rituximab biosimilar / LFB SA - LARVOL DELTA

A Phase 2 Study of the Safety and Efficacy of INCB050465, a Selective PI3Kδ Inhibitor, in Combination with Ruxolitinib in Patients with Myelofibrosis (ASH 2018) - P2; "INCB050465 doses of 10 mg (TG10, n=3) followed by 20 mg (TG20, n=7) were explored in Part 1. The dosing regimen (QD for 8 wks followed by QW) of INCB050465 in this study seemed to mitigate AEs observed with other PI3K inhibitors (limited Gr 3/4 TEAEs and no TEAEs of colitis or rash reported). Long term dosing strategies will be explored in Part 3 of the study, and additional trials are underway to identify optimal dosing of INCB050465 for enhanced safety and efficacy in combination with other agents."

Clinical • Combination therapy • P2 data • Biosimilar • Immunology • Myelodysplastic Syndrome • Myelofibrosis • Neutropenia • Oncology • Pain

Acalabrutinib, Umbralisib, and Ublituximab for the Treatment of Previously Untreated Mantle Cell Lymphoma (clinicaltrials.gov) - P2; N=27; Not yet recruiting; Sponsor: City of Hope Medical Center

Clinical • Combination therapy • New P2 trial • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology • CCND1 • CD20

Lenalidomide, Umbralisib, and Ublituximab for the Treatment of Relapsed or Refractory Indolent Non-Hodgkin Lymphoma or Mantle Cell Lymphoma (clinicaltrials.gov) - P1; N=42; Not yet recruiting; Sponsor: Yazeed Sawalha; Initiation date: Jan 2021 ➔ Apr 2021

Clinical • Trial initiation date • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Lymphoplasmacytic Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Waldenstrom Macroglobulinemia

Lenalidomide, Umbralisib, and Ublituximab for the Treatment of Relapsed or Refractory Indolent Non-Hodgkin Lymphoma or Mantle Cell Lymphoma (clinicaltrials.gov) - P1; N=42; Not yet recruiting; Sponsor: Yazeed Sawalha

Clinical • New P1 trial • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Lymphoplasmacytic Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Waldenstrom’s Macroglobulinaemia

Genome Sequence of Vibrio nigripulchritudo Strain TUMSAT-TG-2018, Isolated from Diseased Pacific White Shrimp, Litopenaeus vannamei. (PubMed, Microbiol Resour Announc) - "Here, we present the genome sequence of Vibrio nigripulchritudo TUMSAT-TG-2018, which was isolated from a diseased Pacific white shrimp (Litopenaeus vannamei). The assembly totaled 6.8 Mbp, consisting of two chromosomes and four plasmids."

Journal

[VIRTUAL] Clinical Implementation of TG-203 for Patients with Implanted Cardiac Devices at One Institution (ASTRO 2020) - "The implementation of TG-203 is still an evolving process. Optimization of the communication process remains an ongoing challenge. More so, the biggest challenge for physicists continues to be the need to educate other health professionals, in and outside Radiation Oncology, about the effects of radiation on implanted electronic devices."

Clinical • Cardiovascular • Oncology

Structural insights into the psychrophilic germinal protease PaGPR and its autoinhibitory loop. (PubMed, J Microbiol) - "TG-20 (PaGPR) in its inactive form at a resolution of 2.5 A. Structural analysis showed that the active site of PaGPR is sterically occluded by an inhibitory loop region (residues 202-216). HycI and HybD are metal-loproteases that also contain two Asp (or Glu) residues in their active site, playing a role in metal binding. In summary, our results provide useful insights into the activation process of PaGPR and its active conformation."

Journal

Loss of prion protein is associated with the development of insulin resistance and obesity. (PubMed, Biochem J) - "PrP(C) KO cells also presented reduced glucose uptake upon insulin stimulation, due to reduced translocation of the glucose transporter Glut4.   Thus, our results suggests that PrP(C) reflects susceptibility to the development of insulin resistance and metabolic syndrome."

Journal • Biosimilar • Diabetes • Metabolic Disorders • Obesity

Management of Radiotherapy Patients with Implanted Cardiac Pacemakers and Defibrillators: A Report of the AAPM TG-203. (PubMed, Med Phys) - "Since the publication of the AAPM TG-34 in 1994, large bodies of literature and case reports have been published about different kinds of radiation effects on modern technology implantable cardiac devices and patient management before, during and after radiotherapy. This task group report provides the framework that analyzes the potential failure modes of these devices and lays out the methodology for patient management in a comprehensive and concise way, in every step of the entire radiotherapy process."

Clinical • Journal

The effect of stereotactic body radiotherapy (SBRT) using flattening filter-free beams on cardiac implantable electronic devices (CIEDs) in clinical situations. (PubMed, J Appl Clin Med Phys) - "The study showed that caution should be paid to managing CIED patients when they undergo SBRT using FFF beams, as it is recommended by AAPM TG-203. Correspondingly, it was found that for FFF beams although there is small risk from dose-rate effects, delivering high dose of radiation with beam energy greater than 6 MV and high-dose rate to CIEDs positioned in close vicinity of the PTV may present issues."

Clinical • Journal

Influence of cone beam CT (CBCT) scan parameters on size specific dose estimate (SSDE): A Monte Carlo study. (PubMed, Phys Med Biol) - "...Best-fit curves were derived from the f size, CBCT values and compared to those reported by AAPM TG-204 for MSCT...Therefore, the use of MSCT factors to convert CTDIIEC for CBCT scans may lead to under/overestimation of doses to patients by 5% and 6%, on average, for the head and body protocols, respectively. Best-fit curves of the results from this study provide values that could be used to convert CTDIIEC for specific water-equivalent diameter (Dw) to a SSDE."

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