The Rise of Oisin Biotechnologies

This recent interview with Gary Hudson of Oisin Biotechnologies covers a range of topics; there is a lot more to it than is quoted here. The company is working on the application of a programmable gene therapy to the targeted destruction of senescent and cancerous cells. Since the approach can be adjusted to kill cells that express significant amounts of any arbitrarily selected target protein, it can in principle be adapted to destroy other types of unwanted cell. The immune system in older individuals or patients with autoimmune diseases, for example, contains any number of problem cells that it would be beneficial to remove. As noted in the interview, destruction is only one possibility, however. Cells could be enhanced or have their behavior changed in other ways: destroying cells is the simple first exploration of a class of genetic technology that will over time grow to power a vast and diverse field of targeted cell reprogramming.

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

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.

Feinerman: Great to hear! However, when can we see some papers?

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.

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

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)" toxicity 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.

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

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 treatment to reach the public, since the regulatory environment will need to change.

Feinerman: Now you use only a 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.

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

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.

Hudson: We could effectively spend tens of millions of dollars 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.

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?

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.

Link: https://medium.com/@arielf/the-rise-of-oisin-d4664ed7e9

Comments

great interview nice to see this

Posted by: scott emptage at March 29th, 2018 7:31 AM

We can see here that the devil is in the details for startup funding and research translation. Great interview.

Posted by: Antonio at March 29th, 2018 9:33 AM

Interesting. I really hope something changes on the regulatory front soon... would hate to see something that would have general use shelved because the FDA doesn't consider aging an indication.

Posted by: Ham at March 29th, 2018 5:26 PM

@Ham, luckily, as Michael Rae has said we need not to wait when ageing will be recognised as a disease. (In fact ageing is not a desease but a complex process of damage accumulation.) Oisin can and will mark your senolytics as a therapy for specific ageing pathology like fibrosis or chronic inflammation in the same way as Unity does.

Posted by: Ariel at March 29th, 2018 6:51 PM

The mega-cap pharma companies and the FDA just have to move slowly step by step to the new paradigm of increasing healthspan for people.

To me the easiest next step is drugs/treatments that may not be directly related to a specific illness, but in clinical trials deliver significant improvements in health for people with that specific illness.

If a senolytic treatment reduces heart attacks and improves cardiac health for people with a heart disease, for purposes of approval it doesn't really make any difference how the treatment works. Most drugs I read about there is only guesses at the mechanisms of action.

In the clinic there is also trial and error with drugs of a class approved to treat the diagnosed ailment. So of 10 people with an ailment, 3 see large improvement with the drug, 3 see improvement but also get bad side effects and 4 see no improvement. So then a different drug is tried for those who the first drug didn't benefit.

Posted by: aa3 at March 30th, 2018 3:40 AM

These companies better pick their formal registrational indications very well, based on robust pre-clinical experience

This is no longer the era of FDA letting "non-inferiority" results sail through

Superiority studies are becomming the norm in some of these disease modifying indications - hence why I worry about the Unity focus in OA - very high hurdles

Oisin has a better focus in oncology as the standards in sold tumors are still so low

Posted by: David Permisov at March 30th, 2018 8:07 AM

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