Benzinga | Jun 30, 2021 06:04AM EDT

Athersys Highlights Data Published In Scientific Reports Journal Involving MultiStem

Athersys, Inc. (NASDAQ:ATHX) announced today that data accumulated from several years of preclinical research was published in the peer-reviewed journal Scientific Reports. The publication describes the findings from extensive in vitro studies investigating the role Multipotent Adult Progenitor Cells (MAPC(r)), clinically known asMultiStem(r) (invimestrocel), have in modulating the inflammatory response. The report provides evidence of potential mechanisms by which MAPC cells promote regulatory T cell (Treg) differentiation and proliferation and influence their immune-suppressive phenotype. Tregs are important cells in the immune system, responsible for controlling inflammation and tissue repair after injury through several mechanisms. Dysregulated inflammatory responses are known to contribute to tissue and organ injury in multiple acute critical care indications, such as stroke, trauma, and acute respiratory distress syndrome (ARDS). Enhancement of endogenous, immunoregulatory mechanisms, including promoting Treg differentiation, proliferation, and phenotypic activity, is one way that MultiStem likely mitigates inflammatory organ injury and promotes recovery following tissue injury.

"Our work helps us understand how MAPC may induce Tregs in vivo, one of the potential mechanisms by which MAPC can help to reshape the hyperinflammatory response, thereby preventing exacerbated tissue damage," commented Dr. Alice Valentin-Torres, Senior Scientist and Immunologist at Athersys, and primary author of the article. "This study identifies factors secreted by MAPC and monocyte/macrophages as the primary mechanisms involved in MAPC induction of Tregs. We also observed that MAPC not only increase the number of Treg, but also enhance Treg suppressive function."

This study adds to the growing collection of scientific publications by Athersys and its collaborators relating to MAPC and the evidence elucidating how the cells modulate the inflammatory response initiated by acute injury, through down-regulation of inflammatory cytokines and immune cells that can exacerbate damage after an injury, such as a stroke. The described studies demonstrate that MAPC cells, via the secretion of soluble factors, not only increase the frequency of Tregs by promoting their differentiation and proliferation, but also promote Treg activation and suppressive functions. These data complement prior reports describing evidence of in vivo induction of Tregs in preclinical animal models and human volunteer participants in the Company's clinical development programs using MultiStem. The publication is available at http://www.nature.com/articles/s41598-021-93025-x and is listed on the Company's directory of scientific publications.

Athersys currently is undertaking three clinical studies evaluating MultiStem therapy, including a Phase 3 clinical study for the treatment of ischemic stroke, a Phase 2/3 clinical study for the treatment of ARDS, and a Phase 1/2 clinical study for the treatment of severe trauma. In addition, the Company's partner in Japan, HEALIOS K.K. (Healios), is nearing completion of its ischemic stroke study (TREASURE) and has recently completed enrollment in its ARDS (ONE-BRIDGE) study using MultiStem cell therapy. The data presented in this publication and other reports support the hypothesized mechanism of action for using MultiStem cell therapy in the ongoing clinical studies and provide support for other clinical indications in the future.

About MultiStem(r)

MultiStem(r) cell therapy (invimestrocel) is a patented regenerative medicine product candidate in clinical development that has shown the ability to promote tissue repair and healing in a variety of ways, such as through the production of therapeutic factors in response to signals of inflammation and tissue damage. MultiStem therapy's potential for multidimensional therapeutic impact may distinguish it from traditional biopharmaceutical therapies focused on a single mechanism of benefit. MultiStem represents a unique "off-the-shelf" stem cell product candidate that can be manufactured in a scalable manner, may be stored for years in frozen form, and is administered without tissue matching or the need for immune suppression. Based upon favorable outcome data, its novel mechanisms of action, and favorable and consistent tolerability data in clinical studies, we believe that MultiStem therapy may provide a meaningful benefit to patients, including those suffering from serious diseases and conditions with unmet medical need.