Glioma

Janux Therapeutics Announces Positive Interim Clinical Data from Phase 1a Dose Escalation for PSMA-TRACTr JANX007 and an Update on Pipeline Programs

Retrieved on: 
Monday, July 17, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Glioma, CD28, CRS, Conference call, TCE, PSMA, Head, Breast, Prostate, Neck, Lung, Colon, Cytokine release syndrome, Patient, Plasma, EGFR, Colorectal cancer, Blood, Trichloroethylene, Therapy, PD-L1, PSA, Conference, Safety, Prostate cancer, Renal cell carcinoma, Vaccine, Medical imaging

“These data showing tumor-activated T cell engagement in patients with prostate cancer represent the first in-human data for the TRACTr platform and give us confidence for continuing clinical development of JANX007 and advancing future programs from this platform.

Key Points: 
  • “These data showing tumor-activated T cell engagement in patients with prostate cancer represent the first in-human data for the TRACTr platform and give us confidence for continuing clinical development of JANX007 and advancing future programs from this platform.
  • JANX007 has been dosed at 300µg flat dose, which is above the projected maximum tolerable dose of the parental T cell engagers.
  • JANX007 clinical development has moved into step-dosing and dose optimization with the goal to enhance efficacy while maintaining suitable safety results.
  • In addition to named programs, Janux is generating a number of unnamed TRACTr and TRACIr programs for potential future development.

HighField Biopharmaceuticals Announces First Patient Dosed in Phase 1b/2 Trial of HF1K16 for Recurrent and Refractory Glioma

Retrieved on: 
Monday, July 17, 2023
Biotechnology, General Health, Health, Pharmaceutical, Clinical Trials, Liposome, Glioma, Myelocyte, Glioblastoma, Myeloid-derived suppressor cell, American Society of Clinical Oncology, Clinical trial, Cancer, MDSC, Patient, ATRA, Diagnosis, Safety, Tumor microenvironment, B cell, Society, SD, Incidence, Vaccine, Medical imaging, Pharmaceutical industry

HighField Biopharmaceuticals (HighField Bio), a clinical stage immuno-oncology company using immunoliposomes to treat cancer, announced today the first patient has been dosed in a Phase 1b/2 trial of HF1K16 for recurrent and refractory glioma.

Key Points: 
  • HighField Biopharmaceuticals (HighField Bio), a clinical stage immuno-oncology company using immunoliposomes to treat cancer, announced today the first patient has been dosed in a Phase 1b/2 trial of HF1K16 for recurrent and refractory glioma.
  • “This clinical trial follows our analysis of interim data from a Phase 1a study in which three out of five glioma patients responded to the single agent treatment.
  • One achieved complete response (CR) and two more had stable disease (SD) diagnosis,” said Yuhong Xu, CEO of HighField Bio.
  • The patients with recurrent and refractory gliomas enrolled in HighField’s Phase 1b/2 trial have failed all other treatments.

Plus Therapeutics Reports Positive Interim Updates from Two ReSPECT™ Clinical Trials at SNMMI Annual Meeting

Retrieved on: 
Thursday, June 29, 2023
Glioma, Society, SNMMI, Ayub Ommaya, Safety, Cohort, Cerebrospinal fluid, Plus Therapeutics, MCI, ML, Patient, Risk, LM, PSTV, Decompression (diving), CSF, Neoplasm, Toxic leukoencephalopathy, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Conference, Food, Pharmaceutical industry, Vaccine, Medical imaging, OS, Rhenium

AUSTIN, Texas, June 29, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today reported positive interim updates from the ReSPECT-GBM and ReSPECT-LM clinical studies evaluating the Company’s lead radiotherapeutic, rhenium (186Re) obisbemeda, for the treatment of recurrent glioblastoma (rGBM) and leptomeningeal metastases (LM) at the Society of Nuclear Medicine & Molecular Imaging (SNMMI) Annual Meeting, which took place June 24-27, 2023 in Chicago, Illinois.

Key Points: 
  • A single dose of rhenium (186Re) obisbemeda was generally safe and well-tolerated, with no dose-limiting toxicities and minimal systemic radiation exposure.
  • The data demonstrates efficacy signals in a prognostically unfavorable patient population.
  • For each 10% increase in the Ratio of Treated to Total Tumor Volume, the risk of death decreases by 66.9% (p=0.002).
  • “As Phase 1 trials are designed for safety, statistically significant correlations between dose and overall survival are unusual.

The European Commission Grants Orphan Drug Designation to Temferon™ for Treatment of Glioma

Retrieved on: 
Thursday, June 29, 2023
Glioma, US Foods, Civil service commission, GBM, ODD, MGMT, Glioblastoma, Toxicity, Medicine, Stem cell, EMA, Patient, Immune system, Cancer, European, Orphan, Neoplasm, Food, European Commission, Pharmaceutical industry, EU

“European Medicine Agency’s Committee reviewed Genenta's ODD application for Temferon and agreed on the potential significant benefit that Temferon could contribute to patients suffering from GBM if approved.

Key Points: 
  • “European Medicine Agency’s Committee reviewed Genenta's ODD application for Temferon and agreed on the potential significant benefit that Temferon could contribute to patients suffering from GBM if approved.
  • The ODD designation supports and facilitates the development of our cell therapy-based technology platform for solid tumors,” said Pierluigi Paracchi, Chief Executive Officer at Genenta.
  • “The EMA ODD designation follows the orphan drug designation granted by the US Food and Drug Administration to Temferon for the treatment of GBM in March 2023.
  • GBM is the most common malignant primary brain tumor and the most aggressive diffuse glioma, with unmethylated MGMT promoter status identified in approximately 60% of the GBM population.

Erasca Granted FDA Orphan Drug Designation for CNS-Penetrant EGFR Inhibitor ERAS-801 for the Treatment of Malignant Glioma

Retrieved on: 
Thursday, June 22, 2023
Central nervous system, GBM, ODD, CNS, Glioblastoma, Patient, EGFR, SAN, FDA, Glioma, Pharmaceutical industry

SAN DIEGO, June 22, 2023 (GLOBE NEWSWIRE) -- Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, today announced the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ERAS-801 for the treatment of malignant glioma, which includes glioblastoma (GBM). ERAS-801 is an orally bioavailable, small molecule EGFR inhibitor that exhibited substantial central nervous system (CNS) penetration in preclinical animal studies.

Key Points: 
  • ERAS-801 is an orally bioavailable, small molecule EGFR inhibitor that exhibited substantial central nervous system (CNS) penetration in preclinical animal studies.
  • Per FDA regulations, ODD is granted by the FDA to investigational therapies addressing rare medical diseases or conditions affecting less than 200,000 people in the United States.
  • Orphan drug status provides benefits to drug developers, including assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees, and the potential for seven years of post-approval marketing exclusivity.
  • This ODD follows the earlier Fast Track Designation granted to ERAS-801 by the FDA and underscores the urgency of finding new treatments for this patient population.

Plus Therapeutics Announces Participation at Upcoming SNO Pediatric Conference and SNMMI Annual Meeting

Retrieved on: 
Thursday, June 8, 2023
Glioma, Society, SNMMI, SNO, Plus Therapeutics, LM, PSTV, Decompression (diving), Rhenium, Therapy, Conference, Pharmaceutical industry

AUSTIN, Texas, June 08, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV ) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced it will exhibit at both the Society for NeuroOncology’s (SNO) Pediatric Conference, taking place June 22-24, 2023 in Washington, D.C., and the Society of Nuclear Medicine & Molecular Imaging’s (SNMMI) Annual Meeting, taking place June 24-27, 2023 in Chicago, Illinois.

Key Points: 
  • AUSTIN, Texas, June 08, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV ) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced it will exhibit at both the Society for NeuroOncology’s (SNO) Pediatric Conference, taking place June 22-24, 2023 in Washington, D.C., and the Society of Nuclear Medicine & Molecular Imaging’s (SNMMI) Annual Meeting, taking place June 24-27, 2023 in Chicago, Illinois.
  • In addition, at the SNMMI Annual Meeting, Norman LaFrance, M.D., Chief Medical Officer, will present data from the ReSPECT-GBM and ReSPECT-LM clinical studies evaluating the Company’s lead radiotherapeutic, rhenium (186Re) obisbemeda, for the treatment of recurrent glioblastoma (rGBM) and leptomeningeal metastases (LM), respectively.
  • Details of SNMMI poster presentations:
    Nanoliposome) (186Re) Obisbemeda in Recurrent Glioma: The ReSPECT-GBM Trial [P988]

Janux Therapeutics Appoints Zachariah McIver, D.O., Ph.D., Vice President, Clinical Development

Retrieved on: 
Monday, June 5, 2023
Biotechnology, Pharmaceutical, Health, Oncology, Glioma, Tulane University School of Medicine, Cleveland Clinic, GVHD, Osteopathic medicine in the United States, University, Next Generation Science Standards, CD28, PSMA, Physician, Ohio University College of Arts and Sciences, American Society of Clinical Oncology, National Heart, Lung, and Blood Institute, Clinical and Translational Science Award, Drug, Head, Breast, Toxicity, Prostate, American Society of Hematology, Immunotherapy, Lung, Neck, Colon, NHLBI, Heritage College of Osteopathic Medicine, Wake Forest, Colorectal cancer, EGFR, Hematology, Wake Forest University School of Law, Renal cell carcinoma, American College of Physicians, American College, Cleveland, Therapy, Society, NIH, PD-L1, National Institutes of Health Clinical Center, Bone marrow, Pharmaceutical industry, Vaccine, Molecular medicine, Physics

Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, today announced the appointment of Dr. Zachariah (“Zach”) McIver as Vice President, Clinical Development.

Key Points: 
  • Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, today announced the appointment of Dr. Zachariah (“Zach”) McIver as Vice President, Clinical Development.
  • “Zach has extensive clinical research experience including leading the clinical development to maximize the value of bispecific T-cell engager assets across multiple hematologic and solid tumor malignancies,” said David Campbell, Ph.D., President and CEO of Janux Therapeutics.
  • “With TRACTr and TRACIr, Janux has built two very powerful platforms designed to overcome the toxicity and efficacy limitations of earlier generations of bispecific immunotherapies,” said Dr. McIver.
  • In addition to named programs, Janux is generating a number of unnamed TRACTr and TRACIr programs for potential future development.

Servier Presents Transformational Data from Pivotal Phase 3 INDIGO Trial of Vorasidenib in Recurrent or Residual Grade 2 IDH-Mutant Diffuse Glioma

Retrieved on: 
Sunday, June 4, 2023
Glioma, The New England Journal of Medicine, Malignancy, BIRC, INDIGO, Oligodendroglioma, Survival, Clinical trial, Enzyme, NDA, Drug, Mutation, Traffic barrier, Brain, PFS, Astrocytoma, ASCO, Patient, HR, Seizure, IDH, Memorial Sloan Kettering Cancer Center, Toxic encephalopathy, FDA, Society, Disease, Medical imaging, Pharmaceutical industry

BOSTON, June 4, 2023 /PRNewswire/ -- Servier, a leader in oncology committed to bringing innovative therapies to the patients we serve, today presented results from the pivotal Phase 3 INDIGO clinical trial investigating vorasidenib, an investigational, oral, selective, highly brain-penetrant dual inhibitor of mutant IDH1/2 enzymes in patients with residual or recurrent isocitrate dehydrogenase 1 or 2 (IDH1/2) mutant low-grade glioma who have been treated with surgery only. INDIGO succeeded in meeting its primary endpoint of progression free survival (PFS) per blinded independent review committee (BIRC) and key secondary endpoint of time to next intervention (TTNI) at the prespecified second interim analysis. The data were presented as a late breaking abstract during the plenary session at the 2023 Annual Meeting of the American Society of Clinical Oncology (ASCO), and simultaneously published in the New England Journal of Medicine.

Key Points: 
  • We look forward to working with the FDA on its review of vorasidenib as a potential therapy in IDH-mutant diffuse glioma."
  • INDIGO is a registration-enabling Phase 3 global, randomized, double-blinded placebo-controlled study of vorasidenib in patients with residual or recurrent grade 2 glioma with an isocitrate dehydrogenase 1/2 (IDH1/2) mutation who have undergone surgery as their only treatment.
  • Of the 331 patients, 172 had oligodendroglioma (88 vorasidenib; 84 placebo) and 159 patients had astrocytoma (80 vorasidenib; 79 placebo).
  • Servier is working to determine timelines for submission of a New Drug Application (NDA) for vorasidenib to the FDA.

Ivy Brain Tumor Center Announces Interim Results of Two Clinical Trials Targeting High-Grade Glioma

Retrieved on: 
Friday, June 2, 2023
Glioma, Abstract (summary), Glioblastoma, Methylation, Drug development, MGMT, Survival, American Society of Clinical Oncology, Niraparib, Brain, ASCO, Barrow Neurological Institute, Radiation therapy, MD, Neuro, PARP, Society, Hedera, Medical imaging, Pharmaceutical industry, Patient

A Phase 0/1b clinical trial was selected for presentation and withdrawn pending resolution of outstanding patent details.

Key Points: 
  • A Phase 0/1b clinical trial was selected for presentation and withdrawn pending resolution of outstanding patent details.
  • Abstracts from the clinical trials of infigratinib and niraparib are now online in the ASCO Meeting Library and will be presented by Ivy Center investigators on June 3, 2023 at the ASCO Central Nervous System Tumors poster session.
  • These new results do not support the continued clinical development of infigratinib in adult glioma patients.
  • “The use of Phase 0 clinical trials in neuro-oncology has never been more critical,” says Nader Sanai, MD, director of the Ivy Brain Tumor Center and director of neurosurgical oncology at Barrow Neurological Institute.

Recently Published Independent Research Reveals New Mechanisms by Which LIXTE Biotechnology’s Lead Clinical Compound, LB-100, Increases Effectiveness of Cancer Immunotherapy

Retrieved on: 
Tuesday, May 30, 2023
Glioma, Carcinoma, University, PP2A, Neurosurgery, Cancer research, Netherlands Cancer Institute, MHC, University of California, Research, Neoplasm, Immunotherapy, Messenger, Patient, Vaccine, Glioblastoma

PASADENA, CA, May 30, 2023 (GLOBE NEWSWIRE) -- LIXTE Biotechnology Holdings, Inc. (“LIXTE” or the “Company”) (Nasdaq: LIXT) today announced that a recently published article in the journal Cancer Research showed that PP2A, the pharmacologic target of LIXTE’s lead clinical compound, LB-100, when inactivated in pre-clinical models of glioma, activates a complex intracellular signaling system, the cGAS-STING pathway. This leads to an activation of interferon signaling, an increase in MHC class I expression on tumor cells, an increase in CD8+ killer T cell proliferation, while at the same time reducing immunosuppressive tumor associated macrophages. Consequently, as shown in the article, PP2A inactivation sensitized the immunologically “cold” glioblastoma cells to immune checkpoint blockade therapy in vivo.

Key Points: 
  • (“LIXTE” or the “Company”) ( Nasdaq: LIXT ) today announced that a recently published article in the journal Cancer Research showed that PP2A, the pharmacologic target of LIXTE’s lead clinical compound, LB-100, when inactivated in pre-clinical models of glioma, activates a complex intracellular signaling system, the cGAS-STING pathway.
  • Consequently, as shown in the article, PP2A inactivation sensitized the immunologically “cold” glioblastoma cells to immune checkpoint blockade therapy in vivo.
  • John S. Kovach, M.D., CEO and Founder of LIXTE, said, “The case for combining LB-100 with immunotherapy is ever more compelling.
  • We reported last year on emerging clinical evidence that PP2A inhibition may sensitize clear cell ovarian cancer patients to checkpoint inhibitors ( https://ir.lixte.com/news-events/press-releases/detail/77/inactivating-m... ).