The rise of Oisin Biotechnologies

Interview with Gary Hudson, CEO of Oisin Biotechnologies

Gary Hudson

Preface

What is ageing? We can define ageing as a process of accumulation of the damage which is just a side-effect of normal metabolism. While researchers still poorly understand how metabolic processes cause damage accumulation, and how accumulated damage cause pathology, the damage itself — the structural difference between old tissue and young tissue — is categorized and understood pretty well. By repairing damage and restoring previous undamaged — young — state of an organism we can really rejuvenate it! Sounds very promising, and so it is. And for some types of damage (for example, for senescent cells) it is already proved to work!

Today in our virtual studio somewhere between cold rainy Saint-Petersburg and warm rainy Seattle we meet Gary Hudson!

He has been involved in private space flight development for over 40 years. Hudson is best known as the founder of Rotary Rocket Company, which in spending ~$30 Million attempted to build a unique single stage to orbit launch vehicle known as the Roton. He helped found Transformational Space T/Space in 2004 and AirLaunch LLC which was awarded the DARPA/USAF FALCON project in 2003.

Previous projects included designs of the Phoenix SSTO, the Percheron, and other rockets, founder of Pacific American Launch Systems, and various consulting projects. Currently, he is the President and CEO of the Space Studies Institute.

Now Hudson brings his excellent engineering skills into rejuvenation biotechnology! He is a founding partner of Oisin Biotechnologies who are developing a liposomally delivered DNA therapy for the removal of senescent cells from the body. Hudson provided an initial seed donation to help fund the creation of the Methuselah and SENS Research Foundation.

Interview

Ariel Feinerman: Hello, Mr Gary Hudson!

Gary Hudson: Thanks for inviting us to this interview!

Ariel Feinerman: You have recently visited an amazing Undoing Aging 2018 conference which took place in Berlin, 15–17 March, where your colleague, Matthew Scholz, was a speaker. What is your impression?

Gary Hudson: It was a great conference with several important presentations. It put me in mind of the early SENS conferences in Cambridge UK, which I helped to sponsor. I understand it will now become an annual event. Our CSO Dr John Lewis also gave an important summary of our work to date.

Ariel Feinerman: Will Oisin’s presentations from conference be available for general public?

Gary Hudson: I believe that the SENS Foundation will be posting them but I don’t have details about the timing.

Ariel Feinerman: Your resent interview was in July 2017, more than half a year ago. What has been accomplished?

Gary Hudson: We have conducted many pre-clinical mouse experiments on both cancer and senescent cell removal. All have been successful and produce very remarkable results. We’ve also conducted a pilot toxicity and safety trial on non-human primates. The results of that trial were also successful and encourage us to proceed to human safety trials as soon as regulatory authorities approve them. We have also spun-out a cancer-focused company, Oisin Oncology, and raised a seed round for that venture.

Ariel Feinerman: Great to hear! However, when can we see some papers? People usually trust papers more than mere interview or press releases. Of course, papers need many efforts not related to research but they will allow you attract more attention from general public, researchers and investors.

Gary Hudson: Papers are being prepared now for submission to major journals, but that process takes time, especially the peer review. For the moment, most of our data is only available to investors and partners in pharma and the biotech industry.

Ariel Feinerman: You planned human clinical trials, have you carried them out?

Gary Hudson: It takes quite some time to organize a human trial and to get it approved. Before one can be conducted, we have to set up so-called “GMP (Good Manufacturing Practice) manufacture of our therapeutic, and then we have to conduct “GLP (Good Laboratory Practice) Tox” studies in two different species. Once that is all completed later this year, then we can begin a human safety trial, or a “Phase 1” trial. All this takes time, but we hope that first safety trials in oncology indications might begin this year, or in early 2019.

Ariel Feinerman: Does that mean we have a race between Unity Biotechnology and Oisin and you have all chances to win the race?

Gary Hudson: I don’t see it as a race or a competition. I believe that future anti-aging treatment will require multiple complimentary approaches.

Ariel Feinerman: When we can expect your therapy available in the clinic?

Gary Hudson: It’s very difficult to predict. I believe that our cancer treatment will make it to the clinic first, and that could happen in less than five years. Since the FDA doesn’t regard ageing as an indication, it may take longer for our SENSOlytic™ treatment to reach the public, since the regulatory environment will need to change.

Ariel Feinerman: As Michael Rae has said we need not to wait when ageing will be recognised as a disease. You can mark your senolytics as a therapy for specific ageing pathology like fibrosis or chronic inflammation in the same way as Unity does.

Gary Hudson: This is certainly true and is part of our strategy, but many of those endpoints are more difficult to ascertain than oncology endpoints. Additionally, going after oncology approvals can be faster and easier to get to clinic. But we will push forward on several fronts as funding permits.

Ariel Feinerman: In your previous interview you have said that you make some tweaks to both the promoter side and the effector side of the constructs that will provide even more interesting and useful extensions to the basic capability, but you can’t discuss those for IP reasons. Can you now say about them?

Gary Hudson: I still can’t say too much about them, but we have conducted animal trials on some of these “tweaks” and they work quite well. The downside to the matter is that every “tweak” requires new trials, and our goal is to get something to the clinic as soon as possible, so many of the improvements will have to wait. Progress is limited based on available funds and personnel resources, of course, but we will move as quickly as we can.

Ariel Feinerman: Do you use any CAD software to design your constructs? Are you going to make them public so independent engineers will be able to help you identify new useful pairs of promoters and effectors? Your technology is so powerful that Open Source approach would be very helpful!

Gary Hudson: No, the design of the current constructs are very straightforward and simple. As our patents are issued their design will become public. If people wish to design their own constructs for particular applications they may contact us for collaboration, though we do have several collaborations active at the moment so we may already be working on similar ideas.

Ariel Feinerman: What do you think on targeting your machinery on cells with abnormal telomerase activity to kill cancer? Can you use several conditions — like in programming — several promoters to be more specific?

Gary Hudson: If we targeted telomerase we’d also kill stem cells, just like the side effects of much of conventional chemotherapy. That’s probably not a good idea. But multiple promoters, or synthetic promoters, might be used to achieve the aims of killing only cancer cells. Our initial therapeutic will likely just employ p53 promoter targeting, since we have good data that works.

Ariel Feinerman: Yeah, the same issue as when we remove or break telomerase gene: there would be nice to do this only in compromised tissue, but as researchers say it is very difficult to make the removal selective. However, it is not a problem with ALT genes, which cause 15–20% of cancers. Are you going to collaborate with OncoSENS lab? Also killing cells actively expressing telomerase will be very useful in WILT implementation.

Gary Hudson: We’ve had conversations with the SENS Foundation about OncoSENS and cooperated in a preliminary fashion, but I don’t believe it is currently a research priority for them. We already have enough projects to keep us busy for some time, too!

Ariel Feinerman: Now you use only suicide gene as an effector, do you plan to use other genes? For example to enhance the cells, give them ability to produce new enzymes, or temporarily shutdown telomerase to help anti-cancer therapy to be more effective.

Gary Hudson: We believe we can express any gene under the control of any promoter we wish to use, so the possibilities are almost endless.

Ariel Feinerman: Now we know that epigenetic changes (shift) play a huge role in ageing. Even though there is no consensus among researchers whether they are a cause or a consequence of ageing, experiments show that temporal expression of OSKM transcription factors may have some health benefits by restoring “young” epigenetic profiles. You can remember Belmonte work, for example. However, the problem in their work is that they used transgenic mice and express OSKM in every their cell. If you temporarily express OSKM in an “old” cell that is OK, you can “rejuvenate” such a cell. While if you express OSKM in a stem cell which is already biologically “young” you can force the cell into iPSC which is a way to cancer. Using your machinery we can target only cells which have “old” expression profiles, and involving normal mice! Such a work will be much “cleaner” and safer than Belmonte’s work.

Gary Hudson: With respect to your comments about reprogramming, Oisin is currently working with a university group on exactly this approach, but I can’t say more at this time. We also believe that first you have to clear existing senescent cells then you can reprogram successfully.

Ariel Feinerman: What is the biodistribution of your LNP?

Gary Hudson: Unlike small molecules, our LNP therapy will not go into every tissue in the body with the same efficiency. Typically, liver, kidney and lung (among other organs) see high transfection efficiency, while muscle and bone see less, and brain least of all (unless there is direct injection into the CNS fluid). To access some tissues will require multiple dosing.

Ariel Feinerman: Can we use your therapy for not only treating cancer but also for preventing one? If people have pre-cacenrous cells using your therapy will be very useful!

Gary Hudson: We do believe that our p53-based treatment will have beneficial effects to prevent malignancies, but we have yet to demonstrate this in vivo.

Ariel Feinerman: How much resources, finances and personnel, you need to move as quickly as possible? Have you open positions? Maybe, some of our readers have enough finances or experience.

Gary Hudson: We could effectively spend tens of millions or dollar or more, very easily, but it isn’t realistic to assume we could raise that amount — and if we did, we’d lose control of Oisin’s ageing focus, since investors would most likely want us to aim at quick returns. We are always interested in talking with “mission minded” investors, however. As for hiring, we have to do that slowly and judiciously, since labour is one of the biggest costs to a start up company and over-hiring can sink a project quickly. We already have more potential hires than we can bring on-board.

Ariel Feinerman: Now cryptocurrencies and blockchain technologies allow completely new and efficient ways for investments. We can see as various no-name companies easily rise tens of millions dollars via ICO for clearly doubtful projects. Would you like to make ICO? Oisin shows real progress and can easily rise big sums! People say that they will be glad to buy your tokens if you issue them. You have said that you prefer to work with “mission minded” investors. There are thousands people out there who can invest from $1000 to $100,000 in cryptocurrencies and who believe that radical extension of healthy life is possible!

If you are worry about legal issues, you can use various cryptocurrency investment funds who act like proxies between holders of cryptocurrencies and companies.

Gary Hudson: We have investigated several of these financing options, but we are not expert in this area, so we have been reluctant to move too quickly. But we continue to have conversations with relevant parties. There is a lot of regulatory uncertainty surrounding ICOs, however, so we must move cautiously.

Ariel Feinerman: Now we know enough about ageing to defeat our main enemy. Do you agree that first comprehensive rejuvenation panel is not a scientific problem and even not an engineering problem but a problem of engineering management?

Gary Hudson: I wouldn’t say that there is no science left to do, but as an engineer myself I naturally agree that proper engineering management and program management skills must be brought to bear on the problem of ageing.

Ariel Feinerman: One person has said, we get what we ask for. Can we now aim high and publicly claim that our main goal is not additional five years of life but LEV — Longevity Escape Velocity and finally unlimited healthy life?

Gary Hudson: This is a difficult “public relations” problem. Most investors, the scientific community and the public are not yet ready to embrace the notion of longevity escape velocity. Thus at Oisin we do pitch health span as a primary goal. But personally I don’t believe that you can obtain health span improvements without making significant progress towards LEV. So in the end, I think we get LEV by targeting health span, and we reduce the controversy by doing so.

Ariel Feinerman: Some people ask me how to buy your stocks or invest in Oisin. What can you say?

Gary Hudson: We do have a number of private investors (angel investors) who are “mission minded” or “mission focused” and we welcome discussions with qualified investors and firms who share our vision for dealing with ageing and cancer. Accredited investor candidates may contact us at info@oisinbio.com

Ariel Feinerman: David Gobel claims that “By advancing tissue engineering and regenerative medicine, we want to create a world where 90-year olds can be as healthy as 50-year olds by 2030.” And I secretly hope that 40 will become new 30 or even 20 by 2030! Can we achieve that — in principle?

Gary Hudson: I certainly hope so! In 2030 I’ll be 80, so I’m looking forward to feeling like I’m 40…

Ariel Feinerman: Thank you very much for your amazing answers! That was a real pleasure to talk with such a great man like you. I hope we all will succeed in our goal and will have hundreds, thousands, and — who knows? — maybe even millions years of healthy life!

Gary Hudson: It is kind of you to say so, but I only consider myself fortunate to be working with the really great men and women in the anti-aging community who are doing the real work. I’m only trying to facilitate their efforts and get treatments to the clinic as fast as possible. I don’t know what will be possible in the long term, but anything will be better than letting nature run its course, producing sickness and declining functional health.