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Description

Organovo

Organovo Holdings, Inc., (NASDAQ: ONVO) is a biotech platform company that has developed a leadership position with its revolutionary ability to 3D bioprint tissues with human functionality.

Headquarters 6275 Nancy Ridge Drive San Diego CA 92121 United States
Categories: Bioprinting /Biofabrication
CEO: Taylor Crouch CEO and President Phone: +1 (858) 224-1000
Links:

Details

Organovo Holdings, Inc., (NASDAQ: ONVO) is a biotech platform company that has developed a leadership position with its revolutionary ability to 3D bioprint tissues with human functionality. The Company earlier has been pursuing multiple IND-track programs to develop its NovoTissues® to address a number of serious unmet medical needs in adult and pediatric populations, focusing on liver disease. Organovo’s first IND-track program for Alpha-1-antitrypsin deficiency recently received orphan drug designation from the FDA, and the Company expects to file its first IND in 2020. In order to help fund its plan to initiate multiple IND-track programs, the Company is providing access to its ExVive™ in vitro tissue disease modeling platform to facilitate high-value drug discovery and development collaborations. Organovo’s wholly-owned subsidiary, Samsara Sciences, provides the Company and its clients with high-quality human liver and kidney cells for research applications. Organovo is changing the shape of life science research and transforming medical care.

The company’s focus on liver disease now appears to have shifted, and a sister-startup Viscient Biosciences co-founded by a group of Organovo and Ardea Biosciences scientists and entrepreneurs.

In September 2020, Organovo announced that it had updated its business model to capitalize on its human 3D tissue technologies in drug discovery, building disease models to find effective therapies that are more likely to succeed in the clinic than drugs discovered using animal models. It has lately focused on the creation of three-dimensional intestinal disease models to discover therapeutic opportunities that leverage the insights possible from the truer human biology achievable in 3D human disease models.

The drug discovery process using 3D tissues consists of several stages. Two early steps that are uniquely important in Organovo’s approach to drug discovery are creation of a disease model followed by target discovery and validation. The steps involved in each require groundbreaking science that involves the application of tools specific to our approach. The remaining steps after validation of a target are typical pharma development steps to advance a drug to Phase 1 clinical trials.

The next phase will be medicinal chemistry, the creation, and evaluation of new chemical entities to pick the best drug candidate. Organovo plans to do this work through an outside contract research organization. Organovo is on track to have its medicinal chemistry program result in an investigative new drug (IND) application by 2025 in alignment with our previously communicated objective to have multiple INDs by that time.

Medicinal chemistry, preclinical safety studies, and other common tasks that follow consist of common practices across pharmaceutical development, and are not unique to 3D drug discovery but can benefit greatly from the additional insights that can be provided by testing candidates in human tissue 3D models as the candidates are screened and developed. Since these steps are more typical, the risk profile is similar to traditional pharmaceutical development at these stages. However, upon entering the clinic and seeking evidence of efficacy in humans, the company believes that the use of human 3D disease models to select drug candidates will result in a significantly higher probability of success.

Organovo is working on additional IBD disease models representing different aspects of the disease, each of which can represent a significant advancement over previous tools. We will also seek to leverage validated targets and scientific knowledge from these disease models into business development deals and partnerships with pharmaceutical companies.