Indapta Therapeutics, Inc., a biotechnology company focused on developing and commercializing a proprietary, first-in-class, off-the-shelf, non-engineered, allogeneic FcRγ-deficient natural killer (G-NK) cell therapy to treat multiple cancers, today provided an update on its progress in advancing the development of its programs.
"Since we emerged from stealth mode in January and announced our founding management team, scientific advisors and strategic partnership with Lonza, we have made substantial progress in advancing our next-generation, off-the-shelf, allogeneic immuno-oncology therapy," said Guy DiPierro, founder and chief executive officer of Indapta Therapeutics. "We have achieved several preclinical, regulatory and manufacturing milestones for our G-NK program, all of which are helping us move our novel program forward towards an IND submission and the initiation of a first-in-human trial in summer 2021."
Recent Program Updates
Presented data from its G-NK cell therapy program in a poster presentation at the American Association for Cancer Research (AACR) Virtual Annual Meeting II in June. In the preclinical study, clinical models injected with human multiple myeloma cells were treated with a monoclonal antibody daratumumab or elotuzumab, which are FDA-approved for multiple myeloma, either alone or in combination with Indapta’s G-NK cells or comparator cells. In response, the G-NK cells demonstrated superior antibody-dependent cellular cytotoxicity (ADCC) and increased survival. G-NK cells show significantly enhanced expression of interferon-gamma (IFNγ) and tumor necrosis factor alpha (TNFα) compared with conventional natural killer (NK) cells.
Submitted a pre-Investigational New Drug (IND) briefing package to the U.S. Food and Drug Administration (FDA) for its G-NK cells. Indapta participated in a Type C meeting with the Agency and received written feedback outlining a clear and detailed roadmap for an IND application and for Chemistry, Manufacturing and Controls (CMC) activity.
Successfully completed the Stage 1 manufacturing transfer to Lonza, which conducted feasibility manufacturing runs at its Houston facility. Lonza will now initiate the next step of process development for the manufacturing of off-the-shelf, allogeneic G-NK cell therapy under current good manufacturing practices (cGMP) for use in the IND submission.
Indapta completed a persistence trial at the University of Houston which determined its G-NK cells remained in the body in both cryopreserved and frozen forms without any issues of functional exhaustion or phenotypic changes in vivo. Results demonstrated that Indapta’s cryopreserved G-NK cells remained in the body more than 26 times longer than cryopreserved conventional NK cells. Indapta also collected new data on cancer killing compounds including TNFα, IFNγ, CD107a, perforin and granzyme, all of which were expressed in higher amounts as a result of Indapta’s G-NK cell therapy.
Granted broad intellectual property protection through an exclusively-held patent related to manufacturing processes, G-NK cell selection and G-NK cell treatment used as a monotherapy and in combination with multiple compounds in multiple oncology and viral indications.
About Indapta’s G-NK Cell Therapy
Indapta Therapeutics is developing a universal, allogeneic G-NK cell therapy designed to substantially improve the cytotoxicity of monoclonal antibody therapy in multiple cancers. G-NK cells are a specific and potent subset of NK (natural killer) cells with specialized anti-tumor activity resulting from an epigenetic change, rather than engineering. Indapta has further enhanced G-NK cells via specific G-NK cell subset selection and its proprietary manufacturing process which, when combined, produce a G-NK cell therapy that demonstrates higher efficacy, persistence and enhanced cryopreservation.
When a monoclonal antibody binds to the tumor target and to Indapta’s G-NK cell therapy product, it initiates the release of dramatically more cancer killing compounds than conventional NK cells, allowing for increased efficacy and potentially less frequent dosing. Indapta’s off-the-shelf G-NK cell therapy is further differentiated from other NK cell therapies in that it is a cell banked product with low variability. In vivo studies have demonstrated the safety of Indapta's G-NK cell therapy.
About Indapta Therapeutics
Indapta Therapeutics, Inc. is a biotechnology company focused on developing and commercializing a proprietary, first-in-class, off-the-shelf allogeneic cell therapy to treat multiple types of difficult-to-treat hematologic cancers and solid tumors. Headquartered in San Francisco, Indapta was founded in 2017 by Guy DiPierro along with Ronald Martell and scientists at the University of California, Davis, and Stanford University. The company has developed allogeneic FcεRIγ-deficient natural killer 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.
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Guy DiPierro, CEO
Nicole Raisch Goelz