An Update on Oisin Biotechnologies and OncoSenX
This short interview with Gary Hudson of Oisin Biotechnologies (and more recently Turn.bio) covers some of the history and the present status of the company and its spinoff OncoSenX. Oisin Biotechnologies is one of the more ambitious senolytics companies working on means of destroying senescent cells in old tissues in order to produce rejuvenation. The company is using a programmable gene therapy approach rather than the small molecule development that the majority of other programs are undertaking.
"As we all know, the dilemma faced by any company that wishes to attack aging as a disease is that the FDA doesn't yet accept that premise, and requires biotechs to identify an indication - a specific disease - to be treated by any new investigational drug. While we can accommodate the FDA rules by picking a specific indication, the normal pressures of business will inevitably require that whatever indication is first chosen will dictate the path for the company into the far future. An aging-focused start-up will thus become a cancer or heart or kidney disease company, and lose its ability to attack the basis for most age-associated maladies. I wanted to avoid that trap at all costs."
This led to a model where Oisín is the platform company, providing the technology to use its unique DNA-plasmid and nanoparticle approach to kill cells based on their internal state. "Once the platform is proven scientifically and pre-clinically demonstrated, our plan was that Oisín would spin out specific indications or classes of indications, either via a conventional out-license to other biotechs or big pharmas, or as partially or wholly-owned subsidiary ventures. The oncology spinout, OncoSenX, is an example of this. In this way, Oisín controls the platform technology and manufactures the therapeutics to maintain quality control, while following the FDA-mandated path to clinical for new drugs. Additionally, since some investors will be more comfortable with conventional indication-focused ventures, this model opens up new avenues for funding, partnerships and collaborations with other companies, broadening the market appeal of our technology."
""We've raised over $8m to date for both Oisín and OncoSenX, and are currently in the process of raising new funding rounds. Oisín has a Series Seed round underway for up to $5m while OncoSenX is raising a Series A of up to $30m. Oisín's funding will be used for additional preclinical studies prior to an IND for an aging-related disease indication while OncoSenX's will be used for the Phase 1 and 2 oncology trials in humans." The company's next goal is to conduct a pre-clinical trial application meeting for OncoSenX to clear the path to a Phase 1 safety and efficacy trial against human solid tumors to be conducted in Canada within a year.
Link: https://www.longevity.technology/oisin-on-aging-as-a-disease-and-raising-5m-seed/
I have a question regarding the access to senolytic therapies. Let's say, because of the FDA, a company have to tell which condition they are developping senolytic for, does that mean that it will be prescription therapies just for that condition ? Will the people with no illness have access to these therapies ?
"After the evident success of our initial aged mouse study conducted between 2018 and 2019"
Have the final results of the study been published somewhere?
@Antonio: No, not as yet. We're waiting on the publication of the platform paper and the oncology paper to precede the aged mouse study paper.
@Jonathan Weaver
FDA's position on "off label"
https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label
It's up to clinicians to "judge that it is medically appropriate for their patient. "
But of course illegal to promote for those uses
@GaryH: Thanks. I will wait for it.
@GarryH
>. "After the evident success of our initial aged mouse study conducted between 2018 and 2019, we have decided to perform a much bigger study - about 5 times larger - to further demonstrate benefits of the therapy in new indications, such as frailty and cognition."
Can you share something about the bigger study? When there could be some results, is it with mice or other animals ?
@cuberat: It's a collaboration with a European lab, will focus on frailty indications, and we should have readouts in about a year. Like the prior study we are starting with 2 year old animals (mice).
@Gary,
I know this is a loaded question and one everyone wants to know, but can you provide an estimate when this treatment would available to the general public if all clinical studies work out as we all hope it would? Also, would you have an estimated guess what the earliest age you would recommend a person to use this treatment where it would impact their general health positively?
Thanks
Robert
@Robert Church: The short answer is, no. ;) The routine answer is "five to ten years". The longer answer -
The simple truth is that the availability of a treatment is a function of both funding and regulatory approval. A company has little control of both; we can easily make it worse but rarely can speed up either process. So, really, no idea.
As for when one might start taking a generic senolytic, it will be a trade-off between side effects and benefits. We accumulate senescent cells throughout our lives but it appears the rate increases as we age. Only speculating, perhaps occasional treatments a few years apart starting at about age 35-40 and then more frequently as one ages might be a strategy, but we are flying blind. Not enough data.
You know the old joke about aging research? A scientist announces they have found the cure to aging but muses "It'll take forever to test..."