nVasive: Unraveling the Enigma of Metastasis

Metastasis is a complex non-linear cascade of events regulated by various cellular mechanisms through overlapping mechanisms. The complexity of this process has resulted in our limited understanding of this phenomenon, underscoring the importance to investigate and comprehend processes governing tumor invasion. To this end, we propose the development of a next-generation TOC system, called nVasive, that will enable us to model metastasis and tumor invasion. The new biochip will grow microtumors for several weeks and allow the cancer cells to detach and migrate from the initial primary microtumor location and invade into a secondary chamber. With nVasive, each microtumor will have a predefined location within the biochip, allowing us to precisely track cellular invasion and monitor variations among samples. This enables automated imaging, data collection, and interpretation, that is particularly beneficial for high-throughput datasets. The nVasive biochip will be utilized in extended assessments over several weeks, as invasion and metastatic behavior analysis occur over longer time periods. The goal of the current proposal is to further develop nVasive, and to demonstrate technical feasibility, pinpoint critical technical hurdles, establish key performance indicators that predict metastasis, assess commercial viability, and outline a plan for commercialization. nVasive will enable investigations into the metastatic behavior, cell motility, and tumor invasion of metastatic and non-metastatic patient-derived tumor samples at a cellular level. In phase I, we will perform preliminary terrestrial experiments to validate the functionality of the automated metastasis-on-a-chip system and integrate it into our on-orbit implementation partner automation systems, PAUL and CubeLab, creating a functional prototype ready for launch. Ultimately, in phase II, we will develop and produce the first clinical diagnostic tool for patient specific metastasis prediction.

The goal of this proposal is to demonstrate technical feasibility of a fully automated metastasis prediction biochip, and to develop nVasive as the next generation of precision oncology tool, with the ultimate aim of predicting metastasis in cancer patients with assistance of µG in phase II. We expect that conducting tumor invasion assays in µG will contribute to preserving the biological properties of cells similar to their innate in vivo conditions and will also be critical for cell migration and invasion to occur without the inhibiting effects of gravity. µG aids in retaining the phenotypic and genotypic characteristics of patient tumor biopsies over the longer time periods that will be necessary for the invasive assays. Encapsulate will use cancer cells from its biobank, which contain comprehensive Encapsulate response predictions, genetic mutations profiles, and clinical chemotherapy regimen responses. Our objectives in this proposal are strongly aligned with NASA’s goals: 1) We use µG and the ISS/ISS hardware to stimulate utilization of the ISS and economic development in the U.S. in the field of precision oncology. 2) Through this proposal, we will improve the existing automation and cell imaging capabilities on-orbit, including in situ analytical tools, and achieve higher quality single-cell imaging capabilities and high-precision automated culture system hardware and software. This will increase the effectiveness of technology demonstrations and science investigations performed on the ISS. 3) This proposed project will increase commercial participation in research, technology development, on board services, and other commercial activities. 4) This proposal will broaden the uses of the ISS and its resources by the U.S. commercial sector. Encapsulate’s products offer comprehensive precision medicine analysis on patient tumor specimens using a phased approach, catering to different timelines and priorities in the patient's treatment journey. First and in the short term, nCapsule, which has reached TRL6 through ISSNL’s 2020 Technology in Space award and that has completed two rounds of clinical pilot studies successfully, will be utilized. nCapsule can accurately compare various FDA-approved treatments to recommend the best treatment course on an individualized basis. Results are delivered within only 5 days. Second and in mid-term studies, our genetic studies combined with nDoser enable the analysis of tumor responses to recommended treatments. With this approach, a report is generated on treatment outcomes, possible mutation developments, and optimal dosing for identified treatments. nDoser results are mid-term studies that take 2 weeks after the biopsy specimens are received. Lastly, the ultimate predictive tool is nVasive (TRL 3), designed to predict the tumor’s ultimate fate. nVasive is designed to strategize treatment in the long-term and to avoid cancer recurrence and spread. The results from nVasive are not urgently required for clinical decision-making and treatment planning and can be incorporated into the treatment plan over a 3-month period.

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