avotaciclib (BEY1107) / BeyondBio - LARVOL DELTA

Evaluation of Safety and Efficacy in BEY1107 in Monotherapy Gemcitabine Combination in Patient with Pancreatic Cancer (clinicaltrials.gov) - P1/2 | N=75 | Recruiting | Sponsor: BeyondBio Inc. | Trial primary completion date: Mar 2021 ➔ Nov 2026 | Unknown status ➔ Recruiting | Trial completion date: Oct 2021 ➔ Dec 2026

Enrollment open • Monotherapy • Trial completion date • Trial primary completion date • Hepatology • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

A Study to Evaluate Safety and Efficacy of BEY1107 in Combination with Capecitabine in Patients with Metastatic Colorectal Cancer (clinicaltrials.gov) - P1/2 | N=27 | Recruiting | Sponsor: BeyondBio Inc. | Trial primary completion date: Aug 2023 ➔ Nov 2026 | Trial completion date: Jul 2024 ➔ Dec 2026

Trial completion date • Trial primary completion date • Colorectal Cancer • Oncology • Solid Tumor

A Study to Evaluate Safety and Efficacy of BEY1107 in Combination with Temozolomide in Patients with Recurrent or Progressive Glioblastoma Multiforme (GBM) (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: BeyondBio Inc. | Trial completion date: Oct 2024 ➔ Dec 2026 | Trial primary completion date: Nov 2023 ➔ Nov 2026

Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

New piperazine derivatives helvamides B-C from the marine-derived fungus Penicillium velutinum ZK-14 uncovered by OSMAC (One Strain Many Compounds) strategy. (PubMed, Nat Prod Bioprospect) - "Beyma were obtained via metal ions stress conditions based on the OSMAC (One Strain Many Compounds) strategy...The absolute configuration of helvamide B (1) as 2R,5R was determined by a combination of the X-ray analysis and by time-dependent density functional theory (TD-DFT) calculations of electronic circular dichroism (ECD) spectra. The cytotoxic activity of the isolated compounds against human prostate cancer PC-3 and human embryonic kidney HEK-293 cells and growth inhibition activity against yeast-like fungi Candida albicans were assayed."

Journal • Embryonal Tumor • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Workshop on Systematically Collecting, Integrating, and Measuring the Impact of Patient Engagement Across Research (ISPOR 2024) - "Beyza Klein will describe the Novartis approach of collaborating with the patient community; building a thorough understanding of patients' life experiences to guide decision-making; and establishing standardized methods to measure the impact of patient engagement efforts throughout a product's lifecycle...Stacie Cavallaro will describe how BioMarin adapted the National Health Council's Patient Experience Mapping Toolkit to standardize a process for capturing and utilizing patient and caregiver insights starting early in clinical development. Jennifer Bright will describe the International Consortium for Health Outcomes Measurement’s (ICHOM) approach to engaging patient representatives to identify the outcomes that matter most to patients, develop core outcome sets, and drive adoption and reporting of these measures worldwide to drive value-based healthcare."

Clinical

Efforts toward elimination of lymphatic filariasis in Guinea: results of transmission assessment surveys (TAS1) in 11 health districts (ASTMH 2023) - "By 2021, 11 HDs (Beyla, Boke, Dalaba, Dinguiraye, Forécariah, Guéckédou, Kérouané, Kindia, Mali, Mandiana and Telimélé) with baseline prevalence between 1.5% -14.4% completed five rounds of MDA with epidemiological coverage > 65%...These results indicate that after five rounds of annual LF MDA with sufficient epidemiological coverage, these 11 HDs have successfully reached the criteria to stop MDA and 4,031,909 people in Guinea are no longer in need of MDA. The 11 HDs are now in the post-treatment surveillance phase, the national program will conduct the second transmission assessment survey (TAS2) in two years' time."

The Prevalence of Trachomatous Trichiasis in People Aged 15 Years and Over in Six Evaluation Units of Gaoual, Labé, Dalaba and Beyla Districts, Guinea. (PubMed, Ophthalmic Epidemiol) - "These TT-only surveys, along with findings from other trachoma interventions, suggest that Guinea is close to achieving elimination of trachoma as a public health problem. This study demonstrates the value of undertaking TT-only surveys in settings where baseline surveys indicated active trachoma prevalences below WHO elimination threshold, but TT prevalences above it."

Journal • Infectious Disease • Inflammation • Ocular Infections • Ophthalmology

Correction to Yalch (2023). (PubMed, Psychol Trauma) - "In the original article, the citation in the second sentence of the first paragraph of the "Introduction to the Special Section" portion was changed from "Beyta and Cuevas" to "Abeyta and Cuevas," and the reference list was corrected and reordered accordingly...This is especially the case for research on psychological trauma, in which the strengths of Bayesian statistics are particularly pronounced. The goals of this introduction to the special section on applying Bayesian statistics to research on psychological trauma are two-fold: first, to overview and discuss the benefits of Bayesian statistics and, second, to introduce the articles in this special section."

Journal • Mood Disorders

A Study to Evaluate Safety and Efficacy of BEY1107 in Combination With Temozolomide in Patients With Recurrent or Progressive Glioblastoma Multiforme (GBM) (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: BeyondBio Inc.

Combination therapy • New P1 trial • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

A Study to Evaluate Safety and Efficacy of BEY1107 in Combination With Capecitabine in Patients With Metastatic Colorectal Cancer (clinicaltrials.gov) - P1/2; N=27; Recruiting; Sponsor: BeyondBio Inc.

Clinical • Combination therapy • New P1/2 trial • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

[VIRTUAL] CLINICAL PRACTICE OF SPIRAL ENTEROSCOPY (SPE) IN THE LEARNING PHASE OF A REAL-WORLD SETTING (UEGW 2021) - "The stability of the enteroscope within the bowel is advantageous for interventions with a high therapeutic success rate of 80-86% (Beyna T et al...in combination with fentanyl and muscle relaxation.In 5/7 pts... Despite the good diagnostic and therapeutic yield of SpE, the first studies carried out in the learning phase of a real-world situation showed a relatively long enteroscopy and intervention time under general anesthesia. This can partly be explained by the high degree of difficulty (average 2.4 out of 3) and various comorbidities of the pts.; however, at the beginning SpE requires a similar timing as for a DBE/SBE in the endoscopy unit and this is in contrary to actual published SpE trials. Due to the high need for sedation, we currently consider performing SpE under intubation anesthesia which is no prerequisite for DBE or SBE."

Clinical • Real-world evidence • Anesthesia • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammatory Bowel Disease • Oncology • Otorhinolaryngology

[VIRTUAL] CLINICAL PRACTICE OF SPIRAL ENTEROSCOPY (SPE) IN THE LEARNING PHASE OF A REAL-WORLD SETTING (UEGW 2021) - "The stability of the enteroscope within the bowel is advantageous for interventions with a high therapeutic success rate of 80-86% (Beyna T et al...in combination with fentanyl and muscle relaxation.In 5/7 pts... Despite the good diagnostic and therapeutic yield of SpE, the first studies carried out in the learning phase of a real-world situation showed a relatively long enteroscopy and intervention time under general anesthesia. This can partly be explained by the high degree of difficulty (average 2.4 out of 3) and various comorbidities of the pts.; however, at the beginning SpE requires a similar timing as for a DBE/SBE in the endoscopy unit and this is in contrary to actual published SpE trials. Due to the high need for sedation, we currently consider performing SpE under intubation anesthesia which is no prerequisite for DBE or SBE."

Clinical • Real-world evidence • Anesthesia • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammatory Bowel Disease • Oncology • Otorhinolaryngology

[VIRTUAL] CLINICAL PRACTICE OF SPIRAL ENTEROSCOPY (SPE) IN THE LEARNING PHASE OF A REAL-WORLD SETTING (UEGW 2021) - "The stability of the enteroscope within the bowel is advantageous for interventions with a high therapeutic success rate of 80-86% (Beyna T et al...in combination with fentanyl and muscle relaxation.In 5/7 pts... Despite the good diagnostic and therapeutic yield of SpE, the first studies carried out in the learning phase of a real-world situation showed a relatively long enteroscopy and intervention time under general anesthesia. This can partly be explained by the high degree of difficulty (average 2.4 out of 3) and various comorbidities of the pts.; however, at the beginning SpE requires a similar timing as for a DBE/SBE in the endoscopy unit and this is in contrary to actual published SpE trials. Due to the high need for sedation, we currently consider performing SpE under intubation anesthesia which is no prerequisite for DBE or SBE."

Clinical • Real-world evidence • Anesthesia • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammatory Bowel Disease • Oncology • Otorhinolaryngology