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Indapta Therapeutics Receives Fast Track Designation from U.S. FDA for Lead Clinical Drug IDP-023, Aimed at Non-Hodgkin’s Lymphoma and Myeloma

Friday, March 01, 2024

Indapta Therapeutics, a privately held biotechnology company focused on developing innovative cell therapies for cancer and immune-related diseases, has received Fast Track designation from the U.S. FDA for its leading clinical program, IDP-023. This designation is for treating patients with non-Hodgkin’s lymphoma and multiple myeloma.

The FDA's Fast Track process is aimed at accelerating the availability of drugs for severe conditions with unmet medical needs. It allows for expedited development and review of drugs. Companies granted Fast Track status may receive benefits such as increased interactions with the FDA, Accelerated Approval, Priority Review, and Rolling Review of a Biologic License Application (BLA).

Indapta, expressed optimism about the designation, stating, "This recognition highlights the potential of Indapta’s potent NK cell platform and will expedite the clinical development of IDP-023 for two significant unmet needs in B-cell driven blood cancers."

Indapta's Phase 1 clinical trial is currently enrolling patients who will receive up to three planned doses of IDP-023 with or without interleukin-2. Following the establishment of safety with multiple doses in combination with interleukin-2, patients with lymphoma and multiple myeloma will be treated with IDP-023 in combination with the monoclonal antibodies rituximab and daratumumab, respectively.

Indapta's cell therapy platform utilizes a subset of naturally occurring NK cells known as "G minus" NK cells, or "g-NK," which have enhanced killing capacity compared to conventional NK cells. These g-NK cells are derived from exposure to cytomegalovirus (CMV). Indapta selectively expands g-NK cells from healthy donors with high quantities of g-NK cells and low donor-to-donor variability.

Preclinical studies have shown that IDP-023, when combined with cancer-targeting monoclonal antibodies, exhibits more potent and durable antitumor activity compared to conventional NK cells.



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