GDF11, Elevian News Story - NYTimes

Perhaps commercially worthless…but for us, as longevity hacks, the actual novelty of anything they are doing IS possibly extremely valuable. Imagine a few injections from plasma fractions to extend longevity? BRING IT ON

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My impression was that Dr. Katcher and company felt they needed the patent before they could bring it on.

Of course, there are exceptions concerning the patent-pending ploy.
What I am referring to is the implications of “More’s Law” that technology and knowledge are expanding at an exponential rate.
I am glad you are enjoying the fruits of your labors. Most engineers have signed an agreement with the company they work for that all inventions discovered while employed by the company belong to the company.
I worked for various companies over many years and assure you, the no patent, or patent pending ploy is used to rush a technical product to market. It doesn’t really matter that much today as foreign companies mainly ignore US patents.
If a product has a limited market, patents work very well, especially for products that have a limited market. A case in point is a little company in Boulder City, Nevada that produces relatively simple, high-precision devices, that are bought mainly by the U.S. government and national labs.
Their simplest product is essentially a resistor, designed for high voltage pulse applications. Basically, it was a “garage” company and still isn’t that much bigger, but they are still doing well over half of a century later.
Sorry folks if TMI.
https://barthelectronics.com/

Bottom line: Whatever they patent or produce, we will soon after be able to buy from China or India

Steve Perry (who’s titled himself “patient 0” for GDF11) is visibly overweight. It never occurred to me that this could be a side effect.

My friend Mark who experiments with practically everything and follows all kinds of biomarkers says that he believes it increases adipocyte proliferation.

Standard playbook. You file and go, you cannot wait for the patent to grant to launch your business venture. But if it’s based on IP, it better be damn super tight or it will be fleeting/useless.

Needing and being being granted, night and day.

Wouldn’t a plasma derivative be considered a natural product which can’t be patented?

This ploy is for unscrupulous marketers. Any serious competitor pays no attention. I’ve called out some competitors to the FTC, they quickly changed their marketing literature.

Yes, engineers enrich the owners, that was my past life. So I quit and started my own company with my own IP. That risk/reward thing.

Yes and no, it’s a matter of what coverage you seek for your patent in what global jurisdictions, and the enforcement in the respective markets. If your market is the US (my business model), awesome legal protection and enforcement, but if you want to go big in say Indonesia (big market, lax enforcement), much more risky.

I tagged you up thread…your thoughts? Karcher talks about using pigs and other farm animals?

Same guy who is using peptides too? Where did he source this, and your thoughts?

“This ploy is for unscrupulous marketers”.
This may be true, but I can tell you major league corporations do this with minor products their engineers discover. Saves money and often works.

Yeah, same guy. I have no idea where he sources it. Seems to be able to get anything.

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It’s a method patent…speaks volumes about the strategy of trying to get protection to your point. But yes, would be likely impossible to patent something that already exists biologically. This is the pharma game…add one tiny tweak to an existing molecule (usually also results in a huge change in pharmacology) and it becomes “novel” and patentable.

Patents are all about “novelty and prior art”: is something already known AND/OR could someone skilled in the art, combine A + B to get to the same place as you. Both of these will get your patent tossed by the examiner and cause you to narrow scope or abandon outright.

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Yes, but it didn’t stop major companies from trying to patent your genes. :sweat_smile:

Additional GDF11 information that may be of interest:

Changing The Licensing, Manufacturing Paradigms Within The Regulatory Framework

Dr. Allen says Harvard was originally planning on licensing its GDF11-associated assets to distinct companies that would engage separate and specific neurodegenerative, musculoskeletal, metabolic, and cardiovascular diseases, following the standard, “siloed” approach most often seen in academic/biotech partnerships. In keeping with his “let’s address aging, rather than its disease-specific symptoms” philosophy, he convinced the team to change that paradigm from the outset. “All of the work that we do on manufacturing and safety is synergistic to multiple different applications of the molecule,” he explains. “Of course, we still have to go through the same regulatory processes for each individual disease we treat, because there’s no regulatory process for aging. If there were, it would take years to develop, akin to AFAR’s TAME trial to study the impact of treating aging by preventing the rate of age-related disease onset – a six-year study requiring 3,000 patients. That ends up being a super long study with thousands of patients because to prevent diseases, you need to wait until the onset of the diseases, which could take years for each patient.”

Instead of initially targeting disease prevention, Dr. Allen and company spent the bulk of its first three years exploring which of dozens of potential age-related diseases might offer the fastest path to market. “Our North star, ultimately, is to get to market with a therapy that prevents multiple age-related diseases,” says Dr. Allen, but he realizes that’s not a pragmatic approach given the regulatory structure. “To move toward that goal, we identified the most devastating age-related diseases that we could treat for the shortest possible duration to see clinically meaningful effects in an unmet need where there’s no good alternative treatment,” he says.

The vascular system was the obvious answer. “The most prominent effects of GDF11 happen in the vasculature, where we see improvement in a very short duration of treatment,” says Dr. Allen. Put simply, the protein regenerates blood vessels. “In our group, Lee Rubin has focused on the effects of the protein in the vasculature of the brain. The vasculature of the brain deteriorates with age. When scientists stain and image brain vasculature, it resembles a large spider’s web in a young brain, but only a few chicken scratches in the elderly brain. When we introduce GDF11 in old animals, their brains look young again, with a higher quantity of vasculature, improved blood flow, and decreased inflammation.” The result, he says, is an increase in nutrient delivery, more efficient expulsion of waste, and release of trophic and healing factors. “When we look at diseases and related trauma having to do with the vasculature, such as heart attack and stroke, we see significant improvement in recovery of cardiac and brain function resulting from the introduction of GDF11.”

Source:

and:

GDF11 protein found to inactivate triple-negative breast cancer cells

Researchers detail a possible way to re-engage a tumour suppressor protein, that has been found to be inactivated in triple-negative breast cancer cells…

On the strength of these preclinical results, Elevian is gearing up to enter human clinical trials with GDF11 for the treatment of stroke.

“We really got the green light to go into humans based upon the animal data that we got there,” Allen said, adding that there is still a lot of work to be done before they reach this phase. “We still have to scale up production of the drug and we have to do extensive safety and toxicology tests – IND-enabling studies. The longest pole in the tent is figuring out how to make manufacturing costs effective. The cost of goods is going to be really, really high. So we’re doing a lot of work in process development right now, and then we’re going to hand it off to a manufacturing partner to scale up. We’re about two years from initiating our human clinical trial in stroke.”

Another unmet need where Elevian believes GDF11 can have an impact is Type 2 diabetes, a disorder whose pathology is also intricately connected to the circulatory system – and often to aging.

Along with blood clotting factors, glucose resides within the inside lining of blood vessels. In Type 2 diabetics, the lining of an individual’s blood vessels begins to become glycosylated, which causes them to narrow, impeding blood flow. Glucose tolerance is known to decrease with age.

In a study published in March 2020, Wagers and her colleagues stated that GDF11 was shown to “significantly improve glucose tolerance in aged mice” and increase glucose homeostasis, under a variety of dietary conditions.

Some negative stories - the first in the MIT tech review magazine:

As a general rule, mouse models are usually pretty bad predictors of efficacy because they typically don’t accurately represent the disease. This is especially true when using a progeroid mouse model. We know that progeria isn’t true age acceleration - so this is probably not a very meaningful failure.

It’s a method patent…speaks volumes about the strategy of trying to get protection to your point. But yes, would be likely impossible to patent something that already exists biologically. This is the pharma game…add one tiny tweak to an existing molecule (usually also results in a huge change in pharmacology) and it becomes “novel” and patentable.

Patents are all about “novelty and prior art”: is something already known AND/OR could someone skilled in the art, combine A + B to get to the same place as you. Both of these will get your patent tossed by the examiner and cause you to narrow scope or abandon outright.

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So, MAC, Desert Shores or anyone with knowledge in this area, is the publishing of this patent application going to help them get E5 out there, or could they have saved themselves the trouble?

Means nothing really…it just an IP marker for their commercial business model. If anything, it should expedite, now that this is out of the way.

They have some huge hurdles yet…actually expanding and replicating in a larger trial (there were some issues and lesser results than expected), and for other labs to replicate that this actually works. And then human trials (other intermediate cross donor/recipient species in between?) that show it works and dosen’t kill people with non human plasma fractions. A myriad of commercial, operational, and regulatory issues. Don’t hold your breath. I wish them much funding and success, this pathway has huge scientific underpinnings for rejuvenation.

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I think E5 , and its rather modest life extension results , leads us to question 2 things.

  1. E5 caused a dramatic decrease in epigenetic aging. This did not translate to actual, real, life extension. Does this tell us something about the value of epigenetic testing?

  2. Will this now set back the entire young/ old blood movement?

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