You are currently viewing NewStem Files FDA Pre-Submission & EMA IVDD for Revolutionary Cancer Diagnostic Device

NewStem Ltd filed for a pre-submission to the FDA for a De Novo Request and an in vitro cancer diagnostic device (IVDD) to the EMA (the European Medicines Agency) for their NewStem Software Diagnostic Device. The announcement followed the company’s graduation from Illumina’s Accelerator 3rd funding cycle in March 2022.

NewStem Diagnostic is an expansive, sustainable, and personalized rapid screening for anti-cancer drugs resistance based on the specific characterization of the patient’s cancer mutagenicity. The NewStem Software Diagnostic Device (NSDD), a bioinformatics-based software medical device platform, provides oncologists with information regarding the presence of mutations in tumors, which may confer patient resistance to certain anti-cancer drugs. The information provided by NSDD, will aid oncologists when deciding which treatment regime to apply. The product is expected to reach the market within two years.

Cancer is the second leading cause of death globally. Despite efforts and achievements made in treating cancer over the past several decades, resistance to anti-cancer drugs continues to be a major problem in cancer therapies. Resistance is the leading cause of relapses in cancer and one of the significant causes of death due to the disease. Drug resistance (whether pre-existing or generated after therapy) is responsible for over 90% of deaths in cancer patients receiving traditional chemotherapeutics or novel targeted drugs treatments.

One of the most prominent biomedical tools is genetic screening. Screening for loss-of-function (LOF) phenotypes is rather limited in diploid cells, because if a mutation is introduced into one allele, the second intact allele may serve as a backup. This phenomenon is intensified in cancerous cells which many times are characterized by polyploidy (condition of possessing more than two complete sets of chromosomes).

For this reason, many global LOF screens were performed in haploid yeast, and only now when the derivation of haploid human ESCs (Embryonic Stem Cells), are available, it enables similar screens in human.

The cells in our bodies are diploid, carrying 46 chromosomes, two sets of 23 chromosomes, one set from the mother, and the other, from the father. The only cells that contain a single set of chromosomes (Haploid cells) are post-meiotic germ cells, namely eggs or sperm. While diploid cells can undergo mitosis and give rise to additional diploid cells, haploid germ cells are terminally differentiated cells incapable of producing progeny by cell division. NewStem is currently the only company worldwide to develop products focused on Haploid Human Pluripotent Stem Cells (HhPSCs).

Genome-wide mutations can be introduced into haploid human ESCs by different methodologies. Libraries of mutant cells can then be subjected to different treatments followed by an analysis of surviving clones, aiming to identify genes whose loss affords a growth advantage (positive selection) or disadvantage (negative selection). A similar approach is also applicable for haploid ESCs already carrying specific mutations, which can be isolated either from diseased eggs or generated by genome editing. In such cells, genome-wide mutagenesis can be performed to identify synthetic lethality interactions between the pre-existing mutation and a novel mutation within the library, based on mutual exclusivity. Alternatively, using diseased haploid human ESCs can reveal genes whose loss leads to reversion of the disease phenotype.

NewStem is a precision oncology company that established a bio-platform for genome-wide screenings based on proprietary Haploid Human Embryonic Stem Cells (HhESCs) technology. These cells can potentially change how we develop genetic-based therapeutics and diagnostics, as they are superior to other cells used for whole-genome screenings. NewStem is currently the only company worldwide to develop innovative practice-changing products based on this innovative and exclusive technology. The company is now raising funds to deepen its internal personnel capabilities and for further research and development.

“The technology, based on our proprietary haploid cells, has changes the dogma and enables what was formerly impossible”, says Prof. Nissim Benvenisty. “NSDD will give oncologists a better understanding of the many variances that present challenges in the treatment of cancer and in the identification of drug-type resistance. That is unprecedented.”

About NewStem

Starting its operation in mid-2018, NewStem Ltd. is a precision oncology company that has established a bio-platform for genome-wide screenings based on proprietary Haploid Human Embryonic Stem Cells (HhESCs) technology. These cells can potentially change the way we develop genetic-based therapeutics and diagnostics, as they are superior to other cells used for whole-genome screenings. NewStem is currently the only company worldwide to develop innovative practice-changing products based on this innovative and exclusive technology. NewStem utilizes this bio-platform for the discovery and development of precision oncology drugs based on synthetic lethal interaction modality and for diagnostics of anti-cancer drugs resistance. NewStemNewStem is a spinoff of Yissum, The Hebrew University of Jerusalem’s technology-transfer company. NewStem holds intellectual property rights related to stem cells, including genome-wide screening methodologies, and its main patents were granted in the United States, Europe, Japan, and Israel and are in the national phase in additional countries. NewStem‘s solutions are based on the research of human haploid pluripotent stem cells (hHPSCs) by Professor Nissim Benvenisty, Director of the Azrieli Center for Stem Cells and Genetic Research at the Hebrew University.

The company is now raising a minimum of $10M, of which $6M is guaranteed. These funds are aimed to deepen its internal personnel capabilities and for further research and development of its pipeline products

To learn more about NewStem Ltd., visit: https://newstem.com/technology/
NewStem Contact: Ayelet Dilion-Mashiah – CEO, NewStem ayelet AT newstem.com
Tel: +972-54-5725477

Source: Apr 11, 2022 Cision PR Newswire

 

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