Associated tags: Bayer, Patient, Heart, Doctor of Philosophy, Pharmaceutical industry, Safety, Heart failure, Gene, MD, Guideline, Learning, Executive Committee, NYHA, Triangle Park (Quezon City), CHF, Cardiomyopathy, Ageing
FDA,
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Pharmaceutical industry Bayer AG and Asklepios BioPharmaceutical, Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for the AB-1002 program.
Key Points:
- Bayer AG and Asklepios BioPharmaceutical, Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for the AB-1002 program.
- AB-1002 is an investigational one-time gene therapy that is administered to the heart with the intention of helping to promote the production of a constitutively active form of protein inhibitor 1 (I-1c) designed to block the action of protein phosphatase 1.
- “The Fast Track Designation for AB-1002 emphasizes the need to rapidly advance new therapeutic modalities such as gene therapy for people living with congestive heart failure,” said Christian Rommel, PhD, Head of Research and Development at Bayer’s Pharmaceuticals Division.
- AskBio is currently enrolling patients in the Phase II GenePHIT (Gene PHosphatase Inhibition Therapy) trial of AB-1002 (also known as NAN-101) for the treatment of CHF.4
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Pharmaceutical industry These included headache, tremor, dyskinesia, arthralgia, musculoskeletal chest pain, fatigue, COVID-19, and magnetic resonance imaging (MRI) abnormalities.
Key Points:
- These included headache, tremor, dyskinesia, arthralgia, musculoskeletal chest pain, fatigue, COVID-19, and magnetic resonance imaging (MRI) abnormalities.
- Bilateral infusions of AB-1005 within the putamen (up to 1.8 mL) were well tolerated, with no SAEs associated with the investigational gene therapy or contrast agent.
- Neurosurgical delivery of AB-1005 resulted in putamen coverage of 63% ± 2%, exceeding the goal of greater than 50% coverage with AB-1005.
- “While much remains to be done, we recognize with increasing confidence the potential of AB-1005 to provide a transformative impact for patients in the future.”
Eli Lilly,
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Management Shannon joins AskBio from Prevail Therapeutics, a wholly owned subsidiary of Eli Lilly and Company
Key Points:
- Shannon joins AskBio from Prevail Therapeutics, a wholly owned subsidiary of Eli Lilly and Company
Co-Founder and former Chief Scientific Officer R. Jude Samulski to remain member of AskBio Board of Directors
Asklepios BioPharmaceutical, Inc. (AskBio), a wholly owned and independently operated subsidiary of Bayer AG, announced today that on April 8, 2024, Mansuo Shannon, PhD, was named the company’s next Chief Scientific Officer (CSO).
- Shannon joins AskBio from Prevail Therapeutics, where she also served as CSO.
- Reporting to Gustavo Pesquin, Chief Executive Officer (CEO), Shannon will be a member of AskBio’s Executive Leadership Team and head its R&D organization.
- As part of her role as CSO at AskBio, Shannon will develop and implement the company’s future R&D strategy.
Retrieved on:
Tuesday, February 13, 2024
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Pharmaceutical industry Berlin, Germany and Research Triangle Park, NC, USA, Feb. 13, 2024 (GLOBE NEWSWIRE) -- Not intended for UK Media
Key Points:
- Berlin, Germany and Research Triangle Park, NC, USA, Feb. 13, 2024 (GLOBE NEWSWIRE) -- Not intended for UK Media
Bayer AG and 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 in GenePHIT (Gene PHosphatase Inhibition Therapy), a Phase II trial of AB-1002 (also known as NAN-101) for the treatment of congestive heart failure (CHF).
- “GenePHIT will evaluate the safety and efficacy of AB-1002 in the largest number of patients to date and improve our understanding of gene therapy overall for the treatment of congestive heart failure.
- “The enrollment of this first patient in the Phase II trial represents the culmination of many years of dedicated research and development in all aspects of cardiac gene therapy for congestive heart failure.
- AB-1002 is manufactured by Viralgen Vector Core, S.L., a wholly owned and independently operated subsidiary of AskBio.
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Pharmaceutical industry 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.
Key Points:
- 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.
- 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 manufactured by Viralgen Vector Core, a wholly owned and independently operated subsidiary of AskBio.
Retrieved on:
Thursday, January 4, 2024
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Medical imaging 18-month assessment of all patients demonstrated feasibility of administration of AB-1005 to the putamen via one-time bilateral convection-enhanced delivery.
Key Points:
- 18-month assessment of all patients demonstrated feasibility of administration of AB-1005 to the putamen via one-time bilateral convection-enhanced delivery.
- AskBio plans to present 18-month study data, including secondary endpoints, at a scientific meeting in Q2 of 2024.
- Planning is underway for a Phase II trial to be initiated in the first half of 2024.
- Planning is underway for a Phase II trial that is expected to begin screening patients in the first half of 2024.
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Dendreon RESEARCH TRIANGLE PARK, N.C., Jan. 10, 2022 /PRNewswire/ --Asklepios BioPharmaceutical, Inc. (AskBio), a leading, clinical-stage adeno-associated virus (AAV) gene therapy company and a wholly owned and independently operated subsidiary of Bayer AG, today announced that Philip Dana has been appointed to its executive team as Chief Human Resources Officer.
Key Points:
- RESEARCH TRIANGLE PARK, N.C., Jan. 10, 2022 /PRNewswire/ --Asklepios BioPharmaceutical, Inc. (AskBio), a leading, clinical-stage adeno-associated virus (AAV) gene therapy company and a wholly owned and independently operated subsidiary of Bayer AG, today announced that Philip Dana has been appointed to its executive team as Chief Human Resources Officer.
- Mr. Dana joins AskBio from Dendreon, where he served as Vice President and Head of Human Resources for the biopharmaceutical company.
- Mr. Dana joins AskBio following a17-year career in increasingly senior human resources roles for companies in biotech, medical device, nutraceuticals, technology and the non-profit sector, as well as a 14-year career serving in the United States Navy.
- Most recently, Dana served as Vice President & Head of Human Resources at Dendreon.
Branches of biology,
Muscular dystrophy,
Biology,
Applied genetics,
Limb–girdle muscular dystrophy,
Emerging technologies,
Medical genetics,
Molecular biology,
Adeno-associated virus,
Gene therapy,
Calpainopathy,
Gene therapy of the human retina LION-101 is a novel recombinant adeno-associated virus (rAAV) based vector being developed as a one-time intravenous infusion for the treatment of patients with Limb-Girdle Muscular Dystrophy Type 2I/R9 (LGMD2I/R9).
Key Points:
- LION-101 is a novel recombinant adeno-associated virus (rAAV) based vector being developed as a one-time intravenous infusion for the treatment of patients with Limb-Girdle Muscular Dystrophy Type 2I/R9 (LGMD2I/R9).
- AskBio's gene therapy platform includes Pro10, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library.
- Limb-girdle muscular dystrophy: MedlinePlus Genetics
2 National Institutes of Health -- National Center of Advancing Translational Sciences: Genetic and Rare Diseases Information Center.
- Limb-girdle muscular dystrophy type 2I | Genetic and Rare Diseases Information Center (GARD) an NCATS Program (nih.gov)
View original content to download multimedia: http://www.prnewswire.com/news-releases/askbio-announces-ind-for-lion-10...
"\nDetails on AskBio\'s presentations and presence at ASGCT include:\nTim Kelly, AskBio\'s President of Manufacturing, will participate in a panel discussion, "Considerations for the Clinical Development of Cell & Gene Therapies."
Key Points:
- "\nDetails on AskBio\'s presentations and presence at ASGCT include:\nTim Kelly, AskBio\'s President of Manufacturing, will participate in a panel discussion, "Considerations for the Clinical Development of Cell & Gene Therapies."
- The panel discussion among industry leaders will take place on Tuesday, May 11, 2021 from 6:00 p.m.
- AskBio\'s gene therapy platform includes Pro10, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library.
- AskBio does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof.\nView original content to download multimedia: http://www.prnewswire.com/news-releases/askbio-announces-presentations-a...\n'
Retrieved on:
Thursday, January 28, 2021
Branches of biology,
Neurological disorders,
Biology,
Neurodegenerative disorders,
Psychiatric diagnosis,
Rare diseases,
Emerging technologies,
Medical genetics,
Multiple system atrophy,
Parkinson's disease,
Glial cell line-derived neurotrophic factor,
Parkinson Dr. Bankiewicz will lead AskBios development efforts in Parkinsons disease and multiple system atrophy (MSA).
Key Points:
- Dr. Bankiewicz will lead AskBios development efforts in Parkinsons disease and multiple system atrophy (MSA).
- Dr. Bankiewicz commented, We are grateful for the collaboration weve had with AskBio and are honored to jointly accelerate clinical development of our gene therapy programs that we hope will benefit patients and families living with Parkinsons disease, multiple system atrophy and other neurological conditions.
- The one-time treatment involves infusion of a gene therapy solution into deep structures of the brain that are affected by Parkinsons.
- By enhancing levels of a naturally occurring growth factor, GDNF gene therapy is intended to promote the survival and functioning of vulnerable brain cells that degenerate in Parkinsons disease and MSA.
