Manus named awardee in ‘Improving Detection of Neurotoxicity in Immunotherapies’ QuickFire Challenge
Edinburgh, UK – 24 April 2023: Manus Neurodynamica Limited (“Manus”), which develops and markets products and technologies for neuromotor assessment, announces that it has been named an awardee in the ‘Improving Detection of Neurotoxicity in Immunotherapies’ QuickFire Challenge managed by Johnson & Johnson Innovation LLC for its application of the NeuroMotor PenTM tech-nology 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 PenTM 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 popu-lation 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 (ex-cess 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.1 2 Early de-tection 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 PenTM.
The NeuroMotor PenTM is a medical device with very 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 PenTM 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 unique scalable potential solution can be applied at home for remote monitoring of patients by a healthcare professional. Patients will perform easy to execute drawing tasks on a daily basis in the month following treatment.
The next step for Manus will be a clinical trial and optimisation of the NeuroMotor PenTM 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 20203.
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 USD 6.1 billion in 2021, and it is predicted to exceed USD 21.0 billion by 2030.4
Dr Rutger Zietsma, CEO of Manus, commented: “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 PenTM 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.”
|Manus Neurodynamica Ltd|
Dr Rutger Zietsma, Chief Executive Officer
|+44 131 563 5465|
|Walbrook PR (PR advisors to Manus)|
Lianne Applegarth / Phil Marriage
|+44 20 7933 8780|
+44 7584 391 303 / +44 78 67 984 0 82
Notes to Editors
About Manus Neurodynamica – www.manusneuro.com
Dr Rutger Zietsma founded Manus in August 2008. The Company’s main activity is designing, patenting and marketing innovative technologies used in medical devices and personal care products which have the capability to improve people’s health and wellbeing. The Company implements quality procedures to medical standards.
Its principal product is a sensory pen designed for use in the diagnosis and monitoring of neuromotor impairments. The pen particularly focuses on patients with Parkinson’s disease and uses limb and hand motion to diagnose patients quickly and non-invasively. It has applications across not just diagnosis but also screening, monitoring, rehabilitation and drug development for a number of different movement disorders.
About NeuroMotor PenTM
NeuroMotor Pen™ (NMP) is a unique, patented and CE marked system that combines sensor technologies built into a digital pen with software and an analytical engine with Decision Support System.
The interface enables users to re cord non invasively and analyse parameters of minute limb and hand motion. This enables quantification of fine motor skill. These parameters are used as ‘digital biomarkers’ to provide objective information about movement abnormalities. NMP can be used to support differential diagnosis and monitoring of movement disorders and other neuromotor impairments. It has the potential to be a quick, inexpensive, non invasive, and objective aid to diagnosis that can provide a low cost alternative to brain scans. Ther e are additional applications in prevention screening, monitoring, rehabilitation and drug development for a number of different movement disorders.
Breakthrough Designation has been granted by the FDA for the proposed indication of using the NeuroMotor PenTM to support health care providers (HCPs) in differentiating between Parkinsonian and non-Parkinsonian tremors in adult patients who are suspected to have Parkinson’s Disease (PD) but have not been diagnosed by other means.
1 Bianca D. Santomasso; Jae H. Park; Darin Salloum; Isabelle Riviere; Jessica Flynn; Elena Mead; Elizabeth Halton; Xiuyan Wang; Brigitte Senechal; Terence Purdon; Justin R. Cross; Hui Liu; Behroze Vachha; Xi Chen; Lisa M. DeAngelis; Daniel Li; Yvette Bernal; Mithat Gonen; Hans-Guido Wendel; Michel Sadelain; Renier J. Brentjens, Clinical and Biological Correlates of Neurotoxicity Associated with CAR T-cell Therapy in Patients with B-cell Acute Lymphoblastic Leukemia, Cancer discovery, Volume 8, issue 8, 1st August 2018. https://aacrjournals.org/cancerdiscovery/article/8/8/958/10154
2 Daniel W Lee, Bianca D Santomasso, Frederick L Locke, Armin Ghobadi, Cameron J Turtle, Jennifer N Brudno, Marcela V Maus, Jae H Park, Elena Mead, Steven Pavletic, William Y Go, Lamis Eldjerou, Rebecca A Gardner, Noelle Frey, Kevin J Curran, Karl Peggs, Marcelo Pasquini, John F DiPersio, Marcel R M van den Brink, Krishna V Komanduri, Stephan A Grupp, Sattva S Neelapu, ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells, Biol Blood Marrow Transplant, 2019 Apr;25(4):625-638. doi: 10.1016/j.bbmt.2018.12.758. Epub 2018 Dec 25.
3 Mafra A, Laversanne M, Gospodarowicz M, et al. Global patterns of non-Hodgkin lymphoma in 2020. Int J Cancer. Published online June 13, 2022. doi:10.1002/ijc.34163
4 CAR T-Cell Therapy Market to Exceed Valuation of US$ 21 Bn by 2030 | BioSpace