A new partnership seeks to advance an experimental new off-the-shelf cell therapy designed to treat multiple types of cancers, such as multiple myeloma. Announced by Lonza and Indapta Therapeutics, this effort seeks to progress G-NK cell therapy, originating from the University of California, San Francisco (UCSF) labs, from preclinical to Phase I clinical trials targeting 2021.
What is G-NK Cell Therapy?
Unlike CAR T cell therapy, where a patient’s immune cells are collected from themselves and engineered in a lab, this novel approach employs natural immune system cells—natural killer (NK) cells—derived from healthy donors that are paired with a therapeutic antibody to stimulate a more powerful response against specific cancer targets. G-NK cells are, in fact, gathered by donors that are infected with cytomegalovirus (CMV), a form of herpes virus infecting around 50% of the human population reports David Melamed, PhD with Myeloma Research News. CMV-infected cells modify some NK cells improving the ability to seek out and kill cancer cells that have been tagged by a therapeutic antibody reports Melamed. Indapta Therapeutics reported that G-NK cells can work with any monoclonal antibody functioning to “flag cancer cells for the immune to ‘see’ them and attack them.” The scientific premise is that the conventional NK cells that have mutated after coming into contact with CMV to be lacking the Fc?RI? adapter (G-NK) will significantly increase ADCC and favorable apoptosis in the presence of a MAB to increase tumor killing as reported in Grantome. What if this approach could be exploited to address a range of cancers? G-NK cell therapy originated from the National Institutes of Health (NIH) funded grants to the UCSF—Indapta is also collaborating with Stanford on an NIH funded grant.
Key Goal: Sidestep Clinical & Financial Challenges
Developing off-the-shelf G-NK cells may sidestep some of the clinical and financial challenges presented by other, more customized, and engineered immuno-oncology approaches, which involve time-consuming and costly manufacturing processes and often can only be delivered in specialized centers. The manufacturing COGS for Indapta’s program will be relatively inexpensive compared to CAR-T or engineered NK cell therapies. Additionally, the regulatory approval process for Indapta’s program may be more straightforward than that for autologous CAR-T cell therapy or engineered NK cells because it does not involve complicated cell engineering.
Indapta is a San Francisco Biotech company with scientific founders from Stanford University and UC Davis. Indapta is developing a First in Class, allogeneic, immuno-oncology NK cell product platform to treat multiple forms of cancer, safely, with no GVHD, or adverse side effects. Its efficient, large scale GMP manufacturing methods allow for low COGS and a more straightforward FDA pathway. Indapta’s product offering can drive the next critical phase of cancer therapy evolution post-CAR-T.
Founded in 2017 by Guy DiPierro, along with Ronald Martell and scientists at the University of California, Davis, and Stanford University, the firm has developed allogeneic FcεRIγ-deficient natural killer (NK) cells, known as G-NK cells, and is working to bring this off-the-shelf cell therapy to patients to address the limitations of currently available autologous T-cell therapies.
The Lonza Deal
Lonza will manufacture Indapta’s off-the-shelf allogeneic G-NK cell therapy under current good manufacturing practices (cGMP) for use in clinical trials. Indapta will leverage Lonza’s process development capabilities and expertise to ensure a robust, reproducible, and scalable cGMP process. The partnership will leverage the Houston-based state-of-the-art gene and cell therapy production facility.
Who is Lonza?
A global leader in life sciences, Lonza is a Swiss company that employs 15,000 employees in more than 100 locations worldwide. By 2018 they generated sales around 5.5 CHF billion. They apply their industry knowledge to pioneer cell therapy and the medicines of tomorrow. Its history goes way back to the 19th century as a supplier to the chemicals industry that clustered around the Rhine River valley.
Call to Action: Guy DiPierro seeks disruption–developing more inexpensive development and delivery models as compared to CAR-T or engineered NK cell therapies. Moreover, his firm strives for a more straightforward regulatory approval process as compared to autologous CAR-T cell therapy or engineered NK cells as it precludes complicated cell engineering. If successful, this could offer powerful cancer therapies at lower costs than current CAR-T therapy models. Only time and results will tell if this model will be successful, but TrialSite News will be monitoring and summarizing for the public. They anticipate an IND application in late 2020 and the initiation of a first-in-human Phase I/2 clinical trial by early 2021.