Advaxis--a Company with 2 Prostate Cancer Vaccine Candidates

[NPfisherman]

Greetings FPC members,

The plot thickens as I present Advaxis, a company with 2 PCa vaccine candidates. The company uses attenuated Listeria monocytogenes, a bacteria, which they utilize to introduce tumor activating antigens (TAA's) to the immune system. This is referred to as their Lm technology or platform--see below:

advaxis.com/lm-technology

The first vaccine candidate of interest is ADXS-PSA. The vaccine is being looked at in monotherapy as well as in combination with the CPI, Keytruda for MCRPC. Recently, results were released regarding the KEYNOTE-046 TRIAL-Phase2. and are listed below:

ascopubs.org/doi/abs/10.120...

ir.advaxis.com/news-release...

What makes this particularly interesting is: 1) it increased median survival time in patients with visceral mets, 2) Resulted in stable disease in almost 3/4 of patients, 3) Was useful with Keytruda in patients that were MSI (Micro Satellite Instability) Negative. ISN'T KEYTRUDA SUPPOSED TO WORK ONLY ON MSI HIGH PATIENTS??? (There may be a subset of MSS patients that Keytruda works on, but it is estimated to be small). There is not a Phase 3 trial announced yet or on NCI.

The second candidate of Advaxis is ADSX-504, a part of their HOT program. The HOT program is focused on hotspot mutations-common mutations that drive tumor genes to grow . Using their Lm technology , they seek to develop an "off the shelf" vaccine which does not require genetic testing. The goal being to introduce 30 or so TAA (tumor activating antigens) to present to the immune system. Clearly, the benefit of this would be that this could be administered in the office when diagnosed as a way to begin the fight against PCa. Some info:

advaxis.com/news-releases/n...

pipelinereview.com/index.ph...

This vaccine will likely be focused post BCR with a goal similar to the RV001 vaccine of initiating an immune response that lasts. I imagine the trial will be announced 1st quarter of 2021.

I hope you are enjoying this information so far. The Science is Coming and it gives us HOPE !!! There is more to come....

Don Pescado

[GreenStreet]

Thanks again. Another very promising set of developments.

[NPfisherman in reply to GreenStreet]

Appreciate your reply...the only one.... either this information is over everyone's head or no one cares. I am done writing for a while....

[keepinon in reply to NPfisherman]

I CARE! I love the information you present. I am in a position now where I don't need these new vaccines, but I am pretty sure I will in the future. I hope by that time, some of these new developments become available.Your time and investigations are much appreciated!

[NPfisherman in reply to keepinon]

Thanks for your reply, but I post "stuff" to provide information AND generate discussions...The generate discussions has been seriously lacking.... I went back and rewrote the initial post breaking it down to 3 posts with appreciation from few. I do not need the vaccines currently either, but good to know they are there. I think I am done....

[GreenStreet in reply to NPfisherman]

Please do continue. I really appreciate your knowledge. I think you are on to something. I am just a “lay person’ and struggle with the complexity of this stuff but I think it is the future. Thanks for all the time and effort you put in.

[NPfisherman in reply to GreenStreet]

In the future....posting...I have posted essentially 3/4 of the last 20 posts....someone else has thoughts and should share.....that is what makes a forum better IMHO...

[TheTopBanana in reply to NPfisherman]

Please continue! I check every day to see if you have written something new.

[NPfisherman in reply to TheTopBanana]

I think you will have to wait a bit....replying not posting for now...

[GreenStreet in reply to GreenStreet]

Forgot to mention I took a mini punt on their stock yesterday after your article. I hope they succeed but not for the money!

[NPfisherman in reply to GreenStreet]

I am watching it as well....I may grab a small piece as price fluctuates...

[Survivor1965]

I thought it was very interesting and very encouraging. I don’t post a lot but read most posts. There are so many talented people here that my replies would be almost trivial. I was told I would fail lupron/xtandi within 2 years, that was 47 months ago. This info you bring could very well be my next trial.

Thank you!

[NPfisherman in reply to Survivor1965]

You're welcome...I think there are several vaccine trials worth doing, but it seems they are focused on patients in the watchful waiting/ surveillance mode or MCRPC. Since I am neither, it kind of makes a trial unavailable. Congratulations on 47 months and still going....some never fail drugs like Xtandi or Zytiga...no one knows why... BTW, no one's replies are trivial... sharing thoughts is what makes a forum stronger....thanks for your reply....

Fish

[Survivor1965 in reply to NPfisherman]

Good morning NP,

I think MCRPC means "metastatic castrate resistant prostate cancer"?

I think Im in that same designation. Question, if you're in that designation why are you not eligible for a trial? I thought to be CR was the worst place to be and consequently the exact person for a trial? This stuff really confuses me.

Many thanks, Johnny

[NPfisherman in reply to Survivor1965]

Hi Johnny,

It seems that most studies are focused on MCRPC--you were correct--metastatic castrate resistant prostate cancer--why?? Because MCRPC is the progressive/ advanced form of cancer and the concern is the limited number of treatments available, the surveillance/watchful waiting group is focused on preventing recurrence so it is also viewed as important to keep people from having metastatic prostate cancer. I am in the group MHSPC--metastatic hormone sensitive prostate cancer--still sensitive to lupron, etc... This group tends to get approved for drugs later after MCRPC approvals--ie: Zytiga. Xtandi--approved for MCRPC first. My group has less clinical trials because they are less at risk of progression/ death and yet too far along to prevent recurrence. There are trials for oligometastatic patients like me that are focused on my subgroup--RAVENS trial being one of my favorites--SBRT plus Xofigo for micrometastasis... The good news is that there are some great new drugs in the pipeline--Phase 2 or further. I am encouraged and hopeful....

Fish the NP

[Survivor1965 in reply to NPfisherman]

Thannk you. The CR part still confuses me. My Onc Mayo clinic tells me Im CR since like 2017 and yet I am responding well to X and L. If I was CR wouldn't I be failing on these meds?

Thanks in advance. Curious, what is the NP in fish lol?

[NPfisherman in reply to Survivor1965]

Not necessarily....why some meds work and for how long is still a mystery...reviewed your profile and you were on Lupron and Zytiga and then switched to Xtandi....you have been through the gauntlet...started at 46.....dang....You are considered CR since your PSA started going up on AR targeted drugs...I saw you had chemo as well....well, I could be or could want to be a Northern Pacific Fisherman (NPFisherman) or a Nurse Practitioner that likes to fish.....hmmm... I'll leave the crowd wondering...

Fish

[Survivor1965 in reply to NPfisherman]

Thank you sir! Lets go with Northern Pacific lol

One last clarification, what is AR targeted?

Many thanks. Incidentally, our favorite meal is swordfish

[NPfisherman in reply to Survivor1965]

AR targeted meaning androgen receptor inhibitors / antagonists...these are Zytiga, Xtandi, Erleada, etc.... You were on Zytiga before Xtandi according to your profile. Did you have chemo in between..?? Sometimes chemo will resensitize PCa to AR inhibitors again after they fail....You are hanging tough, amigo.... I like Swordfish, but partial to Salmon, Mahi, Trout, and Cod...

All the best,

Fish

[Survivor1965 in reply to NPfisherman]

Discovered Gleason 9 in 2011, University of MN put me on a trial, did hormone injections in stomach along with docetaxel for 6 months then RP. Recurrence after 9 months elevated psa. Swithed to Mayo, Kwon. More chemo and Zytiga. Recurrence again and cryo, more chemo (total of 21) jevtana with carboplatin this time, and a switch to Xtandi. Been on Lupron since like 2014.

So ya, lots of chemo. Unbelievably, undetectable psa and this is after having mets in frontal bone, femur, ribs, and infected lymphs. And non active lesions to date.

They keep telling me at Mayo I will eventually fail ADT and then its on to trials, or LU177, hopefully approved in US in time.

Other than that pretty boring

Love trout, salmon, mahi, all of it but love that swordfish, its like a white steak

Best, Johnny

[NPfisherman in reply to Survivor1965]

You are in good hands with Kwon. Some people put him down for the videos of "cures" in PCa, but I disagree with that attitude. It gives people hope, and we all need that at times. The Science is Coming and faster than people realize !!! Congratulations on where you are at currently. Long may it last !!

Fish