A recent partnership between Indapta Therapeutics and Lonza is advancing the development of an off-the-shelf cell therapy designed to treat multiple types of cancers, including multiple myeloma, the companies announced.
The collaboration aims to ultimately guide this treatment from promising preclinical studies into clinical trials, with a first such study in people possible in early 2021.
Known as G-NK cell therapy, the new approach uses natural immune system cells — called natural killer (NK) cells — from healthy donors that can be paired with a therapeutic antibody to elicit a stronger immune response toward a specific cancer target.
In more recent cell therapies, such as chimeric antigen receptor (CAR) T-cell therapy, immune cells are collected from the patient and engineered in the lab. G-NK cells, in contrast, are collected from healthy donors and do not require cell modification.
In fact, G-NK cells are collected from donors that have been infected with cytomegalovirus (CMV), a form of herpes virus that infects about half of the human population and rarely causes any symptoms. The contact with CMV-infected cells induces a slight modification to some NK cells, and this is thought to make them better at killing cancer cells flagged by a therapeutic antibody.
G-NK cells can be coupled with any monoclonal antibody whose function is to flag cancer cells for the immune system to ‘see’ them and attack them, Indapta states in a press release. The approach could theoretically be used to treat a wide array of cancers in addition to multiple myeloma, including lymphoma, leukemia, melanoma, and ovarian, colorectal, renal, liver, breast, and lung tumors.
These preclinical studies, conducted in models of multiple myeloma and lymphoma, demonstrated that the G-NK cell therapy approach can be safely paired with antibodies and increase their effectiveness — seen by greater reductions in tumor growth and improved survival rates — without causing graft-versus-host disease, Indapta reports.
GvDH is a common, potentially life-threatening side effect of cell therapies from unrelated donors, where the donor’s immune cells ‘see’ the patients’ cells and organs as foreign, attacking them and causing significant damage.
G-NK cells are also said to be highly durable when injected with a monoclonal antibody in animal models, lasting four to nine months in circulation, and were seen to be significantly better at inducing antibody-mediated cell death than conventional NK cells.
Studies of G-NK cell therapy in additional tumor models are now ongoing at Stanford University, under a second Indapta NIH grant.
“We believe our first-in-class, off-the-shelf, allogeneic G-NK cell therapy will drive the next critical phase in the evolution of cancer therapies,” Guy DiPierro, founder and chief executive officer of Indapta, said in the release.
“By providing an off-the-shelf solution with our G-NK cell therapy, we can eliminate the need for a patient-specific therapy,” he added. “Additionally, because our investigational cell therapies are not engineered, they are likely to be more effective, less costly and have a simpler regulatory pathway.”
Lonza will provide the infrastructure to continue the development and manufacturing of the G-NK cell therapy, using their state-of-the-art manufacturing facility in Houston, Texas.
“Lonza, with its demonstrated expertise in cell therapy manufacturing, is the ideal strategic partner to help us advance our clinical program and scale the production of our G-NK cell therapy,” said Ronald Martell, a co-founder of Indapta Therapeutics. “We are currently completing Investigational New Drug-enabling studies and plan to submit an IND application in late 2020 and initiate a first-in-human Phase 1/2 study in early 2021.”
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