Earlier this year, IDP-023 received fast track designation by the FDA for the treatment of patients with multiple myeloma and non-Hodgkin lymphoma.
Mark Frohlich, MD
(Credit: LinkedIn)
According to a new announcement, the FDA has cleared the investigational new drug (IND) application for Indapta Therapeutics’ g-natural killer (g-NK) cell therapy IDP-023 to be assessed in a phase 1 clinical trial for the treatment of patients living with progressive multiple sclerosis (MS).1
“We are very encouraged that the FDA has cleared our phase 1 trial for the use of our g-NK cell therapy, IDP-023, for the treatment of patients with progressive MS. There is a high unmet need for these patients, with ocrelizumab (Ocrevus; Roche) being the only FDA approved therapy for patients with primary progressive MS,” Mark Frohlich, MD, CEO at Indapta, told NeurologyLive®. “G-NK cells in combination with ocrelizumab have the potential to eliminate the autoreactive T and B cells that are responsible for the disease. Given the poor prognosis of these patients, a new therapy with novel mechanisms of action has the potential to be transformative for progressive MS."
In the trial, investigators from Stanford University and the University of California, San Francisco (UCSF), will examine the biologic effects of IDP-023 using a translational program developed in collaboration by both universities. During the study, the participants with progressive MS will be given IDP-023 in combination with the FDA approved anti-CD20 monoclonal antibody, ocrelizumab. For context, ocrelizumab remains the only approved therapy for the treatment of progressive MS.
“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,” principal investigator Lawrence Steinman, MD, a professor of medicine at Stanford, said in a statement.1 “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 HLA-E expressing autoreactive T and B cells. In addition, g-NK cells have potent anti-viral activity, and therefore may also address the Epstein Barr Virus reservoir that contributes to the disease pathogenesis.”
The company is currently conducting a phase 1/2 trial (NCT06119685) of IDP-023 among patients with multiple myeloma (MM) and non-Hodgkin lymphoma (NHL)after receiving fast track designation by the FDA in February 2024.2 A month prior to the designation, Indapta announced that the company treated the first 2 participants in the phase 1 portion of the trial.3
One of the patients was treated at the University of Texas MD Anderson Cancer Center and received a single dose of IDP-023. The other patient was treated at NEXT Oncology in Virginia and received the first of 3 planned doses. The study will enroll subsequent cohorts of patients to receive 3 doses of therapy with or without interleukin-2. If safety is established with multiple doses of IDP-023, the cohorts of patients with lymphoma and MM will then receive IDP-023 in combination with rituximab and daratumumab, respectively.
IDP-023 is developed using the company’s allogeneic NK cell therapy platform that uses naturally occurring NK cells, g-NK cells that arise from epigenetic changes resulting from exposure to cytomegalovirus. Indpata preferentially expands g-NK cells from healthy donors with increased numbers of g-NK cells to generate IDP-023. These allogeneic NK cells have low variability. The company noted that it has manufactured sufficient IDP-023 to supply the phase 1 trial through the second half of 2024.
The primary end points in phase 2 of the trial include incidences of adverse events, dose-limiting toxicities, maximum tolerated dose, and anti-tumor activity as assessed by objective response rate (ORR), complete response, stringent complete response, very good partial response, and partial response in patients with MM and ORR in patients with NHL. Secondary outcomes will include pharmacokinetics of IDP-023.
Participants in the study must have a documented diagnosis requiring systemic therapy and relapsed and/or refractory disease after at least 3 prior lines of therapy for MM, or for NHL, at least 2 prior lines of therapy. They must also have Eastern Cooperative Oncology Group performance status of 0 or 1 and life expectancy of greater than 12 weeks per investigator assessment.
Patients with impaired cardiac function or history of clinical significant cardiac disease, human immunodeficiency virus infection, active hepatitis B infection, or hepatitis C infection, active SARS-CoV-2 infection, or untreated central nervous system, epidural tumor metastasis, or brain metastasis will be excluded from the study.
