Salvage therapy

MEI Pharma Reports Update from Clinical Study Evaluating Oral CDK9 Inhibitor Voruciclib in Combination with Venetoclax in Patients with Relapsed and Refractory Acute Myeloid Leukemia

Retrieved on: 
Tuesday, March 26, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Toxicity, Aplastic anemia, Salvage therapy, CLL, AML, CRi, Patient, Venetoclax, Biomarker, Diarrhea, BCL2, University, Acute myeloid leukemia, ELN, Safety, Pharmacokinetics, CDK9, Phase 1, Associate professor, Pharmaceutical industry

The study is currently enrolling a 12-patient expansion cohort evaluating voruciclib administered at 300 mg daily for two weeks in a four-week cycle in combination with venetoclax.

Key Points: 
  • The study is currently enrolling a 12-patient expansion cohort evaluating voruciclib administered at 300 mg daily for two weeks in a four-week cycle in combination with venetoclax.
  • A total of 29 patients with R/R AML, median age 67 years (range 34-89), enrolled in the dose escalation stage of the study evaluating voruciclib in combination with venetoclax.
  • The primary objectives of the study are to determine the safety and biologic effective dose of voruciclib monotherapy or voruciclib in combination with venetoclax.
  • Secondary objectives of the study include assessing the preliminary efficacy, pharmacokinetics, pharmacodynamics, and biomarkers of voruciclib monotherapy or voruciclib in combination with venetoclax.

American Urological Association Releases Salvage Therapy for Prostate Cancer Guideline

Retrieved on: 
Thursday, February 29, 2024
Therapy, Recurrence, Salvage therapy, Prostate cancer, Professor, ASTRO, Quality of life, Metastasis, Patient, Radiation, Risk, Society, University, AUA, SUO, Guideline, MPH, American Urological Association, Radiation therapy, Panel, Partnership, Medical imaging

BALTIMORE, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Today, the American Urological Association (AUA), in partnership with the American Society for Radiation Oncology (ASTRO) and the Society of Urologic Oncology (SUO), released the 2024 clinical practice guideline on salvage therapy for prostate cancer.

Key Points: 
  • BALTIMORE, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Today, the American Urological Association (AUA), in partnership with the American Society for Radiation Oncology (ASTRO) and the Society of Urologic Oncology (SUO), released the 2024 clinical practice guideline on salvage therapy for prostate cancer.
  • Understanding the evaluation and appropriate use of salvage therapies for patients with biochemical recurrence is a critical area of prostate cancer care.
  • “Thanks to the incredible expertise of the entire Panel, this guideline helps provide a roadmap that combines the latest advancements with thoughtful recommendations, empowering patients and clinicians alike.”
    This guideline has 30 recommendations and is a useful reference for effective evidence-based care related to salvage therapy for prostate cancer.
  • Salvage therapy for prostate cancer: AUA/ASTRO/SUO guideline part I: introduction and treatment decision-making at the time of suspected biochemical recurrence after radical prostatectomy.

Blue Earth Diagnostics Highlights Clinical Utility of POSLUMA® (Flotufolastat F 18) PET and Post-scan Changes in Management in Patients with Suspected Recurrence of Prostate Cancer at ASCO GU

Retrieved on: 
Thursday, January 25, 2024
Neurology, Radiology, Biotechnology, Pharmaceutical, Oncology, Health, Health Technology, Clinical Trials, Radiopharmaceutical, Patient, Prostate cancer, F 18, Multimedia, ASCO, PET, Recurrence, Metastasis, PSA, Disease, Salvage therapy, FDA, PSMA, PET/CT, Physician, Medical imaging

The sub-analysis assessed the impact of POSLUMA on treatment plans for patients with recurrent prostate cancer after curative-intent primary therapy.

Key Points: 
  • The sub-analysis assessed the impact of POSLUMA on treatment plans for patients with recurrent prostate cancer after curative-intent primary therapy.
  • View the full release here: https://www.businesswire.com/news/home/20240125625091/en/
    POSLUMA® (flotufolastat F 18) PET/CT image showing uptake in the prostate bed, consistent with recurrent prostate cancer.
  • Photo courtesy of Blue Earth Diagnostics
    Flotufolastat F 18 PET imaging was positive for recurrent prostate cancer in 84% (81/97) of patients in the sub-analysis.
  • In 89% (86/97) of patients, management plans were changed following review of the flotufolastat F 18 PET scan results.

NeuExcell's AAV Gene Therapy for Malignant Glioma Granted Orphan Drug Designation by FDA

Retrieved on: 
Monday, December 18, 2023
Huntington's disease, Glioma, Safety, ATN, Food, ODD, Glioblastoma, GBM, Clinical trial, Mortality, Patient, Multimedia, Radiation, FDA, Alzheimer's disease, Survival rate, Stroke, Health, Salvage therapy, Recurrence, Survival, Quality of life, AAV, Pharmaceutical industry, ALS

PHILADELPHIA, Dec. 18, 2023 /PRNewswire/ -- On December 7, 2023, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation ("ODD") to NXL-004, an investigational AAV gene therapy product being developed by NeuExcell Therapeutics Inc. ("NeuExcell"), for the treatment of malignant glioma.

Key Points: 
  • PHILADELPHIA, Dec. 18, 2023 /PRNewswire/ -- On December 7, 2023, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation ("ODD") to NXL-004, an investigational AAV gene therapy product being developed by NeuExcell Therapeutics Inc. ("NeuExcell"), for the treatment of malignant glioma.
  • This is the world's first AAV gene therapy product for malignant glioma to receive FDA ODD designation.
  • Malignant gliomas are the most common primary malignant brain tumors in adults, about 60% of which are glioblastoma (GBM).
  • Recurrence is virtually inevitable for malignant glioma and there is no clear standard salvage therapy.

PHAXIAM Therapeutics announces high coverage performance of its two anti-Staphylococcus aureus phages over clinical strains

Retrieved on: 
Monday, October 9, 2023
IVD, Salvage therapy, PST, CEST, Therapy, Phage therapy, AAC, Staphylococcus aureus, Medical device, Pharmaceutical industry

A retrospective analysis was carried out with 105 clinical Staphylococcus aureus strains which were tested using PHAXIAM’s phagogram in the context of clinical trials, salvage therapy and early access program (AAC).

Key Points: 
  • A retrospective analysis was carried out with 105 clinical Staphylococcus aureus strains which were tested using PHAXIAM’s phagogram in the context of clinical trials, salvage therapy and early access program (AAC).
  • The results demonstrated that 98% of these pathogenic S. aureus strains were susceptible to at least one of the two PHAXIAM’s anti-S. aureus phages (PP1493 and PP1815).
  • Phagogram is an in vitro diagnostic (IVD) test designed to determine the in-vitro activity of PHAXIAM’s phages to patients’ bacterial strains.
  • The 98% spectrum of activity of our anti-S. aureus phages is exceptionally high when compared with other competing solutions.

Ocean Biomedical Announces Newly Published Findings Demonstrating Ability to Restore Treatment Sensitivity to AstraZeneca’s Leading Lung Cancer Drug After Resistance Has Formed, and Enhanced Tumor Suppression in EGFR-Mutation Lung Cancers

Retrieved on: 
Tuesday, October 3, 2023
Yale University, BioRxiv, RI, FRG, Osimertinib, Lung cancer, TUNEL, TKI, Research, Targeted therapy of lung cancer, Cell, Immunotherapy, AstraZeneca, Glioblastoma, Preprint, Gefitinib, Patient, EGFR, Growth, Neoplasm, Salvage therapy, Pharmaceutical industry, Vaccine, Dietary supplement, Medical imaging, Ocean Biomedical, CHI3L1, NSCLC, Cancer

Providence, RI, Oct. 03, 2023 (GLOBE NEWSWIRE) -- Ocean Biomedical, Inc. (NASDAQ: OCEA) announced today that its cancer-targeting immunotherapy antibody candidate has demonstrated effective tumor reduction against an aggressive subset of Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) mutations. These research findings, which may be the most important Ocean Biomedical has announced to date, generated by Ocean’s Scientific Co-founder Dr. Jack A. Elias and colleagues from Yale University and Brown University, and first published as a preprint last week in bioRxiv, are the first to uncover the role of Chitinase 3-like-1 (CHI3L1) in the pathogenesis of EGFR-mutant cancers, with potential applications not just in NSCLC, but in all EGFR-mutant cancers, including glioblastoma and colon cancer.

Key Points: 
  • Additionally, the findings demonstrate a stunning ability to restore therapeutic sensitivity to current tyrosine kinase inhibitor (TKI) therapies after resistance sets in, including the third-generation TKI, Osimertinib (marketed as Tagrisso by AstraZeneca).
  • In 2022, AstraZeneca’s top pharmaceutical product by revenue was Tagrisso, a medication used in the treatment of non-small-cell lung carcinomas.
  • Non-Small Cell Lung Cancer (NSCLC) is a leading cause of cancer deaths globally, accounting for 85% of all lung cancers.
  • The EGFR-mutant lung cancer is found in 30%-50% of NSCLC patients with Asian heritage and 10%-20% of patients with Caucasian backgrounds.

NexImmune Presents Initial Positive Data from the NEXI-001 Phase 1 Trial for Relapsed/Refractory Post Allo-HSCT AML at the American Society of Clinical Oncology 2023 Annual Meeting

Retrieved on: 
Monday, June 5, 2023
Ohio State University, Antigen, Nanoparticle, AIM, MI, Solar cycle 1, CRS, American Society of Clinical Oncology, Clinical trial, DLT, Cancer, Bone marrow, Transplant, BMT, Chimera, Immunotherapy, Associate, Pleural effusion, Trial of the century, Șaeș, Acute myeloid leukemia, ASCO, City of Hope National Medical Center, AML, City, Influenza, MD, Patient, ECOG, Blood, Internal medicine, NEXI, PET/CT, Periodic breathing, Countersurveillance, Poster, Neoplasm, Phenotype, Society, Memory, Safety, Salvage therapy, Vaccine, Pharmaceutical industry, Medical imaging, Hematology

GAITHERSBURG, Md., June 05, 2023 (GLOBE NEWSWIRE) -- NexImmune, Inc. (Nasdaq: NEXI), a biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells for liquid and solid malignancies, today announced results from its Phase 1/2 clinical trial of NEXI-001 in patients with relapsed/refractory acute myeloid leukemia (AML) post-allogeneic hemopoietic stem cell transplant (allo-HSCT). In this clinical trial to date, NEXI-001 is well tolerated with a favorable safety profile while eliciting an immune response to target antigens and a clinical effect in some patients. The data describing two patients from the dose escalation study of NEXI-001 are being presented in a poster session at the American Society of Clinical Oncology (ASCO) 2023 Annual Meeting in Chicago on Monday, June 5 at 8 AM in Hall A.

Key Points: 
  • “We have seen a clinical response maintained for seven months, which is an additional update from the data reported in our poster.
  • These data have established the ability of our AIM nanoparticles to expand healthy, multi-antigen-specific T cells with anti-tumor activity.
  • The data also show these T cells persist and maintain their memory phenotype at the site of tumor.
  • These data indicating both immunologic and clinical dose responses and observed durability in the patient at the higher dose support further clinical study of NEXI-001.

SCYNEXIS Announces First Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, May 11, 2023
Workforce, GSK, FURI, Medical Affairs Bureau, Candidiasis, Partnership, SG, General Administration of Sport of China, Biotechnology, Voriconazole, Tablet, End-user license agreement, Congress, GSK plc, Antimalarial medication, ECCMID, Investment, Patient, European, License, Commercial, Research, Fluconazole, Infection, Safety, Salvage therapy, Pharmaceutical industry, Beauty salon

JERSEY CITY, N.J., May 11, 2023 (GLOBE NEWSWIRE) -- (NASDAQ: SCYX ), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced financial results for the first quarter ended March 31, 2023.

Key Points: 
  • JERSEY CITY, N.J., May 11, 2023 (GLOBE NEWSWIRE) -- (NASDAQ: SCYX ), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced financial results for the first quarter ended March 31, 2023.
  • On March 30, 2023, SCYNEXIS announced that the Company has entered into an exclusive agreement with GSK to commercialize and further develop BREXAFEMME® (ibrexafungerp tablets) for all indications.
  • BREXAFEMME net sales were $1.1 million in first quarter 2023 and $0.7 million in Q1 2022.
  • Cash, cash equivalents and short-term investments totaled $54.8 million on March 31, 2023, compared to $73.5 million on December 31, 2022.

Bristol Myers Squibb Receives European Commission Approval for CAR T Cell Therapy Breyanzi (lisocabtagene maraleucel) for Relapsed or Refractory Large B-cell Lymphoma After One Prior Therapy

Retrieved on: 
Wednesday, May 3, 2023
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, PMBCL, Bristol Myers Squibb, Civil service commission, Progression-free survival, Hematology, Non-Hodgkin lymphoma, HSCT, Haematopoietic system, PFS, B-cell lymphoma, BMY, CAR, Patient, Cell, EFS, EC, NYSE, European Commission, Salvage therapy, Disease, Pharmaceutical industry, EU, DLBCL

“With Breyanzi, people in Europe living with relapsed or refractory DLBCL now have a differentiated CAR T cell therapy option earlier in the treatment paradigm that provides long-term clinical benefit,” said Anne Kerber, senior vice president, head of Cell Therapy Development, Bristol Myers Squibb.

Key Points: 
  • “With Breyanzi, people in Europe living with relapsed or refractory DLBCL now have a differentiated CAR T cell therapy option earlier in the treatment paradigm that provides long-term clinical benefit,” said Anne Kerber, senior vice president, head of Cell Therapy Development, Bristol Myers Squibb.
  • With Breyanzi, the majority (73.9%) of patients achieved a CR compared to less than half (43.5%) of those who were treated with standard therapy.
  • Any-grade CRS was reported in less than half of patients (48.9%), with Grade 3 CRS reported in 1% of patients.
  • Any-grade neurologic events were reported in 10.9% of patients treated with Breyanzi, with Grade 3 neurologic events reported in 4.3% of patients.

Wugen Presents New Preclinical Data Reinforcing Anti-Tumor Functionality of WU-NK-101 at the American Association for Cancer Research (AACR) Annual Meeting 2023

Retrieved on: 
Wednesday, April 19, 2023
Science, Stem Cells, Biotechnology, Research, Pharmaceutical, Oncology, Health, Clinical Trials, AACR, CPI, CIML, FRSB, MHC, American Association for Cancer Research, NK, Cell, Antibody, AML, Patient, Royal College of Pathologists, Colorectal cancer, TME, CTL, Nottingham Trent University, Immunosuppression, Phenotype, Tumor microenvironment, PD-L1, Salvage therapy, Vaccine, Medicinal plants

“These data build on the growing body of evidence demonstrating the broad, powerful immuno-oncological applications of WU-NK-101,” said Kumar Srinivasan, Ph.D., M.B.A., President and Chief Executive Officer of Wugen.

Key Points: 
  • “These data build on the growing body of evidence demonstrating the broad, powerful immuno-oncological applications of WU-NK-101,” said Kumar Srinivasan, Ph.D., M.B.A., President and Chief Executive Officer of Wugen.
  • PD-L1 and MHC-I checkpoint upregulation by WU-NK-101 was confirmed in in vitro and in vivo solid tumor models.
  • In in vitro models, WU-NK-101 secreted factors augmented PD-L1 and MHC-I expression, with a dose-dependent increase observed.
  • In vivo xenograft models confirmed the efficacy of WU-NK-101 as a monotherapy and confirmed in vitro findings of increased checkpoint expression post-treatment.