Charles River to help FibroBiologics produce 3D cell-based therapies 

Charles River Laboratories has joined up with FibroBiologics to manufacture the company’s spheroids for clinical trials in multiple sclerosis (MS) and several other conditions.

The spheroids are groups of fibroblast cells arranged in a three-dimensional (3D) structure that more closely resemble how cells organize in living tissues. Fibroblasts are abundant in connective tissue and can regenerate damaged tissues, including nerve cell damage in MS.

“We are proud to discuss opportunities to work with Charles River, a global leader in cell and gene therapy development and manufacturing, as we look to advance our unique fibroblast-based spheroids into the clinic,” Pete O’Heeron, FibroBiologics’ founder and CEO, said in a company press release.

The two companies expect to enter into a master services agreement to develop and manufacture FibroBiologics’ cell banks and fibroblast-based spheroids. Charles River will also conduct feasibility studies on FibroBiologics’ cell manufacturing processes and produce drug products for certain clinical trials.

“We are both committed to bringing innovative and potentially curative therapies to patients suffering from chronic diseases,” O’Heeron said.

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Interest in cell-based therapies for MS growing

Cell-based therapies are gaining interest for treating MS and other neurodegenerative conditions. A kind of stem cell called mesencyhmal stem cells (MSCs) have shown promise in regenerating nerve function, but they are difficult and costly to collect, maintain, and grow for therapeutic use because there are so few in the body.

Fibroblasts are the main cell type in connective tissue. They are essential in wound healing and regenerating tissue and can modulate immune responses. Unlike MSCs, fibroblasts are one of the body’s most abundant cell types and they’re easier to harvest and cheaper to maintain and grow.

FibroBiologics is developing CYMS101, a fibroblast-based therapy made of human dermal fibroblasts (HDFs) that has had good results in preclinical studies.

In a MS mouse model, CYMS101 suppressed MS-driving immune cells while promoting the growth of immunosuppressive regulatory T-cells. The number of cells that produce myelin, the fatty, protective substance that surrounds the nerve fibers that’s damaged in MS, also increased.

A Phase 1 trial (NCT05080270) was launched to evaluate the safety of a single CYMS101 infusion directly into the bloodstream in five people with MS. Up to about four months after treatment, no side effects were reported and blood and cardiovascular tests showed no notable safety concerns.

In secondary efficacy measures, the therapy improved hand and finger dexterity along with cognitive function. While there were no changes in motor function, disability levels, or inflammatory lesions, no new lesions were observed.

Isolated cells used in therapies adopt a flat, two-dimensional shape, while spheroids are groups of cells that organize in three dimensions, better mimicking the normal state of cells in living tissues. As a result, spheroids provide stronger cell-to-cell interactions, potentially improving efficacy over standard cell therapies.

FibroBiologics is designing a Phase 2 study to assess the safety and efficacy of HDF spheroids in MS patients and the effect of multiple treatment infusions over 18 months, according to a separate press release.  The company also is developing fibroblast-based therapies for other indications, including degenerative disc disease, wound healing, psoriasis, thymic involution reversal, and cancer.