Research News

Recent News and Study Updates in MS Research

By Susan Wells Courtney and Tom Garry
Reviewed by Dr. Barry A. Hendin, MSAA Chief Medical Officer

Cell Therapy for Treatment-Resistant Progressive MS Receives FDA Fast Track Designation

In January 2024, the Food and Drug Administration (FDA) granted Fast Track designation to a cell therapy being evaluated for the treatment of refractory (treatment-resistant) progressive MS, among other disorders. The investigational medication, KYV-101, is a chimeric antigen receptor T-cell (CAR-T) therapy being developed by Kyverna Therapeutics.

CAR-T therapy is a sophisticated form of immunotherapy being used to treat many cancers and several autoimmune conditions. With these therapies, blood is taken from the patient so that their T cells, which are white blood cells that play a key role in the body’s immune responses, can be isolated. A gene for a receptor – known as a chimeric antigen receptor, or CAR – is added to the T cells to enable them to attach to a specific cell antigen and thus better fight a particular condition. The treated T cells are then reintroduced to the patient through intravenous infusion.

KYV-101 is an autologous (meaning taken from the patient), fully human chimeric CAR-T therapy that targets CD19, a protein expressed on the surface of B cells. Like T cells, B cells are white blood cells that play a role in immune function. They have been implicated in the development of MS.

The FDA Fast Track designation was announced roughly two weeks after the FDA gave Kyverna Therapeutics clearance to evaluate KYV-101 in a Phase II trial that will enroll people with progressive forms of MS who are not responding satisfactorily to currently available treatments. Fast Track designation is an FDA program intended to facilitate and expedite the development and review of new drugs to address an unmet medical need in the treatment of a serious condition.

Ocrevus® Trial Exclusively Enrolling Black and Hispanic People Yields Encouraging Results

More than 94% of Black and Hispanic people with relapsing MS had no relapses during 48 weeks of treatment with the disease-modifying therapy (DMT) Ocrevus® (ocrelizumab), while no evidence of disease activity (NEDA) at Week 48 (the study’s primary endpoint) was achieved by 46% of Black patients and 58% of Hispanic patients. These were the findings of the CHIMES study, the first clinical trial of a DMT conducted exclusively in Black and Hispanic people with MS. CHIMES – which stands for characterization of ocrelizumab in minorities with multiple sclerosis – was a Phase IV trial, meaning that it was conducted following approval of the medication by the Food and Drug Administration (FDA).

The prospective, single-arm trial enrolled 182 Black or Hispanic people with relapsing MS who were 18 to 65 years old and who had an Expanded Disability Status Scale (EDSS) score of 0-5.5, indicating minimal to moderate MS disease burden. Researchers noted that the safety results of CHIMES were consistent with the findings of other trials of Ocrevus, with no new safety signals emerging.

“We are extremely excited about reporting data from CHIMES, the first Phase IV clinical trial focused on Black and Hispanic people living with MS,” said Mitzi Joi Williams, MD, lead trial investigator, founding medical director at Joi Life Wellness MS Center in Atlanta, GA, and chairperson of MSAA’s African American Advisory Board. Dr. Williams added, “We hope that the findings will not only improve the understanding of MS in minoritized groups, but also provide successful strategies to recruit and retain diverse populations in clinical trials on a larger scale.”

Studies with Frexalimab Show Encouraging Results

Frexalimab is an investigational medication that takes a new approach to treating multiple sclerosis. This monoclonal antibody inhibits CD40L, a protein expressed by T-cells, which is a type of immune system cell that plays a role in MS. Frexalimab is thought to block T-cell interactions with two other types of immune system cells – B-cells and innate antigen presenting cells (APCs) – that also are involved in the MS disease process.

While T-cells express CD40L, B-cells and innate APCs express a similar protein, CD40. The CD40/CD40L costimulatory pathway regulates immune responses and has been implicated in both acute and chronic MS. Researchers say that frexalimab modulates T-cell and B-cell activation and innate immune cell function without depleting B-cells.

In the initial, 12-week portion of the Phase II study, participants with relapsing MS taking placebo and then switching to either a high or low dose of frexalimab, saw a significant decline of new gadolinium-enhancing T1 lesions after 12 weeks of treatment. In the open-label portion of the Phase II study, 96% of those taking a high dose of frexalimab developed no new gadolinium-enhancing lesions on Tesla 1 (T1) magnetic resonance imaging (MRI) over a 24-week period, and 91% had no new or enlarging lesions on Tesla 2 (T2) MRI. The results for those taking a lower dose were 80% and 74%, respectively.

These results are the first data to be generated by a Phase II trial of an anti-CD40L medication in multiple sclerosis. Researchers said that the findings support further investigation of frexalimab for the treatment of relapsing MS.

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