BioViva is a gene and cell therapy company researching and developing therapies to delay, prevent and reverse the processes behind biological ageing and complex disease. We are also building a network of clinics to administer these next-generation therapies for consensual use for the health conscious and those most in need. Our team and advisory board include a host of experienced academics and doctors with expertise in the field, and we carefully choose therapies that are feasible and have already been tested on animals.
The company is a health company. Our mission is to delay, prevent and reverse age-related disease and aspects of biological ageing and complex disease. We want to better understand these complex diseases and treat them, including the diseases of childhood. We don’t expect this to be an overnight process but we’re set on targeting specific hallmarks of the ageing and disease process that are already well characterised and amenable to gene or cell based therapies. We began carefully selecting some of the most promising animal studies and relevant human data to develop our initial therapies, and will be expanding our pipeline and researching novel approaches as we evolve as a company; hitting more of those important hallmarks.
Ageing is the master disease at the foundation of other conditions associated with ageing like Parkinsons etc. Time is the enemy that has to be dealt with at the molecular levels, and therefore at the cellular levels because our cells are made up of all these complex molecules that gradually degrade in various ways – folding, aggregates, piling up etc.
BioViva is building on multiple studies of telomere biology that have revealed its critical role in maintaining cellular health and healthy division. Telomeres shorten as we age and are currently one of the best biomarkers of age. They are also one of the major hallmarks of ageing. Shortened telomeres lead to senescent cells and de-stabilise our DNA which leads to inflammation and cancer. We are developing a gene therapy solution that repairs your telomeres, and are moving towards trials to test this technology. Animal studies show that telomerase gene therapy extend both lifespan and healthspan.
Age-related diseases are caused by biological ageing, and these are the biggest killers in developed society today. Even in developing nations there is massive burden from diseases such as cardiovascular disease, cancer and alzheimer’s. Millions of people suffer with these chronic conditions for years, many require constant care and have lost their independence, and millions more die every year. We do not believe ageing has a conventional cure as such, but a whole assortment of therapies will one day allow us to live healthier lives up until the very end. We’re focusing initially on improving people’s healthspan.
The cost associated with ageing must also be considered. An individual can cost more during the final years of their life than at any other time.
We’re working hard to establish our clinic network to administer these therapies for consensual use, expediting treatment options for those in need. These will be gradually rolled out from 2018 onwards, as we hope to have our first clinic operational by the end of next year. We can’t disclose a price at this point, but gene therapy remains expensive to manufacture, which can be expected with an early technology. We will work hard to bring the cost down in the future however, and will offer a variety of different treatment options to offer most cost-effective options.
I believed it was the most responsible and ethical thing to do. I believed the company should take its own medicine first before moving onto patients. Many scientists in the past have made great discoveries through self experimentation. Doing so on a whim isn’t sensible, but when you already have a large amount of data supporting an intervention, we considered the risk to be worth it. Gene therapy today has a great safety record and both our therapeutic gene choices have either already undergone clinical trials in humans (in the case of our myostatin inhibitor), or have been tested in a number of animal studies supporting both safety and efficacy. Comprehensive data from one human is incredibly valuable, and in many cases far more valuable than any amount of animal data.
I feel fantastic, but how much of this is a placebo effect? We don’t know for sure at this point without increasing data. However our first concern was and will remain safety. As a therapy of this magnitude had never been tried on humans. And importantly we’ve seen no negative effects so far. In terms of my results, by measuring my telomeres, we discovered that the telomeres in my white blood cells had lengthened by over 600 base pairs, which would be equivalent to a reversal of around 20 years of telomere ageing. Full body MRI imaging also revealed an increase in muscle mass and a reduction in intramuscular fat. We’ve also seen a reduction in inflammation markers and improved metabolic markers too. We’re looking forward to collecting more molecular and cellular level data from Harvard.
The problem with existing legislation is that it means you have to focus on one disease and see significant results. These kinds of ‘anti-ageing’ therapies are more preventative and less specific, meaning they may delay, prevent or reverse many conditions but they don’t necessarily have immediate effects. We can’t really conduct a study for 40 years to compare individuals who have received a therapy to those who haven’t, so we have to try and go by biomarkers instead.
Going the classical route isn’t necessarily working and plays into risk aversion that all too often doesn’t create an outcome that ensures anyone’s safety. Many breakthrough technologies were forwarded by risk taking and personal testing on individual patients. Transplants for example, and even vaccination. Now, we absolutely intend to verify and peer review, but our priority will always be patient access, safety and expediting effective therapies.
We can use the FDA approval process as an example. There are many admirable features but it requires several phases of testing which are prohibitively expensive and deliver ineffective drugs in many cases. How many chronic conditions do we have real cures for? We want to determine whether these therapies are safe first and foremost and begin treatment of patients without having to pass through years of testing.
While we are unconventional in some respects, we’d like to see an overhaul of the regulatory process and translation process to favour patient access and safety. It takes an extremely long time for existing research to be translated into actual clinical products, and while we completely agree safety is paramount we also believe in people’s right to try; after all the status quo is far from desirable and many people have no effective treatment available or die from existing conditions without any intervention. We think there are ways to make the process more efficient and faster, with more exceptions for promising therapies that have been shown to be safe but perhaps not gone through the later phases of testing.
We are continuing to monitor my data and are aiming to carry out further safety trials on some of our products very soon. These will gather more crucial data on our therapies to determine their efficacy. We are also aiming to offer consensual use gene therapies with sufficient existing clinical data to patients on the opening of our clinics next year. We will be beginning with our muscle targeting gene therapy which has already passed early clinical trials in humans for treatment of muscular dystrophy and myositis, and then rolling out a number of other options.
Our first targets are sarcopenia and cachexia with one of our gene therapies, but we’re interested in conducting small trials on Alzheimer’s disease. Right now we can’t extrapolate exactly how many diseases we might be able to mitigate as these types of preventative therapies are a relatively new concept and are very difficult to test without long term comparison studies. We certainly hope they would reduce the risk of multiple disease however, and from the existing literature we see evidence for that. Once we have more data we’ll know more. As we progress we’d like to treat many other conditions and add more treatments to our clinical pipeline from our research and development – targeting atherosclerosis and Parkinson’s disease for example.