FDA Awards Fast Track Designation to IDP-023 for Non-Hodgkin Lymphoma and Myeloma

FDA

The FDA has granted fast track designation to the natural killer (NK) cell therapy IDP-023 for the treatment of patients with non-Hodgkin lymphoma (NHL) and multiple myeloma.¹

IDP-023 contains g minus NK (g-NK) cells, which have potential cytolytic and antineoplastic activities. IDP-023 is designed to recognize and lyse cancer cells, and the NK cells release proinflammatory cytokines intended to stimulate immune response.² Preclinical studies have shown that g-NK cells have greater cell killing capacity compared with conventional NK cells, and they do not require genetic engineering.1 G-NK cells occur as a result of epigenetic changes that occur because of cytomegalovirus exposure. IDP-023 is generated by expanding g-NK cells from healthy donors, with little variability between donors.

“This [fast track] 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 2 of the largest unmet needs in B-cell driven blood cancers, NHL and multiple myeloma,” Mark Frohlich, MD, chief executive officer of Indapta Therapeutics, stated in a news release.¹

IDP-023 is currently under investigation in a first-in-human phase 1/2 trial (NCT06119685), which is enrolling patients ages 18 years and older with advanced hematologic malignancies.³

To participate, patients with multiple myeloma must have relapsed/refractory disease after at least 3 prior lines of therapy. Those with NHL must also have relapsed/refractory disease after at least 2 lines of systemic chemotherapy. All patients are required to have an ECOG performance status of 0 or 1, as well as a life expectancy of more than 12 weeks per investigator assessment.

Key exclusion criteria include impaired cardiac function or history of clinical significant cardiac disease; HIV infection, active hepatitis B infection or hepatitis C infection; active COVID-19; and untreated central nervous system metastases, epidural tumor metastases, or brain metastases.

The study will evaluate IDP-023 both as monotherapy and as combination therapy. During phase 1, patients will receive a single dose of IDP-023 monotherapy, multiple doses of IDP-023 monotherapy, or multiple doses of IDP-023 in combination with multiple doses of interleukin-2 (IL-2). In phase 2, multiple doses of IDP-023 will be combined with rituximab (Rituxan) for patients with NHL and with daratumumab (Darzalex) for patients with multiple myeloma.

Primary end points for phase 1 include the incidence of adverse effects (AEs) and dose-limiting toxicities, and to determine the maximum tolerated dose. Objective response rate (ORR) for the NHL cohort and the multiple myeloma cohort will be the primary end point in phase 2. Key secondary end points in phases 1 and 2 include the pharmacokinetics of IDP-023. Phase 1 will also evaluate ORR, complete response (CR) rate, stringent CR rate, partial response (PR) rate, and very good PR rate in the myeloma cohort, as well as ORR in the NHL cohort. Phase 2 will also evaluate the incidence of AEs and serious AEs. 

In January 2023, Indapta Therapeutics announced that the first patients were treated with IDP-023 as a part of the study.⁴ The patients were treated at NEXT Oncology in Virginia, as well as The University of Texas MD Anderson Cancer Center in Houston. The first enrolled patient was given a single dose of the NK cell therapy, and the second patient received the first of 3 planned doses. Additional cohorts of patients will receive 3 doses of IDP-023 with or without IL-2.

References

1. Indapta Therapeutics receives U.S. FDA fast track designation for lead clinical drug candidate IDP-023 for non-Hodgkin’s lymphoma and myeloma. News release. Indapta Therapeutics. February 29, 2024. Accessed February 29, 2024. https://www.businesswire.com/news/home/20240229681905/en
2. Allogeneic natural killer cells IDP-023. National Cancer Institute. Accessed February 29, 2024. https://www.cancer.gov/publications/dictionaries/cancer-drug/def/allogeneic-natural-killer-cells-idp-023
3. IDP-023 as a single agent and in combination with antibody therapies in patients with advanced hematologic cancers. ClinicalTrials.gov. Updated February 28, 2024. Accessed February 29, 2024. https://clinicaltrials.gov/study/NCT06119685
4. Indapta Therapeutics announces first patients treated with IDP-023 allogeneic natural killer (NK) cell therapy for cancer. News release. Indapta Therapeutics. January 11, 2024. Accessed February 29, 2024. https://www.businesswire.com/news/home/20240111941372/en/Indapta-Therapeutics-Announces-First-Patients-Treated-with-IDP-023-Allogeneic-Natural-Killer-NK-Cell-Therapy-for-Cancer