Manus Neurodynamica has been named an awardee in the ‘Improving Detection of Neurotoxicity in Immunotherapies’ QuickFire Challenge managed by Johnson & Johnson Innovation for its application of the NeuroMotor Pen technology in the detection of neuromotor adverse effects following CAR T-cell therapy. 

The ‘Improving Detection of Neurotoxicity in Immunotherapies’ QuickFire Challenge looks to improve outcomes for patients undergoing immunotherapy by furthering technologies that enable the early detection of neurotoxic events. Innovators were invited to pitch methods and technologies aiming to identify clinical manifestations to predict acute toxicities, including movement and neurocognitive disorders. The NeuroMotor Pen has the potential to address such a need.

CAR T-cell therapy is a personalised treatment option for various types of cancer. CAR T-cell therapy entails removing or harvesting T-cells from a patient with cancer, transfecting the cells with CAR genes that are directed against the patient’s tumour type, then expanding the modified T-cell population and reinfusing the cells back into the patient.

A significant complication of CAR T-cell therapy is the immune effector cell-associated neurotoxicity syndrome (ICANS). This syndrome presents a continuum from mild tremor to cerebral oedema (excess accumulation of fluid on the brain) and in a minority of cases, death. Management of ICANS is mainly supportive, with a focus on seizure prevention and attenuation of the immune system, often using corticosteroids. 

The earliest manifestations of ICANS include tremor, dysgraphia, mild difficulty with expressive speech, impaired attention, apraxia, mild lethargy, headache, and mild encephalopathy. Early detection of ICANS can prevent progression to debilitating & irreversible deterioration. 

However, there are currently no technologies on the market that are sensitive enough to detect the subtle early signs of ICANS and that’s where Manus aims to address this market with its NeuroMotor Pen. 

The NeuroMotor Pen is a medical device with high sensitivity for detection of subtle movement abnormalities and aspects of cognition that cannot easily be detected with the naked eye or any of the available wearables. The NeuroMotor Pen can be configured to support administering CAR T-cell as well as other immunotherapies in a safe way with reduced risk to patients. 

Following CAR T-cell treatment in the hospital, this solution can be applied at home for remote monitoring of patients by a healthcare professional. Patients will perform easy to execute drawing tasks daily in the month following treatment. The next step for Manus will be a clinical trial and optimisation of the NeuroMotor Pen configuration for the specific utility for improved safety of CAR T-Cell therapy administration. 

Manus aims to improve patient health benefit and reduce anxiety of patients and their carers and family.

CAR T-Cell therapy is used in acute lymphocytic leukaemia, diffuse large B-cell lymphoma, mantle cell lymphoma, follicular lymphoma, and other types of cancer. The diffuse large B-cell lymphoma segment dominates the CAR T-cell therapy market due to increase in incidence of this most common type of non-Hodgkin lymphoma. According to WHO, globally, around 544,352 new non-Hodgkin lymphoma cases were recorded in 2020.

The global CAR T-Cell Therapy market is estimated to develop at a compound annual growth rate (CAGR) of 31.2%. The global CAR T-Cell Therapy market size was valued at $6.1 billion in 2021, and it is predicted to exceed $21 billion by 2030.

Dr Rutger Zietsma, CEO of Manus, said: “I am delighted with the award from Johnson & Johnson Innovation. My first exposure to the medical device industry and training was with The Johnson & Johnson family of companies and this inspired me to take up a career in medical device innovation. We now have a unique opportunity aiming to further the utility of the NeuroMotor Pen that was previously proven in other areas and put it to use in immunotherapy. Reducing the risk of patients developing irreversible and sometimes life-threatening side effects of immunotherapy in cancer is a hugely worthwhile new focus areas for Manus with the potential to improve outcomes for many patients. 

“We look forward to benefiting from the expertise of the Johnson & Johnson Innovation team as part of our award as we look to initiate the clinical trial to deliver a potential solution to this growing cause of long-term illness.”