th International Conference on Malignant Lymphoma

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Thursday, June 15, 2023
Biotechnology, Health, Science, Research, Oncology, Neutropenia, SEQUOIA, Rituximab, Obinutuzumab, Lymphocytosis, BGNE, Progression-free survival, Lymphoid leukemia, Atrial fibrillation, ICML, Lymphoma, Lenalidomide, Multimedia, Petechia, BTK, PFS, EMA, MRD, Acalabrutinib, SSE, International Conference on Population and Development, Patient, CEST, Lower respiratory tract infection, Bone marrow, Fever, Recurrence, Abstract, Thrombocytopenia, Conference, Pharmaceutical industry, Hematology, BeiGene

BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced that it will present data on its Bruton’s tyrosine kinase inhibitor (BTKi) BRUKINSA® (zanubrutinib) at the 17th International Conference on Malignant Lymphoma (ICML), which is taking place from June 13-17 in Lugano, Switzerland.

Key Points: 
  • BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced that it will present data on its Bruton’s tyrosine kinase inhibitor (BTKi) BRUKINSA® (zanubrutinib) at the 17th International Conference on Malignant Lymphoma (ICML), which is taking place from June 13-17 in Lugano, Switzerland.
  • View the full release here: https://www.businesswire.com/news/home/20230615000227/en/
    BeiGene Highlights Significant BRUKINSA® (zanubrutinib) Data at the 17th International Conference on Malignant Lymphoma - Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene (Photo: Business Wire)
    “The data presented at ICML provide further evidence supporting our confidence in BRUKINSA.
  • The complete response rate for BRUKINSA in combination with obinutuzumab was 39.3% compared to 19.4% for obinutuzumab alone.
  • The most common grade ≥3 adverse events were neutropenia (23.1%), thrombocytopenia (7.7%), lung infection (5.8%) (Abstract #153)

FDA Approves Genentech’s Columvi, the First and Only Bispecific Antibody With a Fixed-Duration Treatment for People With Relapsed or Refractory Diffuse Large B-cell Lymphoma

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Friday, June 16, 2023
Research, FDA, Stem Cells, Biotechnology, Health, Pharmaceutical, General Health, Science, Oncology, DSM-IV codes, Rituximab, The New England Journal of Medicine, Polatuzumab vedotin, GemOx, Follicular lymphoma, Solar cycle 1, CRS, DLBCL, Oxaliplatin, OR, Lenalidomide, Aes, Cancer, Advanced Therapy Medicinal Product, B-cell lymphoma, Rash, ROG, RO, Aggressive lymphoma, CAR, HIV disease progression rates, Cytokine release syndrome, Patient, Risk, CR, European Medicines Agency, Phase, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Fatigue, Roche, Pharmaceutical industry, Genentech, Mosunetuzumab

This indication is approved under accelerated approval based on response rate and durability of response in the Phase I/II NP30179 study.

Key Points: 
  • This indication is approved under accelerated approval based on response rate and durability of response in the Phase I/II NP30179 study.
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
  • While many people with DLBCL are responsive to treatment, the majority of those who relapse or are refractory to subsequent treatments have poor outcomes.
  • Columvi is the first and only CD20xCD3 T-cell engaging bispecific antibody for the treatment of R/R DLBCL that is given for a defined period of time.

Enterome's new OncoMimics™ immunotherapy, EO2463, demonstrates early efficacy and favorable safety in Phase 1/2 trial for indolent non-Hodgkin lymphoma

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Wednesday, June 14, 2023
Molecular mimicry, Rituximab, CD20, ICML, Lenalidomide, Lymphoma, CD268, CD22, Adrenal tumor, Immunotherapy, Glioblastoma, Trial of the century, Protein, CD8, Asilomar International Conference on Climate Intervention Technologies, Patient, Standard of care, Colorectal cancer, Epitope, Neoplasm, Poster, Lymphocyte, CD37, Safety, BAFF, UCP2, Conference, Peptide, Inflammation, Vaccine, Pharmaceutical industry

EO2463 is an innovative, off-the-shelf immunotherapy candidate that combines four synthetic OncoMimic™ peptides.

Key Points: 
  • EO2463 is an innovative, off-the-shelf immunotherapy candidate that combines four synthetic OncoMimic™ peptides.
  • These non-self, microbial-derived peptides correspond to CD8 HLA-A2 epitopes that exhibit molecular mimicry with the B lymphocyte-specific lineage markers CD20, CD22, CD37 and CD268 (BAFF receptor).
  • The unique ability of EO2463 immunotherapy to selectively target multiple B cell markers enables the destruction of malignant B lymphocytes that are abundant in iNHL.
  • We are also preparing to enter another new OncoMimics™ candidate, EO4010, for the treatment of metastatic colorectal cancer, into clinical development.”

Starton Therapeutics Receives Authorization from the FDA to Proceed with STAR-LLD Lenalidomide Phase 1b Clinical Trial in Multiple Myeloma

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Monday, June 12, 2023
Research, FDA, Clinical Trials, Cardiology, Biotechnology, Health, Pharmaceutical, Science, Oncology, Multiple myeloma, Lenalidomide, Quality of life, Multimedia, Biomarker, Dexamethasone, Malignancy, Patient, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Safety, Pharmaceutical industry

Starton Therapeutics Inc. (“Starton” or “the Company”), a clinical stage biotechnology company focused on transforming standard-of-care therapies with proprietary continuous delivery technology, today provided updates on its Phase 1b STAR-LLD clinical trial of its investigational continuous delivery lenalidomide in multiple myeloma.

Key Points: 
  • Starton Therapeutics Inc. (“Starton” or “the Company”), a clinical stage biotechnology company focused on transforming standard-of-care therapies with proprietary continuous delivery technology, today provided updates on its Phase 1b STAR-LLD clinical trial of its investigational continuous delivery lenalidomide in multiple myeloma.
  • View the full release here: https://www.businesswire.com/news/home/20230612747752/en/
    The U.S. Food and Drug Administration (“FDA”) notified the Company that it may proceed with the U.S.-based program in second-line transplant-ineligible patients using the combination of STAR-LLD, Velcade, and dexamethasone.
  • The upcoming Phase 1b clinical study in multiple myeloma is on track to begin enrollment in Q4 2023.
  • Please see "Additional Information and Where to Find It" below for additional information related to the proposed business combination.

Salarius Pharmaceuticals Presents SP-3164 Targeted Protein Degrader Preclinical Data at the European Hematology Association 2023 Hybrid Congress

Retrieved on: 
Monday, June 12, 2023
European Hematology Association, Lenalidomide, Bone marrow, Dose, PBMC, Protein, Investigational New Drug, Patient, Knowledge, Poster, Research, Regulation of tobacco by the U.S. Food and Drug Administration, Conference, Food, Vaccine, Salinicola salarius

SP-3164 does not negatively impact PBMC at clinically relevant concentrations up to 96 hours post-treatment.

Key Points: 
  • SP-3164 does not negatively impact PBMC at clinically relevant concentrations up to 96 hours post-treatment.
  • In addition to having direct antitumor effects, SP-3164 also induces an anticancer immunomodulatory effect as demonstrated through the induction of cytokine secretion in human T cells following treatment.
  • We plan to begin a Phase 1 study in the second half of the year,” said David Arthur, president and chief executive officer of Salarius.
  • “Our first therapeutic target is blood cancer, and we are excited to embark on a potential new treatment option for these patients.”

Janssen Submits Supplemental Biologics License Application to U.S. FDA Seeking Approval of CARVYKTI® for the Earlier Treatment of Patients with Relapsed or Refractory Multiple Myeloma

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Tuesday, June 6, 2023
S100, Progression-free survival, DPD, Multiple myeloma, Lenalidomide, Janssen, PVD, PFS, Dexamethasone, ASCO, Bortezomib, American Society of Clinical Oncology, Patient, Janssen Pharmaceuticals, EHA, Annual general meeting, Johnson & Johnson, Daratumumab, FDA, Abstract, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Society, Food, Safety, Medical imaging, Pharmaceutical industry

RARITAN, N.J., June 6, 2023 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of a new indication for CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor, an immunomodulatory agent, and are refractory to lenalidomide.

Key Points: 
  • The application is supported by data from the CARTITUDE-4 study ( NCT04181827 ), the first randomized Phase 3 study evaluating the efficacy and safety of CARVYKTI® versus pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) in the treatment of patients with relapsed or lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy.
  • "We are focused on advancing CARVYKTI® in the treatment of multiple myeloma, including for patients with relapsed or refractory disease, where we hope to intervene earlier with the goal of transforming outcomes for patients," said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC.
  • "We look forward to collaborating with the FDA on the review of this application and continuing to bring CARVYKTI® to patients who are candidates for this CAR-T therapy."
  • The secondary endpoints were safety, overall survival, minimal residual disease negative rate and overall response rate.

Ciltacabtagene Autoleucel (cilta-cel) Reduced Risk of Disease Progression or Death by 74% vs Standard Regimens for Adult Patients with Relapsed and Refractory Multiple Myeloma in CARTITUDE-4 Study

Retrieved on: 
Monday, June 5, 2023
Biotechnology, Pharmaceutical, Health, Oncology, Multiple myeloma, CI, Lenalidomide, HIV disease progression rates, Death, Patient, Hazard, Risk, Pharmaceutical industry

Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS), including fatal and life-threatening reactions, occurred in patients following treatment with CARVYKTI®.

Key Points: 
  • Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS), including fatal and life-threatening reactions, occurred in patients following treatment with CARVYKTI®.
  • CARVYKTI® is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the CARVYKTI® REMS Program.
  • Cytokine Release Syndrome (CRS) including fatal or life-threatening reactions, occurred following treatment with CARVYKTI® in 95% (92/97) of patients receiving ciltacabtagene autoleucel.
  • Grade 3 or higher CRS (2019 ASTCT grade) occurred in 5% (5/97) of patients, with Grade 5 CRS reported in 1 patient.

AMGEN PRESENTS NEW SCIENTIFIC AND CLINICAL RESEARCH ACROSS ITS DIVERSE ONCOLOGY PORTFOLIO AND PIPELINE AT ASCO 2023

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Thursday, June 1, 2023
AMGN, KRAS, Amgen, KID, Osteoporosis, Research and development, Plasma, RAS, Patient, Panitumumab, Blinatumomab, Myelodysplastic syndrome, Carcinoma, CT, Bi-specific T-cell engager, Multiple myeloma, Panama, Lenalidomide, Lung cancer, MRD, Heath Robinson (codebreaking machine), Inotuzumab ozogamicin, Docetaxel, Abstract, Metastasis, RCT, Cancer, Carfilzomib, NSCLC, Denosumab, Sarcoma, Colorectal cancer, Biomarker, Busulfan, Neoplasm, Pembrolizumab, CRC, Dexamethasone, SCLC, ASCO, Talimogene laherparepvec, American Society of Clinical Oncology, ASCT, Melanoma, Annual general meeting, CDT, Melphalan, Society, Pharmaceutical industry, Medical imaging, Communications satellite, Flour, Glass wool, Vaccine, Nursing, Book, Takeda, Allotransplantation, Research

THOUSAND OAKS, Calif., June 1, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the presentation of new scientific and clinical research across its diverse oncology portfolio and pipeline at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from June 2-6 in Chicago. More than 25 abstracts from Amgen-sponsored and collaborative studies, including three oral presentations and two poster discussions, will feature data in hard-to-treat tumor types, including non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and small cell lung cancer (SCLC).

Key Points: 
  • Additional Analyses from DeLLphi-300 Highlight Safety and Clinical Efficacy of Tarlatamab, an Investigational First-in-Class BiTE® Immunotherapy, in Patients with SCLC With Treated and Stable Brain Metastases
    THOUSAND OAKS, Calif., June 1, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the presentation of new scientific and clinical research across its diverse oncology portfolio and pipeline at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from June 2-6 in Chicago.
  • More than 25 abstracts from Amgen-sponsored and collaborative studies, including three oral presentations and two poster discussions, will feature data in hard-to-treat tumor types, including non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and small cell lung cancer (SCLC).
  • "Our presentations at ASCO will illustrate how we're advancing novel approaches to address the toughest thoracic and colorectal cancers with limited treatment options," said David M. Reese, M.D., executive vice president of Research and Development at Amgen.
  • "We're focused on expanding the reach and impact of our transformative, first-in-class medicines to help more people living with cancer."