FDA Fast Track Designation for 225Ac-... - Advanced Prostate...

Advanced Prostate Cancer

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FDA Fast Track Designation for 225Ac-FL-020 for mCRPCa

Maxone73 profile image
42 Replies

Another weapon, from Germany this time....ahhhh zee germanz! Actinium strikes again!

Phase 1 trial will start soon it seems.

morningstar.com/news/pr-new...

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Maxone73 profile image
Maxone73
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42 Replies
JohnInTheMiddle profile image
JohnInTheMiddle

Iz it vunderful? 🙄

Maxone73 profile image
Maxone73 in reply toJohnInTheMiddle

zeemz so :-P

JohnInTheMiddle profile image
JohnInTheMiddle in reply toMaxone73

I suppose it's churlish of me to mention that the original use of the term "Wunderwaffe" was great propaganda but also a big waste of money ☹️. Not to mention other stuff too . . .

KocoPr profile image
KocoPr

This is more great nees!

morningstar.com/news/pr-new...

225Ac-FL-020 employs targeted alpha-radiotherapy designed to selectively attack cancer cells, reducing the damage to healthy tissues. In preclinical models, radiolabeled FL-020 displayed a very promising in vivo biodistribution profile, with high and sustained tumor uptake and fast systemic clearance. 225Ac-FL-020 exhibited robust anti-tumor activity in LNCaP xenograft mice, with a favorable safety profile. The Phase I clinical trial will evaluate the safety, tolerability, and anti-tumor activity of 225Ac-FL-020. In May 2024, Full-Life received clearance of its Investigational New Drug (IND) Application from the FDA for clinical trials of 225Ac-FL-020.

About 225Ac-FL-020

225Ac-FL-020 is a novel, potential best-in-class, next-generation PSMA-targeting radionuclide drug conjugate (RDC) that entered global Ph1 clinical studies in 2024. Its targeting vector, FL-020, was discovered using Full-Life's proprietary UniRDC™ platform, which enables significant improvement of drug uptake in the tumor while maintaining fast systemic clearance. In pre-clinical models, 225Ac-FL-020 has demonstrated potent anti-tumor activity and a favorable safety profile.

JohnInTheMiddle profile image
JohnInTheMiddle in reply toKocoPr

My big question here relates to to the big picture.

At the beginning almost prostate cancer circumstances, I understand that most PCa cells have PSMA receptors? But not all cells?

And therefore does it really matter to do this pretty exciting and elegant new therapy? Because evolution's a b***ch.

I can imagine that one buys time. But one will be left with newly evolved cancer? If you can't get them all, then why bother? I suppose it would be worth it if the regeneration of cancerous masses took years.

(By the way, wasn't it Alpha radiation from Polonium that killed that Russian guy some years ago - the difference being of course that the Polonium wasn't rapidly pushed out of the system.)

Maxone73 profile image
Maxone73 in reply toJohnInTheMiddle

I am afraid the difference was that it's a different element (Actinium) and a different quantity. I am coming to the conclusion that the only way is multiple targets at once or almost. If we can be left with the less aggressive kind of cells, then we can really have years without progression as our own immune system would slow it down. A definitive solution (unless you are in that lucky number that lives for 30 years metastatic) I think can only come from genetic manipulation (CRISPR and company). But I am ok if they get me to have a complete response and have it "frozen" for 5 years for now. Remember the plan: 5 + 5 + 30 :-)

JohnInTheMiddle profile image
JohnInTheMiddle in reply toMaxone73

5 years is a beautiful thing! I'd go for five years! And then as you say, by then there's something else for another 5 years . . . 😃

Maxone73 profile image
Maxone73 in reply toJohnInTheMiddle

with the progress we are making, I am really convinced that within 10 years the disease will be gone or completely manageable

JohnInTheMiddle profile image
JohnInTheMiddle in reply toMaxone73

Max I really appreciate your research on this! It's a beautiful thing and for everybody who reads your comments!

If I recall you are younger than I am and even newly married or something?

The participants in this forum are both fighting cancer and fighting discouragement. And your comments help with the second! Which then gives us more energy to help fight the first!

And my sense is that this current discussion is about real progress and learning about the progress of science and medicine. It's real reportage. Bravissimo!

Maxone73 profile image
Maxone73 in reply toJohnInTheMiddle

Lately I have been restarting to study genetic algorithms because I want to apply them to molecules research, the only thing stopping me is the "ghost" of the amount of stress I had while doing my PhD, it's like I want to do a lot but I don't want the (normal) stress associated with it, same on business side. I am 51, married on last November (3 months after the diagnosis) and thank God I was in perfect shape and I was able to do the triplet therapy! But honestly, it's just that I am doing this research to fight my own discouragement, and I just thought it could help others as well and started posting my findings.

KocoPr profile image
KocoPr in reply toMaxone73

Wasn’t the stress related to pass/fail ?

It’s all pass now brother!

Maxone73 profile image
Maxone73 in reply toKocoPr

Stress was due to my bad engineering habit of splitting the hair into 4, then again into 4 and again and again.... You know "the more I know the more I realize there is a lot more to know"? add to that the obsession common to all PhD students (at least in scientific subjects) that you have to come out with something so original! That was me...

JohnInTheMiddle profile image
JohnInTheMiddle in reply toMaxone73

It's not limited to PhD students 😂

KocoPr profile image
KocoPr in reply toJohnInTheMiddle

If the cancer tumors have PMSA and some non PMSA won’t they still be killed do to proximity? Death by collateral damage?

JohnInTheMiddle profile image
JohnInTheMiddle in reply toKocoPr

Good question.

KocoPr profile image
KocoPr in reply toJohnInTheMiddle

There are still stem cells we have to worry about but that would be preferable by having the tumor start over. Then zap them again.

Maxone73 profile image
Maxone73 in reply toKocoPr

I would say other non PSMA cells would be killed by proximity (together with a hopefully small amount of healthy cells). Stem cells ok, there is someone working on them already, now I do not remember what paper I have read about it. What would really make me smile would be someone saying "It's not that toxic and it's repeatable!" with triplet therapy I have already put on the ground adt, arsi and chemo...and with my atm mutation...let's say I am in a hurry even if at the moment I am fine.

gsun profile image
gsun in reply toKocoPr

Not necessarily. The beauty of Alpha transmitters is the lack of collateral damage as compared to Beta transmitters.

KocoPr profile image
KocoPr in reply togsun

Yes i agree, but i think the damage would encompass the whole tumor including any cancer cell types like neuroendocrine, cancer stem cells, non PMSA cancer cells all within the tumor

gsun profile image
gsun in reply toKocoPr

Nope. It only reacts to PSMA emitting cancer cells and it has a kill zone of only a few cells. Like maybe three. And if it killed neuro endocrine cancer it would be a miracle for patients now it’s not

KocoPr profile image
KocoPr in reply togsun

Thanks for the clarification!

Amazing only apprx 3 cells wide.

Would you happen to know about how much reach the beta radiation is?

gsun profile image
gsun in reply toKocoPr

No but it’s a lot more.

KocoPr profile image
KocoPr

I am also confident we are close. There are plenty of new trials one could try to get into if running out of options like FDA Fast-Track Designation for SYNC-T SV-102 for the Treatment of Metastatic Castrate-Resistant Prostate Cancer (mCRPC) recently posted.

Scout4answers profile image
Scout4answers

Bring it on! I am in the camp of "if we can live for 5 years there will be something that we can use for continual remission and eventually a cure"

inthefight profile image
inthefight in reply toScout4answers

Diddo.

spencoid2 profile image
spencoid2

where are the trials starting?

Maxone73 profile image
Maxone73 in reply tospencoid2

"The company plans to begin clinical studies in the U.S. and globally in 2024." Being a german company I suppose they will start with Germany, but they have been very generic on their website.

CAMPSOUPS profile image
CAMPSOUPS in reply toMaxone73

Generic. They should be genomic.

Sorry couldn't resist. Good thread here. Good heads up from you again.

I'm just not to intellectual today. Reduced to a vegetative smart ass lol.

Maxone73 profile image
Maxone73 in reply toCAMPSOUPS

What’s going on?

CAMPSOUPS profile image
CAMPSOUPS in reply toMaxone73

Ah its ok no worries. Sorry hope I didnt cause concern but thanks for asking.

I dont know. Its raining (drizzle not a exciting storm) and my wife and I had a verbal scuffle earlier.

So I am acting like a child, like I'm hurt and totally avoiding her for the time being. It did depress me though. Life will go on. Just a piece of of it here in my world that many here probably experience. Love my wife like nothing else btw but hey. So many years together. Sometimes enough is enough when it comes to so many years of the same criticism. I am who I am. Things happen.

My attempt at humor was probably me coming back to earth again coming out of the doldrums lol.

Maxone73 profile image
Maxone73 in reply toCAMPSOUPS

Well after 20 years together, I have developed some selective hearing and she did the same. We rarely let the pressure build up too much, better to talk when you feel like it, even through jokes. To me it makes it easier to express but also to receive criticism.

Oh now I am going to post some research that…you will see

CAMPSOUPS profile image
CAMPSOUPS in reply toMaxone73

Oh yea. I know about selective hearing (48 years we've been together). Also selective keep my mouth shut and be agreeable lol.

Got me waiting with baited breath for that research. Thanks again.

SViking profile image
SViking

I was told there is also a clinical trial at City Of Hope for Actinium. They mentioned is that there is still that likelihood of cooking the saliva glands and tear ducts. Anything new with 225Ac-FL-020?

Maxone73 profile image
Maxone73 in reply toSViking

Not enough info yet, but they will have to disclose something if they want to get the $$$ for the trials

Cenerus profile image
Cenerus

Alpha emitters like Actinium and Astinine are both exciting to me. Alpha particles which are basically a helium nucleus composed of 2 protons amd 2 neutrons are humongous compared to Beta particles which are made of a single high speed electron or positron. It’s like hurling 4 bowling balls at the cancer cell DNA instead of a 22 cal bullet. It’s very difficult for a radiation resistant cell to survive Alpha particle damage whereas it’s easier to repair the damage caused by a Beta particle. This is because the Aloha particle has the mass energy needed to sever both strands of a DNA molecule. Beta particles don’t usually have that amount of energy. They tend to just severe one of the 2 strands. This makes it possible for repair proteins to fix the damage. Not so with Alpha particles. They are the cannon balls of radiation therapy.

JohnInTheMiddle profile image
JohnInTheMiddle in reply toCenerus

C, you said "alpha particles are like cannon balls". But earlier you said "alpha particles are like bowling balls". So - which is it?! 🤪

Survivor1965 profile image
Survivor1965

So like a Plucicta but more powerful and effective?

Maxone73 profile image
Maxone73 in reply toSurvivor1965

More powerful but also more focused from what I know, which means less "collateral damages"

spencoid2 profile image
spencoid2

I think there were some trials with actinium that showed a higher chance of saliva gland damage including permanent damage than pluvicto. I do not know what ligand was used and how it compares to the one listed here.

Is this the ligand FL-020 and is it more PSMA specific than previous ones?

i am probably going to be put back on pluvicto and would like to know if this could be an alternate and worth waiting for. Will ask oncologist on the 9th

j-o-h-n profile image
j-o-h-n

Just a reminder to all of us.................... Humor is better than a Doomer....

Good Luck, Good Health and Good Humor.

j-o-h-n

lcfcpolo profile image
lcfcpolo

Thank you Maxone and everyone else who has posted here. Upon diagnosis 4 years ago everything pointed to Actinium. I still feel the same. J591 is also in the same stable.

mdiaz76 profile image
mdiaz76

I’m wondering how this would play in terms of sequencing after chemo/hormone/arpi/radium/pluvicto?

My husband is at City of Hope looking to start Pluvicto in next few weeks so I’d like to ask his MO where they’re at with Actinum 225

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