Biomarkers

DGAP-News: Vivoryon Therapeutics AG: Vivoryon Receives IND Approval for Varoglutamstat's (PQ912) Phase 2 Study in Alzheimer's Disease

Tuesday, August 4, 2020 - 7:01am

FDA clearance of the IND will enable Vivoryon to initiate its U.S.

Key Points: 
  • FDA clearance of the IND will enable Vivoryon to initiate its U.S.
  • Phase 2 clinical trial program for varoglutamstat (PQ912) in Alzheimer's disease as planned.
  • The trial design includes a drug-titration phase and a composite Neuropsychological Test Battery (NTB) score for assessing cognitive efficacy.
  • Data on electroencephalography (EEG) and cerebrospinal fluid (CSF) biomarkers will be complementary to the already active Phase 2b EU trial, VIVIAD.

MyoKardia Doses First Patient in Phase 3 VALOR-HCM Trial of Mavacamten

Monday, August 3, 2020 - 1:30pm

BRISBANE, Calif., Aug. 03, 2020 (GLOBE NEWSWIRE) -- MyoKardia, Inc. (Nasdaq: MYOK) announced that the first patient has been dosed in the Phase 3 VALOR-HCM clinical trial.

Key Points: 
  • BRISBANE, Calif., Aug. 03, 2020 (GLOBE NEWSWIRE) -- MyoKardia, Inc. (Nasdaq: MYOK) announced that the first patient has been dosed in the Phase 3 VALOR-HCM clinical trial.
  • The study is expected to enroll approximately 100 patients randomized on a 1:1 basis to receive mavacamten or placebo.
  • Throughout the study, all dose adjustments will occur in a blinded manner and doses may be down-titrated for safety at any time.
  • In clinical and preclinical studies, mavacamten has consistently reduced biomarkers of cardiac wall stress, lessened excessive cardiac contractility and increased diastolic compliance.

Aileron Therapeutics Announces Completion of Enrollment in Dose Optimization Expansion Cohort of Proof-of-Concept Phase 1b Study of ALRN-6924

Monday, August 3, 2020 - 1:00pm

The protocol for this study consists of a phase 1b and a randomized, controlled phase 2; the Phase 1b has two parts: dose optimization and schedule optimization.

Key Points: 
  • The protocol for this study consists of a phase 1b and a randomized, controlled phase 2; the Phase 1b has two parts: dose optimization and schedule optimization.
  • Per the interim findings, the 0.3 mg/kg dose of ALRN-6924 achieved the most robust and consistent chemoprotective effects of the three dose levels evaluated.
  • As previously guided, in the fourth quarter of 2020, Aileron plans to report final Phase 1b dose optimization data, including data from the dose optimization expansion cohort as well as pharmacodynamic biomarker and tumor efficacy data, in addition to preliminary Phase 1b schedule optimization data.
  • In the dose optimization expansion cohort, which has completed planned enrollment of eight patients, ALRN-6924 is being administered at a 0.3 mg/kg dose level 24 hours before each dose of topotecan.

DGAP-News: SphingoTec to Present at the LifeSci Partners' Summer Symposium

Friday, July 31, 2020 - 12:10pm

Please click the following link to register: https://lifesci.events/SummerSymposium

Key Points: 
  • Please click the following link to register: https://lifesci.events/SummerSymposium
    SphingoTec GmbH ( "SphingoTec"; Hennigsdorf near Berlin, Germany) develops and markets innovative in-vitro diagnostic (IVD) tests for novel and proprietary biomarkers for the diagnosis, prediction and monitoring of acute medical conditions, such as sepsis, acute heart failure, circulatory shock, and acute kidney injury in order to support patient management and provide guidance for treatment strategies.
  • SphingoTec's proprietary biomarker portfolio includes Bioactive Adrenomedullin(bio-ADM(R)), a unique biomarker for real-time assessment of endothelial function in conditions like sepsis or congestive heart failure, Proenkephalin (penKid(R)), a unique biomarker for real-time assessment of kidney function, and Dipeptidyl Peptidase 3 (DPP3), a unique biomarker for cardiac depression.
  • IVD tests for SphingoTec's proprietary biomarkers are made available as sphingotest(R) microtiterplate tests as well as point-of-care tests on the Nexus IB10 immunoassay platform by SphingoTec's subsidiary Nexus Dx Inc. (San Diego, CA, USA) alongside a broad menu of established and commonly used tests for acute and critical care.
  • For more information please visit our website: https://sphingotec.com/

Vituity and GEn1E Lifesciences Announce Strategic Partnership

Thursday, July 30, 2020 - 4:00pm

Vituity , a nationwide, physician-owned-and-led multispecialty partnership, and GEn1E Lifesciences , a Y Combinator and StartX company focused on accelerating cures for diseases of inflammation and aging, today announced a new strategic partnership to speed up development of COVID-19 treatments and improve patient outcomes.

Key Points: 
  • Vituity , a nationwide, physician-owned-and-led multispecialty partnership, and GEn1E Lifesciences , a Y Combinator and StartX company focused on accelerating cures for diseases of inflammation and aging, today announced a new strategic partnership to speed up development of COVID-19 treatments and improve patient outcomes.
  • In addition, Vituity will invest in GEn1E to rapidly advance its drug development platform to ensure these treatments can be rapidly produced and distributed to patients.
  • GEn1E will use precision medicine tools and adaptive clinical trials for successful recruitment of patients in Phase 2/3 studies using efficient patient biomarker matching.
  • The partnership between Vituity and GEn1E is a stellar example of how a leading healthcare company can work with an agile novel platform for speeding up drug development to save lives, said Dr. Alan Levy, a GEn1E board member.

The global cancer/tumor profiling market size is projected to reach USD 13.9 billion by 2025 from USD 8.3 billion in 2020, at a CAGR of 10.9 %

Wednesday, July 29, 2020 - 2:40pm

The global cancer/tumor profiling market size is projected to reach USD 13.9 billion by 2025 from USD 8.3 billion in 2020, at a CAGR of 10.9 %.

Key Points: 
  • The global cancer/tumor profiling market size is projected to reach USD 13.9 billion by 2025 from USD 8.3 billion in 2020, at a CAGR of 10.9 %.
  • By technology, the next generation sequencing segment holds the highest market share during the forecast period.
  • Based on biomarker type, the cancer/tumor profiling market is segmented genetic biomarkers, protein biomarkers, and other biomarkers.The genetic segment held the highest market share in 2019.
  • Based on cancer type, the cancer/tumor profiling market is segmented research and clinical applications.The research application segment held the highest market share in 2019.

Quanterix sNfL Assay and Simoa Technology First to Measure Neuronal Injury in COVID-19 Patients’ Blood

Wednesday, July 29, 2020 - 2:30pm

However, experts caution that it could require years of study to fully understand the long-term effects of these symptoms.

Key Points: 
  • However, experts caution that it could require years of study to fully understand the long-term effects of these symptoms.
  • Harnessing the power of biomarkers to shed light on these scientific mysteries and improve testing precision is the collective missions at Quanterix and PPH.
  • Notably, all positive patients reported mild-to-moderate symptoms with recovery within one-to-three weeks and showed no or only minor neurological symptoms.
  • In patients with two sNfL measurements, sNfL levels were highly correlated.

Cancer Biomarkers Market Revenue to Reach $26.97 Bn, Globally, by 2027 at 11.8% CAGR: Allied Market Research

Wednesday, July 29, 2020 - 2:00pm

According to the report, the global cancer biomarkers industry was estimated at $10.94 billion in 2019, and is expected to hit $26.97 billion by 2027, registering a CAGR of 11.8% from 2020 to 2027.

Key Points: 
  • According to the report, the global cancer biomarkers industry was estimated at $10.94 billion in 2019, and is expected to hit $26.97 billion by 2027, registering a CAGR of 11.8% from 2020 to 2027.
  • Download Sample Report with Detailed COVID-19 Impact Analysis at: https://www.alliedmarketresearch.com/request-sample/1443
    Prevalence of various types of cancers such as breast, prostate, and lung cancer, development of biological & targeted drug therapies, and reliability of cancer biomarkers fuel the growth of the global cancer biomarkers market.
  • However, the global lockdown has led to postponement of the procedures and accordingly, there's been a short-term decline in the revenue rate in cancer biomarkers market.
  • Based on biomolecule, the genetic biomarkers segment contributed to nearly half of the global cancer biomarkers market revenue in 2019, and is anticipated to lead the trail till 2027.

Cancer Biomarkers Market Revenue to Reach $26.97 Bn, Globally, by 2027 at 11.8% CAGR: Allied Market Research

Wednesday, July 29, 2020 - 2:00pm

According to the report, the global cancer biomarkers industry was estimated at $10.94 billion in 2019, and is expected to hit $26.97 billion by 2027, registering a CAGR of 11.8% from 2020 to 2027.

Key Points: 
  • According to the report, the global cancer biomarkers industry was estimated at $10.94 billion in 2019, and is expected to hit $26.97 billion by 2027, registering a CAGR of 11.8% from 2020 to 2027.
  • Download Sample Report with Detailed COVID-19 Impact Analysis at: https://www.alliedmarketresearch.com/request-sample/1443
    Prevalence of various types of cancers such as breast, prostate, and lung cancer, development of biological & targeted drug therapies, and reliability of cancer biomarkers fuel the growth of the global cancer biomarkers market.
  • However, the global lockdown has led to postponement of the procedures and accordingly, there's been a short-term decline in the revenue rate in cancer biomarkers market.
  • Based on biomolecule, the genetic biomarkers segment contributed to nearly half of the global cancer biomarkers market revenue in 2019, and is anticipated to lead the trail till 2027.

Biological Dynamics Expands Biomarkers Research Into Alzheimer's With Funding From Alzheimer's Drug Discovery Foundation (ADDF)

Wednesday, July 29, 2020 - 1:30pm

One of the critical unmet needs in drug development is the lack of tools to measure brain-derived biomarkers in blood.

Key Points: 
  • One of the critical unmet needs in drug development is the lack of tools to measure brain-derived biomarkers in blood.
  • "The Biological Dynamics program represents a valuable opportunity to radically simplify testing the EV-based biomarkers associated with AD, potentially accelerating advancement of drug development pipelines."
  • Biological Dynamics' novel platform, Verita, uses the Alternating Current Electrokinetic (ACE) method to enable a fully automated alternative for on-chip isolation and characterization of EV-based biomarkers.
  • The ADDF has awarded more than $150 million to fund over 626 Alzheimer's drug discovery programs and clinical trials in 19 countries.