Seminal vesicles

Evelo Biosciences Provides Clinical Updates

Retrieved on: 
Wednesday, April 26, 2023

CAMBRIDGE, Mass., April 26, 2023 (GLOBE NEWSWIRE) -- Evelo Biosciences, Inc. (Nasdaq:EVLO), a clinical stage biotechnology company developing a novel platform of orally delivered inflammation-resolving medicines acting on the small intestinal axis (SINTAX), today announced updates to its clinical programs.

Key Points: 
  • ET –
    CAMBRIDGE, Mass., April 26, 2023 (GLOBE NEWSWIRE) -- Evelo Biosciences, Inc. (Nasdaq:EVLO), a clinical stage biotechnology company developing a novel platform of orally delivered inflammation-resolving medicines acting on the small intestinal axis (SINTAX), today announced updates to its clinical programs.
  • The primary endpoint was the proportion of patients who achieve an EASI-50 response at week 16,” said Simba Gill, Ph.D., CEO of Evelo.
  • “Given these results, we will cease further development of EDP1815 in atopic dermatitis, following a wind-down of the study.
  • Evelo will host a conference call and webcast at 8:30 a.m.

Direct Biologics Receives FDA Clearance to Initiate Phase 1b/2a Clinical Trial of ExoFlo™ in Patients with Medically Refractory Perianal Fistulizing Crohn’s Disease

Retrieved on: 
Wednesday, April 26, 2023

“The expansion of our inflammatory bowel disease clinical program into perianal fistulizing Crohn’s disease underscores our commitment to providing treatment options to a patient population that suffers from chronic inflammatory disease,” said Mark Adams, Chief Executive Officer of Direct Biologics.

Key Points: 
  • “The expansion of our inflammatory bowel disease clinical program into perianal fistulizing Crohn’s disease underscores our commitment to providing treatment options to a patient population that suffers from chronic inflammatory disease,” said Mark Adams, Chief Executive Officer of Direct Biologics.
  • The Phase 1b/2a clinical trial is designed to be a safety study with exploratory assessments of efficacy.
  • The trial will also evaluate the efficacy of ExoFlo in fistulizing subtypes, including patients with proctitis and numerous fistula tracts.
  • “FDA clearance to initiate this randomized trial of ExoFlo in perianal fistulizing Crohn’s disease marks a defining moment for patients suffering from this devastating phenotype that greatly diminishes quality of life.

Mercy BioAnalytics Appoints Diagnostics Industry Trailblazer Dr. Myla Lai-Goldman to Its Board of Directors

Retrieved on: 
Monday, April 24, 2023

Mercy BioAnalytics, Inc. , a pioneer in extracellular vesicle-based liquid biopsies for the early detection of cancer, today announced the appointment of Myla Lai-Goldman, MD, to its Board of Directors.

Key Points: 
  • Mercy BioAnalytics, Inc. , a pioneer in extracellular vesicle-based liquid biopsies for the early detection of cancer, today announced the appointment of Myla Lai-Goldman, MD, to its Board of Directors.
  • In addition to GeneCentric, Dr. Lai-Goldman currently serves on the boards of West Pharmaceutical Services, Akoya Biosciences, Qvella Corporation, and NovoPath.
  • Board-certified in both anatomic and clinical pathology, she received her medical degree from Columbia University College of Physicians and Surgeons.
  • “I am honored to join the Mercy Board and support the company’s efforts to advance their diagnostic test portfolio through clinical validation and entry into the market,” said Dr. Lai-Goldman.

Direct Biologics Reports Compelling Data as ExoFlo™ Expanded Access Program in Hospitalized COVID-19 Patients with Moderate-to-Severe ARDS Surpasses 100 Subjects

Retrieved on: 
Wednesday, April 19, 2023

“We are pleased to report compelling findings from more than 100 patients with respiratory failure due to COVID-19 who were treated with ExoFlo as part of our expanded access program.

Key Points: 
  • “We are pleased to report compelling findings from more than 100 patients with respiratory failure due to COVID-19 who were treated with ExoFlo as part of our expanded access program.
  • To date, 103 patients have been enrolled and treated in the program.
  • Further, patients younger than 65 were discharged from the hospital earlier and had more ventilator-free days than patients 65-85.
  • In addition, the trial will evaluate the efficacy of ExoFlo in ARDS subtypes to better understand the disease process.

Biological Dynamics to Present Data at AACR Highlighting ExoVerita Platform-Enabled Earlier Detection of Pancreatic and Lung Cancers

Retrieved on: 
Friday, April 14, 2023

Biological Dynamics’ will exhibit its technology and early cancer detection assays at booth #1368.

Key Points: 
  • Biological Dynamics’ will exhibit its technology and early cancer detection assays at booth #1368.
  • “Pancreatic and lung cancers are two of the deadliest cancers in the U.S., as they are often diagnosed in late stages, making treatment more difficult and lowering survival chances.
  • Results show that Biological Dynamics’ lung assay, performed on the ExoVerita platform, detected cancer with an overall sensitivity and specificity of approximately 91%.
  • The presented data suggest the potential for the company’s technology and assays to become an integral component of surveillance for and early detection of cancers.

Menarini Silicon Biosystems new CELLSEARCH® data presented at AACR 2023 annual meeting highlights trailblazing contributions of liquid biopsies for cancer research

Retrieved on: 
Thursday, April 13, 2023

BOLOGNA, Italy and HUNTINGDON VALLEY, Pa, April 13, 2023 /PRNewswire/ -- Menarini Silicon Biosystems (MSB), a pioneer of liquid biopsy and single cell technologies, announced today the data from two posters to be presented at the April 14-19, 2023 annual meeting of the American Association for Cancer Research (AACR). Among them, one demonstrated the benefit of an AI algorithm for automated, reliable, and reproducible CELLSEARCH® CTC identification, while the other focused on the additional information available through the parallel immunomagnetic enrichment of tumor derived extracellular vesicles and CTCs from a single blood sample.

Key Points: 
  • BOLOGNA, Italy and HUNTINGDON VALLEY, Pa, April 13, 2023 /PRNewswire/ -- Menarini Silicon Biosystems (MSB), a pioneer of liquid biopsy and single cell technologies, announced today the data from two posters to be presented at the April 14-19, 2023 annual meeting of the American Association for Cancer Research (AACR).
  • The posters are scheduled for Monday the 17th of April between 1:30 and 5:00 PM in Session PO.CL01.16 - Liquid Biopsies: Circulating Nucleic Acids and Circulating Tumor Cells 3.
  • Additional posters will be presented during the AACR 2023 annual meeting using the CellSearch® and DEPArray™ technologies.
  • Most importantly, two new biomarkers, ARV7 and DLL3, coupled to CTC enumeration, will be available, for research use, in May 2023.

Menarini Silicon Biosystems new CELLSEARCH® data presented at AACR 2023 annual meeting highlights trailblazing contributions of liquid biopsies for cancer research

Retrieved on: 
Thursday, April 13, 2023

BOLOGNA, Italy and HUNTINGDON VALLEY, Pa., April 13, 2023 /PRNewswire/ -- Menarini Silicon Biosystems (MSB), a pioneer of liquid biopsy and single cell technologies, announced today the data from two posters to be presented at the April 14-19, 2023 annual meeting of the American Association for Cancer Research (AACR). Among them, one demonstrated the benefit of an AI algorithm for automated, reliable, and reproducible CELLSEARCH® CTC identification, while the other focused on the additional information available through the parallel immunomagnetic enrichment of tumor derived extracellular vesicles and CTCs from a single blood sample.

Key Points: 
  • BOLOGNA, Italy and HUNTINGDON VALLEY, Pa., April 13, 2023 /PRNewswire/ -- Menarini Silicon Biosystems (MSB), a pioneer of liquid biopsy and single cell technologies, announced today the data from two posters to be presented at the April 14-19, 2023 annual meeting of the American Association for Cancer Research (AACR).
  • The posters are scheduled for Monday the 17th of April between 1:30 and 5:00 PM in Session PO.CL01.16 - Liquid Biopsies: Circulating Nucleic Acids and Circulating Tumor Cells 3.
  • Additional posters will be presented during the AACR 2023 annual meeting using the CellSearch® and DEPArray™ technologies.
  • Most importantly, two new biomarkers, ARV7 and DLL3, coupled to CTC enumeration, will be available, for research use, in May 2023.

Global Mesenchymal Stem Cells / Medicinal Signaling Cells (MSCs) Strategic Research Report 2023: Activities of 110+ Leading MSC Companies, Including their Core Technologies and Products - ResearchAndMarkets.com

Retrieved on: 
Friday, April 7, 2023

The "Mesenchymal Stem Cells / Medicinal Signaling Cells (MSCs) - Advances & Applications, 2023" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Mesenchymal Stem Cells / Medicinal Signaling Cells (MSCs) - Advances & Applications, 2023" report has been added to ResearchAndMarkets.com's offering.
  • MSCs are multipotent cells that can differentiate into a variety of cell types, including but not limited to osteoblasts, chondrocytes, myocytes, and adipocytes.
  • Therefore, this global strategic report details the activities of 113 leading MSC companies, including their core technologies and products under development.
  • This global strategic report includes:
    Market size determination for the global MSC market, segmented by Geography and Business Segment
    Recent business developments related to MSCs, including strategic collaborations and partnerships
    Company profiles for MSC market competitors, including their products, services, and technologies under development

Direct Biologics Announces FDA Authorization to Expand Ongoing Phase 3 Clinical Study of ExoFlo™ to All-Cause Moderate-to-Severe ARDS

Retrieved on: 
Tuesday, April 4, 2023

In addition, the trial will evaluate the efficacy of ExoFlo in ARDS subtypes to better understand the disease process.

Key Points: 
  • In addition, the trial will evaluate the efficacy of ExoFlo in ARDS subtypes to better understand the disease process.
  • In March 2022, ExoFlo received Regenerative Medicine Advanced Therapy, or RMAT, designation by the FDA, which provides opportunities to expedite ExoFlo’s clinical development for ARDS.
  • “FDA authorization to expand our ongoing Phase 3 clinical trial to all-cause ARDS marks a defining moment for regenerative medicine.
  • In fact, ExoFlo is one of a small handful of biologics that has demonstrated adequate tolerability and clinical activity to gain allowance by the FDA for Phase 3 evaluation in moderate-to-severe ARDS,” said Amy Lightner, M.D., Chief Medical Officer of Direct Biologics.

AGC Biologics Signs Exosome Agreement with The Jikei University in Japan for Idiopathic Pulmonary Fibrosis (IPF) Project

Retrieved on: 
Tuesday, April 4, 2023

AGC Biologics , a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), announced it signed a service agreement with The Jikei University in Japan.

Key Points: 
  • AGC Biologics , a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), announced it signed a service agreement with The Jikei University in Japan.
  • Under the agreement, AGC Biologics will assume a technology transfer and feasibility study for a drug product focused on the treatment of Idiopathic pulmonary fibrosis at the CDMO's center of Cell and Gene Excellence in Milan.
  • We look forward to partnering with the talented team at AGC Biologics Milan to explore feasibility,” said Principal Investigator, Dr. Yu Fujita from The Jikei University School of Medicine.
  • To learn more about AGC Biologics’ global cell therapy services visit www.agcbio.com/capabilities/cell-therapy , go to www.agcbio.com/capabilities/viral-vector and learn more about the CDMO’s viral vector offerings.