Cell therapy weekly: ALS stem cell therapy will not be available under ‘Right to Try’ and new collaboration advances T-cell cancer therapies
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This week: The Alliance for Regenerative Medicine comments on proposed changes to Medicare’s payment system.
The news highlights:
BrainStorm will not make NurOwn® available under ‘Right to Try’
“New MS-DRG required for CAR-T therapies”: Alliance for Regenerative Medicine
AbbVie and Calibr to collaborate to develop solid tumor T-cell therapies
BrainStorm will not make NurOwn® available under ‘Right to Try’
BrainStorm Therapeutics (NY, USA) has announced it will not be making NurOwn®, its investigational platform for making therapeutic mesenchymal stem cells that secrete neurotrophic factors, available under ‘Right to Try’ (RTT) legislation enacted in the USA. NurOwn is currently being evaluated in a Phase III study for patients with amyotrophic lateral sclerosis (ALS).
“We feel a tremendous sense of urgency and responsibility to provide an ethical, compassionate, and well-reasoned practical response to the demand for NurOwn and have worked tirelessly with patients and other stakeholders to find a solution,” commented Chaim Lebovits, president and CEO of BrainStorm. “As we were unable to identify a practical funding solution, we unfortunately are not in a position to initiate access to NurOwn under RTT at this time.”
“New MS-DRG required for CAR-T therapies”: Alliance for Regenerative Medicine
The Alliance for Regenerative Medicine (ARM; DC, USA) has shared its recommendations on proposed changes to how regenerative medicines are paid for in the USA. The Centers for Medicare and Medicaid Services (CMS; MD, USA) proposed modifications to Medicare’s New Technology Add-on Payment Program (NTAP).
In the recommendations, ARM suggests that the unique patient experience in CAR-T therapies necessitates a new Medicare Severity Diagnosis Related Group and that certain FDA designations, such as the RMAT or Breakthrough designations, should be taken into account to reduce barriers to access. Another recommendation was that quarterly NTAP reviews, as opposed to the current annual schedule, would alleviate delayed access to these potentially life-saving therapies.
AbbVie and Calibr to collaborate to develop solid tumor T-cell therapies
AbbVie (Il, USA) and Calibr (CA, USA) have announced a collaboration that will aim to develop T-cell therapies based on Calibr’s proprietary ‘switchable’ CAR-T technology. Molecular ‘switches’ allow the activation and antigen specificity of CAR-T cells to be controlled, which could enable development of universal therapies for hematological and solid tumor indications. Under the agreement, AbbVie will gain exclusive access to the technology for up to four years in return for an upfront license fee.
“Calibr has assembled a premier scientific team and developed an innovative cell therapy technology that can take us to the next frontier of cancer treatment,” explained Mohit Trikha, vice president and head of Oncology Early Development at AbbVie. “The combination of AbbVie’s oncology discovery and early development expertise and Calibr’s novel switchable CAR-T therapy platform aims to advance the current standard of care, with the potential rapidly advancing new treatment options for patients.”
For more weekly cell therapy news, read previous editions of the cell therapy weekly.