Indapta plans trial of cell-based therapy IDP-023 in progressive MS
Trial studying treatment along with Ocrevus to start later this year
Indapta Therapeutics will launch a Phase 1 clinical trial in the U.S. in the second half of 2024 to explore its cell-based therapy IDP-023 in people with progressive forms of multiple sclerosis (MS).
The announcement follows the U.S. Food and Drug Administration’s (FDA) clearance of the company’s investigational new drug (IND) application, a formal request seeking approval to move a drug into clinical trials.
Researchers at Stanford University and the University of California San Francisco will lead the trial, according to a company press release.
The researchers will evaluate the use of IDP-023 along with Ocrevus (ocrelizumab), the only disease-modifying therapy approved for primary progressive MS, one of the progressive types of the disease. Using a translational program developed by both universities, researchers will examine IDP-023’s biological effects in people with progressive forms of MS.
IDP-023 is a cell-based therapy made of natural killer (NK) cells, a type of immune cell that plays an important role in keeping MS-driving inflammation in check. They can also help to eliminate cells that have been flagged by specific antibodies — a process called antibody-dependent cell-mediated cytotoxicity (ADCC).
Eliminating targeted cells
The cells in IDP-023 belong to a rare subset of NK cells that have undergone certain modifications after coming in contact with cytomegalovirus. Known as g-N cells, they lack a protein called FceR1-gamma.
Compared with conventional NK cells, g-NK cell have a greater ability to kill targeted cells via ADCC. They also last longer in the body and have a more favorable metabolic profile.
Because the cells are superior to conventional NK cells in combination with antibodies, it’s expected that IDP-023 can help boost the effects of MS antibodies such as Ocrevus, which is designed to bind to the CD20 protein at the surface of immune B-cells and promote their death.
IDP-023 may also help to eliminate certain other immune cells that participate in the inflammatory attacks that drive MS.
NK cells also are particularly good at recognizing and killing virus-infected cells that may escape other immune surveillance systems. So IDP-023 may help to eliminate immune cells infected with the Epstein-Barr Virus (EBV) to further prevent disease progression. EBV infection is the strongest risk factor for MS; it’s believed that when some immune cells go after the virus, they produce antibodies that can also wrongly target the brain and spinal cord.
“I am excited to participate in this clinical trial because of the multiple potential mechanisms by which g-NK cells may impact the biology of MS,” said Lawrence Steinman, MD, principal investigator and professor of medicine at Stanford. “In addition to being able to achieve B cell depletion by combining with a B cell directed monoclonal antibody, g-NK cells have the ability to kill … autoreactive T and B cells.” The cells’ “potent anti-viral activity” may also “address the Epstein Barr Virus reservoir that contributes to the disease” mechanism, he said.
Separately, Indapta is conducting a Phase 1/2 trial (NCT06119685) to evaluate the safety and efficacy of IDP-023, alone or in combination with antibody-based therapies, in people with non-Hodgkin’s lymphoma and multiple myeloma.
“This IND is another in a series of milestone achievements from our team in recent months,” said Mark Frohlich, MD, CEO of Indapta. “We look forward to the second half of the year during which we plan to initiate this trial and continue progress with our ongoing Phase 1/2 trial of IDP-023 in patients with hematologic cancers, where we have seen very encouraging responses to date.”
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