Brainvectis

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Brainvectis

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Brainvectis

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Paris, Ile de France, France

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With the ultimate aim to create a European alliance for bioproduction in Europe, organisations have joined forces with COBIOE. Discover who are our associates.

Bio-resources and biobanking
  • Cells, tissues and humanized xeno-organs
  • Biosamples
  • Viral, phage or bacterial specimen
Identification of biotherapies
  • Target identification
  • Target validation
  • Screening
Drug design
  • Drug assessment
  • Drug engineering
  • In vitro preclinical studies
Clinical validation
  • Clinical trials
  • In vivo preclinical validation
  • Pre-industrial scale production
Production
  • Upstream processes
  • Downstream processes
  • Quality control
Market access
  • CE mark / market authorisation
  • Payment / Reimbursement
  • Care pathways

Brainvectis last news

05/01/2024

AskBio Announces Initiation of Phase 2 GenePHIT Trial in Congestive Heart Failure (CHF)

Research Triangle Park, N.C.‚Äď January 5, 2024¬†‚ÄstAsklepios BioPharmaceutical, Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, today announced that it is initiating GenePHIT (Gene PHosphatase Inhibition Therapy), a Phase 2 trial of AB-1002 (also known as¬†NAN-101) for the treatment of congestive heart failure¬†(CHF). GenePHIT is an adaptive, double-blind, placebo-controlled, randomized, multicenter trial to evaluate the safety and efficacy of a single intracoronary infusion of AB-1002 in adults with non-ischemic cardiomyopathy classified as New York Heart Association (NYHA) Class III Heart Failure who have¬†been medically stable for at least 4 weeks.1¬†The advancement of AB-1002 into Phase 2 marks a significant milestone for this novel gene therapy for¬†CHF¬†and, if successful, could bring this important investigational therapy one step closer to treating patients with high unmet medical need.¬† GenePHIT will include between 90 and 150 adults with left ventricle ejection fraction between 15 and 35%,¬†who continue to suffer from¬†heart failure symptoms despite guideline recommended therapy. The primary¬†efficacy¬†endpoint at 52 weeks is a modified win ratio¬†of several clinically meaningful assessments.1 "AskBio is excited to initiate GenePHIT under the leadership of Roger Hajjar, MD, Scientific Chair CHF, and Lothar Roessig, MD, Integrated Product Team Lead CHF," said¬†Jude Samulski, PhD, Co-Founder and Chief Scientific Officer, AskBio.¬†"We believe this trial will help determine the potential of AB-1002 as a treatment for one of the world's most devastating diseases, and we look forward to learning more about this important investigational¬†cardiac¬†gene therapy. Our hope is that one day AB-1002 will potentially help patients suffering from congestive heart failure." The GenePHIT trial, which includes 52-week safety and primary efficacy and four-year long-term follow-up periods, is currently recruiting. AskBio plans to¬†conduct the trial in the U.S. and multiple countries in Europe.1¬†For more information, please¬†visit clinicaltrials.gov (NCT#05598333) or visit askbio.com. AB-1002 is an investigational gene therapy that has not been approved by any regulatory authority, and its efficacy and safety have not been established or fully evaluated. AB-1002 is manufactured by Viralgen Vector Core, a wholly owned and independently operated subsidiary of AskBio. About Congestive Heart Failure Heart failure occurs when the heart cannot pump blood efficiently enough to meet the body's needs, including providing sufficient oxygen to the organs.2¬†Congestive heart failure results in the slowing of the blood flow out of the heart, which causes the blood returning to the heart through the veins to back up.3¬†This causes congestion in the body's tissues. Symptoms include swelling in the legs and ankles. Sometimes, fluid collects in the lungs and interferes with breathing. Approximately 26 million people worldwide are living with congestive heart failure.4 About AskBio Asklepios BioPharmaceutical, Inc. (AskBio), a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes therapeutics for congestive heart failure, Huntington's disease, limb-girdle muscular dystrophy, multiple system The post AskBio Announces Initiation of Phase 2 GenePHIT Trial in Congestive Heart Failure (CHF)¬† appeared first on AskBio .

04/01/2024

AskBio Phase Ib trial of AB-1005 gene therapy in patients with Parkinson's disease meets primary endpoint

Berlin, Germany/Research Triangle Park, North Carolina, USA, January 4, 2024 ‚Äď Bayer AG and Asklepios BioPharmaceutical, Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, announced today the completion of the 18-month data collection in the Phase Ib clinical trial for AB-1005 (AAV2-GDNF), an investigational gene therapy for treating patients with Parkinson's disease (PD).1,2 The study met its primary objective, which was to evaluate the safety of a one-time bilateral delivery of AB-1005 directly to the putamen. Eleven patients were enrolled into two cohorts, Mild stage PD (6 patients) and Moderate stage PD (5 patients), based upon the timing from a PD diagnosis and the severity of their PD symptoms at screening.1 Neurosurgical delivery of AB-1005 was well tolerated by all patients with target putamen coverage of 63% ¬Ī 2%, exceeding the goal of greater than 50% coverage with AB-1005. No serious adverse events have been attributed to AB-1005, with continued clinical follow-up for up to 5 years post administration ongoing.2 "We are encouraged by these early data, which show AB-1005 to be well tolerated in this study in patients with mild to moderate Parkinson's disease," said Krystof Bankiewicz, MD, PhD, Scientific Chair, Parkinson's and MSA, AskBio. "Although there is still much to learn about this early-stage investigational gene therapy, these first findings will inform our work in this space and have the potential to contribute to the clinical advancement of AB-1005 for the treatment of Parkinson's disease." Patients also completed 18-month neurological assessments and self-reported questionnaires at regular intervals to evaluate the severity of motor and non-motor symptoms associated with PD. Additionally, brain imaging was performed to longitudinally assess safety and potential changes in dopamine handling or abnormal metabolic patterns associated with PD.1 AskBio is planning to present the 18-month study data, including secondary endpoints, at a scientific meeting in Q2 2024. Planning is underway for a Phase II trial that is expected to begin screening patients in the first half of 2024.¬†The trial design has been harmonized with feedback from U.S. and European health authorities. "People living with Parkinson's disease deserve options to address their unmet medical need," said Christian Rommel, PhD, Member of the Executive Committee of Bayer's Pharmaceuticals Division and Head of Research and Development. "The positive outcome of the AB-1005 Phase Ib clinical trial is an important step forward in our goal to deliver much-needed treatments in areas where innovation has the potential to make a tremendous impact." About AB-1005 AB-1005 is an investigational gene therapy based on adeno-associated viral vector serotype 2 (AAV2) containing the human glial cell line-derived neurotrophic factor (GDNF) transgene, which allows for stable and continuous expression of GDNF in localized regions of the brain after direct neurosurgical injection with MRI-monitored convection enhanced delivery.3,4 GDNF is a homodimer that is a distantly related member of the transforming growth factor-ő≤ superfamily. In midbrain neuronal cell cultures, recombinant human GDNF promoted the survival and morphological differentiation of dopaminergic neurons and increased their high-affinity dopamine uptake. The post AskBio Phase Ib trial of AB-1005 gene therapy in patients with Parkinson's disease meets primary endpoint appeared first on AskBio .

17/11/2023

AskBio Announces First Patient Randomized in Phase 1 Trial of AB-1005 (AAV2-GDNF) Gene Therapy for Multiple System Atrophy-Parkinsonian Type (MSA-P)

Research Triangle Park, N.C. ‚Äď November 17, 2023 ‚Äď Asklepios BioPharmaceutical, Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, today announced that the first patient has been randomized at the Ohio State University Wexner Medical Center in the Phase 1 REGENERATE MSA-101 clinical trial of AB-1005, a gene therapy being developed as a treatment for multiple system atrophy-parkinsonian type (MSA-P).[1] This marks a significant milestone in the development of AB-1005 gene therapy, an adeno-associated viral vector encoding for glial cell line-derived neurotrophic factor (AAV2-GDNF) that is delivered to the putamen, and brings this therapeutic one step closer to potentially reaching patients. AB-1005 is also currently being investigated for the treatment of mild to moderate Parkinson's disease with the enrollment of the Phase 1b study having now been completed.[2] ¬† "It means a lot to the MSA community to know that the first patient has been enrolled in the Phase 1 REGENERATE MSA-101 trial," said Philip M. Fortier, MA, President and Executive Director, Defeat MSA Alliance. "There is no cure for MSA, and there are currently no treatments to stop or slow the progression of the disease. This makes it especially hard for patients, given the rapid decline many will experience. Today's milestone hopefully brings us one step closer to potentially changing the outcome for MSA patients." MSA-P, which can initially be difficult to distinguish from Parkinson's disease, is marked by slow movement, lack of coordination, imbalance, and dizziness, among other symptoms, as individuals experience increasing difficulty with movement.[3] This is the result of a progressive loss of nerve cells in the brain and spinal cord. Affecting an estimated 100,000‚Äď500,000 worldwide, MSA is a rare disease that in most cases seems to occur at random.3,[4],[5] Symptoms tend to appear in people during their 50s, followed by a rapid progression within 5‚Äď10 years.3 "In those with MSA-P, the loss of dopamine producing neurons leads to markedly disabling symptoms, such as profound motor impairment throughout the hands, legs, and trunk. Previous experience with a similar approach in a population of Parkinson's disease patients has been very encouraging and supported the consideration of this approach in MSA-P. The intent is for GDNF levels in the brain to help preserve dopamine neurotransmission, which is noticeably reduced in MSA-P," said Nicolas M. Phielipp, MD, University of California Irvine, REGENERATE MSA-101 Principal Investigator. "We're including a genetic sequence in the AAV2 vector that codes for the GDNF protein and are delivering this to the putamen. In this way, we're targeting local brain cells and adjacent brain tissue that can benefit from the protein's growth properties. This trial marks the first step toward understanding the potential that GDNF gene therapy might have for patients with MSA-P." "Enrolling the first patient in our REGENERATE MSA-101 trial is an important step in AskBio's ongoing work to advance GDNF gene therapy" said Krystof Bankiewicz, MD, PhD, Scientific Chair, Parkinson's and MSA, AskBio. "The clinical advancement of AB-1005 for the treatment of MSA-P The post AskBio Announces First Patient Randomized in Phase 1 Trial of AB-1005 (AAV2-GDNF) Gene Therapy for Multiple System Atrophy-Parkinsonian Type (MSA-P) appeared first on AskBio .