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If, however, a new piece of genetic information is replacing what's been snipped away, then the repair work is done by a less common process called homology-directed repair, or HDR. As exciting as gene editing sounds, it remains to be seen if gene editing can be done effectively and safely in humans and if one gene-editing approach is better than another. The process of cutting out faulty DNA and pasting in fixes is anything but easy.
Identifying the correct piece of DNA requiring a fix is one challenge and engineering a nuclease so that it only targets the desired piece of DNA is difficult. Specific sequences of DNA are often found in many places throughout the human body and targeting the precise location to avoid off-target snipping that could cause problems is tough. Furthermore, keeping tabs on any unwanted changes that could occur because of off-target edits isn't simple, either.
It also shouldn't be ignored that many genetic disorders are caused by multiple mutations. As a result, the complexity associated with creating gene editing therapies that fix multiple errant pieces of DNA simultaneously without increasing the risk of unintended edits could mean it's a long time before gene editing is used in those genetic disorders. Zinc-finger proteins can each bind to about three DNA bases, which means researchers can use various combinations of them to precisely target and bind to different DNA sequences.
For example, combining six zinc fingers allows the targeting of an 18 base sequence. Once the ZFNs bind to DNA on either side of the piece of DNA that's to be edited, the two halves of Fok1 combine, or dimerize, to make a cut between the two sets of zinc-finger proteins see figure 1. This helps the bacteria recognize these invaders should they return.
TAL effectors TALEs are proteins created by a type of plant bacteria, known as Xanthomonas, to infect plant cells to make them more susceptible to invasion. Sangamo Therapeutics has been at the forefront of ZFN research since its inception in and its pipeline of ZFN gene-editing therapies has already advanced from pre-clinical research in laboratories to trials in humans.
Typically, human trials begin with small phase 1 trials to determine dosing and initial safety. Then, they advance to slightly larger phase 2 trials that inform researchers on safety and efficacy before finally entering phase 3 studies where efficacy and safety are evaluated in many people. Hunter Syndrome is a rare genetic disease caused by a genetic mutation that prevents the breakdown of glycosaminoglycans GAGs , a complex sugar important to cell growth.
As GAGs build up in the body, Hunter Syndrome patients can suffer permanent, progressive damage to appearance, mental development, and organ function. Sangamo Therapeutics is also conducting earlier stage research on ZFN gene-editing approaches that may someday help patients with hemophilia B and MPS I, or Hurler syndrome, and it's using ZFN technology to help develop therapies for blood disorders, beta thalassemia and sickle cell disease. Additionally, in collaboration with Pfizer PFE SB hopes to produce factor VIII in the liver using engineered viral vectors, or tools that help deliver genetic material into a cell.
Although this isn't a ZFN-gene editing approach, Pfizer recently expanded its relationship with Sangamo Therapeutics to include researching ZFN for amyotrophic lateral sclerosis ALS , a progressive neurodegenerative disease, and frontotemporal lobar degeneration, a type of dementia caused by progressive nerve loss. If any therapies from this collaboration win approval, then Sangamo will receive tiered royalties on future sales.
These collaboration projects are particularly important to Sangamo Therapeutics because they provide it with a valuable source of funding, research expertise, and potentially, an opportunity to accelerate the commercialization of therapies that eventually secure regulatory approval. Specifically, ZFNs are highly complex to develop -- and that means it takes longer and costs more to engineer them.
The company expects to start reporting data in MPS II patients in and if the results are good, then it would go a long way to validating the efficacy and safety of ZFN gene editing. Rewriting genetic code to fix genetic disorders could reshape patient care and transform life-threatening diseases into manageable ones.
Given there are over 6, genetic disorders affecting hundreds of millions of people worldwide, the potential commercial opportunity associated with ZFN gene editing is massive. Cost basis and return based on previous market day close. Calculated by average return of all stock recommendations since inception of the Stock Advisor service in February of Discounted offers are only available to new members.
Calculated by Time-Weighted Return since Volatility profiles based on trailing-three-year calculations of the standard deviation of service investment returns. Invest better with The Motley Fool.
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