Associated tags: Patient, Doctor of Philosophy, Bayer, Safety, Heart, MD, Pharmaceutical industry, Gene, Guideline, Heart failure, Executive Committee, CHF, Cardiomyopathy, Triangle Park (Quezon City), NYHA
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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.”
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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.
