Solid Tumor CAR T Collaboration Cleared for Trials

The FDA has cleared the investigational new drug application (IND) of Invectys and CTMC’s human leukocyte antigen A (HLA-G) targeting chimeric antigen receptor (CAR) T-cell therapy IVS-3001 for treating solid tumors.¹

“CTMC was created to accelerate impactful cell therapies reaching patients," Jason Bock, chief executive officer, CTMC, said in the statement.¹ “We are excited to partner with Invectys to move the HLA-G CAR-T from contract execution to IND safe-to-proceed, in less than a year.” CTMC is a joint venture between MD Anderson Cancer Center and National Resilience.

Following the IND clearance, IVS-3001 will be evaluated in an MD Anderson sponsored trial led by co-principal investigators Aung Nain, MD, professor, investigational cancer therapeutics, and Samer Srour, MD, assistant professor, stem cell transplantation and cellular therapy, both at MD Anderson. The first-in-human, open-label, single-arm, phase 1/2a study will evaluate the therapy’s safety, tolerability, clinical activity and pharmacokinetics in patients with histologically or pathologically confirmed locally advanced unresectable or metastatic HLA-G+ solid tumors that have failed or were intolerant to standard of care therapies.

READ MORE: Enhanced Cell Therapy Gets Fast Track Designation for HPV16+ Solid Tumors

The trial will enroll up to 117 patients to be treated under the approved protocol, with up to 24 in the first dose escalation phase and up to 93 in the second phase 2a. After completing both phases, all participants will be asked to enter the long-term follow-up study.

IVS-3001 contains an HLA-G antigen-targeting domain fused to intracellular signaling domains for antigen-specific activation designed to improve cytolytic killing of HLA-G-expressing cells as well as CAR-T cell proliferation and cytokine secretion. The therapy was developed by Invectys in collaboration with CTMC, which was announced along with the collaboration in June 2022.² It previously showed sufficient efficacy and safety for the IND clearance in preclinical studies and will be manufactured by CTMC for the phase 1 trial.

“The FDA clearance of the IND application for IVS-3001 represents an important milestone for Invectys and our colleagues at CTMC, and it is the result of years of commitment to developing a novel class of engineered CAR-T therapy,” Praveen Tyle, PhD, chiefexecutive officer, Invectys, added to the statement.¹ “We believe IVS-3001 therapy has the potential to significantly transform the treatment landscape for cancer patients and the potential to achieve improved clinical outcomes.”

REFERENCES

1. Invectys and CTMC announce FDA clearance of IND application for anti-HLA-G CAR-T cell therapy. December 19, 2022. News release. Invectys. https://firstwordpharma.com/story/5687979
2. Invectys, MD Anderson and CTMC announce strategic collaboration for CAR T cell therapy development. News release. Invectys. June 16, 2022. https://www.invectys.com/news/invectys-md-anderson-and-ctmc-announce-strategic-collaboration-for-car-t-cell-therapy-development/