The company also shared that it has manufactured sufficient IDP-023 to supply the Phase 1 clinical trial through the second half of 2024.
Indapta Therapeutics has treated the first 2 patients with multiple myeloma (MM) and non-Hodgkin lymphoma (NHL) in a phase 1 clinical trial (NCT06119685) evaluating IDP-023 natural killer cell (NK) therapy.1
“This is a major milestone achievement for our team who successfully demonstrated the reproducibility of our manufacturing process and designed a robust clinical trial,” Mark Frohlich, MD, chief executive officer, Indapta, said in a statement.1 “G-NK cells have demonstrated highly potent antibody dependent cytotoxicity in combination with monoclonal antibodies in preclinical models and we are excited to evaluate the safety and clinical activity of G-NK cells in this Phase 1 trial.”
One patient was treated at theUniversity of Texas MD Anderson Cancer Center and received a single dose of IDP-023. Another patient was treated atNEXT Oncology in Virginia and has received the first of 3 planned doses. The trial 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, cohorts of patients with lymphoma and MM will then receive IDP-023 in combination with rituximab and daratumumab, respectively.
IDP-023 is developed using Indapta’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. The company 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. Indapta has manufactured sufficient IDP-023 to supply the Phase 1 clinical trial through the second half of 2024.
“We are very pleased with the high yields we are achieving in our good manufacturing practice production runs,” Frohlich added.1 “The recent improvements in our manufacturing process together with additional planned process changes should position us well for a competitive cost of goods by the time of product launch.”
The trial’s primary endpoints are incidences of adverse events, dose-limiting toxicities, maximum tolerated dose, and anti-tumor activity in phase 2 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 include pharmacokinetics of IDP-023. Indpata previously announced the investigational new drug (IND) clearance of IDP-023 in May 2023.2
“We are excited to transition to a clinical stage company,” Frohlich said in an earlier statement.2 “Based on the encouraging clinical activity of NK cells demonstrated by others and the superior activity of IDP-023 compared to conventional NK cells in preclinical models, we are looking forward to evaluating the safety and clinical activity of IDP-023 in this Phase 1 trial.”
Study participants must have a documented diagnosis requiring systemic therapy and relapsed and/or refractory (R/R) 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 (ECOG) 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 (HIV) 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 trial.