Novel Cell Therapy Candidate for Non-Hodgkin’s Lymphoma, Multiple Myeloma Gets Fast-Track Designation

Indapta Therapeutics, Inc. has announced that its novel cell therapy, which uses natural killer (NK) cells, has received Fast Track designation from the FDA.

“This designation highlights the promise of Indapta’s highly potent NK cell platform and will further accelerate clinical development of our lead drug candidate, IDP-023, for two of the largest unmet needs in B-cell driven blood cancers, non-Hodgkin’s lymphoma and multiple myeloma,” Mark Frohlich, M.D., Indapta’s CEO, stated in a Feb. 29, 2024, news release.

The FDA Fast Track process increases communication and collaboration between the FDA and the pharmaceutical developer regarding a new drug candidate. This typically allows fast-tracked drug candidates to receive expedited reviews. The process ultimately helps prioritize new treatment options available for patients with serious, difficult-to-treat conditions.

If approved, IDP-023 would become an additional therapy for the treatment of non-Hodgkin’s lymphoma and multiple myeloma, two of the most common blood cancers. Non-Hodgkin’s lymphoma and multiple myeloma are cancers of the blood. Non-Hodgkin’s lymphoma occurs in white blood cells known as lymphocytes. Non-Hodgkin's lymphoma is one of the most common cancers in the United States, with an estimated 80,000 individuals diagnosed each year. Multiple myeloma, which develops in plasma cells, affects approximately 30,000 Americans annually.

The NK cells that IDP-023 contain are a type of immune cell. Typically, they attach to cells recognized as not belonging to the body, such as bacteria or cancer cells, and release signals that launch a widespread immune response against the foreign target. NK cells can enhance the immune response against cancer cells, particularly when used with immunologic therapies, such as monoclonal antibody agents.

IDP-023 consists of a particular type of NK cell known as a g-NK cell, which shows potential for improving the treatment of certain blood cancers. Animal studies of IDP-023 paired with a certain monoclonal antibody treatment showed a sixfold increase in antimyeloma activity compared to normal NK cell plus monoclonal antibody treatment.

Based on these results in animals, Indapta, which is based in Seattle and Houston, announced an update of IDP-023’s phase 1 trial status, with the first trial participants receiving the drug in January 2024. The trial participants will initially receive one to three doses of IDP-023 in order to establish a safe dose range. Once a potentially safe dosing regimen is identified, participants with non-Hodgkin’s lymphoma or multiple myeloma will begin receiving IDP-023 along with a monoclonal antibody treatment. Those with non-Hodgkin’s lymphoma will receive Rituxan (rituximab), while those with multiple myeloma will receive Darzalex (daratumumab).