Biomarkers

eFFECTOR Therapeutics Initiates Phase 2a Expansion Cohorts Evaluating Zotatifin in Breast Cancer and KRAS-mutant Non-small Cell Lung Cancer

Retrieved on: 
Wednesday, August 4, 2021

eFFECTOR expects to initiate multiple indication-specific expansion cohorts in ER+ breast cancer and KRAS-mutant non-small cell lung cancer (NSCLC).

Key Points: 
  • eFFECTOR expects to initiate multiple indication-specific expansion cohorts in ER+ breast cancer and KRAS-mutant non-small cell lung cancer (NSCLC).
  • The Phase 2a expansion cohorts will evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of zotatifin in subjects with biomarker-positive solid tumor malignancies, including ER+ breast cancer and KRAS-mutant NSCLC.
  • eFFECTOR expects to present additional data from the Phase 1 dose escalation portion of the trial, as well as preliminary response data from Phase 2a expansion cohorts, at a medical conference in 2022.
  • Zotatifin, eFFECTORs inhibitor of eIF4A, is currently being evaluated in a Phase 2a clinical trial in patients with breast cancer and KRAS-mutant NSCLC.

Lenzilumab Treatment May Provide Enhanced Likelihood of Survival Without Ventilation in Hospitalized Black and African-American COVID-19 Patients

Retrieved on: 
Wednesday, August 4, 2021

In the overall population with CRP

Key Points: 
  • In the overall population with CRP
  • LIVE-AIR Phase 3 study met its primary endpoint of survival without ventilation demonstrating a 1.54-fold improvement overall and trended to a 2.68-fold improvement in Black and African-American patients.
  • This study was a randomized, double-blind, placebo-controlled, multi-center Phase 3 trial for the treatment and prevention of serious and potentially fatal outcomes in patients hospitalized with COVID-19 pneumonia.
  • The primary endpoint was the difference between lenzilumab treatment and placebo treatment in SWOV through day 28 following treatment.

Dermatology Industry Veteran Ann Deren-Lewis Joins Mindera as Chief Commercial Officer

Retrieved on: 
Tuesday, August 3, 2021

"Ann has the demonstrated ability and distinct set of skills to support Mindera's efforts to shape the era of digital predictive skin analytics and lead the market in Dermal Intelligence," said George Mahaffey, CEO of Mindera.

Key Points: 
  • "Ann has the demonstrated ability and distinct set of skills to support Mindera's efforts to shape the era of digital predictive skin analytics and lead the market in Dermal Intelligence," said George Mahaffey, CEO of Mindera.
  • "Her experience in commercializing medical and aesthetic products and services, with an emphasis on psoriasis, is a perfect fit with our needs."
  • Mind.Px is the flagship test of Mindera Corporation.The Mindera platform uses a dermal biomarker patch that takes only minutes to extract vast transcriptomic information.
  • Subsequent Next-Generation Sequencing of the extracted RNA allows Mindera scientists to take a genetic and transcriptomic snapshot of the skin.

Personalis, Inc. Publishes New Data Demonstrating a Novel Composite Biomarker NEOPS™ for Predicting Response to Cancer Immunotherapy in Late-Stage Melanoma Patients

Retrieved on: 
Monday, August 2, 2021

The study details the development of the Personalis Neoantigen Presentation Score (NEOPS), a novel composite biomarker for predicting response to cancer immunotherapy.

Key Points: 
  • The study details the development of the Personalis Neoantigen Presentation Score (NEOPS), a novel composite biomarker for predicting response to cancer immunotherapy.
  • Enabled by comprehensive tumor immunogenomic profiling from the Personalis NeXT Platform, NEOPS simultaneously models both neoantigen burden and immune-related resistance mechanisms to better predict immunotherapy response in a cohort of late-stage melanoma patients.
  • In this study, NEOPS was more strongly predictive of therapy response than other standard single analyte and investigational biomarkers tested, including tumor mutational burden.
  • Performance of this composite biomarker was initially tested on a cohort of late-stage melanoma patients receiving immune checkpoint blockade therapies and later validated on an independent dataset of similarly treated late-stage melanoma patients.

InterVenn Biosciences Raises $201 Million for AI-driven Glycoproteomic Platform, Liquid-Biopsy development

Retrieved on: 
Monday, August 2, 2021

InterVenn Biosciences today announced the completion of a $201 million Series C financing.

Key Points: 
  • InterVenn Biosciences today announced the completion of a $201 million Series C financing.
  • To date, the InterVenn glycoproteomics platform has been used to develop 16 clinical use cases across oncology and other indications.
  • InterVenn Biosciences utilizes a proprietary glycoproteomics biomarker interrogation platform using AI and mass spectrometry for next-gen precision medicine.
  • For more information about InterVenn Biosciences, please visit the companys website .

Cassava Sciences Announces Positive Biomarker Data with Simufilam in Alzheimer’s Disease

Retrieved on: 
Thursday, July 29, 2021

Robust Improvements Seen in All Measured Biomarkers of Disease, Neurodegeneration and Neuroinflammation (p

Key Points: 
  • Robust Improvements Seen in All Measured Biomarkers of Disease, Neurodegeneration and Neuroinflammation (p AUSTIN, Texas, July 29, 2021 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA) today announced positive biomarker data from an open-label study of simufilam, the Companys investigational drug for the treatment of Alzheimers disease.
  • CSF biomarker data were collected from 25 patients with mild-to-moderate Alzheimers disease who completed 6 months of simufilam treatment in an on-going open-label study.
  • This press release is contemporaneous with another press release titled, Cassava Sciences Announces Positive Cognition Data with Simufilam in Alzheimers Disease, which reports simufilam improved cognition scores by 3.0 points on ADAS-Cog at 9 months (p
  • Cassava Sciences believes clinical results support advancing simufilam into a Phase 3 clinical program in Alzheimers disease.

Cassava Sciences Announces Positive Cognition Data With Simufilam in Alzheimer’s Disease

Retrieved on: 
Thursday, July 29, 2021

This interim analysis summarizes clinical data from the first 50 patients with mild-to-moderate Alzheimers disease who completed 9 months of open-label simufilam treatment.

Key Points: 
  • This interim analysis summarizes clinical data from the first 50 patients with mild-to-moderate Alzheimers disease who completed 9 months of open-label simufilam treatment.
  • This press release is contemporaneous with another press release titled, Cassava Sciences Announce Positive Biomarker Data with Simufilam in Alzheimers Disease, which reports simufilam significantly improved all measured biomarkers of disease, neurodegeneration and neuroinflammation (p
  • Cassava Sciences is advancing simufilam into a Phase 3 clinical program in Alzheimers disease.
  • Over the past 10 years, Cassava Sciences has combined state-of-the-art technology with new insights in neurobiology to develop novel solutions for Alzheimers disease.

Anavex Life Sciences Announces ANAVEX®2-73 (Blarcamesine) Significantly Prevented Aβ (Abeta)-induced Cognitive Deficits with Confirmed Significant Biomarker-response in Animal Model of Alzheimer’s Disease

Retrieved on: 
Thursday, July 29, 2021

NEW YORK, July 29, 2021 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) disorders, today reported new data that established ANAVEX®2-73 to be a preventive treatment in the pharmacological model of Alzheimer's disease (AD). Pre-treatment with ANAVEX®2-73, repeated once daily for one week before the Aβ (Abeta) challenge was protective in the Aβ25-35 peptide model of Alzheimer’s disease in mice. ANAVEX®2-73 significantly and dose-dependently prevented Aβ25-35-induced biomarker-correlated cognitive impairments, which were assessed one week after the Aβ (Abeta) insult during which no further ANAVEX®2-73 treatment took place.

Key Points: 
  • Pre-treatment with ANAVEX2-73, repeated once daily for one week before the A (Abeta) challenge was protective in the A25-35 peptide model of Alzheimers disease in mice.
  • ANAVEX2-73 significantly and dose-dependently prevented A25-35-induced biomarker-correlated cognitive impairments, which were assessed one week after the A (Abeta) insult during which no further ANAVEX2-73 treatment took place.
  • In these same patients, ANAVEX2-73 also improved ADCS-ADL, by +6.0 points, an 8% mean improvement from baseline to 70 weeks.
  • Anavex Life Sciences product portfolio platform includes orally available small molecule drug lead candidate ANAVEX2-73 for the treatment of Alzheimers disease, Parkinsons disease and Rett syndrome and ANAVEX3-71 for frontotemporal dementia.

Deargen Signs Agreement With Sookmyung Women’s University Research & Business Development Foundation for Licensing ‘NASH Biomarker’ Technologies

Retrieved on: 
Tuesday, July 27, 2021

Deargen (President: Kilsoo Kang), an artificial intelligence (AI)-powered drug discovery and development company, announced on July 27 that it signed an agreement with Sookmyung Womens University Research & Business Development Foundation for licensing biomarker technologies for determining the progression stage of NASH (non-alcoholic steatohepatitis) patients.

Key Points: 
  • Deargen (President: Kilsoo Kang), an artificial intelligence (AI)-powered drug discovery and development company, announced on July 27 that it signed an agreement with Sookmyung Womens University Research & Business Development Foundation for licensing biomarker technologies for determining the progression stage of NASH (non-alcoholic steatohepatitis) patients.
  • View the full release here: https://www.businesswire.com/news/home/20210727005549/en/
    Deargen, an AI-powered drug discovery and development company, signed an agreement with Sookmyung Womens University Research & Business Development Foundation for licensing biomarker technologies for determining the progression stage of NASH (non-alcoholic steatohepatitis) patients.
  • (Graphic: Business Wire)
    Proprietary biomarker technologies licensed by Deargen from Sookmyung Womens University Research & Business Development Foundation can identify stages in patients with steatosis and NASH.
  • With the focus on clinical data in NASH patients and proprietary technologies of Sookmyung Womens University Research & Business Development Foundation that enables NASH patients to be distinguished by stages, we reached the technology transference agreement, said Kilsoo Kang, President of Deargen.

Olink: CORAL to use the Olink Proteomics platform to identify novel protein biomarkers and biological mechanisms for neurological diseases

Retrieved on: 
Tuesday, July 27, 2021

UPPSALA, Sweden, July 27, 2021 (GLOBE NEWSWIRE) -- Olink Holding AB (publ) (Olink) (Nasdaq: OLK) today announced that CORAL, a new collaborative community of scientists, will use the Olink Proteomics platform to identify novel protein biomarkers and biological mechanisms for neurological diseases.

Key Points: 
  • UPPSALA, Sweden, July 27, 2021 (GLOBE NEWSWIRE) -- Olink Holding AB (publ) (Olink) (Nasdaq: OLK) today announced that CORAL, a new collaborative community of scientists, will use the Olink Proteomics platform to identify novel protein biomarkers and biological mechanisms for neurological diseases.
  • CORAL is a new collaborative community of scientists that work on diverse neurological conditions studying blood and cerebrospinal fluid (CSF) on the Olink Proteomics platform to identify novel biomarkers and biological mechanisms for neurological diseases.
  • CORAL is a collaborative community of scientists that work on diverse neurological conditions studying blood and CSF to identify novel biomarkers and biological mechanisms for neurological diseases.
  • The purpose of CORAL is to accelerate the development of biomarkers and mechanisms for neurological diseases, starting from array-based proteomics up to validation and implementation in the clinic.