Stemson is going to use minipigs in the next stage of their hair cloning research

[trialAcc]

Can you elaborate a bit more on this? You think Stemson will just have to do a quick round of safety and efficacy trials do get this approved?

On a different topic, I've been thinking and I may be missing something or something doesn't add up. Stemson recently raised $7.5M in a seed funding (which I know isn't much in biotech but it's something) but now they're trying to raise $15M for minipig studies. It makes me wonder where the $7.5M went or is going to. In an earlier interview Alexey mentioned he only needed $1M for preclinical and $3-5M to get to or to carry out clinical. Anyone know if this is normal or feel there's something fishy going on?

Different types of treatments require different levels of safety data to proceed into human trials. If they were administering a treatment directly into the human body that was intended to grow follicles in-vivo (internally), they would need significant data on the effects locally and through the rest of the body (ie liver/kidney toxicology or other upstream effects). If you're extracting cells from a human body and "treating them" in an external environment for surgical implantation, the bar will probably be a lot lower for proof of safety and efficacy because the treatment is fully localized where the new follicles are being transplanted.

Think about all the crazy types of dermatological treatments you hear about, like PRP, stem cell injections, exxons, etc. None of these things went through 10+ years of human trials prior to being used.

 

[Chads don't bald]

Yeah theoretically it shouldn't be much different than a hair transplant when it comes to safety profile

 

[trialAcc]

Yeah theoretically it shouldn't be much different than a hair transplant when it comes to safety profile

Probably somewhere in the middle, because you still have "synthetic" follicles that would be interacting with the body as if they were natural. I'd assume there would be a bar to establish that the body wouldn't reject them or they would become cancerous.

 

[eeyore]

Different types of treatments require different levels of safety data to proceed into human trials. If they were administering a treatment directly into the human body that was intended to grow follicles in-vivo (internally), they would need significant data on the effects locally and through the rest of the body (ie liver/kidney toxicology or other upstream effects). If you're extracting cells from a human body and "treating them" in an external environment for surgical implantation, the bar will probably be a lot lower for proof of safety and efficacy because the treatment is fully localized where the new follicles are being transplanted.

Think about all the crazy types of dermatological treatments you hear about, like PRP, stem cell injections, exxons, etc. None of these things went through 10+ years of human trials prior to being used.

Ah, yeah hopefully this is how it'll play out.

 

[jan_miezda]

Can you elaborate a bit more on this? You think Stemson will just have to do a quick round of safety and efficacy trials do get this approved?

On a different topic, I've been thinking and I may be missing something or something doesn't add up. Stemson recently raised $7.5M in a seed funding (which I know isn't much in biotech but it's something) but now they're trying to raise $15M for minipig studies. It makes me wonder where the $7.5M went or is going to. In an earlier interview Alexey mentioned he only needed $1M for preclinical and $3-5M to get to or to carry out clinical. Anyone know if this is normal or feel there's something fishy going on?

i think he said that before he realized they need to collaborate with another team to develop the scaffold. Remember prior to that the cloned and implanted hairs were subdermal and couldn't penetrate the skin well

 

[eeyore]

i think he said that before he realized they need to collaborate with another team to develop the scaffold. Remember prior to that the cloned and implanted hairs were subdermal and couldn't penetrate the skin well

If I remember correctly they said it's completely made from the same biodegradable material that dissolvable stitches are made of so that shouldn't give them much trouble in terms of regulations. They could probably legally implant a thousand empty scaffolds in someone right now if they wanted it.

 

[jan_miezda]

If I remember correctly they said it's completely made from the same biodegradable material that dissolvable stitches are made of so that shouldn't give them much trouble in terms of regulations. They could probably legally implant a thousand empty scaffolds in someone right now if they wanted it.

yes but they must have had to spend a lot still on r&d for that and other things they patent. Their cell process is patented as well. Unlike tsuji they chose to differentiate into Neural crest cells and they said that played a significant role in hair induction using their method. From their publication "Our results suggest that the intermediate step of hESC differentiation into the NC lineage seems is critical, skipping the NC induction results in a complete loss of hair-inducing activity"

 

[eeyore]

yes but they must have had to spend a lot still on r&d for that and other things they patent. Their cell process is patented as well. Unlike tsuji they chose to differentiate into Neural crest cells and they said that played a significant role in hair induction using their method. From their publication "Our results suggest that the intermediate step of hESC differentiation into the NC lineage seems is critical, skipping the NC induction results in a complete loss of hair-inducing activity"

Ah, you're referring to past completed objectives right? Like overall they've had to spend much more time on R&D but that's in the past since it's already been accomplished?

 

[jan_miezda]

Ah, you're referring to past completed objectives right? Like overall they've had to spend much more time on R&D but that's in the past since it's already been accomplished?

yes here https://www.businesswire.com/news/h...h-Hair-Regeneration-Therapy-to-Cure-Hair-Loss

it says a part of the money is used for studying the cell process. "The seed funding supports the preclinical development of Stemson’s Induced Pluripotent Stem Cell (iPSC) based technology, which is capable of producing the cell types required to initiate hair follicle growth." now I think they need more money to continue preclinical studies in pigs

 

[eeyore]

yes here https://www.businesswire.com/news/h...h-Hair-Regeneration-Therapy-to-Cure-Hair-Loss

it says a part of the money is used for studying the cell process. "The seed funding supports the preclinical development of Stemson’s Induced Pluripotent Stem Cell (iPSC) based technology, which is capable of producing the cell types required to initiate hair follicle growth." now I think they need more money to continue preclinical studies in pigs

Hm...that kind of makes sense but they sure blew through that $7.5M fast.

 

[jan_miezda]

Hm...that kind of makes sense but they sure blew through that $7.5M fast.

yes im really surpirsed they need 15 million for study on pigs, if everything went well on mice and they proved the concept

 

[trialAcc]

yes im really surpirsed they need 15 million for study on pigs, if everything went well on mice and they proved the concept

Most pre-clinical trials require proof of efficacy on more then just mouse models, usually on 1 larger animal as well before INDs can be pursued with the FDA/drug agencies.

 

[jan_miezda]

Most pre-clinical trials require proof of efficacy on more then just mouse models, usually on 1 larger animal as well before INDs can be pursued with the FDA/drug agencies.

yes but why the cost is so high is they already have everything figured out. now the just have to make follicle and implant into pig

 

[trialAcc]

yes but why the cost is so high is they already have everything figured out. now the just have to make follicle and implant into pig

I mean, they don't have everything figured out. They need to adapt the process for pig cells and pay the people, equipment and rent while they do it. Then they need to prove that they can figure it out on the pig.

 

[eeyore]

I wonder if success in minipigs would be enough to attract big investors who can financially support their human trials. I personally don't feel like mice and minipig would make that much of a difference.

 

[Pls_NW-1]

Wait,
I just found this thread.

Is Stemson Therapeutics really, legit?
Like, a permanent solution!?
Can't find on their website if the new follicles are modified to be insensitive to androgens...

Would love to get more infos, as it sounds to be real, and I really think these kind of multiplication procedures can be a real thing in near future (2030-2060).

 

[Chads don't bald]

Wait,
I just found this thread.

Is Stemson Therapeutics really, legit?
Like, a permanent solution!?
Can't find on their website if the new follicles are modified to be insensitive to androgens...

Would love to get more infos, as it sounds to be real, and I really think these kind of multiplication procedures can be a real thing in near future (2030-2060).

Lol I don't consider 2060 the near future. I'll be 60+ years old by then

 

[eeyore]

Fortunis posted an update today on Linkedin regarding the topics covered in the webinar: “Co-founder Geoff Hamilton will take you through their incredible journey, from vision to proof of concept to clinical trials and full commercialisation.”

exciting

Hoping they shed some light on how they plan to commercialize given all the regulatory and financial hurdles they have to overcome. Though I'm not too optimistic about Fortunis Capital's role in this considering they've only been in business for a couple years and were only able to give Stemson a measly couple million. Kind of seems like they're just trying to hype themselves up.

 

[jan_miezda]

Hoping they shed some light on how they plan to commercialize given all the regulatory and financial hurdles they have to overcome. Though I'm not too optimistic about Fortunis Capital's role in this considering they've only been in business for a couple years and were only able to give Stemson a measly couple million. Kind of seems like they're just trying to hype themselves up.

Anyway there will be less hurdles because they are targeting UK

 

[Pls_NW-1]

Wait,
I just found this thread.

Is Stemson Therapeutics really, legit?
Like, a permanent solution!?
Can't find on their website if the new follicles are modified to be insensitive to androgens...

Would love to get more infos, as it sounds to be real, and I really think these kind of multiplication procedures can be a real thing in near future (2030-2060).

Can someone answer my questions?