Sean M. Healey & AMG Center for Integrated ALS Care and Discovery announces first participant enrolled in Healey ALS MyMatch BANYAN Trial with Tiziana Life Sciences
The Sean M. Healey & AMG Center for ALS at Mass General Brigham is pleased to announce that the first participant has received study medication in the Healey ALS MyMatch BANYAN Trial (ClinicalTrials.gov identifier: NCT07688239) evaluating foralumab sponsored by Tiziana Life Sciences and co-funded by the ALS Association. This marks the initiation of the second trial in Healey ALS MyMatch.
The Healey ALS MyMatch program is reshaping the future of ALS clinical trials by harnessing the power of biomarker-driven personalized trial approaches. By integrating comprehensive genetic and biofluid biomarkers, the program matches subgroups of ALS individuals to various experimental therapies based on their disease markers. Healey ALS MyMatch is an ongoing series of early-phase clinical trials (Phase 1b/2a), aimed at deepening the understanding of biological effects of experimental products, and identifying the optimal population for future phases 2/3 clinical trials. Each trial in Healey ALS MyMatch is named after a tree to symbolize our striving for hope and the deep scientific roots from which the trial stems.
Foralumab, a fully human anti-CD3 monoclonal antibody, is a biological drug candidate that has been shown to stimulate T regulatory cells when dosed intranasally. Intranasal foralumab is currently being studied in a Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in patients with non-active secondary progressive multiple sclerosis (NCT06292923), as well as additional Phase 2 trials in Alzheimer’s Disease and Multiple Systems Atrophy.
On October 1, at 5:00pm ET, the Healey & AMG Center will host a community webinar with Tiziana to discuss the science behind foralumab. Register for the webinar here.
The BANYAN Trial is led by Suma Babu, MBBS, MPH, Principal Investigator of Healey ALS MyMatch and Co-Director of the Neurological Clinical Research Institute (NCRI), and James Berry, MD, MPH, Director of the Mass General Brigham Neuroscience Institute Clinical Trials Center for Neurotherapeutics, Chief of the Division of ALS and Motor Neuron Diseases, and Director of the NCRI.
“This study serves as an important step in advancing the development of foralumab for ALS,” says Dr. Babu. “The BANYAN trial is designed to answer important questions about foralumab – specifically, whether it has a biological effect in ALS, as measured by TSPO-PET, T cell subset profiling, immunological biomarkers, including cell-based assays.”
This trial is made possible by the contributions of patients and families, foundations and anonymous donors to the Healey & AMG Center for ALS, trial sites, and industry and research partners. The BANYAN trial is also partially funded by the ALS Association’s Hoffman ALS Clinical Trial Awards Program.
“We are proud to support the early clinical development of potential new treatments that hold promise for people living with ALS through our Hoffman ALS Clinical Trial Awards Program,” said Dr. Kuldip Dave, Senior Vice President of Research at the ALS Association. “By funding programs at this critical stage, and with the support of partners like the Healey & AMG Center, we are working to accelerate the development of therapeutic candidates that can help make ALS livable until we can cure it.”
“Thank you to all contributors for your dedication to this trial,” says Dr. Berry. “We are excited to continue expanding the program and accelerate the drug pipeline by conducting early phase clinical trials in ALS.”
For more information about the BANYAN Trial and for updates on research centers, please visit ClinicalTrials.gov.
Healey ALS MyMatch is a multi-site collaborative initiative that currently brings together four trial-ready, high enrolling ALS research centers and is a Network of Excellence for ALS (NEALS) affiliated program. Currently the BANYAN trial is being conducted at the Healey & AMG Center in Boston, Mass.; with plans for expanding to additional research centers including University of Minnesota in Minneapolis, Minn.; The Les Turner ALS Center at Northwestern Medicine in Chicago, Ill.; and Nova Southeastern University in Fort Lauderdale, Fla. Additional trial-ready, experienced NEALS member sites will be added to Healey ALS MyMatch for 2026-27. Organizations can apply on the ALS MyMatch website.
Learn more about Healey ALS MyMatch
Media contact
Brandon Chase
Senior Specialist, External Communications
bchase7@mgb.org
About the Sean M. Healey & AMG Center for Integrated ALS Care and Discovery at Mass General Brigham
At the Sean M. Healey & AMG Center for ALS at Mass General Brigham, we are committed to bringing together a global network of scientists, physicians, nurses, foundations, federal agencies, and people living with ALS, their loved ones, and caregivers to accelerate the pace of ALS therapy discovery and development.
Launched in November 2018, the Healey & AMG Center, under the leadership of Merit Cudkowicz, MD is reimagining how to develop and test the most promising therapies to treat the disease, identify cures and ultimately prevent it.
With many clinical trials and lab-based research studies in progress right now, we are ushering in a new phase of ALS treatment and care. Together, we will find the cures.
About the Neurological Clinical Research Institute
The Neurological Clinical Research Institute (NCRI) at Mass General Brigham is an academic research organization composed of innovative researchers experienced and passionate about designing, developing, facilitating, and conducting multicenter clinical trials in neurological diseases. Our mission is to accelerate translational research in neurological disorders by initiating clinical development of novel therapies and leading trials of these compounds. We strive to be at the cutting edge of innovative trial design to accelerate therapy development by creating new trial methodology, discovering novel biomarkers and refining outcome measures.
About Mass General Brigham
Mass General Brigham is an integrated academic health care system, uniting great minds to solve the hardest problems in medicine for our communities and the world. Mass General Brigham connects a full continuum of care across a system of academic medical centers, community and specialty hospitals, a health insurance plan, physician networks, community health centers, home care, and long-term care services. Mass General Brigham is a nonprofit organization committed to patient care, research, teaching, and service to the community. In addition, Mass General Brigham is one of the nation’s leading biomedical research organizations with several Harvard Medical School teaching hospitals. For more information, please visit massgeneralbrigham.org.