May 2022: FDA approves clinical trial application of specific CAR-NK therapy FT536 in the treatment of solid tumours in a CAR-NK clinical trial. The FDA approved an Investigational New Drug Application in January 2022 for the CAR-NK treatment FT536 to treat individuals with relapsed or resistant solid malignancies. In this trial, patients with advanced non-small cell lung cancer, colorectal cancer, head and neck cancer, gastric cancer, breast cancer, ovarian cancer, and pancreatic cancer will receive FT536 as a monotherapy or in combination with a monoclonal antibody. FT536 (Fate Therapeutics) is an allogeneic, multiple-engineered natural killer (NK) cell treatment produced from induced pluripotent stem cells.
This is a genetically engineered NK cell treatment that expresses a CAR that targets the alpha-3 domains of MICA and MICB, two proteins involved in the major histocompatibility complex class I. Both are stress proteins that are extensively produced in many solid tumours and can overcome shedding to restore tumour immunity mediated by NK and T cells. Overall, FT536 contains four functional modifications: a proprietary CAR targeting MICA and MICB’s 3 domain; a novel high-affinity 158V, non-cleavable CD16 (hnCD16) Fc receptor that enhances ADCC; promotes enhanced NK cells Active IL-15 receptor fusion (IL-15RF); and abrogation of CD38 expression, thereby enhancing NK cell metabolic fitness, persistence, and antitumor function.
We expect that FT536 therapy can obtain positive data as soon as possible in clinical trials of solid tumors, and it will be launched as soon as possible to benefit patients.
Dr. Nishant Mittal is a highly accomplished researcher with over 13 years of experience in the fields of cardiovascular biology and cancer research. His career is marked by significant contributions to stem cell biology, developmental biology, and innovative research techniques.
Research Highlights
Dr. Mittal's research has focused on several key areas:
1) Cardiovascular Development and Regeneration: He studied coronary vessel development and regeneration using zebrafish models1.
2) Cancer Biology: At Dartmouth College, he developed zebrafish models for studying tumor heterogeneity and clonal evolution in pancreatic cancer.
3) Developmental Biology: His doctoral work at Keio University involved identifying and characterizing medaka fish mutants with cardiovascular defects.
4) Stem Cell Research: He investigated the effects of folic acid on mouse embryonic stem cells and worked on cryopreservation techniques for hematopoietic stem cells.
Publications and Presentations
Dr. Mittal has authored several peer-reviewed publications in reputable journals such as Scientific Reports, Cardiovascular Research, and Disease Models & Mechanisms1. He has also presented his research at numerous international conferences, including the Stanford-Weill Cornell Cardiovascular Research Symposium and the Weinstein Cardiovascular Development Conference.
In summary, Dr. Nishant Mittal is a dedicated and accomplished researcher with a strong track record in cardiovascular and cancer biology, demonstrating expertise in various model systems and a commitment to advancing scientific knowledge through innovative research approaches.
