Update on Prostate Cancer Vaccines that I follow... another year is gone...

[NPfisherman]

Greetings FPC forum,

It has been another year... and I would love to have better news... there is a new vaccine candidate to monitor, but the reality is that the system takes time... The system needs a revision in my opinion, but I digress...

As I reviewed the last time, the vaccine trial for RhoVac's RV-001, known as onilcamotide, failed in Phase IIb...

Next, I posted on Advaxis, a company with 2 PCa vaccine candidates-- ADXS-PSA and ADXS-504 ( a neoantigen vaccine-off the shelf).:

At this point, ADXS-PSA has not yet announced a Phase III trial, despite positive phase II results with Keytruda... ( more than 2 years waiting)There is an announcement of the expansion of Phase I trial results for ADXS-504 as below:

targetedonc.com/view/study-...

I think that an off the shelf vaccine sequenced properly with other therapies might have a real show stopping effect on PCa.

Next, my post on the 2 vaccine brothers being done at University of Wisconsin:

ttps://healthunlocked.com/fight-prostate-cancer/posts/145167876/vaccine-candidates-of-interest-ptvg-hp-dna-vaccine-and-ptvg-ar-dna-vaccine-brothers-with-different-targets

and the trial itself:

clinicaltrials.gov/study/NC...

The estimated primary completion date is December 2023.

OVM-200. This has been posted on by our own Brysonal, trial participant, on this forum:

healthunlocked.com/fight-pr...

The trial:

clinicaltrials.gov/study/NC...

The new kid on the block--UV1, a peptide based vaccine that targets a universal cancer antigen telomerase... .

precisionvaccinations.com/v...

and the clinical trial:

clinicaltrials.gov/study/NC...

I thought I saw positive clinical results out in a news flash, but can't find it...Here is some other info on UV1 in prostate cancer:

onlinelibrary.wiley.com/doi...

Treatment alternatives continue to evolve as The Science is Coming !!

Don Pescado

[Sunlight12]

Thanks for all the updated info, Fish! It's nice to see you posting again!

-Sun🌞

[Cooolone]

Thanks for Posting! Always great to keep up with things

[Maxone73]

ns-healthcare.com/news/dxvx...

oxfordvacmedix.com/licensin...

latest news!

[NPfisherman in reply to Maxone73]

Hey Max,

That is excellent news.... we'll see how fast they move... lot faster than US... see below:

linkedin.com/pulse/china-gr...

Could we see this vaccine approved in China in 5 years??...maybe

Fish

[Maxone73 in reply to NPfisherman]

Yes in China I must say they are moving faster than ever, so I am quite positive that this option will be available soon! 😀

[MoonRocket in reply to Maxone73]

Treatment naive population is a problem in the Western Hemisphere where clinical trials have been conducted for many decades. The oversight is an issue in places like China..it may take longer for any drugs coming out of China and India to get approved in other countries.

[NPfisherman in reply to MoonRocket]

See my comment below--prove the concept in China, start a revenue stream in China plus travelers, and play the game while making money...

[NPfisherman in reply to Maxone73]

But here is the deal... Big Pharma takes it to China for two reasons--time and cost, the regulatory process is faster, and the total cost for drug development is less--see article below:

communities.springernature....

Now, that was 2012, but even if the price doubled for Total Drug Development cost of 11 million then, that is still much cheaper than the 50 million dollar Phase 3 here...

Prove the concept in China, start a revenue stream plus--hmmm.. will people go to China for it..???

Big Pharma has all the cards, my friend...

[MoonRocket in reply to NPfisherman]

Just curious, how does any drug getting thru the 3 stages of clinical trials and approved in 5 years, even in China?

[NPfisherman in reply to MoonRocket]

OVM-200 wouldn't have to get through all 3.... they could take initial phase 1 data, and move to Phase2...regulatory takes 1/2 the time... and in drugs where there is a real need, they can speed up approval

[MoonRocket in reply to NPfisherman]

I'm not convinced.

[NPfisherman in reply to MoonRocket]

mercatus.org/economic-insig...

from the article:

In 2018, the average drug approval took just over three years. Drugs that received priority status, meaning they meet an unfulfilled medical need, took an astonishingly short 16 months for approval. In comparison, the FDA takes an average of 12 years to approve a new pharmaceutical compound.

[Maxone73 in reply to NPfisherman]

I have a good friend in research field in Taiwan, he told me to wait till the naming of cancers will be changed to the genetic of the cancer instead of the starting organ and you will see an exponential increase in testing and speed (he did not mean only in China in this case) as there will be parallel trials instead of sequential.

[NPfisherman in reply to Maxone73]

The reality is that as we have discussed... The Science is Coming !!! Genetic defects can be potentially overcome by CRISPR... making the disease less aggressive... or resolving some diseases... my version of cancer tested out as no germline, and only something not associated with prostate cancer for the somatic... so how did I get here??..

Look for trials with combos to increase significantly...

[Maxone73 in reply to NPfisherman]

Oh another CRISPR fan?

[MoonRocket in reply to NPfisherman]

Did you read that article? It explicitly said the following: "The most notable factor behind the record approval times seems to be the substantial increase in personnel over those years....."

Reading further..

", China was in the fortunate position of being able to piggyback on other countries’ pharmaceutical testing and clinical experience. It remains to be seen whether the CFDA’s approval times will continue on a downward trend after that low-hanging fruit has been harvested. "

Another source of uncertainty is the performance of clinical trials at facilities that have not been inspected by the government. While it speeds up the approval process, it’s not yet clear that the procedure comes without safety concerns.

[Maxone73 in reply to MoonRocket]

Correct, they will have to find a common ground otherwise there will be problems, but from what I know they are already working in that direction

[MoonRocket in reply to Maxone73]

Let's be honest l, as open as China is, it's still a black box regulatory wise. Until full transparency is provided, I'd be very cautious of drugs coming from China. There's a whole lot of big pharma conspiracy thought on this site, if true, pales to the corruption in China...As Ronald Reagan famously said, "trust but verify". I'm not sure we'll get to the verify part anytime soon. Besides...no one even brings up who will be sued when something goes wrong? Good luck suing a Chinese company....just my HO.

[NPfisherman in reply to MoonRocket]

You mean....you want me to actually read what I put out??

Mother of Pearl.... such a thought...

[MoonRocket in reply to NPfisherman]

It would be nice. You reference an article that I assumed supported you proposition but actually provided arguments that past performance should not be expected and laid out why. Hey, if you want to travel to China to get their drugs before getting approved by the FDA or some other regulatory body, have at it.