The phase 1/2a clinical trial will take place at the University of Texas MD Anderson Cancer Center, aiming to enroll more than 100 patients.
On June 21, 2023, Invectys initiated a phase 1/2a clinical trial (NCT05672459) for IVS-3001, a chimeric antigen receptor T-cell (CAR-T) therapy intended to treat solid tumors, according to a July 13 announcement from the company.1
IVS-3001 targets HLA-G, a checkpoint molecule that under normal conditions is only expressed during pregnancy to protect the fetus from an immune response but is also expressed by some cancers. The clinical trial, which has begun recruiting patients, includes indication-specific cohorts for patients with HLA-G-positive clear cell renal cell carcinoma and HLA-G-positive epithelial ovarian carcinoma, but is also open to patients with other types of HLA-G-positive solid tumors. Development on IVS-3001 was carried out in a collaboration between Invectys, the University of Texas MD Anderson Cancer Center, and the Cell Therapy Manufacturing Center (CTMC), which was itself launched in a collaborative effort by MD Anderson and National Resilience, Inc.2 CTMC’s role in the collaboration was to develop a clinical grade CAR-T product from Invectys’ HLA-G platform able to be produced at-scale. The clinical trial is taking place at MD Anderson Cancer Center.1
“Invectys is entering a new, thrilling phase of its development,” Jake Kushner, MD, an endocrinologist and medical director of McNair Interests whose appointment as Invectys’ new CEO was announced simultaneously with the trial’s initiation, said in a statement.1 “CAR-T cells have delivered stunning results in blood cancers, but their promise in solid tumors has yet to be fulfilled. Invectys has the potential to turn this promise into a reality and breathe new hope into the cancer care field. I am honored and humbled the Board has entrusted me with leading this bold and visionary Company.”
Trial Name:
A Safety and Efficacy Study Of HLA-G- Targeted CAR-T Cells IVS-3001 In Subjects With Previously Treated Advanced HLA-G-Positive Solid Tumors
ClinicalTrials.gov Identifier:
NCT05672459
Sponsor:
MD Anderson Cancer Center; Invectys (Collaborator)
Recruitment Contact:
Aung Naing, MD
713-563-3885
[email protected]
Estimated Completion Date:
June 29, 2029
The FDA originally cleared the investigational new drug application for the IVS-3001 trial in December 2022.3 At the time, Invectys noted that MD Anderson’s Aung Naing, MD, FACP, professor of investigational cancer therapeutics, and Samer Srour, MBChB, MS, assistant professor of stem cell transplantation and cellular therapy, will serve as the principal investigators for the study. The single-arm, open-label trial will enroll up to 117 participants, with up to 24 in the first dose–escalation phase and up to 93 in the phase 2a portion. Patients in the trial will be requested to participate in a long-term follow-up study.
“This is a great step towards bringing new solutions to patients,” Julien Caumartin, PhD, the chief scientific officer of Invectys, added to the statement.1 “There are currently far too few reliable solutions on the market for solid tumor cancer patients, due to the complexity of solid tumors. Our vision is to provide broad-ranging solutions to the patients, and we are eager to carry our CAR-T cells to the clinic and challenge the paradigm of CAR-Ts in solid tumors.”
Invectys has received several awards for the development of IVS-3001. These include the “2023 Best Translational Development” award granted by Maturation & Accelerating Translation With Industry (MATWIN); the Cancer Prevention and Research Institute of Texas Award, granted in 2020; and the “Best Project” award, granted by MATWIN in 2019.1,4 Invectys has noted that CTMC will manufacture IVS-3001 for the phase 1 portion of the clinical trial.2
